<?xml version='1.0'  encoding='UTF-8' standalone='yes'?><?xml-stylesheet href='http://feeds.ochre-media.com/css/rss.css' type='text/css'?><rss version='2.0'><channel><title>pharmatech Pressreleases</title><link>http://www.pharmaceutical-tech.com/</link><description>Pressreleases for the pharmatech community.</description><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><lastBuildDate>Fri, 30 Jan 2009 13:02:57 GMT</lastBuildDate><generator>Ochre Media RSS Generator 2.00</generator><language>en-us</language><image><link>http://www.pharmaceutical-tech.com/</link><title>Ochre Media Limited</title><url>http://www.ochre-media.com/images/ochremedia.gif</url></image><div class='info' xmlns='http://www.w3.org/1999/xhtml'>This is formatted XML site feed. It is intended to be viewed in an RSS or Atom Newsreader or syndicated to another site.<br /></div><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=589</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=589</guid><title>Astellas Proposes to Acquire CV Therapeutics for $16 per Share in Cash</title><description>&lt;P&gt;Tokyo, Japan, January 27, 2009&amp;nbsp;-- Astellas Pharma Inc. (&#8220;Astellas&#8221;) today announced that it has submitted a proposal to the Board of Directors of CV Therapeutics, Inc. (Nasdaq: CVTX) to acquire all outstanding common shares of CV Therapeutics for $16.00 per share in cash. The proposal represents a 41% premium to the closing share price of CV Therapeutics on January 26, 2009, and a 69% premium to CV Therapeutics&#8217; 60-day average closing price. The proposal is not subject to any financing condition and represents a total equity value of $1.0 billion on a fully diluted basis.&lt;/P&gt;
&lt;P&gt;This proposal was previously submitted to the Board of Directors of CV Therapeutics in a letter dated November 14, 2008 and Astellas was informed on November 21, 2008 that the CV Therapeutics Board had rejected the proposal. CV Therapeutics has subsequently declined to engage Astellas in any meaningful discussions regarding a transaction.&lt;/P&gt;
&lt;P&gt;&#8220;We are disappointed that the CV Therapeutics Board of Directors has rejected outright what we believe is a very compelling all-cash proposal that would deliver stockholders significant immediate value that we believe far exceeds what CV Therapeutics can achieve as a standalone company,&#8221; said Masafumi Nogimori, president and CEO of Astellas. &#8220;CV Therapeutics&#8217; product portfolio, including its angina treatment agent Ranexa&#174;, would complement Astellas&#8217; US based hospital and cardiology business, and our established infrastructure and proven track record in drug development and commercialization provide an ideal platform to increase the value inherent in CV Therapeutics.&lt;/P&gt;
&lt;P&gt;&#8220;We are surprised that the CV Therapeutics Board has refused to engage us in meaningful discussions about our proposal; however, we remain committed to working cooperatively with CV Therapeutics to reach a mutually agreeable transaction should the Board reconsider our proposal and decide to engage us in discussions promptly.&#8221;&lt;/P&gt;
&lt;P&gt;Included below is the full text of the letter sent to the CV Therapeutics Board of Directors earlier today:&lt;/P&gt;
&lt;P&gt;January 27, 2009&lt;/P&gt;
&lt;P&gt;CV Therapeutics, Inc.&lt;BR&gt;The Board of Directors&lt;BR&gt;c/o Dr. Louis G. Lange, Chairman of the Board &amp;amp; CEO&lt;BR&gt;3172 Porter Drive&lt;BR&gt;Palo Alto, CA 94303&lt;/P&gt;
&lt;P&gt;Gentlemen:&lt;/P&gt;
&lt;P&gt;I am writing to express our disappointment that you have rejected Astellas&#8217; proposal of November 14, 2008, to acquire CV Therapeutics, Inc. for $16.00 per share in cash, and that you have subsequently refused numerous requests &#8211; made both directly and through our advisors since then, and as recently as January 13, 2009 &#8211; to engage in substantive discussions about a combination that would deliver substantial and immediate value to your stockholders.&lt;/P&gt;
&lt;P&gt;We remain enthusiastic and committed to a transaction with CV Therapeutics, and we continue to believe our proposal provides your stockholders with significant immediate value that we believe far exceeds the value CV Therapeutics could reasonably expect to achieve as a standalone company in the foreseeable future.&lt;/P&gt;
&lt;P&gt;We believe our proposal takes into full account the future potential of CV Therapeutics &#8211; with no execution risk to your stockholders. Our offer represents a 41% premium to CV Therapeutics&#8217; share price as of January 26, 2009, and a 69% premium to its 60-day average price.&lt;/P&gt;
&lt;P&gt;Astellas has built a productive partnership with CV Therapeutics around Lexiscan over several years, and we have watched and helped the company grow during this time. We are enthusiastic about Ranexa, but we believe it will be a significant challenge for CV Therapeutics to deliver the full value of Ranexa to your stockholders given CV Therapeutics&#8217; limited commercial presence and the difficult macro environment. We believe Astellas is better positioned to maximize the value of CV Therapeutics, and Ranexa in particular, by leveraging Astellas&#8217; infrastructure and marketing expertise.&lt;/P&gt;
&lt;P&gt;I want to emphasize that our proposal is not subject to any financing condition, and we expect the transaction would receive regulatory approvals in a timely manner. While we have conducted a substantial amount of due diligence to date, our proposal remains subject to confirmatory due diligence, execution of definitive agreements and the satisfaction of customary conditions to be set forth in such agreements.&lt;/P&gt;
&lt;P&gt;For over the past year we have attempted to discuss a possible acquisition transaction with CV Therapeutics that would maximize the value of CV Therapeutics for your stockholders. Our desire continues to be to work together with the CV Therapeutics Board of Directors to reach a mutually beneficial transaction but we have been very disappointed that you have refused to engage us in such discussions.&lt;/P&gt;
&lt;P&gt;We remain prepared to meet immediately with you and your advisors to discuss our proposal. We believe that we could conclude our due diligence review and execute a definitive agreement in approximately three to four weeks. We have retained Lazard as our financial advisor and Morrison &amp;amp; Foerster as our legal advisor.&lt;/P&gt;
&lt;P&gt;We are very enthusiastic about the prospects for a combination between CV Therapeutics and Astellas. We hope you will reconsider our proposal and we look forward to your prompt response. Yours sincerely,&lt;/P&gt;
&lt;P&gt;Masafumi Nogimori&lt;BR&gt;President and CEO&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Astellas&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Astellas Pharma Inc., with global headquarters in Tokyo and US headquarters in Deerfield, Illinois, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&amp;amp;D and marketing capabilities and continuing to grow in the world pharmaceutical market.&lt;/P&gt;
&lt;P&gt;Astellas was formed by the historical merger of Japan's third and fifth largest pharmaceutical companies - Yamanouchi, founded in 1923, and Fujisawa, founded in 1894. Today, Astellas is one of the largest pharmaceutical companies in Japan with a market capitalization of approximately $17.7 billion as of January 26, 2009, and, for the fiscal year ended March 31, 2008, net income of approximately $1.8 billion.&lt;/P&gt;
&lt;P&gt;The company has approximately 14,000 employees worldwide. This includes 7,500 in Japan, 3,300 in Europe, 2,200 in North America and 1,000 in Asia. Some of Astellas&#8217; core products in the US are: Lexiscan&#174; (regadenoson) and Adenoscan&#174; (adenosine injection), pharmacologic stress agents indicated for radionuclide myocardial perfusion imaging/scintigraphy (MPI/S) in patients unable to undergo adequate exercise stress; Prograf&#174; (tacrolimus), an immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving organ transplants; and VESIcare&#174; (solifenacin succinate), indicated for the treatment of overactive bladder with symptoms of urgency, frequency, and urge incontinence. Astellas is publicly traded on the Tokyo Stock Exchange. For more information about Astellas Pharma Inc., please visit www.astellas.com. For more information about Astellas Pharma US, Inc., please visit http://www.us.astellas.com/. For further information regarding Astellas&#8217; offer for CV Therapeutics, please visit www.cvtxvalue.com. This press release is neither an offer to purchase nor a solicitation of an offer to sell securities of CV Therapeutics. Subject to future developments, additional documents regarding a transaction with CV Therapeutics may be filed with the Securities and Exchange Commission (the &#8220;Commission&#8221;) and, if and when available, would be accessible for free at the Commission&#8217;s website at http://www.sec.gov. Investors and security holders are urged to read such disclosure documents, if and when they become available, because they will contain important information.&lt;/P&gt;
&lt;P&gt;Astellas is not currently engaged in a solicitation of proxies or consents from the stockholders of CV Therapeutics. However, in connection with Astellas&#8217; proposal to acquire CV Therapeutics, certain directors and officers of Astellas may participate in meetings or discussions with CV Therapeutics stockholders. Astellas does not believe that any of these persons is a &#8220;participant&#8221; as defined in Schedule 14A promulgated under the Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), in the solicitation of proxies or consents, or that Schedule 14A requires the disclosure of certain information concerning any of them. If in the future Astellas does engage in a solicitation of proxies or consents from the stockholders of CV Therapeutics in connection with its proposal to acquire CV Therapeutics, Astellas will amend the information provided above to disclose the information concerning participants in that solicitation required by Rule 14a-12 under the Exchange Act.&lt;/P&gt;
&lt;P&gt;No assurance can be given that the proposed transaction described herein will be consummated by Astellas, or completed on the terms proposed or any particular schedule, that the proposed transaction will not incur delays in obtaining the regulatory, board or stockholder approvals required for a transaction, or that Astellas will realize the anticipated benefits of any proposed transaction.&lt;/P&gt;
&lt;P&gt;Any information regarding CV Therapeutics contained herein has been taken from, or is based upon, publicly available information. Although Astellas does not have any information that would indicate that any information contained herein is inaccurate or incomplete, Astellas does not undertake any responsibility for the accuracy or completeness of such information.&lt;/P&gt;
&lt;P&gt;Astellas does not undertake, and specifically disclaims, any obligation or responsibility to update or amend any of the information above.&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=590</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=590</guid><title>Gen-Probe and Novartis Agree to Extend and Expand Blood Screening Collaboration</title><description>&lt;P&gt;-&lt;STRONG&gt; Companies Will Work Together to Protect World's Supply of Donated Blood from Infectious Diseases Until 2025&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;- Partners Anticipate Continued Expansion into New Global Markets and Development of Innovative New Products, Including Next-Generation PANTHER Instrument&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;- Companies Also Plan Exploratory Collaboration in Pharmacogenomics&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;- Gen-Probe Provides Preliminary 2009 Financial Guidance Including Additional Revenue and Profit from Agreement&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;SAN DIEGO, Jan. 27&amp;nbsp;-- Gen-Probe (Nasdaq: GPRO) announced today that it has agreed to extend and expand its blood screening collaboration with Chiron, a Novartis (NYSE: NVS) business, ensuring the companies will work together to develop and commercialize molecular technologies that safeguard the world's donated blood supply until the year 2025.&lt;/P&gt;
&lt;P&gt;&quot;Extending and expanding our agreement with Novartis enables us to continue providing innovative nucleic acid tests that protect the world's blood supply from dangerous pathogens, while benefiting from our partner's extensive global commercial presence,&quot; said Hank Nordhoff, Gen-Probe's chairman and chief executive officer. &quot;At the same time, it enables us to deliver significant additional economic value to our shareholders while minimizing financial and operational risk and potential disruption to an outstanding business.&quot;&lt;/P&gt;
&lt;P&gt;Since 1998, Gen-Probe and Novartis have developed, manufactured and commercialized nucleic acid tests and instrumentation that have been used by blood banks to screen more than 125 million blood donations in the United States alone. These tests have intercepted thousands of units of blood that were infected with HIV-1, hepatitis C and B, and West Nile virus, thereby preventing life-threatening diseases from being passed along to transfusion recipients.&lt;/P&gt;
&lt;P&gt;&quot;Together these two companies have discovered and developed innovative solutions for the screening and prevention of infectious diseases to help protect the nation's blood supply,&quot; said William F. Moore, senior vice president, biomedical services operations, American Red Cross. &quot;We are pleased to see this successful collaboration continue to focus on innovations and reinvestment in technology that will help keep the blood supply as safe as possible.&quot;&lt;/P&gt;
&lt;P&gt;Unlike standard serological testing, nucleic acid testing (NAT) detects viral RNA and DNA during earlier stages of infection, shortening the window period from infection to detection. Scientific models estimate that NAT reduces the infectious window period of HIV-1, HCV and HBV from 35% to 91%, compared with standard serological methods.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About the Revised Agreement&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The collaboration between Gen-Probe and Novartis was established in 1998, and was scheduled to expire in 2013. Under the original terms of the agreement, the companies shared revenue from the sale of blood screening assays. Gen-Probe was responsible for manufacturing costs, while Novartis was responsible for commercial expenses. The companies shared research and development (R&amp;amp;D) costs.&lt;/P&gt;
&lt;P&gt;Under the revised agreement, Gen-Probe will continue to be primarily responsible for R&amp;amp;D and manufacturing. Novartis will remain responsible for sales and marketing of the products, but will collaborate more closely with Gen-Probe on sales, marketing and distribution strategies. In addition to sharing R&amp;amp;D costs, the companies will share manufacturing expenses. Gen-Probe also will receive a percentage of end-user revenue that escalates gradually from 2009 until 2015, and remains constant thereafter.&lt;/P&gt;
&lt;P&gt;As part of the expanded agreement, Novartis has agreed to help fund development of Gen-Probe's PANTHER instrument, a fully automated molecular testing platform, for the blood screening market. The companies also have agreed to evaluate, using Gen-Probe's technologies, the development of companion diagnostics for current or future Novartis medicines.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Gen-Probe Preliminary 2009 Financial Guidance&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Gen-Probe expects the new agreement to add to the Company's revenue and profits in 2009 and future years. Accordingly, Gen-Probe's preliminary expectation is that its total revenues in 2009 will range from $460 to $490 million, and that its earnings per share will range from $1.80 to $2.05. These preliminary ranges incorporate foreign exchange rate fluctuations approximately 10% higher or lower than recent levels, and do not yet include potential revenue from the new PROCLEIX ULTRIO assay in the United States.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Gen-Probe&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,000 people. For more information, go to http://www.gen-probe.com.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Caution Regarding Forward-Looking Statements&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading &quot;Gen-Probe Preliminary 2009 Financial Guidance,&quot; are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning the future financial effects of the new agreement, new products, future sales or profits, potential regulatory approvals, and customer adoption are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of these risks, uncertainties and assumptions include but are not limited to: (i) the risk that the revised collaboration will not be maintained, (ii) the risk that new blood screening products will not be cleared for marketing in the timeframes we expect, if at all, (iii) the possibility that new markets for the sale of our blood screening products may not develop as expected, (iv) we may not be able to compete effectively with other companies currently selling blood screening products or which launch such products in the future, (v) we depend on a small number of contract manufacturers and single source suppliers of raw materials, (vi) changes in third-party reimbursement policies regarding our products could adversely affect their sales, (vii) changes in government regulation affecting our products could harm our sales and increase our development costs, and (viii) litigation involving the assertion of third party patent rights could be expensive and divert management's attention, and/or result in damages or injunctive relief. The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual reports on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Contact:&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Michael Watts&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Sr. director, investor relations and&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; corporate communications&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; 858-410-8673&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=588</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=588</guid><title>Pfizer to Acquire Wyeth, Creating the World s Premier Biopharmaceutical Company</title><description>&lt;P&gt;&lt;STRONG&gt;Diversification, Flexibility and Scale Position New Company for Success in Dynamic Global Health Care Environment&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Establishes Leadership in Human, Animal, and Consumer Health, including Primary and Specialty Care; in Vaccines, Biologics and Small Molecules; and Across Developed and Emerging Markets&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Unique and Flexible Business Model Features Focus and Agility of Smaller Enterprises Backed by Resources and Scale of Global Company&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Combination Strengthens Platform for Improved, Consistent, and Stable Earnings Growth and Sustainable Shareholder Value&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;New Company Will Promote Health and Wellness and Respond More Effectively to Unmet Needs of Patients, Physicians, and Customers Around the World&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;NEW YORK &amp;amp; MADISON, N.J--Pfizer (NYSE: PFE ) and Wyeth (NYSE: WYE ) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Wyeth in a cash-and-stock transaction currently valued at $50.19 per share, or a total of approximately $68 billion. The Boards of Directors of both companies have approved the combination.&lt;/P&gt;
&lt;P&gt;&lt;BR&gt;The combined company will create one of the most diversified companies in the global health care industry. Operating through patient-centric businesses that match the speed and agility of small, focused enterprises with the benefits of a global organization&#8217;s scale and resources, the company will respond more quickly and effectively to meet changing health care needs. The combined company will have product offerings in numerous growing therapeutic areas, a strong product pipeline, leading scientific and manufacturing capabilities, and a premier global footprint in health care.&lt;/P&gt;
&lt;P&gt;With its broad and diversified global product portfolio and reduced dependence on small molecules, the new company will be positioned for improved, consistent, and stable top-line and EPS growth and sustainable shareholder value in the short and long term. It is expected that no drug will account for more than 10 percent of the combined company&#8217;s revenue in 2012.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Financial Highlights&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Under the terms of the transaction, each outstanding share of Wyeth common stock will be converted into the right to receive $33 in cash and 0.985 of a share of Pfizer common stock, subject to the terms of the merger agreement. Based on the closing price of Pfizer stock as of January 23, 2009, the stock component is valued at $17.19 per share. The transaction provides immediate value to Wyeth shareholders through the cash component, as well as continued participation in the future prospects expected to result from the combination through their ownership of approximately 16 percent of Pfizer&#8217;s shares.&lt;/P&gt;
&lt;P&gt;The deal is expected to be accretive to Pfizer&#8217;s adjusted diluted earnings per share in the second full year after closing(1). The transaction is anticipated to yield cost savings of approximately $4 billion to be fully realized by the third year after closing. Savings are expected in selling, informational and administrative functions, research and development, and manufacturing.&lt;/P&gt;
&lt;P&gt;The transaction will be financed through a combination of cash, debt and stock. A consortium of banks has provided commitments for a total of $22.5 billion in debt.&lt;/P&gt;
&lt;P&gt;In connection with the proposed transaction between Pfizer and Wyeth, the Board of Directors of Pfizer has determined that, effective with the dividend to be paid in the second quarter of 2009, it will reduce Pfizer&#8217;s quarterly dividend per share to $0.16, which continues to be competitive with other industry participants. Pfizer believes the transaction offers significant opportunities to enhance long-term shareholder value.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Strategic Overview&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Jeffrey B. Kindler, Chairman and Chief Executive Officer of Pfizer, said: &#8220;The combination of Pfizer and Wyeth provides a powerful opportunity to transform our industry. It will produce the world&#8217;s premier biopharmaceutical company whose distinct blend of diversification, flexibility, and scale positions it for success in a dynamic global health care environment. The new company will be an industry leader in human, animal and consumer health. With our combined biopharmaceuticals business, it will lead in primary and specialty care as well as in small and large molecules. Its geographic presence in most of the world&#8217;s developed and developing countries will be unrivaled.&#8221;&lt;/P&gt;
&lt;P&gt;Bernard Poussot, Chairman, President and Chief Executive Officer of Wyeth, said, &#8220;Wyeth&#8217;s commitment to scientific innovation has enabled us to build a diversified biopharmaceutical company with leadership in attractive growth areas such as vaccines, nutritionals and biologics. For example, Wyeth developed Prevnar, the first pneumococcal vaccine for infants. In addition, because we were early to see the potential of biotechnology to create life-changing medicines, we now have a strong franchise which includes Enbrel, the number one biotechnology product in the world. With our business focused on prevention and wellness, Wyeth is well positioned in today&#8217;s rapidly changing health care environment. Our employees should be enormously proud of what we have built and confident that combining with Pfizer will accelerate our pursuit of innovative new medicines to meet critical unmet patient needs. Wyeth and Pfizer are highly complementary businesses, and together we can build the best diversified health care company in the world. We believe we can better execute our strategy and can accomplish far more together in the years ahead than either company could have achieved on its own.&#8221;&lt;/P&gt;
&lt;P&gt;Mr. Kindler continued, &#8220;With this combination, Pfizer will offer patients around the world a uniquely broad and diversified portfolio of biopharmaceutical innovations through business units--each one focused on different customer needs and backed by the resources of a premier global organization. By combining the spirit of small, agile enterprises with our combined scale, Pfizer will advance its mission of working together toward a healthier world.&#8221;&lt;/P&gt;
&lt;P&gt;Over the last two years, Pfizer has become a leaner, more disciplined, and far stronger company that is now capable of &#8211; and has demonstrated &#8211; superior and consistent execution of its strategies and commitments. As separately announced today, for example, Pfizer achieved its 2008 objectives despite the challenging economy, including meeting or exceeding its financial guidance and cost-reduction target.&lt;/P&gt;
&lt;P&gt;With this essential foundation established, the combination with Wyeth meaningfully advances in a single transaction each of the strategic priorities that Pfizer has identified and pursued over the last two years, including:&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Enhancing the in-line and pipeline patent-protected portfolio in key &#8220;Invest to Win&#8221; disease areas, such as Alzheimer&#8217;s disease, inflammation, oncology, pain and psychosis;&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Becoming a top-tier player in biotherapeutics and vaccines;&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Accelerating growth in emerging markets;&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Creating new opportunities for established products;&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Investing in complementary businesses; and&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; * Creating a lower, more flexible cost base. &lt;/P&gt;
&lt;P&gt;Mr. Kindler added, &#8220;Over the last several years, Wyeth&#8217;s leadership and its employees have done an outstanding job creating a strong, diversified biopharmaceutical company. The people, products, and technologies that Wyeth brings to the new company will enhance our scientific capabilities and drive further commercial innovation to improve the health of the patients we serve. The compelling combination of Pfizer and Wyeth allows us to advance our newly strengthened organization to the next level by harnessing the talents of the best people from both companies. This will enable us to accelerate significantly our progress along &#8216;Our Path Forward&#8217; as we pursue our mission of applying innovative science to improve world health.&#8221;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Global Biopharmaceutical Leadership and Business Diversification&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The combination of Pfizer and Wyeth will create the world&#8217;s premier biopharmaceutical company with a broad range of therapeutic solutions for many health challenges and preventive care.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;For Patients Today &#8211; A Broad Portfolio of Health Care Solutions and Treatments&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The combined company will offer customers and patients a broad range of products for every stage of life--with top tier portfolios in key therapeutic areas such as cardiovascular, oncology, women&#8217;s health, central nervous system, and infectious disease and a diverse product portfolio that includes 17 products with more than $1 billion each in annual revenue. Pfizer will be the second largest specialty care provider, with products including the world&#8217;s leading biologic, Enbrel; Prevnar, the world&#8217;s largest-selling vaccine; Sutent for cancer; Geodon for schizophrenia; and Zyvox for infection. The transaction also builds upon Pfizer&#8217;s position as a global leader in animal health, with strong product lines in attractive segments, for companion animals, biologics and anti-infectives.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;For Patients Tomorrow &#8211; A Diverse Range of Technology and Research Platforms&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The new company will have more resources to invest in research and development than any other biopharmaceutical company and access to all leading scientific technology platforms, including vaccines, small and large molecules, nutritionals and consumer products.&lt;/P&gt;
&lt;P&gt;The combination also brings together a robust pipeline of biopharmaceutical research and development projects, including programs in diabetes, inflammation/immunology, oncology and pain, as well as significant opportunities in Wyeth&#8217;s Alzheimer&#8217;s disease pipeline, which has a number of compounds in development, including phase three biotech compound Bapineuzumab. These will be added to the exciting agents currently in early and later stage development at Pfizer for Alzheimer&#8217;s disease, illustrating the breadth and depth the new company will be able to use in targeting the diseases that most affect patients.&lt;/P&gt;
&lt;P&gt;The new company will have an enhanced ability to innovate, operating as focused business units tailored to patients and other customers. Each business unit will oversee product development from clinical trials to commercialization. This approach will allow for rapid decision-making and a more efficient use of resources and, as a result, will enhance the company&#8217;s ability to invest in long-term opportunities. The combination will also provide additional high quality and high volume manufacturing capabilities, including Wyeth&#8217;s Grange Castle, Ireland facility, the largest integrated biotechnology manufacturing facility in the world.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;For Patients Everywhere &#8211; A Strong Global Presence&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Geographically, the combination will enhance Pfizer&#8217;s and Wyeth&#8217;s compelling portfolios in important growth areas. Based on IMS data, the combined company will be number one in terms of biopharmaceutical revenues in the United States with an approximately 12% market share; in Europe with an approximately 10% share; in Asia (ex-Japan) with an approximately 7% share; in Japan with a 6% share; and in Latin America with a 6% share.&lt;/P&gt;
&lt;P&gt;Pfizer and Wyeth&#8217;s combined presence will be significant in high-growth emerging markets, such as Latin America, the Middle East and China, where Wyeth has an impressive presence in infant nutritionals and Pfizer is a recognized leader in pharmaceuticals. This enhanced geographic position will further strengthen the combined company&#8217;s business, provide increased exposure to high-growth, less-developed and under-penetrated markets, and provide compelling opportunities for expense savings.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Conditions&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The proposed transaction is subject to customary closing conditions, including approval by the stockholders of Wyeth and notification and clearance under certain antitrust statutes. In addition, the proposed transaction is subject to Pfizer&#8217;s financing sources not declining to provide the financing due to a material adverse change with respect to Pfizer or Pfizer failing to maintain credit ratings of A2/A long-term stable/stable and A1/P1 short term affirmed. There are no other financing conditions to closing in the merger agreement. Pfizer and Wyeth expect the transaction to close at the end of the third quarter or during the fourth quarter 2009.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Advisors&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Pfizer&#8217;s lead financial advisors are Bank of America Merrill Lynch, Goldman Sachs and J.P. Morgan. Barclays and Citigroup are acting as financial advisors. Its legal advisor is Cadwalader, Wickersham &amp;amp; Taft LLP. Wyeth&#8217;s financial advisors are Morgan Stanley and Evercore Partners and its legal advisor is Simpson Thacher &amp;amp; Bartlett LLP. In addition, Wachtell, Lipton, Rosen &amp;amp; Katz served as counsel to Wyeth&#8217;s Board of Directors.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Conference Call/Webcast&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Pfizer and Wyeth will be conducting an analyst and investor conference call/webcast Monday January 26, 2009 at 8:30am to discuss its proposed combination. The webcast can be accessed on the investor relations sections of the two companies&#8217; websites, www.pfizer.com and www.wyeth.com. You can also listen to the conference call by dialing either (866) 331-6338 in the United States or (347) 284-6938 outside of the United States. The password is &#8220;Pfizer&#8221;.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Press Conference&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Pfizer and Wyeth will be holding a press conference with senior executives from both companies Monday, January 26 at 10:00am at Pfizer&#8217;s corporate headquarters located at 235 East 42nd Street, N.Y., N.Y.&lt;/P&gt;
&lt;P&gt;Video Interview with CEOs Jeff Kindler and Bernard Poussot&lt;/P&gt;
&lt;P&gt;A video interview with Jeff Kindler and Bernard Poussot is available for viewing at www.premierbiopharma.com, a website set up for information about the combination.&lt;/P&gt;
&lt;P&gt;For Broadcast Media&lt;/P&gt;
&lt;P&gt;Broadcast media may download a broadcast-quality version of the video interview at http://w3.cantos.com/09/pfizer_wyeth/. This link is not for viewing but exclusively designed for broadcast download.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;ABOUT PFIZER&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Pfizer Inc, founded in 1849, is dedicated to better health and greater access to health care for people and their valued animals. Every day, approximately 81,900 colleagues in more than 150 countries work to discover, develop, manufacture and deliver quality, safe and effective prescription medicines to patients.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;ABOUT WYETH&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Wyeth is one of the world&#8217;s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company&#8217;s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.&lt;/P&gt;
&lt;P&gt;(1) &quot;Adjusted income&quot; and its components and &quot;adjusted diluted earnings per share (EPS)&quot; are defined as reported net income and its components and reported diluted EPS excluding purchase-accounting adjustments, acquisition-related costs, discontinued operations and certain significant items. The adjusted income and its components and adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Forward Looking Statements&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;This Press Release includes &#8220;forward-looking statements&#8221; within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Pfizer and Wyeth, including future financial and operating results, the combined company&#8217;s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Pfizer&#8217;s and Wyeth's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.&lt;/P&gt;
&lt;P&gt;The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the proposed merger of Pfizer and Wyeth will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the ability to obtain governmental and self-regulatory organization approvals of the merger on the proposed terms and schedule; the failure of Wyeth stockholders to approve the merger; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; the possibility that the merger does not close, including, but not limited to, due to the failure to satisfy the closing conditions; Pfizer&#8217;s and Wyeth&#8217;s ability to accurately predict future market conditions; dependence on the effectiveness of Pfizer&#8217;s and Wyeth&#8217;s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Pfizer&#8217;s 2007 Annual Report on Form 10-K, Wyeth&#8217;s 2007 Annual Report on Form 10-K and each company&#8217;s other filings with the Securities and Exchange Commission (the &#8220;SEC&#8221;) available at the SEC&#8217;s Internet site (http://www.sec.gov).&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Additional Information&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;In connection with the proposed merger, Pfizer will file with the SEC a Registration Statement on Form S-4 that will include a proxy statement of Wyeth that also constitutes a prospectus of Pfizer. Wyeth will mail the proxy statement/prospectus to its stockholders. Pfizer and Wyeth urge investors and security holders to read the proxy statement/prospectus regarding the proposed merger when it becomes available because it will contain important information. You may obtain copies of all documents filed with the SEC regarding this transaction, free of charge, at the SEC&#8217;s website (www.sec.gov). You may also obtain these documents, free of charge, from Pfizer&#8217;s website, www.pfizer.com, under the tab &#8220;Investors&#8221; and then under the tab &#8220;SEC Filings&#8221;. You may also obtain these documents, free of charge, from Wyeth&#8217;s website, www.wyeth.com, under the heading &#8220;Investor Relations&#8221; and then under the tab &#8220;Financial Reports/SEC Filings&#8221;.&lt;/P&gt;
&lt;P&gt;Pfizer, Wyeth and their respective directors, executive officers and certain other members of management and employees may be soliciting proxies from Wyeth stockholders in favor of the merger. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the Wyeth stockholders in connection with the proposed merger will be set forth in the proxy statement/prospectus when it is filed with the SEC. You can find information about Pfizer&#8217;s executive officers and directors in its definitive proxy statement filed with the SEC on March 14, 2008. You can find information about Wyeth&#8217;s executive officers and directors in its definitive proxy statement filed with the SEC on March 14, 2008. You can obtain free copies of these documents from Pfizer and Wyeth using the contact information above.&lt;BR&gt;&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=586</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=586</guid><title>Celestial Biologicals collaborates with GE Healthcare to set up India&#8217;s first fully integrated chromatography-based plasma fractionation facility</title><description>&lt;P&gt;&lt;STRONG&gt;Major boost to patients with blood/immune disorders or severe blood loss &lt;BR&gt;India could save foreign exchange equivalent of US$ 15 million through local manufacturing of plasma products &lt;BR&gt;Investment of US$ 20 million to US$ 24 million to be spread over next two years &lt;BR&gt;GE Healthcare to provide its leading purification technologies, processes and support&amp;nbsp;&lt;BR&gt;&lt;/STRONG&gt;&amp;nbsp;&lt;/P&gt;
&lt;P&gt;Ahmedabad/Bangalore, January 22, 2009 &#8211; Celestial Biologicals Limited (CBL), an associated company of Intas Biopharmaceuticals Limited, and GE Healthcare, the US$17 billion healthcare business of General Electric Company (NYSE: GE), announced today a collaboration to set up India&#8217;s first Good Manufacturing Practice (GMP) compliant Plasma Fractionation facility in Ahmedabad.&amp;nbsp;&amp;nbsp; The facility will be first of its kind in India. The collaboration will include appropriate technology, products, processes and project development for establishing the Plasma Fractionation facility.&amp;nbsp; The model being developed in India is replicable in other developing economies dependent on imported plasma products today. A Memorandum of Understanding was signed between Celestial Biologicals and GE Healthcare at the Vibrant Gujarat Global Investors Summit 2009. The facility will be fully functional by early 2010.&lt;/P&gt;
&lt;P&gt;Human plasma, a liquid component of blood, is the source of many life-saving proteins. A large number of these proteins can be isolated and used in medicine. The process of extracting and purifying these proteins is known as plasma fractionation. Fractionated proteins are used in the prevention, management and treatment of life threatening conditions caused by trauma, congenital deficiencies, immunologic disorders, infections, Hemophilia-A &amp;amp; B, Von-Willebrnd&#8221;s disease, etc.&lt;/P&gt;
&lt;P&gt;The market demand for blood products is dynamic and, currently, plasma products are imported from other countries.&amp;nbsp; It is estimated that 1 million liters of plasma is required annually in India to meet current clinical demands. Hence, local manufacture is the key to providing plasma products at affordable prices to Indian patients. Local manufacturing also helps reduce delays due to import procedures, transport facilities and helps save precious foreign exchange for the country. As per various reports, India collects over 7 million units of blood every year, but 60% of the blood plasma collected goes to waste because there is no facility available in India for fractionation. The plasma fractionation facility will also help optimize rational use of blood resources and usher in an era of component therapy.&amp;nbsp; Component therapy is a process of transfusing only essential components of blood instead of whole blood for treatment. The balance of components could then be used for other needy patients, bringing in optimization.&lt;/P&gt;
&lt;P&gt;GE Healthcare was chosen as the preferred partner for the project for its technological expertise and the Company&#8217;s platform solution: &#8220;With a comprehensive life sciences facility such as the CBL, a diverse range of solutions and process support are required. GE Healthcare demonstrated an attractive proposition because, as a key healthcare and life sciences infrastructure provider, they presented a holistic approach to cater for multiple aspects of CBL projects seamlessly,&#8221; said Dr. Urmish Chudgar, Managing Director, Intas Biopharmaceuticals Limited.&lt;/P&gt;
&lt;P&gt;Dr. Chudgar added, &#8220;The facility gains national importance as it will help us, as a nation, to be self-reliant in life saving proteins extracted from blood plasma. Apart from uplifting the overall transfusion medicine in India, the fractionation facility will lead to develop new plasma products from Indian plasma and help to become a major hub in the SAARC region&#8221;.&lt;/P&gt;
&lt;P&gt;Under this collaboration, CBL and GE Healthcare will jointly set up a pilot Plasma Fractionation facility of approximately 15,000 liters to 40,000 liters capacity for at least four products at CBL&#8217;s existing GMP-compliant facility.&amp;nbsp; The companies will plan scale-up of the Plasma Fractionation facility to 300,000 liters capacity simultaneously. Celestial Biologicals will also explore the possibility of utilizing the facility for the purpose of contract fractionation.&amp;nbsp; Celestial Biologicals is the first company to undertake organized collection of plasma, which is key to the plasma fractionation process. It will also explore the possibility of utilizing the facility for the purpose of contract fractionation.&amp;nbsp; &lt;/P&gt;
&lt;P&gt;Both companies will work together in the area of developing the desired technology for plasma fractionation thereby enabling the companies to leverage their respective strengths in the areas of biotechnology and transfusion medicine and research. The joint plan of action is to successfully execute the implementation of well-established chromatography technology for processing plasma (recovered and source plasma) and recover high yields of purified products on scales of up to 300,000 liters annually. The laboratory facilities have already been set up along with plans to include dedicated collection, testing and storage facilities for Plasma as well as other ancillary utilities.&#8221; &lt;/P&gt;
&lt;P&gt;GE Healthcare is a global leader in enabling technologies for biopharma. The state-of-the-art Plasma Fractionation unit with CBL will use chromatography technology that is now in widespread use across the globe to produce a new range of biologics. These chromatographic processes give final products that meet the highest purity requirements specified by US and EU Pharmacopeia.&amp;nbsp; &lt;/P&gt;
&lt;P&gt;&amp;nbsp;&#8220;The robustness of the overall GE Healthcare plasma purification process makes it very well suited to Indian conditions,&#8221; said Anurag Gupta, Managing Director, Life Sciences, GE Healthcare. &#8220;This is in line with our vision of &#8216;Early Health&#8217; for India and we will continuously endeavor to bring in affordable solutions to fill in the technology gap in the region.&#8221; &lt;/P&gt;
&lt;P&gt;&amp;nbsp;Celestial Biologicals is investing US$20 million to US$24 million to develop the Plasma Fractionation unit over the next two years. GE Healthcare will provide its leading purifying technologies, processes and support to set up the Plasma Fractionation facility. Celestial Biologicals has a contractual arrangement with South Korea based plasma fractionators for fractionation of plasma to fulfill the increasing demand for plasma products in India. The company will continue to rely on contract fractionation till its own facility starts operating.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Celestial Biologicals Limited: &lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;The Company is involved in plasma sourcing, contractual fractionation and marketing of plasma-derived products such as human Albumin, Immunoglobulin and Factor VIII. The Company has undertaken a societal need-based project and is sourcing plasma from various blood banks of India.&amp;nbsp; It has obtained necessary regulatory permission and approval from the government. Company has acquired land in the Pharmaceutical belt around 22 kms. from Ahmedabad for the proposed Plasma Fractionation plant. &lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About GE Healthcare:&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest. &lt;/P&gt;
&lt;P&gt;&amp;nbsp;GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new &quot;early health&quot; model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention.&amp;nbsp; Headquartered in the United Kingdom, GE Healthcare is a US$17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;STRONG&gt;For Further Information, Please Contact: &lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;GE Healthcare&lt;/P&gt;
&lt;P&gt;Conor McKechnie&lt;/P&gt;
&lt;P&gt;+44 1494 498 276&lt;/P&gt;
&lt;P&gt;conor.mckechnie@ge.com&lt;/P&gt;
&lt;P&gt;&amp;nbsp;College Hill&lt;/P&gt;
&lt;P&gt;Lorna Cuddon, Rebecca Walker &lt;/P&gt;
&lt;P&gt;+44 (0)20 7457 2020&lt;/P&gt;
&lt;P&gt;ge-bioprocess@collegehill.com&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;India Blood Plasma Facts: &lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;There is a serious mismatch between demand and availability of blood in India &#8211; against an 8.5 million units/year requirement, only 4.4 million units/year are available (National AIDS Control Organization). It calls for more voluntary collection as well as optimized usage.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;/P&gt;
&lt;P&gt;There are about 2500 approved blood banks in India. (Central Drugs Standard Control Organization, DGHS, Govt. of India.).&amp;nbsp; In India, the bulk demand for the plasma components is met through imports. Plasma and Plasma derivatives are not accessible to the economically poor patients due to high costs. Hemophiliacs need to take Anti Hemophilic factor (AHF) at periodic intervals, lifelong, depending on the severity of the condition. Thus the bulk portion of existing demand is met through import of plasma products on estimated foreign exchange amounting to US$ 15 million annually.&amp;nbsp; The direct benefit of local preparation of Plasma derivatives to needy patients at affordable prices will reduce our dependence to imports of Factor VIII and Factor IX and save foreign exchange. &lt;/P&gt;
&lt;P&gt;&lt;BR&gt;This email, its content and any files transmitted with it are confidential and are intended only for the addressee. If you are not the addressee, you may not print, copy, use or rely on the contents, attachments or information in any way except with the express written permission of the sender. If this email has been sent to you in error please destroy it and contact the sender. This email has been prepared using information believed by the author to be reliable and accurate, but College Hill makes no warranty as to its accuracy or completeness.&lt;BR&gt;In particular, College Hill does not accept changes made to this email after it was sent.&lt;/P&gt;
&lt;P&gt;Company Name: College Hill Associates Ltd, Company Number: 1036926&lt;BR&gt;Registered Address: The Registry, Royal Mint Court, London EC3N 4QN UK&lt;BR&gt;&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=587</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=587</guid><title>Axikin Pharmaceuticals Spins out of Actimis</title><description>&lt;P&gt;SAN DIEGO, Jan. 22&amp;nbsp; -- Axikin Pharmaceuticals, Inc., a startup company dedicated to developing and commercializing small molecule therapeutics for respiratory and inflammatory diseases, today announced a $3 million private placement of its Series A stock. The financing was led by Sanderling Ventures of San Mateo, California. Additional investors include Mitsui &amp;amp; Co. Venture Partners of New York.&lt;/P&gt;
&lt;P&gt;Axikin Pharmaceuticals, Inc., was formed as a spin-out from Actimis Pharmaceuticals, Inc., (www.actimis.com) following the acquisition of Actimis' lead program by Boehringer Ingelheim in a structured buyout in June 2008. Axikin's pipeline includes an advanced pre-clinical program with multiple highly optimized small-molecule lead candidates, as well as two additional novel target research programs. These programs are expected to have broad applications across respiratory and allergic diseases including asthma, allergic rhinitis and chronic obstructive pulmonary disease (COPD) with, potentially, broader applications in inflammation, autoimmunity, oncology and cardiovascular disease.&lt;/P&gt;
&lt;P&gt;&quot;The establishment of Axikin Pharmaceuticals, Inc., and the additional funding we have received to progress these assets, allows us to hit the ground running and provide significant continuity in the quest to bring our lead candidates to the clinic,&quot; said Kevin B. Bacon, Ph.D., founder, President and Chief Scientific Officer of Axikin, and original founder of Actimis. &quot;Building on our excellent relationship with our prior investor partners, and retaining the same team of highly-dedicated scientists greatly facilitates our goal of filing an investigational new drug application (IND) for our lead program in the very near future.&quot;&lt;/P&gt;
&lt;P&gt;&quot;The investors are delighted to be backing the same proven team again in this new spin-out Company,&quot; said Peter C. M. McWilliams, Ph.D., Chairman and Acting CEO, and a Principal with Sanderling Ventures. &quot;We feel there are some very interesting and novel technologies in the Axikin portfolio and over the next several months we will continue to rationalize and prioritize these with a view to selecting our first clinical program this year.&quot;&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Axikin Pharmaceuticals, Inc.&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Axikin Pharmaceuticals, Inc. is a privately held biopharmaceutical company focused exclusively on the development and commercialization of small molecule therapeutics for severe respiratory, inflammatory and autoimmune diseases such as asthma, chronic obstructive pulmonary disease (COPD), inflammatory dermatoses, inflammatory bowel disease and rheumatoid arthritis. Axikin was spun out from Actimis Pharmaceuticals, in June 2008. Investors include Sanderling Ventures and Mitsui &amp;amp; Co. Venture Partners. www.axikin.com&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Sanderling Ventures&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Founded in 1979, Sanderling is among the oldest investment firms dedicated to biomedical investing. Sanderling's unique approach combines a specialized investment focus with active management and long-term commitment. Since its inception, Sanderling has supported over 40 biomedical companies from very early stages through commercial development. www.sanderling.com&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Mitsui &amp;amp; Co. Venture Partners&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Mitsui &amp;amp; Co. Venture Partners (MCVP) is a New York based venture capital firm that invests primarily in life science and technology companies in North America. MCVP has created three funds totaling approximately $300 million in capital. Having offices in New York, Tokyo and Palo Alto, the firm actively seeks technology and business seeds in Japan and offers North American start-up companies value-added opportunities in Japan and Asia. www.mitsuiventures.com&lt;/P&gt;
&lt;P&gt;&lt;BR&gt;Source:&amp;nbsp; Axikin Pharmaceuticals&lt;/P&gt;
&lt;P&gt;Issuer of this News Release is solely responsible for its content.&lt;BR&gt;Please address inquiries directly to the issuing company.&lt;BR&gt;&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=583</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=583</guid><title>FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine</title><description>&lt;P&gt;BOTHELL, Wash., Jan. 20&amp;nbsp;-- SCOLR Pharma, Inc. (Amex: DDD) today announced that the U. S. Food and Drug Administration (FDA) has issued a Complete Response letter for its Abbreviated New Drug Application (ANDA) for pseudoephedrine. The application, filed by SCOLR on August 5, 2008, seeks approval to market a 120 mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT(R)) platform.&lt;/P&gt;
&lt;P&gt;The Complete Response letter requests additional information, all of which was identified by the FDA as &quot;minor.&quot; The Company said that it believes it can provide the information to the FDA expeditiously. None of the issues cited by the FDA involve the safety or efficacy of the product.&lt;/P&gt;
&lt;P&gt;Tanya Raco, the Company's Associate Vice President of Regulatory Affairs and Quality Assurance, said, &quot;We are pleased that the FDA has moved so quickly to review our application. If approved, this would be SCOLR's first successful product application, but more importantly it would provide additional validation for our underlying technology. We will continue to work closely with the FDA to address the questions raised and advance our CDT(R) 12-hour pseudoephedrine toward approval.&quot;&lt;/P&gt;
&lt;P&gt;SCOLR is currently in discussions with potential partners for an alliance for this product, but is still open to talk with other companies about this opportunity&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Pseudoephedrine&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Pseudoephedrine is a decongestant that is an active ingredient in Sudafed(R) PSE, Allegra(R) D, Claritin(R) D, Zyrtec(R) D and other over-the-counter (OTC) and prescription products. The domestic OTC market for pseudoephedrine-containing products is estimated to exceed $1 billion annually.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About SCOLR Pharma:&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.368.1050 or visit http://www.scolr.com/.&lt;/P&gt;
&lt;P&gt;This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements related to the timing and success of our products under development and the potential for alliances. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products and we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Contact:&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Investor Relations:&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Cameron Associates&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Kevin McGrath&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; 212.245.4577&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp; Kevin@cameronassoc.com&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=584</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=584</guid><title>Alnylam Provides Update on Kreutzer-Limmer Patent Family</title><description>&lt;P&gt;CAMBRIDGE, Mass--Jan. 20, 2009--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the European Patent Office (EPO) has ruled in favor of the opposing parties in oral proceedings before the European Opposition Board related to the '945 (EP 1214945) patent in its Kreutzer-Limmer patent estate. This ruling does not affect other granted claims of the Kreutzer-Limmer patent series, nor does it affect the ongoing examination of other applications in this patent family, which the company expects will result in new granted patents. In addition, the ruling of this Opposition Hearing is not considered final and can be appealed.&lt;/P&gt;
&lt;P&gt;The '945 patent is only one of a number of patents in the Kreutzer-Limmer estate. Other distinct patents in the family include EP 1550719, or '719, which covers siRNAs comprising 15-21 nucleotides in length stabilized by chemical linkages. In addition, patents from the Kreutzer-Limmer patent family have been granted in other countries, including Germany (DE 10080167 and DE 10066235) with claims covering siRNAs with lengths of 15-49 nucleotides. Many additional patents from the Kreutzer-Limmer patent family are pending in the U.S., Japan, and other countries.&lt;/P&gt;
&lt;P&gt;&quot;Notwithstanding the current outcome for the '945 patent in the European Opposition Proceedings, Alnylam maintains an unparalleled intellectual property position that we believe is needed for the development and commercialization of all RNAi therapeutics. In addition, we strongly believe in the inventive matter described in the '945 patent and we intend to take the next step and appeal the decision made today through the EPO's appeal process,&quot; said Barry Greene, President and Chief Operating Officer of Alnylam. &quot;The Kreutzer-Limmer patent family is broad and is comprised of numerous pending applications for which we expect new patent grants and issuances to emerge. Of course, no single patent or patent family defines the full breadth of Alnylam's intellectual property position. We have a clear track record of leveraging our intellectual property estate to enable the field with freedom to operate for RNAi therapeutics as evidenced by more than 25 licensing agreements which have yielded over $660 million in realized cash funding, and we expect this to continue in the future.&quot;&lt;/P&gt;
&lt;P&gt;&quot;We believe that the EPO will recognize the importance of these early discoveries in the RNAi field and that consideration of parallel filings will continue to yield significant patents, such as the new '719 patent announced recently,&quot; said Roland Kreutzer, Ph.D., Head of Roche's Center of Excellence for RNA Therapeutics in Kulmbach, Germany, and an inventor on the Kreutzer-Limmer patent series. &quot;We are very excited about the progress being made in the field of RNAi research and are absolutely committed to advancing RNAi therapeutics to patients. Clearly, a strong IP estate is critical for the success of such an endeavor, and Alnylam and its partners, such as Roche, uniquely enjoy this benefit.&quot;&lt;/P&gt;
&lt;P&gt;Alnylam's intellectual property (IP) position is comprised of fundamental, chemistry, and target IP that the company believes is necessary for the development and commercialization of RNAi therapeutics. In aggregate Alnylam owns or has in-licensed over 1,800 active patent cases, of which over 700 have issued or been granted worldwide, and 317 have issued or been granted in the U.S., Europe, or Japan, the world's largest pharmaceutical markets; together, these define the company's IP estate for RNAi therapeutics. In addition to the Kreutzer-Limmer patent family, Alnylam's fundamental IP estate includes exclusive licenses to the Crooke, Glover, and Tuschl II patent families, and the Li &amp;amp; Kirby, Pachuk I, and Giordano patent families obtained from its acquisition of the patent assets from Nucleonics, Inc. It also includes a co-exclusive license to the Tuschl I patent family and a non-exclusive license to the Fire &amp;amp; Mello patent.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Alnylam Intellectual Property (IP)&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Alnylam's IP estate includes issued, allowed, or granted fundamental patents in many of the world's major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products. These include:&lt;/P&gt;
&lt;P&gt;-- the Crooke Patents (U.S. Patent Nos. 5,898,031, 6,107,094, 7,432,249, 7,432,250 and EP 0928290) issued in over 12 countries and licensed exclusively from Isis Pharmaceuticals, Inc. to Alnylam for RNAi therapeutics, which cover compositions, methods, and uses of modified oligonucleotides to inactivate a target mRNA mediated by a double stranded RNase, such as &quot;RISC,&quot; which is the cellular enzyme complex that mediates RNAi;&lt;/P&gt;
&lt;P&gt;-- the Kreutzer-Limmer I '719 patent (EP 1550719), owned by Alnylam and where the company has received a notification of 'intent to grant', which covers siRNAs comprising 15-21 nucleotides in length stabilized by chemical linkages;&lt;/P&gt;
&lt;P&gt;-- the Kreutzer-Limmer I '167 patent (DE 10080167) granted in October 2007 and owned by Alnylam, which covers pharmaceutical compositions and uses of siRNAs with a length between 15 and 49 nucleotides that target certain broad categories of mammalian genes;&lt;/P&gt;
&lt;P&gt;-- the Kreutzer-Limmer I '235 patent (DE 10066235), granted in January 2008 and owned by Alnylam, which covers methods, uses, and medicaments of siRNAs, with a length between 15 and 49 nucleotides, expressed through a vector;&lt;/P&gt;
&lt;P&gt;-- the Kreutzer-Limmer II '061 patent (EP 1352061), granted in May 2006 and owned by Alnylam, which covers therapeutic compositions, methods, and uses of siRNA and derivatives directed toward over 125 disease targets;&lt;/P&gt;
&lt;P&gt;-- the Tuschl II '704 patent (U.S. Patent No. 7,056,704) issued in June 2006 and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers methods of making siRNAs to silence any and all disease targets;&lt;/P&gt;
&lt;P&gt;-- the Tuschl II '196 patent (U.S. Patent No. 7,078,196) issued in July 2006 and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers methods of making siRNAs with or without chemical modifications;&lt;/P&gt;
&lt;P&gt;-- the Tuschl II '044 patent (EP 1407044), granted in January 2008 and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers compositions, methods, and uses of siRNAs;&lt;/P&gt;
&lt;P&gt;-- the Tuschl II patent (JP 4 095 895) granted in May 2008 in Japan and exclusively licensed to Alnylam from the Max Planck Society, which broadly covers compositions, methods, uses, and systems of siRNAs;&lt;/P&gt;
&lt;P&gt;-- many divisional and continuing patent applications pending of the aforementioned issued or granted patents and additional patent applications pending, including patents and patent applications covering inventions by Fire &amp;amp; Mello (U.S. Patent No. 6,506,559), Glover, Li &amp;amp; Kirby, Pachuk, Tuschl, Hannon, Giordano, and Kay.&lt;/P&gt;
&lt;P&gt;In addition to fundamental patents, Alnylam is the exclusive licensee in the field of RNAi therapeutics for more than 150 issued chemistry patents owned or controlled by Isis Pharmaceuticals broadly covering chemical modifications, including motifs and patterns of modifications of oligonucleotides, including RNAi therapeutics. These patents include:&lt;/P&gt;
&lt;P&gt;-- phosphorothioate and 2'-O-methyl modifications of oligonucleotides (Buhr, U.S. Patent No. 6,476,205);&lt;/P&gt;
&lt;P&gt;-- 2'-Ribose modifications of oligonucleotides (Cook, U.S. Patent Nos. 5,670,633; 6,005,087; 6,531,584; and 7,138,517);&lt;/P&gt;
&lt;P&gt;-- chemical conjugates of oligonucleotides (Manoharan, U.S. Patent No. 6,153,737); and,&lt;/P&gt;
&lt;P&gt;-- &quot;overhang,&quot; &quot;blunt-end,&quot; and nucleotide pairing design motifs (Woppmann et al., UK 2417727), which is owned by Alnylam.&lt;/P&gt;
&lt;P&gt;In addition to fundamental and chemistry patents, Alnylam is also the exclusive licensee in the field of RNAi therapeutics for certain delivery patents, including those owned and controlled by Tekmira Pharmaceuticals, Inc. covering delivery of oligonucleotides, including RNAi therapeutics, with liposomal formulations. These patents include:&lt;/P&gt;
&lt;P&gt;-- formulations of oligonucleotides, including siRNAs, in cationic liposomes (Wheeler, U.S. Patent Nos. 5,976,567 and 6,815,432; and Semple, U.S. Patent No. 6,858,225).&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Alnylam Pharmaceuticals&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world's top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV) infection and is partnered with Cubist and Kyowa Hakko. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including liver cancers, hypercholesterolemia, Huntington's disease, and TTR amyloidosis. The company's leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko, and Cubist. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam established &quot;RNAi 2010&quot; in January 2008 which includes the company's plan to significantly expand the scope of delivery solutions for RNAi therapeutics, have four or more programs in clinical development, and to form four or more new major business collaborations, all by the end of 2010. Alnylam is a joint owner of Regulus Therapeutics, a joint venture focused on the discovery, development, and commercialization of microRNA therapeutics. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit http://www.alnylam.com.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Alnylam Forward-Looking Statement&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Various statements in this release concerning Alnylam's future expectations, plans and prospects, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the company's ability to successfully research and develop products, as well as those risks more fully discussed in the &quot;Risk Factors&quot; section of its most recent quarterly report on Form 10-Q on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.&lt;/P&gt;
&lt;P&gt;&lt;BR&gt;&amp;nbsp; Related News Items&amp;nbsp; &lt;/P&gt;
&lt;P&gt;&amp;gt; Alnylam Appoints Industry Leader John Schmidt as Chief Scientific Officer&lt;/P&gt;
&lt;P&gt;&amp;gt; Regulus Therapeutics Appoints Dr. Stelios Papadopoulos to Board of Directors&lt;/P&gt;
&lt;P&gt;&amp;gt; Regulus Therapeutics Appoints Garry Menzel, Ph.D., as Executive Vice President Corporate Development and Finance&lt;BR&gt;&amp;nbsp;&amp;nbsp;&amp;nbsp;&amp;nbsp; &lt;BR&gt;Source:&amp;nbsp; Alnylam Pharmaceuticals&lt;/P&gt;
&lt;P&gt;Issuer of this News Release is solely responsible for its content.&lt;BR&gt;Please address inquiries directly to the issuing company.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=581</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=581</guid><title>A Milestone in Cancer Genetics: deCODE Discovers First Common Genetic Variants Affecting the Risk of Many Types of Cancer</title><description>&lt;P&gt;&lt;STRONG&gt;Findings point to common mechanisms of susceptibility to cancers of the lung, bladder, prostate, cervix and skin; findings to be integrated into deCODEme(TM), the new deCODEme Cancer Scan(TM), and deCODE's DNA-based risk diagnostic tests&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Reykjavik, Iceland, Jan. 18-- Scientists at deCODE genetics (Nasdaq: DCGN) and colleagues from the US and ten European countries today announced a long-awaited first in cancer research: the discovery of common single-letter variations in the human genome (SNPs) linked to susceptibility not of one, but several different types of cancer, including those of lung, bladder, prostate, skin and cervix.&lt;/P&gt;
&lt;P&gt;Over the past two years, deCODE has led a wave of discoveries by scientists around the world of common SNPs conferring risk of many major types of cancer. Yet without exception, these SNPs have been linked to cancer of only one or at most two tissue types or organs. The SNPs published today, located near each other on chromosome 5p15, may therefore help to tag major biological mechanisms underlying cancer susceptibility more generally. The paper, entitled &quot;Sequence variants at the TERT-CLPTM1L locus associate with many cancer types,&quot; is published today in the online edition of Nature Genetics at www.nature.com/ng, and will appear in an upcoming print edition of the journal.&lt;/P&gt;
&lt;P&gt;&quot;Today's findings demonstrate the power of using genetics to advance our understanding of the biology of cancer and to discover new strategies for assessing and reducing risk. Our next task is to discover how these SNPs affect susceptibility. One plausible, but as yet unproven, explanation is that these variants provide a genetic background that determines how our bodies respond to environmental risk factors. A thread connecting these different cancer types is that most have important known environmental risk factors and all tend to arise in the tissue layers directly exposed to the environment. One of the SNPs we have discovered is in a gene involved in determining the length of the telomeres, or the tail ends of chromosomes. Shorter telomeres have recently been linked to risk of certain cancers, and telomeres are known to become shorter with the accumulation of environmental insults over time. These findings may point us towards a means of addressing these risks by altering our lifestyle or by helping to identify targets for new drugs. We are integrating the SNPs into deCODEme(TM), and into our deCODEme Cancer Scan(TM) launched today,&quot; said Kari Stefansson, CEO of deCODE and senior author on the paper.&lt;/P&gt;
&lt;P&gt;deCODE discovered the first variant, a SNP called rs 401681, in its gene discovery work on basal cell carcinoma (BCC), a common form of skin cancer. The SNP is in the gene encoding cisplatin resistance related protein 9 (CLPTM1L). Because the region of chromosome 5p15 is of interest in cancer biology, the deCODE team then tested this SNP for association with 16 different types of cancer in a total of nearly 80,000 cancer patients and healthy control subjects from Iceland, the Netherlands, Italy, Sweden, Spain, Germany, Hungary, the United Kingdom, Belgium, Romania, Slovakia and the United States. Rs 401681 was found to confer increased risk not only of BCC, but also cancer of the lung, bladder, prostate and cervix, and was also found to protect against melanoma. It is of interest here that the risks of cancers of lung, bladder, prostate and cervix are greater in individuals with shorter telomeres than long, whereas those with long telomeres are at greater risk of melanoma. Through a more detailed analysis of this region, another SNP, rs2736089, was associated with increased risk of BCC and also with risk of cancer of the lung, bladder and prostate. Rs 2736089 is located in the gene encoding the human telomerase reverse transcriptase (TERT), which directs the addition of repeat DNA sequences to the ends of chromosomes. Importantly, the risk of these different cancers conferred by these two SNPs appears to be independent.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Acknowledgments&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;deCODE thanks the many thousands of individuals who participated in this study, as well as the collaborating researchers and institutions. This study was funded in part by the European Commission through the POLYGENE (LSHC-CT- 2005-018827) and GENADDICT (LSHM-CT-2004-005166) grants; by the US National Institutes of Health (R01-DA017932); a research investment grant of the Radboud University Nijmegen Medical Centre; and through numerous grants to collaborating institutions.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About deCODE&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;deCODE is a bio-pharmaceutical company developing drugs and DNA-based tests to improve the treatment, diagnosis and prevention of common diseases. Its lead therapeutic programs, which leverage the company's expertise in chemistry and structural biology, include DG041, an antiplatelet compound being developed for the prevention of arterial thrombosis; DG051 and DG031, compounds targeting the leukotriene pathway for the prevention of heart attack; and DG071 and a platform for other PDE4 modulators with therapeutic applications in Alzheimer's disease and other conditions. deCODE is a global leader in human genetics, and has identified key variations in the genome (SNPs) conferring increased risk of major public health challenges from cardiovascular disease to cancer. Based upon these discoveries deCODE has brought to market a growing range of DNA-based tests for gauging risk and empowering prevention of common diseases. Through its CLIA-registered laboratory, deCODE is offers deCODE T2(TM) for type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE ProstateCancer(TM) for prostate cancer; deCODE Glaucoma(TM) for a major type of glaucoma; and deCODE BreastCancer(TM), for the common forms of breast cancer. deCODE is delivering on the promise of the new genetics(SM). Visit us on the web at www.decode.com; on our diagnostics site at www.decodediagnostics.com; for our pioneering personal genome analysis service and focused disease scans, integrating the genetic variants included in these tests and those linked to another twenty common diseases, at www.decodeme.com; and on our blog at www.decodeyou.com.&lt;/P&gt;
&lt;P&gt;Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, the effect of a potential delisting of our common stock from The Nasdaq Global Market, uncertainty regarding potential future deterioration in the market for auction rate securities which could negatively affect our cash position and result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10-K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. deCODE undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=579</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=579</guid><title>Pfizer Receives FDA Complete Response Letter for Lasofoxifene</title><description>&lt;P&gt;NEW YORK--Pfizer Inc said today it has received a complete response letter from the U.S. Food and Drug Administration (FDA) asking for additional information on the company&#8217;s application for lasofoxifene. The investigational compound is currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.&lt;/P&gt;
&lt;P&gt;Pfizer is reviewing the letter and will work with FDA to determine the appropriate next steps regarding the company&#8217;s application.&lt;/P&gt;
&lt;P&gt;Pfizer submitted the current application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.&lt;/P&gt;
&lt;P&gt;The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on December 18, 2008, recommending marketing authorization for lasofoxifene. The CHMP&#8217;s opinion will be reviewed by the European Commission, which has authority to approve medicines for the European Union.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Lasofoxifene&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Lasofoxifene is a selective estrogen receptor modulator, or SERM, in the same chemical class as raloxifene. With its high affinity for estrogen receptors, lasofoxifene acts as an agonist in bone and as an antagonist in the breast. Thus, it modulates the estrogen receptor in a different manner than estrogen, which accounts for the effects of lasofoxifene observed in multiple target tissues.&lt;/P&gt;
&lt;P&gt;DISCLOSURE NOTICE: The information contained in this release is as of January 16, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.&lt;/P&gt;
&lt;P&gt;This release contains forward-looking information that involves substantial risks and uncertainties regarding a product candidate that is under review by the United States Food and Drug Administration (FDA) and the European Commission (EC) . Such risks and uncertainties include, among other things, whether and when the FDA and the EC will approve the product candidate, their decisions regarding labeling and other matters that could affect its availability or commercial potential, as well as competitive developments.&lt;/P&gt;
&lt;P&gt;A further list and description of risks and uncertainties can be found in Pfizer&#8217;s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and in its reports on Form 10-Q and Form 8-K.&lt;/P&gt;
&lt;P&gt;Contacts&lt;/P&gt;
&lt;P&gt;Pfizer Inc&lt;BR&gt;Media:&lt;BR&gt;Jack Cox, 212-733-5017&lt;BR&gt;or&lt;BR&gt;Investors:&lt;BR&gt;Jennifer Davis, 212-733-0717&lt;/P&gt;</description></item><item><link>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=580</link><pubDate>Fri, 30 Jan 2009 13:02:57 GMT</pubDate><guid>http://www.pharmaceutical-tech.com/press/pressrelease_archives.asp?PID=580</guid><title>Warner Chilcott Files New Lawsuit for Infringement of DORYX(R) Patent</title><description>&lt;P&gt;HAMILTON, Bermuda, Jan. 16&amp;nbsp;-- Warner Chilcott Limited (Nasdaq: WCRX) announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. (&quot;Mayne&quot;), a subsidiary of Hospira, Inc., have filed a lawsuit against Sandoz Inc. (&quot;Sandoz&quot;) in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the &quot;'161 Patent&quot;) which covers DORYX, a tetracycline-class oral antibiotic. Warner Chilcott markets and sells DORYX delayed-release tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008.&lt;/P&gt;
&lt;P&gt;The lawsuit is in response to the submission of an Abbreviated New Drug Application (&quot;ANDAs&quot;) to the U.S. Food and Drug Administration (&quot;FDA&quot;) by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg delayed-release tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;About Warner Chilcott&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S. pharmaceuticals market. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G.&lt;/P&gt;
&lt;P&gt;Read more on www.warnerchilcott.com.&lt;/P&gt;
&lt;P&gt;&lt;STRONG&gt;Warner Chilcott's Forward Looking Statements:&lt;/STRONG&gt;&lt;/P&gt;
&lt;P&gt;This press release contains forward-looking statements, including statements concerning our product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words &quot;may,&quot; &quot;might,&quot; &quot;will,&quot; &quot;should,&quot; &quot;estimate,&quot; &quot;project,&quot; &quot;plan,&quot; &quot;anticipate,&quot; &quot;expect,&quot; intend,&quot; &quot;outlook,&quot; &quot;believe&quot; and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.&lt;/P&gt;
&lt;P&gt;The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon whom we may rely for some of our products or our own manufacturing facility; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2007; and other risks detailed from time-to-time in our public filings, financial statements and other investor communications. &lt;/P&gt;
&lt;P&gt;We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.&lt;/P&gt;
&lt;P&gt;&lt;BR&gt;SOURCE Warner Chilcott Limited&lt;/P&gt;
&lt;P&gt;&amp;nbsp;&lt;/P&gt;</description></item></channel></rss>
