pharma industry

Googles venture capital group is investing millions into Adimab, a biotech company that will construct a massive library of antibodies, some of which may yield powerful new drugs, the New York Times blog Bits reports. A Google Ventures executive said the company invests in “a variety of fields that dont necessarily directly correlate with Google products or services,” but acknowledged that because “heavyduty computation” is now a key part of biotech development, Google may collaborate with Adimab (Pollack, 10/1).

The executive also told Dow Jones VentureWire/Wall Street Journal, “Google Ventures has a pretty broad mandate.” VentureWire reports “The firm, which invests for financial return, is considering opportunities in biotech, genomics, diagnostics and health careIT, including the field of electronic medical records” (Gormley, 10/1).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

According to a recent retrospective analysis of the pivotal Phase 3 CRYSTAL study, ERBITUX® (cetuximab), when added to FOLFIRI, was shown to increase median overall survival to 19.9 months in an intenttotreat (ITT) population of firstline metastatic colorectal cancer (mCRC) patients compared to 18.6 months in those receiving FOLFIRI alone (hazard ratio [HR] 0.878; 95% CI 0.774 0.995; p=0.042). In a subset of mCRC patients with wildtype Kras tumors, median overall survival was increased to 23.5 months in patients who received ERBITUX plus FOLFIRI compared to 20 months for those taking FOLFIRI alone (HR 0. 796; 95% CI 0.670 0.946; p=0.0094).

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the Kras status of patients tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

The recently completed retrospective analysis from CRYSTAL, a multinational study conducted by Merck KGaA, Darmstadt, Germany, marks the first time an overall survival benefit has been demonstrated with an epidermal growth factor (EGFR)inhibitor in the firstline treatment of mCRC in an ITT patient population and in a Kras wildtype subset of patients. An ITT analysis considers all randomized patients in a clinical trial.

In the CRYSTAL trial, the following Grade 3 or 4 adverse events were reported in the April 2009 New England Journal of Medicine as being more frequent with ERBITUX plus FOLFIRI than FOLFIRI alone in the overall patient population skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, p

Therapeutic equivalence to be highlighted in event cosponsored by the Product Quality Research Institute and the International Pharmaceutical Federation

WHO The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, ongoing education, information resources, opportunities for networking, and professional development. This workshop is cosponsored with the Product Quality Research Institute (PQRI) and International Pharmaceutical Federation (FIP).

WHAT In partnership with PQRI and FIP, AAPS is pleased to present the workshop Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products. This twoday event will discuss some of the challenges presented by the complexity of Modified Release (MR) dosage forms. The workshop will consist of talks by experts from the pharmaceutical industry, academia, and the U.S. Food and Drug Administration.

WHYThis workshop aims to convene pharmaceutical scientists from academia, industry and regulatory agencies to review advances and regulations related to MR dosage forms, examine current and emerging issues, and identify critical paths to establishing scientific and regulatory standards for ensuring therapeutic equivalence and therapeutic interchangeability of MR products.

WHEN October 12, 2009
Sheraton Inner Harbor Hotel
Baltimore, MD, USA

Source
Joseph Catapano

ISTA Pharmaceuticals, Inc. (Nasdaq ISTA) announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twicedaily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

“Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009,” stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. “Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scaleup of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too.”

ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two Phase 3 doublemasked, placebocontrolled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreves rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.

“Patients who experience ocular itching due to allergies want comfortable, quick and longlasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years. Allergic conjunctivitis, not to be confused with viral or bacterial conjunctivitis or pink eye, is an eye allergy that often results in ocular itching, and I am excited patients will have this new treatment option,” commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.

Dr. Anido concluded, “As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year. In addition, Xibrom and Istalol are performing particularly well year to date, giving us confidence to increase our fullyear 2009 net product revenue guidance for our four marketed products to $101 million to $104 million. Our total net revenue for fullyear 2009, including net product revenue and $2.9 million from the onetime recognition of deferred revenue resulting from our previously disclosed modification of our partnership with Otsuka, is now expected to be $104 million to $107 million. We also are reiterating our guidance that ISTA will be operating income neutral in 2009, as our increased net revenue will offset the costs associated with launching Bepreve and expanding our sales force.”

About the U.S. Ocular Allergy Market

Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and antiinflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million.

About Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%

Bepreve is a nonsedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compounds primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.

Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION was codeveloped by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.

INDICATIONS AND USAGE

Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

Instill one drop of Bepreve(TM) into the affected eye(s) twice a day (BID).

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONSbr>
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.

Bepreve(TM) should not be used to treat contact lensrelated irritation.

Remove contact lenses prior to instillation of Bepreve(TM).

ADVERSE REACTIONS

The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 25% of subjects were eye irritation, headache, and nasopharyngitis.

About ISTA Pharmaceuticals

ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTAs four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S.

Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%, Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol(R) (timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA Pharmaceuticals.

Any statements contained in this press release that refer to future events or other nonhistorical matters are forwardlooking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to ISTAs financial guidance for 2009, the expansion of ISTAs sales force, and ISTAs anticipated devotion of resources toward the marketing of Bepreve, Xibrom and Istalol are forwardlooking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forwardlooking statements. These forwardlooking statements are based on ISTAs expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, uncertainties and risks regarding market acceptance of and demand for ISTAs approved products; delays and uncertainties related to the FDA or other regulatory agency approval or actions; and such other risks and uncertainties as detailed from time to time in ISTAs public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTAs Annual Report on Form 10K for the year ended December 31, 2008, and its most recent Quarterly Report on Form 10Q for the quarter ended June 30, 2009.

Source ISTA Pharmaceuticals, Inc

Novavax, Inc. (Nasdaq NVAX) announced positive preclinical results with Novavaxs 2009 novel H1N1 influenza viruslike particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak.

Novavax produced the candidate vaccine and delivered it to the CDC in less than four (4) weeks from the day the genetic sequences of the virus strain became available. The speed at which this was accomplished is a testament to the fast response afforded by Novavaxs proprietary, recombinant cellbased VLP technology which is not dependent on growing influenza virus in eggs and the development of virus seed stocks.

The Novavax VLP vaccine candidate protected ferrets against the 2009 novel H1N1 virus. The ferrets received a 3.75, 7.5, or 15.0 mcg dose of the 2009 H1N1 VLP vaccine or a placebo and were boosted with a second dose after three (3) weeks. All of the H1N1 VLP vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 140 or higher, considered a protective level of immunity, against the H1N1 virus. Remarkably, even after receiving a single dose of 7.5 or 15 mcg 2009 H1N1 VLPs, the animals developed an HI titer of 140 or higher against the H1N1 virus.

Vaccinated animals were challenged with nasal exposure of live H1N1 A/Mexico/4482/2009 (MX/4482) influenza virus strain that was distinct from the H1N1 A/California/04/2009 strain against which the vaccine was derived. The MX/4482 challenge strain was isolated in Mexico from a female patient with severe respiratory disease and was described in a study published on July 24, 2009 in the journal Science by the CDC and HarvardMIT Division of Health Science and Technology. In that study, this virus strain was demonstrated to replicate efficiently in the respiratory tract and cause significant disease in ferrets. After three (3) days post challenge, animals immunized with the 15 mcg dose of the H1N1 VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. By day five (5) after challenge, immunized ferrets at all vaccine dose levels had cleared the H1N1 virus and showed no sign of disease. In contrast, control animals that received no vaccine displayed lethargy, elevated body temperatures and shed infectious virus for up to six (6) days post infection.

“Demonstrating that our influenza VLP vaccine candidate protects against the pandemic H1N1 virus in an animal model is another important milestone for us to have met,” said Dr. Gale Smith, Vice President of Vaccine Development. “An even broader significance of this study is that these data, for the first time, indicate that a vaccine against H1N1 A/California/04/2009 influenza strain has the potential to protect against the 2009 pandemic H1N1 virus.”

About Novavax

Novavax is a clinicalstage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary viruslike particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and anticipated milestones are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forwardlooking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forwardlooking statements or historical experience include risks and uncertainties, including the Companys ability to progress any product candidates in preclinical or clinical trials; the scope, initiation, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the US; Novavaxs pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs; the success of the Companys joint ventures and licensing agreements; the Companys ability to enter into future collaborations with industry partners and governments and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Companys ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the Companys ability to obtain adequate financing in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavaxs business, financial conditions and results of operations, is contained in Novavaxs filings with the U.S. Securities and Exchange Commission, which are available at sec.gov. These forwardlooking statements speak only as of the date of this press release, and Novavax assumes no duty to update forwardlooking statements.

Source Novavax, Inc

Novavax, Inc. (Nasdaq NVAX) announced positive preclinical results with Novavaxs 2009 novel H1N1 influenza viruslike particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak.

Novavax produced the candidate vaccine and delivered it to the CDC in less than four (4) weeks from the day the genetic sequences of the virus strain became available. The speed at which this was accomplished is a testament to the fast response afforded by Novavaxs proprietary, recombinant cellbased VLP technology which is not dependent on growing influenza virus in eggs and the development of virus seed stocks.

The Novavax VLP vaccine candidate protected ferrets against the 2009 novel H1N1 virus. The ferrets received a 3.75, 7.5, or 15.0 mcg dose of the 2009 H1N1 VLP vaccine or a placebo and were boosted with a second dose after three (3) weeks. All of the H1N1 VLP vaccinated animals, even in the lowest 3.75 mcg dose group, developed hemagglutination inhibition (HI) antibody titers of 140 or higher, considered a protective level of immunity, against the H1N1 virus. Remarkably, even after receiving a single dose of 7.5 or 15 mcg 2009 H1N1 VLPs, the animals developed an HI titer of 140 or higher against the H1N1 virus.

Vaccinated animals were challenged with nasal exposure of live H1N1 A/Mexico/4482/2009 (MX/4482) influenza virus strain that was distinct from the H1N1 A/California/04/2009 strain against which the vaccine was derived. The MX/4482 challenge strain was isolated in Mexico from a female patient with severe respiratory disease and was described in a study published on July 24, 2009 in the journal Science by the CDC and HarvardMIT Division of Health Science and Technology. In that study, this virus strain was demonstrated to replicate efficiently in the respiratory tract and cause significant disease in ferrets. After three (3) days post challenge, animals immunized with the 15 mcg dose of the H1N1 VLP vaccine had no detectable virus recovered in nasal washes and showed no signs of disease. By day five (5) after challenge, immunized ferrets at all vaccine dose levels had cleared the H1N1 virus and showed no sign of disease. In contrast, control animals that received no vaccine displayed lethargy, elevated body temperatures and shed infectious virus for up to six (6) days post infection.

“Demonstrating that our influenza VLP vaccine candidate protects against the pandemic H1N1 virus in an animal model is another important milestone for us to have met,” said Dr. Gale Smith, Vice President of Vaccine Development. “An even broader significance of this study is that these data, for the first time, indicate that a vaccine against H1N1 A/California/04/2009 influenza strain has the potential to protect against the 2009 pandemic H1N1 virus.”

About Novavax

Novavax is a clinicalstage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary viruslike particle (VLP) technology. The Company produces these VLP based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and anticipated milestones are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forwardlooking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forwardlooking statements or historical experience include risks and uncertainties, including the Companys ability to progress any product candidates in preclinical or clinical trials; the scope, initiation, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the US; Novavaxs pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs; the success of the Companys joint ventures and licensing agreements; the Companys ability to enter into future collaborations with industry partners and governments and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; the Companys ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the Companys ability to obtain adequate financing in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavaxs business, financial conditions and results of operations, is contained in Novavaxs filings with the U.S. Securities and Exchange Commission, which are available at sec.gov. These forwardlooking statements speak only as of the date of this press release, and Novavax assumes no duty to update forwardlooking statements.

Source Novavax, Inc

Burnham Institute for Medical Research (Burnham) has been selected as a comprehensive center in a new National Cancer Institute (NCI) Chemical Biology Consortium, an integrated network of chemical biologists, molecular oncologists and chemical screening centers. The consortium will establish a new paradigm in the use of publicprivate partnerships to translate knowledge from leading academic institutions into new drug treatments for patients with cancer. Both the La Jolla, Calif. campus of Burnham and its new Lake Nona campus in Orlando, Fla. will participate in the consortium.

The highly collaborative program will use stateoftheart communications, datasharing and project management tools. The NCI seeks to coordinate their own drug discovery efforts with those of academic institutions and privatesector companies in order to expedite the development of promising new therapeutics for cancer and to speed their entry into oncologic practice. The strategy is to expand current NCI programs in personalized medicine by applying a collaborative approach to assemble the skills and resources necessary to identify and advance novel drug candidates in highrisk, underrepresented areas of cancer biology.

“Burnhams strategic focus for the past five years has been on building our capabilities in chemical genomics and drug discovery,” said John Reed, M.D., Ph.D., president and CEO of Burnham. “The Chemical Biology Consortium gives Burnham an additional platform to use our advanced technologies, some of which are virtually unprecedented in the notforprofit research world. We welcome the opportunity to contribute to this national effort to develop innovative cancer medicines of the future.”

The network allows scientists from around the country to use the expertise and resources of the screening centers to identify compounds that serve as research tools in the process of validating targets for more advanced drug discovery efforts. The NCI Chemical Biology Consortium, in which Burnham will partner as one of three comprehensive centers in the nation, will discover and refine compounds directed at cancerrelevant targets, advancing these potential therapies from the laboratory and into human clinical trials.

In September 2008, Burnham was awarded a $98 million grant to establish one of four comprehensive national screening centers as part of the National Institute of Healths (NIH) Molecular Libraries Probe Production Centers Network (MLPCN). Burnhams chemical genomics center recently received a gift of $10 million from philanthropist Conrad Prebys resulting in the renaming of the center to The Conrad Prebys Center for Chemical Genomics.

The Chemical Biology Consortium project has been funded in whole or in part with Federal Funds from the National Cancer Institute, National Institutes of Health, under Contract No. NO1CO12400. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

Source
Josh Baxt

Eli Lilly and Company continues to lead the way in advancing lung cancer treatment. On the heels of new FDA and European Commission approvals for ALIMTA((R)) (pemetrexed for injection) as a treatment for nonsquamous nonsmall cell lung cancer (NSCLC) in the maintenance setting, the company will release findings from more than 30 lung cancer studies at the 13th World Conference on Lung Cancer (WCLC) in San Francisco, Calif., from July 31 to Aug. 4, 2009. WCLC is sponsored by the International Association for the Study of Lung Cancer. Data will feature Lillys ALIMTA and GEMZAR((R)) (gemcitabine HCl for injection).

“Our goal is and has always been to improve treatment options for individual patients,” said Richard Gaynor, M.D., Lilly vice president, cancer research and global oncology platform leader. “In lung cancer in particular, histology provides us with one way to tailor treatment with ALIMTA for patients living with nonsquamous NSCLC.”

ALIMTA, launched in 2004, continues to be evaluated in a number of NSCLC treatment settings. At WCLC, the company will share data involving ALIMTAbased regimens in combination with radiation for inoperable stage IIIA/B NSCLC.

Globally, lung cancer impacts more than 3 million people and is one of the most common cancers worldwide, accounting for 1.2 million new cases annually.(i)

Studies of note for ALIMTA include

B2.6 Oral Presentation Aug. 2, 2009, 330 p.m. PDT

Pemetrexed is more effective* in patients with nonsquamous nonsmall cell lung cancer (NSCLC) histology An analysis of three large, randomized, phase III trials (* vs. the respective comparators in these three trials)

D2.6 Oral Presentation Aug. 4, 2009, 130 p.m. PDT

Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) +/ enzastaurin (E) versus docetaxel (D) + Cb as firstline treatment of patients (pts) with stage IIIB/IV nonsmall cell lung cancer (NSCLC)

PD9.1.1 Poster Discussion Session Aug. 3, 2009, 1030 a.m. PDT

Histological analysis in Pemetrexed treated patients with stage IIIB/IV NSCLC Results from an open label randomized phase II study

PD8.1.3 Poster Discussion Session Aug. 3, 2009, 1030 a.m. PDT

Ongoing Phase II Study of Pemetrexed plus Carboplatin or Cisplatin with Concurrent Radiation Therapy Followed by Pemetrexed Consolidation in Patients with FavorablePrognosis Inoperable Stage IIIA/B nonsmall cell Lung Cancer Interim Safety Update

PLLY

ALIMTA((R)) (pemetrexed for injection), Lilly

Important Safety Information for ALIMTA

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal antiinflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the firstline treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) nonsmall cell lung cancer for whom surgery is not possible.

GEMZAR may not be appropriate for some patients

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition.

This press release contains forwardlooking statements about the potential of ALIMTA for the treatment of nonsmall cell lung cancer and reflects Lillys current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the products will receive additional regulatory approvals. There is also no guarantee that the products will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lillys filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forwardlooking statements.

(i) World Health Organization Global cancer rates could increase by 50% to 15 million by 2020, Fact sheet

At 96week follow up, data from the MERIT ES analysis show that treatmentnaïve HIV patients taking Celsentri/Selzentry (maraviroc), in combination with Combivir® (zidovudine/lamivudine) experienced comparable virologic suppression to undetectable levels and significantly greater increases in CD4 Tcell count through 96weeks, compared to patients taking efavirenz in combination with zidovudine/ lamivudine. The data also show the favorable tolerability of Celsentri/Selzentry, which was associated with fewer discontinuations due to adverse events.1

The 96week results from MERIT ES were presented today at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town, South Africa. MERIT ES is an analysis of the data from the MERIT (Maraviroc versus Efavirenz Regimens as Initial Therapy) study following retesting of screening samples using the enhanced sensitivity Trofile™ assay therefore representing a subset of the MERIT primary analysis population. This enhanced sensitivity test was not available at the time of the MERIT study and is the only version of Trofile currently available.

Results from the MERIT ES population show that, at 96 weeks, a similar number of patients taking Celsentri/Selzentry achieved undetectable viral load compared to those taking efavirenz (50 copies/mL. A patient classified as a primary efficacy nonresponder required one viral load measurement of >50 copies/mL.

About Celsentri/Selzentry

Celsentri/Selzentry is an oral medicine that blocks viral entry to human cells. Rather than fighting HIV inside white blood cells, Celsentri/Selzentry prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 coreceptor.

Celsentri/Selzentry has been approved for use in several markets around the world including the United States, Canada and European Union in combination with other antiretroviral medicinal products, for the treatment of experienced adult patients with only CCR5tropic HIV1 detectable.

In South Africa, maraviroc is not available commercially and is currently under review by the Medicine Control Council. Maraviroc is marketed under the trade name Selzentry® in the United States and Celsentri® in all other countries in which it is approved.

Pfizer Inc Working together for a healthier world™

Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE The information contained in this release is as of July 21, 2009. Pfizer assumes no obligation to update any forwardlooking statements contained in this release as the result of new information or future events or developments.

This release contains forwardlooking information that involves substantial risks and uncertainties about a potential additional indication for Celsentri/Selzentry, including its potential benefits, that is under review by the United States Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA). Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the FDA, the EMEA and other regulatory authorities regarding whether and when to approve supplemental drug applications that have been or may be filed for such additional indication as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such additional indication; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizers Annual Report on Form 10K for the fiscal year ended December 31, 2008 and in its reports on Form 10Q and Form 8K.

1 Pfizer Abstract The MERIT study of maraviroc in antiretroviralnaïve patients with R5 HIV1 96week results.

2 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;1063143 3421.

Shire plc (LSE SHP, NASDAQ SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA.

Fast Track designation is an FDA approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the NDA as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review.

Shire is completing a phase III clinical program that includes three phase III controlled studies involving over 100 patients at 24 sites in 10 countries around the world.

On July 6th, Shire announced that it filed a treatment protocol for velaglucerase alfa at the request of the FDA, which if accepted would allow physicians to treat Gaucher disease patients with velaglucerase alfa on an early access basis, ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible.

Velaglucerase alfa is made with Shires proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern.

Background on Gaucher disease

Gaucher disease is an autosomal recessive disease and the most prevalent Lysosomal Storage Disorder (LSD), with an incidence of about 1 in 20,000 live births. Despite the fact that Gaucher Disease consists of a phenotype, with varying degrees of severity, it has been subdivided in three subtypes according to the presence or absence of neurological involvement. It is also the most common genetic disease affecting Ashkenazi Jewish people (Eastern, Central and Northern European ancestry), with a carrier frequency of 1 in 10 (Dr. John Barranger and Dr. Ed Ginns 1989). This panethnic disease involves many organ systems, such as liver, spleen, lungs, brain, metabolism and bone marrow.

Gaucher Disease results from a specific enzyme deficiency in the body, caused by a genetic mutation received from both parents. The disease course is quite variable, ranging from no outward symptoms to severe disability and death. Carrier status can be detected through blood or saliva to identify potential carriers of the Gaucher gene. Gaucher Disease can be diagnosed early through a blood test.

Worldwide the diagnosed population of Gaucher Disease patients is approximately 7,000. Based on incidence, the estimated total world population is likely to be between 10,000 and 15,000 patients.

SHIRE PLC

Shires strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shires inlicensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively smallscale sales forces will deliver strong results.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forwardlooking statements. Such forwardlooking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Companys results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Companys Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Companys products; the Companys ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Companys products; the Companys ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Companys ability to obtain and maintain government and other thirdparty reimbursement for its products; and other risks and uncertainties detailed from time to time in the Companys filings with the Securities and Exchange Commission.