FDA Panel Vote Split 6-6 on NVO Diabetes Drug

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Thursday, 02 April 2009 16:11

SILVER SPRING, Md. (AP) -- Government experts said Thursday an experimental diabetes drug from Novo Nordisk does not appear to carry heart risks, though serious questions remain about its links to tumors.

The Danish drugmaker has asked the Food and Drug Administration to approve its injectable drug liraglutide for millions of patients with type 2 diabetes. The company has touted the drug's ability to control blood sugar levels while reducing weight, whereas many other drugs cause weight gain.

But panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.

The FDA is not required to follow the group's advice, though it usually does.

Denmark-based Novo Nordisk is one of more than a dozen companies developing new therapies to compete in the $5.1 billion U.S. diabetes drug market, which is growing as the disease becomes more prevalent.

While most of the discussion ahead of the meeting centered on potential heart side effects, Thursday's session was dominated by concerns about tumors uncovered in early-stage animal testing. FDA scientists stressed to the panel that most drug studies are discontinued after showing similar findings.

"It is very rare for a drug that has caused tumors in two species, in both genders at clinically relevant exposures to be approved," said FDA drug reviewer Karen Mahoney.

Novo Nordisk argued that while their drug spurs tumor growth in rodent cells, there is no comparable reaction in humans. But that reasoning failed to convince a majority of panelists.

"I just don't think we have enough data to be reasonably confident of safety in humans for long-term use," said Dr. Peter Savage, of the National Institutes of Health.

But half the panelists felt the drug's potential benefits outweighed lingering questions about cancerous tumors. One panelist abstained from voting.

Liraglutide is among the first drugs to go before the FDA's panel of diabetes experts since the agency issued new safety guidelines for diabetes treatments last year. The more cautious stance followed a 2007 controversy surrounding figures suggesting GlaxoSmithKline's blockbuster pill Avandia increased the risk of heart attack.

Because Novo Nordisk conducted its tests before the FDA issued the new guidelines, it primarily studied the drug in otherwise healthy diabetes patients in their 50s, excluding patients with elevated heart risks. The FDA now requires companies to study high-risk patients, including the elderly, to give a more complete picture of the drug's side effects.

Novo Nordisk went back and analyzed rates of heart attack, stroke and related problems, though some panelists complained there were so few events that it was difficult to assess the drug's role.

"It's hard to be confident with this data given the small number of events we've seen," said Michael Proschan, a statistician at the National Institutes of Health.

Ultimately a narrow majority of panelists felt the data on heart risks were acceptable.

"This sponsor came into it after the new regulations were set, and I think they did everything they were asked to do as best as they could," said Dr. Eric Felner of Emory University School of Medicine

If approved, Novo Nordisk plans to the market the drug under the name Victoza. A decision is expected in the coming weeks.

Some 23 million U.S. adults and patients have type 2 diabetes, which disrupts the body's ability to break down carbohydrates and control blood sugar.

Liraglutide belongs to the GLP-1 family of diabetes medications, which also includes Byetta, marketed by Eli Lilly and Amylin Pharmaceuticals. Both drugs help control blood sugar by increasing insulin production, slowing the body's absorption of sugar.

Novo's drug would enjoy an advantage over Byetta because it requires one injection per day, instead of two.


Lannett Provides Update on Morphine, Digoxin Products

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Thursday, 02 April 2009 12:55

PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (NYSE Amex: LCI) today said that it will continue to manufacture and market its Morphine Sulphate products, while it works with the U.S. Food and Drug Administration (FDA) to address the agency’s initiative on halting the marketing of certain narcotic drugs.

Lannett, along with a number of other drug manufacturers, received a warning letter from the FDA dated March 30, 2009 that stated the marketing of the company’s morphine products without an approved application constitutes a violation. Lannett was given 15 working days from the receipt of the letter to notify the FDA whether it plans to cease manufacturing and marketing the drugs referenced in the letter.

“Product safety is our No. 1 priority, and we want our customers to know that Lannett has been manufacturing and distributing its Morphine-based products for some time,” said Arthur Bedrosian, president and chief executive officer of Lannett Company. “Our Morphine-based products are manufactured under strict compliance with cGMP and fill an important healthcare need for patients suffering with pain.

“Certain Morphine-based products, such as ours, have been on the market and safely prescribed in the U.S., in some cases, for more than 100 years. We believe the FDA’s actions with regard to this matter are unprecedented and we intend to resolve this issue as soon as possible. That said, Morphine products currently constitute a relatively small percentage of our total revenues.”

PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (AMEX:LCI - News), a manufacturer of generic pharmaceuticals, said today that it is prepared to supply the U.S. market with an uninterrupted and safe supply of Digoxin Tablets, following the voluntary recall, announced yesterday, of the drug by another generic drug manufacturer.

Lannett said it has secured additional active pharmaceutical ingredient (API) for their Digoxin Tablets, 0.125 mg and 0.25 mg. According to Wolters Kluwer, total sales of Digoxin Tablets for the last three months were $29 million.

“We want to reassure all of our customers as well as the general public that we are prepared to supply this difficult to source medication,” said Arthur Bedrosian, president and chief executive officer of Lannett.

Digoxin is indicated for the treatment of mild to moderate heart failure as well as for the control of ventricular response rate in patients with chronic atrial fibrillation.


Caraco Pharma Markets Generic Topamax for Sun Pharma

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Thursday, 02 April 2009 09:28

DETROIT, April 2 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD) has launched Topiramate tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma), immediately following Sun Pharma's recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Topamax® tablets.

Topiramate tablets are used as initial monotherapy in patients 10 years of age and older with partial onset seizures, or primary generalized tonic-clonic seizures. Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. These generic versions of Topamax 25 mg, 50 mg, 100 mg, and 200 mg tablets are bioequivalent to Topamax® which is a registered trademark of Ortho McNeil Janssen Pharmaceuticals, Inc. According to IMS Data, these strengths of Topiramate had US sales of approximately $2.3 billion for the calendar year of 2008.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to add this product to our portfolio by launching Topiramate tablets immediately to the marketplace. We continue to focus on working towards expanding our product offering both as a marketing partner and through our own development pipeline of products as quickly and effectively as possible."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.


Labopharm Pain Drug Trial Results Disappoint

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Thursday, 02 April 2009 09:17

LAVAL, QC, April 2 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001).

Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group discontinued early (2% due to adverse events).

Results of the efficacy measures in the study demonstrated a statistically significant difference from placebo in some cases but not in others. An analysis of covariance demonstrated a statistically significant difference from placebo on the Sum of Pain Intensity Differences (SPID) over 50 hours using LOCF (last observation carried-forward) as the imputation method, however, the results were not statistically significant using LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A non-parametric analysis, however, demonstrated statistical significance using both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on the Total Pain Relief (TOTPAR) score was also statistically significant using both LOCF and LOCF/BOCF imputation methods and the patients' global impression of the effectiveness of the study medication was statistically different from placebo. Statistical significance reflects a p-value of less than 0.05 in each of the analyses.

Regulatory authorities throughout the world have different requirements for the analysis and demonstration of efficacy in clinical trials. Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration (FDA) in the United States. The Company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products (DAARP) to determine the path forward. The results of this study are however statistically significant under analyses that the Company believes may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions. Accordingly, the Company intends to meet with the regulatory authorities for these jurisdictions at the earliest available opportunity in pursuit of regulatory approval. Should the authorities be in agreement, the Company expects that it would submit a regulatory application in those jurisdictions.

The Company will provide additional information following discussions with the various regulatory authorities.

The results of the study have no bearing on the upcoming launch of the Company's once-daily tramadol product in the United States.

About Tramadol-Acetaminophen Combination Products

Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the U.S. and the symptomatic treatment of moderate to severe pain in the rest of the world.


Shares of Celgene Decline on Weak Outlook

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Wednesday, 01 April 2009 19:41

By Toni Clarke. BOSTON, April 1 (Reuters) - Celgene Corp (CELG.O) shares fell 15 percent on Wednesday after the biotechnology company said first-quarter results will be lower than analysts expected due to the global economic downturn.

The maker of cancer drugs Thalomid and Revlimid said late on Tuesday that preliminary first-quarter results showed revenue rose 30 percent to about $600 million, substantially less than the $648 million some analysts said they had expected.

* Sees Q1 earnings, revenue below Wall Street view

* Blames global economic downturn

* Shares down 15 percent

Celgene expects earnings, excluding one-time items, to rise to about 43 cents a share, much lower than the average estimate cited by analysts of about 48 cents.

The company said its earnings forecast for 2009 will be at the low end of its previously announced range of $2.05 to $2.15 a share.

Summit, New Jersey-based Celgene, long considered one of the darlings of the biotech sector, ascribed its disappointing forecast to the global economic environment. It said it had to increase free supplies of its drugs as patients struggled to pay.

"We are seeing that distributors are thinning their inventories right now due to the economic environment and are therefore not ordering as much drug to keep on hand," the company said in an email.

Nearly a dozen analysts cut their price targets for the company.

Christopher Raymond, an analyst at Robert W. Baird, said that, while management blames inventory draw-downs and free goods to patients, other forces may also be at work.

"Thalomid appears to be a key culprit," he said, noting sales of the drug, used to treat multiple myeloma, may be declining faster than expected.

Raymond also said the company's successor drug, Revlimid, may be facing greater than expected competition from rival Velcade, which was developed by Millennium Pharmaceuticals. Millennium was acquired last year by Japan's Takeda Pharmaceutical Co Ltd (4502.T)

This is the second time in three months the company has issued a disappointing forecast. In January, Celgene's shares fell 1 percent after it said it expected sales of Revlimid, the company's most important product, to be $1.7 billion in 2009, not the roughly $1.84 billion analysts had been expecting.

The company continues to expect sales of Revlimid to be $1.7 billion and sales of Vidaza, its treatment for a group of blood disorders known as myelodysplastic syndromes, of $400 million.

It expects total 2009 revenue of between $2.6 billion to $2.7 billion.


FDA Panel Backs BMY/AZN Diabetes Drug

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Wednesday, 01 April 2009 14:22

SILVER SPRING, Md. (AP) -- Government experts say a potential blockbuster diabetes drug from Bristol-Myers Squibb does not carry heart problems seen with similar treatments in recent years. Bristol-Myers and partner AstraZeneca have asked the Food and Drug Administration to approve their drug Onglyza for millions of Americans with type 2 diabetes. The FDA panel voted 10 to 2 that the companies' data rule out the risk that the drug hastens heart attack, stroke and other problems.

Onglyza (saxagliptin oral tablets) NDA - A dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes -- PDUFA decision date deadline of 4/30/09. On 4/1/09, the FDA panel voted 10 to 2 that the companies' data rule out the risk that the drug hastens heart attack, stroke and other problems.



Orthovita Submits Data to FDA for Bone Product

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Wednesday, 01 April 2009 12:50

MALVERN, Pa.--(BUSINESS WIRE)--Orthovita, Inc. (VITA) announced today that it has submitted additional data to the U.S. Food and Drug Administration in support its 510(k) filing for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation. This 510(k) application is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement.

The data submitted today includes two-year follow-up data from Orthovita’s pivotal, prospective, randomized, multi-site clinical study conducted under an FDA investigational device exemption (IDE). In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. The two-year follow-up period has now been completed for the pivotal study. In addition to two-year follow-up clinical data for patients enrolled in the pivotal study, Orthovita has submitted to FDA data on patients from two pilot U.S. clinical investigations conducted under FDA IDEs and from several European studies with follow-up ranging from 11 months to over 4 years.

“To our knowledge, the CORTOSS 510(k) filing contains the largest prospective, randomized, controlled clinical dataset ever assembled in the treatment of vertebral compression fractures. We are pleased with the high rate of follow-up that we obtained in the geriatric patient population that was enrolled in our pivotal study. We recognize and very much appreciate the diligence and tremendous effort shown by our clinical investigators and their staff in obtaining this critical, long-term data,” said Dr. Maarten Persenaire, Orthovita’s Chief Medical Officer.

FDA clearance of CORTOSS would permit Orthovita to market and sell the material in the United States for vertebral augmentation. CORTOSS has CE Certification for use in the European Union for screw augmentation and for vertebral augmentation. This enables CORTOSS to be sold in the European Union as well as in other countries that have adopted the European Union’s regulatory standards.

About the Company

Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. The orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. The biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS® Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS® Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. CORTOSS Bone Augmentation Material is approved in certain countries outside the U.S. and is under review for clearance in the U.S. for vertebral augmentation. Our hemostasis portfolio includes VITAGEL® Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.


Sepracor Files for FDA Approval of New Seizure Drug

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Wednesday, 01 April 2009 12:42

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sepracor (SEPR) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The proposed trade name for eslicarbazepine acetate is STEDESA™.

“If approved, STEDESA has the potential to be a meaningful new treatment for patients with epilepsy,” said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. “Clinical studies have indicated that STEDESA has the potential to reduce seizure frequency, provide simpler dosage titration and reduce side effects with once-daily dosing.”

STEDESA, a new chemical entity, is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures.

  • Submission includes data from three Phase III studies in 1,000 patients from 23 countries
  • Approximately 2.7 million people in the U.S. are afflicted with epilepsy
  • U.S. epilepsy treatment market estimated to be $3.5 billion
  • “The NDA submission for STEDESA, subject to acceptance and approval by the FDA, represents a significant and near-term opportunity for Sepracor,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “This submission is another step forward in our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline, building a stronger and more productive commercial organization and continuing to execute strategically aligned corporate development and licensing initiatives.”

    Under the Prescription Drug User Fee Act, the FDA has 60 days after submission to review an NDA in order to determine if the application may be accepted for filing. The acceptance of the filing of an application means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review.

    In February 2009, the Committee for Medicinal Products for Human Use of the European Medicines Agency in the European Union (EU) issued a positive opinion to grant marketing authorization for ZEBINIX® (EU-approved trade name for eslicarbazepine acetate) for adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization. BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese pharmaceutical company, was responsible for the research and development and EU filing for eslicarbazepine acetate. Sepracor acquired the rights to commercialize eslicarbazepine acetate for the U.S. and Canadian markets from BIAL in late 2007.

    About STEDESA

    STEDESA has been studied in three Phase III, multi-center, randomized, placebo-controlled trials, which involved more than 1,000 patients from 23 countries. Patients involved in the trials had a history of at least four partial seizures per month despite treatment with one to three concomitant antiepileptic drugs. During the trials, patients were randomized to eslicarbazepine acetate or placebo, and after a 2-week titration period, were assessed over a 12-week maintenance period with continued follow-up over a one-year, open-label period.

    Sepracor is seeking approval of STEDESA for adjunctive therapy with once-daily maintenance doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.

    About partial-onset seizures and their treatment

    Epilepsy is one of the most common neurological diseases that, according to the Epilepsy Foundation, afflicts approximately 2.7 million people in the U.S. Treatment of partial-onset seizures, the most common type of epilepsy, presents a constant challenge – up to 58% of patients with partial-onset seizures do not achieve seizure control with current antiepileptic drugs.2 Patient compliance with antiepileptic agents represents a significant area of unmet need, with poorly compliant patients more likely to have breakthrough seizures3 and have higher mortality risk4. Additionally, patients with epilepsy often suffer from other concomitant diseases, further complicating the management of these patients.5 Finally, adverse events, such as dizziness and somnolence, are highly prevalent with existing antiepileptic agents and may affect as many as 97% of patients.6

    Epilepsy is characterized by abnormal firing of impulses from nerve cells in the brain. In partial-onset epilepsy, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalized; the symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.

    About Sepracor

    Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, BROVANA® brand arformoterol tartrate Inhalation Solution, OMNARIS brand ciclesonide Nasal Spray and ALVESCO® brand ciclesonide HFA Inhalation Aerosol. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.


    Glaxo Files with FDA to Expand Use of Cancer Drug

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    Wednesday, 01 April 2009 08:39
    LONDON and PHILADELPHIA, April 1, /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced the submission of two simultaneous regulatory applications to expand the use of TYVERB(R)/TYKERB(R) (lapatinib). If approved, TYVERB(R)/TYKERB(R) could be used as a first-line therapy regimen combined with anti-hormonal therapy for patients with hormone-sensitive, metastatic (or advanced) breast cancer in Europe and the United States.


    The variation to the EU marketing authorization and the supplemental New Drug Application (sNDA) were submitted respectively to the European Medicines Agency (EMEA) and to the U.S. Food and Drug Administration (FDA) for the combination of TYVERB/TYKERB plus an aromatase inhibitor based on the recent study, EGF30008. This study evaluated TYVERB/TYKERB in combination with letrozole in women whose breast cancer expressed was hormone receptor positive (HR+) and may or may not also over-expressed the HER2+/ErbB2+ receptor.


    These data were presented at the San Antonio Breast Cancer Symposium in December 2008.


    Breast cancer tumors which initially respond to anti-hormonal therapy such as letrozole can become resistant to treatment, leading to disease progression and ultimately, patient death.1 Between 60-70 percent of all breast cancer cases in Europe and the U.S. are HR+.2


    "Tyverb/Tykerb with a hormone therapy is a biologically-rational targeted treatment, since the combination attacks two specific receptors that drive the cancer growth," said Debasish Roychowdhury, MD, Head, Medicines Development, GSK Oncology. "If approved the combination could provide a cytotoxic chemotherapy-free option for these patients and we look forward to working with regulatory agencies to advance the availability of this regimen as a new, oral option for patients in first-line breast cancer."



    About TYVERB(R)/TYKERB(R) (lapatinib)

    Lapatinib is an oral small-molecule inhibitor of the HER2/ErbB2 tyrosine kinase receptor. Stimulation of HER2/ErbB2 is associated with cell proliferation and with multiple processes involved in tumor progression and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.


    Lapatinib, in combination with capecitabine, is approved in 74 countries. On March 13, 2007, the U.S. FDA approved lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2/ErbB2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. On June 10, 2008, the European Commission granted a conditional marketing authorization for lapatinib in all 27 European Union (EU) member states. Other countries in which lapatinib is approved for marketing include Australia, India, Brazil, Russia, Switzerland, Turkey, South Korea, Taiwan and others around the world. Registration dossiers for lapatinib have been filed in Canada, China, Japan, Mexico and a number of countries in Latin America, Middle East, Africa and Asia Pacific.


    GSK in Oncology

    GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is closing in on cancer from all sides with a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


    Wyeth Submits BLA for Prevnar 13 Vaccine

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    Tuesday, 31 March 2009 18:27

    COLLEGEVILLE, Pa., March 31 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), announced today that it has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Prevnar 13(TM), Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). Last year, the FDA granted Prevnar 13 Fast Track designation, which is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

    Prevnar 13 is designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death worldwide. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar®, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Both Prevnar 13 and Prevnar use CRM(197) - an immunological carrier protein with a 20-year history of use in pediatric vaccines.

    "We are pleased that, with this milestone, we are now one step closer to bringing Prevnar 13 to infants and children," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "Prevnar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health impact. Prevnar 13 builds on the scientific foundation of Prevnar and, if approved, will provide coverage for the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease, including serotype 19A, which has emerged as a serious public health threat in the United States and around the world."

    The Prevnar 13 submission to the FDA includes data from 13 Phase 3 studies, involving more than 7,000 infants and young children. The Company initiated its global pediatric filings in late 2008 and, to date, has submitted regulatory applications for the 13-valent candidate vaccine in more than 40 countries worldwide. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

    Pneumococcal Disease

    Pneumococcal disease is complex and describes a group of illnesses, all of which are caused by the bacterium Streptococcus pneumoniae. PD affects both children and adults and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media (middle ear infection).

    Following the inclusion of Prevnar into the routine pediatric immunization schedule in the United States, there has been a 98 percent (95% CI: 97%-99%) reduction in vaccine-type IPD and a 77 percent reduction in all IPD among children younger than 5 years of age through 2005, compared with a pre-licensure baseline. In addition, the incidence of disease caused by the seven conjugate vaccine serotypes declined 55 percent (95% CI: 51%-58%) among adults 50 years of age or older, an unvaccinated group. The Centers for Disease Control and Prevention has reported an increase in the incidence of IPD due to non-vaccine serotypes in children younger than 5 years of age and in adults 40 years of age and older; it is unknown whether these effects would be observed in other populations.

    Most recently, serotype 19A, which is included in the candidate vaccine, has been increasing in prevalence in many regions of the world and is frequently resistant to antibiotics. In fact, serotype 19A has emerged as the predominant invasive pneumococcal serotype in the United States.


    Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly caused these serious diseases in children prior to the introduction of Prevnar. The routine vaccination schedule is 2, 4, 6, and 12 to 15 months of age.

    Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes included in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

    As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease cause by S. pneumoniae. This vaccine should not be used for treatment of active infection.

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