Key Developments: Genzyme Corporation (GENZ.O)
54.87USD
9 Feb 2010
$0.38 (+0.70%)
$54.49
$54.76
$55.47
$54.27
2,267,418
2,782,348
$73.75
$47.09
Latest Key Developments
Genzyme Corporation's Lumizyme BLA Receives Six-Month FDA Review
Genzyme Corporation announced that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application (BLA) for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale. The FDA has classified the resubmission as a class 2 complete response, which carries a six-month review timeframe.
IMPAX Laboratories, Inc. Confirms Patent Challenge Relating to WELCHOL 625 mg Tablets
IMPAX Laboratories, Inc. announced that it has initiated challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL (Colesevelam HCl) tablets, 625 mg. Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of WELCHOL with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from the FDA that Impax`s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its paragraph IV certification. On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax`s generic division, will commercialize the products.
Genzyme Corporation And Relational Investors LLC Enter Into Mutual Cooperation Agreement
Genzyme Corporation and Relational Investors LLC announced that they have entered into a mutual cooperation agreement. Relational, began investing in Genzyme shares in late 2008, and currently owns approximately 4% of the company`s common stock.
Genzyme Corporation Announces Phase 1/2 Trial Provided Early Clinical Data
Genzyme Corporation announced that a Phase 1/2 trial provided early clinical data suggesting that Mozobil (plerixafor injection) in combination with chemotherapy may offer a therapeutic impact on leukemic cells protected in bone marrow. The investigational trial, partially supported by Genzyme, was the subject of an oral presentation at the 2009 annual meeting of the American Society of Hematology in New Orleans, LA. Genzyme has initiated two clinical trials to further explore this potential new strategy to attack blood cancers. Of the 32 patients available for the first follow-up evaluation, researchers observed a complete remission (CR or CRi) in 50 percent of patients. Thirteen of these patients had a CR with normal platelet recovery, and three patients had complete remission with incomplete platelet recovery (CRi). In a larger patient population, Washington University`s historical CR and CRi rate in relapsed and refractory AML patients receiving MEC alone ranges from 25 to 35 percent. The study, developed primarily to determine optimal dosing and safety of Mozobil as a tumor sensitization agent, found no evidence of hyperleukocytosis, excessive release of white blood cells into the bloodstream. There was also no observed delay in the recovery of neutrophils or platelets important to immune system protection and prevention of bleeding, respectively.
Genzyme Corporation Announces Data From CAM314 Randomized Phase III Clinical Trial
Genzyme Corporation announced data from its CAM314 randomized Phase III clinical trial comparing Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) (FluCAM) to Fludara alone in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) demonstrated that the FluCAM regimen significantly reduced the risk of disease progression or death compared to single-agent Fludara. Importantly, advanced-stage, second-line CLL patients receiving FluCAM more than doubled the amount of time without disease progression in comparison to patients receiving Fludara alone. Following a planned second interim analysis, the CAM314 trial`s data safety monitoring panel recommended early closure of the study as it had achieved the pre-specified clinical and statistical significance in progression free survival, the study`s primary endpoint. While patients in the study continue to be followed, and final efficacy and safety data from the study are expected to be available in the second-half of 2010, response data from the second interim analysis (as assessed by the study`s investigators) reported at ASH indicate that the FluCAM combination provided significantly higher overall and complete response rates compared to Fludara alone. The preliminary results also suggest that the FluCAM regimen has an acceptable safety profile when compared to single-agent Fludara. An additional secondary endpoint, overall survival, did not reach significance at this interim analysis.
Genzyme Corporation And FDA Agree Pathway For Lumizyme Approval-Reuters
Reuters reported that Genzyme Corporation And U.S. regulators have agreed on a plan that could lead to approval of the Company's Pompe disease drug Lumizyme. Last month the U.S. Food and Drug Administration declined to approve the drug due to manufacturing problems at Genzyme's Allston Landing plant in Boston.
Genzyme Corporation Announces Results Of Phase 2/3 Trial of Advanced Phosphate Binder
Genzyme Corporation announced results of a phase 2/3 study of its advanced phosphate binder (APB). The trial met its primary endpoint, which was to show that the APB lowered phosphate levels effectively compared to placebo. However, the APB did not show a significant improvement in phosphate lowering compared to the Company`s Renvela (sevelamer carbonate). Based on these results, the Company is not planning to pursue further clinical development of the APB. The Company was seeking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela. In the study, Renvela and the APB both effectively lowered patients` phosphorus levels. Most adverse events associated with both Renvela and the APB were mild in nature, and the most frequently reported events were gastrointestinal disorders. The trial was a randomized, double-blind, placebo-controlled study that enrolled 349 adult hemodialysis patients with hyperphosphatemia. It included seven arms: low, medium and high dose APB; low, medium and high dose Renvela, and placebo. It included a two-week screening period, a two-week washout period, and a three-week treatment period.
Genzyme Corporation Announces Data From Mipomersen Phase 3 Trial In hoFH Patients
Genzyme Corporation announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented at the American Heart Association`s Scientific Sessions. The study met its primary endpoint in an intent-to-treat analysis, with a 25 percent reduction in LDL-cholesterol after 26 weeks of treatment, vs. 3 percent for placebo (p<0.001) which constitutes an average reduction greater than 100 mg/dL. The trial also met each of its secondary endpoints. The phase 3 study in hoFH patients, one of the trials to date in this rare population, was designed to test the efficacy and safety of adding mipomersen to substantial lipid-lowering therapy. Patients' average LDL-C at baseline was greater than 400 mg/dL. All but one of the patients were being treated with lipid-lowering therapy (50/51, 98%), of whom 11 (22%) were taking a statin alone and 39 (78%) were taking a statin in combination with at least one other lipid-lowering agent, most commonly ezetimibe (37/50, 74%). The LDL-C reductions observed in the study were in addition to those achieved with the patients` existing therapeutic regimen.
Genzyme Corporation Receives Complete Response Letter on Lumizyme Application
Genzyme Corporation announced that it has received a complete response letter from the FDA regarding its application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe disease. In its letter, the agency stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed.
Genzyme Corporation Issues Letters to U.S. Healthcare Providers
Genzyme Corporation announced that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme (imiglucerase for injection), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa), Aldurazyme (laronidase), as well as Thyrogen (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles. The safety profile of these products remains unchanged. A review of the global safety database for these products has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles. However, a theoretical safety risk remains should a particle enter the bloodstream. Genzyme`s quality control processes have detected foreign particles in these products at a rate of approximately 1%. The Company`s rate has not increased over time. The global rate of product returns from customers due to the observance of foreign particles is less than approximately 0.02% for these products.
PREVIEW-Genzyme competition may get clearer at conference
BOSTON, Feb 8 (Reuters) - Genzyme Corp , Shire Plc and Protalix Biotherapeutics Inc will each be presenting data this week that could give hints as to how the competitive landscape for Gaucher disease treatments could look a year or two from now.
Earnings vs. 
Estimates
Thomson Reuters is the world's largest international multimedia news agency, providing investing news, world news, business news, technology news, headline news, small business news, news alerts, personal finance, stock market, and mutual funds information available on Reuters.com, video, mobile, and interactive television platforms. Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
NYSE and AMEX quotes delayed by at least 20 minutes. Nasdaq delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
