Genzyme (GENZ) Receives Complete Response Letter From FDA For Lumizyme Application; Anticipates Negative Impact To 2009 Earnings
Genzyme Corporation (Nasdaq: GENZ) 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 outlines the remaining items that need to be addressed before the application can be approved. Lumizyme is produced at the 2000 liter (L) bioreactor scale at Genzyme’s Allston Landing facility.
Specifically, Genzyme and the FDA must finalize agreement on the design of a post-approval verification study to demonstrate the clinical benefit of Lumizyme, as required under the Accelerated Approval process. In addition, Genzyme and the agency need to finalize the Risk Evaluation and Mitigation Strategy (REMS) for the product. Genzyme and the agency have been working closely and making progress toward these goals but were not able to reach them by the PDUFA date.
Genzyme also now needs to resolve issues identified in a warning letter the company received simultaneous with the complete response letter. The warning letter addresses deficiencies related to observations made during an inspection of Genzyme’s Allston Landing manufacturing facility performed in September and October 2008.
Given the substantial progress that Genzyme had made toward addressing the inspection observations, this warning letter was unexpected.
“We have made an enormous effort for more than two years to make this product broadly available in the United States, so we are obviously surprised and disappointed by this further delay,” said Genzyme Chairman and Chief Executive Officer Henri A. Termeer. “We are confident we will be able to resolve all remaining issues with the FDA within three to six months.”
Genzyme believes that all the information requested by the agency is readily at hand and that the company will be able to submit this information within approximately one month.
Assuming a six-month delay, Genzyme anticipates the impact on 2009 non-GAAP earnings will be approximately $0.12 per share. This reflects both forgone commercial sales margin and the costs of continued administration of the MTAP program. Genzyme now expects Myozyme revenue of $370 – $380 million in 2009, assuming a six month delay.
Genzyme Corporation is a biotechnology company. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. [SM]
Specifically, Genzyme and the FDA must finalize agreement on the design of a post-approval verification study to demonstrate the clinical benefit of Lumizyme, as required under the Accelerated Approval process. In addition, Genzyme and the agency need to finalize the Risk Evaluation and Mitigation Strategy (REMS) for the product. Genzyme and the agency have been working closely and making progress toward these goals but were not able to reach them by the PDUFA date.
Genzyme also now needs to resolve issues identified in a warning letter the company received simultaneous with the complete response letter. The warning letter addresses deficiencies related to observations made during an inspection of Genzyme’s Allston Landing manufacturing facility performed in September and October 2008.
Given the substantial progress that Genzyme had made toward addressing the inspection observations, this warning letter was unexpected.
“We have made an enormous effort for more than two years to make this product broadly available in the United States, so we are obviously surprised and disappointed by this further delay,” said Genzyme Chairman and Chief Executive Officer Henri A. Termeer. “We are confident we will be able to resolve all remaining issues with the FDA within three to six months.”
Genzyme believes that all the information requested by the agency is readily at hand and that the company will be able to submit this information within approximately one month.
Assuming a six-month delay, Genzyme anticipates the impact on 2009 non-GAAP earnings will be approximately $0.12 per share. This reflects both forgone commercial sales margin and the costs of continued administration of the MTAP program. Genzyme now expects Myozyme revenue of $370 – $380 million in 2009, assuming a six month delay.
Genzyme Corporation is a biotechnology company. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. [SM]
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