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Continuing Allston Troubles Mean Another Brief Shutdown, Delay For Lumizyme Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

An FDA "complete response" letter in relation to Genzyme's sBLA for Lumizyme says plant problems must be resolved before approval.

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FDA Inspection Of Genzyme Plant Finds Lack Of Follow-up, Old Equipment, Poor Personnel Qualification

A Form 483 posted online by FDA following a five-week inspection of the Allston Landing manufacturing plant cites 49 separate concerns.

FDA Inspection Of Genzyme Plant Finds Lack Of Follow-up, Old Equipment, Poor Personnel Qualification

A Form 483 posted online by FDA following a five-week inspection of the Allston Landing manufacturing plant cites 49 separate concerns.

American Heart Association Scientific Sessions, In Brief

CETP inhibitors gaining traction: Data presented at the American Heart Association's 2009 Scientific Sessions Nov. 14-18 in Orlando, Fla., show that the remaining cholesteryl ester transfer inhibitors - Roche's dalcetrapib and Merck's anacetrapib (MK-0859) - are on track. The CETP class was cast into shadow after Pfizer discontinued work on its potential juggernaut torcetrapib in December 2006 due to elevated blood pressure and increased cardiovascular mortality (1"The Pink Sheet," Dec. 11, 2006). But Roche and Merck have concentrated on learning from the torcetrapib experience and a growing body of evidence shows that dalcetrapib and anacetrapib are sufficiently different from torcetrapib to avoid the negative side effects while still offering the benefit of raising HDL cholesterol (2"The Pink Sheet," Jan. 5, 2009). At AHA, Roche revealed the dal-OUTCOMES study is on track, with 9,000 of the total 15,600 patients enrolled in the morbidity/mortality trial. Roche also announced the initiation of a new, 24-month Phase III clinical trial, dal-PLAQUE 2, to determine the impact of dalcetrapib on artherosclerotic disease progression in more than 900 patients as measured by ultrasound imaging techniques (both intima media thickness and intravenous ultrasound). Additionally, the firm presented preclinical data on dalcetrapib's molecular structure and interaction with CETP to bolster previously reported studies showing the drug's specific mechanism of action. Merck released Phase IIb data showing nearly 600 patients with high cholesterol treated with anacetrapib alone or in combination with atorvastatin showed persistent lipid lowering in the higher-dose arms of the treatment groups. The results strengthen findings originally reported in February 2009 in the American Heart Journal. Data from Merck's Phase III DEFINE trial of anacetrapib are expected in 2010

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