US approval of Genzyme

The Food and Drug Administration  has rejected the New Drug  Application for Genzyme's Lumizyme (alglucosidase alfa), as it needs  to meet with the US biotechnology major to finalize the design of a  post-approval verification study and a Risk Evaluation and Mitigation  Strategy. Genzyme and the FDA have been making progress toward these  goals but were not able to reach them by the NDA action date. The  setback could mean an approval delay of up to six months for the agent,  a treatment for Pompe disease in adults. Lumizyme contains the same  active ingredient as another Genzyme drug for Pompe disease, Myozyme but  was developed as a separate entity because it is made in a 2,000-liter  batch process, raising concerns that it might be different to Myozyme,  which is made in small 160-liter batches in the USA and is only  available to children and infants. Assuming a six-month delay,  Genzyme anticipates the impact on 2009 non-GAAP earnings will be $0.12  per share.