Genzyme Plans New Lumizyme Application in Weeks
Wed, 05/06/2009 - 11:41am
CAMBRIDGE, Mass. (AP) — Biotechnology company Genzyme Corp. said Wednesday that the Food and Drug Administration is ready to review an application for its drug candidate Lumizyme, and it expects to file the application by the middle of May. The company forecast a six-month FDA review. The agency will look at data from a Genzyme registry to fulfill a requirement for further study, and won't need to conduct an inspection of the manufacturing facility where the drug is made. Genzyme is seeking approval for Lumizyme as a treatment for Pompe disease, a genetic disorder that interferes with muscle development and can cause deadly respiratory problems. In March, the FDA said it wanted Genzyme to fix manufacturing problems at its Allston Landing plant before it would grant marketing approval, and also wanted to arrange the design of a post-approval study. Lumizyme is similar to another Genzyme drug, Myozyme, but is manufactured at different scales: Myozyme is made in 160-liter bioreactors, and Lumizyme is made in 2,000-liter bioreactors. The FDA required Genzyme to run separate trials of Lumizyme in order to gain approval, and Genzyme decided to market the drugs under different names. The company said it is also in talks with the FDA about making an application for a version of the drug made in 4,000-liter bioreactors. Separately, the company said it is changing the way it calculates its adjusted profit. It said its new estimates are simpler, and that its goal of increasing its profit by 20 percent per year through 2011 is unchanged. Genzyme now says it expects an adjusted profit of $3.52 per share this year, down from $4.58 per share. The estimate excludes one-time items such as amortization charges of 70 cents per share, and 36 cents per share in other items. Analysts were expecting $4.60 per share, according to Thomson Reuters. The company backed its goal of $7 billion in annual revenue by 2011, and said it expects $5.15 billion to $5.35 billion in revenue this year. Analysts currently expect $6.72 billion in revenue in 2011, and $5.16 billion this year. In afternoon trading, Genzyme shares rose $1.08, or 2 percent, to $55.28.