Investigation Overview
Acording to a press release an investigation on behalf of investors, who purchased Genzyme Corporation stock between February 27, 2009 and March 3, 2009, and current investors of Genzyme Corporation stock over possible state and federal securities claims against Genzyme Corporation in connection with allegations that the company failed to promptly disclose that the Food and Drug Administration delayed approval for Lumizyme, which is one of the Companys key products.
According to the press release the investigation by the law firm focuses on potential state and federal securities claims against Genzyme Corporation in connection with allegations that the company failed to promptly disclose that the Food and Drug Administration delayed approval for Lumizyme, which is one of the Genzyme Corps key products. The company provided a progress update on February 23, 2009, confirming that all corrective actions had either been completed or were on schedule to be completed by the original commitment date of March 31, 2009. Buton February 27, 2009, so the investigation, Genzyme Corp. received two letters from the Food and Drug Administration. The first letter stated that the Food and Drug Administration agency would not approve Lumizyme, to treat a rare genetic disorder called Pompe disease, before a deadline of February 28, 2009, as expected. The second letter stated that the Food and Drug Administration. still had significant problems with the manufacturing plant where Lumizyme is made, which Genzyme Corp. had not corrected. According to the Food and Drug Administration warning letter Genzyme did not update its computerized manufacturing system for Fabrazyme, a treatment for Fabry disease, and ran an aseptic filling line at an unvalidated line speed. The letter cites operations at Genzymes plant in Allston, Massachusetts, which manufactures several of the companys best-selling biologics, like Gauchers disease treatment Cerezyme (imiglucerase), Myozyme (alglucosidase alfa) for Pompe disease and Fabrazyme.
According to the investigation Genzyme Corp. failed to disclose this information until after the close of trading on March 2, 2009 and that Genzyme Corp. stated that the delay would lower its 2009 profit by about 12 cents per share. As a result of this news the price of Genzyme Corp. shares fell to $53.66 on March 3, 2009, a three-day decline of over 23%, so the investigation.
Genzyme Corporation, based in Cambridge, Massachusetts, is a biotechnology company. Genzyme operates in four segments: Genetic Diseases, Cardiometabolic and Renal, Biosurgery and Hematologic Oncology. Genzyme Corp had a total revenue of $4.6Billion in 2008 and a net income of $421Million.