Genzyme announced Wednesday that the company transferred all fill/finish activities from its Allston Landing facility as required under the terms of an FDA consent decree. The drugmaker had until November 28 to complete the transfer of work after the plant was temporarily closed last year due to a viral contamination.
The company indicated that all fill/finish activities for Gaucher disease treatment Cerezyme (imiglucerase), Fabry disease therapy Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa), and Thyrogen (thyrotropin alfa) for the US market will now take place at its facility in Waterford, Ireland, and at an external contract manufacturer. Following the work, Genzyme noted that all restrictions placed on the marketing and distribution of Thyrogen within the US have now been lifted.
The drugmaker said it is working with regulators to move fill/finish operations for products sold outside the US by August 31 next year, which is another of a number of measures the company must meet under the consent decree. If Genzyme fails to meet the deadlines, the company could be required to pay $15,000 per day for each affected drug until it regains compliance.
RBC Capital Markets analyst Michael Yee indicated that as the manufacturing fixes at Genzyme are "on track," sanofi-aventis may now increase its $69 per share offer for the company. "The next step is a slightly higher sanofi bid to the low $70s," Yee said, adding that "a final deal could be done in mid-2011."
Reference Articles
Genzyme meets first deadline on manufacturing changes - (Bloomberg)
Genzyme meets first consent decree deadline - (Forexpros)
Genzyme successfully meets first milestones of FDA consent decree - (Genzyme)
Genzyme: All filling, finishing for US transferred from Allston - (NASDAQ)
Genzyme moves drug vial filling business overseas - (Yahoo!Finance)
**Published in "First Word"
No comments:
Post a Comment