Genzyme Corp is making considerable strides to satisfy the US regulator it is on track to straighten out the manufacturing problems that have plagued the Sanofi-Aventis takeover target.
The biotech major says it has successfully met the first milestones of a consent decree agreed with the US Food and Drug Administration in May. Much of the latter dealt with bringing Genzyme’s plant at Allston Landing in line with the regulatory requirements of the agency.
As such, all fill/finish activities for Cerezyme (imiglucerase) for Gaucher disease, Fabrazyme (agalsidase beta) for Fabry disease. Myozyme (alglucosidase alpha) for Pompe disease and Thyrogen (thyrotropin alpha) for thyroid cancer for the US market now take place at Genzyme’s Waterford, Ireland plant rather than Allston, and at an external contract manufacturer. With this move, Genzyme noted that all previous restrictions on the marketing and distribution of Thyrogen across the Atlantic have been lifted.
All remaining fill/finish activities in Allston for products sold outside the USA must be ended by August 31, 2011 and Genzyme said it is working closely with regulatory authorities globally to achieve this goal.
All good news for the firm, especially at a time when it is trying to get Sanofi to up its offer of $69.00 per share, or $18.50 billion.
