A couple of Regulatory bodies announced significant actions versus two drug manufacturers within the past couple days. These actions follow agency concerns with the manufacturing environment of both companies.
Earlier this week, Genezyme was informed that the FDA planned to take an enforcement action at its troubled Allston Landing, MA plant. This coming in the wake of several manufacturing quality problems - including both viral contamination and "pieces of trash" in its products.
The FDA action will result in its use of a 3rd party overseer for Genzymes operations for an "extended period". Fortunately, there is nothing going on in the board room that will distract management from getting the plant back on task. Needless to say, CEO Henri Termeer is under increasing pressure. Needless, needless to say there have been changes made in the manufacturing plant's management and oversight - although perhaps too little too late.
The only good news for shareholders is that the facility will still be able to produce both Cerezyme (Gaucher's Disease) and Fabrazyme (Fabry's Disease) during this oversight period. Patient's requiring these drugs will not be faced with any interuption in their supply. The fact that these are Orphan Drugs probably did prevent a plant shut down.
In the second instance, the European Medicines Agency' CHMP recommended the precautionary recall of all drugs made with the API clopidogrel manufactured by Acino Pharma GmbH. Final products made by A1 Pharma, Acino Pharma, Ratiopharm and Sandoz will be part of the recall. Acino Pharma is the Marketing Authorization holder in this case.
The committee's recommendation to recall was based on poor audit results of Acino's Glochem Visakapatnam manufacturing site in India. The site was recommended to be removed from sites allowed to manufacture clopiogrel. Significant failings in the facilities GMPs were cited as the reason for the sanction. The CHMP opinion has been forwarded to the European Commission for legal adoption.
Moral: Adherence to GMPs is good business - not to mention upholds public safety. How much money do you think will be lost in reputation alone in both these cases?
Posted by Bruce Lehr March 25th 2010
Icahn on warpath looking for Termeer's scalp as described in today's (May 4th) Xconomy.
http://www.xconomy.com/boston/2010/05/04/icahn-calls-genzymes-manufacturing-broken-advises-against-termeers-re-election-to-board/
Posted by: Bruce Lehr | 05/04/2010 at 05:33 PM
Supply issues continue and regulatory agency recommends alternatives. http://bit.ly/ds4TE9
Posted by: Bruce Lehr | 04/23/2010 at 06:32 PM
More financial consequences as reported in Xconomy.
http://www.xconomy.com/boston/2010/04/21/genzyme-expects-175m-expense-for-manufacturing-problems-in-allston/
Posted by: Bruce Lehr | 04/21/2010 at 10:19 PM
Results from the 1st QTR 2010 are in an the effects of the quality problems were predicatable.
http://online.wsj.com/article/SB10001424052748704133804575198212277925170.html?mod=rss_Health
Posted by: Bruce Lehr | 04/21/2010 at 10:16 PM
Fierce Biotech provided an update on the $175 M fine that the FDA will levy on Genzyme for its manufacturing failings at its MA facility relative to Cerezyme.
http://www.fiercebiotech.com/story/decree-spells-out-175m-fine-new-penalties-genzyme/2010-04-21
Posted by: Bruce Lehr | 04/21/2010 at 01:22 PM
Update from Financial Times (http://bit.ly/bqSvEQ)on Friday, March 26th. Europe did approve recall of clopidogrel from 8 manufacturers in line with CHMP recommendation. It was considered precautionary. Sanofi-Aventis and BMS emphasied that their source of clopidogrel (branded Plavix) was NOT affected by this recall.
Posted by: Bruce Lehr | 03/28/2010 at 10:07 AM