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Biotech / Medical : Munch-a-Biotech Today
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To: DewDiligence_on_SI who wrote (2871)5/24/2010 10:50:50 AM
From: tuck  Read Replies (1) of 3158
 
The "supply chain problem" is a biggie:

Press Release Source: Javelin Pharmaceuticals, Inc. On Monday May 24, 2010, 9:05 am EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel acute care pain products, today announced that Therabel Pharma UK Limited ("Therabel"), a subsidiary of Therabel Pharma N.V. and Javelin's licensee of commercial rights to Dyloject™ (diclofenac sodium) in the European Union recently informed Javelin and publicly announced that it is withdrawing all batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a Drug Alert Class 2 Medicines Recall.

Therabel reported that it became aware of the presence of a white particulate matter in some vials of Dyloject in its supply chain. These findings were promptly reported to The Defective Medicines Reporting Centre (DMRC) of The Medicines and Healthcare Products Regulatory Agency (MHRA) in accordance with standard procedures.

Therabel further reported that its review of pharmacovigilance information does not appear to indicate any detected patient safety concerns linked to the particulate matter found in some vials. Dyloject has been marketed in the UK since December of 2007.

Therabel has indicated that it is cooperating fully with the MHRA and is active in an investigation to resolve this matter and to restore the supply of Dyloject to the UK market as soon as possible. Javelin is providing assistance to Therabel with its investigation.<<

snip

Stock off 25% (ouch!). This might indeed be a deal killer.

Cheers, Tuck
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