Biotech Values

[DewDiligence]

PRCS
An amusing attempt to package bad news as good…

http://biz.yahoo.com/bw/050928/286118.html?.v=1

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PRAECIS PHARMACEUTICALS INCORPORATED Announces German Regulatory Approval for Plenaxis(R)

Schering AG Collaboration Terminated [Oh yeah… that too!]

WALTHAM, Mass.--(BUSINESS WIRE)--Sept. 28, 2005--PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS ) today announced that it has received marketing authorization for Plenaxis® (abarelix 100 mg powder for an injectable suspension) from the German competent authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM). In Germany, Plenaxis® is indicated to initiate hormonal castration in patients with advanced or metastatic, hormone-dependent prostate cancer, if androgen suppression is appropriate.

PRAECIS also announced that it received notice today from Schering AG of Germany that it was exercising its right to terminate the parties' license, supply and distribution agreement due to PRAECIS not having received marketing authorization for Plenaxis® in Germany with a requisite label by June 30, 2005. In connection with the termination notice, Schering AG advised PRAECIS that since the parties differed significantly in their interpretation of the label for Plenaxis® approved by the BfArM, and the consequences for the commercial potential of the product, Schering AG would not continue with the collaboration under the terms of the existing agreement. Schering AG had requested that the parties reconsider the scope of Schering AG's commercialization obligations in Europe, and indicated that it expected a substantial reduction in the milestone payments provided for in the existing agreement upon PRAECIS obtaining marketing authorizations in various European countries.

Kevin F. McLaughlin, President and Chief Executive Officer of PRAECIS, stated, "We are disappointed with Schering AG's decision to terminate our collaboration, especially in light of our receipt of German registration approval which we believe fulfills the contractual requirements for the Plenaxis® label under our agreement. We intend to explore various opportunities for this product, including a license or sale transaction that would enable commercialization of the product in Europe and other territories."

About Plenaxis®

In Germany, Plenaxis® is indicated to initiate hormonal castration in patients with advanced or metastatic, hormone-dependent prostate cancer, if androgen suppression is appropriate. When the duration of therapy is longer than 3 months, the response of the patient to the Plenaxis® therapy must be closely monitored, because in some patients the efficacy decreases between 3 and 12 months and has not been established beyond 12 months. Response to Plenaxis® therapy may be monitored by clinical parameters and by periodically measuring serum testosterone and PSA levels. Following each injection of Plenaxis®, patients should be observed for at least 30 minutes and, in the event of an immediate-onset allergic reaction, managed appropriately (e.g. leg elevation, oxygen, intravenous fluids, antihistamines, corticosteroids, and epinephrine, alone or in combination).
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