Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Cardiome -- CRME -- Ignore unavailable to you. Want to Upgrade?

To: dr.praveen who wrote (258)	7/15/2008 6:50:29 AM
From: kenhott	Read Replies (1) \| Respond to of 285

My issue with CRME is one of valuation. Because ultimately I think they will have to do an outcome trial to get approve for the oral which is where most of the value is. Outcome trials are not cheap or short or easy but high risk. I am also just following my playbook of trading in between events with CRME. The phase 2 data event was a pretty low risk event in my playbook.

To: dr.praveen who wrote (258)	6/25/2010 3:54:36 PM
From: Ian@SI	Respond to of 285

Another step toward Approval for IV Vernakalant: 7:30AM Merck: Investigational BRINAVESS for Infusion recommended for approval by the CHMP in the EU for the rapid conversion of recent onset atrial fibrillation (MRK) 35.61 : Co and Cardiome Pharma (CRME) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing approval for BRINAVESS, an investigational intravenous formulation for the conversion of recent onset atrial fibrillation to sinus rhythm in adults. The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant =========================================================== Merck heart rhythm drug endorsed by EU agency Thomson Reuters * Vernakalant recommended for some atrial fibrillation cases * Drug licensed from Cardiome last year (Adds details on drug, Cardiome deal) LONDON, June 25 (Reuters) - The European Medicines Agency has recommended Merck & Co's drug Brinavess, or vernakalant, as a treatment for acute atrial fibrillation, or irregular heart beats, the London-based regulator said on Friday. Recommendations for marketing approval by the European agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. The move is a boost for the U.S. drugmaker and its Canadian partner Cardiome Pharma . Merck licensed the heart drug from Cardiome for $60 million and additional milestone payments in April 2009. That deal gave Merck global rights to oral vernakalant for maintenance of normal heart rhythm in patients with atrial fibrillation. It also gave it rights outside of the United States, Canada and Mexico to the intravenous formulation of the drug for rapid conversion of acute atrial fibrillation to normal heart rhythm -- the indication now being recommended in Europe. Japan's Astellas Pharma holds North American rights to the intravenous formulation of vernakalant. Under terms of the agreement, Merck will pay Cardiome an initial fee of $60 million and Cardiome is eligible to receive up to $200 million in payments based on achievement of certain development and approval milestones. Cardiome will also receive tiered royalty payments on sales.