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Biotech / Medical : Cardiome -- CRME
CRME 2.330-2.1%May 16 5:00 PM EST

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To: dr.praveen who wrote (133)2/19/2007 9:49:11 AM
From: Ian@SI  Read Replies (2) of 285
 
Congratulations Dr P., NDA accepted by FDA.

I managed to snag 1000 shares at C$13.30, $0.14 below Friday's close. Trading is quite slow - Less than 13000 shares in Toronto with a high of 13.99 and a wide B/A spread.

I suspect that most traders have just taken the day off due to the US market being closed. Or perhaps Canadians don't read press releases???

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Cardiome And Astellas Announce Acceptance Of NDA For Review

cnw

NASDAQ: CRME TSX: COM

VANCOUVER and DEERFIELD, IL, Feb. 19 /CNW/ - Cardiome Pharma Corp. (NASDAQ:CRME / TSX:COM) and its co-development partner Astellas Pharma US, Inc. today announced that the New Drug Application (NDA) for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation, has been accepted for review by the U.S. Food & Drug Administration (FDA).

The NDA for vernakalant (iv) was submitted in December 2006, and is based on a 5-year clinical development program. Upon approval, vernakalant (iv) will be marketed in the United States by Astellas Pharma US, Inc., a US affiliate of Astellas Pharma Inc. The trade name for the marketed product has not yet been determined.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (iv) to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico.

About Cardiome Pharma Corp.

Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), and a pre-clinical program directed at improving cardiovascular function.

[SNIP]
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