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Published on 3/8/2006 in the Prospect News Biotech Daily.

DOV Pharmaceutical says net loss up 61% to $53 million in 2005

By Angela McDaniels

Seattle, March 8 - DOV Pharmaceutical Inc.'s net loss more than tripled to $16.9 million, or $0.73 per share, for the fourth quarter ended Dec. 31 from $4.9 million, or $0.23 per share, for the comparable period last year, according to a company news release.

For the year ended Dec. 31, net loss increased by 61% to $53.0 million, or $2.32 per share, from $32.9 million, or $1.67 per share, for 2004.

Revenue for the fourth quarter of 2005 decreased by 36% to $1.4 million from $2.2 million for the fourth quarter of 2004. For the year, revenue increased by 248% to $8.7 million from $2.5 million for 2004.

In 2005, $6.6 million of revenue was an amortization of a $35 million fee the company received from Merck for a license, research and development agreement signed in August 2004, according to the release. In 2004, $2.4 million of the fee was amortized.

The 2005 revenue also includes a $2.0 million milestone payment from Neurocrine Biosciences Inc.

The company predicted that revenue will reach $7.0 million in 2006, including $5.5 million from the $35 million Merck fee and a $1.5 million milestone payment from Neurocrine.

"This past year has been marked by the achievement of key corporate milestones and encouraging advancements made by our key product candidates toward the marketplace," chief executive officer and president Leslie Hudson said in the release.

"In 2006, we look forward to the potential launch of indiplon, analyzing the data for bicifadine's chronic pain New Drug Administration filing and initiating the phase 2 trial of DOV 21,947."

DOV reported that the Food and Drug Administration has agreed to review an NDA for a broad label chronic pain indication for bicifadine based upon the future successful outcome of two phase 3 chronic low back pain clinical trials, currently ongoing, provided that DOV fulfills a phase 4 commitment to study osteoarthritis and neuropathic pain.

DOV also said it will discontinue the conduct of its ongoing vaginal hysterectomy phase 3 trial as it believes that this more severe post-surgical pain model is unlikely to support the repeat dosing analysis of bicifadine required for registration.

DOV is a biopharmaceutical company based in Hackensack, N.J., that discovers, acquires, develops and commercializes drug candidates for central nervous system disorders.


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