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Onyx, Chelsea Therapeutics, Horizon Pharma, Transcept Pharmaceuticals File For Drug Approvals in US


In a wave of filings, Onyx, Chelsea Therapeutics, Horizon Pharma, Transcept Pharmaceuticals ask the FDA to approve new treatments for cancer, Parkinson's, rheumatoid arthritis and sleeping disorder.

Four companies just took a significant step toward getting US approval to sell their drugs, and each case poses an interesting risk-reward dilemma for investors. In separate filings, Onyx Pharmaceuticals (ONXX), Chelsea Therapeutics (CHTP), Horizon Pharma (HZNP) and Transcept Pharmaceuticals (TSPT) submitted applications to sell their experimental treatments.

The next step is for the Food and Drug Administration to actually accept the applications -- a process that can take two months or so. Onyx is hoping for a fast review of its drug carfilzomib for the cancer multiple myeloma. The company's dealings with the FDA have been controversial because the company is in the middle stages of testing the drug. One analyst called Onyx's strategy "high risk."

"We believe the efficacy and safety data within the (FDA) submission provide a compelling basis for accelerated approval of carfilzomib," Onyx R&D chief Ted W. Love says in a statement.

Investors have been less sure about the drug's chances of winning a speedy review (which would mean possible approval early next year). Shares of the company are down 16% this year, trading at $31.06 midday Wednesday.

Chelsea also is asking for a priority review for its drug Northera, to treat a condition known as neurogenic orthostatic hypotension, or NOH, in patients with Parkinson's disease. Unlike Onyx, Chelsea conducted two late-stage human trials for its drug. The studies haven't been a slam-dunk for the company, however, There has been some trouble meeting trial endpoints. NOH is a nervous system disorder that results in dizziness, fatigue and fainting.

Shares of Chelsea fell less than 1% to $3.96 in midday trading Wednesday. The stock has dropped almost 48% this year.

Newly public Horizon applied for approval of Lodotra, a treatment for rheumatoid arthritis. Lodotra is a delayed-release, low-dose version of the already approved drug prednisone, a steroid used to treat inflammation. Prednisone is an effective treatment but has a number of side effects.

"If approved, Lodotra may offer an important new treatment option for patients struggling with the signs and symptoms of rheumatoid arthritis," Horizon CEO Timothy P. Walbert says in a statement.

Shares of Horizon dipped 4% to $7.90 in midday trading Wednesday. The shares are down 13% since the company's initial public offering in July.

Finally, Transcept seeks redemption after the FDA rejected the company's sleeping pill Intermezzo for a second time in July. (See Transcept Tanks on Drug Rejection) In a two-sentence statement, the company says it resubmitted its application after discussing the issues raised by the FDA two months ago.

Shares of Transcept rose 6% to $7.04 midday Wednesday. The stock is down 5% for the year.

The FDA has been concerned about the safety of Intermezzo. The pill is aimed at helping people who wake up in the middle of the night who can't fall back to sleep. The worry about this drug has centered around people who take the drug but don't sleep off the effects. The FDA previously said it was concerned about people who take the pill with less than four hours of sleeping time left before they wake. Intermezzo's active ingredient is zolpidem, the drug in the sleeping pill Ambien.

Twitter: @brettchase
No positions in stocks mentioned.
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