Valeant Pharmaceuticals International, Inc. (VRX) and GlaxoSmithKline (GSK) received FDA approval for their potassium channel opener, Potiga, designed for the treatment of partial onset-seizures in patients over 18. Valeant announced the milestone in a statement on Monday, declaring that “the product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications."
The FDA approval was granted after the drug proved its efficacy in 3 controlled clinical studies involving 1,239 adult patients. The goal of the study was to observe a noticeable minimization in seizure frequency from baseline in the double-blind treatment phase.
Potiga has not yet received an official classification from the FDA and is not expected to hit the market until the end of the year, when the process is complete. The drug was co-developed alongside Sweden’s Meda AB (MEDA), which will receive an upfront payment of $6 million for the approval and 7% on net U.S. sales.
Shares of both Valeant and GlaxoSmith Klein set the tone for trading alongside a bevy of other positive reports for biotechs. GlaxoSmith Klein though, had some negative news to negate the excitement surrounding Potiga. Relenza, the drug company’s treatment for the swine-flu virus, is no longer effective in combating a new, mutated strain of swine-flu according to recent reports. Tamiflu, sold by Roche (RHHBY) and Gilead Sciences (GILD) has encountered the same roadblock according to piece.
Meanwhile, BioCryst Pharmaceuticals (BCRX) began a rally after reports indicated that its drug, peramivir continues to be effective in combating the new swine-flu strain, making it the default leader in the market for this virus.
Elsewhere in the sector, shares of Forest Laboratory (FRX) rose to 52-week highs after billionaire investor Carl Icahn announced his decision to take a large stake, 6.5 percent, in Forest Laboratories Inc and intentions to nominate four directors to its board. Forest has had to contend with considerable revenue declines for its biggest seller. It has also come under fire for its failure to produce new income possibilities following the approaching patent expirations for its antidepressant Lexapro and Alzheimer's treatment Namenda.
Generic drug maker, Akorn, Inc. (AKRX) were also on the move in trading today. The generic drug maker which has a market capitalization of $613 million has continued to gain market favor, adding more than 30 percent since March. Shares have gone from $5 to their current price of $6.86. Last week, the company announced the closing of its offering of $120 million aggregate principal amount of 3.50 percent due 2016.
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