Specialty pharmaceutical company Valeant Pharmaceuticals International (VRX) is just days away from the FDA's final decision on its epilepsy drug candidate Ezogabine.
Ezogabine, which will be known by the brand name Potiga if approved for marketing, is the first potassium channel opener developed for the treatment of epilepsy. The drug is developed jointly by GlaxoSmithKline plc (GSK) and Valeant.
Ezogabine was unanimously backed by an FDA advisory panel in August with the safety of the drug being a key focus. The most discussed adverse event related to Ezogabine was urinary retention. To deal with the adverse events related to Ezogabine the company has also developed a REMS (risk evaluation and mitigation strategy) plan.
The FDA was scheduled to make a final decision on Ezogabine on August 30 but postponed it by 3 months to November 30. The delay was because of the regulators taking additional time to review the REMS for Ezogabine, which was submitted by the company on August 26.
Ezogabine, known as Retigabine outside the U.S., is also under review by the European Medicines Agency.
If approved, Ezogabine will have to compete with established anti-epilepsy drugs like GlaxoSmithKline's Lamictal XR, Pfizer's Lyrica and Neurontin, and Cephalon's Gabitril. Valeant expects Ezogabine/ Retigabine to garner peak sales of $700 million to $1.5 billion while analysts' estimates for the drug's potential sales range from as little as $200 million to $800 million a year.
For investors who are new to Valeant, here's a brief overview of the company.
In September of this year, Valeant and Canadian drug maker Biovail Corp. merged in a deal worth $3.3 billion. The deal was a reverse merger in which Biovail acquired Valeant Pharma and retained the Valeant name. The merger is expected to generate $200 million in annual cost synergies in 2011.
The combined company's pipeline has early and late-stage drug candidates targeting epilepsy, central nervous system diseases such as Parkinson's disease, pain management, and dermatology compounds for the treatment of rosacea, acne and dermatological fungus.
Last month, the FDA issued a complete response letter for Alexza Pharmaceuticals Inc.'s (ALXA) inhaled schizophrenia drug candidate AZP-004 (Staccato Inhalation Aerosol). Valeant is the co-marketing partner for AZP-004.
Looking ahead to the fourth quarter, Valeant expects combined revenue of $500 million and adjusted cash flow from operating activities of about $200 million.
Early this month, on the third quarter earnings conference call with analysts, Michael Pearson, CEO of Valeant said since it is difficult to quantify and compare due to transactional activity ( merger with Biovail) , financial and strategic guidance will be provided in early 2011.
VRX has thus far hit a 52-week low of $13.46 and a 52-week high of $28.50. The stock closed Monday's trading at $25, which is below its 50-day moving average of $26.39 but above its 200-day moving average of $20.12.
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