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VIDEOThumbs Up for Valeant's Potiga Means Victory for Biovail
Briefing documents seem positive for the company's epilepsy drug.
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The documents were released ahead of the Peripheral and Central Nervous System Drugs Advisory Committee meeting that will be held on Wednesday. The meeting will take a look at the approvability of Potiga, a drug meant to be an add-on therapy for the treatment of seizures in epilepsy patients.
The FDA will make a final decision about the approvability of the drug by August 30, but the panel’s recommendation will likely be a huge factor in the oversight agency’s decision.
While the briefing documents show that the panel views the drug as effective for this indication, it also shows that safety is a concern. Several studies were conducted using different doses of the drug -- adverse events seem to increase (including patients dropping out of the study due to adverse events) as the doses got higher.
“We have identified no issues that would undermine the conclusion that ezogabine is effective in this setting. With regard to effectiveness, we will be particularly interested in the Committee’s view of whether or not a dose of 1200 mg/day offers an additional benefit compared to the 900 mg/day dose, and whether there are adequate data in the US,” said the documents.
Due to a high incidence of urinary tract toxicity in rodent testing, urinary symptoms were given special attention during clinical trials. The biggest issue that arose was the problem of urinary retention, or the inability to urinate.
“The Data clearly establish [Potiga] to produce urinary retention that in most, though not all, cases was shown to be reversible,” continued the documents. “We are particularly interested in the Committee’s View of this safety signal, and whether or not you conclude that the sponsor has identified mean to adequately monitor for urinary retention.”
The documents were relatively positive beyond this one issue. This bodes well for Valeant, which stands to gain 50% of the US sales if the drug is approved. There are approximately 3 million epilepsy patients in the US and 50 million globally, with partial-onset seizures accounting for 57% of seizure cases. About 30% of these patients stop responding to the normal course of treatment and need an alternative. The standard-of-care medications are made by Pfizer (PFE), GlaxoSmithKline, and Johnson & Johnson (JNJ), among others. Analysts at New BioMedicine Research estimate that the drug could pick up about $300 million in sales for Valeant due to the unmet medical need.
“A positive recommendation by the advisory panel will augment the drug’s chances for approval in the US. If approved and successfully commercialized, we expect Potiga to generate peak US revenues of approximately $600 million for epilepsy,” wrote New BioMedicine analyst Kaushik Paul. “Given that Valeant has collaborated with GSK for the development and commercialization of Potiga and both the companies will be sharing the drug’s US revenues on a 50-50 basis, we assign approximately $300 million in peak US sales to Valeant or 7.71% of the company’s current market capitalization.”
This also is a good sign for Canada’s Biovail: The company is expected to close on its purchase of Valeant by the end of the year.
Biovail has had a storied past but is best-known for its marketing of the antidepressant Wellbutrin and the grandiose proxy battle the company had with its founder Eugene Melnyk. Since resolving that fight, the company has vowed to go in a new direction -- specifically, a focus on the Central Nervous System. A recent earnings report from the company shows that this gamble is paying off and the contribution of Valeant will only stand to strengthen the company and the stock.Twitter: @biowriterchik
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