Arena Pharmaceuticals, Inc. ARNA and Eisai Inc. ESALY announced the completion of two phase I studies on their obesity drug, Belviq. The companies are looking to develop Belviq as a once-daily extended release formulation. Presently, a twice-daily immediate release formulation of Belviq is available in the markets.
The randomized phase I studies evaluated the safety, tolerability, pharmacokinetics and bioavailability of an extended-release formulation of Belviq in 36 healthy adult subjects. Positive results would allow the company to file a new drug application with the FDA later this year.
We are encouraged by Belviq’s progress. Once successfully developed and approved, the extended-release formulation will provide patients with additional treatment and dosing options.
The news comes shortly after the companies announced that the U.S. Patent and Trademark Office issued a new patent (U.S. Patent No. 8,999,970) to Belviq. The patent, which covers the method of selecting appropriate patients based on renal function, is expected to extend Belviq’s exclusivity until 2033.
Belviq is approved for weight management in the U.S. Arena Pharma and Eisai are evaluating Belviq for additional indications. Currently, Belviq is being evaluated for smoking cessation and weight management in combination with phentermine.
We note that Belviq is Arena Pharma’s sole marketed product. Arena Pharma has a collaboration agreement with Eisai in the U.S.
Meanwhile, the obesity market is getting more crowded – Novo Nordisk’s NVO Saxenda is the latest entrant in this market. Several health care companies are also looking to bring obesity treatments to the market.
Arena Pharma currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cytokinetics, Inc. CYTK, carrying a Zacks Rank #1 (Strong Buy).
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