Arena Pharmaceuticals expects to launch its weight loss drug lorcaserin within 12 weeks of FDA approval--with or without a partner, according to the company. The agency's deadline for review of the drug is Oct. 22.
"We are pleased with the timely execution and significant progress made in our lorcaserin program," Jack Lief, Arena's president and CEO, says in a statement detailing the company's 2009 financial results. "As we continue efforts to reach a commercial agreement for lorcaserin, we are building a strong foundation for a successful launch upon potential approval."
Lief tells Reuters Arena aims to secure a commercial partner for the drug, but is prepared to hire a contract sales team on its own if needed. "We will certainly be ready to launch either with a commercialization organization or on our own within 12 weeks of hitting the go button," he adds.
The lorcaserin NDA is based on a data package from a development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase III clinical trial program, BLOOM and BLOSSOM, evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin produced statistically significant weight loss with excellent safety and tolerability, according to the company.
Arena and rivals Vivus and Orexigen Therapeutics are all trying to develop the first new prescription weight loss drug in a decade. Vivus announced March 1 that the FDA accepted its NDA for its obesity treatment Qnexa. The target date for the FDA to complete its review of the Qnexa NDA is Oct. 28. And Orexigen has a couple of obesity candidates: Contrave and Empatic.
- read the Arena release
- see the Reuters coverage