The FDA on Friday issued a complete response letter for Arena Pharmaceuticals' (ARNA) lorcaserin data, one of three late-stage drugs in late-stage development for the treatment of obesity. FierceBiotech is taking a look back at five years of ups and downs in lorcaserin's history, including early data, an IPO, a blockbuster deal with Eisai and all the clinical trial successes and woes that come with drug development.
Oct. 18, 2005
Arena reveals significant mid-stage trial weight loss
A total of 352 patients took part in the mid-stage trial, with the experimental drug knocking off an average of 1.3 kilograms at doses of 15 mg compared to .4 kilograms for the placebo group. Researchers said that patients taking a lower dose did not lose a statistically significant amount of weight. Item
June 12, 2006
Arena reports successful lorcaserin trial
The company released data from a mid-stage trial showing patients taking lorcaserin achieved a statistically significant weight loss during the 12-week study. About a third of those patients at the highest dose level lost 5 percent or more of their body weight. Story
Nov. 2, 2007
Arena prices $109M public offering
Arena Pharmaceuticals announced the pricing of its public offering of 11,000,000 shares of its common stock at a public offering price of $9.91 per share. Report
March 17, 2008
Arena touts safety profile of obesity drug
A review of the late-stage drug demonstrated no heart safety issues after 12 months of use, a key issue for Arena, whose drug looks much like the Wyeth obesity therapy that was pulled after demonstrating heart valve risks. Article
March 24, 2009
Arena nails $50M financing deal
With its lead therapy in a late-stage obesity trial, Arena Pharmaceuticals announced that it had nailed down an equity financing commitment of up to $50 million from Azimuth Opportunity. Over the 18-month term of the deal Arena could sell new shares of common stock to Azimuth at a previously negotiated discount. Item
April 24, 2009
Arena cuts 130 workers
Hard on the heels of some disappointing late-stage lorcaserin data, San Diego-based Arena Pharmaceuticals axed 130 staffers--close to a third of its total workforce. "Given the challenging economic environment, we believe it is necessary to reduce our cash usage and provide Arena with additional financial flexibility to support our expected filing of a New Drug Application, or NDA, for lorcaserin," the company stated in an SEC filing. Story
June 9, 2009
Arena shares rise on positive data
Arena's stock jumped 25 percent after it announced that two thirds of the patients taking lorcaserin lost at least five percent of their body weight during the study compared to only about a third of the placebo group. And a third of the lorcaserin group lost at least 10 percent of their weight. Patients taking the drug experienced an average weight loss of 17.9 pounds compared to an average loss of 7.4 pounds for the placebo. Article
Oct. 27, 2009
Arena heralds late-stage obesity data
The CEO of Arena Pharmaceuticals (ARNA) said that a second set of late-stage data on its obesity drug lorcaserin continued to show that the drug significantly outperforms a placebo in triggering weight loss and improves cardiovascular risk factors like cholesterol and triglycerides. Two thirds of the patients who complied with the treatment protocol met the five percent weight loss threshold. Item
July 1, 2010
Arena lands $1.3B pact with Eisai
With an FDA panel review looming in the fall, Arena Pharmaceuticals hammered out a U.S. licensing pact for its weight drug lorcaserin with Japan's Eisai. The complex deal package, contingent on lorcaserin's approval, included $50 million up front, up to $160 million in various milestones through approval and on to product delivery, with a potential $1.16 billion in one-time sales-related payments and a purchase price for the drug that slides from 31.5 percent of net sales to 36.5 percent as it nears blockbuster status. Report
July 15, 2010
Arena shares surge on promising lorcaserin data
San Diego-based Arena Pharmaceuticals said that just about half of the patients taking its drug lorcaserin in a two-year trial lost at least 5 percent of their body weight. And that's about twice the rate of weight loss registered in the placebo group. Arena's shares surged 12 percent on the data. News
Sept. 16, 2010
Arena fails to convince FDA panel on lorcaserin
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 5 to 9 against a question that asked whether the potential benefits of the product outweighed its potential risks "when used long-term in a population of overweight and obese individuals," the Wall Street Journal reports. "The panel's vote against approval for lorcaserin underscores the importance of safety, especially in the face of limited efficacy," Zafgen President and CEO Tom Hughes told FierceBiotech in an emailed statement. News
Oct. 14, 2010
Loyal Arena investors battling for diet drug approval
After the FDA's public unveiling of disappointing lorcaserin, Arena investors turned to grassroots petitions to push the FDA toward approval. The investors are making the case that the agency is ignoring its own guidelines on the subject, noting that when drugs are delivered at more than 25 times the normal amount the results don't relate to humans. And a cancer specialist or someone who understands veterinarian medicine should have been on the panel to explain that. Article
Oct. 22, 2010
FDA responds to outraged Arena investors
When Arena investors used grassroots efforts to spark positive action for lorcaserin, they received an FDA response. "Although FDA strives to have broad representation of appropriate medical and scientific specialties on its advisory committees, optimal representation is often difficult to achieve given the strict conflict-of-interest regulations that apply, as well as calendar conflicts," the agency said in the letter. "In hindsight, FDA regrets that no toxicologist participated in the meeting. However, a team of FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies." Report
Oct. 22, 2010
FDA refuses to approve Arena's lorcaserin
The FDA issued a Complete Response Letter to Arena Pharmaceuticals rejecting an immediate approval for the weight drug lorcaserin and pointing the developer down a very narrow regulatory path that just might let the developer skirt the need for new clinical studies. Story