|Arena Reports on Launch of BELVIQ (lorcaserin HCl) CIV for Chronic Weight Management in Adults; Glaxo's Avandia Wins FDA Victory|
|By Staff and Wire Reports|
|Friday, 07 June 2013 18:26|
Arena Pharmaceuticals (NASDAQ: ARNA) reported on the launch of BELVIQ (pronounced BEL-VEEK) in the United States. BELVIQ will be available to patients by prescription in US pharmacies beginning June 11. Eisai Inc. is responsible for the marketing and distribution of BELVIQ under its agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc.
BELVIQ is approved by the US Food and Drug Administration for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established.
"Our team discovered and developed BELVIQ with the goal of providing physicians with a new tool to help fight the global obesity epidemic," said Dominic P. Behan, Ph.D., Arena's Executive Vice President and Chief Scientific Officer. "We are proud to provide physicians in the United States with a new treatment option that along with diet and exercise can help committed patients effectively manage their weight."
Arena manufactures BELVIQ at its facility in Switzerland, and sells finished commercial product to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales. The purchase price increases on a tiered basis up to 36.5% on the portion of annual net product sales exceeding $750 million. In connection with the US launch of BELVIQ, Arena has achieved $65 million in milestones from Eisai. Arena is also eligible to receive $1.19 billion in purchase price adjustment and other payments based on Eisai's annual net sales levels of BELVIQ.
"BELVIQ is the product of our vision and commitment to bring novel treatments to physicians and patients for unmet medical needs," said Jack Lief, Arena's President and Chief Executive Officer. "Our collaboration with Eisai is an integral component of the strong foundation we have in place to make BELVIQ available to eligible patients."
Arena's marketing and supply agreement with Eisai covers most of North and South America. Eisai has submitted a marketing authorization application for BELVIQ in Mexico, and plans to submit applications for the approval of BELVIQ in Canada and Brazil this year. Arena also has a BELVIQ marketing and supply agreement with Ildong Pharmaceutical Co., Ltd., for South Korea, and Ildong plans to submit an application for the approval of BELVIQ in South Korea around the end of this year. Arena plans to enter into additional collaborations to support the commercialization of BELVIQ in other territories.
Composition of matter patents for BELVIQ are issued in major jurisdictions globally that, in most cases, are capable of continuing into 2023. Arena has filed applications for patent extension in the United States, which, if granted, will extend the patent term for BELVIQ into 2026.
A government panel called for easing restrictions on the one-time big-selling diabetes drug Avandia, in a remarkable about-face nearly three years after concerns over heart risk led regulators to curtail use of the drug.
The vote was a victory for Avandia maker GlaxoSmithKline PLC (NYSE:GSK), which has maintained that the drug was safe. Glaxo asked Duke University to review a study that the company said showed no increase in heart attacks for Avandia patients, and Duke largely confirmed the company's view.
At a two-day meeting of a Food and Drug Administration advisory panel, FDA officials strongly endorsed the Duke readjudication as credible and professionally conducted. A majority of panelists said they no longer think the heart worries are as serious as once believed.
Thirteen of 26 panelists voted to ease restrictions, and seven more wanted the curbs removed entirely. Five members wanted restrictions unchanged, and one panelist wanted the drug pulled from the U.S. market.
"There remains considerable uncertainty, but I do favor loosening the restrictions," said National Institutes of Health statistician and panel member Erica H. Brittain.
Currently, only certified doctors are permitted to prescribe Avandia. These doctors must state that patients have tried and failed on other diabetes drugs, and patients must attest that they understand the heart risks. The restrictions have limited use of the drug to a fraction of the former number when Avandia was one of Glaxo's top sellers and had sales of some $3 billion a year.
Avandia critics expressed dismay at the results and said the FDA failed to review the full evidence.
Testifying before the panel, Sidney Wolfe of the health advocacy group Public Citizen said a variety of population and other studies showed "unequivocal evidence that [Avandia] had a number of toxicities."
The chief subject of the panel meeting was a study, paid for by Glaxo, that was "open-label," meaning that patients and doctors knew who got Avandia and who didn't. Such studies aren't favored by most researchers because of possible bias.
The FDA in 2010, worried about such factors, asked Glaxo to pay for an independent second look at the data from that original study, which was published in 2009 and known as Record. Glaxo then turned to Duke.
James Shannon, Glaxo's chief medical officer, said: "We appreciate the committee's thorough examination of the Record results and will continue to work with the FDA as it considers the recommendation of the committee." He added, "We continue to believe that Avandia is a safe and effective treatment option for Type 2 diabetes when used for the appropriate patient and in accordance with labeling."
The Record trial contradicted the results of a 2007 analysis of multiple studies by Cleveland Clinic doctors, which showed a 43% heart-attack increase. The Record study, done entirely outside the U.S. and mostly in Europe, did show a doubling of heart failure in Avandia patients.
The FDA in September 2010 put the limitations on the sale of Avandia, following a review by an earlier advisory panel. By keeping the drug on the market, albeit with restrictions, FDA Commissioner Margaret Hamburg was viewed as tilting toward the view of FDA drug chief Janet Woodcock, who maintained for years that the evidence against Avandia wasn't conclusive. By contrast, European regulatory authorities in 2010 barred Avandia altogether.
Glaxo added a black-box warning to the Avandia label in November 2007 saying the drug can cause or worsen congestive heart failure. At the time, Dr. Woodcock said the drug had been "convicted without a trial."
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