FDA panel turns down Arena/Eisai obesity drug

The likelihood of Arena Pharmaceuticals and Eisai's lorcaserin getting approval any time soon has been reduced by a rejection of the investigational weight loss treatment by advisors to the US Food and Drug Administration.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 9 to 5 that the available data do not adequately demonstrate that the potential benefits of lorcaserin outweigh the potential risks, when used long-term in overweight and obese individuals. Arena, which does not have any products on the market, had argued that the drug was safe at recommended doses but the panel was not convinced.
They noted concerns that had been raised earlier this week by FDA staff who claimed results from Arena's Phase III BLOOM trial did not meet "mean efficacy criterion," where the difference in weight loss between patients on a drug compared to patients on placebo differs by at least 5%. In the aforementioned study, patients on lorcaserin lost an average of 5.8% of body weight compared with 2.2% in the placebo arm.
The FDA committee also noted that studies of lorcaserin in rodents revealed breast tumours among those dosed at seven times higher than the proposed clinical dose for humans, but acknowledged that no such increase was seen in the 7,000 patients treated with the drug.
Jack Lief, Arena's chief executive, was not particularly downbeat, saying that "we believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity". He added that "we will work with the FDA as the agency completes its review".
The regulator is expected to deliver its verdict by October 22 but things do not look good for Arena, which signed up Eisai as its US marketing partner in July. Since the FDA staffers voiced their concerns, the San Diego-based firm's stock has collapsed over 45% and will likely fall again when the markets open later today.
Arena is battling with Vivus and Orexigen Therapeutics to be the first firms to get a new weight loss drug approved by the FDA since Roche's Xenical (orlistat) in 1999. In July, the EMDAC voted 10-6 against backing Vivus' Qnexa (phentermine/topiramate) and Orexigen's Contrave (sustained-release naltrexone/bupropion), partnered with Takeda, is scheduled to go in front of the panel on December 7.

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**Published in "Pharma Times"

FDA panel votes benefits of Arena, Eisai's lorcaserin do not outweigh risks

An FDA panel on Thursday voted 9-5 that the benefits of Arena Pharmaceuticals and Eisai's experimental weight loss drug, lorcaserin, did not outweigh its safety risks "when used long-term in a population of overweight and obese individuals." Panelist Jessica Henderson noted "I do think (lorcaserin) is promising, but there's too much uncertainty at this time."
Echoing concerns raised in FDA staff documents released ahead of the meeting, panelists raised concerns about cancer risks associated with the drug after tumours were observed in studies involving rats given high doses of lorcaserin. No such increased risk was observed in human trials of the drug. Despite the verdict, a number of panel members said lorcaserin was promising and encouraged Arena to keep studying the drug to rule out uncertainties.
Commenting on the vote, Arena CEO, Jack Lief, said the company and marketing partner Eisai "believe that lorcaserin has a positive benefit-risk profile."
An FDA decision on the drug is expected by October 22. Analysts predict that if approved, lorcaserin could have peak annual sales of $822 million. In July, the same FDA panel voted against recommending approval for Vivus' weight loss drug Qnexa (phentermine/topiramate) due to safety concerns. In addition, Orexigen Therapeutics' obesity treatment Contrave (bupropion/naltrexone) is scheduled to have its agency panel review in December.

--Reference Articles
Arena and Eisai provide update on lorcaserin FDA Advisory Committee Meeting - (Arena Pharmaceuticals)
Arena fails to win US panel’s backing for obesity treatment - (Bloomberg)
FDA panel rejects diet drug lorcaserin - (Chicago Tribune)
FDA briefing document - (FDA)
US advisers reject Arena diet drug - (Forexyard)
FDA panel rejects diet pill - (The New York Times)
FDA panel rejects Arena's weight-loss drug lorcaserin (free preview) - (The Wall Street Journal)
FDA panel says 'no' to experimental diet pill - (The Washington Post)
FDA panel votes no on Arena Pharmaceuticals' locaserin drug - (TheStreet.com)
Arena Pharmaceuticals obesity drug shot down by FDA panel - (Xconomy)

**Published in "First Word"

FDA staff question effectiveness of Arena, Eisai's obesity drug lorcaserin

FDA staff said Tuesday that Arena Pharmaceuticals and Eisai's experimental weight loss drug, lorcaserin, met one of the agency's effectiveness standards "by a slim margin," but concerns remain about the drug's safety. Arena shares fell as much as 37 percent on the news.
In documents released ahead of an advisory panel meeting Thursday, Eric Colman, deputy director of the FDA’s Division of Metabolism and Endocrinology Products, noted that lorcaserin did "satisfy the categorical efficacy criterion" of helping at least 35 percent of patients lose at least 5 percent of their weight.
However, the study results "did not satisfy the guidance’s mean efficacy criterion," where the difference in weight loss between patients treated with the drug compared to patients in the placebo group be different by at least 5 percent. In the BLOOM trial, patients treated with the drug lost an average of 5.8 percent of their body weight compared with 2.2 percent body weight loss in the placebo group. The agency noted that a product is considered effective if it meets at least one of the criteria after one year of treatment.
FDA staff also noted that studies of the lorcaserin in rodents demonstrated there was an excess of breast tumours among those dosed at 7 times higher than the proposed clinical dose for humans, but said that no such imbalance in reports of cancer was observed among the more than 7000 patients treated with lorcaserin in late-stage clinical trials. The panel will be asked to vote on whether it thinks the benefits of lorcaserin outweigh the potential risks "when used long-term in a population of overweight and obese individuals."
Commenting on the documents, Hapoalim Securities analyst, Jon Lecroy, said that "knowing the drug doesn’t work that well, I knew the safety concerns would be looked at extremely closely," but said that "the big surprise to us here is the cancer" risk.

Reference Articles
Arena’s diet pill works by a ‘slim margin,’ FDA says - (Bloomberg)
FDA questions safety, effectiveness with diet pill - (MSN Money)
FDA: Arena's weight-loss drug lorcaserin meets one standard (free preview) - (The Wall Street Journal)
Arena tanks on drug safety concerns - (TheStreet.com)
Arena obesity drug was effective by ‘slim margin,’ FDA staff raises rat concern; shares tumble - (Xconomy)

**Published by "First Word"

Helsinn Healthcare S.A. y Eisai Inc. amplían sus relaciones

Helsinn Healthcare S.A. y Eisai Inc. han anunciado hoy la firma de un acuerdo de licencia que concede a Eisai Inc. los derechos de comercialización de un nuevo producto para su uso potencial en la prevención de los vómitos y náuseas inducidos por quimioterapia (CINV) en Estados Unidos. El acuerdo cubre el desarrollo de un producto de combinación de dosis fija (en forma oral y IV) que contiene netupitant, un antagonista receptor de la neuroquinina-1 (NK1), y palonosetron, un antagonista receptor de la serotonina-3 (5-HT3).
Según los términos del acuerdo, Helsinn Healthcare S.A. será responsable de realizar todas las actividades de desarrollo (CMC, preclínicas y clínicas), consiguiendo la aprobación normativa y disponiendo de la aplicación de nuevo fármaco. En caso de recibir aprobación por parte de la Administración de Fármacos y Alimentos, la combinación de dosis fija de productos oral y IV se promocionará de forma conjunta en Estados Unidos por medio de Eisai Inc. y Helsinn Therapeutics (U.S.) Inc. La filial de fabricación de Helsinn en Irlanda, Helsinn Birex Pharmaceuticals Ltd., será responsable de la fabricación y suministro de los productos acabados para uso clínico y comercial en Estados Unidos.
Además, Helsinn Therapeutics (U.S.) Inc. ha firmado un acuerdo de servicio detallado con Eisai Inc. para promocionar de forma conjunta la marca existente Aloxi(R) (palonosetron hidrocloruro) en el mercado de Estados Unidos. Como resultado, Helsinn Therapeutics (U.S.) Inc. reclutará y contratará una fuerza de ventas dedicada para visitar a los principales oncólogos médicos de Estados Unidos.
Riccardo Braglia, consejero delegado de Helsinn group, afirmó: "Estamos muy orgullosos de que la colaboración de éxito existente con Eisai Inc. en Estados Unidos para Aloxi(R) ya se haya ampliado a una promoción conjunta de Aloxi(R) y en caso de recibir aprobación, a Netupitant-Palonosetron FDC, además de fortalecer a nuestras dos compañías para permitir que los pacientes dispongan de tratamientos adicionales para CINV ahora y en el futuro".
"Eisai se ha comprometido a satisfacer las necesidades médicas no cumplidas y contribuir a la salud y bienestar de las personas en todo el mundo", indicó Lonnel Coats, director general y responsable de operaciones de Eisai Inc. "Nuestras relaciones esperadas con Helsinn demuestran que nuestro objetivo en la oncología y tratamiento de apoyo ayudarán a fortalecer nuestra presencia dentro del sector de la terapia anti-emesis".