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As new weight-loss drugs hit market, no single one to fatten up category

BY Michael Johnsen

NEW YORK —As many as eight pharmaceutical solutions to a condition that affects some one-third of Americans—a condition that plays a significant role in the development of diabetes, heart disease and arthritis—are expected to reach the market in the next few years.

The condition is obesity. And while no one pharmaceutical weight-loss solution is expected to reach blockbuster sales of more than $1 billion, collectively, the market may be as large as $3 billion by 2016, according to a Wolters Kluwer Pharma Solutions analysis of the drugs in development.

The highest revenue generator in Wolters Kluwer’s model is Arena Pharmaceutical’s lorcaserin, which is expected to reach peak worldwide sales of $850 million if approved.

The four drugs closest to filing a new-drug application are Arena’s lorcaserin, currently being tested in phase-3 trials; Orexigen’s Contrave, a fixed-dose combination of sustained-release naltrexone and bupropion in a single, trilayer tablet with an NDA planned for first half 2010; Vivus’ Qnexa, a combination of low-dose phentermine and topiramate, which currently is part of three phase-3 studies for obesity and a phase-2 study for diabetes; and Novo Nordisk’s liraglutide, a long-acting, stable analogue of the natural hormone glucagon-like peptide-1 (glp-1), which currently is in phase 3 for obesity, and under regulatory review in the United States, Europe and Japan for diabetes.

Of the prescription drugs that currently are available in the United States to treat obesity, only two—Abbott’s Meridia (sibutramine) and Roche’s Xenical (orlistat)—are approved for long-term use. And in June 2008, Roche partnered with GlaxoSmithKline on the launch of a nonprescription orlistat 60 mg under the brand name Alli.

While Meridia has the ability to control appetite, offering an average weight loss of4.3% over one year, it can lead to hypertension and increased heart rate. Xenical leads to weight reduction through the inhibition of fat absorption in the gastrointestinal tract. Despite leading to an average weight loss of 2.9% over one year, approximately 20% to 30% of patients taking the drug experienced embarrassing and unpleasant gastrointestinal side effects, including fecal incontinence and urgency.

Between efficacy of less than 5% weight loss and the fact that neither is reimbursed by third-party payers, neither obesity drug really has taken off in sales.

There actually are a total of three factors that will drive widespread adoption of antiobesity agents, Wolters Kluwer Pharma Solutions analyst Claudia Wiatr told Drug Store News—safety, efficacy and reimbursement. Cost and reimbursement perhaps are the most critical to the ultimate adoption of any antiobesity medication, especially as current antiobesity drugs generally are not reimbursed by third party payers in the United States, and many patients are unwilling to pay the more than $100 per month, Wiatr said.

Promising developmental obesity agents

*In millionsSource: Company reports, Wolters Kluwer Pharma Solution
DRUG NAME DEVELOPER PHASE ESTIMATED U.S. APPROVAL PROJECTED 2016 U.S. REVENUE*
lorcaserin Arena Pharmaceuticals 3 March 2011 $713
Contrave (naltrexone/buproprion) Orexigen Therapeutics 3 March 2011 546
Qnexa (phentermine/topiramate) Vivus 3 August 2011 437
liraglutide Novo Nordisk 3 March 2012 517
empatic Orexigen Therapeutics 2 March 2013 243
tesofensine NeuroSearch 2 March 2013 267
pramlintide/metreleptin Amylin 2 August 2013 291
cetilistat Takeda/Alizyme 2 March 2014 12
TOTAL PROJECTED REVENUE       $3,026

The first hurdle that these new obesity drugs need to clear, though, is safety, Wiatr said. “The environment at the [Food and Drug Administration] is very risk-averse,” she said. And the agency likely is to be especially cautious with obesity drugs in light of the psychiatric side effects associated with the class of weight-loss drugs called cannabinoid-1 receptor blockers, such as Acomplia (rimonabant), an obesity remedy that has never been approved for use in the United States and was removed from the European Union market.

The greatest hurdle for any of these new weight-loss drugs, however, is reimbursement—the higher the out-of-pocket expenses are to the end-consumer, the less trial that is likely to ensue. “For a patient to pay $100 per month out-of-pocket for something that only gives 5% weight loss—a lot of patients don’t want to do that,” Wiatr said. At the same time, no drug is going to be reimbursed if it only offers 5% weight loss on average, which is the minimum amount of weight loss that has to occur in clinical trials to prove efficacy to the FDA. “In order for a drug to have commercial success, you need weight loss and efficacy on the order of at least 15%,” she said. “That gives you the greatest chance at optimal reimbursement.” However, only one drug—the pramlintide/metrelptin combination—approaches some 12.7% of weight-loss efficacy, Wiatr added, which is partly the reason no one obesity drug will become a blockbuster.

However, a second aspect of reimbursement is being able to obtain a label for an additional application that already is reimbursable, Wiatr said. For example, Qnexa and liraglutide also are being studied for diabetes, thereby increasing their chances for reimbursement as an obesity remedy.

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Late-stage clinical trial results: MS drug is effective

BY Alaric DeArment

ALISO VIEJO, Calif. Patients taking an investigational drug for multiple sclerosis fared better than those taking placebo, according to late-stage clinical results presented Friday at a neurology conference.

Avanir Pharmaceuticals said MS patients taking Zenvia (dextromethorphan and quinidine) in 30 mg/10 mg doses experienced a 11.9% greater reduction in pseudobulbar effect – an MS-related condition also known as PBA that causes sudden, uncontrollable episodes of laughter, crying and other emotional outbursts – than those taking placebo in a 12-week phase 3 trial, results of which the company presented at the 3rd World Congress on Controversies in Neurology in Prague, Czech Republic. Patients taking the 20 mg/10 mg dose did not do better than the placebo group.

“PBA represents an area of high, unmet medical need with no FDA-approved treatments currently available,” study presenter and trial steering committee member Daniel Wynn of the Consultants in Neurology Multiple Sclerosis Center stated. “Although the involuntary emotional outbursts of PBA cause considerable impairment for millions of individuals in the United States, it is under-recognized and commonly misdiagnosed.”

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New report projects 12.6% increase of probiotics market

BY DSN STAFF

NEW YORK The two takeaways from this story are “the [U.S.] market is expected to grow at a rate of almost 14%” and “the early movers in the industry will benefit in terms of market share.”

 

That about describes the opportunity in a probiotic nutshell.

 

 

The rising interest in probiotics can be credited in part to Dannon’s Activia brand, a line of yogurts and yogurt drinks, which has been heavily advertised to the American consumer with the message that not all bacteria is bad for you — and in fact some bacteria taken on a regular basis can impart some pretty significant health benefits. That advertising message — that probiotics can be an important piece in a healthier-for-you diet — has been all the more reinforced as Bayer supports its probiotic Phillips Colon Health, and as Procter & Gamble rolls out its Align probiotic.

 

 

And the consumers already are core drug store shoppers. The ratio of women to men in search of a product delivering digestive benefits is about 2-to-1, according to industry experts. When women hit their 30s and 40s, that’s the point in their lives when they’re looking for a strategy in life to help them manage their digestive issues.

 

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