healthmedicinet

By Esha Dey and Zeba Siddiqui

Thu Feb 7, 2013 2:05pm EST

(Reuters) – Vivus Inc, opposed to emanate a world’s initial billion-dollar weight-loss pill, is holding a discreet proceed to selling in an try to overcome a skepticism, reserve concerns and lawsuits that have stubborn a diet drug industry.

The association has mislaid scarcely half of a marketplace value given muted sales tarnished a Sep launch of a initial new weight-loss tablet in a United States for 13 years. Two of a it’s largest shareholders have questioned a company’s strategy.

But Vivus, that sent out usually 150 sales member to a aim marketplace of 25,000 doctors, is betting on slow, solid selling of a Qsymia drug to win over customers. Its model, contend analysts, could turn a plans for diet drug makers.

“A slower launch that allows people some time to try and use a drug, and make certain a effects they are saying are good and any risks are some-more modest, creates some-more clarity both in a medical and financial sense,” pronounced Kurt Kessler of ZS Associates, that consults on curative marketing.

Thomson Reuters Pharma estimates sales of Qsymia will strech $1.2 billion by 2017, adult from $128 million in 2013, creation it a largest weight-loss tablet on a market. A drug with annual sales of $1 billion is famous as a “blockbuster” in a industry.

That intensity goldmine has analysts rating a batch of Mountain View, California-based Vivus highly.

Six of 12 analysts suggest shopping Vivus batch and nothing has a “sell” recommendation, according to Thomson Reuters StarMine. Their meant cost aim for a batch is $20.30, some-more than 50 percent above a Wednesday tighten of $13.45 on a Nasdaq.

More than one-third of Americans are obese, a condition that can lead to problems such as heart illness and diabetes. A Sep 2012 news by run organisation Trust for America’s Health estimated a annual weight on a U.S. medical complement from plumpness during between $147 billion and $210 billion.

The widespread has desirous initiatives such as a anathema on vast sweetened drinks in New York, calorie boundary on propagandize lunches and U.S. First Lady Michelle Obama’s childhood anti-obesity campaign, “Let’s Move”.

Demand for weight-loss pills is also high, that is since some investors were unhappy when Vivus warranted only $41,000 from a initial dual weeks of sales of Qsymia. Analysts had approaching it to acquire scarcely 8 times as much.

‘NO IDEAL PATIENT’

Vivus Chief Commercial Officer Michael Miller pronounced a Qsymia launch was “focused and really educationally based.”

Weight-loss pills, that typically work by suppressing appetite, are formed on mind chemistry that is still not entirely accepted by science.

A delayed rollout will concede time for post-marketing studies requested by a U.S. Food and Drug Administration (FDA) to exam for increasing risk of heart conflict or stroke.

Dr. Leonid Poretsky, a medicine with a Albert Einstein College of Medicine in New York City, sees about 100 patients a week who need to remove weight. He says he is nonetheless to accommodate “that ideal Qsymia patient.”

“The drug multiple (in Qsymia) is new, yet a drugs are not,” he told Reuters. “The indicate is to learn a lot about it, and afterwards try it on one or dual patients who are suitable for it.”

Qsymia, a initial tablet to guarantee users 10 percent weight detriment within a year, contains dual formerly authorized drugs that have encountered reserve issues: a ardour suppressant phentermine and a anti-epilepsy drug topiramate.

Phentermine was partial of a “fen-phen” drug combination, a diet remedy pulled from a marketplace in 1997 after causing serious heart problems. Its maker, Wyeth, now partial of Pfizer Inc, paid out billions of dollars in indemnification to patients.

Topiramate, marketed as Topamax by Johnson Johnson, has been shown to boost a risk of split lips in infants when taken by their mothers during pregnancy.

Women aged between 18 and 45 will be compulsory to take a pregnancy exam before being prescribed Qsymia. Neither is Belviq, a opposition tablet grown by Arena Pharmaceuticals Inc and due to strike marketplace soon, suggested during pregnancy.

There are also reputational risks to failure.

John Singer, a selling consultant concerned in a 1999 launch of Roche’s Xenical – a final diet tablet to be launched before Qsymia – pronounced partial of a plea faced by a drug attention now was to conduct open perception.

Many patients, he said, shunned Xenical since of one annoying side-effect in particular: diarrhea.

“Xenical became a boundary of jokes on late-night speak shows – Jay Leno, David Letterman, that kind of stuff. Very quickly, a side-effects form of Xenical became front and core of a story of a drug,” Singer said.

WORD OF MOUTH

Kessler of ZS Associates pronounced drug manufacturers could arrange for patients and physicians to share their practice with a new weight-loss pills in open forums.

“There is flattering high studious rendezvous in obesity,” he said. “It’s expected a drugs will get certain word-of-mouth.”

Arena is available regulatory sequence for Belviq to establish a risk of abuse before it can launch a new pill, giving a association time to fine-tune a possess sales strategy.

“Arena competence sell (Belviq) during a reduce cost or do something crafty with a pricing that would be an advantage,” pronounced Robin Davidson, an researcher with Edison Investment Research. A month’s supply of Qsymia now costs about $160.

Mindy Nichols, a Seattle-based dietician, pronounced Belviq could also advantage from Qsymia’s comparatively aloft risk profile.

“Even yet Belviq’s efficacy is maybe three-quarters that of Qsymia, it could be prescribed some-more often,” she said, adding that clinical trials have shown Belviq to have a additional advantage of fighting smoking addiction.

Starmine information shows a accord cost aim among analysts on Arena is $9.17, or 5 percent above a Wednesday tighten of $8.72.

With health insurer Aetna Inc carrying announced it would yield coverage both for Qsymia and Belviq, a prospects for a adoption of both pills are good.

Referring to Qsymia, Vivus President Peter Tam said: “Once patients and physicians turn wakeful and benefit a knowledge of regulating a remedy … it will be a multi-billion dollar drug flattering quickly.”

(Editing by Anthony Kurian and Robin Paxton)