Wednesday, May 25, 2016

Obesity is $eriou$ Bu$ine$$

One might almost believe they want to fatten you up:

"Drug makers struggle to revive interest in anti-obesity pills once seen as surefire hits" by Meghana Keshavan, May 17, 2016

SAN DIEGO — Obesity may be on the rise, but the market for fat-loss pills? Flat.

With more than one-third of Americans obese, the market seemed ripe for a pharmaceutical that promotes weight loss. Yet company executives acknowledged in a recent earnings call that Contrave sales have basically flatlined.

CEO Mike Narachi said on the call that his team has developed “a focused, creative” plan to promote the drug — in part by targeting patients who are highly motivated to lose weight — and predicted the company would turn a profit in the “near term.”

As recently as five years ago, analysts were predicting that anti-obesity drugs could ring up as much as $3 billion in sales by 2020. Companies were racing to develop next-generation medication that would boost metabolism, dampen appetite, and melt away fat.

Now the mixed me$$ages and ma$$ marketing regarding bad food makes $en$e.

In 2012, San Diego’s Arena Pharmaceuticals launched a new weight loss drug called Belviq, and San Francisco’s Vivus introduced one called Qsymia.

But physicians proved reticent to prescribe the new drugs as they hit the market, in part because of a cultural reluctance to see obesity as a disease requiring medication.

Now your very metabolism is a disease.

Others feared a redux of the diet pill horror stories of the 1990s, imagining the new wave of obesity medications would harm more than help.

“Most doctors are kind of scared to prescribe these drugs,” said Dr. Eduardo Grunvald, director of the University of California, San Diego, Weight Management Program. “That said, I don’t think we’ve done a good job on educating doctors on how to manage obesity today.”

Grunvald said he’s “had great success” prescribing all of the approved weight loss meds.

How much has the industry they paid you?

But the market continues to struggle. Patients who do try one of the new medications often see only modest benefits, in part because some individuals are simply wired to respond better to certain drugs than others.

Newer weight loss drugs only command a small portion of the broader US obesity market, Narachi said. About 75 percent of the prescriptions doled out for weight loss are actually generic amphetamines. Orexigen’s angle, now, is to point out to doctors that these amphetamines can be addictive and only work in the short term — whereas weight loss drugs like Contrave could prove safer.

“In order for us to win, to succeed, our bet is pretty simple: About 18,000 prescribers write the mass majority of obesity prescriptions, and we think they’ll respond to our message of differentiation against generics,” Narachi said.

I thought we all won when.... never mind.

Companies are still pushing obesity treatments through their pipelines, but investors have largely lost interest.


Zafgen reports promising results from drug study
Clinical results for obesity drug lift Zafgen shares
Zafgen ends obesity drug trial after patient death
Zafgen says patient died in clinical trial of obesity drug
Zafgen shares plummet after death of 2d patient
Zafgen drug trial halted after second patient dies

That's when the share price dropped as Zafgen perseveres despite the deaths of two patients.

When Arena launched its obesity drug four years ago, the share price hovered around $10; today, it’s a buck and change. When Vivus got regulatory approval for its drug, shares peaked above $28. It’s been more than a year since it traded above $2.

Novo Nordisk’s Saxenda had a strong start last year, but sales appear to be slowing for this weight loss drug as well.

As for Orexigen, it’s scaling back its dreams and forging ahead.

The company has partnered with Valeant Pharmaceuticals to sell the drug in Europe.

RelatedDrug prices keep rising despite intense criticism

'Twas a Valiant effort anyway.

The company projects it’ll command about 10 percent of the US obesity market by 2018.

But that market is a whole lot slimmer than investors once predicted....

No, thank you, I've had enough puns.


Have you gotten your cholesterol checked yet?

"Cambridge biotech Aegerion Pharmaceuticals Inc. said it is eliminating 80 jobs, about 25 percent of its workforce, as part of a cost-cutting push. The move, which will affect all major departments, will leave about 230 employees at the 11-year-old company, which develops treatments for rare diseases. Aegerion said in a statement that the cuts are an effort to conserve cash and reduce expenses in the face of increased competition. In particular, it cited the introduction of rival therapies vying with its cholesterol-lowering drug Juxtapid, approved by US regulators in 2012. Mary Szela took the helm at Aegerion at the start of 2016 after the resignation of her predecessor, Marc Beer, who was scolded in a so-called warning letter from the Food and Drug Administration in 2013 for exaggerating Juxtapid’s benefits in a television appearance."

More like $colded:

"Aegerion to pay $40M and plead guilty to illegally marketing cholesterol drug" by Ed Silverman, May 12, 2016

Aegerion Pharmaceuticals has agreed to pay $40 million and plead guilty to two misdemeanor charges to settle allegations of improperly marketing a pricey cholesterol drug and violating different federal laws.

Specifically, the company failed to market Juxtapid, which costs about $250,000 a year and is used to treat a rare form of high cholesterol, with adequate directions. The settlement, which is still preliminary, also notes that the drug maker failed to comply with the terms of a mandatory program for ensuring that the risks of taking the medicine are followed by doctors and patients.

In a statement released on Thursday announcing the settlement, Aegerion acknowledged obstructing justice concerning the risk management program, and violating both the Health Insurance Portability and Accountability Act and the False Claims Act. The specific nature of the violations was not disclosed.

The deal was reached with the US Department of Justice and the US Securities and Exchange Commission. The drug maker noted that under preliminary terms of the settlement, it will not be excluded from doing business with federal health care programs, such as Medicaid and Medicare. However, Aegerion will be required to enter into a Corporate Integrity Agreement, which means company executives will be responsible for bolstering and overseeing compliance efforts.

The settlement comes nearly a year after former Aegerion Chief Executive Marc Beer resigned amid a controversy over comments he made about Juxtapid during two different appearances on CNBC’s “Fast Money” television show in 2013. In one episode, Beer said that “patients are going to die of a cardiac event, either a stroke or a heart attack, if we don’t have them on therapy.”

The remarks raised the ire of the US Food and Drug Administration, which sent a letter to the company warning it that his comments “misleadingly” suggested that the drug could reduce cardiovascular events and prolong life.

Something ironic about a lying government accusing others of misleading.

The FDA approval was based on data showing that the pill lowers cholesterol levels in people with a rare genetic disease, homozygous familial hypercholesterolemia. But the company did not submit data showing its drug lowered the risk of a heart attack or death.

And in January 2014, the drug maker received a subpoena from the Justice Department requesting documents regarding its marketing and sale of Juxtapid. Aegerion and Beer are currently defendants in a class action lawsuit brought by shareholders, who claimed his remarks damaged the value of Algerian stock.

And that is the mo$t important thing, health-wi$e.


I'm so stuffed I haven't even read a word and look, it's past time for lunch.

Bayer offers $62b to buy Monsanto

It got $pit out and I missed it?

UPDATE: Aegerion Pharmaceuticals to merge with Canadian drug maker

Also see:

Bayer ups bid for Monsanto

Monsanto rejects latest takeover bid from Bayer

Aegerion to cut 25 jobs

Boston’s Zafgen cuts jobs, shifts focus on obesity drugs after deaths in clinical trials

Just $limming down?