Over the past few years, we’ve seen some drugmakers choose new executives from the ranks of consumer-products companies. Joe Jiminez, Novartis’ new chief, says his experience hawking Heinz ketchup helps him manage more effectively in the pharma world. Pfizer CEO Jeff Kindler is famous for his status as a former McDonald’s executive.

So if pharma’s going to borrow talent from consumer goods, why not borrow consumer-goods marketing? A New York Times story takes a look at one current pharma campaign–ads and rebates pushing Dysport, the wrinkle-relaxer from Medicis–and asks experts that very question.

To compete with the well-entrenched wrinkle drug Botox, the Dysport campaign takes a satisfaction-guaranteed approach: If patients don’t like their results from Dysport, then Medicis will foot some of the bill for a Botox treatment. “We are so confident that we are literally willing to bet our money that patients will love their Dysport treatment,” CEO Jonah Shacknai told the Times.

Other examples: Sepracor’s free trial of its sleeping drug Lunesta, Merck’s free 30-day supply of the diabetes drug Januvia. And so on. In fact, there are so many free trials and discount offers, you’d have to have a coupon organizer to keep track of them all.

Some experts tell the Times that treating medicine as a consumer product “seems a little creepy.” But there’s no FDA rule against coupons or other offers. Just think of that staple of drug promotion, the free sample. Are rebates and money-off coupons really that different?

Source: FiercePharma

Popularity: 1% [?]

Roche rolled out data from a pair of Phase III trials of its experimental diabetes drug taspoglutide, saying that researchers have nailed down its superiority to Merck’s blockbuster Januvia. The pharma giant also reported that the Type 2 diabetes drug bested a placebo and proved to be well tolerated among patients, but left a sour taste among analysts who wanted to learn more about its side effects.

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Roche licensed the drug, which is injected once a week, from France’s Ipsen. The latest data comes from the second and third of eight planned late-stage trials, as Roche collects a stack of data for regulators in the U.S.Europe.

Analysts appeared happy to see that the drug beat out Januvia–which earned $1.4 billion in 2008–but were left hungering for more insight on the drug’s side effects. New diabetes drugs like Byetta have had trouble gaining a significant foothold in the market due to frequently reported incidents of nausea and vomiting–the two most common side effects of the Roche drug. Bank Sarasin analyst David Kaegi told Dow Jones that the data reported by Roche today shed “little light” on the side effect issue. Analysts will be watching for that at an upcoming diabetes conference in 2010.

Source: FierceBiotech

Popularity: 2% [?]

Should pharma-watchers be worried about Eli Lilly and Bristol-Myers Squibb? After all, they both launched blockbuster hopefuls–the clot-buster Effient for Lilly, the diabetes remedy Onglyza for Bristol–but haven’t racked up the kind of early numbers that the drugs-that-would-be-blockbusters did in the past.

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But as In Vivo points out, times are changing. With insurers steering patients toward generics, patients worrying about drug risks, and these particular drugs facing some heavy-hitting competition, the quick uptake once expected of blockbuster meds may not be in the cards for most drugs, no matter how successful they may be in the long term

Effient is covered by a risk-management plan, which effectively slows down any launch, In Vivo says. Plus, it’s chasing Plavix, the world’s No. 2 drug. Onglyza enters a diabetes drug market shaken by Avandia safety concerns. Its marketing materials still aren’t FDA-approved, which has got to slow down sales efforts. And Onglyza will be competing against Januvia and Janumet, which have been romping and stomping for Merck.

So maybe the sales model should be like Prozac, which built sales slowly, then became a breakout success. In Vivo argues that regulators want new meds like Effient and Onglyza to be slow out of the gate. After all, some fast-growing meds proved not so safe when administered to thousands of new patients not hand-picked by clinical trial committee. What do you think?

Source: FiercePharma

Popularity: 3% [?]

The EU today gave AstraZeneca and Bristol-Myers Squibb the green light to start marketing their blockbuster diabetes drug Onglyza, laying the stage for a head-to-head battle with Merck’s Januvia for market supremacy. And Boehringer Ingelheim is following close behind, angling to position its late-stage diabetes drug in what is shaping up as a fiercely competitive market.

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Boehringer medical affairs chief Klaus Dugi tells Bloomberg that the company is under no illusions just how hard it will be to grab market share from a well-established Januvia and the highly anticipated Onglyza. Both are new generation DPP-4 inhibitors, like Boehringer’s linagliptin, designed to spur insulin production in patients. “The big challenge will be that by the time linagliptin comes to the market, prescribers will have four to five years of experience with Januvia,” Dugi says. ”It will be an uphill battle to convince them of the benefits of linagliptin.”

If Boehringer does win an approval on schedule next year, Dugi adds, it will have one big advantage: Doctors won’t have to test patients with kidney problems to determine the right dose of the drug. And if physicians can avoid having to test patients, they may be more inclined to prescribe the therapy. A fourth quarter launch of Onglyza, meanwhile, is planned in the EU in the fourth quarter.

Source: FierceBiotech

Popularity: 2% [?]

The FDA said today that Merck’s diabetes drug Januvia may be associated with pancreatitis, a serious inflammation of the pancreas that can lead to hospitalization and, in rare cases, death. Merck said that the data suggest the drug doesn’t cause pancreatitis.

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This is the second time in just over a year that a popular, new-ish diabetes drug has been linked to pancreatitis — the previous case was Byetta, which is co-marketed by Amylin and Eli Lilly. In that instance, several deaths were reported.

The FDA said today it had received 88 reports of pancreatitis in patients taking Januvia and Janumet, a related drug that combines Januiva with the diabetes medicine metformin. The agency didn’t report any deaths in cases of pancreatitis in patients taking the drugs, but 66% of the cases did require hospitalization. In 21% of cases, pancreatitis occurred within 30 days of starting Januvia or Janumet; 53% of the cases resolved once after the drug was discontinued.

Merck said that data from clinical trials that included more than 6,000 people, as well as reports that have emerged since the drug has been on the market, don’t show an increased risk of pancreatitis associated with Januvia. The statement notes that simply having diabetes increases the risk of the disorder.

Amylin and Lilly have been named as defendants in Byetta cases brought by 110 plaintiffs in cases primarily related to pancreatitis, Amylin said in its most recent quarterly report. Byetta sales fell slightly in the first half of this year, to $332.8 million from $336 million in the year-earlier period.

Byetta and Januvia are different classes of drugs. But they work in related ways. Januvia slows the breakdown of a hormone known as GLP-1 and a related hormone; Byetta mimics naturally occurring GLP-1.

Merck’s sales of Januvia and Janumet totaled more than $1 billion in the first six months of this year.

Source: The Wall Street Journal

Popularity: 3% [?]

The FDA just approved saxagliptin, a diabetes medicine that will be co-marketed by Bristol-Myers Squibb and AstraZeneca. The drug, which will be sold under the brand name Onglyza, is in a relatively new class, called DPP-4 inhibitors, that can be taken along with older diabetes drugs.

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Until now, Merck’s Januvia has been the only drug in the class on the market in this country. But in late 2006, when Januvia was approved by the FDA, you wouldn’t have guessed that Merck would have the market to itself for so long. That it has is a sign of the tough safety scrutiny the FDA has given to many new drugs in recent years.

The 2006 WSJ story on Januvia’s approval noted that Galvus, a DPP-4 drug from Novartis, was also awaiting approval. But that drug was delayed, then delayed again, over safety concerns based on animal studies — and Novartis finally walked away from getting it approved here (it is approved in Europe).

Takeda submitted its own DPP-4 drug, alogliptin, back in 2007, but that drug also has yet to be approved by FDA — and a statement from Takeda in March of this year suggested that the company may need to gather more data for FDA because of broad concerns about cardiovascular risks for all diabetes drugs.

All these delays, of course, have been just fine for Merck. In the first quarter of this year, the company’s sales of Januvia were over $400 million.

Source: The Wall Street Journal

Popularity: 5% [?]

Merck & Co. entered into a performance-based contract with a US insurer for Januvia (sitagliptin) and Janumet (sitagliptin/metformin), which will link discounts for the products to improvements in medication adherence and the reduction of blood glucose levels in patients with type 2 diabetes, health service company Cigna announced Thursday. Eric Elliott, the president of the pharmacy benefit management division of Cigna, stated that “Merck should be recognized as the first major pharmaceutical company to offer increased discounts on its oral anti-diabetic products, supporting…efforts to reduce A1C levels…regardless of what medication [patients] may be taking.”

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Under the terms of the agreement, Merck will increase discounts on its two products for the insurer if the A1C levels for patients taking any oral anti-diabetic medications show improvement at the end of the year. In addition, if Cigna’s claims data for patients taking Januvia and Janumet show that they are adhering to their physician-prescribed treatment regimen, discounts on the two drugs will increase further. Merck’s products will also benefit from preferred status on Cigna’s drug coverage lists.

Merck commented that it was “committed to finding new approaches to demonstrate the value of our products to patients, physicians and payers,” while Sethu Reddy, a regional director for scientific affairs for the company, said Merck “is confident in the value of both Januvia and Janumet.” Meanwhile, Elliott indicated that Cigna is negotiating similar contracts with other drugmakers. In response to news of the agreement, former chief pharmacy officer for WellPoint, Robert Seidman, remarked that “we’re going to see a growth in outcomes guarantees for pharmaceuticals, and it’s very healthy.”

Last week, sanofi-aventis and Procter & Gamble announced they signed a deal with another US health insurer, in which the companies agreed to reimburse the medical costs of non-spinal fractures in women taking osteoporosis drug Actonel (risedronate sodium).

Source: FirstWord

Popularity: 6% [?]

Merck’s blockbuster diabetes drug Januvia may finally face competition. A Food and Drug Administration panel of outside experts gave a thumbs-up on safety yesterday to the investigational medicine saxagliptin from Bristol-Myers Squibb and AstraZeneca, saying it doesn’t appear to increase risk of heart attack and stroke, the WSJ reports.

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These safety concerns include many drugs in this class of DPP-4 inhibitors and prompted the FDA to issue new industry guidance for investigating cardiovascular risk for new Type 2 diabetes medicines back in December. Merck’s Januvia is the only drug of this type that has made it to market so far, though a number of other companies have tried to get FDA approval.

Novartis was developing Galvus, which was approved in Europe but has been twice delayed by the FDA because of safety concerns. In January, 2008, Novartis said it might give up on seeking U.S. approval for the drug altogether. Last month, Takeda Pharmaceutical was told its DDP-4 contender didn’t meet the FDA’s December safety standards for the class.

With yesterday’s positive committee vote, saxagliptin appears to be one step closer to FDA approval, assuming the agency follows its usual course and accepts the recommendation of its advisory committee.

Source: The Wall Street Journal

Popularity: 3% [?]

The FDA issued guidance documents on Wednesday recommending that drugmakers provide evidence that type 2 diabetes drugs will not increase the risk of cardiovascular events. The guidance is effective immediately and affects future drug applications as well as those currently awaiting regulatory approval.

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Under the new guidance, the FDA recommends that companies testing type 2 diabetes medications recruit patients who are at higher risk of cardiovascular events, and should follow the subjects for up to two years. Moreover, trials should be designed to allow for easier comparisons to assess cardiovascular risks. The guidance also suggests that an independent committee of experts be set up to assess in blinded fashion the cardiovascular events reported during mid- and late-stage trials.

The changes follow an FDA advisory panel recommendation in July in favour of requiring pharmaceutical firms to conduct long-term studies examining the cardiovascular risks for all new diabetes treatments. Mary Parks, director of the FDA’s metabolic and endocrine drug products division, said that “it is safe to assume that if we are going to be requiring a longer duration of trials, that it will add some years, some time to the clinical development process.” She added that more than 100 letters were sent to companies with type 2 diabetes drugs in development.

In response to the news, Cleveland Clinic cardiologist Steven Nissen said: “I think the FDA got this one right,” adding that “the idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need.”

Commenting on the move, Rodman & Renshaw analyst Jason Butler remarked that “there is an increased possibility that drugs in late-stage development, and currently under registration review at the agency, will be delayed should the FDA view the data from ongoing completed clinical trials as insufficient to demonstrate an acceptable risk ratio.” Meanwhile, Washington Analysis’ Ira Loss suggested that any delay to new treatments would benefit Merck & Co., which markets diabetes product Januvia.

Type 2 diabetes compounds currently awaiting US regulatory action include AstraZeneca’s and Bristol-Myers Squibb’s investigational diabetes drug Onglyza, as well as Eli Lilly’s and Amylin’s once-weekly Byetta LAR. Novo Nordisk’s liraglutide is scheduled for review by an FDA advisory committee in early April.

The agency is drafting separate guidance for approved diabetes drugs.

Source: FirstWord

Popularity: 4% [?]

Drugmaker Merck & Co. said Wednesday it will slash 7,200 jobs as part of a new restructuring program that comes as its third-quarter profit plunged 28 percent, due to a hefty restructuring charge and flat sales.

The maker of allergy and asthma treatment Singulair and cervical cancer vaccine Gardasil said it will cut nearly 13 percent of its work force, including many executives, to lower overhead and become more competitive, in its second major restructuring in less than three years.

Whitehouse Station, N.J.-based Merck & Co. said that because of a $612 million charge for restructuring, net income for its third quarter amounts to $1.09 billion, or 51 cents per share. That’s down from $1.53 billion, or 70 cents per share, a year earlier.

The $612 million charge, after taxes, includes a $720 million pretax charge for the new restructuring program, plus $127 million in costs related to the prior restructuring program, announced in December 2005.

Excluding the restructuring charge, which amounts to 29 cents per share, Merck would have posted earnings of 80 cents, 1 cent better than Wall Street was expecting.

The company narrowed its 2008 earnings forecast, to $3.28 to $3.32 per share excluding one-time items. The prior forecast, issued in April, was for $3.28 to $3.38 per share.

Third-quarter revenue was down 2 percent at $5.9 billion, from $6.07 billion in 2007. Analysts surveyed by Thomson Reuters were expecting sales of $6.1 billion.

Sales were hurt by a further decline in Merck’s cholesterol franchise, lower sales for nearly all its vaccines and generic competition for former blockbuster osteoporosis drug Fosamax, which lost U.S. patent protection in February and saw sales cut in half this quarter to $354 million.

The cholesterol drugs Vytorin and Zetia, which Merck jointly markets with partner Schering-Plough Corp., saw sales dip about 15 percent to $1.1 billion in the quarter, cutting Merck’s equity income from the joint venture by 17 percent, to $400 million.

Singulair sales edged up 1 percent, to $1.03 billion, and blood pressure drugs Cozaar and Hyzaar rose 9 percent to $888 million. Some new products, including HIV drug Isentress and diabetes drugs Januvia and Janumet, also sold well.

The new restructuring program announced Wednesday aims to eliminate about 7,200 jobs, 400 of them currently vacant, across the company worldwide by the end of 2011. As part of the program, Merck will streamline management layers by eliminating about 25 percent of senior and mid-level executives. The company currently has a total of about 56,700 employees.

The new job cuts come on top of a massive December 2005 restructuring program, just about completed, that eliminated 10,400 jobs.

The company said the new cuts are expected to produce cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013, but it will cost between $1.6 billion and $2 billion through the end of 2011, when the program is expected to be completed.

For the first nine months, net income jumped nearly 26 percent to $6.16 billion, or $2.86 per share, compared with $4.9 billion, or $2.24 per share, in the January-September period of 2007. Much of that improvement was due to one-time items this year, particularly a $2.2 billion gain related to Merck’s partnership with AstraZeneca LP. Sales for the first nine months were down about 1 percent, to $17.82 billion from $17.94 billion.

Source: Merck & Co.

Popularity: 4% [?]