Aside from the closely-watched taspoglutide data, a slew of new reports came out of the ADA meeting on experimental diabetes drugs. Here’s a sampling of the top news stories:

Boehringer Ingelheim laid out data from five trials of its diabetes drug linagliptin, demonstrating lowered blood glucose compared to a placebo. Boehringer is hopeful that the therapy can compete against Januvia and Onglyza after proving that the DPP-4 inhibitor works effectively without having to adjust the dose to the patient.

Orexigen released new data demonstrating how Contrave spurred weight loss among diabetics, helping them to achieve healthier blood glucose levels. Priscilla Hollander, an investigator at Baylor Medical Center, said the data showed how weight loss and weight management could help diabetics. Orexigen’s study involved more than 500 Type 2 patients. Contrave has been filed for an approval.

Bristol-Myers Squibb and AstraZeneca revealed that a late-stage study demonstrated that its drug dapagliflozin outperformed a placebo. The trial recruited more than 800 Type 2 patients and tested three doses of dapagliflozin and insulin in comparison to an insulin/placebo combo.

On Saturday Novo Nordisk announced that a mid-stage study of the experimental degludec insulin could effectively lower blood sugar levels when administered only three times a week. “(Blood sugar) reductions were similar across the once-daily and three-times-weekly insulin degludec groups … and comparable to insulin glargine,” Novo said. Novo also touted new data on Victoza, which was approved in the U.S. earlier this year.

A 12-week study of Johnson & Johnson’s canagliflozin produced a bigger drop in blood sugar than Merck’s Januvia. The drug is headed into Phase III.

Source: FierceBiotech

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Novo Nordisk’s new diabetes drug Victoza proved more effective than Merck & Co’s Januvia in a head-to-head study, boosting prospects for a product that has got off to a strong start in key markets.

Daily injections of both high- and low-dose Victoza reduced blood sugar levels by more than a daily tablet of Januvia in people with type 2 diabetes who had not responded adequately to the older drug metformin, researchers said on Friday.

The results may help the Danish drugmaker, which funded the study published in the Lancet journal, to differentiate its medicine in a highly competitive marketplace.

Victoza is Novo’s biggest new drug hope and is expected to generate annual sales of more than $1.4 billion by 2014, according to consensus forecasts compiled by Thomson Reuters.

After a delayed path to market, prescription trends suggest it is now doing well in both Europe and the United States, in contrast to disappointing sales of some other recently launched new drugs, such as Eli Lilly’s bloodthinner Effient.

Mads Krogsgaard Thomsen, Novo’s chief scientific officer, said the results followed other positive comparative studies and would bolster Victoza’s reputation among medical experts.

“The fact that Novo Nordisk has now done most, if not all, of the major comparator studies against different classes of oral and injectable anti-diabetic drugs really shows our commitment to showing comparative efficacy in a serious way,” he said in a telephone interview.

Novo demonstrated two years ago that Victoza controlled blood sugar better than Byetta, a drug from the same class of medicine that is sold by Eli Lilly and Amylin Pharmaceuticals.

PROGRESS REPORT

With investors awaiting a progress report on Victoza’s sales prospects when Novo reports first-quarter results on April 27, Thomsen said demand for the new drug was following the company’s own “optimistic” expectations.

“We have overtaken Byetta in several European markets in the first nine months post launch and in the U.S. we are already seeing, nine weeks into the launch, a rather sizeable uptake,” he said.

In the latest study, 1.8 milligrams of Victoza, or liraglutide, lowered levels of HbA1c — a standard blood measure that is indicative of a patient’s glucose levels — by 1.5 percentage points against 0.9 percent for Januvia, or sitagliptin.

The lower dose of 1.2 mg of Victoza cut HbA1C by 1.2 points in the six-month trial.

Researcher Dr Richard Pratley of the University of Vermont College of Medicine and colleagues said the difference was “clinically relevant,” adding that patients on Victoza, which caused some nausea, also lost more weight.

In an accompanying comment, Dr Andre Scheen and Dr Regis Radermecker of Belgium’s University of Liege said 1.2 mg of Victoza should be considered as a starting dose in most cases, with patients moving up to 1.8 mg if necessary.

On the downside, they noted that Januvia was cheaper, caused fewer gastrointestinal upsets and “one pill of sitagliptin daily might be judged as easier to administer than one subcutaneous injection of liraglutide daily.”

Source: Reuters

Popularity: 5% [?]

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: 3% [?]

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: 3% [?]

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: 6% [?]

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: 3% [?]

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: 4% [?]

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: 6% [?]

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: 7% [?]

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: 4% [?]