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Long-acting Byetta superior in diabetes trial
31 Mar 2009 16:57:33 GMT
Source: Reuters
* Byetta LAR tops other diabetes drugs in head-to-head

* Byetta better at blood glucose control, weight loss

* Amylin shares up 17 percent

By Bill Berkrot

NEW YORK, March 31 (Reuters) - The experimental long-acting version of Byetta, being developed by Amylin Pharmaceuticals Inc <AMLN.O> and Eli Lilly and Co <LLY.N>, demonstrated superior blood sugar control and weight loss to two other widely used diabetes medicines in a head-to-head study.

The data on the drug that only needs to be taken once a week sent Amylin shares up as much as 19 percent on Tuesday, while shares of Lilly, the much larger drugmaker, were 2 percent higher.

Amylin expects to file for regulatory approval of once weekly Byetta by the end of the second quarter. The version of Byetta currently on the market is typically injected twice a day.

The 491-patient, 26-week study compared Byetta LAR, also known as exenatide once weekly, with maximum doses of Merck & Co Inc's <MRK.N> Januvia, known chemically as sitagliptin, and pioglitazone, sold under the brand name Actos by Japan's Takeda Pharmaceutical Co Ltd <4502.T>.

Type 2 diabetes patients taking Byetta LAR experienced a reduction in A1C -- a measure of average blood sugar over three months -- of 1.7 percentage points from baseline, compared with a reduction of 1.0 percentage point for Januvia and 1.4 percentage points for Actos, Amylin said.

The results of the DURATION-2 trial were deemed to be statistically significant.

"Today's data confirm the superiority of exenatide LAR, which has only been assumed to this date, but not tested head- to-head versus existing oral therapies," Lazard Capital Markets analyst Matthew Osborne wrote in a research note.

"We believe data from DURATION-3 trial comparing exenatide LAR versus Lantus could show similar superiority, or at least similar A1C, but with greater weight loss," Osborne said. Lantus is sold by French drugmaker Sanofi-Aventis SA <SASY.PA>.

In addition to the blood sugar control advantage, Byetta patients lost an average of 6.2 pounds (2.8 kg) at 26 weeks compared with a loss of 1.9 pounds (0.9 kg) for Januvia and a weight gain of 7.4 pounds (3.4 kg) for Actos.

Weight loss is a particularly desirable side effect for diabetes treatments as obesity is one of the leading causes of the disease and some treatments, such as Actos, can cause weight gain. Patients in this study were generally not obese, making the weigh loss even more impressive.

"A once-weekly therapy that helps patients achieve A1C targets, with the added benefits of weight loss and no major hypoglycemia, could provide patients with an important option to improve their diabetes care," Dr Richard Bergenstal, executive director of the International Diabetes Center, said in a statement.

The most frequently reported adverse events among Byetta LAR users were nausea and diarrhea, which was similar to Januvia. Upper respiratory tract infection and peripheral edema were the most frequently reported adverse events reported by those taking Actos in the study.

There were no cases of pancreatitis, or inflammation of the pancreas, seen with Byetta LAR patients in the study. That should be viewed as good news as Byetta carries a warning about rare cases of the condition and any that crop up in Byetta LAR studies could arouse extra scrutiny from health regulators making an approval decision.

Amylin shares were up $1.97, or 17.4 percent, at $13.29 on Nasdaq after rising as high as $13.50 earlier in the session. Lilly shares were up 64 cents, or 1.9 percent, to $33.48 on the New York Stock Exchange and shares of Alkermes Inc <ALKS.O>, which is developing the injection device for Byetta LAR, were up 48 cents, or 4 percent, to $12.30 on Nasdaq. (Reporting by Bill Berkrot; Editing by Andre Grenon)
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