Amylin: Byetta outperforms Januvia

You have to give them credit for trying. Following all the bad news about Byetta possibly leading to severe acute pancreatitis and six resultant deaths, Amylin Pharmaceuticals is looking for something positive to say about the drug. The company yesterday revealed study findings comparing Byetta with Merck's Januvia.

Januvia, Amylin and Eli Lilly claim, is a less potent diabetes medication than Byetta and does not work as well at reducing blood-sugar levels during the two hours following a meal. The study looked at 61 patients who tried each drug for two weeks. Amylin and Lilly together launched Byetta in 2005, and currently nearly three-quarters of a million people take the diabetes medication.

However, at least one analyst seems to think the study was purposed solely to create marketing buzz, since comparing the once-daily pill Januvia with Byetta, a twice-daily injectable in a separate drug class, is an "apples to oranges" comparison. 

The companies released the study results in Rome on Tuesday, at the European Association for the Study of Diabetes. Merck was also there presenting positive data on Januvia. Both drugs aim to treat individuals with type 2 diabetes.

The differences between the drugs aren't just in the mode of administration. Primary care physicians are the main prescribers of Januvia and they tend to prescribe it early in the course of the disease, whereas Byetta is typically more of a specialist-prescribed medication used in more advanced diabetes cases. 

For its part, Merck responded quickly with some of its own study critiques. Dr. Barry Goldstein, vice president of clinical research at Merck told that the study neglected to note that Januvia has less severe side effects than Byetta and works steadily over a 24-hour period. "The study is really looking at the peak of when Byetta is in the body after it is injected," he said.

Byetta prescriptions have been holding at about 50,000 per week, but Januvia prescriptions are almost double that.

Amylin and Eli Lilly have also collaborated with Alkermes in the development of a long-acting version (a once-weekly injection) of Byetta, but the industry buzz is that the pancreatitis news might affect FDA approval of the new version.

While Merck revealed some good news about Januvia, competitors were hot on the trail with revelations about two new drugs in the same class as Januvia, called alogliptin and saxagliptin. The drugs also help insulin-boosting proteins remain in the blood longer, and are in trials and under consideration with the FDA. Takeda Pharmaceutical Company makes alogliptin, while Bristol Myers Squibb and AstraZeneca together will market saxagliptin as "Onglyza" once it clears FDA hurdles.

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