Boehringer Sees Uphill Battle With Merck, Astra In Diabetes
Boehringers trump card could be that unlike Mercks Januvia and Bristol-Myers and AstraZenecas Onglyza, doctors wont have to adjust the dose of its pill linagliptin for patients with impaired kidney function, said Klaus Dugi, Boehringers head of medical affairs. That means doctors wont have to do extra tests for patients with kidney problems, he said.
“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 said in an Oct. 2 interview at the European Association for the Study of Diabetes conference in Vienna. “It will be an uphill battle to convince them of the benefits of linagliptin.”
Initial results from final-stage trials of linagliptin, the Ingelheim-based drugmakers first diabetes drug, confirm the pill is safe and effective, Boehringer said on Sept. 28, without giving more detailed data. Like Januvia and Onglyza, the pill is in a class of diabetes treatments known as DPP-4 inhibitors that spur the body to produce more insulin and less glucose, or blood sugar.
Significant Potential
Boehringer is analyzing trial results to study how safe and effective the medicine is for patients with different levels of impaired kidney function, Dugi said. The clinical trials will be presented at the American Diabetes Association meeting in June, and Boehringer aims to request regulators approval to sell the drug in 2010, he said. Reviews typically last a year.
Diabetes compounds will be important for Boehringer, Dugi said. Linagliptin has “significant potential,” though it may not equal Januvias sales, he said, declining to provide a specific forecast.
Januvia was approved in the U.S. in 2006 and had $1.4 billion in sales worldwide last year. The U.S. Food and Drug Administration cleared Onglyza in August.
Only about 3 percent of patients who could benefit from a DPP-4 inhibitor are taking one, said Anthony Barnett, clinical director of the diabetes department at Heart of England NHS Foundation, at a Boehringer-sponsored forum on Oct. 2.
“There is a massive amount of room at the moment for these new drugs,” Barnett said, comparing diabetes to the $33.8 billion market for drugs to regulate cholesterol. “Were crying out for them.”
Seeking Revenue
Boehringer, the worlds biggest closely held drugmaker, needs new drugs to replace about 1 billion euros ($1.46 billion) in sales it expects to lose when two of its medicines lose patent protection in 2010. The company announced its expansion into the $27.3 billion diabetes market last fall.
That medicine belongs to a new class of diabetes medicines known as SGLT2-inhibitors, which spur the kidneys to flush excess blood sugar out through the urine. Previous trials have shown SGLT2-inhibitors might be able to help diabetes patients lose weight as well as control their blood sugar.
Bristol-Myers and AstraZenecas dapagliflozin is on track to be the first SGLT2-inhibitor. The two drugmakers presented data at the Vienna conference showing the compound helped control blood sugar levels when used with metformin, a standard diabetes treatment, in patients who didnt benefit from the older drug alone. They have said they plan to seek regulators approval to sell the new pill next year.