Roche licensed taspoglutide, which can be taken just once a week, from French drugmaker Ipsen in 2006. Now, it says, the weekly treatment showed superior reduction of HbA1c -- a measure of blood-glucose levels -- against a dummy pill or placebo in one of the studies. The company also said another study showed its drug reduced blood-glucose levels better than sitagliptin, the generic name for Merck's diabetes drug Januvia, which must be taken daily.
Roche said its drug met initial targets and was well tolerated by patients taking it. As the drug is injected once a week, it has an advantage over daily medicine.
But so far, Merck's fast-growing Januvia, with its $1.4 billion in annual sales as of 2008 merely two years after gaining U.S. Food and Drug Administration approval in late 2006, has managed to firmly entrench itself in the market. The reason, it seems, is the minimal side effects. Januvia's label is also "marginally less cautious" on its use with other drugs, UBS analyst Gbola Amusa told Reuters.
Bank Sarasin analyst David Kaegi explains how Eli Lilly (LLY) diabetes drug Byetta, approved in 2005, didn't gain the same market share because of its side effects, the most common of which include nausea, vomiting and diarrhea. Of course, the recent FDA warning about kidney failure following six deaths won't help.
To compare, Byetta sales were $751.4 million in 2008. But that could come under pressure as a previous study also found Roche's drug performed better than Byetta.
As for Roche's drug side effects, a previous study noted that the most common ones were nausea and vomiting. So even though the data is encouraging in its efficacy and performance, analysts are concerned about the side effects, saying its success hinges on that. Without more data on that front, analysts won't commit.
Then there are the other recent drugs trying from other companies to tap into the ever growing type 2 diabetes market. AstraZeneca (AZN) and Bristol-Myers Squibb (BMY) finally won FDA approval for their diabetes drug Onglyza in August. They pitched it to directly compete with Merck's treatment.
Onglyza is expected to gain blockbuster status eventually, analysts said. There's expected to be plenty of room for growth in this type of diabetes drug -- DPP-4 -- market, with predictions of $7 billion in global sales by 2015.
But the FDA has increased scrutiny of diabetes meds. AstraZeneca and Bristol-Myers are required to perform a post-market study designed to look at the risk of cardiovascular side effects in high-risk patients, while Novo Nordisk's (NVO) drug Victoza, suffered a setback when the FDA this spring couldn't decide on its marketability following data on a type of thyroid tumors seen in rodent studies. Roche's drug so far in studies deemed safe and analysts believe it will gain approval.
So while efficacy and safety are definitely important, as Byetta for example has been shown in studies to have better results than Januvia, it's still often up to patients to determine whether they can tolerate the side effects or not.
Type 2 diabetes is a global epidemic that affects more than 180 million adults worldwide, a number that is expected to more than double by 2030. Even with available therapies, managing type 2 diabetes remains a challenge and patients often fail to achieve important measures. Uncontrolled type 2 diabetes can lead to severe complications such as cardiovascular diseases, stroke, blindness, amputations and kidney failure.