Recently, the US Food and Drug Administration (FDA) approved a revision to the label of type II diabetes drug, Onglyza (saxagliptin), which has been co-developed by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN).
The expanded label includes data from two studies. While one study indicated that Onglyza can be used in adults with type II diabetes suffering from kidney failure, another study emphasized the effectiveness of the combination of Onglyza and metformin.
One of the studies (n=170; 12 week) evaluated the safety and efficacy of the drug (2.5 mg once a day) versus placebo in adults suffering from moderate (n=90) to severe (n=41) kidney damage or end-stage renal disease (n=39).
Data from the study revealed that there were greater improvements in the blood sugar levels of patients treated with Onglyza. The incidence of side effects and opt-outs due to side-effects were similar in both arms. The data indicates that Onglyza can safely be used to treat this patient population.
The other study (n=858: 52 week) evaluated the efficacy of Onglyza versus titrated diabetes drug Glucotrol (glipizide) in patients suffering from inadequate glycemic control. The blood sugar levels of patients in both groups declined identically on being combined with metformin.
Data also revealed that body weights of patients treated with a combination of Onglyza and metformin reduced as against weight gain observed in patients treated with titrated glipizide and metformin. Moreover, the incidence of hypoglycemia (abnormally low blood sugar levels) was lower in patients in the Onglyza combination arm. The data further emphasizes the efficacy of the use of Onglyza as an add-on to metformin.
In November last year, the FDA cleared Bristol-Myers/Astra Zeneca’s diabetes drug, Kombiglyze XR as a once-daily therapy for treating adults suffering from type II diabetes. Kombiglyze XR is a combination of Onglyza and metformin HCl extended-release tablets. In 2009, the FDA approved Onglyza in addition to diet and exercise for treating adults suffering from type II diabetes.
The updation of the label of Onglyza to treat type II diabetes patients with kidney failure broadens the scope of the drug significantly as renal failure is one of the most common side-effects of diabetes.
Our Take & Recommendation
Bristol-Myers currently carries a Zacks #4 Rank (short-term Sell rating). Our biggest concern for the company is the high exposure to generic risk on many of its leading franchises. The loss of exclusivity of key drugs including the blockbuster Plavix will result in significant loss of revenues for Bristol-Myers.
However, we are Neutral on Bristol-Myers in the long-term. The more stable long-term outlook is based on measures taken by Bristol-Myers like the extension of the Abilify agreement with Otsuka, the acquisition of ZymoGenetics and Medarex to combat the looming threat of generics. Moreover, the company intends to launch new products to compensate for the loss of revenues due to the genericization of key drugs at Bristol-Myers.
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