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Encouraging Data on Dapagliflozin

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AstraZeneca (AZN - Free Report) and partner Bristol-Myers Squibb Company (BMY - Free Report) presented encouraging data from an ongoing phase III study on their type II diabetes candidate dapagliflozin. Data from the study revealed that treatment with dapagliflozin combined with metformin and sulfonylurea significantly reduced glycosylated hemoglobin (HbA1c) levels at 24 weeks compared to those in the placebo arm. The study is evaluating the safety and efficacy of dapagliflozin for treating adults suffering from type II diabetes whose disease was unsatisfactorily controlled by the combination therapy of metformin and sulfonylurea.

Data from the study further revealed that treatment with dapagliflozin resulted in a significantly greater number of patients achieving the targeted HbA1c level (<7%). Moreover, patients in the dapagliflozin arm witnessed significant reductions in fasting plasma glucose and body weight at 24 weeks compared to those treated with placebo. Furthermore, a marked improvement in systolic blood pressure was observed at 8 weeks in the dapagliflozin cohort and adverse events were similar in the two arms.

We note that dapagliflozin is marketed in the EU under the trade name Forxiga for treating type II diabetes. The drug is also approved in Australia, Brazil, Mexico and New Zealand. However, the approval path for dapagliflozin has been bumpy in the U.S.  In Jan 2012, the U.S. Food and Drug Administration (FDA) refused to approve the new drug application (NDA) in the submitted form and issued a complete response letter (CRL) to Bristol-Myers/AstraZeneca.

While issuing the CRL, the U.S. regulatory body asked for additional data. The FDA felt that additional data was required for assessing the risk-benefit profile of dapagliflozin in a better manner. Following the receipt of the CRL, Bristol-Myers/AstraZeneca conducted several new studies on dapagliflozin. The companies not only included data from the new studies in the resubmitted NDA but also additional long-term data (up to four years’ duration) from earlier studies. The FDA acknowledged the receipt of the re-submitted NDA for dapagliflozin and assigned a target date of Jan 11, 2014.

We note that sales of the type II diabetes drug were insignificant in the second quarter of 2013. U.S. approval should significantly boost the drug’s sales potential as the type II diabetes market is very lucrative. The market includes big players like Merck and Co. (MRK - Free Report) .

Moreover, generic competition has adversely impacted AstraZeneca's revenues over the past few quarters. This has put significant pressure on the company. Consequently, strong sales of dapagliflozin would provide the company’s top line with the much needed boost.

AstraZeneca, a large cap pharma company, carries a Zacks Rank #3 (Hold). Roche (RHHBY - Free Report) appears to be well paced in the large cap pharma space with a Zacks Rank #1 (Strong Buy).

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