Pfizer, Merck ready diabetes combos
- Pfizer and Merck & Co on Thursday announced Phase 3 results from the VERTIS study of their SGLT-2 inhibitor ertugliflozin in type 2 diabetes patients who were also on Merck's blockbuster DPP-4 inhibitor Januvia (sitagliptin) and stable metformin.
- Both the 5mg and 15mg doses of ertugliflozin showed significantly greater reductions in A1C, a measure of glucose levels, than placebo. The study was presented on Thursday at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Germany.
- The pair of big pharmas intend to submit a New Drug Application for approval from the U.S. Food and Drug Administration for ertugliflozin, as well as two fixed dose combinations, ertugliflozin + Januvia and ertugliflozin + metformin, before the end of the year.
A greater proportion of patients taking ertugliflozin 5mg and 15mg achieved the A1C goal of less than 7.0% recommended by the American Diabetes Association (32.1% and 39.9%, respectively) compared with only 17% in the placebo group.
Ertugliflozin also achieved placebo-adjusted mean reduction in body weight of 4.4 lbs for the 5mg dose and 3.7 lbs for the 15mg dose.
Pfizer and Merck, rivals in some respects, teamed up in 2013 on the diabetes collaboration. Both companies were trying to become more competitive in the therapeutic space. Ertugliflozin was Pfizer's first entry into diabetes, but was meant to bolster Merck's blockbuster Januvia franchise.
Januvia has sales of more than $4 billion annually and is one of Merck's best-selling drugs, but increased competition from rival DPP-4 inhibitors and other diabetes drug classes has the New Jersey-based pharma trying to beef up its presence.
Ertugliflozin will be a late entry to the SGLT-2 space, however. Johnson and Johnson's Invokana (canagliflozin) was the first drug in this class and has so far been the market leader, but other companies like AstraZeneca and Eli Lilly & Co are doing their best to differentiate their respective offerings.
Being able to offer ertugliflozin in combination with Januvia could be a major differentiator in the space, if it clears regulatory hurdles.
- Pfizer and Merck Statement
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