Pfizer and Merck create major diabetes alliance
pharmafile | April 30, 2013 | News story | Research and Development, Sales and Marketing | Merck, Pfizer, diabetes
Pfizer and Merck have unveiled a major new alliance in diabetes which is likely to raise the stakes in the highly competitive therapy area.
The firms have signed a long-term deal to co-develop and market Pfizer’s ertugliflozin (PF-04971729), a competitor in the new SGLT2 inhibitor class.
The two US companies have been great rivals over the years, but Pfizer has now clearly recognised it needs the extra firepower of Merck – and its diabetes blockbuster Januvia – to help gain traction in the therapy area.
Ertugliflozin is now ready to enter Phase III, with trials expected to begin later in 2013, but is in a fierce race to market with other SGLT2 drugs.
J&J’s Invokana (canagliflozin) was the first to gain approval in March this year, with Lilly/Boehringer’s empagliflozin (NDA filed), BMS/AstraZeneca’s Forxiga (dapagliflozin, approved in Europe) and Astellas’ ipragliflozin (filed in Japan) all close behind.
Launched in 2006, Merck’s Januvia is now the top-selling brand in oral diabetes medicine, and marketing a new SGLT2 alongside it – or in a single pill combination – could be a huge success for the partnership.
Januvia and Janumet (Januvia combined with metformin) saw sales rise 23% to $5.7 billion in 2012, and is the clear leader in the DPP-IV class.
Pfizer will be confident that ertugliflozin, despite not being first to market, can however prove to be the best-in-class. Pfizer’s greatest success, Lipitor, joined the statin market in similar circumstances, and the firm will use its experience to maximise market share.
“We are pleased to join forces with Merck in the battle against type II diabetes and the burden that it poses on global health,” said John Young, president and general manager, Pfizer Primary Care.
“Through this collaboration, we believe we can build on Merck’s leadership position in diabetes care with the introduction of ertugliflozin, an innovative SGLT2 inhibitor discovered by Pfizer scientists.”
AstraZeneca and BMS diabetes success
Pfizer and Merck seem to have taken inspiration from rivals AstraZeneca and BMS, and their long-term diabetes collaboration. AZ and BMS have been in partnership in diabetes since 2007, and have been able to share costs and risks (including some pipeline failures) as well as success, such as the marketing of Onglyza, and the joint purchase of Amylin last year.
AZ and BMS have their own SGLT-2 inhibitor Forxiga, which is now approved in Europe, but was rejected by the FDA in January who requested more data, due to concerns about bladder cancer risks.
Pfizer and BMS will expect ertugliflozin to shine in Phase III trials, but if it does not, the blow will be softened by the partnership having shared the costs.
The partnership
Merck and Pfizer have confirmed they will also develop fixed-dose combinations of ertugliflozin with metformin and Januvia (sitagliptin) tablets.
Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products. Pfizer has received an upfront payment and milestones of $60 million and will receive additional payments for clinical, regulatory and commercial milestones. Merck and Pfizer will share potential revenues and certain costs on a 60/40 per cent basis.
“Merck continues to build upon our leadership position in the oral treatment of type II diabetes through our own research and business development,” said Nancy Thornberry, senior vice president and Diabetes and Endocrinology franchise head, Merck Research Laboratories.
“We believe ertugliflozin has the potential to complement our strong portfolio of investigational and marketed products, and we look forward to collaborating with Pfizer on its development.”
More challengers
Texas-based Lexicon Pharmaceuticals is one other player in the market, with its LX4211 tipped as another best-in-class. LX4211 is not only an SGLT-2 inhibitor, but also inhibits SGLT-1.
Phase II trials suggest the drug may produce greater reductions in blood pressure and have a lower rate of infection than other drugs in this class. The firm is understood to be seeking development partners to help fund Phase III trials.
Andrew McConaghie
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