Amgen entered into a definitive agreement to purchase Dezima Pharma for as much as $1.55 billion, boosting its cardiovascular portfolio with the latter's late-stage oral CETP inhibitor TA-8995, the companies announced Wednesday. Sean Harper, executive vice president of R&D at Amgen, remarked that a portfolio containing TA-8995 alongside its PCSK9 inhibitor Repatha (evolocumab), which was recently approved in both the US and EU, will allow the company "to offer more treatment options with different mechanisms of action and modes of administration across varying LDL-cholesterol levels and risk profiles."
Under the agreed terms, Amgen will pay $300 million in cash at closing, as well as up to an additional $1.25 billion in various development and sales milestones. Dezima will also be eligible for low-single-digit royalties on net product sales exceeding a certain threshold. Following completion of the transaction, which is anticipated in the fourth quarter, Dezima will become a fully-owned subsidiary of Amgen.
Results from the Phase IIb TULIP study published earlier this year in The Lancet demonstrated that TA-8995, both as monotherapy and in combination with statins, significantly reduced LDL cholesterol from baseline in patients with dyslipidaemia by 45 percent and 48 percent, respectively, compared to placebo. The study also found TA-8995 to be safe and well tolerated, "without any drug accumulation, as has been reported with other CETP inhibitors," Dezima stated at the time.
Meanwhile, Mitsubishi Tanabe Pharma, from which Dezima in-licenced TA-8995 in 2013, will receive a portion of the $300-million upfront payment, future sales and development milestone payments and royalties from Dezima. Further, Mitsubishi Tanabe will retain development and commercialisation rights to the drug in certain Asian markets, including Japan.
Analysts have expressed caution about CETP-inhibitor development after Roche and Pfizer halted their respective dalcetrapib and torcetrapib programmes. Meanwhile, RBC Capital Markets' analysts suggested recently that CETP-inhibitor programmes being run by Eli Lilly and Merck & Co. are likely to have only a 25-percent to 40-percent probability of success. Still, Eli Lilly said in July that it will continue a Phase III trial investigating its experimental drug evacetrapib based on data from an interim futility analysis. Meanwhile, Merck is developing the CETP inhibitor anacetrapib.
Also on Wednesday, Amgen entered into a research and licencing agreement valued at as much as $1.7 billion for use of Xencor's XmAb bispecific technology platform to develop treatments in the areas of cancer immunotherapy and inflammation.
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