THOUSAND OAKS, Calif. & NAARDEN, The Netherlands—Amgen is looking at a growth spurt with the newly announced acquisition of Dezima Pharma B.V. Amgen has entered a definitive acquisition agreement with the privately held biotechnology company, which focuses on innovative treatments for dyslipidemia, an abnormal amount of lipids (such as cholesterol or triglycerides) in the blood.
SOURCE: Amgen press release
Per the terms of the agreement, Amgen will pay $300 million in cash at the closing of the deal and up to $1.25 billion in additional payments if certain development and sales milestones are met, with low single-digit royalties to be paid on net product sales about a set threshold. The agreement subject to customary closing conditions and regulatory approvals, and is expected to close in the fourth quarter of 2015. Dezima's shareholders have approved the agreement. Once the deal closes, Dezima will become a wholly owned subsidiary of Amgen.
"We are delighted to join Amgen, as the company has shown impressive leadership in the cardiovascular space by their rapid and state-of-the-art development program for Repatha, their injectable PCSK9 inhibitor," said Rob de Ree, CEO of Dezima, in a press release. "Owning both Repatha and TA-8995, each innovative and complementary therapies with the potential to serve a broad range of patients with high cholesterol, will further solidify Amgen's position in the future treatment of dyslipidemia."
TA-8995 is Dezima's lead molecule, an oral, once-daily cholesteryl ester transfer protein (CETP) inhibitor being developed as a treatment for dyslipidemia. In a Phase 2b clinical trial in that indication, the compound reduced low-density lipoprotein cholesterol (LDL-C) by 45 to 48 percent compared to baseline, and that reduction was consistent whether TA-8995 was administered as a monotherapy or in combination with statins. The most common adverse events noted in the trial were nasopharyngitis (inflammation of the nose and throat) and headache.
Dezima originally licensed rights to the compound from Mitsubishi Tanabe Pharma Corporation (MTPC); given this, MTPC will receive a portion of the upfront payment from Dezima, as well as future development and sales milestone payments and royalties on net product sales if the specified threshold is met. In addition, MTPC will retain development and commercialization rights to TA-8995 in certain Asian territories, including Japan.
"TA-8995 has demonstrated dramatic LDL-C lowering," Dr. Sean E. Harper, executive vice president of Research and Development at Amgen, remarked in a statement about the deal. "With a portfolio of TA-8995 and Repatha, our recently launched LDL-C lowering PCSK9 inhibitor, we will be able to offer more treatment options with different mechanisms of action and modes of administration across varying LDL-C levels and risk profiles."
Amgen's Repatha received U.S. Food and Drug Administration approval in August as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia, who require additional lowering of LDL-C. The previous month, it received marketing authorization from the European Commission for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or from whom a statin is contraindicated; and as a treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
SOURCE: Amgen press release