As Spinoff Rumors Spin, Sanofi’s Cholesterol Drug Praluent Gets Approval in Europe
September 28, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Amidst rumors that Paris-based Sanofi will sell off its bio-surgery and renal units, the company, along with Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) had granted the companies approval to market high cholesterol drug Praluent in the European Union’s 28 countries.
Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor approved for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, in other words, a genetic form of high cholesterol.
The EC decision was based on data from 10 pivotal Phase III ODYSSEY trials, including five that were placebo-controlled and five that were ezetimibe-controlled. All trials met primary efficacy endpoints, showing greater reductions from baseline compared to placebo or ezetimibe.
“We are pleased to bring Praluent to European patients in need of further LDL-cholesterol lowering,” said Leonard Schleifer, founder, president and chief executive officer of Regeneron in a statement. “This approval was made possible through the tremendous hard work of our innovative scientists who translated a genetics-based discovery into an important new medicine, as well as thousands of dedicated investigators and patient participants.”
Praluent will go head-to-head with Amgen ’s Repatha (evolocumab), which is also a PCSK9 inhibitor approved for the treatment of high cholesterol.
Meanwhile, investors expect Sanofi to make an announcement on Nov. 6 regarding plans for its animal health unit, Merial. Earlier this year Sanofi reorganized into five business unit, general medicines and emerging markets, diabetes and cardiovascular, Sanofi Pasteur for vaccines, specialty care and Merial.
Inside sources reported by BloombergBusiness indicate that Olivier Brandicourt, Sanofi’s chief executive officer, is considering selling its bio-surgery and renal units, as well as Merial. The company is also apparently evaluating selling Oenobiol, its nutritional, health and beauty supplements unit.
Sanofi bought its bio-surgery unit in 2011 when it acquired Genzyme Corporation It has annual sales of approximately 200 million euros, according to sources.
Brandicourt took over Sanofi after the ouster of controversial chief executive Chris Viehbacher in Oct. 2014. Viehbacher oversaw the acquisition of Genzyme Corporation, and during his tenure more than doubled company stock in six years. His overall strategy was to cut costs and shift the company’s focus to biotechnology, vaccines and OTC medications. He also pushed the company to become more international.
At least some of the controversy was that Viehbacher only spent about a third of his time in France, with the rest of his time spent in the U.S. or traveling internationally. He also had made plans to sell Sanofi’s portfolio of about 200 mature drugs worth about $7.9 billion. Included in the portfolio were blood thinner Plavix, antibiotic Pyostacine and Dapekine, and an epilepsy medication. The portfolio brought in about 2.1 billion euros annually, but due to patent expirations, decreased drug prices and European healthcare budget cuts, was expected to drop by 40 percent over the next decade.
Prior to his appointment to chief executive of Sanofi in February, Brandicourt led Bayer AG ’s healthcare business. He is a French citizen and was chief executive officer and chairman of Bayer HealthCare since 2013. He also ran Pfizer Inc. ’s global specialty and primary care business units.
Brandicourt has indicated he will reveal his five-year strategic plan for Sanofi at the company’s business meeting on Nov. 6. In July he announced the restructure of the company’s management into five operating units, which will take place in January.