October 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
On Sept. 16, 2015, Thousand Oaks, Calif.-based Amgen acquired Naarden, Netherlands-based Dezima Pharma BV for $300 million and up to $1.25 billion in milestone payments. But now analysts are wondering if the company made a mistake.
The concern revolves around a class of cardiac drugs called CETP inhibitors. Back in 2006, Pfizer Inc. was working with the first generation of CETP inhibitors, studying the compound torcetrapib. The drug was believed to raise HDL, the so-called “good cholesterol.” However, an independent safety board halted a 15,000 clinical trial that compared torcetrapib and Pfizer’s Lipitor because 82 patients died taking the combination compared to only 51 patients dying who received only Lipitor.
Pfizer Inc. killed the torcetrapib program and pretty much discontinued HDL research in 2007. Other companies have continued work on CETP inhibitors. Merck & Co. has anacetrapib and Eli Lilly and Company has evacetrapib. Merck has an enormous clinical trial dubbed DEFINE that showed anacetrapib was safe and increased HDL by 150 percent. It went on to initiate another clinical trial, REVEAL, which started in 2011 and includes 30,000 patients comparing ancetrapib with atorvastatin, a generic version of Lipitor, to atorvastatin alone. It’s not expected to be completed until 2017.
Which brings up Eli Lilly and Company , which yesterday announced it was ending its late-stage development of evacetrapib. This very large Phase III study involved 12,095 patients at 540 sites in 37 countries. Company stock plunged more than 10 percent at the news, before rebounding a bit. In this case, the study wasn’t halted because of safety issues, but because an independent data monitoring committee “suggested there was a low probability the study would achieve its primary endpoint based on results to date,” Lilly said in a statement.
Now all heads are turning to Amgen, who just spent $300 million on a company that has a CETP inhibitor, TA-8995. Writing in Forbes today, John LaMattina said, “Amgen appeared to be willing to press ahead in the CETP field despite being years behind with a Phase III program with TA-8995 that, including the obligatory CVOT trial, has a price tag in excess of $500 million? In light of today’s Lilly announcement, Amgen should cut its losses and drop the program.”
Amgen doesn’t seem to be hurting by the news. Though it’s been down recently, it’s showing an upward trend. Shares traded at a high of $176.59 on July 31, dropped to $147.64 on Aug. 24, then further to $132.24 on Sept. 28. However, shares are currently trading for $150.77.
Hannah Ishmael, writing for BidnessEtc yesterday, noted that Amgen stock seems to be recovering after two major sell-offs, also pointing out that the biotech sector has been volatile recently. “During the past two months, Amgen has received approval for a potential blockbuster drug likely to change the cholesterol market dynamics, and entered into two strategic collaborations. It also finalized an acquisition to further expand into the cholesterol market.”
The approval refers to Repatha, a new class of drugs called PCSK-9 inhibitors. Analysts estimate it could hit sales of $2 to $5 billion.
