Like a pebble skimming the surface of a pond, the decision by Pfizer to end development of an injectable cholesterol treatment has a ripple effect on rivals. The company cited lower effectiveness over time and safety issues, such as higher levels of immunogenicity and reactions patients felt at injection sites.
But to what extent is its move a positive or negative for these other drug makers? By exiting the market, some Wall Street wags suggest that Pfizer may have provided a boost, albeit in varying degrees.
Right now, three companies — Amgen, as well as a partnership between Sanofi and Regeneron Pharmaceuticals — already sell so-called PCSK9 inhibitors, which are the first major medicines for combating heart disease since statins were introduced nearly three decades ago. Other drug makers, including Alnylam Pharmaceuticals and The Medicines Company, are still developing their own treatments.
So far, the existing drugs have been underwhelming.
Sanofi and Regeneron, and Amgen are running clinical trials to measure the extent to which their medicines lower the risk of heart attacks and strokes. But cardiologists are more likely to prescribe the drugs if the trials show cardiovascular risks drop by at least 20 percent, according to a survey conducted last April by the Leerink brokerage firm. And results won’t be known until next year.
Meanwhile, the list prices for their two treatments are more than $14,000, which have caused a hurdle with insurers. As STAT noted the other day, payers have denied more than 88 percent of first-time prescriptions for patients with commercial insurance in the past year, according to Symphony Health Solutions. For those on Medicare, the first-time rejection rate was about 77 percent.
For these reasons, Pfizer gave the companies currently marketing a PCSK9 inhibitor a big gift.
“From a commercial standpoint, having one less competitor on the market to pressure pricing is positive for Amgen and Sanofi and Regeneron,” Credit Suisse analyst Vamil Divan wrote in an investor note. “A specific concern that we have heard from investors is that Pfizer would likely come in and undercut the price or provide greater rebates to get share in this market.”
In his own note, Barclays analyst Geoff Meacham pointed out that while the drugs share the same mechanism of action, there was a higher rate of antidrug antibodies noticed in the Pfizer drug than what has been seen in the currently marketed treatments. These antibodies can counteract the therapeutic effects of a medicine which, of course, would make the Pfizer medicine less competitive.
He also explained that the rate of such reactions was higher in Praluent, which is sold by Sanofi and Regeneron, compared with a placebo, than in Repatha, which is sold by Amgen. Nonetheless, “the long-term commercial success for Praluent and Repatha are clearly dependent on outcomes data expected in early 2017, but we do not see added risk from this update” on the Pfizer drug, Meacham wrote.
As for the PCSK9 inhibitors that are being developed, The Medicines Company has a treatment that is being closely watched by investors, largely because it’s relying on a different technology provided by Alnylam. Phase 2 clinical trial data is expected to be released later this month at the American Heart Society meeting that will be closely watched for signs of safety and effectiveness.
In a note to investors, RBC Capital Markets analyst Adnan Butt posits that as long as there are no surprises, the drug should prove to be a “highly competitive” alternative to payers since The Medicines Company has boasted about lower costs for developing the treatment. And he believes that “any big biopharma looking for an LDL-lowering program should want” to do a deal.
In other words, The Medicines Company is “now in the catbird’s seat to be the market disruptor,” wrote Leerink analyst Joseph Schwartz.