A study released Tuesday by research and advisory firm DecisionResources projects the dyslipidemia market will grow to $31 billion in 2022—at an annual rate of 2%—due to growth from a new class of treatments: PCSK9 and CETP inhibitors.
While the up-and-comers will help spur future growth, the report says the now 26-year old statins, despite having a large generics presence, will still remain the “sales-leading drug class through 2022.”
PCSK9 is an enzyme that acts in cholesterol synthesis. Investigational antibodies promise to block the enzyme and subsequently lower LDL cholesterol. CETP Inhibitors raise HDL cholesterol in order to reduce the risk of cardiovascular disease.
While this new class of treatments is appealing because of their mechanisms of action, it has not yet been proven that lowering LDL cholesterol levels translates into outcome benefits. Drugmakers are also averse to CETP inhibitors after Pfizer’s torcetrapib and Roche’s dalcetrapib both failed in trials
Amgen and Sanofi/Regeneron appear the most likely to get in on the ground floor for PCSK9 inhibitors. Amgen told investors in its second-quarter filing that it expects to release “pivotal data” about its PCSK9 contender, Phase III AMG-145 in the first quarter of 2014. Sanofi/Regeneron, which are collaborating on alirocumab, expect to serve up its initial results from its phase III trial by the end of this year.
Despite the 2014 lag time, Amgen has already prepped for success: the company has already selected three factories—located in Colorado, Puerto Rico and Rhode Island—to manufacture the drug. In a November 2012 interview with Bloomberg, Amgen’s executive vice president Sean Harper had this to say about the program: “AMG-145 is the biggest single thing we have in the pipeline, just in terms of raw horsepower from the perspective of how it affects patients in a positive way. This is a major focus for us because of the potential for impacting the numbers of patients we’re talking about, at levels of outcomes that are very serious.”
The other set of treatments, CETP inhibitors, are currently in development by Merck and Eli Lilly. Merck’s anacetrapib is in phase III trials to assess if it provides a clinical benefit and has an estimated completion date of 2017. Lilly’s candidate, evacetrapib, is also in phase III trials with an approximate completion date of 2016.
However, Dr. Sanjay Kaul, an attending cardiologist at Cedars-Sinar Medical Center in Los Angeles, remains wary of the new treatments: “Monoclonal antibodies…do not have a strong long-term safety record,” which we reported in January’s Therapeutic Focus.
Kaul’s attitude towards CETP drugs is also tempered: “The harsh lessons learned from the ILLUMINATE (torcetrapib) and OUTCOMES (dalcetrapib) studies scream loudly, ‘outcomes, hard outcomes, nothing but the cold hard outcomes.’”