April 11, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Although predicting the next blockbuster drug is tricky, Todd Campbell, writing for The Motley Fool, gives it a shot. He looks at three biopharma companies with late-stage drugs that, if approved in the next couple years, could blow company stock into the stratosphere.
It was just reported yesterday that Medivation ’s David Hung will be leading Vivek Ramaswamy’s Axovant Sciences . Axovant Sciences (AXON) acquired intepirdine for mild-to-moderate Alzheimer’s disease for $5 million from GlaxoSmithKline . In early trials, the drug showed a favorable safety and tolerability profile, as well as immediate and sustained efficacy over placebo.
Axovant’s MINSET clinical trial recently completed enrollment. It will look at 1,315 patients on a stable background therapy of Aricept (donepezil) who will receive either intepirdine or a placebo. Topline results are expected in late September 2017.
There’s likely two factors here. First, any successful Alzheimer’s drug is going to rake in money. The second is that intepirdine is being evaluated in conjunction with Aricept, which is the best-selling drug for Alzheimer’s. For all that, it’s not really all that great a drug, so anything that improves on it would be a good thing for patients.
Campbell writes, “If intepirdine proves that it can improve cognition and brain function when used alongside Aricept, it could become part of standard of care for patients with mild-to-moderate Alzheimer’s disease. If so, Axovant Sciences share price could climb because Aricept was generating $2.4 billion in sales prior to losing patent protection, and Axovant’s market cap is only $1.5 billion.”
Axovant is currently trading for $20.35.
Based in Ann Arbor, Mich., Esperion Therapeutics is focused on cholesterol, and is developing bempedoic acid. It is an oral formulation that can be taken alongside statins. In mid-stage clinical trials, bempedoic acid and statins combined improved bad cholesterol levels by an additional 20 percent. The drug is currently in Phase III clinical studies, with data expected sometime next year. There is some speculation that Pfizer (PFE) might be interested in acquiring Esperion.
Statins don’t work for everyone, and a new class of cholesterol drugs, PCSK9 inhibitors, which work fairly well for high-risk, statin-resistant patients, are very expensive. If bempedoic acid can do what PCSK9 inhibitors do, but at a lower price, there’s a big carve-out in the market.
Campbell notes, “At first, bempedoic acid could get approved for use alongside patients taking the maximum tolerated dose of statins, who have hypercholesterolemia, and who are at high risk of cardiovascular disease. Additional studies, however, could expand the addressable market opportunity to include the 5% to 20% of patients who are statin intolerant, as well as patients who use statins plus Zetia, another cholesterol-lowering medicine.”
Experion is currently trading for $37.93.
In September 2016, this Irvine, Calif.-based Aerie Pharmaceuticals ' stock jumped over 55 percent when it announced that its Roclatan for glaucoma had positive data on its Phase III clinical trial. Roclatan is a once-daily eye drop. It combines Rhopressa, another Aerie product, with latanoprost, the most widely prescribed glaucoma drug in the world. Rhopressa (netasudil ophthalmic solution) targets the trabecular meshwork, which is the primary drainage system of the eye, and the damaged tissue primarily responsible for glaucoma.
It submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Rhopressa on September 6, 2016. It expects a final decision sometime in September 2017.
Campbell writes, “If Roclatan does eventually secure an FDA market share, then it could be a billion-dollar blockbuster because latanaprost represents 36% of the glaucoma market—and its sales were $1.6 billion per year before losing patent protection.”
Aerie Pharmaceuticals is currently trading for $42.80.
