February 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff
All through the upcoming year there are a number of drugs being evaluated by the U.S. Food and Drug Administration (FDA) for marketing approval. The Motley Fool asked three of its contributors to pick one that they’re excited about and why.
Brian Feroldi picked San Diego-based Acadia Pharmaceuticals and its experimental compound Nuplazid. The drug is being evaluated for treatment for psychosis associated with Parkinson’s disease (PDP). There are no other approved drugs for PDP on the market and a decision is expected on May 1, 2016.
On Nov. 2, 2015, the company announced that its New Drug Application (NDA) for Nuplazid had been accepted for review and received Priority Review status. It also had been granted Breakthrough Therapy designation.
Nuplazid is a new class of non-dopaminergic antipsychotic drugs. It acts as a selective serotonin inverse agonist (SSIA), and targets 5-HT2A receptors. In Phase III trials, the drug showed positive effects, and also improved patients’ sleep cycles.
The drug is also being evaluated for the treatment of Alzheimer’s Disease Psychosis and Schizophrenia. According to Feroldi, “This date (May 1) should be exciting for investors, as well, as peak sales for Nuplazid are currently running around $2 billion.”
Sean Williams chose New York, NY-based Intercept Pharmaceuticals and its obeticholic acid (OCA) to treat primary biliary cirrhosis (PBC). Williams notes that the company has had its ups and downs recently when the FDA pushed back the PDUFA data from February to May 29, with a panel review scheduled for April 7. There were potential safety concerns reported around OCA in a midstage study for nonalcoholic steatohepatitis (NASH).
He notes, however, that “OCA was wildly successful in treating PBC. As noted in the late-stage POISE trial, 47 percent and 46 percent of patients in the 10 mg OCA and 5-10 mg OCA cohorts met the primary endpoint, respectively, whereas just 10 percent of patients in the placebo cohort met the primary endpoint.”
Another reason for investors to keep an eye on Intercept is it may be an acquisition target, possibly by AstraZeneca plc (AZN). There are rumors to that effect, although they may just be rumors. Supposedly the company has hired CenterView Partners to consult on a potential merger. There were earlier rumors that Dublin, Ireland-based Shire was interested, but is currently tied up in its acquisition of Bannockburn, Ill.-based Baxalta .
And last, but not least, Cheryl Swanson chose Boulder, Colo.-based Clovis Oncology . She notes that the company’s stock tanked in November when the FDA delayed its review of Clovis’ rociletinib, which gave AstraZeneca ’s competing lung cancer drug, Tagrisso, an open window. Swanson says, “The market is acting as if rociletinib is dead, but the FDA saw enough in the clinical data to delay, not kill, the review. At this point, it’s likely roceletinib will eventually get approved.”
The company also has rucaparib, a PARP inhibitor for ovarian cancer, in late-stage trials. And analysts are projecting $1 billion peak sales for the drug if approved. And roceletinib also has accelerated review in the European Union, with a decision expected sometime in the middle of this year. It is also being evaluated with a Roche checkpoint inhibitor.
“Clovis is a high-risk stock,” Swanson writes, “but it’s worth remembering that the pendulum swings both ways in biotech. If roceletinib gets the FDA nod, that will do a lot to restore faith in Clovis’ management, and this stock could head skyward again.”
Seamus Fernandez, an analyst with Leerink Partners, wrote last October in a research note, “Heading into WCLC (World Conference On Lung Cancer), feedback from MEDACorp key opinion leaders (KOLs) was that if AZD9291 (Tagrisso) maintained its three-months PFS advantage over rociletinib as highlighted at ECLC and ASCO, they would use AZD9291 in 80 to 90 percent of T790m+ patients. With these data, most KOLs still prefer AZD9291, but the impact frequency of rash with AZD9291 versus diabetes with rociletinib suggests that AZD9291 may not dominate the market to the degree previously assumed.”
In other words, AstraZeneca won, but Clovis is a close second, and may very well take a chunk out of the potential $3 billion in top annual sales projected for drugs in this category.
