July 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff
Sometimes promising drug trials fail. It’s nothing new to the pharma industry. Despite the appeal of the drug, things can fall apart as the potential therapy moves through regulatory hurdles.
A recent Fox Business story suggested that investors estimate about 90 percent of experimental therapies fail to win approval. Several promising drugs have fallen flat this year, including BioMarin ’s stumble when the U.S. Food and Drug Administration rejected BioMarin’s application for Kyndrisa (drisapersen), for the treatment of Duchenne muscular dystrophy. That rejection caused BioMarin’s stock to tumble a bit, but there have been other notable hiccups this year. Fox Business highlighted three failed drugs in the first six months of 2016 that caused stocks to tumble by 50 percent.
Rintega
The failure of Celldex Therapeutics ’ cancer vaccine Rintega was cause for the company’s stock to fall about 80 percent this year. The stock has climbed back a bit, but is still down about 71 percent since January. The company ultimately terminated its research on Rintega, which had at one time earned Breakthrough Therapy Designation by the FDA for treatment of glioblastoma. Despite that loss, Celldex has another promising treatment in its pipeline, this time for triple negative breast cancer. Celldex’s candidate, glembatumumab vedotin, is a protein that binds to gpNMB, a protein found on the surface of tumors. Renauer believes the promise of glembatumumab vedotin for triple negative breast cancer, as well as other cancers, could turn the company around and send its shares back up. Shares of Celldex are currently trading at $4.65.
Rociletinib
Clovis Oncology ’s Rociletinib looked to be a promising drug. However, in the late spring the failure to gain regulatory approval for rociletinib, prompted Clovis Oncology to end all trials of the lung cancer drug and ultimately forced the company to terminate 35 percent of its workforce to address shifting costs. With the failure of rociletinib, Clovis is now focused on the potential U.S. launch of rucaparib, a monotherapy treatment for patients with advanced ovarian cancer with deleterious BRCA-mutated tumors. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015 and the company has commenced the submission of a rolling New Drug Application. Clovis said it anticipates the completion of its NDA submission soon. Clovis said it will also seek approval of rucaparib in Europe later this year. Shares of Clovis are down about 57 percent since the beginning of the year. Clovis is currently trading for $14.58 per share.
Algenpantucel-L
In May, shares of NewLink Genetics cratered after the company announced its pancreatic cancer vaccine Algenpantucel-L failed to meet Phase III endpoints and could even ultimately harm patients. Study results showed that patients taking drug during the trial actually fared worse when it came to survivability than patients taking placebo. Newlink is now looking at its experimental cancer drug indoximod to turn things around. It is also continuing to see if algenpantucel-L has legs when used for other purposes. Shares of the stock fell about 70 percent and is currently trading at $11.71 per share.
