Shuttered, Closed, Halted and Killed: Biopharma Companies End Programs
Published: Jun 05, 2018 By Mark Terry
Biopharmaceutical companies cancel programs all the time. Usually it’s either because of clinical failures—somewhere along the line they’re just not getting positive data, or because of cost-benefit ratios, which is to say, it’s taking longer to get the data they want in a competitive market and throw in the towel because the company’s business analysis finds it wouldn’t be profitable. Sometimes it’s simply a matter of priorities changing—the company acquired or developed assets in one area and just didn’t have the resources to pursue it appropriately.
Here’s a look at some notable programs that have been shuttered so far this year.
- Roche ends its olesoxime for spinal muscular atrophy program. This broke on June 1. Roche had acquired olesoxime from Trophis for $140 million in 2015, but recently abandoned the drug. “We have had many difficulties in developing this molecule for people with SMA,” Roche stated. “These difficulties have focused on the formulation (the actual liquid preparation of olesoxime), the most appropriate dose to be given and requests from Health Authorities (FDA and EMA) to run a new Phase III study.” The company is still committed to developing a drug for SMA, just not olesoxime. It still has RG7916 in development in collaboration with PTC Therapeutics and SMA Foundation.
- Johnson & Johnson’s Janssen ended its trials of atabacestat for Alzheimer’s disease. The company indicated that it was shuttering the program because of safety issues, rather than any question about the drug’s efficacy. Patients in the EARLY Phase IIb/III clinical trial with preclinical Alzheimer’s disease, as well as a Phase II long-term safety trial, had elevated liver enzymes. EARLY launched in 2015 and was scheduled to wrap in 2024.
The company stated that “the benefit-risk ratio is no longer favorable to continue development of atabacestat for people who have late-onset preclinical stage Alzheimer’s disease.”
Despite the setback, the company indicated it “continues to maintain a strong commitment to discovery and developing new treatments for this devastating disease.”
- Prothena Corporation, headquartered in Dublin, Ireland, announced in April it had shuttered its NEOD001 program for AL amyloidosis after the failure of its Phase IIb PRONTO study and Phase III VITAL study. Shares dropped 60 percent in premarket trading at the news.
The Phase IIb trial did not meet its primary or secondary endpoints. Prothena then asked an independent data monitoring committee (DMC) to review the futility of the Phase III VITAL trial. The committee recommended discontinuing the VITAL study. As a result, Prothena executives decided to discontinue all development.
“We are deeply disappointed by this outcome, particularly for patients suffering from this devastating disease,” said Gene Kinney, president and chief executive officer of Prothena, in a statement. “We are surprised by the results from these two placebo-controlled studies and will continue to analyze the resulting data to share insights with our collaborators in the scientific, medical and advocacy communities. We thank all of the patients, their families, caregivers, investigators, study staff and our employees. Their participation in and commitment to these studies are indispensable to advancing our shared goal of improving the lives of patients with amyloidosis.”
- Merck & Co., announced in February it was halting protocol 019, its APECS Phase III clinical trial of verubecestat (MK-8931) in Alzheimer’s disease.
The company indicated that an external Data Monitoring Committee (eDMC) had recommended ending the trial after an interim safety analysis, saying that the likelihood of benefits didn’t outweigh the risks.
“We are disappointed with this outcome, especially given the lack of treatment options for patients suffering from Alzheimer’s disease,” said Roger Perlmutter, president, Merck Research Laboratories, in a statement. “We are grateful to the patients and caregivers who participated in this study, and despite this outcome, Merck remains committed to developing novel therapies for the treatment of Alzheimer’s and other neurodegenerative diseases.”
- As part of its fourth-quarter earnings report in February, Paris-based Sanofi released a pipeline update, showing it plans to halt several mid-stage drug programs.
Sanofi ended a mid-stage program for isatuximab for acute lymphoblastic leukemia, and SAR428926, an anti-LAMP1 ADC for solid tumors. With no explanation, the company ended its next-generation version of Lemtrada, GLD52 (GZ402668) for relapsing multiple sclerosis, and SAR100842, an LPA1 receptor antagonist for systemic sclerosis.
In addition, after a Phase II trial for SAR156597 for idiopathic pulmonary fibrosis was finished, they ended the program. SAR156597 is an IL-4/IL-13 antibody. It also shuttered a late-stage program for a vaccine for Clostridium difficile.
- In January, Pfizer announced it was abandoning research and development into new neuroscience development, including Alzheimer’s and Parkinson’s disease. The company indicated it will continue working on tanezumab, a late-stage drug for pain it is developing with Eli Lilly & Co., as well as Lyrica, for fibromyalgia. It also intends to continue working on developing neurological drugs for rare diseases.
In a statement, Pfizer said, “This was an exercise to re-allocate spend across our portfolio, to focus on those areas where our pipeline, and our scientific expertise, is strongest.”