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Top 7 Jaw-Dropping Pipeline Blowups This Year

12/5/2016 5:57:36 AM

Top 7 Jaw Dropping Pipeline Blowups This Year December 5, 2016
By Alex Keown, Breaking News Staff

NEW YORK – It’s no secret that 2016 has been a rough year when it comes to the loss of numerous celebrated artists, such as Prince, David Bowie, Alan Rickman and Harper Lee. It’s also been a tough year for the biotech industry with notable drug pipeline failures that caused many investors to cringe. The Motley Fool picked seven of the biggest “pipeline blowups of 2016” that shook many investors and companies to their foundations.

1. Alnylam Pharmaceuticals

Shares of RNAi pioneer Alnylam (ALNY) cratered in October when the company announced it was discontinuing development of revusiran for hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM). The company discontinued the drug development after reports indicated more patients on the drug died than those on placebo. In all there were 18 deaths, but the company did not disclose the numbers of those on the drug versus placebo. The shuttering of the RNAi program has raised questions about the other programs in Alnylam’s pipeline, the Fool’s Brian Feroldi said.

2. Clovis Oncology

Colorado-based Clovis (CLVS) was shaken in the spring of 2016 after its failure to gain regulatory approval for its experimental lung cancer drug rociletinib. Following the failure, the company announced it was terminating 35 percent of its workforce to address shifting costs. As a result of the U.S. Food and Drug Administration’s Complete Response Letter, Colorado-based Clovis said it was eliminating enrollment in all ongoing sponsored clinical studies of rociletinib. Although rociletinib was a failure, the company has hinged its hopes on its ovarian cancer drug, rucaparib. Rucaparib is a PARP inhibitor developed for the treatment of patients with platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015. The FDA accepted rucaparib for priority review in August.

3. Celldex Therapeutics

The failure of Celldex Therapeutics (CLDX)’ cancer vaccine Rintega caused company stock to fall about 80 percent this year. 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.

4. Eli Lilly

Eli Lilly (LLY)’s addition to the list is due to the recent failure of solanezumab, the drug the company hoped would be the answer to Alzheimer’s disease. The Phase III failure marked the second time solanezumab failed in a late-stage Alzheimer’s trial. The last time was in 2012, but for this go-round, Eli Lilly opted to use the drug to focus on milder-forms of Alzheimer’s and using a “delayed start” method. However, Phase III data showed that solanezumab failed to show a statistical slowing in cognitive decline compared to placebo. As a result of the drug failure, Eli Lilly announced it will begin layoffs of sales force members expected to handle solanezumab accounts in 2017.
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5. Novavax

In September, shares of Novavax (NVAX) plunged more than 82 percent after the company released data that its Phase III trial for its RSV F Vaccine for older adults did not meet its goals, failing to demonstrate “vaccine efficacy.” The Phase III Resolve trial failed to meet both its primary and secondary endpoints. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease. The secondary endpoint was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV.

6. Arrowhead

Arrowhead (ARWR) ended November with announcements it was terminating 30 percent of its workforce and shuttering three clinical programs—ARC-520, ARC-521 and ARC-ATT. The termination of the programs aimed at liver disease treatments were placed on clinical hold by the FDA so Arrowhead could provide answers to questions from a nonclinical toxicology study in non-human primates using EX1, the company’s liver-targeted, intravenously administered delivery vehicle. The company said the hold was prompted following the death of primate study subjects at the highest doses of EX1. Arrowhead said it was turning its focus to its subQ and extra-hepatic pipeline, which includes programs in HBV, AAT, Factor 12, HIF-2alpha and other unannounced programs.

7. BioMarin Pharmaceuticals

BioMarin (BMRN) started 2016 with some bad news when the FDA rejected Drisapersen, also known as Kyndrisa, the company’s experimental treatment for Duchenne muscular dystrophy (DMD). In late 2015, an FDA review panel outlined a number of concerns about the efficacy of the drug, saying that in some clinical data the efficacy data is inconsistent and in other areas the data is contradictory. Members of the review panel said the long-term data presented by California-based BioMarin did not warrant approval at the time.

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