The U.S. Court of Appeals for the Second Circuit Monday revived a class action shareholder suit against Newlink Genetics Corp. that alleged the Ames, Iowa-based company and its leadership materially misrepresented the efficacy of algenpantucel-L, a novel pancreatic cancer candidate that failed in phase III development, as well as the scientific literature on pancreatic cancer and the design of the phase III trial in which the control arm outperformed the study drug. The appeals court found that some of the challenged statements Newlink and its leadership made about the drug candidate were puffery and not material misrepresentations. However, other statements were “plausibly” misleading or false, the court said in remanding Trevor Abramson v. Newlink Genetics Corp. back to the lower court. For instance, Newlink co-founder Nicholas Vahanian touted the 24.1-month median survival results from a phase II trial to prospective investors at a September 2013 biotech conference, adding that “resected pancreatic cancer patients live 15 months, 19 months … 20 months. That’s it.” He failed to note other studies that had shown longer survival times, according to the Second Circuit.
The FDA Tuesday expanded its list of diseases that could lead to a tropical disease priority review voucher (PRV). The agency added opisthorchiasis, paragonimiasis and brucellosis to the list, saying they meet the statutory criteria as tropical diseases because no significant markets exist for the treatment or prevention of the conditions in developed nations and the three diseases disproportionately affect poor and marginalized populations around the world. Companies that successfully develop a therapy for the diseases would be rewarded with a PRV they could sell or use to trim four months from the review of another drug candidate. At the same time, the FDA determined that coccidioidomycosis and clonorchiasis don’t meet the tropical disease criteria because of the potential significant market for preventive products in the U.S. or other developed nations.