Five things for pharma marketers to know: Wednesday, March 25
An independent data-monitoring committee halted Merck's Keytruda trial, saying Tuesday the drug had already met its primary endpoint in patients with advanced melanoma. The Phase-III trial, which measured progression-free survival, pitted Keytruda against Bristol-Myers Squibb's immunotherapy drug Yervoy. Keytruda, a PD-1 inhibitor, bested Yervoy in the trial, according to Merck, which said the results were “statistically significant and meaningful.” Merck hopes to receive marketing authorization for Keytruda as a first-line treatment. Keytruda was approved as a second- and third-line therapy for advanced melanoma in September.
Novartis CEO Joe Jimenez increased the company's R&D spend by 25% over five years. “I've told analysts: don't look at research as a place for margin improvement,” he said in an interview with Bloomberg. “If we let unmet medical need be the decider of resource allocation, that's when magic happens.” A New England Journal of Medicine study found that the US share of global R&D spend had fallen from 51.2% in 2007 to 45.5% in 2012, citing a $12.9-billion reduction in industry investment as the reason for the decline.
New legislation would allow the FDA to continue its rare pediatric disease priority review voucher program. The sellable vouchers expedite the FDA's review of a drug—with a decision coming in six months rather than 10 months. United Therapeutics was granted the last voucher in early March for Unituxin, a treatment for neuroblastoma. It was the third one given out in a 12-month period. If three vouchers are distributed in a given year, then the program ends one year from the last awarded voucher due to a sunset clause, the Regulatory Affairs Professionals Society reported. The program is slated to end on March 17, 2016, unless new legislation is enacted.
A Teva and Boehringer Ingelheim antitrust class action lawsuit will continue, a federal judge ruled Monday. Reuters wrote that the court would not dismiss federal antitrust claims filed against the two drugmakers for conspiring to keep Aggrenox off the market. Aggrenox is a treatment meant to reduce the risk of stroke.
AstraZeneca and the Harvard Stem Cell Institute inked a five-year research agreement. The pact allows the British drugmaker to convert stem cells into human beta cells as a method for developing new diabetes treatments. Because beta cell functions decline in diabetes, the collaboration hopes to understand why this occurs and ultimately make that information available to the scientific community, PharmaTimes wrote.