Hospira’s Remicaide biosimilar cleared the European Commission. Known as Inflectra, the look-alike monocolonal antibody was approved for a slew of indications including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and psoriasis. This is the first monoclonal antibody to clear the European Medicines Agency’s biosimilar requirements. The all-in-one approval was not a surprise – in July the advisory committee known as the Committee for Medicinal Products for Human Use indicated that it approved the drug for these multiple indications. Goldman Sachs analyst Jami Rubin wrote at the time that CHMP’s decision to provide a slate of indications was a surprise because Hospira’s clinical data was only for the RA indication.
FDA draft guidance that would allow Advair generics to bypass human testing put GlaxoSmithKline’s stock into a tailspin, into its largest intraday drop since January 2012, reports Bloomberg. Monday’s draft guidance indicates the regulator has changed its mind about the importance of the inhaler to the overall medication delivery. Bloomberg notes that both GSK and the FDA had long said that a different inhaler amounts to a different product because of the impact it can have on dosing. Bloomberg reports that this has been a clear advantage for GSK, because while Advair’s US patent lapsed in 2012, the Diskus inhaler’s patent is good through 2016. Bernstein analyst Tim Anderson wrote in his September 2 research note that few analysts have put possible Advair generics into their GSK models, but that the company’s LAMA/LABA treatment Anoro, which goes before and advisory panel today, could be a hedge against generic Advair erosion.
In other GSK news, allegations of misconduct in China have drawn US authorities to the drug maker, reports Reuters, which said on Friday that the investigation is for possible violations of US anti-bribery laws. Reuters adds that the Department of Justice is also looking into GSK’s operations in countries beyond China. The company is just one among many that have become a focus of a sweeping Chinese government investigation into allegations that drug makers paid doctors and hospitals to garner favorable prescription traffic.
Roche has put $10 million down and up to $412 million in milestone payments for Inovio’s experimental prostate cancer and hepatitis B treatments. The deal gives Roche the exclusive licenses for the two drugs, INO-5150, which targets to prostate cancer antigens and IN0-1800 which targets hep. B. The agreement also gives Inovio a royalty on sales of these drugs and any add-on indications, and Roche will cover all research, development and commercialization costs from here on out.
Biogen and Amicus are partnering up for some Parkinson’s R&D. The companies said in a statement Tuesday that the multi-year deal will leverage preclinical studies at Amicus and independent research that focuses on the lysosomal enzyme glucocerbrosidase and its potential to “correct alpha-synuclein pathology and other deficits associated with Parkinson’s.” Biogen will fund all of the discovery, research and commercialization efforts, in exchange for developmental and regulatory milestones. This is Biogen’s second neurological pact announced in two days: press release ink is still wet from Monday’s announcement that it extended its relationship with Isis.
Forest has picked a new CEO. As of October 1, former Bausch & Lomb CEO Brenton Saunders, who is currently serving as a Forest director, will take over the chief executive role, Forest said. Saunders will replace Howard Solomon, who will stay on as non-executive chairman of the board until after the company holds its 2014 stockholder’s meeting.
