Johnson & Johnson’s busy start to the week has continued with approval in Europe for its HIV combination therapy Rezolsta.
Rezolsta is a combination of J&J’s big-selling HIV therapy Prezista (darunavir) and Gilead Science’s Tybost (cobicistat) in a single pill.
The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in September 2014.
Christiane Moecklinghoff, medical director of virology at J&J’s Janssen EMEA unit, said Rezolstas eliminates the need to take a boosting agent in a separate tablet with once-daily Prezista, “reducing the pill burden”. She added that “progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life”.
The combo was approved in Canada in June 2014 as Prezcobix and is currently undergoing regulatory review in the USA.
Yondelis filed at last
The approval came a day after J&J filed Yondelis (trabectedin), a cancer treetment licensed from Spain’s Zeltia, with the US Food and Drug Administration for advanced soft tissue sarcoma (STS) patients who have received prior chemotherapy.
The filing “represents our commitment to Yondelis”, Janssen oncology head Peter Lebowitz said, something that some observers had questioned given that the company pulled a submission in May 2011 of the drug for ovarian cancer after the FDA called for an additional Phase III trial. However Dr Lebowitz claimed that the advanced STS landscape “has been relatively stagnant for decades and it's our hope that Yondelis will be a new treatment option for people living with this aggressive disease”.
Yondelis, originally derived from the sea squirt Ecteinascidia turbinata, is already available in Europe as a single agent for advanced STS and in combination with J&J’s Doxil/Caelyx (doxorubicin) for ovarian cancer.
Inks CAR-T deal with Transposagen
Finally, J&J has linked up with Transposagen Biopharmaceuticals to develop allogeneic Chimeric Antigen Receptor T-cell (CAR-T) therapies.
Janssen will pay Transposagen up to $292 million per CAR-T therapeutic, a closely-watched area, which includes an upfront fee and potential development, regulatory, and commercial milestones, plus tiered royalties.