Johnson & Johnson's Rezolsta Approved in the EU for HIV-1
Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Earlier this week, Johnson & Johnson’s (JNJ) subsidiary, Janssen, announced that it has gained EU approval for its HIV-1 drug, Rezolsta. Rezolsta, has been approved by the European Commission (EC) for use with other antiretroviral therapies in patients aged 18 years and above. Rezolsta is a fixed-dose combination of Johnson & Johnson’s Prezista and Gilead Sciences’ (GILD) Tybost.
The EC’s decision was expected, given the Committee for Medicinal Products for Human Use’s (CHMP) positive opinion on the candidate for this indication.
Rezolsta is currently under review in the U.S. for the same indication.
Meanwhile, Johnson & Johnson is working towards strengthening its oncology pipeline. Earlier this week, the company inked a deal with Transposagen Biopharmaceuticals, Inc. for the development of allogeneic chimeric antigen receptor T-cells (CAR-T)
According to the deal, Johnson & Johnson will enjoy exclusive rights to any allogeneic CAR-T therapy developed under the agreement. Moreover, Johnson & Johnson obtained a non-exclusive license to Transposagen’s gene editing technologies for developing gene and cell therapy solutions. However, Transposagen will retain the rights to develop autologous CAR-T therapies using Natural Killer (NK.V) cells or NK-like cells.
Johnson & Johnson will pay Transposagen up to $292 million (including an up-front fee and potential milestone payments) for the development of each CAR-T therapeutic apart from tiered royalties on net sales of allogeneic CAR-T products.
Meanwhile, Johnson & Johnson is seeking approval from the FDA for Yondelis for the treatment of advanced soft tissue sarcoma (including liposarcoma and leiomyosarcoma subtypes) in patients who have received prior chemotherapy including an anthracycline.
The company said in a press release that it intends to amend the phase III study protocol (which is currently evaluating the safety and efficacy of Yondelis compared to dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma) in order to accommodate an optional Yondelis treatment for patients who have received dacarbazine.
Johnson & Johnson carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Allergan Inc. (AGN) and Impax Laboratories Inc. (IPXL). Both carry a Zacks Rank #1 (Strong Buy).
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