Archive for January, 2018

Novartis Reaches Licensing, Supply Agreement With Spark For LUXTURNA Outside US

Posted on January 25th, 2018 by Valorem Life Sciences

Novartis ( NVS ) announced a licensing agreement with Spark Therapeutics covering development, registration and commercialization rights to voretigene neparvovec in markets outside the US. Novartis will make an upfront payment as well as pay milestones and royalties to Spark Therapeutics. The market authorization application with the European Medicines Agency was filed on July 31, 2017. Commercialization rights will be transferred to Novartis upon successful completion of registration and issuance of market authorization.

Voretigene neparvovec, known as LUXTURNA in the US, received FDA approval on December 19, 2017 as a one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 (retinal pigment epithelial 65 kDa protein) gene. Spark Therapeutics retains exclusive rights for LUXTURNA in the US.

Source: NASDAQ

Breakthrough status for Pfizer/Merck’s avelumab combo

Posted on January 2nd, 2018 by Valorem Life Sciences

Merck and Pfizer’s avelumab has picked up its second breakthrough therapy status in the US, this time for use in combination with Inlyta for treatment-naïve patients with advanced renal cell carcinoma (RCC).

The breakthrough designation – designed to expedite the development and review medicines that target serious or life threatening conditions and have the potential to offer substantial benefit over existing therapies – is based on preliminary evaluation of clinical data from JAVELIN Renal 100, a global Phase Ib study assessing the safety and efficacy of the combination.

Findings show that combining the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor Inlyta (axitinib) induced a response in 58.2 percent of patients with advanced RCC.

Pfizer’s Chris Boshoff, head of Immuno-Oncology, Early Development and Translational Oncology at the firm, noted that a combination approach with an immunotherapy, the activity of which may complement existing agents such as Inlyta, “has the potential to improve outcomes for patients with advanced renal cancer – a disease where the five-year survival rate remains low”.

“Pfizer’s expertise in developing treatments for advanced RCC is a distinct advantage in tackling this tumor type, and we look forward to the completion of our Phase III study combining avelumab with Inlyta, which we’re expecting at the end of next year.”

Avelumab is approved in the US and EU under the trade name Bavencio to treat Merkel cell carcinoma, and also in the US for urothelial carcinoma.

Source: Pharma Times