Global Briefs: Novartis, Mallincrodkt, Sanofi & More

A roundup of news from Novartis, Mallincrodkt, Sanofi, Neuraxpharm,. Highlights below.

* Mallinckrodt To Sell Priority Review Voucher to Novartis for $100 M
* Sanofi To Sell 17 Established Products to Neuraxpharm
* Vertex To Acquire Regenerative Medicine Company ViaCyte for $320 M

Mallinckrodt To Sell Priority Review Voucher to Novartis for $100 M
Mallinckrodt has agreed to sell a priority review voucher to Novartis for $100 million. Mallinckrodt received the priority review voucher for StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), a treatment for reducing or eliminating autografting in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns). Mallinckrodt announced the sale late last month (June 2022).

The FDA awards priority review vouchers to drug sponsors that develop drugs for tropical diseases or rare pediatric diseases or to use as medical countermeasures. The voucher, which can be sold to another drug sponsor, may be redeemed later to receive priority review from the FDA with a targeted review time of six months, rather than the 10-month standard review. The voucher may be used for a drug application of the choice of the holder of the priority review voucher.

The treatment was approved by the US Food and Drug Administration (FDA) in June 2021.The FDA granted StrataGraft orphan drug designation and designated the product as a regenerative medicine advanced therapy. At the time of approval, the FDA awarded Stratatech Corporation, a Mallinckrodt company, a priority review voucher.

The development of StrataGraft was funded in part with $86 million from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services to support its development as a medical countermeasure.

The deal is subject to closing conditions.

Source: Mallincrodkt

Sanofi To Sell 17 Established Products to Neuraxpharm
Sanofi has agreed to sell two portfolios of established products for central nervous system (CNS) disorders, pain, and vascular diseases to Neuraxpharm, a Barcelona, Spain-based specialty pharmaceutical company. Financial terms were not disclosed.

The first portfolio combines 15 products addressing CNS disorders in psychiatry and neurology. The second portfolio includes two products in pain and vascular diseases. Combined, both portfolios include 17 molecules representing 38 brands. Following the acquisition of these new portfolios, Neuraxpharm’s annual gross sales will be approximately EUR 600 million ($600 million).

Source: Neuraxpharm

Vertex To Acquire Regenerative Medicine Company ViaCyte for $320 M
Vertex Pharmaceuticals has agreed to acquire ViaCyte, a San Diego, California-based company developing regenerative medicines for Type I diabetes, for $320 million. 

The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem-cell lines, intellectual property around stem-cell differentiation, and GMP manufacturing facilities for cell-based therapies, to assist in the development of Vertex’s VX-880, an investigational allogeneic stem cell-derived, insulin-producing islet cell therapy for Type I diabetes, in Phase I/II development. The acquisition also provides Vertex access to hypoimmune stem-cell assets via ViaCyte’s collaboration with CRISPR Therapeutics, a US and Swiss gene-editing company.

The acquisition is expected to close later this year (2022), subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Source: Vertex Pharmaceuticals