Welcome to this week's FiercePharmaAsia report, which includes stories about the launch of Samsung and partner Merck & Co.'s Remicade biosimilar in the U.S., Mitsubishi Tanabe's $1.1 billion NeuroDerm acquisition, Takeda and Schrödinger's multiprogram drug discovery pact and more.
Samsung and partner Merck & Co. have launched their Remicade Biosim, Renflexis, in the U.S. at a 35% markdown to the Johnson & Johnson blockbuster. This follows last year’s launch by Pfizer for its version, Inflectra, at a milder 15% discount. The launch comes earlier than the biosim’s expected market debut date, thanks to a Supreme Court ruling that made it easier for developers to launch biosimilars upon winning approval.
Mitsubishi Tanabe is shelling out $1.1 billion on Parkinson’s disease specialist NeuroDerm. The Israeli company’s lead product ND0612 works as a combination of the two Parkinson’s drugs that control symptoms of the disease by replacing reduced dopamine in the brain. The drug is in late-stage testing, and the biotech expects to gain U.S. approval by 2019 and reach peak sales of about $1.7 billion.
After outsourcing most of its clinical development efforts to PRA Health Sciences, Takeda is seeking help from outside forces, this time in the upper stream, forming a multiyear R&D collaboration with in silico drug discovery expert Schrödinger. Schrödinger will be responsible for the discovery and ensuing costs, while Takeda will provide protein crystal structures, with the option to exclusively license the programs for milestones of up to $170 million per project.
Takeda and BioSurfaces have signed an agreement to develop medical devices for the treatment of gastrointestinal diseases. The Japanese pharma will contribute its gastroenterology know-how, while the devicemaker will bring its nanomaterial technology, which could potentially help prevent narrowing of the GI tract caused by inflammation and encourage the healing of fistulas, abnormal openings in the GI tract.
Rodeo Therapeutics has secured a $5.9 million series A financing round with a list of venture capital and biopharma all-stars as backers, including WuXi AppTec. The money will go toward the upstart’s preclinical work on small-molecule therapies designed to encourage regeneration and repair of multiple tissue types. The company's early work focuses on boosting tissue levels of prostaglandin E2 (PGE2).
Chinese oncology expert BeiGene is adding Medidata’s electronic patient-reported outcome solution to its cancer clinical studies, expanding on a previous two-year partnership. Medidata recently reported a strong second quarter with revenues reaching $137.4 million, representing a 20% year-on-year jump, and Patient Cloud's incremental bookings quadrupled in the first half of 2017 compared to last year.
French drug regulators slapped Chongqing Succeway Pharmaceutical with a warning letter, citing a total of 22 issues with the facility, one of which was classified as critical and three as major. The problems included manipulation, backdating and falsification of documents, and the French agency called for a recall of all batches of rilmenidine dihydrogen phosphate the Chinese API maker made.