Protocols

Tracon inks deal with Ambrx to develop cancer drug in China; Roche wins consecutive approvals in EU and US

→ Two San Diego companies have inked a licensing deal to develop a cancer drug in China and Taiwan. Ambrx gets exclusive rights to develop and commercialize Tracon Pharmaceuticals $TCON lead product TRC105 in all indications except ophthalmology (those rights are already held by Santen Pharmaceutical). The drug carotuximab, a proprietary endoglin antibody, is currently being tested by Tracon in angiosarcoma, RCC, HCC, GTN, lung and breast cancer. Tracon will receive an upfront payment of $3 million, and is eligible to receive development and regulatory milestones of up to $10.5 million and commercial sales milestones of up to $130 million. Ambrx intends to file an initial CTA with the Chinese Food and Drug Administration (CFDA) in 2018.

→ In two consecutive wins across the Atlantic, Roche $RHHBY has scored a European approval for Alecensa for ALK-positive non-small cell lung cancer on the heels of a US green light for Perjeta in HER2-positive early breast cancer patients after surgery. The EU decision followed a positive recommendation in October from experts, with data showing that Alecensa performed better than Pfizer’s Xalkori in terms of disease progression and death. The combo of Perjeta and Roche’s old drug Herceptin, on the other hand, demonstrated lackluster benefits that inspired confidence in nobody but Roche itself. The boost is much needed for the Swiss drug maker, which is seeing patents go off from its main products. CEO Severin Schwan told Reuters this month that the pipeline of new products, which had been “de-risked,” would enable the company to compensate for the significant impact from competing biosimilars.

JSR Life Sciences scored its latest and largest M&A deal with the $400 million acquisition of CrownBio, a Taipei-based contract research organization. The outsourcing company, a branch of Japanese conglomerate JSR Corporation, has been beefing up its suite of capabilities to encompass cell line, diagnostics and process development as well as manufacturing.


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