The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Are deals such as M&As between biotechs and big pharma becoming a thing of the past? That was a key question posed during the opening keynote at this year’s BIO-Europe Spring conference in Basel, Switzerland. Although Susanne Kreutz, global head of corporate and business development of Basel-based Novartis AG, doesn’t think this is the case, she told delegates that she believes M&A will increasingly focus in on “high-quality, high-impact, late-stage assets, where reimbursement is securable and where regulatory paths appear.”
The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas.
Pfizer Inc.’s appetite for acquisitions shows no signs of abating as it announced this morning its plan to acquire biotech Seagen Inc. for a whopping $43 billion in a move that will double the size of its early stage oncology pipeline. Under the deal, unanimously approved by the boards of directors of both firms, Pfizer will pay Seagen $229 per share. Bothell, Wash.-based Seagen expects to amass $2.2 billion in revenue in 2023, representing 12% year-on-year-growth, royalties and collaboration and license agreements from its four, FDA-approved products for the treatment of solid tumors and hematologic malignancies, antibody-drug conjugate drugs Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin), and tyrosin kinase inhibitor Tukysa (tucatinib).
As broader markets struggled throughout 2022, the biopharma industry’s largest and most lucrative companies ended the year in a strong position, according to BioWorld’s Biopharmaceutical Index (BBI), which showed the 22 component stocks climbed by 17.3% throughout the year. Neither the Nasdaq Biotechnology Index (NBI) nor the Dow Jones Industrial Average (DJIA) demonstrated such gains. They were down by 10.9% and 8.8%, respectively. All three indices, however, are following the same path in 2023, shooting up throughout the month of January and back down in recent weeks.
The U.S. FDA granted accelerated approval to Seagen Inc. on Jan. 19 for Tukysa (tucatinib), extending the therapy’s reach beyond HER2-positive metastatic breast cancer, and clearing its way for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer.
An uptick in positive clinical data reported in recent months has helped nudge the BioWorld Biopharmaceutical Index (BBI) to its highest point this year. BBI is up by 15.58%, significantly higher than the 1.36% increase recorded at the end of August, just as statistically significant clinical results began to roll in from a number of biopharma companies.
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan.
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan. Seagen is also eligible to receive development, regulatory, and commercial milestone payments of undisclosed value, as well as tiered royalties on net sales of the drug in Zai’s territory.
Seagen Inc. and Lava Therapeutics NV have entered into an exclusive license agreement under which Seagen will work to develop, manufacture and commercialize LAVA-1223, a bispecific T-cell engager designed to target and activate Vγ9Vδ2 T cells in the presence of epidermal growth factor receptor (EGFR)-expressing solid tumors.
