US biotech company Seattle Genetics has secured deals worth up to $4.4 billion with Merck, that include two new strategic oncology collaborations.

The two major pharma companies will develop and commercialize Seattle Genetics’ ladiratuzumab vedotin across the world. Ladiratuzumab vedotin is an investigational antibody-drug conjugate (ADC) that targets LIV-1, which is presently in phase 2 trials for breast cancer and other solid tumors.

The collaboration between the companies will pursue a larger joint development program for assessing ladiratuzumab vedotin as monotherapy and also in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer, and other LIV-1-expressing solid tumors.

As per the deal terms, Seattle Genetics will get and upfront payment of $600 million apart from an equity investment of $1 billion from Merck in exchange of its five million shares at a price of $200 per share. Apart from that, Seattle Genetics stands to earn up to $2.6 billion in the form of progress-dependent milestone payments.

In a seperate deal, Seattle Genetics has granted an exclusive license to Merck to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, in development for the treatment of HER2-positive cancers. The license is valid for countries in Asia, the Middle East, and Latin America, and other regions with the exception of the US, Canada, and Europe.

Seattle Genetics will be paid an upfront payment of $125 million from Merck in this regard besides being eligible to earn up to up to $65 million from progress-dependent milestones.

Clay Siegall – President and CEO of Seattle Genetics said: “Collaborating with Merck on ladiratuzumab vedotin will allow us to accelerate and broaden its development program in breast cancer and other solid tumors, including in combination with Merck’s KEYTRUDA, while also positioning us to leverage our U.S. and European commercial operations.

“The strategic collaboration for TUKYSA will help us reach more patients globally and benefit from the established commercial strength of one of the world’s premier pharmaceutical companies.”

The closing of Merck’s equity investment is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Dr. Roger M. Perlmutter – President of Merck Research Laboratories said: “These two strategic collaborations will enable us to further diversify Merck’s broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible.

“We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.”

  Breast Cancer, Clay Siegall, Dr. Roger M. Perlmutter, Keytruda, ladiratuzumab vedotin, Merck, Oncology, pembrolizumab, Seattle Genetics, Solid tumors, Tucatinib, TUKYSA, USA