Partnering News: ADC Therapeutics, Merck & Co.

A roundup of bio/pharmaceutical partnering news from ADC Therapeutics/Sobi and Merck & Co./Orion. Highlights below.

* ADC Therapeutics, Sobi in $435-M Deal for ADC
* Merck & Co, Orion in $290-M Prostate Cancer Drug Pact

ADC Therapeutics, Sobi in $435-M Deal for ADC
ADC Therapeutics, a Lausanne, Switzerland-based bio/pharmaceutical company, has entered into a license agreement with Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-based bio/pharmaceutical company specializing in rare diseases, worth up to $435 million ($55 million upfront and up to $380 million in milestone payments) for the development and commercialization outside of the US, greater China, Singapore, and Japan of Sobi’s Zynlonta (loncastuximab tesirine-lpyl), an antibody drug conjugate for treating hematologic and solid tumors,

Under the agreement, ADC Therapeutics will receive an upfront payment of $55 million, and is eligible to receive $50 million upon regulatory approval by the European Commission of Zynlonta in third-line diffuse large B-cell lymphoma (DLBCL) and up to approximately $330 million in additional regulatory and sales milestones. ADC Therapeutics will also receive a percentage of royalties ranging from the mid-teens to the mid-twenties based on net sales of the drug in Sobi’s territories. Sobi will share a portion of select global Zynlonta clinical trial costs.

The companies expect a regulatory decision by the European Commission in the first quarter of 2023.

Zynlonta was granted accelerated approval by the US Food and Drug Administration in April 2021 for treating relapsed or refractory DLBCL. ADC Therapeutics has an exclusive license agreement with Mitsubishi Tanabe Pharma for the development and commercialization of Zynlonta for all hematologic and solid tumor indications in Japan. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize Zynlonta in greater China and Singapore. Overland ADCT BioPharma is conducting a registrational Phase III clinical trial of Zynlonta in relapsed or refractory DLBCL in China.

Source: ADC Therapeutics

Merck & Co, Orion in $290-M Prostate Cancer Drug Pact
Merck & Co. and Orion, an Espoo, Finland-based pharmaceutical company, have entered a $290-million development and commercialization agreement for Orion’s ODM-208, a prostate cancer drug, and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production and related cancers.

ODM-208 is an oral drug in a Phase II trial for treating metastatic castration-resistant prostate cancer. The drug is a non-steroidal and selective inhibitor of the CYP11A1 enzyme for treating hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway, a determinant in prostate cancer.

Under the agreement, the companies will co-develop and co-commercialize ODM-208. Merck & Co. will make an upfront payment to Orion of $290 million. Of this upfront payment, Orion recognizes approximately EUR 220 million ($221 million) as income at the time of signing and approximately EUR 60 million ($61 million) is reserved to cover Orion’s share of ODM-208 development costs to be accrued in the future. Orion will be responsible for the manufacture of clinical and commercial supply of ODM-208.

In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck & Co. If the option is exercised, Merck would assume full responsibility for all accrued and future development and commercialization expenses associated with the program. Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 as well as tiered double-digit royalties on sales if the product is approved.

Source: Merck & Co.