ADC Therapeutics is eligible to receive up to $435 million, including $55 million upfront, $50 million on first European Commission approval and up to approximately $330 million in additional regulatory and sales milestones
ADC Therapeutics to receive royalties from mid-teens up to the mid-twenty percent of net sales in Sobi’s territories
Sobi to cost-share in select global ZYNLONTA clinical trials
LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics SA (NYSE: ADCT) today announced it has entered into an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi®) for the development and commercialization of ZYNLONTA® for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan. The Marketing Authorization Application (MAA) for ZYNLONTA was validated by the European Medicines Agency (EMA) at the end of October 2021, and orphan drug designation was granted for ZYNLONTA for the treatment of diffuse large B-cell lymphoma (DLBCL) in Europe. ADC Therapeutics and Sobi intend to make ZYNLONTA available following a regulatory decision that is expected by the first quarter of 2023.
Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $55 million, and is eligible to receive $50 million upon regulatory approval of ZYNLONTA in third-line DLBCL by the European Commission 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 ZYNLONTA in Sobi’s territories. Sobi will share a portion of select global ZYNLONTA clinical trial costs.
“We are thrilled to establish this important partnership with Sobi to continue expanding our global reach to bring ZYNLONTA to as many patients as possible worldwide,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “Sobi has a strong global commercial infrastructure, proven capabilities in the areas of hematology and rare diseases, and importantly, shares our passion for improving the lives of patients.”
Guido Oelkers, Chief Executive Officer of Sobi, said, “ADC Therapeutics has an innovative and validated technology platform and is a leader in the evolving field of antibody-drug conjugates. We are delighted about this collaboration to bring loncastuximab tesirine to Europe and beyond to serve an unmet need in debilitating orphan diseases in haematology.”
In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. ADC Therapeutics has an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) 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 now conducting a registrational pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China.
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Providing sustainable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East and Asia. In 2021, revenue amounted to SEK 15.5 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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Mary Ann Ondish