A German biotech company developing a drug for blood cancers has signed a development and commercialization deal with a U.S. based firm worth up to $2 billion.
MorphoSys, headquartered near Munich, said Monday that it had inked the deal with Wilmington, Delaware-based Incyte for the drug tafasitamab, an Fc-engineered monoclonal antibody that MorphoSys hopes to market for B-cell non-Hodgkin’s lymphomas. Both companies are presenting at the J.P. Morgan Healthcare Conference in San Francisco.
Under the deal, both companies will develop and commercialize tafasitamab in the U.S., while Incyte will have exclusive commercialization rights outside the U.S. Incyte is paying MorphoSys $750 million upfront and making a $150 million equity investment, while the agreement includes up to $1.1 billion in milestones.
“The global partnership with Incyte is an important step towards unlocking the full potential of tafasitamab and achieving our goal of rapidly bringing tafasitamab to patients inside and outside of the U.S.,” MorphoSys CEO Jean-Paul Kress said in a statement. “The combination of our strong antibody and drug development expertise partnered with Incyte’s well-established hematology-oncology experience and their commercial operations in key territories has the potential to significantly broaden the tafasitamab opportunity.”
Incyte’s most well-known marketed product is Jakafi (ruxolitinib), a JAK inhibitor approved for the blood cancers myelofibrosis and polycythemia vera, as well as acute graft-versus-host disease, which is expected to lose patent protection later this decade. It also markets the Takeda Pharmaceutical’s leukemia Iclusig (ponatinib) in Europe and has a partnership for the rheumatoid arthritis drug Olumiant (baricitinib) with Eli Lilly. Product candidates in pivotal development include a topical formulation of Jakafi’s active ingredient and a PD-1 inhibitor for non-small cell lung cancer, among others.
Another drug in Incyte’s pipeline is parsaclisib, a PI3K-delta inhibitor that is in Phase II development for follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, which are slow-growing histologies of B-cell NHL. Under the partnership, Incyte will be responsible for starting combination study of the two drugs in B-cell malignancies, along with any potentially pivotal studies in chronic lymphocytic leukemia, which is also a B-cell cancer, and Phase III studies in the aforementioned lymphoma histologies.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Tafasitamab targets CD19, the same antigen as Amgen’s approved drug Blincyto (blinatumomab) and both currently marketed CAR-T cell therapies, Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). However, rather than directly competing with those therapies, it is aimed at patients who are too old or frail to receive them. The company submitted a regulatory approval application for the drug at the end of last month and expects the Food and Drug Administration to rule on it in the middle of this year. It had started building out its manufacturing infrastructure in anticipation of the launch in June.
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