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Courtesy of joreks/Getty Images Novo Nordisk has entered into an agreement to acquire Forma Therapeutics for $1.1 billion. Forma’s lead development candidate, etavopivat, is being developed for sickle cell disease. Novo Nordisk has entered into an agreement to acquire Forma Therapeutics for $1.1 billion, the company announced Thursday. The deal includes Forma’s lead development candidate, etavopivat. The drug is being assessed in the Phase II GLADIOLUS trial in patients with transfusion-dependent sickle cell disease (SCD) and thalassemia and in the Phase II/III HIBISCUS trial in SCD. Etavopivat is an oral, once-daily, selective pyruvate kinase-R (PKR) activator. It is being developed for anemia and red blood cell health in SCD patients. “By adding Forma’s differentiated approach to address unmet needs for patients, we are taking a step forward in enhancing our sickle cell disease pipeline,” said Ludovic Helfgott, EVP and head of rare disease at Novo Nordisk, in a statement. Novo Nordisk is better known for its diabetes and obesity products, including Tresiba, Rybelsus, Victoza and Ozempic. It also has marketed products for hemophilia, such as NovoSeven (recombinant factor VIIa), Esperoct (turoctocog alfa pegol, N8-GP) and NovoThirteen (recombinant factor XIII). Frank D. Lee, president and CEO of Forma, called the announcement “an exciting milestone”. “Novo Nordisk will partner closely with the sickle cell community to amplify our impact for patients around the world who urgently need new treatment options,” he said in a statement. Forma’s board has unanimously approved the deal, which is expected to close in the fourth quarter of this year. In an email to BioSpace, Novo Nordisk said, “Novo Nordisk has a strong heritage and commitment of 40 years in rare blood disorders, initially within hemophilia and expanding to other rare blood disorders. The acquisition of Forma Therapeutics, including its lead candidate etavopivat, enriches and accelerates the development of Novo Nordisk’s preclinical and clinical pipeline in haemoglobinopathies such as sickle cell disease and thalassemia.” The deal is for $20 per share in cash, a total equity value of $1.1 billion. This amounts to a 92% premium for Forma’s volume-weighted average price per share over the last 30 days ending August 31. Forma also has programs underway in prostate cancer, acute myeloid leukemia and glioma and preclinical programs in hematological diseases and cancer. On August 2, Forma signed an exclusive, worldwide license deal with Rigel Pharmaceuticals for olutasidenib for relapsed or refractory acute myeloid leukemia. The FDA has accepted Forma’s New Drug Application for the drug with a target action date of February 15, 2023. Rigel paid Forma $2 million upfront. Forma is eligible for another $17.5 million based on various milestone payments, as well as future development and commercial milestones of $215.5 million and tiered royalties in the low-teens to mid-thirties.

"Securing rest of world IL-21 rights supports our strategy of seeking a global partner for this oncology asset, and we're pleased to have accomplished this without near-term cash outlays," said Heather Franklin, Senior Vice President, Business Development. "In the first half of this year, we plan to present Phase 2 results in renal cell carcinoma and metastatic melanoma, which we believe will heighten partnering interest among oncology-focused companies." Under the terms of the arrangement, Novo Nordisk A/S agreed to license rest of world (ex-North American) development and commercialization rights for IL-21 to ZymoGenetics in exchange for potential regulatory approval milestones and royalties related to the ex-North American territory. In addition, upon licensing worldwide rights for IL-21 to a third party, Novo Nordisk A/S would receive a portion of related licensing fees if a certain threshold level were exceeded. About IL-21 IL-21 has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play key roles in surveillance of the body to eliminate malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of preclinical models, ZymoGenetics is developing IL-21 for the treatment of cancer, initially in renal cell carcinoma and metastatic melanoma. About ZymoGenetics ZymoGenetics discovers and develops novel protein therapeutics that are based on the company's research and biological insights into key disease pathways. The Company developed and markets RECOTHROM(R) Thrombin, topical (Recombinant). Other product candidates span a wide array of clinical opportunities that include cancer, autoimmune and viral diseases. ZymoGenetics intends to commercialize product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com. This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven preclinical and clinical development and results, strategic partnering, including efforts by and results of collaborations, regulatory oversight and approvals, product sales and marketing abilities, discovery strategy, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2007. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise. SOURCE: ZymoGenetics, Inc.