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Sobi and Selecta Announce Closing of Previously Announced Strategic Licensing Agreement for Sel-212, a Phase 3-ready Novel Treatment for Chronic Refractory Gout

Swedish Orphan Biovitrum AB (OTC: BIOVF) today announced that the strategic licensing agreement with Selecta Biosciences, Inc.

Benzinga · -
Swedish Orphan Biovitrum AB (OTC: BIOVF) today announced that the strategic licensing agreement with Selecta Biosciences, Inc. (NASDAQ: SELB) for SEL-212, entered into as earlier announced on June 11, 2020, became effective on July 28, 2020, following the expiration of the Hart-Scott-Rodino Antitrust Improvements Act waiting period. Under the licensing agreement Sobi must pay USD 75 million in cash as an upfront license fee within 45 days of the effective date. In addition, pursuant to the terms of the share purchase agreement entered into by the parties simultaneously with the licensing agreement, Sobi must pay USD 25 million in cash on the closing date of its investment in a private placement of Selecta common stock, which closing will happen following the effective date of the licensing agreement. "We are pleased to complete this agreement and become a shareholder and partner of Selecta," said Guido Oelkers, Chief Executive Officer of Sobi. "SEL-212 may become an important therapeutic option that could significantly improve outcomes for patients with chronic refractory gout, and we are proud to help address the demonstrated unmet medical need." "This transaction enables Selecta to further its research into the application of ImmTOR to improve the efficacy of biologics, enable re-dosing of life-saving gene therapies, and create novel immunotherapies for autoimmune diseases," said Carsten Brunn, Ph.D., President and CEO ofSelecta. "We are confident that Sobi's strategic focus on immunology, commercial expertise, and resources will maximize the value of SEL-212 and have the greatest benefit for patients, and we look forward to working closely with them to execute a successful phase 3 pivotal program, which we expect to begin later this year." The licensing agreement includes the global rights, excluding China, for the product candidate SEL-212. SEL-212 is a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase) that is designed to durably control serum uric acid, reduce immunogenicity, and allow for repeated monthly dosing for the treatment of chronic refractory gout. The chronic refractory gout market is estimated to be worth at least USD 1 billion in sales in the US alone. The phase 3 program for SEL-212, which will be run by Selecta and funded by Sobi, is expected to commence in 2H 2020 and Sobi's R&D expenses are expected to increase by up to SEK 150 M in 2H 2020. Transaction terms Under the terms of the license agreement, Sobi will assume responsibility for development, regulatory, and commercial activities for SEL-212 in all markets outside of China. Sobi will make initial payments to Selecta of USD 100 million, which include USD 75 million up-front license fee and USD 25 million in a private placement of shares of Selecta common stock. Selecta is eligible to receive potential milestone payments of up to USD 630 million from Sobi, which are dependent upon specific regulatory and development targets having been met, as well as sales thresholds. Additionally, Selecta is eligible to receive tiered double-digit royalties on net sales. Sobi and Selecta have entered into a share purchase agreement, pursuant to which Sobi will invest USD 25 million in a private placement of 5,416,390 shares of Selecta common stock at a purchase price of USD 4.62 per share (representing a 20 per cent premium to the volume weighted average price over the 10 days prior to signing). Sobi has financed the considerations above by available funds.