STOCKHOLM, Sweden and WATERTOWN, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) 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 of Selecta. “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.
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.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its pioneering immune tolerance platform (ImmTOR™). Selecta is committed to utilizing ImmTOR to potentially improve the efficacy of biologics, enable re-dosing of life-saving gene therapy, and create novel immunotherapies for autoimmune diseases. Selecta’s late-stage product candidate, SEL-212, is designed to be a monthly treatment for chronic refractory gout, a debilitating rare disease with a significant unmet medical need. SEL-212 consists of a combination of its ImmTOR platform co-administered with pegadricase, an enzyme designed to treat patients with symptomatic gout, refractory to standard uric acid lowering treatment. Selecta’s proprietary gene therapy product candidates are in development for certain rare inborn errors of metabolism and incorporate our ImmTOR platform with the goal of addressing barriers to repeat administration. In addition to our own pipeline of core discovery and clinical candidates, Selecta has established collaborative relationships with leading biopharmaceutical companies, including Asklepios BioPharmaceutical (AskBio) and Sarepta Therapeutics for gene therapy, and Swedish Orphan Biovitrum AB (Sobi™) for SEL-212. Selecta is based in Watertown, Massachusetts. For more information, please visit www.selectabio.com.
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenue amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.
Selecta Forward-Looking Statements
Any statements in this press release about the future expectations, plans and prospects of Selecta Biosciences, Inc. (“the company”), including without limitation, statements regarding the clinical development, commercialization, and regulatory activities related to SEL-212 by either the company or Sobi, including with respect to anticipated geographic markets, the anticipated timing of the planned Phase 3 clinical trial, the potential market opportunity for SEL-212, the potential of SEL-212 to fulfill unmet needs in chronic refractory gout patients including sustained SUA reduction, reduced flares, and repeated once monthly dosing, as well as the ability to dose longer than the current standard of care, the company’s and Sobi’s commercial plans, the expected upfront, milestone, and royalty-based payments to the company under the strategic licensing agreement with Sobi, the anticipated closing of the investment by Sobi in the company’s common stock in connection with the share purchase agreement, the ability of the company’s ImmTOR platform, including SEL-212, to unlock the full potential of biologic therapies, the potential of SEL-212 to treat chronic refractory gout patients and resolve their debilitating symptoms, the potential treatment applications for product candidates utilizing the ImmTOR platform in areas such as enzyme therapy and gene therapy, the Company’s ability to re-dose patients and the potential of ImmTOR to allow for re-dosing, the potential of the ImmTOR technology platform generally and the company’s ability to grow its strategic partnerships, the company’s development of a product candidate to treat an autoimmune indication, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including their uncertain outcomes, the effect of the COVID-19 outbreak on any of the company’s planned or ongoing clinical trials, manufacturing activities, supply chain and operations, including the company’s ability to initiate a Phase 3 clinical trial for SEL-212 or to initiate a clinical trial in any of its gene therapy programs, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, the unproven approach of the company’s ImmTOR technology, undesirable side effects of the company’s product candidates, the company’s reliance on third parties to manufacture its product candidates and to conduct its clinical trials who could be affected by the COVID-19 outbreak or could otherwise materially fail to perform, failure to identify additional product candidates and develop or commercialize marketable products, including SEL-212, the company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, Sobi’s ability to perform its obligations under the strategic licensing agreement, Sobi’s ability to make upfront, milestone and royalty-based payments, Sobi’s ability to invest in the company’s common stock, the company’s inability to protect its proprietary technology and intellectual property, management’s ability to perform as expected, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the company’s recurring losses from operations and negative cash flows from operations raise substantial doubt regarding its ability to continue as a going concern, substantial fluctuation in the price of its common stock, and other important factors discussed in the “Risk Factors” section of the company’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and in other filings that the company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The company specifically disclaims any intention to update any forward-looking statements included in this press release.