Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, and a company it founded, Caelum Biosciences, Inc. (“Caelum”), a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases, today announced that AstraZeneca’s Alexion notified Caelum that it has exercised its option to acquire Caelum, pursuant to the Development, Option and Stock Purchase Agreement in place between Fortress, Caelum, Alexion and the other parties thereto (as amended, the “DOSPA”). In addition, the waiting period under the Hart-Scott-Rodino (“HSR”) Antitrust Improvements Act of 1976, as amended, has expired in connection with such acquisition. Expiration of the waiting period under the HSR Act satisfies one of the conditions precedents for the consummation of the acquisition.
Under terms of the DOSPA, upon closing of the acquisition, which is expected to take place on October 5, 2021, Alexion will purchase all of the outstanding shares of Caelum and will pay Caelum the agreed option exercise price of approximately $150 million. Distributions will be made to all existing Caelum stockholders. The agreement also provides for additional potential payments to Caelum stockholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones. The fortress is eligible to receive approximately 43 percent of all proceeds from the transaction.
“The acquisition of Caelum is a positive development and monetization opportunity for our shareholders while validating the Fortress business model,” said Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President, and Chief Executive Officer. “We believe in CAEL-101’s potential to be a best-in-class treatment for AL amyloidosis and look forward to the continued progression of CAEL-101 in the CARES Phase 3 clinical program under the leadership of the renowned team at Alexion.”
Michael Spector, Co-Founder, President, and Chief Executive Officer of Caelum, said, “I am proud to have been a co-founder of Caelum in 2017 with Fortress Biotech. Caelum formed a collaboration with Alexion Pharmaceuticals in 2019 to develop CAEL-101 for patients with AL amyloidosis, and we achieved significant milestones together through the ongoing Phase 3 program. The acquisition of Caelum is an important step for patients with AL amyloidosis, as our partners at Alexion have the resources required to expedite the development of CAEL-101. Treatments that target amyloid deposits remain an important unmet medical need.”
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The Cardiac Amyloid Reaching for Extended Survival (CARES) clinical program is evaluating CAEL-101, and enrollment is ongoing in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease (ClinicalTrials.gov Identifier: NCT04512235 and NCT04504825). The company also has a Phase 2 clinical study that is evaluating the safety and tolerability of CAEL-101 in patients with AL amyloidosis (ClinicalTrials.gov Identifier: NCT04304144).
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions, or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Source: Biospace
