Fortress Biotech Announces Exclusive Worldwide License Agreement With AstraZeneca and Cincinnati Children’s Hospital Medical Center to Develop a Novel Treatment for Select CNS Disorders

Baergic Bio, a Fortress partner company, enters into an agreement with AstraZeneca for AZD7325, a novel α2/3–subtype-selective GABA A positive allosteric modulator


NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) today announced that Baergic Bio, Inc. (“Baergic”), a newly formed Fortress partner company, has entered into an exclusive worldwide licensing agreement with AstraZeneca for AZD7325, a novel α2/3–subtype-selective GABA A positive allosteric modulator (“PAM”), as well as an agreement with Cincinnati Children’s Hospital Medical Center (“Cincinnati Children’s”) to advance clinical development in select central nervous system (“CNS”) disorders. As part of Baergic’s formation, AstraZeneca will provide exclusive worldwide rights to AZD7325, now known as BAER-101, including clinical data generated to date, and will have an equity position in Baergic.

BAER-101 will continue to be evaluated in pre-clinical and clinical settings in areas of unmet need where a selective GABA A PAM has shown evidence to be an impactful therapeutic. By specifically targeting α2/3–subtypes, BAER-101 may minimize adverse events that are typically seen with benzodiazepines, which engage α1. Among these adverse events is a significant sedative liability, which makes benzodiazepines not well suited for chronic use. BAER-101’s unique selectivity will give Baergic the ability to explore its use in a number of CNS disorders where patients are not adequately treated.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We are thrilled to be working with AstraZeneca and Cincinnati Children’s Hospital Medical Center to develop BAER-101. There are several CNS disorders where a selective GABA A PAM has the potential to improve the care of patients. We look forward to exploring the indications for which BAER-101 is most suitable and efficiently advancing the development of this novel therapy.”

About BAER-101
BAER-101 is a high affinity, selective modulator of the GABA A receptor system, with differential binding and modulatory properties dependent on the particular GABA A subtype. For more information, visit https://openinnovation.astrazeneca.com/azd7325.html.

About Baergic Bio
Baergic Bio, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of CNS disorders. Baergic Bio’s lead asset, BAER-101, is currently being explored in clinical and pre-clinical settings in areas of unmet need. Baergic Bio is located in New York City and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO).

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period.  Fortress is focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market therapeutic areas, including oncology, rare diseases and gene therapy, which allow it to create value while mitigating risk for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited) and St. Jude Children’s Research Hospital.  For more information, visit www.fortressbiotech.com.

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; 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. 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.

Company Contacts:
Jaclyn Jaffe and William Begien
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com

Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 430-7576
daniel@lifesciadvisors.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com