Sarepta Therapeutics Enters into Long-term Strategic Manufacturing Partnership with Brammer Bio to Support Gene Therapy Development and Commercial Supply
06/13/18 8:30 AM EDT
-- The partnership will provide commercial supply for a potential micro-dystrophin gene therapy product launch and other neuromuscular programs in the pipeline --
-- Hybrid model enables Sarepta to maintain control over process development, while leveraging Brammer Bio’s world-class manufacturing capabilities --
Sarepta has adopted a hybrid internal and external development and manufacturing model. Under this model, Sarepta will continue to build internal expertise in all aspects of AAV-based manufacturing while externally Brammer Bio will provide scalable best-in-class manufacturing capabilities. The collaboration model will integrate process development, clinical production and testing, and commercial manufacturing with the goal of bringing micro-dystrophin gene therapies to the patient community urgently and in sufficient supply.
Brammer Bio will partner with Sarepta to design and build dedicated commercial manufacturing capacity within their facility with cutting-edge capabilities. Once complete, the facility is expected to provide robust manufacturing capacity to support the unusually high demands typical for systemic administration of the micro-dystrophin therapy for DMD.
“As we have stated in the past, Sarepta is committed to becoming one of the most meaningful genetic medicine companies in the world over the coming few years. The Brammer Bio partnership and dedicated gene therapy capacity, once complete, will represent more annual gene therapy supply than any currently existing facility,” stated
Mr. Ingram added, “At Sarepta, we pride ourselves in partnering with the best and brightest to advance our mission. With that in mind, we are proud to have selected Brammer Bio as our partner because they are among the world’s most advanced cGMP gene therapy manufacturers, with expertise that spans all aspects of AAV-based gene therapy development, manufacturing and release. Our hybrid approach enables us to leverage both our internal expertise and capabilities and Brammer Bio’s capacity and expertise, allowing for minimal changes to the process to accelerate therapies for patients with DMD and LGMD.”
“Brammer is delighted to partner with
Brammer Bio’s team of 400+ operates in
Brammer Bio has 165,000 square-feet of facilities in
About Brammer Bio
Brammer Bio provides clinical and commercial supply of viral vectors for in vivo gene and ex vivo modified-cell based therapies, process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patient health. Brammer is owned by
This press release contains "forward-looking statements." Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the expectation that the partnership with Brammer Bio will provide Sarepta access to clinical and commercial manufacturing capacity for its micro-dystrophin DMD gene therapy program and a manufacturing platform for future gene therapy programs, such as LGMD; Sarepta’s plan to continue to build internal expertise in all aspects of AAV-based manufacturing while Brammer Bio will provide scalable best-in-class manufacturing capabilities; the collaboration model integrating process development, clinical production and testing, and commercial manufacturing with the goal of bringing micro-dystrophin gene therapies to the patient community urgently and in sufficient supply; the expectation that Brammer Bio’s facility will provide robust manufacturing capacity to support the unusually high demands typical for systemic administration of the micro-dystrophin therapy for DMD; Sarepta’s commitment to becoming one of the most meaningful genetic medicine companies in the world over the coming few years; the expectation that the Brammer Bio partnership and dedicated gene therapy capacity, once complete, will represent more annual gene therapy supply than any currently existing facility;and the hybrid approach allowing Sarepta for minimal changes to the process to accelerate therapies for patients with DMD and LGMD.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the expected benefits and opportunities related to the agreement with Brammer Bio may not be realized or may take longer to realize than expected;Sarepta’s dependence on Brammer Bio to produce its product candidates, including any inability on Sarepta’s part to accurately anticipate product demand and timely secure manufacturing capacity to meet product demand, may impair the availability of product to successfully support various programs, including research and development and the potential commercialization of Sarepta’s gene therapy product candidates; if Brammer Bio were to cease providing quality manufacturing and related services to Sarepta, and Sarepta is not able to engage appropriate replacements in a timely manner, Sarepta’s ability to manufacture its gene therapy product candidates in sufficient quality and quantity would adversely affect Sarepta’s various product research, development and commercialization efforts; if Brammer Bio fails to adhere to applicable cGMP and other applicable government regulations, or experiences manufacturing problems, Sarepta will suffer significant consequences, which could significantly delay or negatively impact the success of Sarepta’s development efforts for its product candidates; Sarepta may not be able to successfully scale up manufacturing of its product candidates in sufficient quality and quantity or within sufficient timelines, or be able to secure ownership of intellectual property rights developed in this process, which could negatively impact the development of its product candidates and next generation chemistries like gene therapy; Sarepta’s gene therapy programs may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons, including the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates or may never become commercialized products due to other various reasons including possible limitations of Company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and even if Sarepta’s gene therapy programs result in new commercialized products, Sarepta may not achieve any significant revenues from the sale of such products; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended
Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta's 2017 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q filed with the
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For Brammer Bio
Manager, Corporate Communications
Office: 386-418-8199 x2083
Source: Sarepta Therapeutics, Inc.
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