- The deal is designed to accelerate BridgeBio’s gene therapy programs
- The dedicated suite will support clinical and commercial supply needs for BridgeBio’s gene therapy programs for congenital adrenal hyperplasia (BBP-631) and Canavan disease (BBP-812)
Catalent’s commercial facility is fully compliant with cGMP requirements and allows for up to 5000 liters of production. The over 400,000 square feet footprint is complete with all necessary support functions for storage and fill finish for final product supply.
“Having flexibility and greater certainty in manufacturing capacity is critical to success in gene therapy,” said
“Catalent’s expertise in the cGMP manufacturing of viral vectors complements our internal investment in the CMC process and analytical development to support our gene therapy portfolio,” said
About
BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio’s pipeline of over 15 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit bridgebio.com.
About Paragon Gene Therapy
Paragon Gene Therapy, a unit of Catalent Biologics, is an industry leader focusing on transformative technologies, including adeno-associated virus (AAV) gene therapies, next-generation vaccines, and oncology immunotherapies. Paragon Gene Therapy has facilities in
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including over 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over
BridgeBio Pharma Forward-Looking Statements
This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the clinical development plans, clinical trial designs, the clinical and therapeutic potential, and the strategy of BridgeBio’s gene therapy product candidates, the clinical and commercial manufacturing supply needs of BridgeBio’s gene therapy product candidates, the ability of Catalent to provide adequate clinical and commercial supplies of active pharmaceutical ingredient to BridgeBio’s gene therapy product candidates that adhere to current good manufacturing practices (cGMP) regulations, the success of the collaboration agreement with Catalent, and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, Catalent’s ability to provide adequate clinical and commercial supply of active pharmaceutical ingredient for BridgeBio’s gene therapy product candidates that comply with cGMP regulations, BridgeBio’s ability to maintain the collaboration agreement with Catalent, the benefits that will be derived from the collaboration agreement with Catalent, BridgeBio’s ability to support its gene therapy portfolio and advance its gene therapy product candidates through clinical development, and the novel nature of gene therapy technology and the related heightened challenges for obtaining and maintaining regulatory approval, as well as those risks set forth in the Risk Factors section of
Contact:
Grace.rauh@bridgebio.com
(917) 232-5478
Source:
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