PTC Announces Further Strategic Prioritization and Associated Reduction in Workforce
- Translarna CHMP opinion re-examination request to be submitted -
SOUTH PLAINFIELD, N.J.,
"We remain confident that we have the data to address the concerns raised by CHMP in its negative opinion," said
The workforce reduction impacted approximately 25% of the organization, and primarily included employees working on early-stage research programs, employees at the gene therapy manufacturing facility located in
"I would like to acknowledge the tremendous contribution of the PTC team members affected by the reduction in workforce," Klein continued. "The workforce and OPEX reductions continue the efforts we began in May to focus resources on key R&D programs and our commercial enterprise. PTC has a number of valuable assets that form the foundation of a promising future including the sepiapterin PKU program, the PTC518 Huntington disease program and the Evrysdi collaboration and royalty revenue."
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC's strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, Instagram, LinkedIn and Twitter at @PTCBio.
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CHMP: Committee for Medicinal Products for Human Use
OPEX: Operating Expenses
SG&A: Selling, General and Administrative
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historic fact, are forward-looking statements, including statements regarding the extent, timing and financial aspects of the strategic prioritization and reduction in workforce; PTC's plans for interactions with the
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward -looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; the timing of and actual expenses incurred in connection with the strategic prioritization and reduction in workforce, which may be in different periods and may be materially higher than we estimate; the savings that may result from the strategic prioritization and reduction in workforce, which may be materially less than we expect; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including Translarna.
The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.