Full Press Release Details
"As we continue towards our goal of providing Translarna to all who may benefit, we are pleased by the EC ratification of the recent CHMP positive opinion," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics. "This important regulatory milestone supports the continued growth of our sustainable ex-US business in both the European Union and countries that reference the authorization. Duchenne is a rapidly progressive disease and physicians need access to medicines, like Translarna, that have the potential to slow the devastating progression of this disorder."
About PTC Therapeutics, Inc. PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary small molecule drugs targeting an area of RNA biology we refer to as post-transcriptional control. Post-transcriptional control processes are the regulatory events that occur in cells during and after a messenger RNA, or mRNA, molecule is copied from DNA through the transcription process. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology. PTC has discovered all of its compounds currently under development using its proprietary technologies. PTC plans to continue to develop these compounds both on its own and through selective collaboration arrangements with leading pharmaceutical and biotechnology companies. For more information on the company, please visit our website www.ptcbio.com .
For More Information:
Investors: Emily Hill +1 (908) 912-9327 [email protected]
Media: Jane Baj +1 (908) 912-9167 [email protected]
Forward Looking Statements:
All statements, other than those of historical fact, contained in this press release, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC; the timing and outcome of PTC's regulatory process, including with respect to PTC's plan to conduct an additional trial of Translarna in nmDMD; our ability to continue commercial growth in the European Union and countries that may reference the Translarna marketing authorization in the European Economic Area; the clinical utility and potential advantages of Translarna; PTC's strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management. Other forward-looking statements may be identified by the words "will," "plan," "expect," "target," "anticipate," "believe," "estimate," "intend," "may," "possible," "potential," "would," "could," "should," "continue," and similar expressions.
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 Translarna will receive full regulatory approval in any territory or maintain its current marketing authorization in the EEA, or prove to be commercially successful in general, or specifically with respect to the treatment of nmDMD.
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.
SOURCE PTC Therapeutics, Inc.