Commercial build-out to support anticipated launch of suvodirsen and other future commercialized products
CAMBRIDGE, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases, today announced the appointment of Mark Baldry as Chief Commercial Officer. In this newly created position, Mr. Baldry will build and oversee Wave’s global commercial strategy and organization, including its sales, marketing and market access and reimbursement teams. Initially, he will focus on the launch planning for suvodirsen, the company’s investigational stereopure oligonucleotide intended for boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.
“Mark has a proven track record of developing and executing global commercialization plans and delivering on the promise of transformative medicines in the highly complex world of rare neurological diseases,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “He will be instrumental as we begin preparing for our first potential launch of suvodirsen in the United States, as well as the future expansion of our portfolio globally and in other neurological diseases such as Huntington’s disease.”
Mr. Baldry joins Wave with almost 30 years of global commercial experience in neuroscience and rare disease and has held positions of increasing responsibility in the United States, Canada, France and the United Kingdom. Most recently, Baldry served as Senior Vice President, Global Marketing & Commercial Operations at Amicus Therapeutics. At Amicus, Mr. Baldry was responsible for market assessments, strategic brand planning, market access strategies and leadership of product launches. He oversaw the global launch of Galafold® (migalastat) in Fabry disease; he also acted as head of the U.S. commercial business, developing U.S. launch plans, establishing a U.S. leadership team and hiring the rare disease field sales force.
Mr. Baldry previously served in multiple leadership positions at Biogen, including Vice President, Public Affairs and Vice President, New Product Commercialization. His responsibilities included building functional excellence within the Public Affairs team in support of four product launches, including Tecfidera® (dimethyl fumarate), as well as providing commercial insights for early-stage product and business development assessments. Prior to his time at Biogen, Mr. Baldry also held leadership roles at Shire Pharmaceuticals, including Head of Marketing, Market Access and Public Affairs, Europe, Middle East and Africa (EMEA) and Head of Global Strategic Marketing for the Human Genetic Therapies division.
“I am thrilled to be joining Wave at such a transformative moment, as we aim to build a best-in-class, global commercial organization,” said Mr. Baldry. “Suvodirsen represents a compelling opportunity to transform the lives of those living with Duchenne, and I am humbled and excited to help bring this promising investigational therapy to patients in need.”
Suvodirsen is an investigational stereopure oligonucleotide currently being evaluated in an ongoing open-label extension (OLE) study for the treatment of boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping. Approximately 13% of DMD patients have genetic mutations that are amenable to treatment with an exon 51 skipping therapy. Exon-skipping technology has the potential to induce cellular machinery to ‘skip over’ a targeted exon and restore the reading frame, resulting in the production of internally truncated, but functional dystrophin protein.
The company expects to deliver an interim analysis of dystrophin expression from muscle biopsies in boys receiving suvodirsen in the OLE in the fourth quarter of 2019. Suvodirsen is also being a studied in DYSTANCE 51, a global Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of suvodirsen. Results from the DYSTANCE 51 trial are intended to support global regulatory filings for suvodirsen.
Suvodirsen has been granted orphan drug designation for the treatment of DMD by the U.S. Food and Drug Administration (FDA) and the European Commission, as well as rare pediatric disease designation by the FDA. Pending positive clinical dystrophin expression data, the company expects to file for an accelerated approval of suvodirsen in the United States in the second half of 2020.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a fatal X-linked genetic neuromuscular disorder caused predominantly by out-of-frame deletions in the dystrophin gene, resulting in absent or defective dystrophin protein. Dystrophin protein is needed for normal muscle maintenance and operation. Because of the genetic mutations in DMD, the body cannot produce functional dystrophin, which results in progressive and irreversible loss of muscle function, including the heart and lungs. Worldwide, DMD affects approximately one in 5,000 newborn boys.
About Wave Life Sciences
Wave Life Sciences (NASDAQ: WVE) is a clinical-stage genetic medicines company committed to delivering life-changing treatments for people battling devastating diseases. Wave aspires to develop best-in-class medicines across multiple therapeutic modalities using PRISM, the company’s proprietary discovery and drug development platform that enables the precise design, optimization and production of stereopure oligonucleotides. Driven by a resolute sense of urgency, the Wave team is targeting a broad range of genetically defined diseases so that patients and families may realize a brighter future. To find out more, please visit www.wavelifesciences.com and follow Wave on Twitter @WaveLifeSci.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the potential for suvodirsen, which is an investigational therapy being studied in clinical trials, to become Wave’s first commercially marketed product globally and the potential for other investigational therapies from Wave’s pipeline to be approved for commercial use in the future, the expected timing and plans to report interim data from the ongoing OLE, the intention to use the results from the OLE and Phase 2/3 trials to seek various regulatory approvals for suvodirsen globally, and the anticipated timing of such regulatory filing in the United States. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. These risks and uncertainties include but are not limited to the following: Wave’s current and planned clinical trials, other studies for suvodirsen and Wave’s other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in later-stage or larger-scale clinical trials; and the other risk factors discussed under the heading “Risk Factors” contained in Wave’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission (SEC), as well as in other filings Wave makes with the SEC from time to time. All statements contained in this press release are made only as of the date of this press release, and Wave undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
Source: Wave Life Sciences