Evoke Pharma Achieves Significant Manufacturing Milestone With Successful Completion of Commercial Scale Production of EVK-001
Manufacturing Program Includes Three Year Registration Stability Data
SOLANA BEACH, Calif., April 14, 2015 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has completed the production of a commercial scale lot of EVK-001 as required by the U.S. Food and Drug Administration (FDA).
With the completion of this large scale production of EVK-001, the Company has demonstrated its ability to manufacture EVK-001, its patented intranasal formulation of metoclopramide, at commercial scale quantities in accordance with the FDA standards for chemistry, manufacturing, and controls (CMC). In addition to data from this recent program, Evoke has a three-year registration stability data package from previous studies which have all met proposed specifications. These CMC datasets will be used as part of a New Drug Application (NDA) following data readout from Evoke's ongoing pivotal Phase 3 clinical trial for EVK-001.
Dave Gonyer, R.Ph., President and CEO, stated, "The ability to successfully manufacture EVK-001 at commercial scale volumes, along with our existing registration stability dataset that meets FDA requirements, is another important milestone for Evoke. This moves us one step closer to our ultimate goal of providing patients and their health care providers with an improved standard of care for treating symptoms related to diabetic gastroparesis in women. This is just one of the many steps we have accomplished and will continue to pursue, as we work toward FDA approval."
Mr. Gonyer continued, "With 12 to 16 million patients in the U.S. who show symptoms of gastroparesis, there is a large market opportunity for a more effective treatment option than what is currently available. We believe EVK-001 can provide the relief that female patients need in a more predictable manner by avoiding the absorption problems typically experienced by people with this disease. We look forward to completing enrollment of our Phase 3 clinical trial in the second half of 2015 and providing data from this study."
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration. Visit www.EvokePharma.com for more information.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding the enrollment completion of Evoke's ongoing Phase 3 clinical trial of EVK-001, the potential approval and commercialization of EVK-001 as a new and effective treatment for gastroparesis and Evoke's datasets and completed and ongoing trials and studies serving as a basis for submission of an NDA. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke's business, including, without limitation: Evoke is entirely dependent on the success of EVK-001, for which it has commenced a Phase 3 clinical trial and male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; risks that issues with future manufacturing production will arise, whether as a result of noncompliance with CMC requirements or otherwise; Evoke's reliance on outsourcing arrangements for many of its activities, including clinical development, manufacturing and supply of EVK-001, and Evoke's current lack of long-term commercial manufacturing agreements; the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke's Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; the inherent risks of clinical development of EVK-001, including continued delays in enrollment and completion of the Phase 3 trial as well as potential delays in any other clinical trials and studies; Evoke will require substantial additional funding to complete the Phase 3 clinical trial and potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor / Media Contact: The Ruth Group David Burke / Kirsten Thomas Tel: 646-536-7009 / 7014