SOLANA BEACH, Calif., July 07, 2016 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), today announced that it has entered into a master service agreement with inVentiv Commercial Services LLC (“inVentiv”) in connection with Evoke’s preparation for commercial activities for EVK-001, its lead product candidate for the treatment of diabetic gastroparesis in women. Evoke recently completed its Phase 3 clinical trial for EVK-001, with data expected early in the third quarter.
Evoke’s partnership with inVentiv will enable Evoke to build its commercial infrastructure as it prepares for the potential commercialization of EVK-001, pending the filing of a New Drug Application (NDA) and U.S. Food and Drug Administration (FDA) approval. Under terms of the agreement, inVentiv may provide services including, but not limited to, sales representatives, sales management, marketing, account management, advertising, medical communications, distribution support, and overall commercial management. Evoke and inVentiv will add commercial team members and capabilities on an as-needed basis over the coming months as certain development and regulatory milestones are met. In the past five years, inVentiv has created more than 110 teams for clients, about 50 of which were created to launch new products.
“As we await pivotal phase 3 clinical trial data, we have begun to ramp up our efforts to prepare for commercialization, should we be in a position to move forward with the submission of our NDA,” commented Dave Gonyer, R.Ph., President and CEO of Evoke. “We estimate that the market opportunity for EVK-001 is very large given the significant unmet need within the gastroparesis community and the lack of FDA-approved treatments. Working with inVentiv, a leader in providing services to assist healthcare companies to effectively and efficiently commercialize their products, we have full confidence in successfully bringing EVK-001 to market following approval from the FDA.”
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 nasal 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," , or 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 timing of data from the Phase 3 clinical trial of EVK-001; the sufficiency of such data and the other activities completed to data providing a basis for the submission of an NDA for EVK-001 to the FDA and the timing thereof; and the potential commercialization of EVK-001. 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: the inherent risks of clinical development of EVK-001 as well as potential delays in any other clinical trials and studies; Evoke is entirely dependent on the success of EVK-001, for which it has completed a Phase 3 clinical trial and continues enrollment in a male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; 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; Evoke will require substantial additional funding to 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; Evoke may not be able to successfully commercialize EVK-001, if approved, as a result of risks associated with market acceptance, coverage and reimbursement and competing products; 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.