Evoke Pharma, Inc. (NASDAQ:EVOK)Posted on July 28, 2016
Evoke Pharma Receives Conditional FDA Acceptance of Proposed Brand Name for EVK-001
SOLANA BEACH, Calif., July 26, 2016 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the US Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, “Gimoti,” for the Company’s product candidate, EVK-001 (metoclopramide nasal spray). A request for proprietary name review for Gimoti will be included if and when Evoke submits a New Drug Application (NDA) for the product candidate.
The name Gimoti (pronounced “jye-MOH-tee”) was developed in compliance with the FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names (issued in February 2010). The development program, which included research with physicians and pharmacists, as well as an international name assessment, confirmed Gimoti is a proprietary name with strong marketing potential that is also consistent with the FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use.
“The naming of EVK-001 as Gimoti further demonstrates our belief that there is value in pursuing the approval of our product candidate for the treatment of diabetic gastroparesis in women. We are pleased to have the FDA’s conditional approval of this brand name,” said Dave Gonyer, R.Ph., President and CEO. “As we consider our options to move forward with Gimoti, we are analyzing data from our recently completed Phase 3 trial as well as additional trials to assess continued development opportunities for this product candidate and all possible submission strategies. These efforts will be supported by the recent financing we successfully completed.”
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 value in continuing to pursue approval of Gimoti for the treatment of diabetic gastroparesis in women; the marketing potential of the new brand name; the potential for a future submission of an NDA for the product candidate; and the Company’s ability to fund its assessment of development opportunities for Gimoti and evaluation of various submission strategies. 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 a number of risks and uncertainties, including: Gimoti failed to achieve its primary endpoint of symptom improvement in the Company’s recently-announced Phase 3 clinical trial; Evoke is entirely dependent on the success of Gimoti, and cannot be certain that it will be able to identify a viable regulatory submission strategy or otherwise conduct continued development of this product candidate; additional analyses of data from the Phase 3 trial may produce negative or inconclusive results, or may be inconsistent with previously announced topline results, and may preclude submission or approval of an NDA; the Company is seeking to negotiate a resolution with its secured lender concerning defaults under its credit facility and may be unable to reach acceptable terms; even if a viable regulatory strategy is identified for Gimoti and the defaults under the credit facility are waived, the Company will need to continue to raise additional capital in order to complete an NDA submission and fund its ongoing operations; and other risks and uncertainties inherent in Evoke’s business, including those described in the Company’s filings with the SEC. 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.