December 11, 2014
Wilshire Confirms First-to-File Patent Challenge Relating to LASTACAFT®
–Expects to be eligible for 180 days of marketing exclusivity–
ATLANTA, Dec. 11, 2014 /PRNewswire/ — Wilshire Pharmaceuticals, Inc. ("Wilshire") today confirmed that it has been sued by Allergan, Inc. and Vistakon Pharmaceuticals, LLC (collectively, "Allergan") in connection with Wilshire's filing of an Abbreviated New Drug Application ("ANDA") with the U.S. Food and Drug Administration ("FDA") for Alcaftadine (alcaftadine ophthalmic solution) 0.25%. This product is the generic version of LASTACAFT® (alcaftadine ophthalmic solution) 0.25%, which is indicated for the prevention of itching associated with allergic conjunctivitis.
Wilshire believes that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
Wilshire's President, Scott White, stated, "We are excited about the continued development of our pipeline, and Alcaftadine represents another key milestone for Wilshire. This filing affirms Wilshire's commitment to bringing affordable, quality medicines to patients who need them."
About Wilshire Pharmaceuticals
Wilshire, headquartered in Atlanta, Georgia, is a wholly owned subsidiary of Allergan Pharmaceuticals, LLC. Wilshire is a generic pharmaceutical company focused on developing select generic pharmaceutical products. In addition to its extensive pipeline, the company continues to actively pursue growth through acquisition and product development opportunities. For more information regarding Wilshire or any of its products, visit www.wilshirerx.com.
About Allergan Pharmaceuticals
Allergan Pharmaceuticals, headquartered in Parkway Parsippany, NJ, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets as well as generics through its Wilshire division. The company has approximately 400 employees, with over 300 sales professionals that promote its products to hospitals and physicians. In addition to its extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of marketed or late-stage development products. Allergan currently markets seventeen approved NDA and ANDA products, and, along with Wilshire, has over forty products in development. For more information regarding Allergan Pharmaceuticals or any of its products, visit www.Allerganpharm.com or send email inquiries to info@Allerganpharm.com.
This press release contains forward-looking statements. Forward-looking statements include statements regarding Allergan's or Wilshire's plans, outlook, strategies, results for the future and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Allergan's and Wilshire's business, including general economic conditions in the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory, judicial or other governmental authorities and the timing thereof and (6) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
Any forward-looking statements contained in this press release speak only as of the date of this press release, and neither Allergan nor Wilshire undertakes any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement and, if such an update or correction occurs, investors and others should not conclude that additional updates or corrections are required or will be forthcoming.
CONTACT: Allergan Pharmaceuticals, Ed Schutter, email@example.com