SOURCE: Velcera, Inc.

June 30, 2008 06:01 ET

Velcera Announces FDA Confirms VEL504 Clinical Program

YARDLEY, PA--(Marketwire - June 30, 2008) - Velcera, Inc. (OTCBB: VLCR), a specialty pharmaceutical company focused on pet health, announced today the results of a pre submission conference held with the U.S. Food and Drug Administration's Center for Veterinary Medicine ("CVM") concerning Velcera's novel canine pain management product, VEL504. The meeting was held to review progress on target animal safety and efficacy studies conducted to date, and to confirm CVM's acceptance of the agreed upon plan of development. CVM confirmed the concurred protocol for the U.S. clinical field study is acceptable.

"As stated earlier to our investors, Velcera is advancing the development plan for VEL504 in an expeditious manner with the second positive FDA meeting within a 30 day period," stated Dennis Steadman, Velcera's President and Chief Executive Officer. "As a result of these two recent meetings, we have now received FDA confirmation on our existing formulation and our safety and efficacy program," added Mr. Steadman.

About Velcera, Inc.

Velcera (www.velcera.com) is a specialty pharmaceutical company focused on innovation in the expanding pet health market. Velcera's product development targets new pet medicines in pain management, anti-allergy and parasiticides that can provide pet-parents with superior convenience and greater compliance. Certain product candidates are based upon the patented Promist™ delivery technology, which has the potential to increase compliance and improve pet health as pet parents avoid the challenges of getting pets to swallow pills.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Risks that may affect forward-looking information contained in this press release include, without limitation, the risk that the results of clinical trials may not support our claims and our lack of experience in developing and commercializing pet pharmaceutical products. Additional risks are described in our post effective-amendment No. 1 on Form S-1 to our SB-2/A Registration Statement filed on April 28, 2008. We assume no obligation to update these statements, except as required by law.

Contact Information

  • Contact:
    Dennis Steadman
    CEO
    267-757-3600