LIVINGSTON, N.J.--(BUSINESS WIRE)-- Columbia Laboratories, Inc. (Nasdaq: CBRX) has entered into a license agreement with Invaron Pharmaceuticals Inc. (“Invaron”), a privately-held Canadian pharmaceutical company, for STRIANT® (testosterone buccal system) in Canada.
Under the terms of the agreement, Invaron will seek regulatory approval for and will market STRIANT in Canada. Columbia will receive a royalty on annual net sales of STRIANT in Canada, assuming Invaron receives Health Canada regulatory approval. Revenues to Columbia are not expected to be material.
Invaron is a Canadian based pharmaceutical company focusing exclusively on the acquisition of niche drugs and medical devices registered in other countries but not in Canada. By facilitating local registration, bridging clinical gaps, and launching with innovative marketing strategies Invaron will effectively meet the under serviced needs of Canadian patients in a wide variety of therapeutic areas.
Invaron’s press releases and other company information are available online at www.invaron.ca. Invaron encourages patients, physicians, potential pharmaceutical partners and other stakeholders to visit www.invaron.ca/contact_us to request that Invaron examine the regulatory approval for a particular drug or medical device.
About Columbia Laboratories
Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel), for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. STRIANT® (testosterone buccal system) is marketed by Actient Pharmaceuticals (U.S.) and The Urology Company (Europe). The Company’s New Drug Application (NDA) for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy was accepted for filing by the Food and Drug Administration (FDA) with a PDUFA date of February 26, 2012.
Columbia's press releases and other company information are available online at www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the outcome of further analyses by the FDA of the clinical data in the PROCHIEVE® NDA; success in obtaining timely approval of PROCHIEVE in the preterm birth indication by the FDA; the timing and level of success of a future product launch, if any; the ability of Columbia's third-party manufacturers to supply CRINONE®, PROCHIEVE and STRIANT; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; the ability to obtain and enforce patents and other intellectual property rights; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.
STRIANT® is a registered trademark of Actient Pharmaceuticals, LLC., in the U.S.
STRIANT® SR is a registered trademark of The Urology Company in the United Kingdom and the E.U.
CRINONE® and PROCHIEVE® are registered trademarks of Watson Pharmaceuticals, Inc.
Columbia Laboratories, Inc.
Lawrence A. Gyenes, 973-486-8860
Senior Vice President, CFO & Treasurer
The Trout Group LLC
Seth Lewis, 646-378-2952
KEYWORDS: United States North America Canada New Jersey
INDUSTRY KEYWORDS: Health Biotechnology