MISSISSAUGA, ON, March 7, 2016 /CNW/ - Crescita Therapeutics Inc. (TSX:CTX) (Crescita), a drug development company that owns topical products for treating medical conditions in dermatology and pain, today provided an update on its priorities for the coming 120 days. Crescita was created on March 1, 2016 by the reorganization of Nuvo Research Inc. (Nuvo Research) into two separate publicly traded companies, Crescita and Nuvo Pharmaceuticals Inc. (TSX:NRI) (the Reorganization).
- The Company will be finalizing its strategy for the commercialization of Pliaglis which is approved for sale in Canada and the United States with regulatory approval pending in Mexico. In December 2015, Nuvo Research reacquired the development and marketing rights for Pliaglis in these territories from its global licensing partner. These rights were transferred to Crescita as part of the Reorganization.
- The Company is in communication with the U.S. Food and Drug Administration (FDA) and expects to receive feedback from the FDA in Q2 2016 on the clinical and regulatory requirements for its development of Flexicaine for the treatment of neuropathic pain.
- The Company is evaluating strategic merger and acquisition opportunities to grow its commercial product portfolio and development-stage pipeline.
- Pending execution of these priorities in Q2 2016, the Company will focus on preserving its cash position, which as of March 1, 2016was $35 million.
"We feel Crescita, with its combination of development and commercial stage assets and a strong balance sheet, is very well positioned for today's biotech environment," said Dan Chicoine, Crescita's Chairman and CEO. "We are well funded to take our promising development-stage asset, Flexicaine deeper into the clinic, but await feedback from the FDA before determining our next clinical steps. Our plan is to take a measured approach towards R&D at this stage, while also being opportunistic for product acquisitions to complement our pipeline."
Pliaglis is a topical anesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes proprietary phase-changing topical cream Peel technology.
Flexicaine is a proprietary patent-protected topical formulation of lidocaine and tetracaine that is designed for the topical treatment of pain conditions such as post herpetic neuralgia or diabetic peripheral neuropathy. The formulation dries to form a film which can be easily peeled from the skin once the actives have been delivered to the site of pain providing a long-lasting anesthetic effect and simple removal of the product.
About Crescita Therapeutics Inc.
Crescita (TSX:CTX) is a well-capitalized drug development company that owns topical products for treating medical conditions in dermatology and pain. Crescita owns multiple proprietary drug delivery platforms that support the development of patented formulations that can facilitate the delivery of active drugs into or through the skin. Crescita has one commercial product, Pliaglis that is licensed globally (except for Canada, the United States and Mexico where Crescita owns the rights). Crescita was created on March 1, 2016 by the reorganization of Nuvo Research into two separate publicly traded companies. Crescita common shares will commence trading on the TSX on March 7, 2016. Crescita's board and management team have demonstrated success in building Crescita's predecessor company, Nuvo Research, including developing multiple drugs that are now approved and commercialized and negotiating multiple transactions that have generated more than $100 million in non-dilutive funding. For additional information, please visitwww.crescitatherapeutics.com.
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, management's beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "believe", "should" or "plans", or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include, but are not limited to, general business and economic uncertainties and adverse market conditions; uncertainties related to Crescita's ability to realize the anticipated benefits of the Reorganization; the expected future attributes and success of Crescita; the successful execution of Crescita's priorities and strategies; the reliability of Nuvo Research's historical financial information as an indicator of Crescita's historical or future results; as well as other risk factors included in Nuvo Reseach's Management Information Circular dated December 31, 2015(the Reorganization Circular) and most recent Annual Information Form dated February 17, 2016 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Crescita with Canadian securities regulatory agencies and commissions. Certain risks and uncertainties specific to the Reorganization and Crescita are further described in the Reorganization Circular. These and other factors should be considered carefully and readers should not place undue reliance on Crescita's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither Crescita nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. Although the forward-looking information contained in this press release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press release and, except as required by applicable law, Crescita undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.