Amneal Enterprises, an affiliation of independent pharmaceutical marketing, discovery and development companies, and Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), innovator and developer of products based upon the Microcyn® Technology platform, announced today that Amneal alliance members have formed a broad multi-year collaboration with Oculus to realize the development and commercial potential of Microcyn Technology. Chirag Patel, Co-Chairman of Amneal Enterprises, said, “We are deeply impressed by the wide importance and potential of Oculus’ Microcyn Technology and are excited by the prospects of what our strategic, organizational and financial collaboration can accomplish.” There are three key components to the collaboration: Drug Opportunities:
- AmDerma Pharmaceuticals, LLC, an Amneal alliance member, will pay Oculus $500,000 as a non-refundable initial payment as an option to license the Microcyn technology for an acne new drug application, with the option expiring June 30, 2011. Assuming execution of the option, the new acne drug will be the subject of a separate agreement for U.S. and European rights, with Oculus retaining rights to the rest of world, that will include undisclosed upfront, milestones and royalty payments.
- Another Amneal alliance member, Quinnova Pharmaceuticals, Inc., has licensed, with a $500,000 prepayment and ongoing double-digit royalties, the U.S. and Canadian rights to Microcyn-based dermatology atopic dermatitis hydrogel that received FDA clearance this past week. Future Rx dermatology products will also be licensed for undisclosed upfront payments.
- Amneal will co-promote the current Rx Microcyn-based wound care products to podiatry professionals in the United States and Canada.
- Amneal Pharmaceuticals, LLC
- Prolong Pharmaceuticals, LLC
- AmDerma Pharmaceuticals, LLC
- Quinnova Pharmaceuticals, Inc.
- Kashiv Pharma, LLC
- TcNet, LLC.
Although each company operates independently, working together Amneal Enterprises can leverage value across the alliance for exponential advancement and more dynamic growth for each individual business. The venture is an excellent example of the whole being greater than the sum of its parts.About Atopic/Radiation Dermatitis More than 15 million patients have symptoms of atopic dermatitis, characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor. Radiation dermatitis is an unintended and often unavoidable skin reaction commonly experienced by patients receiving radiation therapy as part of their cancer treatment. This side effect, caused by radiation passing through skin cells, is often unpleasant and painful and may contribute to poor quality of life in cancer patients. In some cases, radiation dermatitis may become so severe as to necessitate interruption or cessation of radiation therapy. A wide variety of products have been used to treat radiation dermatitis with little or no evidence to support their use. Of total cancer patients, approximately 60 percent receive radiation treatment, and up to 95% of those are afflicted with radiation dermatitis. About Acne Research published by Research and Markets suggests that the global acne market was worth $2.8 billion in 2009. It is estimated to reach revenues of $3.02 billion by 2016 at a Compound Annual Growth Rate ( CAGR) of 0.7%. The acne therapeutics market is witnessing a shift towards combination products, using two or more acne treatments. The acne market is primarily genericised and is moderately served by the currently marketed drugs. The majority of the pipeline products of large pharmaceutical companies also consist of combination products with very few first-in-class molecules. With emerging me-too combination products in the pipeline that are not significantly different from the current monotherapies, the acne market awaits a blockbuster drug. Increases in the population in general and an increase in the prescription rate are estimated to sustain the acne market in the future.
With the recent characterization of acne as a chronic disease, research and development (R&D) in acne therapeutics requires, if not effective new launches, immediate prioritization of research on the pathology of this seemingly simple but actually complex disease.About Oculus Innovative Sciences Oculus Innovative Sciences is a commercial healthcare company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, which significantly reduces the need for antibiotics while reducing infections and accelerating healing. The Microcyn Technology addresses the need for improved solutions in multiple markets including dermatology, oral care, cosmeceutical, wound care and others. It features a biocompatible, shelf-stable solution that is currently commercialized in the United States, Europe, India, China and Mexico and select Middle East countries under various country specific regulatory clearances and approvals. Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores; increase blood flow to the wound site; and reduce both inflammation and pain while assisting in faster wound closure. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. More information can be found at www.oculusis.com. Forward-Looking Statements Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the Company’s commercial and technology progress and future financial performance. These forward-looking statements are identified by the use of words such as "that will," “advance” and “licensed,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the annual report on Form 10-K for the year ended March 31, 2010. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements except as required by law.
Oculus, Epicyn and Microcyn Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.