Amneal and Oculus Innovative Sciences Announce Broad Multi-Market, Multi-Product Collaboration for Microcyn®-Based Drugs and Devices
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$1 Million Upfront Payment
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Drugs — Mutual Exploration of Microcyn-Based Drug Prospects —
Starting Immediately with Acne
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Dermatology — Amneal to Market Current and Future Microcyn-Based
Dermatology Products in United States and Canada, Including Recently
Cleared Atopic Dermatitis HydroGel
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Chronic Wound Care — Amneal to Co-Promote Microcyn-Based Products
to Podiatrists
BRIDGEWATER, N.J. & PETALUMA, Calif.--(BUSINESS WIRE)--
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:
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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.
Dermatology Device Opportunities:
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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.
Chronic Wound Care:
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Amneal will co-promote the current Rx Microcyn-based wound care
products to podiatry professionals in the United States and Canada.
Hoji Alimi, CEO of Oculus, said, "This next-generation collaboration is
an important milestone for Oculus. The breadth of the resources of the
Amneal Enterprises alliance members — encompassing multiple
sites, nearly a thousand employees and hundreds of scientists — are
complemented by their demonstrated ability to perform. In just a few
short years, Amneal Pharmaceuticals, a member of the Amneal Enterprises
alliance, has become the ninth largest provider of generic prescriptions
in the United States as well as the fastest growing company in the
highly competitive U.S. generics industry — and also looking towards the
development of new drugs. Together, we can advance towards realizing
what we have always believed to be the extraordinary promise of
Microcyn."
About Amneal
Amneal Enterprises is a powerful alliance of independent businesses.
Each company is strategically aligned based on its ability to bring
significant value and tremendous growth potential to the group as well
as each of its members.
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Amneal
Pharmaceuticals, LLC
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Prolong Pharmaceuticals, LLC
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AmDerma Pharmaceuticals, LLC
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Quinnova Pharmaceuticals, Inc.
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Kashiv Pharma, LLC
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TcNet, LLC.
In this way, Amneal Enterprises continues to grow aggressively, yet
intelligently, and in keeping with the group's strategic plan.
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.

Media and Investor Contact:
Oculus Innovative
Sciences, Inc.
Dan McFadden, 425-753-2105
dmcfadden@oculusis.com
Director
of Public and Investor Relations
Source: Oculus Innovative Sciences, Inc.
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