HedgePath Pharmaceuticals Enters into Key Collaboration with Mayne Pharma

  HedgePath Pharmaceuticals Enters into Key Collaboration with Mayne Pharma

Acquires Exclusive U.S. Rights for use of Mayne Pharma's SUBA™ Itraconazole
for treatment of cancer

Mayne Pharma to supply product to HPPI, and companies to jointly pursue
clinical development of SUBA Itraconazole for multiple oncology indications

PR Newswire

TAMPA, Fla. and SAN DIEGO, Sept. 10, 2013

TAMPA, Fla. and SAN DIEGO, Sept. 10, 2013 /PRNewswire/ --HedgePath
Pharmaceuticals, Inc. (OTCPink: HPPI) (HPPI) announced today that it has
signed an exclusive Supply and License Agreement with Mayne Pharma
International Pty Ltd (Mayne Pharma), a wholly owned subsidiary of Mayne
Pharma Group Limited, an Australian ASX listed company, whereby HPPI will
pursue clinical development of Mayne Pharma's patented formulation of the drug
itraconazole, known as SUBA-Itraconazole, for treatment of a variety of
cancers with a focus on seeking regulatory approvals and marketing in the
United States.

The agreement represents a significant step forward for HPPI in the
progression of its business plan of repurposing itraconazole as a potential
treatment for cancer. Itraconazole, in other formulations now off-patent, is
already approved by the U.S. Food and Drug Administration (FDA) for human use
as a treatment for fungal infections.

The agreement provides for the supply to HPPI of specially formulated capsules
of SUBA-Itraconazole, manufactured by Mayne Pharma under cGMP (current good
manufacturing practice) standards, for use by HPPI in its anticipated clinical
trials, and for the future exclusive  commercial supply following FDA
approvals, if obtained. "SUBA technology" (which stands for "super
bioavailability") is designed to improve the bioavailability of orally
administered drugs that are poorly soluble. SUBA-Itraconazole is a patented
formulation developed by Mayne Pharma, which has improved absorption and
significantly reduced variability compared to generic itraconazole. These
benefits provide enhancements to patients and prescribers with reduced intra-
and inter-patient variability, enabling a more predictable clinical response
and a reduction in the active drug quantity to deliver the required
therapeutic blood levels.

HPPI and Mayne Pharma will collaborate through a joint development program for
SUBA-Itraconazole for multiple oncology indications. Under the agreement, HPPI
has been granted exclusive rights to SUBA-Itraconazole for treatment of cancer
in the United States, and Mayne Pharma retains rights for use of the drug
outside the U.S., including a license from HPPI for current and future
developments of anti-cancer therapies using SUBA-Itraconazole.

Under the terms of the agreement, Mayne Pharma has the ability to appoint one
person to HPPI's Board of Directors and is preparing to name a senior
executive of Mayne Pharma to such position in the near future. Although the
Supply and License Agreement is effective immediately, it remains subject to
certain conditions being achieved. As part of the achievement of these
conditions, Mayne Pharma is expected to acquire an equity stake in HPPI of
between 30-45%.

"This is a milestone event for HPPI, and we are very pleased to be
collaborating with an innovative developer and manufacturer such as Mayne
Pharma" stated Nicholas J. Virca, HPPI's President and Chief Executive
Officer.

"Our clinical strategy is to repurpose itraconazole as a potential treatment
for cancer, and we believe that Mayne Pharma's patented formulation of
itraconazole creates the potential to offer cancer patients the benefits of
greater bioavailability of the active drug. In short, this agreement is more
than just a supply agreement. It jumpstarts our business plan by giving us
access to the key technology we need to progress our clinical development
programs forward and, if ultimately approved by the FDA, market our
anti-cancer therapies in the U.S. with exclusivity. We look forward to what we
expect will be a long term and mutually beneficial collaboration with Mayne
Pharma" concluded Mr. Virca.

Additional details regarding this agreement and the collaboration between HPPI
and Mayne Pharma will be provided in a Current Report on Form 8-K to be filed
by the company with the Securities and Exchange Commission.

About SUBA-Itraconazole

SUBA™ technology is proprietary technology that improves the oral
bioavailability of poorly soluble drugs. It utilizes a solid dispersion of
drug in a polymer to improve the absorption of drugs in the gastrointestinal
tract to achieve "super bioavailability"compared to conventional
formulations. In testing its use as an anti-fungal medication, clinical trials
demonstrated that SUBA Itraconazole had approximately double the
bioavailability of the generic formulation and could  be taken with or without
meals. HPPI plans to administer SUBA-Itraconazole at doses lower than the
generic itraconazole formulations previously tested in human cancer trials.
This greater bioavailability at lower dosing is intended to improve product
performance, while reducing the side-effects associated with the level of
doses required for cancer therapy.

About HedgePath Pharmaceuticals

HedgePath Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company
that is seeking to repurpose the FDA approved antifungal pharmaceutical
itraconazole as a potential treatment for cancer. HPPI is the exclusive
licensee of a patented formulation of itraconazole, called SUBA-Itraconazole,
which clinical studies have shown to have greater bioavailability than generic
itraconazole.

The Hedgehog signaling pathway is a major regulator of cellular processes in
vertebrates, including cell differentiation, tissue polarity and cell
proliferation. Based on published research, HPPI believes that inhibiting the
Hedgehog pathway could delay or possibly prevent the development of certain
cancers in humans. Leveraging research undertaken by key investigators in the
field, HPPI plans to explore the effectiveness of SUBA-Itraconazole as a
cancer inhibitor and to pursue its potential commercialization. HPPI has
offices in Tampa, Florida and San Diego, California. For more information,
please visit www.hedgepathpharma.com.

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company that develops
and manufactures branded and generic product globally - either directly or
through distribution partners, while applying its drug delivery expertise for
contract development and manufacturing services. Mayne Pharma has a 30-year
track record of innovation and success in developing new oral drug delivery
systems and these technologies have been successfully commercialized in
numerous products that have been marketed around the world. Mayne Pharma has
two drug development and manufacturing facilities based in Salisbury,
Australia and Greenville, NC, USA with expertise in formulating complex oral
dose forms including highly potent compounds, controlled substances, modified
release products and inherently unstable compounds.

Cautionary Note Regarding Forward Looking Statements

This press release and any statements of representatives and partners of
HedgePath Pharmaceuticals, Inc. (the "Company") related thereto contain, or
may contain, among other things, certain "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve significant risks and uncertainties. Such
statements may include, without limitation, statements with respect to the
Company's plans, objectives, projections, expectations and intentions and
other statements identified by words such as "projects," "may," "will,"
"could," "would," "should," "believes," "expects," "anticipates," "estimates,"
"intends," "plans," "potential" or similar expressions. These statements are
based upon the current beliefs and expectations of the Company's management
and are subject to significant risks and uncertainties, including those
detailed in the Company's filings with the Securities and Exchange
Commission. Actual results (including, without limitation, the outcome of the
Company's collaboration with Mayne and timing for and results of the Company's
clinical trials) may differ significantly from those set forth in the
forward-looking statements. These forward-looking statements involve certain
risks and uncertainties that are subject to change based on various factors
(many of which are beyond the Company's control). The Company undertakes no
obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as required by
applicable law.

Contact: HedgePath Pharmaceuticals, Inc., Nicholas J. Virca, President and
CEO, 813-864-2559, nvirca@hedgepathpharma.com

© 2013 HedgePath Pharmaceuticals, Inc. All rights reserved.







SOURCE HedgePath Pharmaceuticals, Inc.

Website: http://www.hedgepathpharma.com
 
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