MAYNE PHARMA GROUP LIMITED — Capital/Financing Update 2013

Sep 10, 2013

ASX Announcement

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MAYNE PHARMA ENTERS INTO EXCLUSIVE US LICENSE AND SUPPLY AGREEMENT FOR SUBA™-ITRACONAZOLE IN CANCER

11 September 2013, Melbourne Australia: Mayne Pharma Group Limited (ASX: MYX) is pleased to announce it has signed an exclusive Supply and License Agreement with US-based HedgePath Pharmaceuticals, Inc. (HPPI), whereby HPPI will pursue clinical development, registration and commercialisation of Mayne Pharma’s patented formulation of itraconazole, known as SUBA™Itraconazole, for treatment of a variety of cancers in the United States. This agreement is independent of Mayne Pharma’s commitment to progress the commercialisation of SUBACAP® globally for the treatment of fungal infections.

As part of the agreement, Mayne Pharma expects to appoint one representative to the HPPI Board. Although the Supply and License Agreement is effective immediately, it remains subject to certain conditions being achieved, as detailed in the Current Report on Form 8-K that HPPI filed with the US Securities and Exchange Commission on 10 September 2013. Subject to meeting these conditions, and in return for granting HPPI exclusive US rights, Mayne Pharma is expected to acquire an equity stake in HPPI of between 30-45%.

Under the terms of the agreement, Mayne Pharma will supply HPPI with SUBA™-Itraconazole for use in clinical trials and for future exclusive commercial supply following FDA approval. Mayne Pharma and HPPI will collaborate through a joint development program for SUBA™Itraconazole in oncology, with the initial areas of investigation being selected indications in prostate, lung and skin cancer. In the US, there are more than 2 million[1] new cases of these three cancers reported annually and the pharmaceutical market size to treat these diseases exceeds US$5 billion[2] and forecast to grow more than 5% per annum over the coming decade. Mayne Pharma has granted HPPI exclusive rights to SUBA™-Itraconazole for the treatment of cancer in the United States, and Mayne Pharma retains rights outside the US, and also obtains an exclusive license from HPPI to utilise all current and any future development intellectual property generated by HPPI.

Mayne Pharma CEO Mr Scott Richards said, “We are very excited to announce our collaboration with HPPI which we believe is the best commercial vehicle for the development and exploitation of SUBA™-Itraconazole as a potential treatment for certain cancers. HPPI has an experienced management team who are passionate about the potential of SUBA™-Itraconazole in treating cancer. HPPI also brings relevant intellectual property to supplement that of our existing SUBA technology patent. Over the last 18 months, the team behind HPPI has explored the clinical potential of itraconazole as a treatment for cancer which culminated in a restructure of HPPI into a public company which has commenced trading on the OTCPink market. HPPI will be seeking market funding for the clinical development and regulatory program. We look forward to a productive partnership with HPPI as we work closely together to progress SUBA™Itraconazole through the development process.”

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1 American Cancer Society and Skin Cancer Foundation

2 Datamonitor Healthcare, 2012

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ASX Announcement

Although itraconazole is used extensively to treat fungal infections globally, the product appears to have notable anti-cancer effects through two key mechanisms, being the control of cell division via the Hedgehog pathway[3] and anti-angiogenesis effects. Research has shown that inappropriate activation of the Hedgehog pathway can lead to the formation of a number of cancers. Itraconazole has demonstrated its ability to inhibit the Hedgehog signalling pathway in animal models and in clinical studies of patients with cancer. In animal studies, itraconazole has also demonstrated an anti-angiogenic effect (i.e., inhibiting the formation of new blood vessels supplying solid tumours), which may be important in controlling the proliferation of cancerous cells and tumours. HPPI’s SUBA™-Itraconazole cancer development program will investigate the use of the product as an inhibitor of two key mechanisms in the progression of cancer.

Mr Richards said: “Since itraconazole is already an FDA approved drug, we believe that the potential exists for an expedited development program due to the drug’s well established safety profile. We are further encouraged by the recently reported third party Phase II data demonstrating itraconazole’s anti-cancer effects in humans.[4] The superior pharmacokinetic profile of the SUBA™-Itraconazole capsule formulation is expected to be advantageous in the cancer setting, as research in patients with prostate cancer has shown a significant correlation between the anti-cancer effects and levels of itraconazole in the blood. We would expect SUBA™-Itraconazole Capsules to achieve these blood levels in a greater proportion of patients compared with conventional itraconazole formulations.”

For further information contact: Scott Richards +61 8 8209 2410 Lisa Pendlebury +61 419 548 434, lisa.pendlebury@maynepharma.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 commercialised 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.

3 The Hedgehog signalling pathway is a major regulator of cellular processes in vertebrates, including cell differentiation, tissue polarity and cell proliferation.

4 Itraconazole was tested as a treatment for men with metastatic castrate resistant prostate cancer in a multi-institutional Phase II trial led by a prominent US University and published in 2013 (Antonarakis et al. The Oncologist 2013, 18:163-173), which showed that at a specified dose, there was a significant correlation to slowing the progression of cancer and extending survival.

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ASX Announcement

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 signalling 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.

About SUBA™-Itraconazole

SUBA™-Itraconazole is a patented formulation, 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.

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