- Neura Therapeutik to advise on TPM/oxycodone program
MELBOURNE, Australia, Aug. 1, 2012 /PRNewswire-Asia/ -- Australian drug delivery technology company Phosphagenics Limited (ASX: POH, OTCQX: PPGNY) has appointed US pharmaceutical consulting company, Neura Group LLC, the consulting unit of the pain specialty company, Neura Therapeutik LLC, to provide strategic commercial and development advice for its TPM/oxycodone patch development program.
The pain specialty company, established by former Johnson & Johnson, Pfizer and King Pharmaceuticals executives in 2010, has extensive experience in the commercialisation and development of analgesics, primarily in the non-steroidal anti-inflammatory drug (NSAID) and opioid classes of the pain market.
Members of Neura's management team have launched some of the largest US analgesic brands, including the first transdermal pain patch, Duragesic® and Vicodin ES® tablets, as well as directing pain franchise build outs for pharmaceutical companies.
The appointment will enable Phosphagenics' access to substantial development, clinical and commercial expertise in the field of pain management.
Phosphagenics CEO, Dr Esra Ogru, said the strategic partnership would assist with development, approval, partnering and marketing processes. The companies would collaborate to ensure all appropriate commercial parameters were considered in the design of the pivotal Phase 3 program.
"We remain committed and focused on the commercialisation of our TPM/oxycodone patch," Dr Ogru said.
"We are confident this partnership will ensure success at these crucial final stages. Together with our existing Pain Advisory Board, we believe the appointment of Neura will ensure the development of a commercially relevant product as we prepare a high quality package for the FDA."
Dr Ogru acknowledged Neura's ability to leverage its expertise in the analgesic market and build strong working alliances with strategic operational partners.
Neura Therapeutik is the holding company for Neura Labs LLC, the in-licensing business unit, and Neura Group LLC the consulting unit, providing companies interested in entering the analgesic market with a highly experienced commercial infrastructure and leadership team capable of rapidly establishing a comprehensive US operational presence. Neura offers high quality functional area expertise in CMC, regulatory and manufacturing scale up to sales, marketing, launch readiness and life-cycle management.
Neura Therapeutik CEO, Mr John La Lota, said: "We are excited to work with Phosphagenics on the development of the TPM/oxycodone program.
"Our Neura Group business unit provides Phosphagenics an experienced analgesic commercial team to successfully navigate the US analgesic market and address an unmet medical need with this very important product."
The Neura strategic alliance coincides with the ongoing patch optimisation undertaken by the German company, Labtec GmbH, Phosphagenics' specialist opioid patch developer. Very promising results have been achieved in in-vitro studies, undertaken to validate the delivery and stability attributes of the patch.
Dr Ogru said Phosphagenics' expectation of returning to the clinic before the end of the year with an improved patch that has no crystallisation issues is on track, with patch development work progressing "according to plan".
Duragesic® is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Vicodin ES® is a registered trademark of Abbott Laboratories
Phosphagenics Limited is commercialising drug delivery applications based on its novel transdermal (drugs administered via skin) TPM® - Targeted Penetration Matrix technology. TPM® is a patient friendly and cost effective system used to deliver proven pharmaceutical and nutraceutical products.
The lead product advancing through clinical trials is an oxycodone matrix system for the relief of chronic pain.
Phosphagenics' shares are listed on the Australian Securities Exchange (POH) and its ADR - Level 1 program in the US is with The Bank of New York Mellon (PPGNY).
About Neura Therapeutik
Neura Therapeutik, LLC (Neura) is a pain specialty company focused on the commercialisation of innovative analgesics that address unmet needs in the marketplace. Neura is divided into two strategic business units:
- Neura Labs, LLC - Focused on the in-licensing and launch of pharmaceutical products where Neura's development and commercial experience can be leveraged to provide value enrichment through optimal clinical development and commercial advancement.
- Neura Group, LLC - Focused on providing an array of commercial services and management oversight that will optimise the value of development and currently marketed products.
Please visit www.neuratherapeutik.com for more information.