02 Aug 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Australian drug delivery technology company Phosphagenics has appointed US pharmaceutical consulting company, Neura Group, the consulting unit of the pain specialty company, Neura Therapeutik, to provide strategic commercial and development advice for its TPM or 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 III program.
"We remain committed and focused on the commercialisation of our TPM or 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 or 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".