As UK-based Prosonix transitions from a particle engineering specialist into a pharmaceutical company with three inhaled respiratory drugs in its pipeline, it has announced the appointment of Rob Crocker as its first Head of Regulatory Affairs. Crocker, who has overseen marketing applications for a number of inhaled and nasal drug products as Managing Director of the regulatory and development consulting firm PhRAction, will create a regulatory strategy for the Prosonix pipeline, the company says.
“Prosonix has taken several important steps to strengthen its product development capabilities since its £11.4 million fundraising in June 2011,” Prosonix CEO David HipKiss said. “We recently announced the formation of a new Scientific Advisory Board and we are also building our expertise in regulatory affairs and clinical development. Rob’s appointment is the next step and we expect his regulatory expertise, particularly submissions for generic respiratory medicines, to be crucial given our plans to file PSX1001, our lead drug candidate, for asthma in late 2012. We also expect him to play an important role in the planning and execution of our regulatory and clinical development strategies for PSX1002 and the PSX2000 series of combination medicines.”
PSX1001 is “a drug-only directly substitutable generic version of fluticasone propionate,” PSX1002 is a drug-only version of glycopyrrolate for the treatment of COPD, and the PSX2000 series involves “multi-component particles” created using Prosonix’s proprietary ultrasonic particle engineering technology, including fluticasone/salmeterol and budesonide/formoterol combinations.
Crocker commented, “Prosonix’s novel approach to respiratory drug development and its unique particle engineering capabilities offer the potential to revolutionise respiratory drug development and deliver better products with significant benefits to patients. The company is entering an exciting period of development and I am pleased to have the opportunity to contribute my regulatory expertise and experience to help it achieve its objectives of getting these new products to market.”
Read the Prosonix press release.
