Prosonix Appoints Respiratory Drug Development Expert Dr Geoff Down as Chief Medical Officer

Prosonix (Oxford, UK), an emerging pharmaceutical company developing a portfolio of enhanced respiratory medicines enabled by its novel proprietary particle engineering technology, announces the appointment of Dr Geoff Down to the newly created role of Chief Medical Officer. Dr Down takes up his position immediately and will oversee the clinical development of Prosonix's product pipeline, including PSX1001, PSX1002 and the novel PSX2000 combination series.

Dr Down has more than 18 years' clinical development experience in the pharmaceutical sector, following ten years in clinical practice in a range of hospital specialties.

He joins Prosonix after a successful period running his own company, providing services as a consultant pharmaceutical physician. During this period he worked in clinical safety for Pfizer R&D, in clinical development for RespiVert Ltd (a spinout from Imperial Innovations that aims to identify new treatments for COPD, cystic fibrosis and severe asthma), and since December 2010 he has been working in clinical pharmacology at GlaxoSmithKline's R&D Respiratory and Immuno-Inflammation medicines development centre (GSK RII MDC).

Dr Down worked in a permanent role at GSK RII MDC from 2002 to 2007, as Director Clinical Pharmacology and Discovery Medicine. In this position, he managed global clinical development programmes and post-licensing support, including significant contributions to the progression of two significant programmes through to global marketing licence submissions [Ariflo (oral cilomilast for COPD) and Avamys/Veramyst (inhaled fluticasone furoate for allergic rhinitis]. He has also held senior roles at Johnson & Johnson Pharmaceutical R&D, ASTA Medica/Baxter and Rhône-Poulenc Rorer.

Dr Down has been a principal investigator or company sponsor for more than 50 early clinical development studies, including first-in-human studies, and over 30 full clinical development trials. He has authored and co-authored several papers, principally in the respiratory field, and presented on a range of regulatory and clinical development topics. He is a Fellow and Senior Specialist Adviser at the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians (UK).

Commenting on the appointment, David Hipkiss, Prosonix' CEO, said:

"Geoff's appointment is pivotal for Prosonix as we aim to become a fully-fledged pharmaceutical company operating within the respiratory space. Geoff's extensive clinical, regulatory and medical experience makes him ideally suited to lead Prosonix' clinical development. We are on course to file our lead candidate PSX1001 for asthma later this year and expect to announce further progress on the clinical strategy for PSX1002 and the PSX2000 combination series in the near future. With the recent appointment of Rob Crocker as Head of Regulatory Affairs, I believe that we are in a strong position to successfully implement and advance our clinical and commercial strategy."

Dr Down, added:

"There is still a large need for better and more effective treatments despite the development of new respiratory therapeutics. I have been very impressed with Prosonix' drug development strategy, based on its proprietary particle engineering technology, which has shown the potential to create more effective and safer respiratory medicines for patients. I am excited to be joining the Company as it enters the next stage of growth and look forward to contributing my expertise to help it achieve its upcoming clinical and regulatory milestones."

For more information, please contact:

David Hipkiss, CEO
+44 (0)1865 784 250
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Mark Swallow, Sita Shah, David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
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Prosonix Appoints Rob Crocker as its First Head of Regulatory Affairs

Prosonix (Oxford, UK), an emerging pharmaceutical company developing a portfolio of enhanced respiratory medicines enabled by its novel proprietary particle engineering technology, announces the appointment of Rob Crocker as its first Head of Regulatory Affairs. Mr Crocker will be responsible for defining and implementing the regulatory strategy to underpin the development of Prosonix' emerging product pipeline.

Mr Crocker has over 20 years' experience in pharmaceutical regulatory affairs and drug development, with significant expertise in the area of generic respiratory and inhaled medicines. Since 1999, he has been Managing Director of PhRAction (formerly Pharmaxis), a pharmaceutical regulatory affairs and drug development consultancy, at which he was responsible for ten submissions of orally inhaled drug products to international regulatory agencies. Before that, he held senior drug development regulatory affairs positions at Boehringer Ingelheim, Ethical Generics (now Genus Pharmaceuticals), Trinity Pharmaceuticals (now Trinity Chiesi), Norton Healthcare (now Teva EU) and Glaxo Group Research (now GSK). Mr Crocker is a member of The Organisation for Professionals in Regulatory Affairs (TOPRA).

Commenting on the appointment, David Hipkiss, Prosonix' CEO, said:

"Prosonix has taken several important steps to strengthen its product development capabilities since its £11.4 million fundraising in June 2011. 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."

Rob Crocker, said:

"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."

For more information, please contact:

David Hipkiss, CEO
+44 (0)1865 784 250
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Mark Swallow, Sita Shah, David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
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Rob Crocker appointment.pdf	381 Kb

Prosonix Describes its Development of Multi-component Drug Particles Combining Two Respiratory Drugs

Presentation at "Drug Delivery to the Lungs 2011" Conference

Prosonix (Oxford, UK) today presented new research demonstrating that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP^TM) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix' Dipesh Parikh at the "Drug Delivery to the Lungs 2011" (DDL2011) conference in Edinburgh, UK.

In the presentation, Prosonix describes how its UMAX® technology has enabled the development of one such example of MCP^TM, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with exquisite control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca's multi-billion dollar respiratory drug product Symbicort®.

Combining multiple active drug components into a single particle using UMAX® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.

The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance (ref. 1). Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation (refs 2, 3). Compared to these combination products, the improved co-localisation of MCP^TMs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.

A copy of the presentation can be downloaded at the foot of this article.

David Hipkiss, Prosonix' CEO, said:

"Using proven respiratory medicines in combination potentially offers patients the best option for treating pulmonary disease. We are very excited to have demonstrated that our UMAX® technology can create Multi-component Particles that consistently and predictably co-localise an ICS and a LABA in the lung. We have also engineered MCP^TMs comprising ICS and long-acting muscarinic antagonists (LAMA) as well as LABA/LAMA combinations. Developing this area of our business is important for our future growth as we aim to build a pipeline of next-generation combination medicines (our PSX2000 series) offering multiple benefits to patients such as enhanced efficacy, true synergy, fewer side effects and improved compliance."

References
1) Rescue Treatment in Asthma: More Than As-Needed Bronchodilation. Papi, A., et al (2009) Chest, 135; 1628-1633
2) Co-deposition of Salmeterol and Fluticasone Propionate by a Combination Inhaler. Theophilus, A., et al (2006) Int. J. Pharmaceutics, 313; 14-22
3) Enhanced Synergy between Fluticasone Propionate and Salmeterol Inhaled from a Single Inhaler versus Separate Inhalers. Nelson, H.S., et al (2003) J. Allergy Clin. Immunol. 112(1); 29-36

For more information, please contact:

David Hipkiss, CEO
+44 (0)1865 784 250
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Mark Swallow, Sita Shah, David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
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Characterisation of Engineered Combination Particles	1276 Kb

Prosonix Appoints New Scientific Advisory Board Comprising Distinguished Experts in Respiratory Disease, and in Clinical and Regulatory Aspects of Respiratory Drug Development

Prosonix (Oxford, UK), an emerging pharmaceutical company developing a portfolio of enhanced respiratory medicines enabled by its novel proprietary particle engineering technology, today announces the appointment of a new Scientific Advisory Board. The new SAB comprises internationally renowned scientific, regulatory and clinical advisors who will act as both as key collaborators and advocates for the business in the global pharmaceutical arena.

The SAB will be chaired by Dr Ken Cunningham, who recently joined Prosonix' board as a Non-executive Director. He brings over 20 years' experience in the pharmaceutical industry with a strong focus in recent years on respiratory drug development and drug delivery.

In addition to Dr Cunningham, the inaugural members of Prosonix' SAB include:

Professor Peter Barnes

Professor Barnes is Professor of Thoracic Medicine and Head of Airway Disease at the National Heart and Lung Institute and Honorary Consultant Physician at Royal Brompton Hospital, London. He is amongst the top 50 most highly cited researchers in the world and has been the most highly cited clinical scientist in the UK and the most highly cited respiratory researcher in the world over the past 20 years. He was elected a Fellow of the Royal Society in 2007, the first respiratory researcher for over 150 years. He is currently a member of the Scientific Committee of the WHO/NIH global guidelines on asthma (GINA) and COPD (GOLD). He also serves on the Editorial Board of over 30 journals and is currently an Associate Editor of Chest and respiratory Editor of PLoS Medicine.

Dr Marianne Mann

Dr Mann is a board-certified pulmonologist and independent consultant specialising in regulatory and clinical drug development, with specific interest in respiratory diseases. She worked at the US Food and Drug Administration (FDA) for nine years, between 1994 and 2003, the last three of which were as Deputy Director of the Division of Pulmonary and Allergy Drug Products.

Dr John Pritchard

Dr Pritchard is Chief Technology Officer at Philips' Respironics drug delivery unit. In this role, he is responsible for global R&D activities in respiratory drug delivery, focusing on next-generation adaptive aerosol delivery technology. Dr Pritchard has over 30 years of experience in the aerosol and respiratory field, including experience at AstraZeneca as head of respiratory project management. He has also worked for 3M Healthcare and GlaxoSmithKline.

Commenting on the new SAB, David Hipkiss, Prosonix' CEO, said:

"The formation of our first formal Scientific Advisory Board is a significant step for Prosonix, signalling our strong intent to build on our past successes and advance the development of our pipeline of respiratory drug candidates into the clinic and towards regulatory approval. In particular, the next 12 months will see the Company prepare to file PSX1001 in Europe for asthma based on strong in vitro bioequivalence data, being potentially the first company to do so. The Company also plans to launch a Phase II proof of concept clinical study with PSX1002 in COPD and to initiate the development of our first PSX2000 combination therapy for respiratory diseases based on our unique UMAX® Multi-Component Particle (MCP^TM) platform. We are therefore delighted to announce the new members of our SAB, all of whom are distinguished experts in their relevant fields and will provide invaluable advice and guidance to the Company during this exciting period."

For more information, please contact:

David Hipkiss, CEO
+44 (0)1865 784 250
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Mark Swallow, Sita Shah, David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
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Prosonix new SAB announcement.pdf	383 Kb

Prosonix Elects Dr Ken Cunningham to its Board of Directors
Adding Significant Experience in Respiratory Drug Development

Prosonix (Oxford, UK), an emerging pharmaceutical company developing a portfolio of enhanced respiratory medicines enabled by its novel proprietary particle engineering technology, is very pleased to announce that it has elected Dr Ken Cunningham to its Board of Directors as a Non-Executive Director and Chair of its Advisory Board.

Dr Cunningham has over 20 years' experience in the pharmaceutical industry with a strong focus in recent years on respiratory drug development and drug delivery. He is Executive Chairman of PolyTherics Ltd and until August 2010 was CEO of Skyepharma plc. Before that he was Chief Executive Officer of Arakis Ltd, Vice-President European Affairs at Alza Corporation and Vice-President Clinical Development at Sequus Inc. Prior to this he held a variety of clinical development and commercial strategy roles at GlaxoWellcome plc and Warner-Lambert earlier in his career. Ken is also a Non-Executive Director of Xention Ltd. He holds a medical degree from St Mary's, Imperial College, London University.

Prosonix Secures £11.4M Series B Financing

Prosonix is pleased to announce the successful conclusion of a £11.4M Series B financing round. The round was led by Ventech (Paris, France), with support from additional new Investor Gilde Healthcare Partners (Utrecht, Netherlands) and existing Investors including Entrepreneurs Fund (London, UK) Quest for Growth (Leuven, Belgium) and Solon Ventures (London, UK).

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Prosonix Series B Financing June 2011	142 Kb

Prosonix is delighted to announce the successful GMP commercial-isation of its world leading respiratory particle engineering technology at Sterling's FDA approved facilities in Perugia, Italy. This combines Prosonix acknowledged leadership in the particle engineering of complex respiratory products and Sterling's position as Europe's leading independent steroid producer. http://www.sterling.it/

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Sterling Announcement May 2011.pdf	128 Kb

Prosonix is delighted to announce the launch of its new co-crystal development and processing service, aimed specifically at the manufacturing of pharmaceutical co-crystals suitable for use in inhaled and oral medicine, using its proprietary technologies to facilitate co-crystal production at any scale alongside controlled particle size distribution and high purity.

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Press release: Co-crystals processing launch	299 Kb

In just a short space of time since its launch Prosonix has successfully scaled up of the UMAX^® particle engineering technology. The scale-up has now been carried out on several APIs in cGMP facilities and importantly demonstrates a seamless transition from laboratory to commercial scale batches, with no loss of formulation performance, independent of delivery platform or device.

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Press release UMAX Scale-up April 2010	299 Kb