Investors endorse CriticalMix drug delivery technology and own pipeline potential

Nottingham, UK November 10, 2008 –Critical Pharmaceuticals, the speciality pharmaceuticals company, today announced  at BioPartnering Europe that it had successfully closed a third round of investment totalling £650,000. Based on the company’s success in developing its unique CriticalMix delivery technology and matching pipeline of candidate drugs, the funding was fully supported by existing shareholders. The company has now raised in excess of £2 million in investment and grants since its formation in 2004 as a spin-out from Nottingham University. It also follows the recent announcement of preclinical results for a sustained release somatropin formulation, which demonstrated considerable advantages over existing once-daily products.

Lisbeth Illum, Chief Executive Officer Critical Pharmaceuticals welcomed the new round: “ The new funds will be used to advance the development of our pipeline of candidate drugs and drug delivery technologies, secure and develop our intellectual property portfolio and invest in our business development capability to secure partnerships with pharmaceutical and biotechnology companies. Already we are attracting growing interest from leading names who can see the advantages of using our drug delivery technology platforms across their drug pipelines. We believe this points to an exciting future for investors and employees. We are also delighted to have attracted new investors in this round as well as the continuing and invaluable support from East Midlands Business Angels (EMBA) and the University of Nottingham who have been with us from the start.”

This confidence was mirrored by one of the lead investors, Jonathan Earl, Investment Director with Catapult Venture Managers: “We believe Critical Pharmaceuticals represents an exciting opportunity. The CriticalMix drug delivery technology not only provides pharmaceutical and biotechnology companies with the opportunity to enhance their own products, but also opens the possibility of Critical developing its own pipeline of differentiated drug products. We look forward to providing support in the company’s growth.”

Existing investor, Nick Wright, Fund Manager of the East Midlands Early Growth Fund at E-Synergy was naturally pleased with the company’s continued success: “For us, Critical Pharmaceuticals is an ideal showcase for the region’s excellence in pharmaceutical services. By combining worldclass research with knowledge of the real needs of the pharmaceutical sector, Critical Pharmaceuticals has made rapid progress. We now welcome the involvement of new investors to help take the company through the next exciting stage of its development.” 

Critical Pharmaceuticals, the speciality pharmaceuticals company, today announced that the successful completion of preclinical trials of a sustained release formulation of the synthetic human growth hormone (hGH) somatropin. Trials demonstrated therapeutic plasma concentrations were achieved over an extended period of time supporting the development of the product as a once every two weekly injection. In addition, the efficacy profile using biomarkers was comparable to current daily formulations. The new formulation was produced using Critical’s patented CriticalMix delivery technology, based on supercritical fluid liquification of the encapsulating polymer and efficient distribution of the hGH in the dry state. This enables the optimal encapsulation of drugs into injectable microparticles with superior drug release properties.  hGH delivery is a natural application for this technology, and the company now intends to take this product forward into Phase 1 clinical trials. This decision coincides with a recent report by Frost & Sullivan valuing the European market at $846.4m in 2007, with a compound annual growth rate (CAGR) of 2.4 per cent from 2007 to 2014. The report also highlighted new delivery methods together with approval for new indications as keys to success.

According to Chief Business Office Gareth King, these preclinical results mark an important milestone for the company: “Over the past few years, we have concentrated on optimizing our delivery technologies and ensuring they are transferable from the lab into an industrial setting. Sustained release hGH is one of three projects we are now developing in areas of unmet need. There is no doubt that a sustained release version of hGH would be preferred by patients, particularly paediatric, but there are naturally concerns over safety and efficacy. We are confident the highly controlled release rates achieved with our technology will overcome these concerns. The plan is now to take this product into clinic either by ourselves or in partnership. We are also in preclinical development with sustained release Risperidone and, demonstrating the versatility of our technology platform, a once-daily nasal formulation of hGH.”

Critical Pharmaceuticals has been awarded a £33000 grant by the bioKneX Industrial Partnership Scheme to help it assess the potential of a recent discovery made at the company. The scheme was set up to help businesses access the expertise and facilities within universities in the East Midlands. Critical Pharmaceuticals will use the money to pay for research to be performed at the University of Nottingham which will assess the effectiveness and tolerability of a novel absorption enhancer that was discovered by the company last year that allows drugs such as insulin and human growth hormone to be given to patients by a nasal spray.

Dr Andy Lewis, Head of Formulation Development said, “This discovery is incredibly exciting because it opens up the possibility of developing nasal sprays for drugs that currently need to be injected, often several times a week. However before we can develop a product we need to carry out extensive testing and this award will help us begin this process. We are tremendously pleased to receive this award which helps us to not only work with Dr Snow Stolnick - one of the world leaders in the field - but also have access to the state of the art facilities at the School of Pharmacy at the University of Nottingham.”

Critical Pharmaceuticals has been awarded two CASE awards by the Biotechnology and Biological Sciences Research Council (BBSRC). The awards will fund the training of two PhD students at the University of Nottingham starting October 2008. The two projects that will funded are:

• The Effect of Supercritical Fluid Processing Parameters on Product Performance – Sustained Release Biologics (Academic Supervisor – Professor Steve Howdle).

• Supercritical Fluid Technology for Gastroretentive Formulations(Academic supervisor – Dr Snow Stolnick).

Dr Andy Naylor, Head of Process Development at Critical Pharmaceuticals said,”We are delighted to be successful in these applications and participate in training the next generation of bioscience researchers”. Professor Steve Howdle said, “The CASE award scheme is a fantastic opportunity for graduate students to gain experience in both academic and industrial environments.” 

Critical Pharmaceuticals today announced the successful completion of proof of concept of two single shot vaccines developed using their NanoMix™ technology. Vaccination has had a greater impact on public health and the treatment of infectious diseases than any other healthcare intervention. However, many vaccines require multiple doses over many months in order to develop a robust and protective immune response which leads to compliance and cost implications, particularly affecting the developing world. The development of effective vaccines that could be effective after one injection is therefore highly desirable.

Critical Pharmaceuticals today announced the completion of a series of pre-clinical studies investigating the effect of supercritical CO₂ on a therapeutically relevant protein – human growth hormone (hGH). The work, carried out in collaboration with scientists at the University of Nottingham, was the most comprehensive analytical study ever carried out, and proved that protein drugs remain stable when formulated using supercritical CO₂.

Critical Pharmaceuticals Limited today announced that Professor Lisbeth Illum has been appointed Chief Executive Officer. Chairman of the Board, Dr Alan Raymond said, “Professor Illum brings with her years of experience in commercialising innovative drug delivery technologies, and we look forward to benefiting from her expert guidance and leadership.”

Lisbeth Illum was the founder and for 12 years the Managing Director of DanBioSyst UK Ltd. and for 3 years the Managing Director of Phaeton Research Ltd. both companies that specialised in Drug Delivery Systems. She is also associated with Nottingham University as a Special Professor. She was awarded her M. Pharm, Ph. D and D.Sc. from the Royal Danish School of Pharmacy in 1972, 1978 and 1988, respectively. She is a world renowned scientist in the field of novel drug delivery systems for difficult drugs such as peptide and proteins. She has published more than 300 scientific papers, and is among the top 100 most cited scientists in the field of pharmacology. She has co-edited four books including "Peptide Drug Delivery Systems" published by Plenum Press, 1986, and has filed nearly fifty patents on novel drug delivery systems. She has been awarded the title of "Docent" in the Royal Danish School of Pharmacy and has been the recipient of several scientific awards. She has been elected a Fellow of the AAPS and is the Vice-President of the Controlled Release Society. She has lectured throughout the world at conferences and workshops. She is on the Editorial Boards of seven scientific journals. She joins Critical Pharmaceutical as the CEO on her extensive business and managing experience from running small drug delivery companies.