Critical Pharmaceuticals is a Nottingham UK-based biotechnology company developing a pipeline of unique biological drug products utilizing it proprietary drug delivery technologies. Critical Pharmaceuticals lead product is a nasal formulation of human growth hormone that has significant advantages over existing daily injectable products and has shown equivalent bioactivity to a subcutaneous injection of marketed product in an ongoing Phase 1 clinical program. In addition, Critical Pharmaceuticals partners its drug delivery technology with other biopharmaceutical companies to develop long acting injectable products and nasal delivery of poorly absorbed drugs. The technologies have been proven in clinical and preclinical proof of concept studies, further validated by seven revenue-generating collaborations with biopharmaceutical companies and £1.5 million funding from the Wellcome Trust to further develop its lead product.

Unique Drug Products and Technology Addressing Significant Market Needs

Critical Pharmaceuticals has developed proprietary technologies for the delivery of high value recombinant protein and peptide therapeutics (biologics). Biologics have a market of $90 billion and represent over 30% of all new drug applications. However, biologics are labile, clear rapidly from the blood circulation and often need to be administered by frequent injections that are strongly disliked by patients. A market opportunity therefore exists for alternative drug delivery systems that reduce the need for frequent injections and allow the administration by non‐invasive routes. To meet this need, Critical Pharmaceuticals has developed two unique drug delivery technologies that have significant advantages over competing technologies:

• CriticalSorb for the non‐invasive nasal delivery of high value biologic products and challenging small molecule drugs.
• CriticalMix for the manufacture of highly active sustained release depot products that enables bimonthly, monthly or even less frequent injectable products.

CriticalSorb and CriticalMix may be applied to the delivery of all types of drugs, including small molecules, but Critical Pharmaceuticals is focused on the large unmet need for the delivery of biologics. The company is commercializing its platform technologies through drug delivery partnerships with originating biopharmaceutical companies and through the development of an in-house pipeline of high-value unique biological drugs. The initial focus for its in-house pipeline is on the large market opportunity for improved human growth hormone (hGH) products for the treatment of growth hormone deficiency:

• CP024 is a nasal spray of hGH using CriticalSorb with clinical proof of concept in an ongoing Phase 1 clinical development program.
• CP016 is a long acting injectable depot of hGH using CriticalMix currently in preclinical development.

Critical Pharmaceuticals drug delivery technology and therapeutic products are protected by five families of patents, the earliest of which have already been granted in the United States, Europe and many major territories worldwide. The patents are all either owned by Critical Pharmaceuticals or exclusively licensed to the company by the University of Nottingham. In addition to the patent portfolio, significant know-how of the process and formulation exists within the company.