Critical Pharmaceuticals Receives Notice of Allowance from US Patent and Trademark Office for Intranasal Growth Hormone and Parathyroid Hormone Products

CriticalSorb™ formulation technology covered by this patent has exceptional utility for the delivery of poorly absorbed biological and small molecule drugs

(PresseBox) ( Nottingham, UK, )
Critical Pharmaceuticals today announces that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for a patent application directed towards the Company's CP024 Intranasal Growth Hormone and CP046 Intranasal Teriparatide (parathyroid hormone 1-34) products formulated using it's proprietary CriticalSorb™ drug delivery technology.

The patent application allowed by the USPTO (application number 13/063,411) relates to pharmaceutical compositions of growth hormone or parathyroid hormone and the CriticalSorb™ absorption enhancer in a form suitable for administration to the nasal, buccal and / or respiratory tract. Similar patent protection has already been obtained in Russia, Singapore and New Zealand with pending patents in other major territories including Europe and Japan. Together the market for growth hormone and parathyroid hormone products is in excess of $4bn per annum with strong interest in alternatives to the current daily injectable products.

Professor Lisbeth Illum, co-inventor of the CriticalSorb™ technology and an internationally recognised expert in drug delivery, said "The CriticalSorb™ formulation technology covered by this allowed application has been shown to have exceptional utility for the delivery of poorly absorbed biological and small molecule drugs in both preclinical and clinical studies. CriticalSorb™ has the potential to enable intranasal dosing of a wide-range of therapeutics and provide an attractive alternative to frequent injection that are strongly disliked by patients."

Dr Gareth King, CEO Critical Pharmaceuticals commented "The allowance of a US patent further strengthens the data package on our CP024 nasal growth hormone product that has demonstrated strong biological activity in Phase I clinical trials. It will provide important protection to future license partners for the continued development and commercialisation of CP024 and CP046 intranasal teriparatide products."

The allowed applications are part of Critical Pharmaceuticals broader capability and intellectual property in advanced drug delivery and formulation technology for challenging molecules such as peptide, protein and antibody drugs. La Marie Business Intelligence recently estimated this market to be worth in excess of $140bn and growing at +12% a year. Potter Clarkson LLP, a leading European firm of patent and trademark attorneys, advises the company on intellectual property matters.

The CriticalSorb™ technology was developed by Critical Pharmaceuticals scientists in Nottingham, UK. Dr Faron Jordan, co-inventor of the CriticalSorb™ technology and Head of Preclinical and Clinical Project Management at Critical Pharmaceuticals, said "The CriticalSorb™ technology has rapidly progressed from the lab to clinical proof of concept. I'm extremely pleased with the allowance of the US patent application and look forward to progressing additional Critical Pharmaceuticals products and partner programs into the clinic and into the hands of patients who prefer nasal administration over injection."

About CriticalSorb™ and CP024 Intranasal Growth Hormone

CriticalSorb™ is a pharmaceutically acceptable excipient with a drug master file (DMF) in the US, Europe and Japan. It is currently used in marketed products as a solubility enhancer for intravenous and oral administration. In preclinical toxicology studies, CriticalSorb™ has been found to be nontoxic and not irritating to the skin or eyes and was well tolerated by the nasal mucosa. Furthermore it is not mutagenic to bacteria, mammalian cells and mammals, and no developmental toxicity or teratogenicity has been found. Using conventional manufacturing technologies and delivery devices, possible formulation presentations include liquid nasal sprays or powders for nasal administration.

Critical Pharmaceuticals has used the CriticalSorb™ technology to develop CP024, a nasal growth hormone product that has completed two Phase I clinical studies and has established clinical proof of concept for CP024 and the technology: CP024 was shown to be well tolerated and able to induce insulin-like growth factor I (IGF-I) to the same levels as a subcutaneous injection of the marketed product. IGF-I is the main mediator of hGH activity in the body and a clinically relevant indicator of bioactivity.
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