Unigene Laboratories acquires exclusive licence for therapies from University of London

Unigene Laboratories, Inc. has acquired exclusive commercial rights to a combination therapy with potential value in the treatment of certain inflammatory diseases, and a novel peptide that may find application in the treatment of cardiovascular diseases.

Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical, Unigene's nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005.

It has licensed the US rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis.

These rights were acquired from Queen Mary, University of London. The conditions targeted by the inventions include osteoarthritis, rheumatoid arthritis, inflammatory bowel disease, and cardiac reperfusion (restoration of blood flow) injury in heart attack and stroke.

Queen Mary is one of the leading research facilities in the federal University of London, with an annual turnover of £200 million, research income worth £43 million, and generates employment and output worth nearly £500 million. roots lie in four historic colleges: Queen Mary College, Westfield College, St Bartholomew's Hospital Medical College and the London Hospital Medical College.

Unigene will gain rights to inventions already identified, and to future developments in exchange for research funding of approximately $400,000 per year over the next three years, milestones based on clinical and commercial progress, and royalty payments representing a percentage of Unigene's revenues.

The two licensed programmes are being developed in the laboratory of Dr Mauro Perretti, professor of immunopharmacology at the William Harvey Research Institute, part of Queen Mary's School of Medicine and Dentistry.

Programme 1 covers a combination therapy using calcitonin and glucocorticoids for inflammatory diseases.

Dr Perretti's group has filed patent applications disclosing the unexpected benefit of combining calcitonin and various glucocorticoids (steroid drugs) to treat various inflammation conditions. This combination allows for a significant reduction in the dose of the glucocorticoid, which may decrease the severe side effects often associated with high dose glucocorticoid treatment that currently inhibits their use for chronic treatment.

Also, data from Dr Perretti's group suggest that glucocorticoids may improve the long-term efficacy of calcitonin. Potential applications for this combination therapy include osteoarthritis, rheumatoid arthritis and inflammatory bowel disease.

"This work has demonstrated an important synergy between calcitonin and glucocorticoids, and may allow for the development of safer and more efficacious treatments that could provide significant advantages to the patient," said Dr Warren Levy, president and CEO of Unigene.

"In addition, the development of this therapy should be expedited since both components of the combination are previously approved, well-established drugs and because Unigene has considerable expertise in the recombinant production, oral delivery, and clinical development of calcitonin," Dr Levy said

Samuel Ogunsalu, who led the licensing effort for these two programmes for Innovation and Enterprise, Queen Mary's technology commercialisation arm, said, "Glucorticoids are used in a diverse range of anti-inflammatory therapies; however the side-effects, which limit their use, may include immunosuppression, 'Moon face' (round puffed face) and abdominal distension, as well as osteoporosis, muscle weakness and cataracts for those who have to take glucocorticoids over a prolonged period.

"We are excited that the combination of calcitonin and glucocorticoids may well reduce the side effect profile of glucocorticoids while enhancing their activity. This could give the glucocorticoid market new impetus, and enhance the quality of life for hundreds of thousands of patients in an anti-inflammatory drug market worth in excess of $30 billion," added Ogunsalu.

Programme 2 annexin and related peptides, for cardiovascular disease.

The Queen Mary team has developed proprietary information related to the natural protein annexin and smaller peptide fragments of annexin that may be developed as a part of the treatment modalities for strokes and heart attacks. Animal experiments have shown that these peptides are extremely effective at preventing the damage that occurs to blood vessels or the heart following removal of the blockage and reperfusion of the blood flow to the blocked areas. Treatment with the peptides may markedly improve the clinical outcome to the patient following reperfusion.

"We believe that exploitation of this natural mechanism could lead to innovative anti-inflammatory therapeutics with better safety, since they will be mimicking the way our organs and tissues operate to regulate inflammation in the body," said Professor Mauro Perretti, at whose laboratories the programmes were developed..

Prof Paretti added, "As well as treating the effects of heart attack, stroke and reperfusion injury, we envisage that we may be able to use this system for the prevention of post-surgical inflammation, and for treating or preventing inflammation that results from conditions such as rheumatoid arthritis, asthma and septic shock.

"We are keen to integrate the expertise and know-how at Queen Mary's William Harvey Research Institute with Unigene's unique technologies and delivery system, and together develop products that deliver significant therapeutic impact."