Asthma and allergic diseases in horses (like humans) are growing. As more focus is placed on the disease incidence, one would expect an increase in the diagnosis of horses with heaves. Currently available inhalation drugs used in the treatment of horses are all off-label prescription human drugs. Their off-label prescription will not be permitted in Europe with the approval of a "like compound", specifically registered for use in heaves. In the United States and other markets, the specific formulation of a product for horses, together with competitive pricing for the Pulmovet product, will deter the use of human medications.

Clenbuterol is the only drug approved by the FDA for heaves in horses. It is administered orally by granules added to the feed or by a syrup mixed into the feed.

Several articles have alluded to the potential side-effects of high doses of clenbuterol (sweating, trembling, tachycardia, and excitement and, in recent studies, down regulation of ß2 receptors has also been reported). Oral delivery of the drug also results in variability in the actual dose administered and a loss of effect because of the systematic application for a problem concentrated in the airways.

No other bronchodilators or any or any corticosteroids are registered for use in heaves therapy in either the United States or Europe. All steroids are used on an off-label basis by veterinarians.

Pulmovet's product range will have a considerable market advantage:

Pulmovet will complete product development and registration trials in three major territories - North America, Europe and Australia New Zealand.

The company will initially develop a range of products for the treatment of heaves in horses and will then utilise its expertise to develop new intellectual property associated with respiratory disorders across a range of animals, large and small. Pulmovet will complete product development and registration trials in three major territories - North America, Europe and Australia New Zealand.

Revenues will mainly be generated from out-licensing royalties on gross sales and will be used to return dividends to shareholders and progress further intellectual property development within the company.

Pulmovet does not intend to establish capital expensive R&D facilities or resource intensive sales and marketing forces, opting instead to develop specific and mutually beneficial partnerships in each of these areas.

Pulmovet's business strategy is supported by a business plan that sees the company returning profits in a short timeframe after the registration and market approvals which are anticipated as early as 2008.

Investment Opportunity:

The risk profiles of the intended products are considered to be extremely low. There is minimal risk associated with the revised EquineHaler introduction as it is already well-accepted in the marketplace and among equine veterinarians.

Salbutamol in a less purified formulation has been previously registered in both Europe and the United States and has a proven track record of effective therapy in both the horse and humans. Pulmovet's R-salbutamol has an enhanced therapeutic profile.

Drug therapy associated with steroid treatment is also considered low as the drugs proposed for steroid therapy are already in use for humans and for horses, the latter through off-label treatment.

"No specific inhalation therapies exist currently for the treatment of heaves in horses. Aerosol delivery of bronchodilators and corticosteroids will become the most common way to treat respiratory disorders like heaves."

 

Pulmovet's Management Team:

Ms Helle Funch Nielsen - is currently the Managing Director of Equine HealthCare. Helle has over 10 years' experience working as an asthma and allergy product specialist for Fisons Ltd and later in the career as a product manager for asthma and allergy products. Helle is the patent holder for several diagnostic and device inventions associated with equine medicine. She has a life time experience with horses having been a horse owner herself. Helle became involved in the treatment of heaves when several of her own horses started suffering from heaves.

Professor Clive Page - is currently the Chairman of the Board of Directors, Stirling Products Limited and the Director of the Sackler Institute, King's College, London. Clive is an internationally renowned expert in the area of pulmonary pharmacology and well known for his contributions to pulmonary medicine and equine lung diseases. Clive is also a director of several European and North American biopharmaceutical companies.

Dr Calvin London - is currently the CEO and Managing Director, Stirling Products Limited. Calvin has extensive experience in the technical development and management of pharmaceuticals and has been a senior executive for several international pharmaceutical companies. Calvin is also the Director of Stirling's private companies associated with intellectual property and business development.

Mr Per Riis - is a chartered accountant in Denmark. Per is a partner and Managing Director of a mid-sized Danish Accounting company and has considerable expertise and experience in the establishment, development, commercial management and fund-raising of Limited companies in Denmark. Per also has practical expertise and experience with horses as a private horseowner and competition showjumper.