AMI focuses on delivering lower dosage treatments to people suffering from Impotence and Premature Ejaculation. Unlike many of our competitors, we treat the whole patient, individually and over the long term. AMI’s strategy is to provide new and innovative methods of treatment and delivery systems that provide a non-invasive method of drug delivery to the body and by using existing drug products with known safety. We market directly to the public. All medications are provided under individual prescriptions and our treatments are only available through our dedicated clinics under the supervision of trained medical personnel.
Sexual Health Treatments
AMI is a service provider company that arranges for patients with Sexual Dysfunction to be provided with medical services, pharmaceuticals and associated support services.
Treatment options include push button self injections, lozenges, tablets and nasal spray and oral strip program options for the treatment of Erectile Dysfunction and for the treatment of Premature Ejaculation.
All medications used in each treatment program are prescribed by licensed doctors and are prepared and delivered by a registered compounding pharmacy in compliance with the relevant applicable regulatory requirements. Our products and services are only available by prescription and are sold on an “off-label” basis.
Treatment options are generally provided under a treatment program (2-24 months).
As part of its treatment programs, AMI arranges for a fully licensed pharmacy to fill its patients’ individual prescriptions and supply medications to those patients.
One of our existing treatment methods involves delivering medication via a Nasal Delivery System. This allows AMI physicians to prescribe much lower medication doses.
We are also in the initial stages of developing new methods of treatment delivery.
AMI’s Path Breaking Research and Development
Australian Sexual Dysfunction market
Information published by the research firm IMS in October 2006 estimated the Australian Erectile Dysfunction market to have AUD$63 million (approximately $47.25 million) in annual sales (Australian Financial Review, October 23, 2006, page 50).
About 90,000 Australian men are expected to develop impotence each year and all up 1 million Australian men face the prospect of needing this type of assistance (West Australian March 8, 2004, page 12).
We compete with rival treatments such as Viagra *, Cialis * and Levitra * in the Erectile Dysfunction field. AMI does not currently have any known competitors in the Premature Ejaculation market.
Worldwide Sexual Dysfunction market
It has been estimated that worldwide 152 million men suffer from erection problems with the number being anticipated to reach 304 million by 2020 (1st international consultation on Erectile Dysfunction, July 1-3, 1999 and Hartmut Porst, Restoring a Normal Sexual Response: The Ultimate Goal of Erectile Dysfunction Therapy, European Urology Supplements, volume 1, November 8, 2002, page 1924, also reported in the Australian Financial Review, October 2, 2004, page 25).
The U.S. Food and Drug Administration (“FDA”) advisory committee reports that there are over 30 million impotent men in the United States and 30 million Europeans with this condition. This equates to approximately 20% of the male population in these areas.
Studies conducted in Europe and Australia discovered that 75% – 88% of men with Erectile Dysfunction had not sought treatment. Effective oral Erectile Dysfunction therapies such as Sildenafil (Viagra **), Vardanafil (Levitra *)* and Tadalafil (Cialis **) are now well established and effective treatments, for some men. Many others with existing medical conditions such as coronary heart disease, diabetes and high blood pressure are unable to take advantage of these standard treatment methods.
Medications that need to be swallowed must be absorbed from the gastrointestinal tract. Unlike rivals such as Viagra *, Levitra * and Cialis *, AMI’s most pharmacological formulations are not affected by food intake as the medications are not delivered through the gastrointestinal system.
Latest filed financial statements by Pfizer, Eli lily and Bayer, the leading worldwide providers of Erectile Dysfunction medications, show more than $3 billion in total annual revenue relating to these medications.
There are no figures available on the worldwide sale of Premature Ejaculation products as the market appears to be relatively untapped with no current competitive products to AMI’s Australian Premature Ejaculation product.
Based on its experience in selling Premature Ejaculation treatment programs in Australia AMI anticipates the worldwide PE market to be substantial and to be of at least the same size as the Erectile Dysfunction market.
The Future of AMI
One of AMI’s goals is to extend the reach of our innovative treatment programs beyond Australia, New Zealand and China. We are exploring growth opportunities in Asia, Europe and the United States.
Based on publicly available Australian and Worldwide market information, the Sexual Dysfunction market share we have achieved in Australia and our analysis of the regulatory and market opportunities available in the United States and elsewhere, we are extremely excited by our prospects and our opportunities for growth in the coming years.
**Viagra * –trademark of Pfizer, Levitra *-Bayer ,Cialis * –ELlilly
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