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Dynamic Outlines Initial Target Markets for Pharmaceutical Cannabinoid Products

By Richard Evans, Pharmaceutical Manufacturing News
Monday, 08 December 2008

President & CEO, Richard Cowan, commented upon the manufacturing and development of Pharmaceutical Cannabinoid Products, "We are certainly pleased at the speed in which our business model is rolling out. The potential market size for some of these products is obviously very large. When multiplied by the various categories and compounded by multiple country roll outs, we are certainly undertaking a major pharmaceutical venture. Our success will be determined by the successes of our patients.

Hence Dynamic Alert Limited has now identified its target markets for its pharmaceutical product line-up. The modalities will include a lozenge with some capacity for enhancing rapid onset through oromucosal absorption, topical applications, such as lotions and salves, and various products for internal use.

Some products will have specific uses, while others may treat a range of problems. In keeping with both the historic medical uses of cannabis and the new scientific understanding of how cannabinoids work, Dynamics's cannabinoid pharmaceuticals will be targeting a wide-variety of serious needs.

Cowan further commented that,” Our strategy for success includes increasing the speed of bringing each product to market by using a multi-pronged approach. It is important to bear in mind that our ability to receive licensing fees for the various products will not have to wait on approval for use. Moreover, conventional measures of the various pharmaceutical markets do not offer a fair measure of the potential for cannabis-based medicines.

For example, the huge cost of treating diseases such as MRSA is not measured by the cost of specific pharmaceuticals. Moreover, there is no simple metric for the value of reducing a patient's need for debilitating opiates. Consequently, we are extremely excited to bring

such important medical advances to the people who need them most."

Recent advances in science have opened the door to develop, produce, and commercialize, a variety of effective whole plant cannabinoid based pharmaceutical products with a wide variety of important applications. Although cannabis has been used medicinally for thousands of years, until very recently little was known about how it actually worked. Some uses of cannabis are well known, such as alleviating nausea and stimulating the appetite for people with AIDS and cancer.

However, Dynamic Outlines team of scientists will develop more effective ways to produce and commercialize the production of whole plant cannabinoid based pharmaceutical products. Even today new uses for cannabis are being found, such as the recent discovery that topical cannabis preparations can be effective against MRSI, the deadly antibiotic-resistant flesh-eating disease. Other topical applications, which are largely non-psychoactive, would target localized pain, such as arthritis, and burns, but also neuropathic pain, for which there are few effective treatments.

In 2001, an article published in the Canadian Medical Association Journal revealed that, based on self-identified needs, an estimated 2% (or 400,000) Canadian adults were already using cannabis for medical purposes. That number would extrapolate into roughly 4 million in the US. Consequently, we believe that it would not be unreasonable to think that the global medical cannabis market will potentially reach several billion dollars.

Cannabis Pharmaceutical Products on the Market Today

GW entered into agreement with the German pharmaceutical firm Bayer Healthcare for marketing Sativex® in the UK. This agreement provided GW with millions of dollars in licensing fees and operating capital.

In February of last year, GW Pharmaceuticals sold the rights to develop and market Sativex® for cancer pain in the US to Japanese firm Otsuka Pharmaceutical. Otsuka paid GW a signature fee of $18 million, and may pay up to $273 million in royalties and fees. In addition, Otsuka will bear the costs of all US development activities for Sativex® in the treatment of cancer pain, additional indications, and future formulations. GW and Otsuka will jointly oversee all US clinical development and regulatory activities.

Clearly, Otsuka's willingness to contemplate paying up to a quarter of a billion dollars in royalties and fees for one cannabis-based pharmaceutical with a less than overwhelming efficacy profile indicates that the total market for medical cannabis products is a multi-billion prospect. Also, in 2005 GW and the Spanish pharmaceutical company Almirall Prodesfarma, S.A. announced that they had entered into an exclusive agreement for Almirall to market Sativex® in Europe (excluding the UK) Almiral paid GW a "£12 million signature fee." (approx $20 million at present exchange rates.)

Director and Chief Science Officer, Dr. Robert Melamede, stated, "There is an enormous need for these products. Recent advances in science have opened the door to develop, produce, and commercialize a variety of effective whole plant cannabinoid-based pharmaceutical products with a wide variety of important applications”.

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