Unfortunately, there's no cure, or even one in sight. As a result, psoriasis
patients worldwide spend in excess of 7 billion dollars annually on treatments,
none of which combine an optimum degree of safety and efficacy.
Allegiance: utilizing its expertise,
acquired 6,040,458 shares of Prime out of 16,284,680 common shares representing
a 37.5% Equity Interest.
Unknown to most people is the fact that over 8 million North Americans are suffering
from psoriasis, a chronic, painful, unsightly, and often emotionally devastating
disease.
Unfortunately, there's no cure, or even one in sight. As a result, psoriasis
patients worldwide spend in excess of 7 billion dollars annually on treatments,
none of which combine an optimum degree of safety and efficacy.
Three years of scientific research, clinical trials and product development,
has Prime in a position to license a unique, highly effective, non-irritating
psoriasis treatment that delivers superior results with virtually no side effects
or risks to the patient.
Prime’s treatment, Reliéva®, meets all North American regulatory
requirements and is now ready for distribution.
Reliéva® is a safe and effective treatment that can be obtained without
a prescription and is used on its own or in combination with other products.
This makes Reliéva® a treatment alternative for all psoriasis sufferers.
Plants have
long been the source of many active ingredients found in pharmaceuticals. Aspirin,
likely the most well known, was originally formulated by extracting solacing
from the bark of the willow tree.
Like aspirin, Reliéva® also derives its effectiveness from an active
ingredient found in a plant extract. Combining scientific developments from
both university and industry based experts; Prime has created a new extraction
process designed to maximize the concentration of targeted active ingredients
within plant extracts thereby vastly improving product effectiveness.
Reliéva® was created by formulating this unique plant extract within
a “state of the art” biotech topical delivery system to further
enhance the effectiveness of the product.
Prime owes the trademarks and patents covering both the extraction process and
the micro-encapsulation of the extract.
Relieva™ has significantly competitive advantages over existing treatments
including the world’s largest selling psoriasis treatment that has estimated
gross sales of $1 billion USD worldwide and gross margins of $700 million USD,.
Other psoriasis treatments (including the leader) may lose their effectiveness
over time as patients build up tolerability. Reliéva® has a “0”
irritancy rating, no health risks or side effects (whereas the leading treatment
can be irritating to approximately 25% of patients, which makes it difficult
for them to use). Current treatments such as ultra-violet light, lotions and
creams containing coal tar or steroids lack the combined efficacy and safety
of Reliéva®. No current treatment is totally satisfactory, and doctors
and patients are all looking for something that provides optimal effectiveness
with a greater safety profile.
Psoriasis is an incurable skin disease that is characterized by rapid cell proliferation
and inflammation. It affects 3% of the world’s population, and The Medical
Technology Stock Letter estimates the global market for psoriasis therapies
to exceed $7 billion annually. Current treatments are primarily topical creams
and ointments, most of which have side effects or safety concerns that preclude
long-term use.
Prime licensed world wide rights to Reliéva® to Apollo Pharmaceutical
Inc. and receives minimum annual royalties of $180,000 per annum and other considerable
benefits. ("Apollo") ("Apollo Group")
Apollo funded a new clinical trial with leading dermatologists from across North
America. Based on the results of this 200 patient placebo double blind controlled
clinical trial, Reliéva® proved to be just as effective as Dovonex®,
the world’s #1 selling treatment for mild to moderate psoriasis. Dovonex®
can not be used by 25% of the population because of the irritation caused by
its usage. Relieva® has zero irritance ratings and can be used on the face
whereas Dovonex® cannot. This trial was conducted by Global Clinical Research
Inc. in multiple centres in Canada and the USA. Global Clinical Research Inc
is based in Los Angeles and their website is www.globalclinicals.com.
The license and distribution agreements between Prime Pharmaceutical Corporation
and Apollo Group were amended as of Dec 29, 2005. The new agreements provided
that the Apollo Group would be responsible for all costs of patent applications
and filings in various countries around the world. However all patent applications
and filings will be in the name of Prime and owned by Prime. Furthermore the
Apollo Group will be responsible for registration of all trademarks and foreign
jurisdictions and these trademarks will be owned by the Apollo Group. However,
the trademarks will be subject to an Intellectual Property security agreement
that provides that the trademarks will revert to Prime ownership if there is
a breach or termination of existing licensing agreements.
The Apollo Group is in the process of negotiations and discussions to sublicense
the right to Prime's IP and these agreements are necessary to clarify the responsibility
for the costs of the new trademarks and patents as well as the cost of defending
any lawsuits concerning infringements of the patents and trademarks.
The new agreements put Prime in a position of not having any financial exposure
in regard to the costs associated with the expansion of marketing its IP.
David Solomon is President and CEO of Innovative. As President of Prime Pharmaceutical
Corporation he successfully developed, marketed and licensed an OTC treatment
for psoriasis, named Relieva®. See www.relieva.ca. Relieva® is based
on an enhanced proprietary plant extract; it is far superior to Dovonex®,
a prescription drug and the world's leading psoriasis treatment. Dovonex®
has estimated sales of $1 billion a year and estimated gross margins of 70%.
Prime licensed Relieva® and its enhanced extract for future minimum contractual
royalties of $1.8 million annually. The potential for Cinnicelon™ and
CM-X™ are many time greater than Relieva®.
Mr. Solomon has provided financial consulting services, through Allegiance Equity
Corporation, as well as independently, for the past 15 years. He has participated
in and initiated the funding of several high-tech computer software corporations,
a biotech company, and various real-estate limited partnerships.
Innovative Life Sciences Corporation and its partners have developed a model
based on the experience with Relieva® for the treatment of psoriasis to
develop other medical treatments. The first such treatment is CinnicelonTM,
for the treatment of diabetes and cholesterol.
Ms. Maggie Laidlaw, a PhD candidate in human nutrition, is the Interim Director of the Human Nutraceutical Research Unit at the University of Guelph, where the focus is on conducting clinical trials on natural health products for private companies, while adhering strictly to new government guidelines. She assesses the efficacy and safety of nutraceutically-based treatments for many of the so-called “lifestyle” diseases and conditions of the industrialized world by using clinical trial expertise. She evaluates unique properties of naturally-occurring foods, plants and herbs in novel products targeted to the marketplace.
Ms. Laidlaw conducts clinical trials under strict regulations from the Natural
Health Products Directorate of Health Canada, and is familiar with the intricacies
and regulatory framework involved in human drug trials.
Natasha Koifman
NKPR is a full-service public relations firm with a proven track record of success. Their strong commitment to client service and results drives their creativity, and they specialize in thinking “Outside the Box”. This creativity has lead to the development of unique strategic initiatives and strong media relationships, as they provide the press with the thought-provoking material they are looking for.
The NKPR team has comprehensive skills and experience in dealing with all aspects
of PR including:
• Media relations, strategic planning and implementation
• Strategic development of targeted media lists for each campaign
• Event planning from concept to execution
• Writing of all speaker and press mat4erial including: key messages,
speeches, Q&As, media advisors, fax blasts, press releases, backgrounds,
etc.
• Production and distribution of video news releases
• Assembly of press kits (French or English)
• Speaker and media coaching for spokespersons
• Media pitching pre, post campaign and ongoing
• Posting of media advisories, news releases, photographs, satellite feeds,
etc. on newswire services
In three and a half short years, NKPR has attracted customer base of 50 of North America’s largest and most exciting companies.
Experchem, headquartered in Toronto, Ontario, is a government-accredited laboratory that specializes in pharmaceutical products and regulatory affairs, including a wide range of testing and consulting services.
With years of regulatory experience working with American and Canadian authorities the company prepares natural health product (NHP) license applications and natural health product site license applications; it reviews NHP labelling for regulatory compliance and negotiates with regulatory agencies including TPD, FDA and EMEA.
Providing quality control evaluation and consultation the company conducts manufacturing facility assessment and on site product inspection; conformity testing and quality control in natural health products, pharmaceuticals and cosmetics; and ensures regulatory compliance for Good Manufacturing Practices (GMP) documentation.
Barbara J. Kovensky, President of Experchem, is recognized as a world leading expert in food science and technology. She works in all matters of an organic nature from foods, drugs, microbiology, environment and industrial hygiene; additionally, she is listed in the prestigious Leaders of Science Technology and Engineering.
Corporation Canadian Custom Packaging Corporation manufactures Relieva’s
products and formulations in their 110,000 square foot custom built facility
with their own in-house Microbiology Laboratory and USP Sterility testing for
both raw materials and finished goods. Canadian Custom Packaging manufactures
and packages over 1,500 different products including sterile pharmaceuticals
for small local businesses and major international pharmaceutical corporations.
Achievement of ISO 9001 Certification in February 1998 is the latest stride
in their Continuous Improving Process – This is another step towards their
goal attaining QS 9000 accreditation by Spring 1999.