- Apanol - Drug for treatment of asthma. Asthma is a serious global health problem. People of all ages in all countries are affected by this chronic airway disorder. The market for asthma drugs is approximately $6 billion annually
- Tiesole - Drug for treatment of allergies. This drug has demonstrated efficacy in the prevention and reduction of allergic reactions in an experimental model of allergies, including allergic rhinitis and hayfever. The market for anti-allergy drugs is estimated at $5 billion annually.
- Bispan - Drug for treatment of arthritis. Bispan has demonstrated significant efficiency in laboratory models of rheumatoid arthritis. The market for anti-arthritic drugs is estimated to be $7 billion annually.
- Sortac - Drug for treatment of psoriasis.
Inflazyme's new compounds, Apanol, Tiesole and Bispan are known by the group name IZP-94005. The company believes that its family of proprietary drugs, including a group of 50 compounds covered by a broad-based patent, can replace steroids as the therapeutic-of-choice for the treatment of inflammatory conditions.
A US patent for the composition of matter and usage for IZP-94005 has been issued, with similar applications filed in Canada, Japan and Europe. This "jumbo" patent covers over 50 compounds and provides meaningful intellectual property for the company.
A synthetic formulation for the production of IZP-94005 has been developed by the company using commercially available and inexpensive basic ingredients. Inflazyme's lead IZP-94005 drug is called Apanol. This highly promising compound is being developed as a treatment for asthma and is currently scheduled to begin a four-month Phase I clinical trial in the United Kingdom by March 1997.
What is Asthma
- Inflammatory disease of the lungs.
- Affects 13 million Americans (280 million worldwide)
- Has two phases (early 15 mins., late 8 hours)
- Affects 20% of children
- Affects 8% of adults
- It is increasing 14% annually
- Causes 5000 deaths annually
Currently $6 billion Expected to grow by 14% - 17%/year
- Aging Population
- Earlier Diagnosis
- Longer Treatment
Apanol Safety Profile
- Safe Drug (nontoxic)
- Is not immunosuppressive
- Does not have effects on bone metabolism
- Does not have effects on hearts
- Does not cause hypotension or hyperten- sion
- Well tolerated given in multiple doses
- No effect on liver or blood
IND (months) 1-3 - IND (Investigational New Drug) application approval refers to the U.S. Food & Drug Administration (FDA) process for approving a compound to advance into human clinical trials. Many regulatory jurisdictions outside of the U.S. are considered to provide the same degree of rigorous review but frequently provide faster approvals. The U.K. is one such jurisdiction. Submissions go before an Ethics Committee, which is roughly the equivalent of the U.S. FDA. (The FDA IND approval process can require five to nine months to complete.)
Phase I - months 5 - 8 - First testing on humans. The subjects are normal people, i.e. those not afflicted with the targeted disease. Assesses the compound for toxicity, or unwanted side effects, and more precisely, determines the amount and frequency of doses at which side effects become evident. Submission and approval by regulatory body required to advance to next stage. Involves between 20 - 50 people. Anticipated during March 1997
Phase II - months 6 - Validation of efficacy in humans and confirmation of safety results achieved in Phase I. Involves between 20 -50 subjects afflicted with the target disease. Determination of dosage levels that allow maximum efficacy with tolerable side effects. Regulatory approval required to
Phase III - months 12 - 15 - More rigorous, expanded human testing that may involve hundreds or even thousands of subjects and control groups in multiple centres. Allows the collection of highly objective data on a drugs efficacy and comparison with other forms of treatment. Allows monitoring for adverse reactions after long-term use.
NDA - months 5 - 10 - NDA (New Drug Approval) is required by the FDA prior to the commercial introduction of a drug. Additional studies in a Phase IV clinical trial may have to take place concurrently with early marketing. For comments regarding the NDA-equivalent in the U.K., refer to IND-Equivalent above.
Marketing Launch - months 2 - 6 - May involve additional market testing to refine a marketing plan in terms of pricing and other variables. Ramping up of commercialization and the marketing launch.
BRIEFS - RECENT DEVELOPMENTS
|November 12, 1996 -
lnflazyme Pharmaceuticals Ltd. (OTC-BB:IZYPF, VSE:IZP) today announced the
appointment of Mr. James M. Rae to its Board of Directors. Mr. Rae is the
immediate past President and CEO of Cangene Corporation. Prior to that he held
key management positions at G.D. Searle, Ltd., E.R. Squibb and Ciba-Geigy Corp.|
"By bringing extensive experience in business development, marketing and strategic alliances to Inflazyme, Jim Rae will add significant strength to our management team", said Dr. Hassan Salari, Inflazyme's President and CEO.
October 7, 1996 - Inflazyme Pharmaceuticals Ltd. (OTC BB: IZYPF, VSE: IZP) announced today that it has received approval to trade its common stock on the OTC Bulletin Board, under the symbol IZYPF. The companys stock will continue to trade on the Vancouver Stock Exchange under its IZP symbol.
Inflazymes President and CEO Dr. Hassan Salari stated, We anticipate that the OTC Bulletin Board listing will expand shareholder interest in Inflazyme, and that it will facilitate trading among our following of U.S. investors, which has been increasing steadily.
September 11, 1996 - Inflazyme Pharmaceuticals Ltd. (the Company) announced today that its Rights Offering To Shareholders, oversubscribed by more than 45%, has been successfully completed.
"It is edifying to see the faith which our shareholders and the investing public have exhibited in our Company, stated Dr. Hassan Salari, lnflazymes President and CEO. The approximately C$3.2 million generated by this Offering will increase our working capital to in excess of C$4.7 million. Further, our Company is expected to receive an additional C$1.9 million through the exercise of the Warrants which were part of the just completed Rights Offering. With these funds we will proceed at once to initiate and complete the Phase I and Phase II clinical trials of Apanol, our lead anti-asthma drug, in accordance with U.S. FDA regulations.
More or less simultaneously, Inflazyme would initiate the process of bringing its anti-arthritis drug, Bispan, to the early Phase I trial stage, at which time negotiations would be entered into with one of the major pharmaceutical companies which have already expressed serious interest in forming a joint-venture to co-develop the drug. In addition, the Company plans to expand its research programs for the preclinical optimization of certain other of its anti-inflammatory drugs, especially those targeted as preventatives and therapeutics for allergies and such skin diseases as eczema and psoriasis.
August 27, 1996 - Inflazyme Pharmaceuticals Ltd., (Vancouver Stock Exchange: IZP) and SuperGen, Inc. (Nasdaq: SUPG & SUPGW) jointly announced today that the two companies have signed a letter of intent that grants SuperGen the exclusive worldwide rights to anti-cancer and all other applications, except inflammation, of certain Inflazyme technologies and drugs.
Inflazyme stated that preclinical laboratory studies of its drugs have shown effectiveness against lung, colon and skin cancers, as well as lymphomas and leukemias. Additionally, certain of the drugs target multi-drug resistant (MDR) cancers that no longer respond to available therapies. Based on results to date, the companies said U.S. human clinical trials could begin as early as 1997.
While the terms of the agreement have been defined, they were not specifically disclosed. The companies said the License granted to SuperGen is based on a combination of equity investment in Inflazymes common stock, milestone payments and royalties to Inflazyme on net product sales. The final Licensing Agreement between the companies remains subject to mutual review.
Three Criteria that Enhance IZYPF as an Investment Opportunity