Letter to the Shareholders of ALDA Pharmaceuticals Corp
posted on
Jun 02, 2008 08:37AM
VANCOUVER, BRITISH COLUMBIA--(Marketwire - June 2, 2008) - ALDA Pharmaceuticals Corp. (TSX VENTURE:APH) -
Since the last letter to shareholders was provided on February 29, 2008, a lot of effort has gone into a number of important projects at ALDA Pharmaceuticals Corp. For example, we have:
- completed the re-branding of the retail and commercial disinfectant products with new names, logos and tag lines,
- scheduled production of retail products and the new Disinfectant Cleaner "CONCENTRATE" under the new identities and plan to introduce these to the market in the 3rd quarter of 2008
- received the US Patent Number 7,338,927 for the T36(R) formulation,
- filed extensions of the original patent in the US and China to cover therapeutic applications,
- filed an extensive new patent application to cover a broad range new therapeutic applications of T36(R),
- observed the share price rise to a new high of $1.57 on March 4, 2008,
- received and tested the first pilot scale samples from ALDA's agent in China, who has achieved the first sales of our products and has obtained commitments from distributors in China to sell CDN $2 million worth of products,
- provided our agent in China with samples of the new hand sanitizer for registration, manufacturing and marketing in China,
- filed the 2007 20F and the preceding quarterly statements with the SEC for the registration of the company's securities in the US,
- identified a market maker to assist ALDA with its US listing,
- successfully completed all of the initial testing T36(R) formulation for therapeutic markets and
- prepared a pre-IND package for the USFDA and scheduled a pre-IND meeting with USFDA officials for July 15, 2008, in Washington, DC,
Here are the details.
Financing Activities
During the quarter ended March 31, 2008, ALDA received over $1 million from the exercise of over 5 million warrants at an exercise price range of $0.20 to $0.30 and 350,000 options at an exercise price range of $0.10 to $0.11 resulting in a cash position of over $2.4 million at the end of March. We are now in a position to pursue a number of projects including the testing, registration and marketing of the therapeutic and commercial products discussed below. Further financings will be required but ALDA is able to make significant progress on its own while assessing financing opportunities. I will be making further trips to eastern Canada and probably to the US to introduce ALDA to new potential shareholders and discuss financing possibilities.
Retail Products
The "re-branding" has now been completed and, the new name, "T36(R) Disinfex", has been registered as a trademark in Canada and the US. The new name will be applied to two retail products, the "Personal Disinfectant" spray and the "Ready to Use" Disinfectant Cleaner Wipes. The wipes are still in progress and are currently being tested. Once inventory is available, it will be supplied to ALDA's current distributors in the beauty and dental markets and to Group 270 for the retail chains.
"T36(R) Disinfex" will also be used for the new, superior antiseptic skin cleanser that is in the process of being registered with Health Canada, as announced on October 30, 2007. Although the Company had been advised that the new DIN would be provided within 60 days, the process went beyond that time because of staffing issues at Health Canada and lost e-mails. Once communication was re-established, ALDA was informed that the Category IV Monograph registration process did not apply to the new antiseptic skin cleanser due to the presence of more than one active ingredient in the formulation. The DIN application was then redirected into the regular stream for disinfectant products and the time for processing such an application is longer. ALDA's representatives are in continual contact with Health Canada and are doing everything possible to assist them in processing the application. In the meantime, the Company is starting work with a regulatory consulting firm to assist with future Health Canada applications.
Manufacturing and Marketing in China
The facility in China has been completed, a pilot batch of T36(R) Disinfectant has been prepared and the first sales have been made. Anti-microbial testing of the pilot batch demonstrated complete effectiveness against E. coli and other bacteria. Samples have been analyzed by ALDA and met the required manufacturing specifications. Full-scale manufacturing has now started, agreements for the sales of CDN$2 Million are already in place. ALDA's agent has also received samples of the new antiseptic skin cleanser and has started the registration of this new product for manufacturing and sale in China. New molds have been completed for the "Ready to Use" Disinfectant Cleaner wipes and samples have been produced and are currently being tested by ALDA's contract manufacturer.
Therapeutic Products
The patented T36(R) formulation is versatile, powerful and safe. It consists of a unique combination of four active ingredients in very low concentrations that act in concert to disrupt the physical structure of all infectious organisms rather than interfering with their metabolic pathways or genetic makeup. The competitive advantage is a high degree of effectiveness and safety while preventing microbial resistance, side effects or toxicity. A number of therapeutic applications have been identified and registrations for these purposes are being actively pursued as funding becomes available. All of the applications are topical and, therefore, the clinical trials and registrations are much faster than those required for drugs that are taken internally. Global markets for the products described below have been estimated to exceed $10 Billion per year.
Clinical Testing - BioScience Laboratories Inc. has completed all of the preliminary clinical testing that was required for ALDA to move forward, including testing against bacteria, fungi, viruses, mycobacteria and two organisms responsible for athlete's foot. All of the testing showed that the T36(R) formulation easily meets the criteria established by the regulatory agencies in the US, Canada and Europe.
In Canada, the next step is to prepare a Clinical Trial Application ("CTA")to Health Canada, requesting permission to undertake human studies. For Europe, a similar application will be made to the European Medicines Agency. In the US, a pre-IND ("Investigational New Drug") package has been prepared and presented to the Food and Drug Administration ("FDA")and a pre-IND meeting is scheduled for July 15, 2008 in Washington, DC to determine what additional laboratory studies or animal trials must take place before human trials can begin.
These applications will cover the use of the T36(R) formulation as a skin antiseptic for surgical use, a hand sanitizer for use against all classes of infectious organisms and as a treatment for athlete's foot.
T36(R) Antiseptic - Two types of registrations are in progress for the T36(R) Antiseptic. The current DIN that is in progress, but delayed, applies to the retail version that will be marketed under the name of "T36(R) Disinfex". The registration of this product in Canada does not require any additional testing to be done. The second registration requires new testing to be done so that T36(R) can be registered for use as pre-operative and pre-injection antiseptic in hospitals and clinics and for personal sanitation. The studies that were successfully completed by Bioscience Laboratories Inc. are the first step in this process. Once all of the testing, including human trials, is completed, much more extensive claims can be made and T36(R) can be sold in the EU, the US and other counties that accept the EU or US registrations. The strategy, then, is to obtain the first registration without the need for any testing so that sales of T36(R) can take place in Canada while the new testing is in progress for the larger markets.
T36(R) First-Aid Ointment and Topical Treatment - On March 25, 2008, we announced that new T36(R) formulations containing anti-inflammatory compounds, such as steroids, anesthetics or analgesics, for use on topical infections and, in particular, inflamed infections, had been developed. Typically, infections with associated inflammation are treated with separate antiseptic and anti-inflammatory preparations. The new T36(R) formulations combine these properties into a single treatment, making the prescription process easier for the physician and the application easier for the patient.
In preliminary studies under the direction of a physician, the new T36(R) formulations quickly resolved a number of serious skin infections, some of which had resisted all other treatments. Examples include chronic eczema with secondary Staphylococcus infections and fungal infections, such as athlete's foot and Tinea versicolor. We were told that the combination of T36(R) with 2% hydrocortisone is the "best thing ever seen" for such intractable conditions.
The new formulations open up significant therapeutic markets that had not been originally targeted. Athlete's foot is the first indication that will be targeted for these formulations because it is a relatively easy condition to treat, comparative products are available and the market is substantial. Further, with a registration for athlete's foot, physicians will be able to prescribe the product "off-label" for other conditions. This will allow the accumulation of information for future registrations.
T36(R) Microbicidal Gel - As a result of our attendance at the 4th Canadian Microbicides Symposium that took place on January 28, 2008, in Ottawa, new possibilities have arisen that are being investigated. Of particular interest is the discovery of potentially suitable delivery systems for the Microbicidal Gel that can be used in conjunction with T36(R) to prevent the spread of HIV and AIDS. If these delivery systems do prove to be useful, clinical trials can start under the direction of Dr. Brian Conway, Scientific Advisor.
Commercial Products
As a result the re-branding work that has been completed, "T36(R) Safe-T-Cide" is the new name selected for the commercial Disinfectant Cleaner CONCENTRATE. The product now in the manufacturing queue and will be introduced to our current distributors as soon as it in the boxes. Dr. Bill McCoy, our Director in the US, will be heading up the work to have this product and T36(R) Disinfectant registered with the EPA in the US.
Patents
Progress has been made on the protection of the Company's intellectual property as described below.
US - US Patent Number 7,338,927 was granted on March 4, 2008. Intellectual property protection in the US is a very important asset for ALDA and we are immensely pleased that it was granted with no significant changes to the original application. In addition, a major extension to the original patent, adding therapeutic uses, has also been filed. This extension, if granted will increase the protection of T36(R) technology in the US.
China - An extension to the original Chinese patents, virtually identical in scope to the US extension, has also been filed.
Australia - Now that the patent has been issued in Australia, assistance is being sought to register our products in Australia for manufacturing and distribution.
Europe - This patent is still in progress and the European Patent Office is waiting for additional information from ALDA. This will be provided in due course.
Canada - The Canadian Patent Office has responded to the patent application and additional information is required from ALDA. This will also be provided in due course.
Anti-Infective, Anti-Inflammatory PCT Application - As described above, a comprehensive new patent application under the Patent Cooperation Treaty ("PCT application"), seeking protection for the new anti-infective, anti-inflammatory formulations, has been filed with the Canadian Intellectual Property Office ("CIPO"). Once the PCT application has been reviewed by CIPO, modifications may be required. Once CIPO is satisfied, the PCT application can be submitted to the intellectual property office of each separate country and the EU for "national review" and examined again. Each patent office acts independently and can request its own actions during the process. A patent in any country is material because each country acts totally independently. A patent in any one country does not automatically lead to a patent in any other countries except that the EU reviews and issues patents on behalf of its member countries.
Foreign Securities Registration
The 2007 Form 20F and the preceding quarterly statements have been filed with and can be reviewed on the EDGAR system. A market maker has been identified and we are in the process of completing the additional documents required by the market maker to list ALDA's stock in the US. Two more quarterly statements also need to be filed.
Summary
A lot of progress has been made since the last letter to shareholders was presented three months ago. The stock market has shown some displeasure but, after 20 years in public companies, I have learned that not all people can be pleased all the time. Small pharmaceutical companies like ALDA take time to mature but I feel that ALDA is in a good position to capitalize on its assets of effective, patented technology, new products on the threshold of manufacturing and sales (despite the inevitable delays), production and sales in China that have now begun, the US registration of the shares nearly completed, successful initial testing for therapeutic applications completed and a solid team of people who make things happen (in my humble opinion). Next year could be as exciting as the last year.
Sincerely yours,