Re: Letter to share holders more readable
posted on
Feb 29, 2008 03:55PM
VANCOUVER, BRITISH COLUMBIA--(Marketwire - Feb. 29, 2008) - Since the last
letter to shareholders was provided on November 15, 2007, a lot of progress
has occurred at ALDA Pharmaceuticals Corp. (TSX VENTURE:APH). For example,
the Company completed a third financing in 2007, received patents for China
and Australia and the issue notification for the US patent, continued the
process of introducing its products to consumers, made progress on the
manufacturing of its products in China and the registration of the
company's securities in the US, received the first results from testing
T36(R) formulation for therapeutic markets and observed the share price
rise to new highs and increase by nearly 4-fold. Here are the highlights
and our expectations.
Financing activities
The private placement for $525,000, arranged in October, was completed in
December with the sale of 3.5 Million Units consisting of one common share
and one warrant priced at $0.30 for the first year and $0.45 for the second
year. Due to the increase in the Company's share price from $0.37 in
November to a high of $1.47 in February on a volume of nearly 60 Million
shares over the same period, over 5 million warrants have been exercised,
resulting in a cash position of approximately $2.4 million. The company is
now in a position to pursue a number of activities well ahead of the
original plan. In anticipation of future activities, such as the testing,
registration and marketing of the therapeutic and commercial products
discussed below, further financings will be required but the Company is now
in a position to assess its opportunities and seek the best terms possible.
Retail Products
Brand Institute, Inc. was added to the team working on "re-branding" which
has now created new identities for the Company's products. During this
process, more than one identity was developed and it became clear that one
was particularly suited to commercial products and two others were
appropriate for retail products. Trade marking of all three is in progress
and the new identities will be revealed when the marketing programs are in
place. Containers, graphics, labels and other marketing materials will also
be prepared.
The new retail identity will also be used for the new, superior hand rub
that is in the process of being registered with Health Canada, as announced
by the company on October 30, 2007. Although the Company had been advised
that the new DIN would be provided within 60 days, the process has taken
longer than expected due to staffing issues at Health Canada and lost
e-mails. The Company is in close contact with Health Canada and providing
as much assistance as possible to speed the process along. This new product
is expected to have an advantage in the market because it is more powerful
than typical alcohol hand sanitizers and also kills a wider variety of
infectious organisms. A third product, the "Ready to Use" Disinfectant
Cleaner that was announced by ALDA on November 1, 2005, will be
incorporated into a wipe for the retail market under the same new identity
using the wipes provided by He-Yi She Ye Limited. These three retail
products will provide a unique combination of infection control products to
the consumer that will be effective, versatile and safe.
Manufacturing and marketing in China
Progress is also being made in establishing manufacturing facilities in
China. The Company has received samples wipes in canisters that have been
manufactured in China and can be used with T36(R) Disinfectant and T36(R)
"Ready to Use" Disinfectant Cleaner. No firm start date has been
established as yet, but the target is to have product on the market in
China before the start of the 2008 Olympics that are being hosted in
Beijing.
European Union ("EU")
The Company's consultant in the UK, Tincali Tech Consulting ("Tincali"),
has just completed a report on the process required for ALDA to market
T36(R) Personal Disinfectant in both the EU and the Middle East using the
existing EU registration. The Company is in the process of reviewing the
report to determine the most suitable path for initiating sales in the EU.
Tincali will then assist ALDA in coordinating the clinical trials that are
required for EU, US and Canadian registration of ALDA's therapeutic
products.
Therapeutic Products
The patent-pending 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 extended and highly expensive clinical trials that are
associated with drugs taken internally do not apply to the products planned
by ALDA. Global markets for the products described below have been
estimated to exceed $10 Billion per year.
Clinical testing - Studies are in progress at a US certified lab that will
allow T36(R) therapeutic products to be registered in Canada, the EU and
the US are in progress. Positive results for bacteria and fungi were
disclosed by the Company in news releases dated January 25, 2008 and
January 30, 2008, respectively. It was observed in these tests that the
T36(R) formulation killed all of the bacteria, including antibiotic
resistant stains of MRSA and VRE (both serious bacterial infections with
few treatments available), within 30 seconds, and Candida albicans, the
organism responsible for yeast infections, within 5 minutes. For both the
bacteria and C. albicans, the T36(R) formulation was completely effective
within the shortest time tested under the FDA testing protocols. Based on
these positive results, the Company is moving forward to start testing the
T36(R) formulation against the organisms responsible for Athlete's Foot so
that a product for treating this condition can enter into human testing as
soon as possible.
On completion of this first round of tests, the Company will be approaching
Health Canada and the European Medicines Agency ("EMeA") with the test
results and the toxicology studies for the T36(R) formulation. If the
toxicology studies are deemed to be satisfactory by these agencies, human
clinical trials can be started using the protocols that have been prepared
for the Company by Bioscience Laboratories Inc.
For the US, a pre-IND ("Investigational New Drug") meeting will be
scheduled with the FDA and all of the results obtained by the Company to
date will be presented. This meeting will determine if any additional
studies are required by the FDA. It is known that other laboratory tests
and certain animal studies are required by the FDA before human trials can
begin. The objective is to be able to use the data from the human trials to
be conducted for the EU and Canada for the FDA submissions once the
additional preliminary tests required by the FDA are completed.
T36(R) "Complete" Hand Sanitizer - The T36(R) formulation in gel form can
be used in hospitals as a superior hand antiseptic in nursing stations,
patient rooms, hallways, washrooms, etc. to completely kill all bacteria,
fungi and viruses, including resistant infectious organisms such as MRSA
and VRE. The T36(R) formulation is many times more powerful than the
leading hand sanitizers and it will also be marketed to consumers under the
new identity that has been established by ALDA's marketing team.
Registration of an interim product, a superior hand rub, is in progress, as
discussed above. Although the registration had been expected within 60
days, some delays have been encountered. These delays do not reflect on the
validity of the product or the application, but are internal matters
encountered at Health Canada.
T36(R) Antiseptic - The T36(R) formulation, both with and without a
biological dye, will be registered for use as pre-operative and
pre-injection antiseptic in hospitals and clinics. Studies for the US, the
EU and Canada have started. The bacterial and fungal testing discussed
above will also be used in the registration of this product.
T36(R) First-Aid Ointment and Topical Treatment - The T36(R) formulation in
a spray and in ointment form can be used on cuts, scrapes, insect bites,
topical infections and other conditions that require a safe and effective
anti-microbial treatment. The bacterial and fungal testing discussed above
will also be used for the registration of this product. One of the first
indications intended for this formulation is a treatment for Athlete's Foot
mentioned above.
T36(R) Vulvo-Vaginitis ("VVI") Treatment - Yeast infections account for
only one-third of all vulvovaginal infections, yet most products are only
effective against yeast. The T36(R) formulation can be used for treatment
of all vulvovaginal infections including yeast, bacteria, parasitic and
combinations of all infectious organisms. Studies for the registration of
this product will be started on closing of additional funding.
T36(R) Microbicidal Gel - A diluted form of the VVI Treatment has been
developed as a personal lubricant to prevent Sexually Transmitted
Infections ("STI's"). This product was introduced to the attendees of the
4th Canadian Microbicides Symposium that took place on January 28, 2008, in
Ottawa. The event was attended by a select group of approximately 40
invitees from government departments, research organizations, the private
sector and community organizations. The goal of the symposium was to
implement the Canadian Microbicide Action Plan (CMAP), which is a
commitment from Canada to contribute to microbicides both domestically and
internationally, with an emphasis on the urgent need for improved products.
The AIDS epidemic is in its third decade and it is now very evident that
the scale of the AIDS crisis outstrips even the worst case scenarios of a
decade ago. Since 1981, 25 million people have died of AIDS worldwide. The
CMAP is an important initiative because, globally, it is estimated that
33.2 million people are now infected with HIV or have AIDS with 6,800 new
cases being reported every day. A round table discussion at this conference
on the current status of microbicide research revealed that no microbicidal
products available to date have proven to be effective against the spread
of HIV and AIDS, a conclusion that is supported by statements from the
World Health Organization.
After participating in the symposium, the ALDA team met with Senator Celine
Hervieux-Payette and the Hon. Robert Thibault, Member of Parliament. In
these meetings, discussions took place about Canada's position domestically
and on the global stage of HIV and AIDS prevention and how ALDA might
contribute to this effort. A meeting was also held with Health Canada to
determine the best path to follow to obtain regulatory approval of T36(R)
Microbicide.
By attending and participating in the symposium and the subsequent
meetings, the Company found support for continuing its investigation of
T36(R) Microbicide as a means of preventing the spread of HIV and AIDS. Dr.
Brian Conway, who is a member of ALDA's Scientific Advisory Board and is
also Co-Chair of The Ministerial Advisory Council on the Federal Initiative
to Address HIV/AIDS in Canada, has agreed to assist the Company with the
design and completion of preliminary clinical trials.
Commercial Products
As announced by the Company on November 1, 2005, ALDA received Drug
Identification Number ("DIN") 02272989 from Health Canada for T36(R) "Ready
to Use" Disinfectant Cleaner which is a safe, non-corrosive, disinfecting
cleaner suitable for industrial, commercial, institutional and consumer
use. In addition to its use in a wipe for retail markets, this product and
T36(R) Disinfectant Wipes will be introduced to commercial customers
through the distributors that currently sell the Company's products.
As announced by the Company on March 16, 2006, DIN 02278820 was received
for T36(R) Disinfectant Cleaner CONCENTRATE. This product is safer than
competing products and is expected to be very price competitive. It is
intended for use on large areas, such as floors and walls that need to be
cleaned and disinfected. The Concentrate will be suitable for use in
institutions, commercial establishments, cruise ship lines and domestic
use. Manufacturing of this product is being arranged and if it sells well
in Canada, EPA registration in the US will be investigated.
Patents
Progress has been made on the protection of the Company's intellectual
property as described below.
China - Chinese Patent Number ZL02829642.7 has been issued by the State
Intellectual Property Office of the People's Republic of China. The patent
provides protection for the composition and production methods for ALDA's
T36(R) formulation until August 20, 2022 which is 20 years from the date of
filing the original patent application.
Australia - Australian Patent Number 2002322916 has been issued by the
Australia Patent Office. The patent provides protection for the composition
and production methods for ALDA's T36(R) formulation, also for 20 years
until August 20, 2022.
United States - The United States Patent and Trademark Office ("USPTO") has
provided ALDA with an "Issue Notification" stating that US Patent
Application No. 10/525,110 is projected to be issued on March 4, 2008 as
U.S. Patent No. 7,338,927. The patent provides protection for the
composition and production methods for ALDA's T36(R) formulation.
Europe - The Company will be filing additional information with the
European Patent Office. Once this is completed, it is anticipated that the
European patent will be issued in due course since the patents have been
granted in the US, China and Australia with no significant modifications
required to the claims.
Singapore - A Request for Examination was submitted to the Intellectual
Property Office of Singapore on May 18, 2007.
Canada - A Request for Examination was submitted to the Canadian
Intellectual Property Office on September 19, 2007. An accelerated Request
for Examination will be submitted so that this review is completed in
months rather than years.
The issued patents are the result of more than 5 years of effort and are
important assets of the Company. The original patent application was filed
with the European Patent Office ("EPO") under the Patent Cooperation Treaty
("PCT") on August 20, 2002. The PCT application was reviewed and accepted
by the EPO in April, 2004. The PCT application was then submitted to the
intellectual property office of each separate country and the EU for
"national review" and examined again. Each patent office asked its own
questions, requested its own modifications and required its own response. 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. Often, companies like ALDA have an
opportunity to sell rights to technologies, like the T36(R) formulation,
and having a patent in place is important validation of the technology.
The Company is also in the process of preparing new patent applications and
seeking expanded claims for the original patent.
Foreign securities registrations
As announced in a news release dated September 13, 2007, ALDA is continuing
its work towards registration of its securities and reporting in the US and
has appointed HLB Cinnamon Jang Willoughby, Chartered Accountants as its
auditors so that the financial statements will continue to be prepared and
audited in accordance with US requirements. As announced in a subsequent
news release dated October 2, 2007, the company retained the services of
Stanislaw Ashbaugh, LLP, located in Seattle, Washington, to assist the
Company with US securities law. In March 2006, the Company had completed
the filing of its initial 20-F registration statement, dated June 30, 2005
with the SEC in the US but then management let the matter rest while
contemplating foreign registration strategies for ALDA. A new filing, dated
June 30, 2006, is nearing completion and should be filed with the SEC
fairly soon. After that, the SEC responds within 30 days with questions,
comments and requests for further information. In the meantime, US
residents can purchase ALDA shares through US brokers who can place orders
with Canadian brokers. The Company trades in the US under the symbol
"APCSF". The Company is still contemplating the possibility of obtaining a
Frankfurt listing but no decision has been made yet on whether or not to
proceed.
Summary
It has been a busy few months at ALDA with the completion of a private
placement just before the end of the year, selection of new identities for
both the retail and commercial application of the T36(R) formulation,
seeing new supporters coming into the market leading to a substantial
increase in the price and liquidity of the Company's shares, issuance of
patents in Australia, China and the US, progress on new and expanded
patents, clinical testing, accelerated regulatory plans and the US
registration of the Company's securities. As we proceed toward the 2008
fiscal year end, the initiatives described above are expected to generate
new interest in the company both in Canada and abroad.
I also offer my thanks and gratitude to our dedicated employees, directors
and shareholders who have all helped with the growth and development of
ALDA into a product-based company with great potential.
Sincerely yours,
Terrance G. Owen, Ph.D., M.B.A., President & CEO