SEC Company Response from UMeWorld Inc. (UMEW) (CIK 0001114936) (UMEW) — Jun 6, 2005
UMeWorld Inc. (UMEW) (CIK 0001114936)
Date: June 6, 2005 · CIK: 0001114936 · Accession: 0001204459-05-000344
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AlphaRx, Inc. - Correspondence - Prepared By TNT Filings Inc.
Securities and Exchange Commission
Washington, D.C., 20549
RE: Comment letter on AlphaRx, Inc., dated May 26, 2005
June 3, 2005
Attention: Mr. Gregory Belliston
Division of Corporation Finance
FAX: (202) 772-9217
TEL: (202) 551-3861
Dear Sir;
Please find our proposed answers or discussion related to the
questions posed to us in your letter of May 26, 2005. If the responses are
deemed adequate, we will reflect same in our 10KSB and refile accordingly.
Answers proposed for inclusion into our 10KSB are seen in bold. Please
contact either of the undersigned to discuss at your convenience.
2. COMPANY OVERVIEW
We are a pharmaceutical company, engaged in
the research, development and marketing of innovative therapeutic products using
advanced drug delivery technologies, which we believe, can be combined with a
broad range of therapeutic products.
In January 2003, we acquired the world-wide exclusive
commercialization rights of VT1, a potential cancer therapeutic compound, from
Select Therapeutics Inc. Given our recent experience with Flexogan™, Indaflex
and our new focus on drug delivery products and plans to evolve into a sales and
marketing organization, we have decided VT1 no longer meets our strategic
objective and the VT1 program has been terminated.
In August 2003, we out licensed Indaflex, our lead pharmaceutical product, to
Industria Farmaceutica Andromaco, S.A. de C.V. ("Andromaco") for
commercialization in Mexico. Subject to the terms of the Agreement, Andromaco
will have the exclusive and non-transferable manufacturing rights and
distribution rights of Indaflex and we will receive 15% royalties of the gross
revenue from future product sales. Furthermore, Andromaco will be responsible
for funding and completing any clinical and regulatory activities in support of
Indaflex marketing registration in Mexico. The Agreement shall be for an initial
term of five (5) years commencing on the effective date, and it shall
automatically be renewed on terms as
provided in the Agreement and shall not be
terminated without cause. In November, 2004, Andromaco received approval from
Mexico Food and Drug Administration to manufacture, market and distribute
Indaflex in Mexico.
We are also attempting to establish other international
licensing and distribution arrangements to generate revenues from our existing
and future proprietary pharmaceutical products.
In August 2003, we delivered our first purchase order of
Flexogan to Loblaws Group, one of the largest mass market retailers in Canada.
This and other orders for our product are initiated via issuance of a purchase
order from our customers. We continue to make progress on Flexogan sales in
Canada.
We intend to use our proprietary drug delivery technologies in
collaborative arrangements with pharmaceutical companies to formulate their
existing commercialized drugs as well as drugs under development by them. By
improving drug efficacy and reducing side effects, we believe our drug delivery
technologies will provide pharmaceutical companies with the opportunity to
enhance the commercial value of their existing products and new drug candidates.
We also intend to develop either independently or jointly certain off-patent and
over-the-counter ("OTC") products utilizing our proprietary drug delivery
technologies.
3. Comment on market size has been eliminated in its entirety.
Ultimately we do intend to target markets for all orally -administered drugs,
but until we become successful in using our delivery system for one drug, it may
be overly aggressive to mention a market of this size.
PRODUCT PIPLELINE Questions 4-6
Our existing table will be replaced by the table and footnotes as well as a
brief description of the products mentioned in the table as seen below
The following is a list of some of our products in the product pipeline:
Brand Name
Application
Delivery
Stage
Route
Pharmaceuticals
2.5% Indaflex
Osteoarthritis
Topical
Phase I completed*
Rifampicin SLN
Tuberculosis
Oral
Preclinical underway **
Gentamicin SLN
Sepsis
Oral
Preclinical underway**
Consumer Health (over-the-counter)
Flexogan
Analgesic
Topical
Market*
CoQ10ER
Nutritional Supplement
Oral
Market*
NuProm
Acne Control
Topical
Preclinical underway**
V-Relief
Anti-fungal
Topical
Preclinical underway**
* Indaflex is approved for sale in Mexico, but must undergo FDA approval for
sale in United States and other countries.
CoQ10ER and Flexogan is approved for sale in Canada.
** Preclinical activities include basic in vitro and in vivo research
attempting to adopt our Bioadhesive Colloidal Dispersion delivery system to the
respective drug while maintaining or improving efficacy and effectiveness of the
active ingredients.
Indaflex is a topical NSAID (Non-Steroidal Anti-inflammatory
Drug) formulation intended to be used in the treatment of arthritis. Indaflex's
active ingredient, Indomethacin, has a long-standing and proven clinical
treatment record. With our enhanced proprietary delivery system, its clinical
effectiveness is thought to be significantly enhanced. Topical Indaflex delivery
is intended to circumvent the significant GI side-effects found with orally
ingested NSAID's. We completed a Phase I human trial for Indaflex in Canada and
are planning to initiate a Phase II human trial in the third quarter of 2005.
Rifampicin SLN is encapsulating Rifampicin, an antibiotic
mainly used to treat tuberculosis, in the Company's colloidal drug delivery
platform for intracellular delivery. This early stage drug candidate is
currently going through in-vitro and in-vivo studies including biodistribution
study, evaluation of the efficacy in murine infection models and toxicological
studies.
Gentamicin SLN is encapsulating Gentamicin, a broad spectrum
antibiotic, in the Company's colloidal drug delivery platform for intracellular
delivery. This early stage drug candidate is currently going through in-vitro
and in-vivo studies including biodistribution study, evaluation of the efficacy
in murine infection models and toxicological studies.
Flexogan is a series of topical pain relief creams available
over-the-counter at major drug chain stores across Canada. Flexogan has a unique
delivery formulation that significantly increases the speed, volume, and
sustained duration of drug penetration through the skin in animal studies.
CoQ10 ER is a novel formulation incorporating the Company's
drug delivery process which completely disperses CoQ10 ER into sub-micron oil
droplets in the GI tract. The average size of these oil droplets is less than
200 nanometers. These oil droplets can easily penetrate the bilayer of human
cells and increase serum Coenzyme Q10 concentration according to one human trail
conducted by the Company.
NuProm is formulated with solubilized Benzoyl Peroxide for
effective delivery to target sites underneath the skin for maximum therapeutic
effect. Undissolved Benzoyl Peroxide powder may not penetrate deep into pores to
kill bacteria and instead merely stays on the skin surface causing severe
dryness and irritation. NuProm is currently going through in-vitro study for
formulation optimization.
V-Relief is the Company's drug candidate for mild fungal
infection treatment. This product is currently going through in-vitro study for
formulation optimization
7. The product is not
currently material to our business and no sales of this product were made during
Fiscal 2004 or fiscal 2005 to date. The product may become material to our
business if a distribution agreement is reached with a third party or if we
decide to actively market the product. It has therefore been added to the table
and a description of the drug is included above.
8. PATENTS, TRADEMARKS AND PROPRIETARY RIGHTS
It is our policy to file patent applications in the United States and certain
foreign jurisdictions.
We currently have one issued United States patent under the title "Toothpaste
comprising bioadhesive submicron emulsion for improved delivery of antibacterial
and anticaries agents" for the use of certain oral care products which has never
been developed. This patent was issued on September 12, 2000 and will expire on
xxx. We also have four United States patent pending applications as follows:
"Vehicle for topical delivery of antiinflammatory compounds" for the use of
Indaflex to increase efficacy of non steroidal antiinflammatory drugs,
"Colloidal solid lipid vehicle for pharmaceutical application" for the use of
Rifampicin SLN and Gentamicin SLN to treat Tuberculosis and other infectious
diseases, "Topical composition for acne treatment" and "Stabilization of benzoyl
peroxide in solution" for the use of NuProm to treat acne. We have also applied
for patents in Mexico, Japan and China uder the title "Vehicle for topical
delivery of anti-inflammatory compounds" for the use of Indaflex to increase
efficacy of non steroidal anti-inflammatory drugs which are still pending.
No assurance can be given that our patent applications will be approved or that
any issued patents will provide competitive advantages for the BCD System or our
technologies or will not be challenged or circumvented by competitors. With
respect to any patents which may be issued from our applications, there can be
no assurance that claims allowed will be sufficient to protect our technologies.
Patent applications in the United States are maintained in secrecy until a
patent issues and we cannot be certain that others have not filed patent
applications for technology covered by our pending applications or that we were
the first to file patent applications for such technology. Competitors may have
filed applications for, or may have received patents and may obtain additional
patents and proprietary rights relating to, compounds or processes that may
block our patent rights or compete without infringing our patent rights. In
addition, there can be no assurance that any patents issued to us will not be
challenged, invalidated or circumvented, or that the rights granted thereunder
will provide proprietary protection or commercial advantage to us.
We also rely on trade secrets and proprietary know-how which it seeks to
protect, in part, through confidentiality agreements with employees,
consultants, collaborative partners and others. There can be no assurance that
these agreements will not be breached, that we will have adequate remedies for
any such breach or that our trade secrets will not otherwise become known or be
independently developed by competitors. Although potential collaborative
partners, research partners and consultants are not given access to our
proprietary trade secrets and know-how until they have executed confidentiality
agreements, these agreements may be breached by the other party thereto or may
otherwise be of limited effectiveness or enforceability.
9. MANUFACTURING, MARKETING AND SALES
We do not have and do not intend to establish in the foreseeable future
internal manufacturing capabilities. Rather, we intend to use the facilities of
our collaborative partners or those of
contract manufacturers to manufacture products using the BCD Systems. Our
dependence on third parties for the manufacture of products using the BCD
Systems may adversely affect our ability to develop and deliver such products on
a timely and competitive basis. There may not be sufficient manufacturing
capacity available to us when, if ever, it is ready to seek commercial sales of
products using the BCD Systems. In addition, we expect to rely on our
collaborative partners or to develop distributor arrangements to market and sell
products using the BCD Systems. We may not be able to enter into manufacturing,
marketing or sales agreements on reasonable commercial terms, or at all, with
third parties. Failure to do so would have a material adverse effect on us.
Applicable good manufacturing practices ("GMP") requirements and other rules
and regulations prescribed by foreign regulatory authorities will apply to the
manufacture of products using the BCD Systems. We will depend on the
manufacturers of products using the BCD Systems to comply with current good
manufacturing practices ("cGMP") and applicable foreign standards. Any failure
by a manufacturer of products using the BCD Systems to maintain cGMP or comply
with applicable foreign standards could delay or prevent their commercial sale.
This could have a material adverse effect on us.
We rely on Canadian Custom Packaging Inc., Patheon Inc. and Industria
Farmaceutica Andromaco, S.A. de C.V. located in Mexico ("Andromaco") to
manufacture our products.
We have only one written contract with the above mentioned manufacturers -
namely Patheon Inc. Other manufacturing runs commence upon receipt of a purchase
order from us.
10. GOVERNMENT REGULATION
We are subject to regulation under various federal laws regarding
pharmaceutical products and also various Canadian federal and provincial laws
regarding, among other things, occupational safety, environmental protection,
hazardous substance control and product advertising and promotion. In connection
with our research and development activities, AlphaRx is subject to federal,
provincial and local laws, rules, regulations and policies governing the use,
generation, manufacture, storage, air emission, effluent discharge, handling and
disposal of certain materials and wastes. We believe that we have complied with
these laws and regulations in all material respects and we have not been
required to take any action to correct any material non-compliance.
In the United States, pharmaceutical products, including any drugs utilizing
the BCD System, are subject to rigorous regulation by the FDA. If a company
fails to comply with applicable requirements, it may be subject to
administrative or judicially imposed sanctions such as civil penalties, criminal
prosecution of We or our officers and employees, injunctions, product seizure or
detention, product recalls, total or partial suspension of production, FDA
withdrawal of approved applications or FDA refusal to approve pending new drug
applications, premarket approval applications, or supplements to approved
applications.
Prior to commencement of clinical studies involving human beings, preclinical
testing of new pharmaceutical products is generally conducted on animals in the
laboratory to evaluate the potential efficacy and the safety of the product. The
results of these studies are submitted to the FDA as a part of an IND
application, which must become effective before clinical testing in
humans can begin. Typically, clinical evaluation involves a time consuming
and costly three-phase process. In Phase I, clinical trials are conducted with a
small number of subjects to determine the early safety profile and the
pharmacokinetic pattern of a drug. In Phase II, clinical trials are conducted
with groups of patients afflicted with a specific disease in order to determine
preliminary efficacy, optimal dosages and expanded evidence of safety. In Phase
III, large-scale, multi-center, comparative trials are conducted with patients
afflicted with a target disease in order to provide enough data to demonstrate
the efficacy and safety required by the FDA. The FDA closely monitors the
progress of each of the three phases of clinical testing and may at our
discretion, re-evaluate, alter, suspend or terminate the testing based upon the
data which have been accumulated to that point and our assessment of the
risk/benefit ratio to the patient.
The results of the preclinical and clinical testing on drugs are submitted to
the FDA in the form of an NDA for approval prior to commencement of commercial
sales. In responding to an NDA, the FDA may grant marketing approval,