SEC Company Response from UMeWorld Inc. (UMEW) (CIK 0001114936) (UMEW) — Jun 21, 2005
UMeWorld Inc. (UMEW) (CIK 0001114936)
Date: June 21, 2005 · CIK: 0001114936 · Accession: 0001204459-05-000370
AI Filing Summary & Sentiment
Referenced dates: June 17, 2005
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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 June 17, 2005
June 21, 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 June 17, 2005. Answers proposed for inclusion into our
10KSB are seen in bold. Please contact either of the undersigned to
discuss at your convenience.
We will update our 10KSB as well as our SB-2 Post Effective Amendment, and
await your approval on our proposed responses prior to filing same.
Responses below are in the same numerical sequence as your questions posed in
your letter dated June 17, 2005.
General
We are aware that our responses and subsequent 10KSB amendment will also
have to be reflected in our Form SB-2 post-effective amendment. Both documents
will be filed within a few days of receipt of your approval regarding our
responses.
We will also disclose in our amended Form SB-2 post -
effective amendment, the same level of information about the joint venture
with Basin Industrial Limited as was disclosed in our recently filed Form 8K,
filed May 18 and June 6, 2005.
Company Overview, page 3
We will absolutely file the agreement with Andromaco with our
refiling of the 10KSB. No agreement exists with Loblaw Group.
Product Pipeline, page 5
Our response to Product Pipeline question will be enhanced. The
footnote indicated by "**" in our original response will read as follows:
** 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. We anticipate that clinical trials, if they take
place at all, will initially be conducted in Canada, at test sites which are
pre-approved by both Health Canada and FDA.
Government Regulation, page 8
Detailed discussion of the Canadian regulatory structure and
approval process
The wording under this section will be revised as follows: (new wording is in
bold)
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 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 Canada and the United States, the manufacture and sale of pharmaceutical
products is rigorously controlled by the Canadian Health Products and Food
Branch ("HPFB") and the United States Food and Drug Administration ("FDA"),
respectively. The laws of both countries require appropriate manufacturing
facilities and carefully controlled research, manufacturing and testing of
products. Pharmaceutical companies must establish control over manufacturing and
testing of their products, through the use of good manufacturing practices ("GMP")
before being allowed to market their products. The safety and efficacy of a new
product must be demonstrated through clinical trials of the drug carried out
under procedures acceptable to the HPFB and FDA.
In Canada, new in vivo products must pass through a number of testing
stages including pre-clinical testing and clinical trial testing. Pre-clinical
testing usually involves evaluating the product's pharmacokinetics, pharmacology
and toxicology in animals. Successful results (that is, potentially valuable
pharmacological activity combined with an acceptable level of toxicity) can lead
to Investigational New Drug ("IND") status. This enables the manufacturer of the
new product to begin clinical trials on humans.
In order to achieve IND status in Canada, a clinical trial application ("CTA")
must be filed with the HPFB. The submission must contain specified information
including the results of the preclinical tests completed at the time of the
submission together with any available data on testing in humans. In addition,
since the method of manufacture may affect the efficacy and safety of a product,
information on manufacturing methods and standards and the stability of the
substance and dosage form must be presented to enable the HPFB to evaluate
whether the product that may eventually be sold to the public has been shown to
be comparable to that determined to be effective and safe in the clinical
trials. Production methods and quality control procedures must be in place to
ensure that a product meets its specifications for identity and purity and other
parameters for assessing product quality. The submission must also provide
details on the testing that is to be performed, including who will be performing
the testing and where it will be performed.
Once the HPFB clears a CTA, clinical trials can begin. Clinical trials are
generally carried out in three phases. Phase I involves studies to evaluate
safety in humans. The new product is administered to consenting subjects to
determine the safety profile and prevalence of adverse side effects. In many
Phase I studies the effects of dosing and scheduling are also studied. Phases II
and III involve efficacy studies. Phase II trials seek clues to clinical
efficacy, while furthering the safety profile in patients with the condition the
product is intended to treat. In Phase III, controlled clinical trials are
conducted in which the product is administered to a large number of patients who
may receive benefit from the product. In Phase III, the effectiveness of the new
product is usually compared to that of a control or accepted methods of
treatment or best standard of care, in the anticipation that significant
clinical efficacy can be demonstrated. After clearance of the initial CTA
application, the manufacturer has certain reporting responsibilities to the HPFB.
If the clinical studies are successful, the manufacturer submits a New Drug
Submission ("NDS") (referred to in the United States as a New Drug Application
or "NDA" or Biologics Licence Application or "BLA") to the HPFB for marketing
approval. The NDS contains all information pertaining to the proposed claims
about the product's performance including the results of the pre-clinical and
clinical studies. Information about a substance contained in an NDS includes its
proper name, its chemical name, details on its method of manufacturing and
purification and its biological, pharmacological and toxicological properties.
The NDS also gives information about the dosage form of the product including
the quantitative listing of all ingredients used in the formulation, its method
of manufacture, packaging and labelling, the results of stability tests, its
diagnostic or therapeutic claims and side effects as well as details of the
clinical studies to support the safety and efficacy of the product. All aspects
of the NDS are critically reviewed by the HPFB. Where an NDS is found
satisfactory and the manufacturing establishment(s) is found satisfactory a
Notice of Compliance is issued permitting the substance to be sold.
The controls of a new product do not cease once it is on the market. For
example, a manufacturer of a new product must report any new information
received concerning serious side effects, including the failure of the product
to produce desired effects. In
addition, if it is determined to be in the interest of the public health, a
Notice of Compliance for a new product may be suspended and the new product may
be removed from the market.
The requirements for in vivo products outlined for Canada are similar
to those in all major pharmaceutical markets and while the tests carried out for
Canada are likely to be acceptable for all other countries, supplementary
testing may be requested by individual regulatory authorities during their
assessment of any submissions by the Company.
In the United States, a manufacturer must prepare and file an IND submission
with the FDA before testing can begin on humans. An application contains a
variety of information about the products, including the results of previous
animal and human studies, the basic chemistry of the product and manufacturing
information. The submission also provides details on the testing that is to be
performed, including who will be performing the testing and where it will be
performed. As in Canada, human studies are characterized as Phase I, Phase II or
Phase III studies. Phase I studies focus on the safety profile of the product,
Phase II seeks clues as to efficacy, and Phase III seeks to statistically
confirm in larger trials the efficacy of the product.
After acceptance of the initial IND application, the manufacturer has certain
reporting responsibilities to the FDA including the submission of yearly updates
on the product's safety. As the testing progresses into Phases II and III, the
focus shifts to the efficacy of the product and the clinical studies that will
enable the manufacturer to receive FDA approval for the marketing of the
product.
The process of completing clinical testing and obtaining regulatory approval
for a new product is, in general, likely to take a number of years and require
the expenditure of substantial resources. If an application is submitted, there
can be no assurance that the HPFB or FDA will review and approve the marketing
application in a timely manner. Even after initial approval has been obtained,
further studies may be required by an agency to provide additional data or may
be voluntarily conducted to gain approval for the use of a product as a
treatment for clinical indications other than those for which the product was
initially tested. Also, the HPFB and FDA require post-market surveillance
programs to monitor a product's side effects. Results of post-marketing programs
may limit or expand the further marketing of products. It is not possible to
accurately predict the time required for new product approval or the extent of
clinical testing and documentation that may be required by regulatory
authorities. Any delays in obtaining, or failing to obtain, regulatory approvals
would significantly delay the development of markets and the receipt of revenues
from the sale of these products.
In addition to the regulatory product approval framework, pharmaceutical
companies are subject to regulation under provincial, state and federal law,
including requirements regarding occupational safety, laboratory practices, the
use, handling and disposition of radioactive materials, environmental protection
and hazardous substance control, and may be subject to other present and future
local, provincial, state, federal and foreign regulation, including possible
future regulation of the biotechnology field.
Furthermore, even if required FDA approval has been obtained with respect to
a product, foreign regulatory approval of a product must also be obtained prior
to marketing the product internationally. Foreign approval procedures vary from
country to country and the time required for approval may delay or prevent
marketing. In certain instances we or
our collaborative partners may seek approval to market and sell certain of
our products outside of the U.S. before submitting an application for U.S.
approval to the FDA. The regulatory procedures for approval of new
pharmaceutical products vary significantly among foreign countries. The clinical
testing requirements and the time required to obtain foreign regulatory
approvals may differ from that required for FDA approval. Although there is now
a centralized EU approval mechanism in place, each EU country may nonetheless
impose our own procedures and requirements, many of which are time consuming and
expensive, and some EU countries require price approval as part of the
regulatory process. Thus, there can be substantial delays in obtaining required
approval from both the FDA and foreign regulatory authorities after the relevant
applications are filed, and approval in any single country may not be a
meaningful indication that the product will thereafter be approved in another
country.
The foreign regulatory approval process includes all of the risks associated
with obtaining FDA approval set forth above, and approval by the FDA does not
ensure approval by the health authorities of any other country, nor does the
approval by foreign health authorities ensure approval by the FDA.
We presently have a licensed manufacturer and distributor in Mexico - Industria Farmaceutica Andromaco S.A. de C.V. ("Andromaco"). We rely on
Andromaco to complete, maintain and adhere to the required regulatory processes
and procedures needed to manufacture and distribute our product in Mexico.
Andromaco is a large pharmaeceutical manufacturer in Mexico with more than 50
years of experience in manufacture, marketing and distribution of drugs. We will
attempt to complete licensing and distribution arrangements in foreign countries
and in the United States with larger, experienced organizations to ensure that
regulatory processes and country-specific regulations are being observed and
maintained.
Item 6. Management's Discussion and Analysis of Financial Condition and
Results of Operations
General, page 17
We propose to insert the following, more detailed description of our research
and development activities into the general section of the MD&A:
Please refer to the table under Product
Pipeline, Item 1 for the current status of our product research and
development activities. We have one pharmaceutical drug in the clinical trial
stage (Phase 1 completed in March, 2005), and two pharmaceutical drugs in the
preclinical stage. We also have two over the counter topical drugs in the
preclinical stage.
The costs incurred for each of these initiatives to date cannot be readily
determined because (i) there is no clear distinction between initiatives in
order to be able to differentiate between them; (ii) all initiatives have a
common goal and that is to adopt our Bioadhesive Colloidal Dispersion drug
delivery system to the specific drug in order to improve that drug's
effectiveness; and (iii) we do not maintain a time control system to
differentiate research and development activities.
The nature, timing and estimated costs to