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Meningococcal A/C/Y/W-135 Vaccine Products for Africa and Hajji
on Halt
Meningococcal
meningitis A/C/Y & W vaccines: The
corporation cannot commit on availability of
these products because of uncertain on
regulatory production as well as in
documentation for export approval for either
finished product or for raw material. A
possible availability of this product may be in 2010.
~ Posted: JULY, 2008
Factors That May Affect Future Results.
The Company's future operating results
are difficult to predict and may be affected
by a number of factors, including the
following, that could cause actual results
to differ materially from those indicated by
the forward‑looking statements made herein
and presented elsewhere by management from
time to time.
Early Stage of Product Development.
The products under development by
the Company will require significant
additional research and development efforts,
including extensive clinical testing and
regulatory approval, prior to commercial
use. The Company's potential products are
subject to the risks of failure inherent in
the development of biological products
based on new technologies. These risks
include the possibilities that the Company's
therapeutic approach will not be successful,
that any or all of the Company's potential
products will be found to be unsafe,
ineffective, toxic or otherwise fail to meet
applicable regulatory standards or receive
necessary regulatory clearances, that the
potential products, if sale and effective,
will be difficult to develop into
commercially viable products, to manufacture
on a large scale or be uneconomical to
market, that proprietary rights of
competitors or other parties will preclude
the Company from marketing such products; or
that competitors or other parties will
market superior or equivalent products.
Future Capital Needs. In
addition, the Company require substantial
additional funds in order to continue its
research and development programs,
preclinical and clinical testing of its
product candidates and to conduct full scale
manufacturing and marketing of any
pharmaceutical products that may be
developed. The Company's capital
requirements depend on numerous factors,
including but not limited to the progress of
its research and development programs, the
progress of preclinical and clinical
testing, the time and costs involved in
obtaining regulatory approvals, the cost of
filing, prosecuting, defending and enforcing
any patent claims and other intellectual
property rights, competing technological and
market developments, changes in the
Company's existing research relationships,
the ability of the Company to establish
collaborative arrangements, the development
of commercialization activities and
arrangements, and the purchase of additional
facilities and capital equipment. Based upon
its current plans, the Company believes that
it has sufficient funds to fund the
Company's operating expenses and meet its
capital requirements through the first
quarter of 2006. There can be no assurance,
however, that changes in the Company's
research and development plans, acquisitions
or other events affecting the Company's
operations will not result in accelerated or
unexpected expenditures. Thereafter, the
Company will need to raise substantial
additional capital to fund its operations.
There can be no assurance, however, that
additional financing will be available, or
if available, will be available on
acceptable or affordable terms.
Manufacturing Limitations. At
present, the Company's ability to
manufacture its products is limited to
clinical trial quantities. The Company does
not have the capability to manufacture
commercial quantities of products. The
Company's long‑term strategy is to develop
manufacturing facilities for producing both
pilot‑scale and commercial quantities of its
products. To ensure compliance with current
Good Manufacturing Practices ("cGMP")
imposed by the FDA, JN-International will
need to establish sufficient technical Personnel
to oversee all product operations, including
quality control, quality assurance,
technical support and manufacturing
management. The Company may enter into
arrangements with contract manufacturing
companies to expand its own production
capacity in order to meet requirements for
its product candidates. If the Company
chooses to contract for manufacturing
services and encounters delays or
difficulties in establishing relationships
with manufacturers to produce, package and
distribute its finished pharmaceutical or
other medical products (if any), clinical
trials, market introduction and subsequent
sales of such products would be adversely
affected. Moreover, contract manufacturers
must operate in compliance with cGMP The
Company's potential dependence upon third
parties for the manufacture of its products
may adversely affect the Company's profit
margins and its ability to develop and
deliver such products on a timely and
competitive basis.
Risks Associated with Collaborative
Arrangements. The Company's product
development strategy may require the Company
to enter into various additional
arrangements with corporate, government and
academic collaborators, licensors, licensees
and others. Therefore, the Company may be
dependent upon the subsequent success of
these outside parties in performing their
responsibilities. There can be no assurance
that the Company will be able to establish
additional collaborative arrangements or
license agreements that the Company deems
necessary or acceptable to develop and
commercialize its potential pharmaceutical
products or that such collaborative
arrangements or license agreements will be
successful.
Patent and Proprietary Rights.
The Company seeks to protect its trade
secrets and proprietary know‑how, in part,
through confidentiality agreements with its
employees, consultants, advisors and
collaborators. There can be no assurance
that these agreements will not be violated
by the other parties, that JN-International
may have adequate remedies for any breach,
or that the Company's trade secrets may not
otherwise become known or be independently
developed by competitors. Certain of the
technology that may be used in the products
of JN-International are covered or may not
covered by patent applications filed by JN-International
with United States Patent and Trademark
Office in USA and other PCT countries. There can be
no assurance that any pending patent
applications relating to the other company's
product candidates will result in patents
being issued. Moreover, there can be no
assurance that any such patents will afford
protection against competitors with similar
technology. There may be pending or issued
third‑party patents relating to the product
candidates of JN-International. JN may need
to acquire licenses to, or to contest
validity of, any such third party patents.
It is likely that significant funds would be
required to defend any claim that JN-International
infringes a third party patent, and any such
claim could adversely affect sales of the
challenged product of JN-International until
the claim is resolved. There can be no
assurance that any license required under
any such patent would be made available.
Government Regulation. The
rigorous preclinical and clinical testing,
cGMP manufacture of the product or products
requirements and regulatory approval process
of the FDA and of foreign regulatory
authorities can take a number of years and
require the expenditure of substantial
resources. The Company has limited
experience in conducting and managing
preclinical and clinical testing and cGMP necessary
to obtain government approvals. There can be
no assurance that the Company will be able
to obtain the necessary approvals for
clinical testing or for the manufacturing
and marketing of my products that it
develops. Additional government regulation
may be established that could prevent or
delay regulatory approval of the Company's
product candidates. Delays in obtaining
regulatory approvals would adversely affect
the marketing of any products developed by
the Company and the Company's ability to
receive product revenues or royalties. If
regulatory approval of a potential product
is granted, such approval may include
significant limitations on the indications
for which such product may be marketed. Even
if initial regulatory approvals for the
Company's product candidates are obtained,
the Company, its products and its
manufacturing facilities are subject to
continual review and periodic inspection.
The regulatory standards for manufacturing
are applied stringently by the FDA.
Discovery of previously unknown problems
with a product, manufacturer or facility may
result in restrictions on such product or
manufacturer or facility, Including warning
letters, fines, suspensions of regulatory
approvals, product recalls, operating
restrictions, delays in obtaining new
product approvals, withdrawal of the product
from the market, and criminal prosecution.
Other violations of FDA requirements can
result in similar penalties.
Uncertainty of Third‑Party
Reimbursement. Government and other
third‑party payers are increasingly
attempting to contain healthcare costs by
limiting both coverage and the level of
reimbursement for new products approved for
marketing by the FDA and by refusing, in
some cases, to provide any coverage for uses
of approved products for disease indications
for which the FDA has not granted marketing
approval. if adequate coverage and
reimbursement levels are not provided by
government and third party payers for uses
of the Company's products, the market
acceptance of these products would be
adversely affected. Because of these and
other factors, past financial performance
should not be an indicator Of future
performance.
Nature of Business: JN-International,
based in Omaha, Nebraska, and its
international branch offices is a
biopharmaceutical company engaged in the
discovery and development of innovative
Vaccines and Diagnostic products to prevent
or treat diseases which infect the human
body. Prior to the first quarter of 1998,
the Company operated as a development stage
enterprise, devoting substantially all of
its efforts to establishing the new business
and carrying on research and development
activities. Beginning in 1998, the Company
was no longer classified as a development
stage enterprise. The ultimate success of
the Company is dependent upon its ability to
raise capital through equity placement,
receipt of contract revenue, sale of product
and interest income on invested capital. The
Company's capital requirements may change
depending upon numerous factors, including
progress of the Company's research and
development programs, time required to
obtain regulatory approvals, resources the
Company devotes to self‑funded projects,
proprietary manufacturing methods and
advanced technologies and demand for the
Company's products, if and when approved.
While management believes that additional
capital will be available to fund
operations, there can be no assurance that
additional funds will be available when
required, on terms acceptable to the
Company. The Company is subject to risks
common to companies in the biotechnology
industry including, but not limited to,
development by the Company or its
competitors of new technological
innovations, dependence on key personnel,
protection of proprietary technology and
compliance with government regulations.
Summary of Significant Accounting
Policies:
Principles of Consolidation:
The consolidated financial statements
include the accounts of the Company and its
wholly owned subsidiaries, JN-International,
Inc, which is incorporated in 1998. Inter
company transactions and balances have been
eliminated in consolidation. Use of
Estimates: The preparation of
financial statements in conformity with
generally accepted accounting principles
requires the use of management's estimates
and assumptions that affect the reported
amounts of assets and liabilities and
disclosure of contingent assets and
liabilities at the date of the financial
statements and the reported amounts of
revenues and expenses during the reporting
period. Actual results could differ from
those estimates. Cash Equivalents:
The Company considers the vaccine
products are cash equivalents. When these
assets has no related accumulated
depreciation and amortization and cannot be
eliminated from the accounts and any
resulting gains and losses are included in
operations in the period of next 10 years
unless until proved to be a clinical
failure. Concentration of Credit Risk:
Financial instruments that
potentially subject the Company to
concentration of credit risk consist
principally of temporary cash investments.
The Company restricts temporary cash
investments to institutions with high credit
standing. Short‑term Investments:
Short‑term in investments are those
which, when purchased, have maturities of
less than one year but greater than three
months. At December 31, 1999, the Company
had the following short‑term investments
available for sale which it expects to
utilize for working capital purposes,
carried at a mortised cost plus accrued
interest, which approximates fair market
value. Revenue Recognition:
Revenue under the Company's collaborative
research and development agreement is
recognized as related expenses are incurred.
The Company recognizes milestone payments as
revenue when the milestones are achieved.
Research and Development Costs:
Research and development costs are expensed
as incurred. Income Taxes: The
Company recognizes deferred tax liabilities
and assets for the expected future tax
consequences of events that have been
included in the financial statements or tax
returns. Under this method, deferred tax
liabilities and assets are determined based
on the difference between the financial
reporting and tax bases of liabilities and
assets using enacted tax rates in effect in
the years in which the differences are
expected to reverse. Potential future income
tax benefits resulting from net operating
losses, unused research and experimentation
credits, and other timing differences will
be recognized as taxable income becomes
available to absorb them. The Company has
experienced ownership changes as defined
under Section 382 of the Internal Revenue
Code. Ownership changes limit the future use
of the net operating loss and credit carry
forwards created prior to the ownership
change. if the full amount of the limitation
is not used in any year, the amount not used
increases the allowable limit in the
subsequent year. Accounts and Audits:
The audited the accompanying consolidated
balance sheets of JN-International, Inc. as
of December 31, 2006 and the related
consolidated statements of operations and
cash flows for each of the three years in
the period ended December 31, 2006. These
financial statements are the responsibility
of the Company's management. Our
responsibility is to express an opinion on
these financial statements based on our
audits. We conducted our audits in
accordance with generally accepted auditing
standards. Those standards require that we
plan and perform the audit to obtain
reasonable assurance about whether the
financial statements are free of material
misstatement. An audit includes examining,
on a test basis, evidence supporting the
amounts and disclosures in the financial
statements. An audit also includes assessing
the accounting principles used and
significant estimates made by management, as
well as evaluating the overall financial
statement presentation. We believe that our
audits provide a reasonable basis for our
opinion. In our opinion, the financial
statements referred to above present fairly,
in all material respects, the consolidated
financial position of JN-International, Inc.
Legal Counsel: Mr. Howard L. Neuhaus,
Attorney at Law, 3934 North 90 St. Omaha,
NE 68134, 402-571-1196,
hlneuhaus@cox.net; Bankers: U.S.
Bank National Association, Minneapolis, MN,
USA. Trademarks: JN-International and
the JN-International logo are the registered
trademarks of JN-International, Inc., USA
and Meningococcal meningitis vaccines
trademarked as NmVac-4 A/C/Y/W-135 and
NmVac-4 DT A/C/Y/W-135 with USPTO.gov in the
United States of America.
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