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Filed by Insmed, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
of the Securities Exchange Act of 1934
Subject Company: Insmed, Inc.
Commission File No. 333-30098
On March 14, 2000, Insmed Pharmaceuticals, Inc. issued the following press
release:
For more information, contact:
Michael Baer
Chief Financial Officer
Insmed Pharmaceuticals, Inc.
(804)828-6893
Sophia Twaddell
Fleishman Hillard, Inc.
(312) 751-3738
INSMED PHARMACEUTICALS, INC. SIGNS LETTER OF INTENT
WITH TAISHO PHARMACEUTICAL CO., LTD.
RICHMOND, VA (March 14, 2000) - Insmed Pharmaceuticals, Inc. announced today
that it has signed a letter of intent with Taisho Pharmaceutical Co., Ltd.
regarding development and commercialization rights for Insmed's lead compound,
INS-1, for the treatment of Polycystic Ovary Syndrome (PCOS) and Type 2 diabetes
in Japan and other Asian countries. Insmed will retain all the rights to INS-1
in the rest of the world. The Letter of Intent specifies that Taisho will make
up-front, development, milestone and royalty payments pursuant to a definitive
license agreement to be negotiated between the parties. In addition, Taisho will
make a several million-dollar equity investment in Insmed Pharmaceuticals, Inc.
INS-1 is a low molecular weight oral drug that is believed to be an essential
component of an inositol glycan that activates the key enzymes controlling the
metabolism of glucose in people who are insulin resistant. Approximately 20% of
the population is believed to be insulin resistant. Although frequently
undetected, insulin resistance is implicated as a major cause of PCOS, Type 2
diabetes, and a wide range of serious metabolic disorders. INS-1 is currently in
Phase II clinical trials for the treatment of both PCOS and Type 2 diabetes.
PCOS is the most common female endocrine disorder, affecting up to 6% of
premenopausal women. It is the leading cause of anovulatory infertility in the
U.S. and Japan. Women suffering from this disorder are often overweight, have
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excess facial hair and suffer from menstrual irregularities. They have a
significantly increased risk of developing Type 2 diabetes, coronary artery
disease, and endometrial cancer.
Diabetes is a serious metabolic disorder characterized by the body's inability
to properly use or produce insulin, the principal hormone that regulates glucose
metabolism. More than 20 million people in the in the U.S. and Japan have been
diagnosed with Type 2 diabetes. By 2008, this number is expect to increase to
over 34 million. It is the sixth leading cause of death by disease and the cost
of diabetes management in the U.S. alone is nearly $100 billion annually.
Insmed Pharmaceuticals, Inc. is focused on the development of pharmaceutical
products to treat metabolic and endocrine diseases. Insmed recently announced
that it had entered into a definitive agreement to acquire Celtrix
Pharmaceuticals, a biopharmaceutical company based in San Jose, California.
Celtrix is developing SomatoKine(R), a novel IGF-BP3 (insulin growth factor-1,
binding protein 3) complex for the treatment of a broad range of metabolic
disorders.
Taisho Pharmaceutical Co. Ltd. (President: Akira Uehara), headquartered in
Tokyo, is the leading over-the-counter pharmaceutical company in Japan. It
continues to expand its sales and research, both internally and through
collaborations, in the prescription drug area. In the fiscal year 1999 ended
March 31, Taisho's sales were more than $2.2 billion, with prescription drugs
accounting for 25% of total sales. Taisho is focused on contributing to the
maintenance and improvement of consumer's health by creating and providing
quality drugs, related healthcare products and information services that satisfy
consumers with various lifestyles.
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Statements included within this press release, which are not historical in
nature, constitute forward-looking statements for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995. Such
statements involve risks and uncertainties that could cause actual results to
differ materially from those described herein. Risks and uncertainties include:
product candidates may fail in the clinic or may not be successfully marketed;
lack of financial resources to complete development of clinical candidates; and
competing products.
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The matters discussed throughout these materials filed pursuant to Rule 425
under the Securities Exchange Act of 1933 on March 14, 2000, that are not
historical facts are forward-looking and, accordingly, involve estimates,
projections, goals, forecasts, assumptions and uncertainties that could cause
actual results or outcomes to differ materially from those expressed in the
forward-looking statements.
These forward-looking statements may include, but are not limited to,
future capital expenditures, acquisitions (including the amount and nature of
acquisitions), future revenues, earnings, margins, costs, demand for new
pharmaceutical products, market trends in the pharmaceutical business, inflation
and various economic and business trends. You can identify forward-looking
statements by the use of words such as "expect," "estimate," "project,"
"budget," "forecast," "anticipate," "plan" and similar expressions. Forward-
looking statements include all statements regarding expected financial position,
results of operations, cash flows, dividends, financing plans, business
strategies, operating efficiencies or synergies, budgets, capital and other
expenditures, competitive positions, growth opportunities for existing or
proposed products or services, plans and objectives of management, and markets
for stock of Insmed, Inc., Celtrix and Insmed Pharmaceuticals.
Any forward-looking statement speaks only as of the date on which the
statement was made.
Examples of factors that should be considered with respect to any forward-
looking statements made throughout these materials include, but are not limited
to, the following:
o Legislative and regulatory initiatives that impact the provision of
pharmaceutical products and services;
o Market demand for pharmaceutical products and services, changes in the
economies of areas served by the companies and catastrophic natural
disasters;
o The ability of Celtrix, Insmed Pharmaceuticals, Insmed, Inc., their suppliers
and customers to successfully address Year 2000 readiness issues;
o Unanticipated changes in operating expenses and capital expenditures;
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o General industry trends and the effects of vigorous competition in the
biotechnology, biopharmaceutical and pharmaceutical industries;
o Financial or regulatory accounting principles or policies imposed by the
Financial Accounting Standards Board, the Securities and Exchange Commission
and similar agencies with regulatory oversight;
o Employee workforce factors, including loss or retirement of key executives
and scientists;
o Technological developments resulting in competitive disadvantages and
creating the potential for impairment of existing assets;
o Unexpected costs or difficulties related to the integration of the businesses
of Celtrix and Insmed Pharmaceuticals;
o Regulatory delays or conditions imposed by regulatory bodies in approving the
reorganizations;
o General economic factors including inflation and capital market conditions;
and
o Adverse changes in the securities markets.
These factors are difficult to predict. They also contain uncertainties
that may materially affect actual results, and may be beyond the control of
Celtrix, Insmed Pharmaceuticals or Insmed, Inc. New factors may emerge from
time to time and it is not possible for us to predict new factors, nor can we
assess the effect of any new factors on Celtrix, Insmed Pharmaceuticals or
Insmed, Inc.
These forward-looking statements are found at various places throughout
these materials. We caution you not to place undue reliance on these forward-
looking statements, which speak only as of the date they were made. None of
Celtrix, Insmed Pharmaceuticals or Insmed, Inc. undertakes any obligation to
publicly release any revisions to these forward-looking statements to reflect
events or circumstances after the date of this filing pursuant to Rule 425 or to
reflect the occurrence of unanticipated events.
In connection with the reorganizations of Insmed Pharmaceuticals and
Celtrix into a newly formed holding company, Insmed, Inc., Insmed, Inc. has
filed with the Securities and Exchange Commission (the "SEC") a Registration
Statement on Form S-4 (File No. 333-30098) containing the joint proxy
statement/prospectus of Insmed Pharmaceuticals and Celtrix. Insmed, Inc. will
also be filling an amended Registration Statement on Form S-4 which will contain
the definitive joint proxy statement/prospectus of Insmed Pharmaceuticals and
Celtrix in addition to other relevant documents concerning the reorganizations
with the SEC. WE URGE INVESTORS TO READ THE DEFINITIVE JOINT PROXY
STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE SEC
BECAUSE THEY CONTAIN IMPORTANT INFORMATION. Investors will be able to obtain
the documents free of charge at the SEC's web site, http://www.sec.gov. In
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addition, documents filed by Insmed, Inc. with the SEC can be obtained by
contacting Insmed, Inc. at the following address and telephone number: 800 East
Leigh Street, Richmond, Virginia 23219, Attention: Michael D. Baer, Telephone
(804) 828-6893. Information about Insmed Pharmaceuticals can be obtained by
contacting Insmed Pharmaceuticals at the following address and telephone number:
800 East Leigh Street, Richmond, Virginia 23219, Attention: Michael D. Baer,
Telephone (804) 828-6893. Documents filed with the SEC by Celtrix can be
obtained by contacting Celtrix at the following address and telephone number:
2033 Gateway Place, Suite 600 San Jose, California 95110, Attention: Donald D.
Huffman, Telephone (408) 988-2500. READ THE DEFINITIVE JOINT PROXY
STATEMENT/PROSPECTUS CAREFULLY BEFORE MAKING A DECISION CONCERNING THE
REORGANIZATIONS.
Insmed Pharmaceuticals, its directors, executive officers and certain other
members of management and employees may be soliciting proxies from Insmed
Pharmaceuticals shareholders in connection with the reorganizations.
Information concerning the participants in the solicitation is set forth in the
preliminary joint proxy statement/prospectus included in the Registration
Statement on Form S-4 filed by Insmed, Inc. with the SEC on February 10, 2000.
Celtrix, its directors, executive officers and certain other members of
management and employees may be soliciting proxies from Celtrix stockholders in
connection with the reorganizations. Information concerning the participants in
the solicitation is set forth in the preliminary joint proxy
statement/prospectus included in the Registration Statement on Form S-4 filed by
Insmed, Inc. with the SEC on February 10, 2000.