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Filed by Insmed Incorporated
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 Incorporated
Commission File No. 333-30098
On April 3, 2000, Celtrix Pharmaceuticals, Inc. issued the following press
release:
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
Sophia Twaddell
Fleishman Hillard Inc.
(312) 751-3738
CELTRIX RECEIVES KEY U.S. PATENT TO TREAT DIABETES
San JOSE, CA - April 3, 2000 -- Celtrix Pharmaceuticals, Inc. (Nasdaq: CTRX)
announced today that it has been issued a U.S. patent on the use of
SomatoKine(R)(IGF-I/BP3), its lead product, for the treatment of both type 1 and
type 2 diabetes.
"We are delighted that the United States Patent and Trade Office granted
broad claims in this area, allowing us to protect a substantial business
opportunity," said Andreas Sommer, Ph.D., President and CEO of Celtrix.
"SomatoKine is targeted to improve glycemic control of both type 1 and type 2
diabetic patients who have failed to achieve adequate glycemic control with
insulin therapy and thus are at risk for damaging diabetic complications."
Dr. Sommer added, "We have previously reported statistically significant
Phase IIA data which demonstrated that SomatoKine treatment improved insulin
sensitivity in type 1 diabetics. The average daily insulin requirement of the
patients in this trial decreased by 49% and average daily blood glucose declined
by 23% from the levels attained by conventional insulin therapy. SomatoKine also
reduced total serum cholesterol by 12% and improved glycemic control."
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed by
the hormone insulin-like growth factor-I (IGF-I) and its major regulatory
binding protein (BP3). IGF-I plays multiple roles in diverse biological
processes, including control of blood glucose and preservation and formation of
bone and muscle. BP3 contains biological information important for the body's
natural regulation of IGF-I bioavailability and biodistribution. Administration
of SomatoKine, the IGF-BP3 complex, establishes a circulating reservoir of IGF-I
that is proving in clinical research to be both safe and effective.
- -more-
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"Celtrix Receives Key U.S. Patent to Treat Diabetes"
Page 2
ABOUT DIABETES
Diabetes is a disease in which the body does not produce or properly use
insulin, a hormone that is needed to convert sugar, starches and other food into
energy. Diabetes affects over 5% of the populations of North America, Europe and
Japan. In the United States alone, the American Diabetes Association estimates
10.3 million people have been diagnosed with the disease, and it is the seventh
leading cause of death.
Diabetes is associated with a number of life-threatening complications
including heart disease and stroke, kidney disease, blindness, nervous disorders
and circulatory problems which can lead to amputations. As a result, it is one
of the most costly health problems in America, with medical expenses related to
treatment of the disease and its complications estimated at $100 billion
annually.
THE ACQUISITION OF CELTRIX BY INSMED
Celtrix announced in December 1999 that it had entered into a definitive
agreement to be acquired by Insmed Pharmaceuticals, Inc., of Richmond, Virginia.
Insmed Pharmaceuticals is a biopharmaceutical company developing drugs to treat
serious metabolic diseases and disorders. Upon completion of the acquisition,
Insmed, Inc., a holding company recently formed by Insmed Pharmaceuticals, will
become a public company. The combined company's product portfolio will include
two drug candidates in advanced clinical trials for the treatment of types 1 and
2 diabetes, severe osteoporosis and polycystic ovary syndrome.
Celtrix is a biopharmaceutical company developing novel therapeutics for a
broad range of metabolic disorders. The company's focus is on SomatoKine, a
novel IGF-BP3 complex. Celtrix has completed Phase IIA clinical trials for the
treatment of diabetes, severe osteoporosis (recovery from hip fracture) and
traumatic burns. Other potential indications include protein wasting diseases
associated with cancer, AIDS, advanced kidney failure and other life-threatening
conditions.
This news release contains certain forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as amended.
Actual results may differ materially from the statements made, as a result of
various factors, including risks associated with the ability of the company to
complete the merger with Insmed, and that future trials in diabetes will
continue to show the same observations, including any statistically relevant
results in larger Phase II or Phase III trials, as well as risks associated with
future research, the regulatory approval process, competitive products and other
factors which are listed from time to time in Celtrix's Securities and Exchange
Commission (SEC) filings. These forward-looking statements represent Celtrix's
judgment as of the date of this news release.
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The matters discussed throughout these materials filed pursuant to Rule 425
under the Securities Exchange Act of 1933 on April 7, 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 Incorporated, 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
Incorporated, their suppliers and customers to successfully
address Year 2000 readiness issues;
o Unanticipated changes in operating expenses and capital
expenditures;
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;
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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 Incorporated 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 Incorporated
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 Incorporated 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 Incorporated, Insmed
Incorporated has filed with the Securities and Exchange Commission (the "SEC") a
Registration Statement on Form S-4, as amended (File No. 333-30098) containing
the preliminary joint proxy statement/prospectus of Insmed Pharmaceuticals and
Celtrix. Insmed Incorporated 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 addition, documents filed by Insmed
Incorporated with the SEC can be obtained by contacting Insmed Incorporated 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 Amendment No. 1 to
the Registration Statement on Form S-4, filed by Insmed Incorporated with the
SEC on March 24, 2000.
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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 Amendment No. 1 to the Registration
Statement on Form S-4, filed by Insmed Incorporated with the SEC on March 24,
2000.
