<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: November 12, 1997
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 94-3121462
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
3055 Patrick Henry Drive, Santa Clara, CA 95054-1815 (Address of
principal executive offices and zip code)
Registrant's Telephone Number: (408) 988-2500
<PAGE> 2
ITEM 5. OTHER EVENTS
On November 12, 1997, Celtrix Pharmaceuticals, Inc., a Delaware
corporation (the "Company") announced it has received a key patent from the U.S.
Patent and Trademark Office for the treatment of osteoporosis and tissue repair.
Further details regarding this announcement are contained in the Company's news
release dated November 12, 1997, attached as exhibit hereto and incorporated by
reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) EXHIBITS
Exhibit 21 Celtrix Pharmaceuticals, Inc. News Release dated November 12,
1997.
<PAGE> 3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CELTRIX PHARMACEUTICALS, INC. (Registrant)
Date: November 12, 1997 By: /s/ DONALD D. HUFFMAN
---------------------------------------
Donald D. Huffman
Vice President, Finance & Administration
Chief Financial Officer
(Duly authorized principal financial
and accounting officer.)
<PAGE> 4
CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
Exhibit Number
--------------
Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release
dated November 12, 1997.
<PAGE> 1
[CELTRIX Letterhead]
NEWS RELEASE
CONTACT: David M. Rosen, Ph.D.
Vice President, Research and Development
(408) 988-2500
CELTRIX RECEIVES KEY U.S. PATENT WITH BROAD COVERAGE
FOR THE TREATMENT OF OSTEOPOROSIS AND TISSUE REPAIR
SANTA CLARA, CA -- November 12, 1997 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced today that it has received a patent from the United
States Patent and Trademark Office providing important commercial protection for
the use of SomatoKine(R) in the treatment of osteoporosis. U.S. Patent Number
5,681,818, entitled "Therapeutic Uses of Human Somatomedin Carrier Proteins,"
covers methods for treating osteoporosis and other medical conditions requiring
stimulation of bone and tissue growth.
"Looking ahead, we are very enthusiastic about the potential for
treating severe osteoporosis," said Andreas Sommer, Ph.D., Celtrix's president
and chief executive officer. "An estimated 1.5 million elderly Americans (a
subset of the estimated 24 million Americans affected by osteoporosis) suffer
bone fractures annually as a result of this debilitating disease, often in the
hip. Many become immobile and bedridden leading to high healthcare costs. There
is presently no treatment available to help these patients regain significant
quantities of both lost bone and muscle tissue."
Dr. Sommer added, "While estrogens and other therapies are available for
osteoporosis, these treatments are used primarily to prevent further bone loss
rather than to form new bone. In contrast, we believe that SomatoKine is a
unique agent in that it offers important potential to substantially increase the
patient's bone content, build bone density and, equally important, add lean body
mass (typically muscle). Celtrix intends to establish new corporate partnerships
to advance product development for severe osteoporosis."
The new patent protecting these and other potential clinical
applications brings Celtrix's total to 12 issued or allowed U.S. patents plus 13
families of patent applications related to the composition, production and
methods of use for SomatoKine. In addition, patent protection is being
established by Celtrix in fields of key strategic importance in Europe, Japan
and other countries.
Celtrix is a biopharmaceutical company developing novel therapeutics for
the treatment of seriously debilitating, degenerative conditions primarily
associated with severe trauma, chronic diseases or aging. The company's
development focus is on SomatoKine, a novel IGF-BP3 complex, for use in
regenerating lost muscle, bone and other tissues essential for the patient's
health and quality of life. Ongoing product development programs target acute
traumatic injury, such as hip fracture surgery in the elderly and severe burns.
SomatoKine is currently undergoing Phase II clinical feasibility testing for
these two indications. Other potential indications include severe osteoporosis
and protein wasting diseases associated with cancer, AIDS and other
life-threatening conditions. Through strategic alliances with Celtrix, The Green
Cross Corporation is developing SomatoKine for the treatment of osteoporosis in
Japan, and Genzyme Corporation is developing TGF-beta-2 as part of a
comprehensive approach to tissue repair and the treatment of systemic disease.
-more-
<PAGE> 2
"Celtrix Receives Key U.S. Patent With Broad Coverage For The Treatment of
Osteoporosis and Tissue Repair"
Page 2
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 to enroll a
sufficient number of patients in clinical feasibility studies, as well as future
company research, clinical study results, the regulatory approval process,
competitive products and other factors which are listed form 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.
-end-
