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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: July 12, 1999
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)
2033 Gateway Place, Suite 600, San Jose, CA 95110
(Address of principal executive offices and zip code)
Registrant's Telephone Number: (408) 988-2500
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ITEM 5. OTHER EVENTS
On July 12, 1999, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced Celtrix's SomatoKine(R) Receives Orphan Drug
Designation from FDA to Treat Severe Burns. Further details regarding this
announcement are contained in the Company's news release dated July 12, 1999,
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 July 12, 1999.
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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: July 12, 1999 By: /s/ DONALD D. HUFFMAN
--------------------------------------------------
Donald D. Huffman
Vice President, Finance & Administration
Chief Financial Officer
(Duly authorized principal financial and
accounting officer.)
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CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
Exhibit Number
Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release
dated July 12, 1999.
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[CELTRIX LETTERHEAD]
EXHIBIT 21
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
CELTRIX'S SOMATOKINE(R) RECEIVES ORPHAN DRUG DESIGNATION FROM FDA TO TREAT
SEVERE BURNS
SAN JOSE, CA -- July 12, 1999 -- Celtrix Pharmaceuticals, Inc. (Nasdaq:
CTRX) announced that it has received notification from the Food and Drug
Administration that SomatoKine(R) qualified for orphan designation for the
treatment of major burns that require hospitalization.
Celtrix applied for orphan drug status to the FDA based on the results
of its Phase II trial which treated pediatric and adult patients with severe
acute burns covering 20 to 90 percent of their body surface area. The results
demonstrated significant beneficial effects of SomatoKine treatment on reducing
protein wasting (catabolism) in severely burned patients. Treatment also showed
positive effects on the immune system and on heart function.
"The data obtained from the treatment of 60 severely burned patients
with SomatoKine indicate substantial improvement in restoring the balance
between protein synthesis and degradation, a prerequisite for accelerated tissue
repair and reduced hospital stay," said Andreas Sommer, Ph.D., Celtrix's
president and chief executive officer. "These results also demonstrate the
potential effect of SomatoKine in the treatment of serious medical conditions
associated with muscle and weight loss such as observed in cancer cachexia, AIDS
wasting and advanced kidney failure. "
Principal investigator of the trial, David N. Herndon, M.D., Director of
Burns Services of the University of Texas Medical Branch in Galveston and Chief
of Staff of the Shriners Burns Institute commented, "Based on these results, we
believe that SomatoKine may be efficacious in attenuating the protein wasting
response to burns, and holds significant promise to shorten the recovery of
these patients from burn trauma. What is particularly exciting about these
results is the fact that SomatoKine can attenuate the adverse catabolic response
to injury without side effects."
-more-
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"Celtrix's SomatoKine(R) Receives Orphan Drug Designation from FDA to Treat
Severe Burns"
Page 2
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed
by the anabolic hormone insulin-like growth factor-I (IGF-I) and its major
binding protein (BP3). IGF-I is an important anabolic hormone responsible for a
broad range of metabolic processes in the body. Following traumatic injury,
blood levels of SomatoKine drop substantially. With the trauma of severe burns,
this drop appears to be associated with imbalances in various biological
processes that may impact the length of time patients spend in a burn trauma
center. Treatment with SomatoKine offers the potential to restore biological
processes that would reduce the risk of complications, accelerate tissue repair,
and shorten the patients hospital stay.
ADDITIONAL INFORMATION
Celtrix is a biopharmaceutical company developing therapeutics for
seriously debilitating, degenerative conditions primarily associated with severe
trauma, chronic diseases or aging. The company's focus is on SomatoKine, the
novel IGF-BP3 complex, for treatment of a broad range of metabolic disorders.
SomatoKine has recently completed a Phase II feasibility trial in severely
osteoporotic patients recovering from hip fracture surgery and Phase II clinical
testing for the treatment of diabetes. Celtrix has also licensed rights for
development of another molecule, TGF-beta-2, to Genzyme Corporation for
incorporation into their comprehensive program for tissue repair. TGF-beta-2 is
currently in Phase II clinical testing for treatment of dermal ulcers.
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
continue clinical trials in severely burned patients and that the results of
this small feasibility study will continue to show the same observations, or
that there will be any statistically relevant results in a larger Phase II or
Phase III trial, as well as risks associated with future research, clinical
study results, 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.
-end-
