-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RAf/WrEJD/ugFeo4sx9a7aksPWmZ9g7+0jGSK13raZZcK411ti3uYlt3iAwJvEj9 S3qgNhZXJXM048AsGpOctQ== 0000891618-97-004643.txt : 19971117 0000891618-97-004643.hdr.sgml : 19971117 ACCESSION NUMBER: 0000891618-97-004643 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19971112 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19971114 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELTRIX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000871395 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943121462 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-18976 FILM NUMBER: 97717855 BUSINESS ADDRESS: STREET 1: 3055 PATRICK HENRY DR CITY: SANTA CLARA STATE: CA ZIP: 95054 BUSINESS PHONE: 4089882500 MAIL ADDRESS: STREET 2: 3055 PATRICK HENRY DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 FORMER COMPANY: FORMER CONFORMED NAME: CELTRIX LABORATORIES INC DATE OF NAME CHANGE: 19600201 8-K 1 FORM 8-K 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 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. 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.) 4 CELTRIX PHARMACEUTICALS, INC. INDEX TO EXHIBITS Exhibit Number -------------- Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated November 12, 1997. EX-21 2 PRESS RELEASE DATED NOVEMBER 12, 1997 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- 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- -----END PRIVACY-ENHANCED MESSAGE-----