-----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, PnlrnIdqaLDCJAS/v4+6UJ4DePGLY5RFyFy4Lg/8zvRDQ/7s2tQb2Yfso3eewJLa nPhDaQBZ9lYSdKyDWoaOKQ== 0000891618-99-003185.txt : 19990719 0000891618-99-003185.hdr.sgml : 19990719 ACCESSION NUMBER: 0000891618-99-003185 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990712 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990716 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: 99665893 BUSINESS ADDRESS: STREET 1: 2033 GATEWAY PLACE STREET 2: SUITE 600 CITY: SAN JOSE STATE: CA ZIP: 95110 BUSINESS PHONE: 4089882500 MAIL ADDRESS: STREET 1: 2033 GATEWAY PLACE STREET 2: SUITE 600 CITY: SAN JOSE STATE: CA ZIP: 95110 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: 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 2 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. 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: 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.) 4 CELTRIX PHARMACEUTICALS, INC. INDEX TO EXHIBITS Exhibit Number Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated July 12, 1999. EX-21 2 PRESS RELEASE DATED JULY 12, 1999 1 [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- 2 "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- -----END PRIVACY-ENHANCED MESSAGE-----