-----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, UeOvFlQqpxaZcC1FrnlMmqGFtnQCWQhbzKAZ3DTro8A1oBgf4NOdPYQRrLfNcbS9 eUlk9wWgEibykCPiK67Fmg== 0000891092-03-003402.txt : 20031119 0000891092-03-003402.hdr.sgml : 20031119 20031119111348 ACCESSION NUMBER: 0000891092-03-003402 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031118 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031119 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSGENOMIC INC CENTRAL INDEX KEY: 0001043961 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 911789357 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30975 FILM NUMBER: 031011923 BUSINESS ADDRESS: STREET 1: 12325 EMMET ST CITY: OMAHA STATE: NE ZIP: 68164 BUSINESS PHONE: 4027385480 MAIL ADDRESS: STREET 1: 12325 EMMET STREET CITY: OMAHA STATE: NE ZIP: 68164 8-K 1 e16272_8k.txt FORM 8-K ================================================================================ 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 (Date of earliest event reported): November 18, 2003 TRANSGENOMIC, INC. (Exact name of registrant as specified in its charter) Delaware 000-30975 (State of Formation) (Commission File Number) 911789357 (IRS Employer Identification Number) 12325 Emmet Street Omaha, NE 68164 (Address of principal executive offices) (Zip Code) (402) 452-5400 (Registrants' telephone number, including area code) Not applicable (Former name or former address, if changed since last report) Item 5. Other Events and Regulation FD Disclosure. On November 18, 2003, the Company issued a press release announcing it has signed a contract with Austrian vaccine developer Intercell AG to develop a manufacturing process for production of an immune stimulating oligonucleotide, which will be used as a component of one or more of Intercell's novel vaccine candidates. The Company is attaching the press release as Exhibit 99.1 to this Current Report on Form 8-K. Item 7. Financial Statements and Exhibits. (c) Exhibits 99.1 Press Release, dated November 18, 2003, announcing Transgenomic has signed a contract with Austrian vaccine developer Intercell AG to develop a manufacturing process for production of an immune stimulating oligonucleotide, which will be used as a component of one or more of Intercell's novel vaccine candidates. 2 SIGNATURE 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 hereunto duly authorized. TRANSGENOMIC, INC. By /s/ Michael J. Draper ------------------------------------------ Michael J. Draper, Chief Financial Officer November 18, 2003 2 EX-99.1 3 e16272ex99_1.txt PRESS RELEASE Exhibit 99.1 Tuesday, November 18, 2003 COMPANY PRESS RELEASE Transgenomic Inc. Selected by Intercell AG to Develop Manufacturing Process for Immune Stimulating Oligonucleotide Partnering with Austrian-based Vaccine Developer to Advance Drug Candidate OMAHA, Neb., Nov. 18, 2003 -- Transgenomic Inc. (Nasdaq:TBIO) announced today that it has signed a contract with Austrian vaccine developer Intercell AG to develop a manufacturing process for production of an immune stimulating oligonucleotide, which will be used as a component of one or more of Intercell's novel vaccine candidates. The contract also calls for the development of analytical methods, investigational new drug supporting studies, stability studies and manufacture of pre-clinical material. The extensive development work and subsequent oligonucleotide manufacture will be done at the Company's facility in Boulder, Colo. Phosphoramidites, the building blocks used to make synthetic nucleic acids, will be supplied by Transgenomic's plant in Glasgow, Scotland. The oligonucleotide under development is one of two synthetic components of Intercell's proprietary adjuvant ("Immunizer"), IC31. Intercell's IC31 constitutes a combination of a synthetic peptide and a synthetic oligonucleotide. When delivered as part of a vaccine formulation, Immunizer IC31 increases vaccine efficacy by stimulating multiple arms of the immune system. IC31 has been shown to stimulate immune responses mediated by both B cells and T cells. "Intercell is the type of customer we had in mind when we began assembling and staffing our nucleic acid synthesis unit in 2002," said Collin D'Silva, Transgenomic CEO. "We offer companies seeking to commercialize nucleic acid-based therapeutic and diagnostic products a comprehensive menu of services, including nucleic acid chemistry R&D, process development, analytical methods development, cGMP manufacturing, quality control and regulatory support." D'Silva added, "These product and service offerings represent a complete solution for support of the transition of a nucleic acid-based drug candidate from bench-scale research to production-scale cGMP manufacturing." Robert Zak, Intercell's head of production and quality, explains that the know-how Transgenomic offers is hard to find. Zak stated, "There is currently a limited pool of industry expertise to take oligonucleotide pharmaceuticals rapidly from R&D into the clinic. With Transgenomic as a partner, companies such as ours can access the needed expertise to develop such substances without having to commit to the significant long-term fixed costs associated with having similar resources within our organization. We feel that Transgenomic has the capability to develop very efficient manufacturing processes that will yield low-cost product." Zak concluded by pointing out another favorable aspect of partnering with Transgenomic: "Transgenomic's manufacturing facilities are capable of producing material in quantities that will see us through each of the clinical stages with our drug candidate." About Transgenomic Transgenomic provides versatile and innovative research tools and related consumable products to the life sciences industry for the synthesis, separation, analysis and purification of nucleic acids and a wide variety of nucleic acid-based specialty chemicals. Through its nucleic acids business segment, Transgenomic provides specialty chemicals, including advanced nucleic acid building blocks and associated reagents, used in applications such as genetic diagnostics and therapeutics. Manufacturing operations include a cGMP facility for the synthesis of oligonucleotides. Transgenomic's biosystems segment offers its WAVE(R) Systems and associated consumables. These systems are specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. WAVE Systems have broad applicability to genetic research and molecular diagnostics. To date there have been approximately one thousand systems installed in over 30 countries around the world. For more information about the innovative genomics research tools developed and marketed by Transgenomic, please visit the Company's Web site at www.transgenomic.com. About Intercell Intercell is a biotechnology company focused on the development of vaccines against infectious diseases and cancer. Intercell's lead products are a therapeutic hepatitis C vaccine, which has entered Phase II clinical testing in November 2002, and a vaccine against Japanese encephalitis, which has successfully undergone a Phase II clinical study. A Phase III clinical study is planned for 2004. The work of Intercell is based on two technological programs: antigen identification and novel adjuvants ("Immunizers"). The constantly growing portfolio of Intercell's proprietary patents and patent applications is flanked by an aggressive in- and out-licensing strategy to strengthen the company's business objectives. For further information on Intercell AG, visit www.intercell.com. Forward-Looking Statement Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to the development of efficient, low-cost manufacturing processes for the manufacture of complex nucleic acid molecules. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's reports to the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, Transgenomic claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release, and Transgenomic undertakes no duty to update this information, including any forward-looking statement, unless required by law. # # # For confirmation of release or further information, please contact: Mitchell L. Murphy Transgenomic, Inc. 402-452-5437 mmurphy@transgenomic.com Robert J. Pogulis, Ph.D. Transgenomic, Inc. 845-782-9617 rpogulis@transgenomic.com -----END PRIVACY-ENHANCED MESSAGE-----