-----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, AJYTNA83ihkkm2yJI+azhNC+ob2w/qgkpyEQS3a6+pjZawj1OR0CPIfP35Cd6MHu QzAWb63KgiaPEbPjimsFJA== 0000912057-00-025694.txt : 20000522 0000912057-00-025694.hdr.sgml : 20000522 ACCESSION NUMBER: 0000912057-00-025694 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000509 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000519 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIGEN CORP CENTRAL INDEX KEY: 0000730272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042729386 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-14656 FILM NUMBER: 640604 BUSINESS ADDRESS: STREET 1: 117 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 02494 BUSINESS PHONE: 7814499560 MAIL ADDRESS: STREET 1: 117 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 02494 8-K 1 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): May 9, 2000 Repligen Corporation --------------------- (Exact name of Registrant as specified in its charter) 117 Fourth Avenue, Needham, Massachusetts ----------------------------------------- (Address of principal executive offices) 02494 ----- (Zip Code) (781) 449-9560 --------------- Registrant's telephone number, including area code No change since last report --------------------------- (Former name or address, if changed since last report) Delaware 000-14656 04-2729386 -------- --------- ---------- (State or other jurisdiction of (Commission file (I.R.S. Employer incorporation or organization) number) Identification No.) Item 5. Other Events. - ---------------------- On May 9, 2000, Repligen Corporation (the "Company") entered into an agreement with Tolerance Therapeutics LLC ("Tolerance") pursuant to which Tolerance assigned its rights to a patent application claiming the use of CTLA4-Ig as an immunosuppressive agent. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. - ---------------------------------------------------------------------------- (a) Financial Statements of Business Acquired: None required. (b) Pro Forma Financial Information: None required. (c) Exhibits: --------- Exhibit No. Description ----------- ----------- 99.1 Press release of the Company dated May 18, 2000. 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 thereunto duly authorized. REPLIGEN CORPORATION By: /S/ Walter C. Herlihy -------------------------------- Name: Walter C. Herlihy Title: President and Chief Executive Officer Date: May 19, 2000 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press release of the Company dated May 18, 2000. EX-99.1 2 EX-99.1 Exhibit 99.1 REPLIGEN Repligen Corporation 117 Fourth Avenue Needham, Massachusetts 02494 Telephone: 781-449-9560 Telefax: 781-453-0048 CONTACT: WALTER C. HERLIHY, PH.D. JONATHAN FASSBERG (INVESTORS) PRESIDENT AND CHIEF EXECUTIVE OFFICER THE TROUT GROUP (781) 449-9560, EXT. 2000 (212) 477-9007, EXT. 16 REPLIGEN ACQUIRES CTLA4 PATENT RIGHTS FROM TOLERANCE THERAPEUTICS NEEDHAM, MA -- MAY 18, 2000 -- Repligen Corporation (Nasdaq: RGEN) announced today that it has acquired rights to a U.S. patent application broadly claiming the use of CTLA4-Ig in immune-based diseases and organ transplantation. The rights were acquired from Tolerance Therapeutics, LLC, a company formed by Dr. Jefferey Bluestone, a named inventor on the application. Dr. Bluestone was the first investigator to demonstrate that CTLA4-Ig was effective in an animal model of disease. In a seminal paper published in SCIENCE in 1992 (v. 257, pp. 789-792) Bluestone transplanted insulin-producing cells from healthy mice into diabetic mice and monitored their ability to control blood sugar. Untreated mice rejected the transplant within one week; however, mice treated with CTLA4-Ig for two weeks showed no sign of rejection even after the CTLA4-Ig treatment was discontinued. These data demonstrated for the first time that CTLA4-Ig has the potential to be used as an immunosuppresive drug and that it may induce tolerance - maintenance of the immune suppression after withdrawal of the drug. Following these initial observations, CTLA4-Ig has been shown by numerous research groups to have activity in animal models of solid organ transplantation (heart and kidney), bone marrow transplantation and autoimmune diseases such as lupus and multiple sclerosis. In 1999 Repligen announced the results of a Phase 1 clinical trial in which CTLA4-Ig was shown to block rejection (Graft versus Host Disease) in bone marrow transplantation. "This acquisition strengthens our CTLA4-Ig patent position," said Walter C. Herlihy, Ph.D., President and CEO of Repligen. "CTLA4 is acknowledged as a key mediator of the immune response and may be capable of inducing tolerance, a long sought goal not possible with current immuosuppressive agents. We are currently planning expanded testing of CTLA4-Ig in Phase 2 clinical trials." CTLA4-Ig is a derivative of a natural immune cell protein (CTLA4), which is capable of blocking immune responses. A key characteristic which distinguishes CTLA4-Ig from other approaches to immune suppression is its ability to induce tolerance to specific immune responses. Induction of tolerance may allow for the treatment of immune disorders without globally compromising the ability of the immune system to mount a response to an infection. Additional inventors named on this patent application include scientists from Bristol-Myers Squibb Corporation (BMS). If a patent is issued, it will be jointly owned by Repligen and BMS and both parties will have unrestricted rights to practice the invention without obligation to the other. Repligen Corporation develops new drugs for autism, organ transplant and cancer. Repligen also manufactures and markets a set of patented products based on Protein A, which are used by the pharmaceutical industry to produce therapeutic antibodies. Its corporate headquarters are located at 117 Fourth Avenue, Needham MA, 02494. Additional information may be requested from www.repligen.com. This press release contains forward-looking statements based on current management expectations. There are certain key factors which could cause future results to differ materially from those anticipated by management. Such factors include, but are not limited to: uncertainty in the realization of future revenues, the uncertain timeline for clinical activity, results of pending or future clinical trials, the Company's ability to continue to establish collaborative arrangements with third parties, the Company's ability to maintain financial stability, the technical risks associated with development and manufacture of clinical products, the fact that there can be no assurances that patents relating to the Company's potential products will afford adequate protection to the Company, the risks of technological change and competition, and the competitive environment of the biotechnology and pharmaceutical industries. These factors are more fully discussed in the Company's periodic filings with the Securities and Exchange Commission. ### -----END PRIVACY-ENHANCED MESSAGE-----