-----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, Ax//3nmWR9juOXrTAktLfiWYB3RyYdeTwv9AMuOjDmP0o/Ybx1tf//Ev20h7LD2a aaIcdSDz6JVZJc5DCihz6w== 0000891554-02-001980.txt : 20020416 0000891554-02-001980.hdr.sgml : 20020416 ACCESSION NUMBER: 0000891554-02-001980 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020405 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020409 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: 1934 Act SEC FILE NUMBER: 000-14656 FILM NUMBER: 02605161 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 d50321_8k.txt CURRENT REPORT 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): April 5, 2002 REPLIGEN CORPORATION (Exact Name of Registrant as Specified in its Charter) DELAWARE 000-14656 04-2729386 (State or Other Jurisdiction of Commission (I.R.S. Employer Incorporation) File Number) Identification No.) 117 Fourth Avenue, Needham, Massachusetts 02494 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (781) 449-9560 No change since last report (Former Name or Former Address, if Changed Since Last Report) Item 5. Other Events. On April 5, 2002, Repligen Corporation announced that the United States Food and Drug Administration (FDA) has granted approval to market SecreFlo(TM) (synthetic porcine secretin), the first synthetic version of the hormone secretin. SecreFlo(TM) has been approved for stimulation of pancreatic secretions. 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 April 5, 2002. 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. REPLIGEN CORPORATION By: /s/ Walter C. Herlihy ------------------------- Name: Walter C. Herlihy Title: President and Chief Executive Officer Date: April 9, 2002 -2- EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press release of the Company dated April 5, 2002. -3- EX-99.1 3 d50321_exh99-1.txt PRESS RELEASE Exhibit 99.1 [LOGO] Repligen Corporation 117 Fourth Avenue Needham, Massachusetts 02494 Telephone: 781-449-9560 Telefax: 781-453-0048 FDA GRANTS APPROVAL TO MARKET SECREFLO(TM) FOR PANCREATIC ASSESSMENT NEEDHAM, Mass., April 5 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN - news) announced today that the United States Food and Drug Administration (FDA) has granted approval to market SecreFlo(TM) (synthetic porcine secretin), the first synthetic version of the hormone secretin. SecreFlo(TM) has been approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, or chronic pancreatitis and stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, a pancreatic tumor which may become cancerous. "We are pleased that the FDA has approved SecreFlo(TM)," stated Walter C. Herlihy, President and CEO of Repligen. "We look forward to providing this important diagnostic tool to the gastroenterology community." About Repligen Corporation Repligen Corporation develops new drugs for debilitating pediatric disorders including autism, immune and metabolic disorders. 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 release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance, management's strategy, plans and objectives for future operations, clinical trials and results and product plans and performance, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward- looking information contained in this press release or with respect to the announcements described herein. Walter C. Herlihy, Ph.D. Isabel Cordova (investors) President and Chief Executive Officer The Trout Group (781) 449-9560, ext. 2000 (212) 477-9007, ext. 13 -----END PRIVACY-ENHANCED MESSAGE-----