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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): October 1, 1999
REPLIGEN CORPORATION
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(Exact name of Registrant as specified in its charter)
117 FOURTH AVENUE, NEEDHAM, MASSACHUSETTS
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(Address of principal executive offices)
02494
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(Zip Code)
(781) 449-9560
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Registrant's telephone number, including area code
NO CHANGE SINCE LAST REPORT
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(Former name or address, if changed since last report)
DELAWARE 000-14656 04-2729386
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(State or other jurisdiction of (Commission file number) (I.R.S. Employer
incorporation or organization) Identification No.)
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ITEM 5. OTHER EVENTS.
On October 1, 1999, Repligen Corporation (the "Company") entered into a
license agreement with ChiRhoClin, Inc. ("CRC") to obtain from CRC the exclusive
rights for two in vivo diagnostic products based on the hormone, secretin.
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:
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<CAPTION>
Exhibit No. Description
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99.1 Press release of the Company dated October 4, 1999.
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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
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Name: Walter C. Herlihy
Title: President and Chief
Executive Officer
Date: October 6, 1999
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EXHIBIT INDEX
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Exhibit No. Description
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<S> <C>
99.1 Press release of the Company dated October 4, 1999.
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Exhibit 99.1
REPLIGEN REPLIGEN CORPORATION
117 Fourth Avenue
Needham, Massachusetts 02494
Telephone: 781-449-9560
Telefax: 781-453-0048
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CONTACT: RELEASE:
IMMEDIATE
Walter C. Herlihy, Ph.D. Brad Miles
President and Chief Executive Officer BMC Communications Group
(781) 449-9560, ext. 2000 (212) 477-9007, ext. 17
REPLIGEN LICENSES SECRETIN DIAGNOSTIC PRODUCTS FROM CHIRHOCLIN
NEW DRUG APPLICATION UNDER REVIEW BY FDA
NEEDHAM, MA -- OCTOBER 4, 1999 -- Repligen Corporation (Nasdaq: RGEN) announced
today that it has acquired exclusive rights for two in vivo diagnostic products
based on the hormone secretin from ChiRhoClin, Inc. Secretin is a peptide
hormone produced naturally by the body to stimulate the pancreas during the
digestion of food and has been used for decades to test pancreatic function and
diagnose gastrinoma. The only secretin diagnostic product approved by the FDA
for sale in the United States is SECRETIN-FERRING -TM-, a natural porcine
version extracted from pig intestines, which the company stopped producing in
1998. Following national publicity in October 1998 about the effects of secretin
in reducing the symptoms of autism in several children, the remaining supply of
SECRETIN-FERRING -TM- was exhausted in the United States.
ChiRhoClin is currently developing two synthetic forms of secretin, one based on
porcine (pig) secretin, and one based on human secretin. Under terms of the
Agreement, Repligen will be responsible for product marketing and distribution
following approval by FDA, and will pay ChiRhoClin an upfront payment,
development milestones and a royalty based on sales. ChiRhoClin will be
responsible for regulatory affairs and manufacturing, and the companies will
work together to develop additional diagnostic applications for secretin.
Pending approval by the FDA, the products will be marketed by Repligen.
"This agreement dramatically accelerates our drive to commercialize secretin and
investigate its potential in other disease areas," commented Walter C. Herlihy,
Ph.D., President and CEO of Repligen. "Pending FDA approval, these products will
be an important step in building a sustainable product revenue base to partially
offset expenses associated with the development of our therapeutic products:
secretin for autism and CTLA4 for organ transplantation."
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A New Drug Application (NDA) for diagnostic applications of synthetic porcine
secretin was filed in May 1999 and is currently under review by the FDA. An NDA
for synthetic human secretin is expected to be filed in early 2000. Synthetic
versions of hormones such as secretin are preferred over the natural versions
extracted from animals because they have higher levels of purity and consistency
and no risk of contamination with animal viruses. In addition to the established
in vivo diagnostic applications, ChiRhoClin is currently evaluating secretin for
prevention of ERCP-induced pancreatitis.
Both versions of synthetic secretin have been granted Orphan Drug status by the
FDA. Under the Orphan Drug law, diagnostic secretin will be available
exclusively from Repligen for a period of seven years from the date the NDA is
approved.
Additional information about secretin and the secretin-autism connection may be
found at www.secretin-repligen.com or at www.repligen.com.
ChiRhoClin, Inc. is a privately held company based in Silver Spring, MD.
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 found at www.repligen.com.
THIS DOCUMENT 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, INCLUDING BUT NOT
LIMITED TO: THE COMPANY'S ABILITY TO MEET ITS WORKING CAPITAL AND FUTURE
LIQUIDITY NEEDS, SUCCESSFULLY IMPLEMENT ITS STRATEGIC GROWTH STRATEGIES,
UNDERSTAND, ANTICIPATE AND RESPOND TO RAPIDLY CHANGING TECHNOLOGIES AND MARKET
TRENDS, DEVELOP, MANUFACTURE AND DELIVER HIGH QUALITY, TECHNOLOGICALLY ADVANCED
PRODUCTS ON A TIMELY BASIS TO WITHSTAND COMPETITION FROM COMPETITORS WHICH MAY
HAVE GREATER FINANCIAL, INFORMATION GATHERING AND MARKETING RESOURCES THAN THE
COMPANY, OBTAIN AND PROTECT LICENSING AND INTELLECTUAL PROPERTY RIGHTS NECESSARY
FOR THE COMPANY'S TECHNOLOGY AND PRODUCT DEVELOPMENT ON TERMS FAVORABLE TO THE
COMPANY, RECRUIT AND RETAIN HIGHLY TALENTED PROFESSIONALS IN A COMPETITIVE JOB
MARKET, REALIZE FUTURE REVENUES, MAINTAIN A TIMELINE FOR CLINICAL ACTIVITY,
OBTAIN SUCCESSFUL RESULTS OF PENDING OR FUTURE CLINICAL TRIALS, CONTINUE TO
ESTABLISH COLLABORATIVE ARRANGEMENTS WITH THIRD PARTIES, AND COMPETE AGAINST THE
BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES. FURTHER INFORMATION ON POTENTIAL
FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS ARE INCLUDED IN
FILINGS MADE BY THE COMPANY FROM TIME TO TIME WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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