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) July 25, 2002 (July 24, 2002) ------------- REGENERON PHARMACEUTICALS, INC. ------------------------------------------ (Exact name of registrant as specified in its charter) NEW YORK 0-19034 No.13-3444607 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NY 10591-6707 - ------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (914) 347-7000 --------------- NOT APPLICABLE --------------- (Former name or former address, if changed since last report) Page 1 of 9
INFORMATION TO BE INCLUDED IN REPORT - ------------------------------------ Item 5. OTHER EVENTS. ------------- On July 24, 2002 and July 25, 2002, the Company issued press releases, copies of which are included as exhibits to this filing. Item 7. FINANCIAL STATEMENTS AND EXHIBITS. ---------------------------------- (c) Exhibits 99(a) Press Release dated July 24, 2002. 99(b) Press Release dated July 25, 2002. -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 thereunto duly authorized. REGENERON PHARMACEUTICALS, INC. ------------------------------- By: /s/ Stuart Kolinski Stuart Kolinski Vice President & General Counsel Date: July 25, 2002 ------------- -3-
EXHIBIT 99(a) ------------- FOR IMMEDIATE RELEASE REGENERON INITIATES PHASE II CLINICAL TRIAL OF IL1 TRAP IN PATIENTS WITH RHEUMATOID ARTHRITIS Lead Compound in Regeneron's Custom-designed Trap Program Advances in Clinic Tarrytown, NY - July 24, 2002 - Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that it has initiated a dose-ranging Phase II trial to study the safety and efficacy of the Interleukin-1 (IL1) Trap in patients with rheumatoid arthritis (RA). The multi-center Phase II trial is a randomized, placebo-controlled, double-blind study in patients with active RA, who have had an inadequate response to at least one disease-modifying anti-rheumatic medicine. The study will involve approximately 200 participants, who will be randomized equally into placebo or one of three fixed-dose groups (25, 50, or 100 milligrams) to receive self-administered, weekly subcutaneous injections. The double-blind treatment period will be 12 weeks, and participants will also be evaluated for 10 weeks following treatment. The American College of Rheumatology (ACR20) criteria for improvement in RA as a function of IL1Trap dose will be the primary end-point. "Despite the recent advances in the treatment of rheumatoid arthritis, there is still a major need for new treatment options for patients suffering from this disease," noted Leonard S. Schleifer, M.D., Ph.D., Regeneron's President and Chief Executive Officer. "The IL1 Trap is a highly potent blocker of Interleukin-1 that works through a new mechanism of action. The advancement of this molecule into Phase II is an important milestone for our research program that uses a
thorough understanding of disease biology to validate pharmaceutical targets and discover novel therapeutic candidates for development." "The IL1 Trap is the leading candidate in our proprietary Trap program and is an excellent example of the therapeutic potential of these custom-designed molecules," noted Neil Stahl, Ph.D., Senior Vice President of Preclinical Development and Biomolecular Science. "With this cornerstone of our Trap franchise entering Phase II testing, we are extremely excited about the potential of building a premier pipeline of internally derived product candidates based on our Trap technology." ABOUT REGENERON Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, and cancer, and has preclinical programs in asthma, allergies, and other diseases and disorders. Regeneron's platform technologies include Targeted GenomicsTM, FunctionomicsTM, and Designer Protein TherapeuticsTM. THIS NEWS RELEASE DISCUSSES HISTORICAL INFORMATION AND INCLUDES FORWARD-LOOKING STATEMENTS ABOUT REGENERON AND ITS PRODUCTS, PROGRAMS, FINANCES, AND BUSINESS, ALL OF WHICH INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES, SUCH AS RISKS ASSOCIATED WITH PRECLINICAL AND CLINICAL DEVELOPMENT OF DRUGS AND BIOLOGICS, DETERMINATIONS BY REGULATORY AND ADMINISTRATIVE GOVERNMENTAL AUTHORITIES, COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENTS, THE AVAILABILITY AND COST OF CAPITAL, THE COSTS OF DEVELOPING, PRODUCING, AND SELLING PRODUCTS, THE POTENTIAL FOR ANY COLLABORATION AGREEMENT TO BE CANCELED OR TO TERMINATE WITHOUT ANY PRODUCT SUCCESS, AND OTHER MATERIAL RISKS. A MORE COMPLETE DESCRIPTION OF THESE RISKS CAN BE FOUND IN REGENERON'S FILINGS WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION, INCLUDING ITS FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2001 AND THE FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2002.
REGENERON DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE PUBLICLY ANY FORWARD-LOOKING STATEMENT, WHETHER AS A RESULT OF NEW INFORMATION, FUTURE EVENTS, OR OTHERWISE, UNLESS REQUIRED BY LAW. ### Investor Relations Contact: Charles Poole Vice President, Investor Relations Regeneron Pharmaceuticals, Inc. charles.poole@regn.com (914) 345-7641 Media Contact: Jeanne Abi-Nader Vice President Robinson, Lerer, Montgomery jabi-nader@rlmnet.com (212) 484-7954 Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regn.com. Fax copies of news releases can be obtained from Regeneron's News-on-Demand Service by dialing (800) 311-0841.
EXHIBIT 99(b) FOR IMMEDIATE RELEASE REGENERON COMPLETES ENROLLMENT OF PHASE III STUDIES FOR SHORT-TERM TREATMENT REGIMENS WITH AXOKINE(R) FOR OBESITY STUDIES WILL MEASURE SHORTER DOSING PERIODS AND SUBJECTS' ABILITY TO MAINTAIN WEIGHT LOSS WITHOUT RAPID WEIGHT GAIN FOLLOWING CESSATION OF TREATMENT Tarrytown, NY (July 25, 2002) - Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today that it has completed enrollment for two additional studies within its Phase III clinical development program of AXOKINE for the treatment of obesity. The trials are designed to study maintenance of weight loss following short-term treatment regimens with AXOKINE. "Full enrollment of these studies marks another important milestone in the development of AXOKINE," said Hans-Peter Guler, M.D., Regeneron's Vice President, Clinical Sciences. "In our Phase II trial, subjects treated with AXOKINE for three months experienced, on average, statistically significant weight loss that was not followed by the rapid rebound weight gain often associated with weight loss programs. These new studies are designed to confirm these earlier results." Commenting on the overall Phase III program, Dr. Guler said, "We have now enrolled more than 2,600 participants in four separate studies and plan to initiate additional specialized and confirmatory studies later this year. In our pivotal trial, which enrolled nearly 2,000 patients, the average time on study
exceeds eight months. The final patient in the pivotal trial will complete 12 months of treatment early next year, and we expect to have weight loss data in the spring of 2003." THE SHORT-TERM TREATMENT STUDIES The randomized, double-blind, short-term treatment studies will assess the safety and efficacy of AXOKINE compared with placebo in two different dosing periods. Participants in the first study are being given AXOKINE or placebo for 6 months and will then be observed for another 6 months off-treatment. The companion study is treating subjects with AXOKINE or placebo for 3 months and will observe them for an additional 9 months off-treatment. The primary end-point of these studies is weight loss at the end of 12 months. The trials, running concurrently and each with about 300 subjects, are being conducted at approximately 20 study sites within the U.S. At the end of the initial 12-month treatment and observation periods of the two studies, participants will receive an additional 6 months of treatment of which 3 months is on AXOKINE and 3 months on placebo. A follow-up evaluation will be made to assess the safety and weight-loss effects of re-treatment with AXOKINE. ABOUT REGENERON Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, and cancer, and has preclinical programs in asthma, allergies, and other diseases and disorders. Regeneron's platform technologies include Targeted Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics(TM).
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of drugs and biologics, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be canceled or to terminate without any product success, and other material risks. A more complete description of these risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2001 and the Form 10-Q for the quarter ended March 31, 2002. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law. ### Investor Relations Contact: Charles Poole Vice President, Investor Relations Regeneron Pharmaceuticals, Inc. charles.poole@regn.com (914) 345-7641 Media Contact: Jeanne Abi-Nader Vice President Robinson, Lerer, Montgomery jabi-nader@rlmnet.com (212) 484-7954 Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regn.com. Fax copies of news releases can be obtained from Regeneron's News-on-Demand Service by dialing (800) 311-0841.