-----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, T+ptw9pVhHq8gVuGCgzs2BvudrbwdamBqoFJ+6g9Pou1wtahB6OM7Md2ri6it76f vDJX6pgzlKsvioU2eLz3Tw== 0000903893-97-000008.txt : 19970108 0000903893-97-000008.hdr.sgml : 19970108 ACCESSION NUMBER: 0000903893-97-000008 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19961219 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 19970107 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: INTERNEURON PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000854222 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043047911 STATE OF INCORPORATION: DE FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-18728 FILM NUMBER: 97501744 BUSINESS ADDRESS: STREET 1: ONE LEDGEMONT CENTER STREET 2: 99 HAYDEN AVE CITY: LEXINGTON STATE: MA ZIP: 02173 BUSINESS PHONE: 6178618444 MAIL ADDRESS: STREET 1: ONE LEDGEMONT CENTER STREET 2: 99 HAYDEN AVE CITY: LEXINGTON STATE: MA ZIP: 02173 8-K 1 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 1934 Date of Report: December 19, 1996 INTERNEURON PHARMACEUTICALS, INC. --------------------------------- (Exact name of registrant as specified in charter) DELAWARE -------- (State of other jurisdiction of incorporation) 0-18728 043047911 ------- --------- (Commission File Number) (IRS Employer Identification No.) One Ledgemont Center, 99 Hayden Avenue, Lexington, Massachusetts 02173 - ---------------------------------------------------------------- ----- (Address of principal executive offices) (Zip Code) Registrant's telephone no. including area code: (617) 861-8444 Item 5. Other Events ------------ In December 1996, Intercardia, Inc., a majority-owned subsidiary of the Registrant ("Intercardia"), CPEC, Inc., a majority-owned subsidiary of Intercardia ("CPEC") and Knoll A.G. ("Knoll"), entered into an agreement relating to the development and commercialization of bucindolol for the treatment of congestive heart failure outside the United States and Japan (the "Foreign Territory"). The agreement requires Knoll to make certain payments to CPEC, including $2 million upon execution of the agreement and $1 million in January 1997, as well as future payments contingent upon achieving regulatory and net sales related milestones. Knoll and Intercardia will share the development and marketing costs of bucindolol in the Foreign Territory and CPEC will be entitled to 40% of net profits (and responsible for 40% of net losses) of the product in the Foreign Territory. Knoll has the right to terminate this agreement at any time prior to termination of the BEST Study and within 60 days after the BEST Study's primary end-point results are reported in writing to Knoll. Reference is made to the related press release filed as Exhibit 20.1 hereto, which is incorporated by reference herein. In December 1996, Progenitor, Inc. ("Progenitor"), a majority-owned subsidiary of the Registrant, entered into a license agreement with Amgen, Inc. ("Amgen") granting Amgen certain exclusive rights for the development and commercialization of products using Progenitor's leptin receptor technology. The agreement provides for payment of a $500,000 licensing fee to Progenitor upon execution of the agreement, for Amgen to purchase up to $5.5 million of Progenitor Common Stock in the event of a Progenitor initial public offering meeting specified conditions and for development and regulatory milestone payments to Progenitor, plus potential royalties on product sales. Reference is made to the related press release filed as Exhibit 20.2 hereto, which is incorporated by reference herein. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits ------------------------------------------------------------------ (c) Exhibits 20.1 Press Release dated December 19, 1996 20.2 Press Release dated January 6, 1997 -2- SIGNATURES 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. INTERNEURON PHARMACEUTICALS INC. By: /s/Glenn L. Cooper -------------------------------- Glenn L. Cooper, M.D. President and Chief Executive Officer Dated: January 6, 1997 EX-99.20.1 2 PRESS RELEASE DATED DECEMBER 19, 1996 Exhibit 20.1 Contact: Intercardia: W. Bennett Love 1-919-558-1907 Knoll AG: Monika Enzenbach 49-621-589-2319 For Immediate Release: Intercardia and Knoll Announce Agreement for International Development of Heart Failure Drug Research Triangle Park, N.C., USA, December 19, 1996 -- Intercardia, Inc., (Nasdaq:ITRC) and BASF Pharma/Knoll, AG of Ludwigshafen, Germany, announced today the execution of a binding Agreement for the development and commercialization of bucindolol for the treatment of congestive heart failure (CHF) for areas outside the United States and Japan. The Agreement sets forth the basic terms and conditions upon which Intercardia, CPEC, Inc. and Knoll have completed a definitive License Agreement. CPEC, which owns the rights to bucindolol, is an 80% owned subsidiary of Intercardia. Under the terms of the Agreement, Intercardia/CPEC and Knoll will share development expenses and operating profits for the commercialization of bucindolol worldwide outside of the United States, Puerto Rico and Japan. Additionally, Knoll will make initial payments of $3 million and will make future payments of up to $20 million upon the achievement of product approval and sales milestones. Bucindolol is a non-selective beta-blocker with vasodilating properties in Phase III clinical development for the treatment of congestive heart failure. In Phase II clinical trials, bucindolol produced improvements in left ventricular function and in the signs and symptoms of CHF. Bucindolol is currently being evaluated in the Beta-blocker Evaluation of Survival Trial (BEST), a NIH/VA sponsored Phase III mortality study initiated in June 1995. The BEST study has now enrolled approximately 1,389 CHF patients. Intercardia/CPEC has an agreement for the development and commercialization of bucindolol in the United States with Astra Merck, Inc. Congestive heart failure is a condition in which the heart progressively loses the ability to pump sufficient quantities of blood to meet the metabolic needs of the body. It -1- is estimated that 4.5 million people in Europe and 3.5 million people in the United States are afflicted. CHF is the most common reason for hospitalization in patients over the age of 65 in the U.S. and Europe. "We are pleased to enter into this collaboration with Knoll," stated Clayton I. Duncan, President and CEO of Intercardia and CPEC. "Knoll has a long and distinguished history in developing cardiovascular drugs and is a market leader in Europe, especially with Isoptin(R) (verapamil). They are committed to continuing this successful route into the future as evidenced by the recent launch of the fixed combination of verapamil and the ACE inhibitor trandolapril." "The collaboration with Intercardia gives us access to a new and innovative treatment of the cardiovascular disease congestive heart failure," states Dr. Dirk Wuppermann, Member of the Board of Directors at Knoll AG. "With the beta-blocker bucindolol we are able to complement our existing products portfolio for cardiology with Isoptin(R) (verapamil), Gopten(R)/Mavik(R) (trandolapril) and Tarka(R) (verapamil + trandolapril) for hypertension. Furthermore, with this product we will be among the first entering this new area of non-selective, vasodilating beta-blocker therapy for congestive heart failure. The cooperation concerning bucindolol underlines Knoll's dedication to the cardiovascular area and its future commitment in this indication." Intercardia, a majority-owned subsidiary of Interneuron Pharmaceuticals, Inc. (Nasdaq:IPIC), focuses on late stage discovery and development of therapeutics for the treatment of cardiovascular and pulmonary disease. The Company's strategy is to develop and add value to in-licensed products and sponsored research programs and to enter into collaborations and licensing agreements with corporate partners for final product development, manufacturing and marketing. BASF Pharma researches, develops, manufactures and markets drugs. The main research areas consist of cardiovascular disease, the central nervous system, oncology/immunology and metabolism including antiobesity. Top BASF Pharma sellers include the calcium channel blocker verapamil (trade name Isoptin(R)) and the thyroid drug Synthroid(R) which is sold exclusively in the USA and Canada. Promising future products include sibutramine, a drug to treat obesity and diseases associated with being overweight, Tarka(R), an antihypertensive drug and MAK 195F, a monoclonal anti- TNF antibody for treatment of septic shock. The last of BASF Pharma's four top priority projects is ancrod, a drug for ischemic stroke. Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged in the development and commercialization of a portfolio of products and product candidates primarily for neurological and behavioral disorders. Interneuron's lead products include: Redux(TM) for obesity, currently marketed by American Home Products and co-promoted by Interneuron; citicoline for stroke, in Phase 3 clinical trials; -2- and bucindolol for congestive heart failure, in Phase 3 clinical trials through Intercardia. Interneuron's other subsidiaries include: Progenitor, Inc. focused on gene discovery through developmental biology, Transcell Technologies, Inc. focused on carbohydrate- based drug discovery, and InterNutria, Inc. focused on dietary supplement products. The statements in this press release that are not purely statements of historical fact are forward-looking statements that are subject to factors that could cause the actual results to differ materially from those projected. For more detail regarding these factors, see Intercardia's SEC filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company assumes no obligation to update the information in this release. -3- EX-99.20.2 3 PRESS RELEASE DATED JANUARY 6, 1997 Exhibit 20.2 CONTACTS: For Amgen Media Inquiries: For Progenitor: - -------------------------- --------------- David Kaye Douglass B. Given, M.D., Ph.D. Assoc. Director of Corp. Communications President and Chief Executive Amgen, Inc. Officer Tel: (805) 447-6692 Progenitor, Inc. Tel: (614) 488-6688 For Amgen Investor Relations: For Interneuron: - ----------------------------- ---------------- Ron Renaud William B. Boni Assoc. Manager, Investor Relations Vice President, Corp. Communications FOR IMMEDIATE RELEASE AMGEN AND PROGENITOR SIGN LEPTIN RECEPTOR AGREEMENT Thousand Oaks, CA and Columbus, OH January 6, 1997 -- Amgen Inc. (NASDAQ: AMGN) and Progenitor, Inc., a majority-owned subsidiary of Interneuron Pharmaceuticals, Inc. (NASDAQ: IPIC), announced today that they have entered into a license agreement granting Amgen certain exclusive rights for the development and commercialization of products using Progenitor's leptin receptor technology. The agreement provides for payment of a $500,000 licensing fee to Progenitor, and also for Amgen to purchase $5.5 million of Progenitor Common Stock in the event of a Progenitor public offering. In addition, the agreement provides for development and regulatory milestone payments to Progenitor, which could total $22 million with the successful development and worldwide launch of a first product, plus potential royalties on product sales. Additional milestone and royalty payments could be made to Progenitor related to the development and commercialization of a subsequent product. Under the terms of the agreement, Amgen gains an exclusive worldwide license to develop and commercialize Progenitor's leptin receptor technology for human therapeutic, diagnostic and prophylactic uses. Progenitor retains exclusive rights to the leptin receptor technology for ex vivo ligand screening, small molecule screening and cell sorting. Progenitor also retains exclusive rights for all human uses of leptin receptor DNA anti-sense molecules, and in vivo human uses of leptin receptor-specific antibodies, plus certain other co-exclusive rights to the licensed leptin receptor technology. - MORE - - 2 - "This agreement confirms Amgen's commitment to develop effective treatments for severe obesity, based on a thorough understanding of its biology. We are extremely pleased to have the opportunity to explore the potential role of the leptin receptor in the treatment of this disease, and we are happy that Progenitor has selected Amgen to be its licensee," said Gordon Binder, Amgen's chairman and chief executive officer. "We are pleased to have Amgen's commitment to the evaluation and development of the therapeutic potential of our leptin receptor technology, a lead discovery from our developmental biology approach to functional genomics," remarked Douglass B. Given, MD, PhD, president and chief executive officer of Progenitor. "Amgen enjoys unparalleled success in development and commercialization of recombinant proteins, and has taken a leadership role in leptin research. We see this agreement with Amgen as the ideal vehicle for development of initial pharmaceutical applications of this important genomics achievement, as we explore additional product development opportunities in our retained fields," Dr. Given added. Leptin is a naturally-occurring hormone produced by fat cells. It is thought that leptin helps control the amount of body fat, and overall body weight, by regulating appetite and metabolism. In May 1996, Amgen began the initial human clinical trial of leptin to evaluate the safety and tolerability of the hormone across a variety of weight categories. Recently, Progenitor scientists, led by H. Ralph Snodgrass, Ph.D., vice president, research and chief scientific officer, reported additional effects of leptin, including receptor-mediated roles for leptin in the formation of blood and immune cells from bone marrow. Their data suggest that leptin receptors potentially may be used to sort immature blood cells and create sub-populations of cells with desired characteristics for therapeutic applications. Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology. Progenitor is a functional genomics company engaged in the discovery, characterization and validation of novel genes, receptors and related proteins as therapeutic leads and targets for the treatment of major diseases. The company's functional genomics approach combines expertise in developmental biology with molecular biology techniques and bioinformatics to accelerate the discovery process. Interneuron Pharmaceuticals is a diversified biopharmaceutical company engaged in the development and commercialization of a portfolio of products and product candidates - MORE - -3- primarily for neurological and behavioral disorders. Interneuron's lead products include: Redux(TM) for obesity, currently marketed by American Home Products and co-promoted by Interneuron; citicoline for stroke, in Phase 3 clinical trials; and bucindolol for congestive heart failure, in Phase 3 clinical trials through Intercardia, an Interneuron subsidiary focused on cardiovascular disease. Interneuron's other subsidiaries include Transcell Technologies, Inc., focused on carbohydrate- based drug discovery; and InterNutria, Inc., focused on dietary supplement products. Except for the descriptions of historical facts contained herein, this news release contains forward-looking statements that involve risks and uncertainties as detailed from time to time in Amgen's and in Interneuron's SEC filings under the Securities Act of 1933 and the Securities Exchange Act of 1934, including the early stage of development of Progenitor's technology; need for additional funds; patent, regulatory, and competitive risks; dependence on third parties; product liability; and other risks. ### -----END PRIVACY-ENHANCED MESSAGE-----