-----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, QrQBTFogQFQOO34FLR23VFBlRQMr8M/ARUgKjnX0a7FF95kgo7qxlBQH1HfLhAsS 8WINJDf/G2cP7MCFqXODQw== 0000950135-96-002862.txt : 19960701 0000950135-96-002862.hdr.sgml : 19960701 ACCESSION NUMBER: 0000950135-96-002862 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19960626 ITEM INFORMATION: Other events FILED AS OF DATE: 19960628 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: GELTEX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001001425 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043136767 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26872 FILM NUMBER: 96588435 BUSINESS ADDRESS: STREET 1: 303 BEAR HILL RD CITY: WALTHAM STATE: MA ZIP: 02154 BUSINESS PHONE: 6172905888 MAIL ADDRESS: STREET 1: 303 BEAR HILL RD CITY: WALTHAM STATE: MA ZIP: 02154 8-K 1 GELTEX PHARMACEUTICALS, INC. FORM 8-K 1 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): JUNE 26, 1996 GELTEX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 0-26872 04-3136767 (State or other jurisdiction (Commission File (IRS Employer of incorporation) Number) Identification No.) 303 BEAR HILL ROAD, WALTHAM, MASSACHUSETTS 02154 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (617) 290-5888 Page 1 of 5 Exhibit Index Appears on Page 4 2 ITEM 5. OTHER EVENTS. ------------ On June 26, 1996, GelTex Pharmaceuticals, Inc. ("GelTex"), announced that it has received notice from Ono Pharmaceutical Co., Ltd., of Osaka, Japan, that it has terminated its agreement to develop CholestaGel[Registered Trademark] non-absorbed cholesterol reducer for sale in Japan, China, Korea and Taiwan. GelTex also announced that it has initiated a multi-center dose refinement, Phase IIb clinical trial with CholestaGel in the United States. GelTex hereby incorporates by reference the contents of its press release dated June 26, 1996, filed as Exhibit 99.1 to this report. - 2 - 3 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. Date: June 28, 1996 GELTEX PHARMACEUTICALS, INC. By: /s/ Mark Skaletsky ------------------ Mark Skaletsky President and Chief Executive Officer - 3 - 4 EXHIBIT INDEX EXHIBIT SEQUENTIAL NO. DESCRIPTION PAGE NO. - ------- ----------- -------- 99.1 Press release dated June 26, 1996. Filed herewith. 5 - 4 - EX-99.1 2 PRESS RELEASE DATED JUNE 26, 1996 1 EXHIBIT 99.1 Contact: - -------- Amy Wilson Robert Gottlieb Director, Business Development Senior Vice President GelTex Pharmaceuticals, Inc. Feinstein Partners Inc. Phone: (617) 290-5888 (617) 577-8110 For Immediate Release --------------------- GELTEX PHARMACEUTICALS ANNOUNCES CHOLESTAGEL[Registered Trademark] DEVELOPMENTS Agreement with Ono Pharmaceutical Terminated Phase IIb Trail Commences on Schedule WALTHAM, MA, JUNE 26, 1996 - GelTex Pharmaceuticals, Inc. (Nasdaq: GELX) has received notice from Ono Pharmaceutical Co., Ltd., of Osaka, Japan, that it has terminated its agreement to develop CholestaGel[Registered Trademark] non- absorbed cholesterol reducer for sale in Japan, China, Korea and Taiwan, GelTex announced today. GelTex has re-acquired all rights to the product in these countries. The Company also announced that is has initiated a multi- center dose refinement, Phase IIb clinical trial with CholestaGel in the United States. This double-blind, placebo-controlled, dose-ranging trial in 125 patients will be used in developing protocols for the Phase III clinical program. GelTex expects to complete the Phase IIb study in the first quarter of 1997. "The Ono termination will not materially impact the CholestaGel development timeline," commented Mark Skaletsky, president and CEO of GelTex. "Our recently completed Phase IIa CholestaGel study demonstrated that our compound is significantly more potent than cholestyramine, an established non-absorbed agent," Mr. Skaletsky said. "This Phase IIb study will help determine the lowest dose of CholestaGel needed to achieve clinically important, 20-30 percent reductions in LDL cholesterol." Mr. Skaletsky added that a recent process enhancement in the manufacturing of CholestaGel is expected to increase the product's efficacy and to extend its shelf life to more than two years. CholestaGel is a non-absorbed hydrogel that binds and removes bile acids from the intestinal tract. This activity stimulates the liver to remove cholesterol from the bloodstream in order to restore bile acid levels. Of the 65 million Americans with elevated cholesterol, 13 million may require drug therapy. GelTex Pharmaceuticals, Inc. is developing polymer-based pharmaceuticals that selectively bind to and eliminate target substances from the intestinal tract. The Company's products under development are orally delivered in a convenient capsule form, are not absorbed into the bloodstream, and are eliminated from the body through normal digestive processes. GelTex's advanced polymer technology is applicable to a broad number of diseases and conditions treatable through the intestinal tract. This press release may contain forward-looking statements based on current management expectations. There are certain key factors that could cause future results to differ from those anticipated by management. Such factors include, but are not limited to, technical risks associated with the development of new products, the continued progress of clinical trails of the Company's products, the Company's ability to continue to establish collaborative agreements with third parties, the continued availability of raw material for the Company's products, the competitive environment of the biotechnology and pharmaceutical industries, and general economic conditions. # # # - 5 - -----END PRIVACY-ENHANCED MESSAGE-----