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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
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ITEM 5. OTHER EVENTS.
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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.
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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
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Mark Skaletsky
President and Chief Executive Officer
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EXHIBIT INDEX
EXHIBIT SEQUENTIAL
NO. DESCRIPTION PAGE NO.
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99.1 Press release dated June 26, 1996. Filed herewith. 5
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EXHIBIT 99.1
Contact:
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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
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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.
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