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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
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Date of Report (Date of earliest event reported): November 15, 1999
GELTEX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 0-26872 04-3136767
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
153 SECOND AVENUE, WALTHAM, MASSACHUSETTS 02451
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 781-290-5888
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Nine Fourth Avenue, Waltham, Massachusetts 02451
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS.
On November 15, 1999, the Registrant publicly disseminated a press release
announcing that the Registrant had entered into a binding Letter of Intent with
Sankyo Pharma, Inc. to grant Sankyo Pharma, Inc. exclusive marketing rights in
the United States for Cholestagel(R) (colesevelam hydrochloride) for the
treatment of hypercholesterolemia, characterized by undesirably high blood
cholesterol levels. Under the Letter of Intent, Sankyo has also agreed to
purchase an option to global rights to GelTex's second generation
cholesterol-lowering product. The information contained in the press release is
incorporated herein by reference and filed as Exhibit 99.1 hereto.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
99.1 The Registrant's Press Release dated November 15, 1999.
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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.
GelTex Pharmaceuticals, Inc.
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(Registrant)
Date: November 15, 1999 /s/ Mark Skaletsky
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Mark Skaletsky
President and CEO
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EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit Sequential
Number Description Page Number
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<S> <C> <C>
99.1 The Registrant's Press Release 4
dated.
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EXHIBIT 99.1
CONTACTS: Mark Skaletsky Jonathan M. Nugent (investors)
President and CEO Justin Jackson or
GelTex Pharmaceuticals, Inc. Lisa Fern (media)
(781) 434-3500 Burns McClellan
(212) 213-0006
FOR IMMEDIATE RELEASE
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GELTEX PHARMACEUTICALS AND SANKYO SIGN LETTER OF INTENT
FOR LICENSING AGREEMENT FOR GELTEX'S
CHOLESTEROL-LOWERING PRODUCTS
SANKYO PARKE DAVIS TO MARKET CHOLESTAGEL(R)
WALTHAM, MA, NOVEMBER 15, 1999 -- GelTex Pharmaceuticals, Inc. (Nasdaq: GELX)
announced today that the company has signed a binding letter of intent to grant
Sankyo Pharma, Inc. exclusive marketing rights in the United States for
Cholestagel(R) (colesevelam hydrochloride) for the treatment of
hypercholesterolemia, characterized by undesirably high blood cholesterol
levels. Under the letter of intent, Sankyo has agreed to purchase an option to
global rights to GelTex's second generation cholesterol-lowering product,
GT102-279.
Under the terms of the agreement, which will be finalized by the end of the
year, Sankyo will have an option to license GT102-279, currently in Phase 2
clinical trials. Sankyo will provide to GelTex upfront licensing and option fees
of $13 million, a $20 million milestone payment upon marketing approval of
Cholestagel by the U.S. Food & Drug Administration, and following the exercise
of the option, additional milestone payments for marketing approval of the
second generation product in Europe and Japan. Additionally, GelTex will receive
royalties on net sales of Cholestagel and the second generation product.
Sankyo has agreed to pay for all development costs for the second generation
compound for so long as Sankyo's option to license the product remains in
effect. Sankyo Parke Davis, a 50/50 joint venture between Sankyo and Parke
Davis, will be responsible for sales and marketing of Cholestagel in the United
States.
"We are extremely excited to announce our strategic relationship with Sankyo and
Sankyo Parke Davis as we will be working with two world leaders in the marketing
of lipid-lowering products," commented Mark Skaletsky, President and Chief
Executive Officer of GelTex. "The experience and success of Sankyo and Parke
Davis in the commercialization of cholesterol-lowering products will greatly
enhance the sales and marketing of Cholestagel."
"Cholestagel provides physicians and their patients with an effective treatment
alternative for cholesterol management. Additionally, this agreement allows
Sankyo to accelerate their expansion into the United States," stated Joseph
Pieroni, President of Sankyo Parke Davis.
In July, 1999, GelTex submitted a new drug application (NDA) to the FDA to
market Cholestagel for the treatment of hypercholesterolemia. The NDA has been
accepted for filing and GelTex anticipates an FDA decision in mid-2000.
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GelTex and Sankyo Sign Letter of Intent to Market Cholestagel(R)
November 15, 1999
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Cholestagel has been studied in eight clinical trials as a monotherapy and in
combination with statins, the current standard of treatment for lowering LDL
cholesterol. In these studies, when evaluated as a monotherapy, Cholestagel
significantly reduced LDL cholesterol levels while demonstrating high levels of
safety and tolerability among the target population. Additionally, Cholestagel
was shown to lower LDL cholesterol whether it was given once per day with
breakfast or dinner, or if the dose was split between the two meals. This allows
for greater flexibility in drug administration to the patient.
In these studies, Cholestagel, administered with the HMG-CoA reductase
inhibitors lovastatin (Merck's Mevacor(R)), simvastatin (Merck's Zocor(R)), or
atorvastatin (Warner-Lambert's Lipitor(R)), resulted in at least additive
reduction of LDL cholesterol.
In each trial, adverse events reported during Cholestagel treatment were similar
to those reported with placebo. No serious drug-related adverse events were
attributed to Cholestagel treatment.
The second generation compound was twice as potent as Cholestagel in a Phase 2
clinical trial. GelTex anticipates initiating Phase 3 studies with this compound
in the second half of 2000.
Cholestagel is designed to bind bile acids and block their reabsorption.
Cholestagel subsequently passes from the body, taking significant amounts of
bile acids with it. Since the body requires a certain amount of bile acids to
perform the functions of fat digestion, cholesterol is drawn from the blood
stream and into the liver, where it is converted into bile acids. This results
in an overall lowering of blood cholesterol levels. Elevated levels of
cholesterol are a major risk factor in the development of atherosclerosis and
coronary artery disease.
Sankyo is the second largest pharmaceutical company in Japan. Headquartered in
Tokyo and established in 1899, Sankyo employs nearly 7,000 people. Sankyo
discovered three products now marketed in the United States: Pravachol(R)
(pravastatin sodium), licensed to Bristol-Myers Squibb for reducing cholesterol
biosynthesis; Vantin(R) (cefpodozine proxetil), an oral cephalosporin antibiotic
licensed to Pharmacia & Upjohn; and Rezulin(R) (troglitazone) for managing type
II diabetes, licensed to Warner Lambert and co-promoted by Sankyo Parke Davis.
GelTex Pharmaceuticals, Inc. develops polymer-based, non-absorbed
pharmaceuticals that selectively bind and eliminate target substances from the
intestinal tract resulting in a systemic medical benefit.
This press release contains forward-looking statements based on current
management expectations regarding the execution of a definitive agreement with
Sankyo, Sankyo's plans for marketing Cholestagel, and the timing for a Food and
Drug Administration decision regarding the Company's NDA. There are certain key
factors that could cause future results to differ materially from those
anticipated by management. Such factors include, but are not limited to,
uncertainties regarding negotiations of the final agreement, marketing of
Cholestagel, and the FDA action and decisions regarding Cholestagel.
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