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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
September 25, 1998
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Date of Report (Date of earliest event reported)
Guilford Pharmaceuticals Inc.
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(Exact name of registrant as specified in its charter)
Delaware 0-23736 52-1841960
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(State or other jurisdiction of (Commission File (I.R.S. Employer
incorporation or organization) Number) Identification No.)
6611 Tributary Street Baltimore, Maryland 21224
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(Address of principal executive offices) (Zip Code)
(410) 631-6300
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Registrant's telephone number, including area code
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(Former name or former address, if changed since last report)
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Exhibit Index is on page 5.
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GUILFORD PHARMACEUTICALS INC.
ITEM 5. OTHER EVENTS.
On September 25, 1998, Guilford Pharmaceuticals Inc. (the "Company")
entered into Amendment No. 1 (the "Marketing Rights Amendment") to its
Marketing, Sales and Distribution Rights Agreement (the "Marketing Rights
Agreement") dated June 13, 1996 with Rhone-Poulenc Rorer Pharmaceuticals Inc.
("RPR") and GPI Polymer Holdings, Inc. (formerly named GPI Holdings, Inc.,
"Holdings"). On September 25, 1998, the Company also entered into Amendment No.
1 (the "Stock Purchase Amendment") to its Stock Purchase Agreement (the "Stock
Purchase Agreement") dated June 13, 1996 with RPR. The Marketing Rights
Agreement granted to RPR the worldwide (excluding Scandinavia) rights to market,
sell and distribute GLIADEL(R) wafer ("GLIADEL"), a novel treatment for
malignant glioma, the most common and rapidly fatal form of primary brain
cancer. The Stock Purchase Agreement provided the terms under which RPR made an
initial $7.5 million equity investment in the Company, as well as the terms for
an additional $7.5 million investment upon the achievement of certain goals and
representation on the Company's Board of Directors following such second
investment. The U.S. Food and Drug Administration ("FDA") cleared GLIADEL for
marketing in September 1996 for use as an adjunct to surgery to prolong survival
in patients with recurrent glioblastoma multiforme for whom surgical resection
is indicated. In February 1997, RPR commercially launched GLIADEL in the United
States, and in December 1997 RPR commenced a multi-center Phase III clinical
trial in Europe, the United States and Israel for GLIADEL in patients undergoing
initial surgery for malignant glioma (the "First Surgery Trial").
Pursuant to the terms of the Marketing Rights Amendment, RPR will
use commercially reasonable efforts to conduct the First Surgery Trial, for
which the Company will pay one-half of the costs, not to exceed $3 million. In
addition, the Marketing Rights Amendment provides that RPR shall reimburse the
Company for certain costs incurred after September 25, 1998 relating to work
performed by the Company at the request of RPR to the extent that the work
exceeds requests made by the FDA and other government regulators. The terms of
the Marketing Rights Amendment also confirm that all rights to market GLIADEL in
Japan have reverted to Holdings, and provides for adjustments to the milestone
payments provided for in the Marketing Rights Agreement.
The Stock Purchase Amendment deletes a term in the Stock Purchase
Agreement which would have entitled RPR to representation on the Company's Board
of Directors following any FDA approval for commercial sale of GLIADEL for the
treatment of primary forms of malignant glioma and investment by RPR of its
second $7.5 million tranche.
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There can be no assurance that RPR will be able to achieve any of
the milestones set forth in the Marketing Rights Amendment, and accordingly
there can be no assurance that the Company will receive the related milestone
payments. For a description of these and other risks, readers should review
"Item 4A. Risk Factors" set forth in the Company's annual report on Form 10-K
for the year ended December 31, 1997, filed with the Securities and Exchange
Commission on March 27, 1998.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
10.63* Amendment No. 1 to Marketing, Sales and Distribution Rights
Agreement
10.64 Amendment No. 1 to Stock Purchase Agreement
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*The registrant has requested confidential treatment of certain portions of this
agreement from the Securities and Exchange Commission.
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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.
GUILFORD PHARMACEUTICALS INC.
Date October 2, 1998 By: /s/ Craig R. Smith, M.D.
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Craig R. Smith, M.D.
President and Chief Executive Officer
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INDEX TO EXHIBITS
EXHIBIT
NUMBER EXHIBIT DESCRIPTION PAGE
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10.63* Amendment No. 1 to Marketing, Sales
and Distribution Rights Agreement
10.64 Amendment No. 1 to Stock Purchase Agreement
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*The registrant has requested confidential treatment of certain portions of this
agreement from the Securities and Exchange Commission.
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