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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
AUGUST 20, 1997 DATE OF REPORT
(DATE OF EARLIEST EVENT REPORTED)
GUILFORD PHARMACEUTICALS INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 0-23736 52-1841960
(State or other (Commission (I.R.S. Employer
jurisdiction of File Number) Identification
incorporation or Number)
organization)
6611 TRIBUTARY STREET
BALTIMORE, MARYLAND
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
21224
(ZIP CODE)
(410) 631-6300
(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS
On August 20, 1997, the Company entered into a Binding Term Sheet (the
"Amgen Agreement") with Amgen Inc. ("Amgen") respecting the research,
development and commercialization of the Company's FKBP-based
neuroimmunophilin ligand technology ("Neuroimmunophilin Technology") for
all human therapeutic and diagnostic applications. Pursuant to the terms of
the Amgen Agreement, on August 21, 1997, Amgen paid a $15 million signing
fee to the Company. Following the expiration or termination of the
applicable review period under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976 ("HSR Act"), the Company will issue to Amgen 640,095 shares of
the Company's common stock, par value $.01 per share ("Common Stock") and
Warrants to purchase up to an additional 700,000 shares of Company Common
Stock for a total of $20 million. The Warrants will be exercisable for up
to five years from the closing date of the sales of such securities to
Amgen and will have an exercise price equal to 150% of the purchase price
of the Common Stock (i.e., an exercise price of approximately $35.15 per
share). Following the closing, Amgen will also have certain demand and
"piggyback" registration rights under the Securities Act of 1933, as
amended, covering the shares of Common Stock and Warrants sold to Amgen as
described above and the shares of Common Stock issuable upon exercise of
the Warrants. The closing with respect to the sale of these securities to
Amgen is conditioned upon the expiration or earlier termination of the
applicable HSR Act review period or the final decision of any court,
arbitrator or governmental body approving the transactions contemplated in
the Amgen Agreement.
Under the terms of the Amgen Agreement, Amgen will provide to the
Company up to $13.5 million over three years to support research activities
at the Company relating to the Neuroimmunophilin Technology. In the event
that at the end second year of the research program, no neuroimmunophilin
compound has been identified which, in Amgen's opinion, is an IND candidate
or likely to lead to an IND candidate, Amgen may elect to terminate the
research program at that point. In addition, Amgen may elect to fund an
additional year of research. The Amgen Agreement provides for certain
milestone payments to the Company in up to ten different specified clinical
indications, seven of which are neurological (i.e., Parkinson's disease;
Alzheimer's disease; stroke; peripheral neuropathies; traumatic brain
injuries; and multiple sclerosis) and three of which are for
non-neurological indications, in the event Amgen achieves certain
development milestones with respect to compounds being developed under the
collaboration with the Company. In addition, the Company will receive
royalties on products sales, if any, falling under the Neuroimmunophilin
Technology in the future. Subject to Amgen's two year research funding
obligation, Amgen may elect to discontinue all activities relating to the
development and commercialization of the Neuroimmunophilin Technology
whereupon the Amgen Agreement will terminate.
There can be no assurance that Amgen will be able to achieve any of the
development milestones set forth in the Amgen Agreement with respect to any
specified indication. The research, development and commercialization of
early stage technology like the Neuroimmunophilin Technology is subject to
significant risks and uncertainty respecting, among other things, selection
of an appropriate lead compound, successful completion of the pre-clinical
and clinical development activities, regulatory clearances, formulation of
final product dosage forms, scale-up from bench quantities to commercial
quantities and manufacture of products and commercialization of such
products as well as the successful preservation and extension of the patent
and other intellectual property rights. For a description of these and
other risks, readers are directed to the Company's other filings with the
Securities and Exchange Commission, including the Company registration
statement on Form S-3 declared effective April 7, 1997.
The Amgen Agreement also provides that Amgen will fund and control
substantially all development, manufacturing and commercialization
activities respecting the Neuroimmunophilin Technology. Under certain
circumstances set forth in the Amgen Agreement, Guilford has the option to
conduct certain Phase I and Phase II clinical trials. In addition, in other
circumstances, Guilford has the right to co-promote in the U.S. one product
commercialized under the Amgen Agreement, subject to certain terms and
conditions set forth therein.
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ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS
10.47 Binding Term Sheet, dated August 20, 1997, between Guilford
Pharmaceuticals Inc and GPI NIL Holdings, Inc., and Amgen Inc.*
99.1 Press Release, dated August 21, 1997, entitled "AMGEN
ACQUIRES RIGHTS FROM GUILFORD PHARMACEUTICALS FOR BREAKTHROUGH
NEUROTROPHIC AGENTS ".
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* Confidential Treatment has been requested for portions of this document.
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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 thereunto duly authorized.
GUILFORD PHARMACEUTICALS INC.
Date: September 4, 1997 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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