FORM 10-Q/A
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT TO APPLICATION OR REPORT
Filed Pursuant to Section 12, 13 or 15 (d) of
THE SECURITIES EXCHANGE ACT OF 1934
MEDCO RESEARCH, INC.
(Exact name of registrant as specified in its charter)
AMENDMENT NO. 2
Part II: OTHER INFORMATION
The undersigned registrant hereby amends Part II. Other Information - Item 1. -
Legal Proceedings, section 2, of its 10-Q for the quarter ended September 30,
1996 as set forth in the pages attached hereto.
MEDCO RESEARCH, INC.
(Registrant)
Date: November 18, 1996 /s/ Glenn C. Andrews
Chief Financial Officer
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ITEM 1. LEGAL PROCEEDINGS
1. Incorporated herein by reference is Class Action Litigation paragraph 4,
inclusive, set forth in the Notes to the Financial Statements set forth in Item
1 of Part I of this Report, set forth on page 7 hereof.
2. Dr. Eliezer Rapaport, the licensor of the Company's potential adenosine
triphosphate ("ATP") drug, has notified the Company that he has requested
arbitration by the American Arbitration Association of his claim that the
Company has breached its May 20, 1991 license agreement by failing to devote
reasonable efforts in preparing and filing within three years of FDA approval of
its Investigational New Drug application, that is, by May 8, 1995, a New Drug
Application ("NDA") for the use of ATP in the treatment of at least one type of
human cancer. (Arbitration is the binding dispute resolution method provided for
in the agreement).
The licensor is seeking the return of all licensed ATP patent rights for the
Company's alleged breach of contract and the failure to return such rights. He
also is seeking an unspecified amount of punitive damages and $44 million in
compensatory damages. He has computed such compensatory damages on the basis of
"total worldwide billings of an approved ATP medication for treatment of
cancer..." As discussed below, ATP demonstrated no tumor response in non-small
cell lung cancer patients. Therefore, the Company believes such damage claim,
which is based on ATP as a cancer treatment, is not only extremely speculative
but also is unfounded. The Company believes Dr. Rapaport has incurred no damages
from the Company's drug development activities. The Company intends to
vigorously defend itself against the allegations of Dr. Rapaport, which the
Company believes are without any merit.
In discussions with Dr. Rapaport held as early as May 1995, the Company
continuously maintained, and it currently believes, that it has not breached the
agreement. Data from the Company's Phase II clinical trials for ATP did not show
any tumor response, as defined in the protocol, in patients with non-small cell
lung cancer, and the Company so advised its licensor. (The Company believes that
such responses are the benchmark accepted in the pharmaceutical industry for
filing an NDA for a cancer treatment drug.) However, data from the Company's
multicenter clinical trial completed in 1995 indicated that the administration
of ATP to such patients may have produced an anti-cachexic effect, that is, it
may have reduced the weight loss associated with cancer, and it may have
improved quality of life, in late stage cancer patients.
With Dr. Rapaport's knowledge and consent, the Company has been attempting to
sublicense ATP to a partner interested in further developing its anti-cachexic
effect.
