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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 AND EXCHANGE ACT OF 1934
January 4, 2001
Date of Report (Date of earliest event reported)
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NEOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 000-28782 93-0979187
(State or other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) Identification Number)
157 TECHNOLOGY DRIVE 92618
IRVINE, CALIFORNIA (Zip Code)
(Address of principal executive offices)
(949) 788-6700
(Registrant's telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
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ITEM 9. REGULATION FD DISCLOSURE
On January 4, 2001, NeoTherapeutics, Inc. issued a news release, the text of
which is set forth below. NeoTherapeutics, Inc. is furnishing the information
contained in this Current Report on Form 8-K pursuant to the Securities and
Exchange Commission's Regulation FD.
NEOTHERAPEUTICS' SUBSIDIARY, NEOONCORX, TO ACQUIRE PHASE 2 ANTI-CANCER
DRUG EO9 FROM NDDO RESEARCH FOUNDATION
PHASE 2 TRIAL IN BLADDER CANCER TO BEGIN SHORTLY IN THE UNITED KINGDOM
IRVINE, California, January 4, 2001 - NeoTherapeutics, Inc. (NASDAQ: NEOT,
NEOTW) announced today that its newly formed anti-cancer subsidiary, NeoOncoRx,
Inc., has signed a letter of intent to acquire anti-cancer compound E09 and 79
analogs from Netherlands based NDDO Research Foundation. EO9 and its analogs
originated from research carried out at the University of Amsterdam and
supported by the Dutch Cancer Society. Most of the pre-clinical and clinical
studies have been performed in collaboration with several EORTC (European
Organization for Research and Treatment of Cancer) research groups and clinical
centers in Europe. In conjunction with the acquisition of the compounds,
NeoOncoRx will receive the patent and worldwide rights for EO9 and its analogs.
NeoOncoRx has chosen the name Neoquin(TM) for EO9.
Neoquin(TM) and its analogues make up a family of bioreductive alkylating
indolequinones, a novel class of anti-cancer agents. Pre-clinical data has shown
Neoquin(TM) to have preferential toxicity against solid tumors, such as colon,
melanoma, brain, renal, and non-small cell lung cancers. In animals, Neoquin(TM)
has shown additional anti-tumor effects against stomach, ovarian and breast
tumors. Neoquin(TM) appears to have no bone marrow toxicity, a common side
effect of anti-cancer agents.
"In humans, E09 clinical studies have confirmed the lack of bone marrow
suppression, which is the most common problem with most cancer chemotherapy
drugs, and have shown some signs of activity", stated Coenraad van Kalken, M.D.,
Director of the NDDO Research Foundation, "We are pleased to partner with
NeoTherapeutics' subsidiary, NeoOncoRx to complete the clinical development of
our lead compound. The experience of NeoOncoRx's president, Dr. Luigi Lenaz, and
his great success in shepherding anti-cancer drugs through clinical trials and
regulatory approvals is unmatched, and we are very confident to place EO9's
development in his capable hands."
"Neoquin(TM) holds out great promise for patients suffering from bladder cancer,
and we are honored that NDDO has chosen to partner with NeoOncoRx", stated Luigi
Lenaz, M.D., president of NeoOncoRx, Inc. "Over 54,000 people in the US and
approximately 60,000 people in Western Europe are diagnosed with bladder cancer
each year. Through an accelerated clinical trial program we plan to demonstrate
the effectiveness of this new treatment, and position ourselves to file for
regulatory approvals within the next 2 to 3 years. We also look forward to the
further development of the other analogs of Neoquin(TM)."
"Expenditures in excess of $5 million dollars and years of effort have brought
Neoquin(TM) to Phase 2 clinical trials", stated Rajesh Shrotriya, M.D., Chairman
of the Board of NeoOncoRx. "We are excited to partner with NDDO Research
Foundation on such a promising anti-cancer treatment, and look forward to
initiating a Phase 2 trial in bladder cancer in the United Kingdom during the
first quarter of 2001. This agreement demonstrates our commitment to
successfully executing our plans for NeoOncoRx and delivering new treatments to
cancer patients and value to our shareholders."
The NDDO Research Foundation and its CRO arm NDDO Oncology, Inc., headquartered
in Amsterdam, The Netherlands, are two complementary entities of the New Drug
Development Organization (NDDO), with an exclusive focus on new agents for the
treatment of cancer. New oncology drugs and treatment concepts are developed in
partnership both with public organizations and pharmaceutical and biotechnology
companies.
NEOTHERAPEUTICS is a biopharmaceutical company focused on the development of
small molecule drugs for the treatment of important diseases. The Company's most
advanced drug, Neotrofin (TM) is currently being developed for Alzheimer's
disease, Parkinson's disease, spinal cord injury and other neurodegenerative
diseases. In animal models of cognitive decline, aging and spinal cord injury,
Neotrofin(TM) has been shown to restore neurological function. NEOGENE
TECHNOLOGIES, INC. a subsidiary of NeoTherapeutics, is engaged in functional
genomics
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research. NEOONCORX, INC., a NeoTherapeutics subsidiary, is focused on
the development of anti-cancer drugs. For additional Company information, visit
NeoTherapeutic's web site at WWW.NEOTHERAPEUTICS.COM.
This press release may contain forward-looking statements regarding future
events and the future performance of NeoTherapeutics that involve risks and
uncertainties that could cause actual results to differ materially. These risks
are described in further detail in the Company's reports filed with 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.
NEOTHERAPEUTICS, INC.
Date: January 4, 2001 By: /s/ Samuel Gulko
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Name: Samuel Gulko
Title: Chief Financial Officer
