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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
Date of Report (Date of earliest event reported) January 27, 1999
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NEOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 000-28782 93-0979187
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(State or other jurisdiction (Commission (IRS Employer
(of incorporation) File Number) Identification No.)
157 Technology Drive, Irvine, California 92618
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code:(949) 788-6700
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Not Applicable
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(Former name or former address, if changed since last report)
(Telephone area code changed from (714) to (949)
Page 1 of 5
Exhibit Index on Page 3
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ITEM 5. OTHER EVENTS
Reference is made to the press release issued to the public by the
Registrant on January 27, 1999, the text of which is attached hereto as Exhibit
99.1, for a description of the events reported pursuant to this Form 8-K.
ITEM 7. EXHIBITS
EXHIBIT:
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99.1 PRESS RELEASE DATED JANUARY 27, 1999.
SIGNATURE
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.
NEOTHERAPEUTICS, INC.
Date: January 28, 1999 By: /s/Samuel Gulko
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Samuel Gulko
Chief Financial Officer
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EXHIBIT INDEX
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EXHIBITS DESCRIPTION
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<S> <C>
99.1 Press Release dated January 27, 1999
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
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POSITIVE PHASE 2 RESULTS FOR NEOTROFIN-TM- IN ALZHEIMER'S DISEASE
IRVINE, Calif.-- January 27, 1999--NeoTherapeutics, Inc. (Nasdaq: NEOT, NEOTW)
announced today that NEOTROFIN-TM- (AIT-082, leteprinim potassium) produced a
positive effect on behavioral function as well as memory improvement in a Phase
2 clinical study involving patients with Alzheimer's disease. This
double-blinded, placebo-controlled, Phase 2a study enrolled 74 patients with
mild to moderate Alzheimer's disease for twenty-eight days of treatment.
NEOTROFIN-TM- was safe and well tolerated when doses from 50 to 500 mg were
administered once daily for twenty-eight days.
"These preliminary results represent the first positive clinical finding with
NEOTROFIN-TM- on standard behavioral function tests in addition to memory
improvement in patients with Alzheimer's disease" said Dr. Alvin J. Glasky,
President and Chief Scientific Officer of NeoTherapeutics. "These new clinical
results extends the observations we have seen in the earlier Phase 1 clinical
studies which evaluated single and multiple doses of NEOTROFIN-TM- (AIT-082) in
healthy volunteers and a single dose study in patients with Alzheimer's disease.
Further, we are encouraged that these results may be based upon the unique basis
of action of NEOTROFIN-TM-, which in pre-clinical studies demonstrated enhanced
nerve regeneration. NEOTROFIN-TM- could mark the beginning of a new era of hope
for the four million Americans suffering from Alzheimer's disease," Dr. Glasky
stated.
Steven Targum, M.D. of Clinical Studies Ltd., the principal investigator on the
study which involved 13 clinical centers in the United States, stated "We are
very pleased that in this Phase 2a clinical trial, NEOTROFIN-TM- demonstrated
benefits in Alzheimer's disease patients within 28 days of treatment. If these
observations are confirmed and expanded upon in larger clinical trials,
NEOTROFIN-TM- could be an important new medication for the management of
Alzheimer's disease."
NEOTROFIN-TM- is NeoTherapeutics' lead compound and is being developed for nerve
regeneration, with Alzheimer's disease as its first clinical indication.
Pre-clinical studies have demonstrated that NEOTROFIN-TM- can control the
production of multiple natural neurotrophic factors and restore function in
animal models of aging, brain injury and spinal cord injury.
- more -
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Positive Phase 2 Results for NEOTROFIN-TM-
January 27, 1999
Page Two
NeoTherapeutics' research program is focused on designing and developing small
molecules capable of promoting nerve regeneration and repair for a range of
neurological diseases and conditions such as Alzheimer's and Parkinson's
diseases, stroke and spinal cord injury. Additional compounds in
NeoTherapeutics' product pipeline address other health issues such as migraine
and depression. For additional Company information, visit the NeoTherapeutics
web site at www.neotherapeutics.com.
THIS PRESS RELEASE CONTAINS 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
INCLUDE, BUT ARE NOT LIMITED TO, THE EARLY STAGE OF PRODUCT DEVELOPMENT, THE
NEED FOR ADDITIONAL FUNDING, THE INITIATION AND COMPLETION OF CLINICAL TRIALS
AND DEPENDENCE ON THIRD PARTIES FOR CLINICAL TESTING, MANUFACTURING AND
MARKETING. THESE RISKS ARE DESCRIBED IN FURTHER DETAIL IN THE COMPANY'S REPORTS
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONTACTS:
Carol Gruetter John Lockhart
NeoTherapeutics, Inc. Halsted Communications, Inc.
Tel: (949) 788-6700 Tel: (800) 600-7111 x.224
e-mail: [email protected] (213) 957-3111 x.224
e-mail: [email protected]
Margaret Wyrwas and Christine Seketa
Hill and Knowlton, Inc.
Tel: (212) 885-0544 or (212) 885-0350
e-mail: [email protected]
[email protected]
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