-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DZhNkc3+n4plxTnQP06gC8o+7kMr0MKMm5VeawzWUueONNw0UWbsqcZgPY3l/698 0vVecJvqfHamDjAwjAGKjQ== 0001047469-99-002477.txt : 19990129 0001047469-99-002477.hdr.sgml : 19990129 ACCESSION NUMBER: 0001047469-99-002477 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990127 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990128 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOTHERAPEUTICS INC CENTRAL INDEX KEY: 0000831547 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 930979187 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-28782 FILM NUMBER: 99515039 BUSINESS ADDRESS: STREET 1: 157 TECHNOLOGY DR STREET 2: STE J-821 CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497886700 MAIL ADDRESS: STREET 1: 157 TECHNOLOGY DR STREET 2: STE J-821 CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: AMERICUS FUNDING CORP DATE OF NAME CHANGE: 19920703 8-K 1 FORM 8-K 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 ---------------- NEOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 000-28782 93-0979187 - ------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer (of incorporation) File Number) Identification No.) 157 Technology Drive, Irvine, California 92618 ---------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code:(949) 788-6700 -------------- Not Applicable ---------------------------------------------- (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 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: ------- 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 ----------------------------------- Samuel Gulko Chief Financial Officer 2 EXHIBIT INDEX
EXHIBITS DESCRIPTION - -------- ----------- 99.1 Press Release dated January 27, 1999
3 EX-99.1 2 EXHIBIT 99.1 EXHIBIT 99.1 FOR IMMEDIATE RELEASE --------------------- 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 - 4 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: cgruetter@neotherapeutics.com (213) 957-3111 x.224 e-mail: jlockhart@halsted.com Margaret Wyrwas and Christine Seketa Hill and Knowlton, Inc. Tel: (212) 885-0544 or (212) 885-0350 e-mail: mwyrwas@hillandknowlton.com cseketa@hillandknowlton.com # # # 5 -----END PRIVACY-ENHANCED MESSAGE-----