8-K

QuickLinks -- Click here to rapidly navigate through this document

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): October 4, 2002

Bio-Technology General Corp.
(Exact name of issuer as specified in its charter)

Delaware
(State or Other Jurisdiction
of Incorporation) 0-15313
(Commission File Number) 13-3033811
(IRS Employer
Identification No.)

70 Wood Avenue South
Iselin, New Jersey
(Address of Principal Executive Offices)
08830
(Zip Code)

Registrant's telephone number, including area code: (732) 632-8800

None.
(Former address, if changed since last report.)

ITEM 4. CHANGES IN REGISTRANT'S CERTIFYING ACCOUNTANT.

        Late in the day on Friday, October 4, 2002, KMPG LLP ("KPMG") notified Bio-Technology General Corp. (the "Company") that it resigned as the Company's independent auditors.

        On May 8, 2002, the Board of Directors dismissed Arthur Andersen LLP ("Arthur Andersen") as the Company's independent public accountants and engaged KPMG to serve as the Company's independent public accountants for 2002. The Company subsequently determined to restate its financial statements for the years ended December 31, 1999, 2000 and 2001 and engaged KPMG to reaudit the restated financial statements.

        During the Company's two most recent fiscal years ended December 31, 2000 and 2001, and through the date of this Form 8-K, there were no disagreements between the Company and Arthur Andersen, as previously disclosed or, since May 8, 2002, with KPMG on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to KPMG's satisfaction, would have caused KPMG to make reference to the subject matter of the disagreement in connection with its report. Except as described in the last paragraph of this Item 4, none of the reportable events described under Item 304(a)(1)(v) of Regulation S-K occurred within the Company's two most recent fiscal years ended December 31, 2000 and 2001 or through the date of this Form 8-K.

        The audit report of KPMG on the consolidated financial statements of the Company and subsidiaries as of and for the fiscal years ended December 31, 2000 and 2001 did not contain any adverse opinion or disclaimer of opinion, nor was it qualified or modified as to uncertainty, audit scope or accounting principles, except as follows: (i) as discussed in Note 1k to the consolidated financial statements, the Company changed its method of revenue recognition for certain up-front nonrefundable fees in 2000, and (ii) as discussed in Note 2 to the consolidated financial statements, the Company has restated its consolidated financial statements for the years ended December 31, 1999, 2000 and 2001, which consolidated financial statements were previously audited by other independent auditors.

        The Company provided KPMG with a copy of this Form 8-K. Attached as Exhibit 16.1 to this Form 8-K is a copy of KPMG's letter, dated October 11, 2002, stating its agreement with the statements concerning KPMG.

        The Audit Committee of the Board of Directors of the Company is currently in the process of engaging a new independent public accounting firm for the Company.

        Attached as Exhibit 99.1 to this Form 8-K is a copy of the management letter dated October 2, 2002 delivered by KPMG to the Audit Committee of the Board of Directors of the Company. The management letter states that the Company's restatement of its financial statements for the years ended December 31, 1999, 2000 and 2001". .. indicates a significant need for the Company to employ additional technical accounting and financial reporting resources." The Company notes that with the exception of the non-recognition of compensation costs in connection with stock option modifications, the original accounting treatment of all other matters subsequently restated were discussed with and approved by the Audit Committee of the Company's Board of Directors and Arthur Andersen LLP, the Company's independent auditors at the time. The Company is in the process of seeking additional employees with technical accounting and financial reporting experience in light of KPMG's recommendation to enhance the Company's technical accounting and financial reporting resources. The management letter also stated that the Company's need for additional technical accounting and financial reporting resources ".. .was considered in determining the nature, timing, and extent of the audit tests applied in our audit of the consolidated financial statements for the years ended December 31, 2001, 2000 and 1999, and this report does not affect our report on these consolidated financial statements dated September 20, 2002." KPMG has not withdrawn its September 20, 2002 report on the Company's consolidated financial statements for the each of the years ended December 31, 1999, 2000 and 2001.

ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

(a)

Financial Statements of Business Acquired.

        None.

(b)

Pro Forma Financial Information.

        None.

(c)

Exhibits.

16.1	Letter, dated October 11, 2002, from KPMG LLP to the Securities and Exchange Commission.
99.1	Letter, dated October 2, 2002, from KPMG LLP to the Audit Committee of the Board of Directors of Bio-Technology General Corp.

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.

BIO-TECHNOLOGY GENERAL CORP. (Registrant)
By:
	/s/  JOHN BOND            John Bond             Senior Vice President-Finance

Dated: October 11, 2002

QuickLinks

ITEM 4. CHANGES IN REGISTRANT'S CERTIFYING ACCOUNTANT.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

SIGNATURES

EX-16.1

QuickLinks -- Click here to rapidly navigate through this document

Exhibit 16.1

[KPMG Logo]

Princeton Pike Corporate Center
PO Box 7348
Princeton, NJ 08543-7548 Telephone 609 896 2100
Fax 609 896 9782

October 11, 2002

Securities and Exchange Commission
Washington, D.C. 20549

Ladies and Gentlemen:

On May 8, 2002, we were appointed auditors for Bio-Technology General Corp. (the Company) for the year ending December 31, 2002. Subsequently, we were engaged to audit and, under the date of September 20, 2002, we reported on the restated consolidated financial statements of Bio-Technology General Corp. and subsidiaries for the years ended December 31, 1999, 2000 and 2001. On October 4, 2002 we resigned.

We have read the Company's statements included under Item 4 of its Form 8-K dated October 4, 2002, and we agree with such statements, except that we are not in a position to agree or disagree with the following:

i.

The Company's statements in the third paragraph to the extent that they relate to Arthur Andersen LLP or the period prior to May 8, 2002, the date of our appointment as auditors;



ii.

The Company's statements in the sixth paragraph; and



iii.

The Company's statements in the seventh paragraph that, "The Company notes that with the exception of the non-recognition of compensation costs in connection with stock option modifications, the original accounting treatment of all other matters subsequently restated were discussed with and approved by the Audit Committee of the Company's Board of Directors and Arthur Andersen LLP, the Company's independent auditors at the time. The Company is in the process of seeking additional employees with technical accounting and financial reporting experience in light of KPMG's recommendation to enhance the Company's technical accounting and financial reporting resources."

Very truly yours,

/s/ KMPG LLP

QuickLinks

Exhibit 16.1

EX-99.1

QuickLinks -- Click here to rapidly navigate through this document

Exhibit 99.1

[KPMG Logo]

Princeton Pike Corporate Center
PO Box 7348
Princeton, NJ 08543-7548 Telephone 609 896 2100
Fax 609 896 9782

Audit Committee of the Board of Directors
Bio-Technology General Corp.
70 Wood Avenue South
Iselin, NJ 08830

Ladies and Gentlemen:

We have audited the consolidated financial statements of Bio-Technology General Corp. and subsidiaries for the years ended December 31, 2001, 2000 and 1999 and have issued our report thereon dated September 20, 2002. In planning and performing our audit of the consolidated financial statements of Bio-Technology General Corp. and subsidiaries we considered internal control in order to determine our auditing procedures for the purpose of expressing our opinion on the consolidated financial statements. An audit does not include examining the effectiveness of internal control and does not provide assurance on internal control. The maintenance of adequate internal control designed to fulfill control objectives is the responsibility of management. Because of inherent limitations in internal control, errors or fraud may nevertheless occur and not be detected. Also, controls found to be functioning at a point in time may later be found deficient because of the performance of those responsible for applying them, and there can be no assurance that controls currently in existence will prove to be adequate in the future as changes take place in the organization.

However, we noted a matter involving internal control and its operation that we consider to be a reportable condition under standards established by the American Institute of Certified Public Accountants. Reportable conditions are matters coming to our attention that, in our judgment, relate to significant deficiencies in the design or operation of internal control and could adversely affect the organization's ability to record, process, summarize, and report financial data consistent with the assertions of management in the consolidated financial statements. Our consideration of internal control would not necessarily disclose all matters in internal control that might be reportable conditions. Furthermore, reportable conditions do not include potential future internal control problems; that is, control problems coming to our attention that do not affect the preparation of consolidated financial statements for the period under audit.

Audit Committee of the Board of Directors
Bio-Technology General Corp.
October 2, 2002
Page 2

        A material weakness is a reportable condition in which the design or operation of one or more internal control components does not reduce to a relatively low level the risk that errors or fraud in amounts that would be material in relation to the consolidated financial statements being audited may occur and not be detected within a timely period by employees in the normal course of performing their assigned functions. We consider the following matter involving internal control and its operation to be a material weakness.

Need for Additional Technical Accounting and Financial Reporting Resources

        One of the fundamental components of the control environment, as described in the AICPA auditing standards in the Appendix to AU 319 Consideration of Internal Control in a Financial Statement Audit is the "Commitment to competence". Another of these fundamental components of the control environment is "Management's philosophy and operating style" which includes "...management's attitudes toward information processing and accounting functions and personnel." The Company restated its financial statements for each of the years ended December 31, 2001, 2000 and 1999 in its recently filed Form 10-K/A for the year ended December 31, 2001. The principal adjustments related to the deferral of costs which should have been expensed as incurred, the non-recognition of compensation costs in connection with stock option modifications, and revenue recognition. We believe that the occurrence of these adjustments indicates a significant need for the Company to employ additional technical accounting and financial reporting resources. Additionally, the complexity of external financial reporting has increased significantly over the past few years and this trend is expected to continue.

        We note that the CFO resides in Israel and spends only part of his time in the USA and that the Company does not have a corporate controller. We believe that the Company should strengthen the competence of the finance department by employing, as soon as possible, additional resources who have significant expertise in external financial reporting and disclosure matters applicable to public companies. These additional personnel should have the appropriate level of authority, responsibility, lines of reporting and operating philosophy to enable them to be successful in improving the Company's financial reporting system, including the appropriate support and commitment from senior management and the Audit Committee.

        This condition was considered in determing the nature, timing, and extent of the audit tests applied in our audit of the consolidated financial statements for the years ended December 31, 2001, 2000 and 1999, and this report does not affect our report on these consolidated financial statements dated September 20, 2002. We have not considered internal control since the date of our report.

Audit Committee of the Board of Directors
Bio-Technology General Corp.
October 2, 2002
Page 3

        This report is intended sorely for the information and use of the audit committee, management, and others within the organization and is not intended to be and should not be used by anyone other than these specified parties.

Very truly yours,

/s/ KPMG LLP

QuickLinks

Exhibit 99.1