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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): July 31, 1999
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PHARMAKINETICS LABORATORIES, INC.
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(Exact name of registrant as specified in its charter)
Maryland 0-11580 52-1067519
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(State or other (Commission File Number) (I.R.S. Employer
jurisdiction of Identification No.)
incorporation)
302 West Fayette Street
Baltimore, Maryland 21201
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (410) 385-4500
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ITEM 5. OTHER EVENTS.
On August 3, 1999, PharmaKinetics Laboratories, Inc. issued a
press release with respect to its receipt of a Warning Letter from the
United States Food and Drug Administration (FDA) regarding
Pharmakinetics' noncompliance with certain required protocols in its
bioequivalence studies. In the warning letter, the FDA advises
PharmaKinetics to take immediate corrective action and that the failure
to do so may result in regulatory action. The press release describes,
among other things, actions being taken by PharmaKinetics in connection
with the matters raised in the warning letter. The full text of the
press release is set forth in Exhibit 99.1 attached hereto and is
incorporated in this report as if fully set forth herein.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Not applicable.
(b) Not applicable.
(c) Exhibits:
99.1 Press Release dated August 2, 1999.
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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.
PHARMAKINETICS LABORATORIES, INC.
Date: August 5, 1999 By: /s/ James K. Leslie
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James K. Leslie,
President and
Chief Executive Office
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<PAGE>1 Contact: James K. Leslie
President and
Chief Executive Officer
Taryn L. Kunkel
Vice President and
Chief Financial Officer
(410) 385-4500
FOR IMMEDIATE RELEASE
PHARMAKINETICS LABORATORIES, INC.
FDA WARNING LETTER
Baltimore, Maryland, August 2, 1999 - - PharmaKinetics
Laboratories, Inc. (OTCBB: PKLB) announced today that it has
received a Warning Letter from the Food and Drug Administration
as the result of the FDA's inspection of a number of
bioequivalence studies conducted by the Company. The inspections
took place during the past 18 months covering various studies
conducted between 1995 and 1998. The letter states that the
Company has failed to conduct certain studies in accordance with
the protocol in areas set forth to protect the rights, safety and
welfare of test subjects and with respect to test subject
inclusion/exclusion criteria and has requested the Company to
take immediate corrective action.
Prior to receiving the Warning Letter the Company had already
begun to address the issues that had been identified in these FDA
inspections. Quality systems and procedures have been evaluated
by an outside consultant and procedures to improve study conduct
and protocol compliance have been put in place. The Company is
confident its ongoing corrective actions will resolve the
deficiencies.
James K. Leslie, President & CEO, said, "We intend to respond to
the Warning Letter promptly. We plan to meet with FDA to discuss
the procedures we have put in place to prevent the re-occurrence
of these issues. We will work with FDA to ensure that the issues
raised in the letter are addressed to their satisfaction."
This press release contains certain forward-looking statements
based on current expectations, and which entail various risks and
uncertainties that could cause actual results to differ
materially from those expressed in such forward-looking
statements. Such risks and uncertainties include the dependence
of the Company on the product development cycles of its clients,
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dependence of the Company on certain customers, dependence of the
Company on its key personnel and their ability to continuously
develop new methodologies for clinical and analytical
applications, and the Company's ability to bring its information
technology and non-information technology systems into compliance
with standards for successful operations as of January 1, 2000.
Other more general factors that could cause or contribute to such
differences include, but are not limited to, general economic
conditions, conditions affecting the pharmaceutical industry, and
consolidation resulting in increased competition within the
Company's market. Additional risks are detailed in the Company's
periodic filings with the Securities and Exchange Commission,
including those risks identified in the section captioned,
"Management Discussion and Analysis of Financial Condition and
Results of Operations" in the Company's annual report on Form
10-K for the year ended June 30, 1998 and its quarterly report on
Form 10-Q for the quarter ended March 31, 1999, which discussion
is incorporated in this press release by reference.
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