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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) September 10, 1998
SCHEIN PHARMACEUTICAL, INC.
(Exact name of registrant as specified in its charter)
New Jersey
(State or other jurisdiction of incorporation)
1-14019 11-2726505
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(Commission File Number) (IRS Employer Identification No.)
100 Campus Drive
Florham Park, New Jersey 07932
(Address of principal executive offices)
(973) 593-5500
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(Registrant's telephone number, including area code)
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Item 5. Other Events
On September 10, 1998, Schein Pharmaceutical, Inc. ("SCHEIN") reported
that the Federal Food and Drug Administration ("FDA") had filed a seizure action
against all products manufactured by Schein's Steris Laboratories, Inc.
subsidiary and which are in Schein's possession.
A copy of SCHEIN's press release is attached to this Form 8-K as an
Exhibit and is incorporated herein by reference.
Item 7. Exhibits
Exhibit 99 Press Release dated September 10, 1998
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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 thereunto duly authorized.
SCHEIN PHARMACEUTICAL, INC.
DARIUSH ASHRAFI
By:-------------------------------------
Dariush Ashrafi
Executive Vice President and
Chief Financial Officer
Dated: September 11, 1998
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INDEX TO EXHIBIT
Exhibit No. Description
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99 Press Release dated September 10, 1998
Schein Pharmaceutical, Inc.
100 Campus Drive
Florham Park, NJ 07932
Tel. 973 593-5500
Fax 973 593-5598
PRESS RELEASE
Contact: Melody A. Carey, Investor Relations
Telephone: (973) 593-5535
Fax: (973) 593-5598
FOR IMMEDIATE RELEASE
- --------------------------------------------------------------------------------
SCHEIN PHARMACEUTICAL'S STERIS PRODUCTS SEIZED BY FDA
Florham Park, New Jersey - September 10, 1998 - Schein Pharmaceutical, Inc.
(NYSE:SHP) announced that the Food and Drug Administration ("FDA") today filed a
seizure action against all products manufactured by its Steris Laboratories,
Inc. subsidiary and which are in the Company's possession. These actions do not
involve products manufactured at any of the Company's other sites. "The FDA
generally uses seizures as preludes to negotiations of consent orders," noted
Paul Feuerman, Schein's Senior Vice President and General Counsel.
"The practical effect of these actions has been to halt manufacturing and
distribution of Steris products, which account for a very significant portion of
the Company's sales and profits. As soon as the actions were filed, the Company
was advised by the FDA that it would shortly receive a draft of a proposed
consent order," Mr. Feuerman continued. "We hope to reach a settlement with the
FDA within a matter of days, which would permit resumption of manufacturing and
distribution of Steris products."
As previously reported, Steris has been in discussion with the FDA concerning
certain cGMP deficiencies noted in recent inspections of its Phoenix facility
and cited in the Warning Letter Steris received in early 1998. While Steris
believes that progress has been made in those discussions, Steris had been
apprised that it has not yet satisfactorily addressed the FDA's concerns in
these and certain other areas. "Still, today's actions were inconsistent with
the Company's understanding of the progress that had been made in meeting the
FDA's concerns," Mr. Feuerman noted. "A consent arrangement would allow us to
formalize a process for resolving the open issues."
Schein Pharmaceutical is one of the leading generic pharmaceutical companies in
the United States. The Company develops, manufactures and markets one of the
broadest generic product lines in the pharmaceutical industry through the
integration of its product development expertise, diverse, high-volume
production capacity and direct sales and marketing force. The Schein product
line includes both solid dosage and sterile dosage generic products, and the
Company is also developing a line of specialty branded pharmaceuticals. The
Company's branded product, INFeD(R), is the leading injectable iron product in
the United States. The Company has a substantial pipeline of products under
development. The Company enhances its internal product development,
manufacturing and marketing capabilities through strategic collaborations.
Schein Pharmaceutical has more than 1,900 employees with manufacturing plants
located in Arizona, Connecticut, New Jersey, New York and Puerto Rico.
Certain of the matters discussed in this press release contain statements
concerning future events or results. These "forward looking" statements involve
certain significant risks and uncertainties, and actual results may differ
materially from the forward-looking statements. Some important factors which may
cause results to differ include: the difficulty of predicting FDA approvals, the
uncertainty of acceptance and demand for the Company's new products, the impact
of competitive products and pricing, the availability of raw materials,
uncertainties associated with litigation and regulatory matters, and
fluctuations in operating results. Other important factors that may cause actual
results to differ materially from the forward looking statements are discussed
in the "Risk Factors" and "Management's Discussion & Analysis of Financial
Condition and Results of Operations" sections of the Company's prospectus dated
April 8, 1998, which is on file with the Securities and Exchange Commission as
part of the Company's Registration Statement on Form S-1. Readers are urged to
read the prospectus carefully to better understand these factors. The Company
does not undertake to publicly update or revise any of its forward looking
statements even if experience or future changes show that the indicated results
or events will not be realized.
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Editor's note: This release is available on the Internet at
http:/www.noonanrusso.com
