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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 0R 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) December 22, 1994
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CENTOCOR, INC.
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(Exact name of registrant as specified in its charter)
PENNSYLVANIA 0-11103 23-2117202
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(State or other juris- (Commission file (IRS Employer
diction of incorporation) number) Identification No.)
200 GREAT VALLEY PARKWAY, MALVERN, PENNSYLVANIA 19355
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (215) 651-6000
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NOT APPLICABLE
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(Former name or former address, if changed since last report)
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Item 5. OTHER EVENTS.
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The Registrant has recently made several announcements concerning
marketing approvals for certain of its products and the settlement of certain
patent litigation filed against the Registrant by Genentech, Inc. Because of the
proximity in time of the several announcements, the Registrant prepared a letter
to shareholders, to be mailed on or about January 30, 1995, summarizing the
announcements. A copy of the letter to shareholders, and copies of each of the
Registrant's press releases for the announcements, are filed as exhibits to this
Current Report on Form 8-K.
Item 7. FINANCIAL STATEMENTS AND EXHIBITS.
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EXHIBITS:
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99.1 Registrant's letter to Shareholders dated January 30, 1995.
99.2 Registrant's Press Release dated December 22, 1994.
99.3 Registrant's Press Release dated January 4, 1995.
99.4 Registrant's Press Release dated January 5, 1995.
99.5 Registrant's Press Release dated January 10, 1995.
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SIGNATURES
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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.
CENTOCOR, INC.
Registrant
Dated: January 31, 1995 By: /s/ George D. Hobbs
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George D. Hobbs, Vice President,
Corporate Counsel and
Secretary
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January 30, 1995
Dear Fellow Shareowners:
Since the past month has been an eventful and exciting period for Centocor, we
wanted to summarize our recent announcements and provide you with a brief
update. Through the hard work and cooperation of Centocor people, our partners
and the regulatory agencies, we have received the following product approvals
and recommendations:
1) December 22, 1994: Centocor and Eli Lilly and Company announced that the
U.S. Food and Drug Administration (FDA) granted a license to market
ReoPro(TM) in the United States. ReoPro(TM) is indicated for the
reduction of acute cardiac complication in patients undergoing
angioplasty procedures who are at high risk of abrupt closure. It will be
marketed and distributed by Eli Lilly and Company worldwide.
On the same day, Centocor and Lilly announced that the Committee for
Proprietary Medicinal Products (CPMP) of the European Union issued a
positive opinion regarding the granting of marketing authorization in 11
of 12 member states in Europe for ReoPro(TM). The issuance of national
licenses and approvals for pricing and reimbursement applications is
still pending.
2) January 4, 1995: Centocor and Wellcome Foundation, Ltd. announced that
the Paul Ehrlich Institute, the German regulatory body for vaccines and
antibodies, had granted marketing authorization for the use of
Panorex(TM) as adjuvant therapy in the treatment of post-operative
colorectal cancer. Centocor will manufacture Panorex(TM) and the Wellcome
Foundation, Ltd. will market and distribute the product.
3) January 10, 1995: Centocor announced that the FDA granted
clearance/approval to market two diagnostic test kits addressing syphilis
and ovarian cancer. CAPTIA (TM) Syphilis-G, is an infectious disease
serology test for use as a primary screening method for the detection of
Treponema pallidum antibodies in human serum or plasma, as performed in
blood bank or plasma center testing laboratories. CA 125 II (TM), a
second generation cancer assay, received premarket approval application
(PMA) supplement approval for use as an aid in the detection of residual
epithelial ovarian cancer.
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-2-
Centocor also announced on January 5, 1995, the settlement of the patent
litigation regarding ReoPro(TM) and certain other of the Company's products
which was filed by Genentech, Inc. in the United States District Court for the
Northern District of California.
In addition to these recent announcements, there has been a good deal of public
discussion about our 1995 goal of profitability, and I would like to give some
insight into that goal. While no company -- including Centocor -- can make
promises and give assurances surrounding its future financial performance, we
felt it was the right time to signal to our employees and shareowners that we
should be measured not solely on scientific advancements and technological
innovation. In 1995, with several products approved, we should focus on
translating our strengths into an improved sales and earnings picture, as well.
To that end, we have articulated many times that, while we are flexible in our
planning and approach, our goal for 1995 would be to achieve profitability.
To become profitable, it is clear that we need several things to occur: we must
have early and strong market acceptance for both ReoPro(TM) and Panorex(TM); we
must develop growth in our core Diagnostics business that is better than the
current industry rate; we must conclude a financially sound long-term strategic
alliance for our CenTNF(TM) product (for rheumatoid arthritis and inflammatory
bowel disease); and, we must continue to aggressively manage our internal cost
structure. Of course, if these developments do not occur, our goal of
profitability this year would not be attained, and we would show an operating
loss. All of our actions will be aimed at balancing the near-term financial
prospects of the company with its long term health. Our top priority remains:
increasing the value of Centocor for its shareowners.
With several noteworthy announcements behind us and several operational
challenges ahead, we look forward to another year of growth and increased focus.
Thank you for your continued support.
Regards,
David P. Holveck
President and CEO
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[LOGO OF CENTOCOR APPEARS HERE] NEWS RELEASE
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December 22, 1994
Immediately
(317) 276-3655 Edward A. West(Lilly)
(610) 889-4459 Tim Cost (Centocor)
(610) 651-6122 Beth Field Wallace (Centocor)
CENTOCOR ANNOUNCES THE CLEARANCE TO MARKET REOPRO IN THE U.S.
(Leiden, The Netherlands) -- Centocor B.V., a wholly owned subsidiary of
Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA)
has granted a license for the product ReoPro(TM) (Abciximab). ReoPro is
indicated for the reduction of acute cardiac complications in patients
undergoing angioplasty procedures who are high risk for abrupt artery closure.
It will be marketed and distributed in the U.S. by Eli Lilly and Company. ReoPro
is the first monoclonal antibody that inhibits platelet aggregation and will be
available to the market in February 1995.
In addition, the Committee for Proprietary Medicinal Products (CPMP) of the
European Union (EU) has also issued a positive opinion regarding the granting of
marketing authorization in 11 of the 12 member states for ReoPro. Belgium, the
only dissenting country in the EU, will require additional clinical trial
results. The issuance of national licenses and approvals for pricing and
reimbursement applications is still pending.
ReoPro is a monoclonal antibody that has been found to reduce the incidence of
blood-clot-related complications associated with high-risk coronary angioplasty.
RepPro works by binding to a specific receptor on platelets, thereby inhibiting
their aggregation. It is through this action that ReoPro reduces the
development of blood clots in the treated coronary artery. Coronary-artery
blood clots can lead to ischemic complications such as heart attacks, death,
emergency repeat angioplasty, or bypass surgery.
The results of clinical trials involving more that 2,000 high-risk patients
undergoing angioplasty indicate that ReoPro administered in addition to
standard therapy reduced acute ischemic complications associated with the
procedure. The lower incidence of complications using ReoPro was sustained at
the six month follow-up. While bleeding is a complication of angioplasty
procedures, use of ReoPro was associated with a significant increase in the
incidence of major bleeding.
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More than 400,000 angioplasty procedures will be performed in the U.S. in 1994,
and this figure is estimated to grow approximately 10 percent each year through
1997. Nearly 30 percent of all angioplasties may be performed in patients who
are at high risk for ischemic complications.
Developed by Centocor, Inc., ReoPro (Abciximab) is the company's first
therapeutic agent to enter the U.S. marketplace. With their expertise in
monoclonal antibody technology, Centocor, Inc., will continue to investigate
additional indications for ReoPro. ReoPro is manufactured by Centocor B.V. in
Leiden, The Netherlands. Eli Lilly and Company will market, sell, and
distribute the product.
"The clearance to market ReoPro represents a breakthrough for Centocor and
cardiovascular medicine," said David P. Holveck, president and chief executive
officer of Centocor, Inc. "We have reached the significant milestone of
bringing our first pharmaceutical product to market in collaboration with Lilly.
Equally important, we believe that ReoPro meets a critical medical need for
certain patients with heart disease." Holveck also noted that the review of
ReoPro by the FDA took only one year from the application's submission on
December 15 of last year.
"The therapeutic class of cardiovascular disease is the largest category in the
global market for pharmaceutical products. The introduction of ReoPro reinforces
our commitment to strengthening Lilly's presence in cardiovascular research, and
it emphasizes the importance of the collaborative alliances we have developed
with our biotechnology company partners," said Randall L. Tobias, Lilly
chairman and chief executive officer.
Centocor develops, manufactures, and markets diagnostic and therapeutic products
for human health care. The company's products are based on monoclonal antibody
and peptide technology and are primarily intended for use in the management of
patients with infectious, cardiovascular, and autoimmune diseases and cancer.
Lilly is a global research-based pharmaceutical corporation headquartered in
Indianapolis, Indiana, that is working with its customers worldwide to help
ensure that diseases are prevented, managed, and cured with maximum benefit and
minimum cost to patients and society.
________________________
ReoPro(TM), Lilly
Full prescribing information is available on request.
# # #
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[COMPANY LOGO GOES HERE] NEWS RELEASE
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FOR IMMEDIATE RELEASE CENTOCOR CONTACT: TIMOTHY P. COST
(610) 889-4459
BETH FIELD WALLACE
(610) 651-6122
WELLCOME CONTACT: JUSTINE FRAIN
011-44-71-387-4477
WELLCOME AND CENTOCOR ANNOUNCE APPROVAL
TO MARKET PANOREX IN GERMANY
NEW DRUG FOR THE TREATMENT OF COLORECTAL CANCER
London, England and Malvern, PA January 4,1995 (8:30 AM/EDT/U.S.) -- Wellcome
plc (NYSE:WEL) and Centocor, Inc. (Nasdaq:CNTO) today announced that the Paul
Ehrlich Institute, the German regulatory body for vaccines and antibodies, has
granted marketing authorization for the use of Panorex(R) as adjuvant therapy in
the treatment of post-operative colorectal cancer. Centocor will manufacture
Panorex(R) and Wellcome will distribute the product. Wellcome expects to launch
the product in Germany in the next few months.
Pivotal clinical study results of Panorex(R) (Mab 17-1A) for the treatment of
colorectal cancer were published in The Lancet in May 1994. These results of a
study of 189 patients, half of whom received Panorex(R) after surgery for Dukes'
C colorectal cancer, showed that the overall death rate after a median follow-up
of five years was reduced by 30% and the recurrence rate decreased by 27%.
Marketing authorization for Panorex(R) was applied for in Germany in July 1994.
Applications for market authorization have also been submitted in Austria,
Finland and Sweden. Additional clinical studies with Panorex(R) will be
conducted by Wellcome and are expected to begin in Europe, the U.S., and Japan
during 1995.
Dr. David Barry, Wellcome's Group Director of Research, Development and Medical
Affairs said, "This represents a major step forward for colorectal cancer
patients and is the first approval of an antibody for cancer therapy."
David P. Holveck, Centocor's president and chief executive officer, also
commented, "The approval of Panorex(R) expands and diversifies Centocor's
approved therapeutic product line beyond cardiology to include the critical area
of cancer treatment, complementing our line of advanced cancer diagnostic
products." On December 22, 1994, Centocor also announced that it had received
U.S. approval and CPMP recommendation for its first cardiology drug, ReoPro(TM).
(MORE)
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It is estimated that there were approximately 230,000 cases and 87,000 deaths in
Europe from colorectal cancer in 1992. Colorectal cancer is the second most
prevalent cancer in the western world.
Wellcome is a research based pharmaceutical group which discovers and markets
innovative products worldwide.
Centocor develops, manufactures, and markets diagnostic and therapeutic products
for human healthcare. Centocor's products are based on monoclonal antibody and
peptide technologies, and are primarily intended for the management of patients
with infectious, cardiovascular and autoimmune diseases, and cancer.
Panorex is a trademark of Centocor, Inc.
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[COMPANY LOGO GOES HERE] NEWS RELEASE
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FOR IMMEDIATE RELEASE CENTOCOR CONTACT: TIMOTHY P. COST
(610-889-4459)
BETH FIELD WALLACE
(610-651-6122)
CENTOCOR CONFIRMS LAWSUIT RESOLUTION WITH GENENTECH
MALVERN, PA, January 5, 1995 -- Centocor, Inc. (Nasdaq:CNTO) confirmed today
that Genentech, Inc. has "agreed to dismiss its pending action against Centocor,
Inc. for infringement of Genentech's Cabilly patent and to grant Centocor a
non-exclusive royalty bearing license under Genentech's patents for ReoPro (7E3
antibody) product" as stated this morning in a news release from Genentech.
No terms of the agreement were disclosed.
"We are extremely pleased to have this litigation concluded in a positive and
timely way," said David P. Holveck, president and chief executive officer of
Centocor. ReoPro(TM), an anti-platelet monoclonal antibody which will be
manufactured by Centocor and distributed worldwide by Eli Lilly and Company, was
granted market clearance on December 22 by the U.S. Food and Drug Admistration,
and has been recommended for marketing authorization by the Committee for
Proprietary Medicinal Products (CPMP) in Europe.
Centocor develops, manufactures, and markets diagnostic and therapeutic products
for human healthcare. Centocor's products are based on monoclonal antibody and
peptide technologies, and are primarily intended for the management of patients
with infectious, cardiovascular and autoimmune diseases, and cancer.
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[LOGO OF CENTOCOR GOES HERE] NEWS RELEASE
______________________________________________________________________________
FOR IMMEDIATE RELEASE CENTOCOR CONTACT: TIMOTHY P. COST
(610-889-4459)
BETH FIELD WALLACE
(610-651-6122)
CENTOCOR RECEIVES FDA CLEARANCE/APPROVAL
TO MARKET TWO DIAGNOSTIC TEST KITS
MALVERN, PA, January 10, 1995 -- Centocor, Inc. (Nasdaq:CNTO) announces today
that it has received clearance/approval from the U.S. Food and Drug
Administration to market new diagnostic products addressing syphilis and ovarian
cancer.
CAPTIA (TM) Syphilis-G, an infectious disease serology test, received 510(k)
clearance for use as a primary screening method for the detection of Treponema
pallidum antibodies in human serum or plasma, as performed in blood bank or
plasma center testing laboratories. This is the first syphilis
microtiter-based enzyme immunoassay approved for blood and plasma screening, and
is designed to be fully automated.
CA 125 II(TM), a second generation cancer assay, received premarket approval
application (PMA) supplement approval for use as an aid in the detection of
residual epithelial ovarian cancer. CA 125 II(TM) enhances low-end sensitivity
as compared to the original assay.
"We are pleased to add these two key U.S. diagnostics product approvals to our
list of recent regulatory approvals," said David P. Holveck, president and chief
executive officer of Centocor. "Our Diagnostics business continues to be a key
driver for our current financial performance, and we are committed to identify
ways to enhance its prospects. Placing our unique antibodies into our partners'
automated test kits represents a solid new technology platform for us to build
on."
Centocor currently manufactures diagnostic tumor markets for epithelial ovarian
cancer (CA 125), pancreatic cancer (CA 19-9), breast cancer (CA 15-3), gastric
cancer (CA 72-4), and lung cancer (CYFRA 21-1). These markers are incorporated
into test kits marketed and sold by a variety of global and regional partners.
In addition, Centocor manufacturers infectious disease test kits that are
marketed by partners worldwide for rubella, cytomegalovirus, and toxoplasma.
Centocor develops, manufactures, and markets diagnostic and therapeutic products
for human healthcare. Centocor's products are based on monoclonal antibody and
peptide technologies, and are primarily intended for the management of patients
with infectious, cardiovascular and autoimmune diseases, and cancer.
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