SANGSTAT MEDICAL CORP
8-K, 1999-01-12
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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<PAGE>   1

                       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 4, 1999
                                                  ------------------------------

                          SANGSTAT MEDICAL CORPORATION
               --------------------------------------------------
               (EXACT NAME OF REGISTRANT AS SPECIFIED IN CHARTER)


<TABLE>
<S>                                  <C>                    <C>
      Delaware                         0-22890                  94-3076-069
- --------------------------------------------------------------------------------
(State or other jurisdiction         (Commission               (IRS Employer
  of incorporation)                  File Number)           (Identification No.)
</TABLE>

<TABLE>
<S>                                                                   <C>
1505 Adams Drive, Menlo Park, California                                94025
- --------------------------------------------------------------------------------
(Address of Principal Executive Offices)                              (Zip Code)
</TABLE>

Registrant's telephone number, including area code         (650) 328-0300
                                                   -----------------------------


- --------------------------------------------------------------------------------
         (Former name or Former Address, if Changed Since Last Report.)

<PAGE>   2

ITEM 5.   OTHER EVENTS.

          On January 4, 1999, SangStat Medical Corporation, a Delaware
          corporation, ("SangStat" or the "Company") announced that President
          and Chief Operating Officer, Jean-Jacques Bienaime, will take over as
          Chief Executive Officer on February 1, 1999. Dr. Philippe Pouletty
          will remain actively involved as Chairman of the Board of Directors of
          the Company.

<PAGE>   3

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

          (a)  Financial Statements of Business Acquired. - Not applicable

          (b)  Pro Forma Financial Information.  -  Not applicable

          (c)  Exhibits.

               Exhibit        Description
               -------        -----------
               99.1           Text of Press Release dated January 4, 1999.

<PAGE>   4

                                   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.


                                       SANGSTAT MEDICAL CORPORATION



Date:  January 11, 1999                By: /s/ James F. Hinrichs
                                           ---------------------------------
                                           James F. Hinrichs, CFA
                                           Chief Financial Officer
                                           (Duly Authorized Officer and
                                           Principal Financial Officer)

<PAGE>   5

                                  EXHIBIT INDEX

<TABLE>
<CAPTION>
Exhibit
Number         Description
- -------        -----------
<S>            <C>
99.1           Text of Press Release dated January 4, 1999.
</TABLE>


<PAGE>   1

                                                                    EXHIBIT 99.1

                   TEXT OF PRESS RELEASE DATED JANUARY 4, 1999



MONDAY JANUARY 4, 5:15 PM EASTERN TIME

COMPANY PRESS RELEASE

JEAN-JACQUES BIENAIME CEO OF SANGSTAT MEDICAL CORPORATION EFFECTIVE FEBRUARY
1ST, 1999

PHILIPPE POULETTY, MD, TO CONTINUE AS CHAIRMAN OF SANGSTAT'S BOARD OF DIRECTORS

     MENLO PARK, Calif.--(BW HealthWire)--Jan. 4, 1999--SangStat, The Transplant
Company(R), (Nasdaq:SANG - news) announced today that Jean-Jacques Bienaime will
be CEO of SangStat on February 1, 1999. Mr. Bienaime joined SangStat 6 months
ago as President and COO. Philippe Pouletty, MD, founder, Chairman and CEO will
resign as CEO but will remain actively involved with the Company as Chairman of
SangStat's Board of Directors.

     "In 1998, SangStat transitioned from a development stage to a commercial
stage global specialty pharmaceutical company. The FDA approvals of two
therapeutic products, SangCya(tm) and Thymoglobulin(R), the acquisition of Rhone
Poulenc's transplant division, now IMTIX-SangStat, the issuance of our
cyclosporine US patents, the near term potential approval of our cyclosporine in
Europe, and a strong management team in North America and Europe opened a new
phase," said Dr. Pouletty. "Jean-Jacques has extensive experience with product
launches, strategic marketing, product in-licensing and pharma-group operations.
He is an outstanding CEO for the next phase of SangStat's development: striving
to become the leading transplant care company generating significant revenues
and profits. Jean-Jacques has already had a significant impact through his
initial role as President and COO where he concentrated on shaping SangStat's
commercial infrastructure to prepare the launch of SangCya and Thymoglobulin in
the US, and cyclosporine in Europe".

     "I am grateful to Philippe and the Board for this exciting opportunity and
look forward to the challenges and demands of the position of CEO. The
management, the Board and I are enthusiastic about SangStat's future and I am
delighted to be part of this exciting time in SangStat's development into a
global specialty pharmaceutical company." said Jean-Jacques Bienaime. "I believe
SangStat is one of the most promising pharmaceutical companies today, with a
well defined mission for a focused disease management strategy, strong ties with
the transplant community, products on the market in the US and Europe all with
significant revenue potential, and attractive opportunities for growth from our
pipeline and through potential acquisitions. Reaching profitability will be my
first priority."

     Before joining SangStat as President and COO, Jean-Jacques Bienaime was
Senior Vice-President of Corporate Marketing and Business Development at Rhone
Poulenc Rorer Inc. (RPR), a leading pharmaceutical company worldwide. Since 1992
he held various

<PAGE>   2

positions of increasing responsibility within RPR's US and International
marketing, sales and corporate strategy including full P&L responsibility for a
650 person US organization with 1997 revenues of over $400 million and
successful US launches of RPR's two leading products, Lovenox and Taxotere.
Previously, Mr. Bienaime was responsible at Genentech for launching Activase(R)
(tPA or tissue-plasminogen activator), a break-through drug for use in the
management of heart-attack and stroke patients and one of the most successful
biotechnology drug launches in the United States (1997 worldwide sales of $261
MM). Mr. Bienaime received his Masters of Business Administration from the
Wharton School University of Pennsylvania and a degree in Economics from Ecole
Superieure de Commerce de Paris in France. He is a member of the board of
directors of Fox Chase Cancer Center in Philadelphia.

     Philippe Pouletty intends to remain actively involved in the Company as
chairman of the Board of Directors of SangStat focusing on corporate strategy,
product pipeline and potential acquisitions. Philippe Pouletty, MD, was founder
of SangStat in 1988, President and CEO and a director of the company from 1988
to 1995, and chairman of the Board of Directors and CEO since 1995. He is
chairman of the board of directors of DrugAbuse Sciences Inc., a private
emerging pharmaceutical company dedicated to drug addiction care, and a member
of the board of Conjuchem, a private biotechnology company.

SangStat, The Transplant Company(R)

     SangStat is a specialty pharmaceutical company applying a disease
management approach to improve the outcome of organ transplantation. SangStat
has a total of 12 monitoring and therapeutic products and product candidates to
address the pre-transplant, acute care and chronic phases of transplantation.
SangStat received FDA marketing approval for SangCya (Cyclosporine Oral
Solution, USP (MODIFIED) 100 mg/mL) in October 1998 and for Thymoglobulin on
December 30, 1998. SangStat is based in Menlo Park, California, and operates The
Transplant Pharmacy(R), a comprehensive pharmacotherapy management program, and
wholly owned subsidiaries, IMTIX-SangStat, SangStat's European base of
operations in Lyon, France, SangStat Canada, Ltd. in Mississauga, Ontario,
Canada and Human Organ Sciences(tm), in Menlo Park, California.

     This press release contains forward-looking statements that involve risks
and uncertainties. Forward-looking statements reflect SangStat's current views
with respect to future events. Actual results may vary materially and adversely
from those anticipated, believed, estimated, or otherwise indicated. Important
risk factors common to the regulatory review and approval process, as well as
new product launches, could cause actual results to differ materially with
regard to the possible market acceptance of SangStat's finished cyclosporine
drug product SangCya, CycloTech device and Thymoglobulin.

     Factors that could cause actual results to differ materially include,
without limitation, uncertainty related to the current or future manufacturing
of commercial quantities of SangCya, CycloTech and Thymoglobulin on commercially
favorable terms, adequate and continuous supply of bulk cyclosporine drug
substance and CycloTech devices, market acceptance, profitability, competition,
potential litigation and governmental review of The Transplant Pharmacy. For a
discussion of other factors that might result in different outcomes, see
SangStat's 1997 Form 10-K, in particular "Risks Associated with CYCLOSPORINE"
set

<PAGE>   3

forth therein, and the Company's filings on Form 10-Q with the Securities and
Exchange Commission.

     You can find copies of our latest press releases on the web at
www.sangstat.com

     SangStat, The Transplant Company(R), Jim Hinrichs, 650/688-2304 (Chief
Financial Officer), Therese Crozier, 650/688-2331 (Corp. Communications).


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