Wednesday February 21, 11:00 am Eastern Time
Press Release
SOURCE: BioTransplant Incorporated
BioTransplant Announces CE Mark Authorization for
Eligix Cell Separation Product
- Eligix Prepares to Market Cancer Products in Europe -
CHARLESTOWN, Mass., Feb. 21 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN - news) announced today
that Eligix Inc. has received European Community authorization to affix the CE Mark to its BCell-HDM (high density
microparticle) cell separation devices for the treatment of B cell malignancies commonly treated by bone marrow stem cell
transplantation which include non-Hodgkins lymphoma, multiple myeloma, chronic lymphocytic leukemia, and other
malignancies commonly treated by bone marrow stem cell transplantation. BioTransplant previously announced that it has
signed a definitive agreement to acquire Eligix in a merger, which is expected to close in the first half of 2001. Assuming the
merger closes as planned, this advance will enable BioTransplant, to market the first of a planned series of Eligix Cell
Separation products in all member countries of the European Community.
The Eligix Cell Separation products are further targeted by BioTransplant for development as a component of the
AlloMune(TM) System, along with its proprietary monoclonal antibody MEDI-507, as a complete approach to increase the
safety and efficacy of immune modulation and transplantation for cancer and other diseases.
Through its planned acquisition of Eligix, BioTransplant seeks to further its strategic vision to become the leading company in
cellular therapies for cancer and other life threatening diseases, including human organ transplantation. ``Earning the CE Mark
for Eligix' lead product, BCell-HDM, underscores the near term value that we expect will arise from the merger between
BioTransplant and Eligix,'' stated Elliot Lebowitz, Ph.D., CEO of BioTransplant. ``Together we are committed to bringing to
market a series of bio-therapeutic products with the potential to substantially enhance patient outcomes following stem cell
transplantation and immune therapy for cancer and other serious diseases.''
``Earning the CE Mark enables us to market the first of our therapeutic products in the European Union. This achievement
represents a substantial accomplishment by the Eligix organization,'' said Walter Ogier, President and CEO of Eligix. ``In
addition to preparing for commercial launch with BioTransplant, our development efforts will now be focused on our second
therapeutic product, TCell-HDM, which is expected to receive CE marking later this year. The combined product portfolios of
BioTransplant and Eligix will present a strong near- and mid-term pipeline of development-stage therapeutic products which we
will seek, pending regulatory approval, to introduce in Europe and North America over the next several years. These products,
targeted to enhance the practice of autologous and allogeneic bone marrow stem cell transplantation as well as solid organ
transplantation, are being designed to address large, underserved patient markets that represent a very substantial commercial
opportunity for the company.''
The current European market opportunity for BCell-HDM comprises approximately 12,000 autologous stem cell transplants
performed in that region each year for the treatment of B-cell malignancies, a number which has been growing steadily over the
past decade and includes principally Non-Hodgkin's lymphoma, multiple myeloma, and chronic lymphocytic leukemia patients.
The Companies estimate that autologous transplantation for cancer accounts for an estimated $1 billion in healthcare
expenditures worldwide each year. The annual expenditures on autologous transplantation for cancers reflects the widespread
publication over the past decade of clinical evidence for superior long term patient outcomes from transplantation in comparison
to other healthcare options including conventional chemotherapies, radiation therapies and newer biologic therapies.
BCell-HDM is targeted to further enhance transplant outcomes versus those obtainable using non-transplant approaches.
BioTransplant Incorporated utilizes its proprietary technologies under development to re-educate the body's immune responses
to allow tolerance of foreign cells, tissues and organs. Based on this technology, the Company is developing a portfolio of
products for application in a range of medical conditions, including treatment of cancer and autoimmune diseases, organ and
tissue transplantation, for which current therapies are inadequate. BioTransplant's products under development are intended to
increase the therapeutic benefit of bone marrow transplants, reduce or eliminate the need for lifelong immunosuppressive
therapy, and induce long-term functional transplantation tolerance in humans.
Other Important Information:
This announcement contains, in addition to historical information, forward-looking statements about BioTransplant that involve
risks and uncertainties. Such statements reflect management's current views and are based on assumptions, including statements
about the benefits of the BioTransplant/Eligix merger, the timing of the closing of the merger and the benefits of the merger.
Actual results could differ materially from those currently anticipated as a result of a number of important factors. Factors that
could cause future results to differ materially from such forward-looking statements include, but are not limited to:
BioTransplant's ability to secure the substantial additional funding required for its operations and research and development
programs; failure of BioTransplant's or Eligix's stockholders to approve the merger; the failure of the combined business to
realize anticipated benefits of the merger; the risk that, if the merger is consummated as planned, BioTransplant's and Eligix'
business will not be integrated successfully; BioTransplant's ability to successfully discover, develop and commercialize its
products, obtain required regulatory approvals in a timely fashion, and overcome other difficulties inherent in developing
pharmaceuticals and procedures for organ transplantation; BioTransplant's ability to obtain and enforce the patent protection
required for its products; uncertainties to the extent of future government regulation of the transplantation business; and
BioTransplant's ability to maintain collaborations and joint venture alliances with third parties. For a detailed discussion of these
and other factors, please refer to BioTransplant's filings with the Securities and Exchange Commission, including the discussion
set forth in the section titled ``Business -- Factors Which May Affect Results'' in BioTransplant's current annual report on Form
10-K, as filed with the Securities and Exchange Commission.
Investors and stockholders are urged to read the proxy statement/prospectus relating to the BioTransplant/Eligix merger, filed
with the Securities and Exchange Commission by BioTransplant (file no. 333-53386), because it contains important
information. The proxy statement/prospectus will be sent to the stockholders of BioTransplant seeking their approval of the
proposed transaction. A free copy of the proxy statement/prospectus and other documents filed by BioTransplant with the
Commission are available free at the Commission's web site at sec.gov. BioTransplant stockholders may also
obtain the proxy statement/prospectus and these other documents without charge by directing a request to: BioTransplant
Incorporated, Attention: Richard V. Capasso, Building 75, Third Avenue, Charlestown Navy Yard, Charlestown, MA 02129,
telephone (617) 241-5200. BioTransplant and its directors, executive officers, employees and certain other persons may be
deemed to be participants in the solicitation of proxies from BioTransplant's stockholders to approve the proposed
BioTransplant/Eligix merger. Such individuals may have interests in the merger, including as a result of holding options or shares
of the companies. A detailed list of the names, affiliations and interests of the participants in the solicitation are contained in
BioTransplant's proxy statement/prospectus contained in its registration statement filed with the Commission with respect to the
proposed merger.
ELIGIX TECHNOLOGY BACKGROUND
The Eligix Cell Separation System
The Eligix Cell Separation System is a cell therapy platform that allows for isolation and removal of subsets of cells from blood
and stem cell products. The BCell-HDM product is the first of a series of monoclonal antibody-coated High Density
Microparticle, or HDM, products that are being developed for a range of applications in transplant medicine. The BCell-HDM
system will be indicated in Europe for the removal of malignant B-cell lymphocytes from autologous stem cell transplants, as are
typically performed in conjunction with high dose chemotherapy for B-cell malignancies including non-Hodgkins lymphoma,
multiple myeloma and chronic lymphocytic leukemia.
The BCell-HDM system should provide physicians a commercial product for the first time, to achieve the ultimate treatment
goal of minimal residual disease in the patient, while allowing for nearly quantitative recovery of stem cells and other immune
cells (approximately 90%.) BioTransplant and Eligix believe that maximum stem cell and immune cell recovery is critical to
achieving optimal patient outcomes following transplantation. A multi-center, randomized Phase III study of the BCell-HDM
system is being planned for initiation in North America, and trials to develop further indications of the BCell-HDM system are
also being planned in the US and Europe.
A feasibility clinical trial sponsored by Eligix and performed by the Dana Farber Cancer Institute, to evaluate the BCell-HDM
product, showed that the technology is effective in purging potentially malignant B-cells from stem cell transplants to below
levels detectable by a very sensitive assay, while retaining an exceptionally high yield of desirable stem cell and other cell
populations for transplantation. The presence of potentially malignant B-cells in the transplant cell dose of patients suffering from
B-cell malignancies has been shown to correlate with relapse and reduced periods of disease free survival in clinical studies
conducted by transplant centers in North America and Europe, suggesting a potentially beneficial role for B-cell purging.
Although various purging methods are widely used by transplant physicians, the lack of efficient technology for B-cell purging
has limited the ability of physicians to complete a prospective, randomized trial of purging in transplantation.
Contacts:
BioTransplant Incorporated
Elliot Lebowitz, Ph.D.
President and CEO
(617) 241-5200
biotransplant.com
Noonan/Russo Communications, Inc.
Prateek Patnaik, (Media) ext. 273
Sharon Weinstein, (Investor) ext. 334
(212) 696-4455
e-mail: news@noonanrusso.com
Eligix, Inc.
Walter C. Ogier,
President and CEO
(781) 870-4601
SOURCE: BioTransplant Incorporated |
