The Liposome Company on Track to File NDA for TLC D-99 for Metastatic Breast Cancer
PR Newswire, Friday, November 21, 1997 at 11:59
- Wyeth-Ayerst to Launch ABELCET(R) in France and Italy in December -
PRINCETON N.J., Nov. 21 /PRNewswire/ -- At a meeting of investment
analysts sponsored by The Liposome Company, Inc. (NASDAQ:LIPO) executives led
by Charles A. Baker, Chairman and Chief Executive Officer, delivered an
assessment of the Company's recent progress and prospects. The Company's
marketed anti-fungal agent, ABELCET(R), continues to be well received in the
U.S., where it is the leading lipid-based formulation of amphotericin B, and
interest continues to grow internationally. Mr. Baker said that the Company
"expects to be able to file an NDA and to be able to make a European filing
for TLC D-99 in 1998." TLC ELL-12, a novel anti-cancer therapeutic, is
expected to enter human clinical studies in 1998, and the Company plans to
have a third anti-cancer agent, bromotaxol, in human clinical studies in 1999.
Mr. Baker also outlined the Company's program to in-license or co-promote
other hospital-based oncology products to leverage the proven capabilities of
its U.S. sales force and to further its goal of "developing a strong oncology
franchise."
The Company's new drug application ("NDA") for TLC D-99 to be filed with
the FDA will target the first line treatment of metastatic breast cancer, a
devastating disease that affects approximately 60,000 women annually in the
U.S. alone. "Our strategy has always been to develop TLC D-99 for solid
tumors," said James A. Boyle, Senior Vice President, Medical and Regulatory
Affairs. "Data from midpoint interim looks at each of our two Phase III
studies indicate that TLC D-99 is significantly less cardiotoxic than
conventional doxorubicin. Cardiotoxicity is the major dose-limiting
side-effect of doxorubicin. Notably, efficacy of the two drugs also appears
to be equivalent."
The Liposome Company is conducting two Phase III studies of TLC D-99,
liposomal doxorubicin, comparing it to conventional doxorubicin when used as a
single agent, and when each drug is used in combination with cyclophosphamide.
In addition to the encouraging cardiotoxicity and efficacy results, TLC D-99
appears to be associated with significantly less severe nausea and vomiting
and shows a strong trend towards less stomatitis and mucositis. In no case
were adverse events seen more frequently for TLC D-99 than for conventional
doxorubicin, nor were any additional toxicities observed. Data from these
studies are expected to be presented early next year.
Guest speaker Gerald Batist, M.D., of McGill University gave his
perspective on TLC D-99 as a practicing oncologist. Dr. Batist was the
primary investigator for a Phase II study of TLC D-99 and has studied the drug
for over ten years. In his remarks, he noted that doxorubicin is one of the
most active chemotherapeutic agents used today, but that the cardiotoxicity
risk is a key concern of practicing physicians. Dr. Batist added that even as
new drugs and other modalities are developed, doxorubicin will likely always
be used as an important component of therapy, particularly if cardiotoxicity
can be reduced. He observed that the results of TLC D-99 clinical studies
appear to confirm pre-clinical research that showed the anti-tumor efficacy of
TLC D-99 to be as good as conventional doxorubicin while being less
cardiotoxic. Finally, Dr. Batist indicated that in addition to playing a
potential role in treating metastatic breast cancer, TLC D-99 could
potentially have a role in other diseases where doxorubicin has activity,
including sarcomas, gastric cancer and lymphoma.
Don Yarson, Vice President, Sales, Marketing and Business Development,
updated analysts on ABELCET noting that in the U.S., the drug continues to be
well received, maintaining its market share despite the presence of two
competing products and significant amounts of free goods available to large
hospitals. He attributed its continuing success to the strong relationships
developed over the past two years with oncologists, infectious disease
specialists and pharmacists, innovative clinician support services like the
pioneering CLEAR(TM) program, and the strong clinical data supporting the
drug. To date, more than 10,000 patients in the U.S. have been treated with
ABELCET.
"Internationally, performance of ABELCET should strengthen," commented
Mr. Baker in his remarks. The Company expects its partner, Wyeth-Ayerst, to
launch ABELCET in the large French and Italian markets in December. In
France, where ABELCET is the only approved lipid-based formulation of
amphotericin B, one-half time of its partner's sales team of more than
30 people will focus on marketing ABELCET. Similarly, in Italy, ABELCET will
be promoted by over 40 representatives. On the Italian market, ABELCET is the
only lipid-based amphotericin B formulation to have its price approved by the
government for reimbursement.
The Liposome Company reported exciting developments in its programs
focusing on bioactive lipids. Andrew Janoff, Ph.D., Vice President, Research
and Development, said that TLC ELL-12, liposomal ether-lipid, was active in
several mouse tumors, both early and established, with demonstrated activity
comparable to the powerful chemotherapy treatment paclitaxel. ELL-12 has also
been shown to be active against a human prostate cancer model. Research has
revealed the drug to be one million times less toxic to bone marrow cells than
to tumor cells, which means it will not be myelotoxic to patients. ELL-12 is
undergoing pre-clinical toxicology testing in anticipation of commencing human
clinical studies in the second half of 1998.
Dr. Janoff also outlined several other cancer research programs including
development of a paclitaxel derivative called bromotaxol. In preclinical
studies bromotaxol showed promising efficacy with minimal toxicity. The
Company's scientists have demonstrated that bromotaxol completely cures
ovarian cancer in experimental models, something that paclitaxel does not do.
This novel anticancer agent could enter formal drug development in 1998 and
human clinical studies in 1999. Dr. Janoff concluded with a review of the
Company's research into gene delivery systems including encouraging results of
experiments to encapsulate DNA in liposomes and to achieve fusion with the
host cell.
In a question and answer session, Dr. Boyle outlined intriguing clinical
results that had been observed from sub-analyses of the Phase III study of
VENTUS(TM) for acute respiratory distress syndrome, ("ARDS") which ended in
June 1997. In these analyses, patients who had received a full course of
therapy of VENTUS spent significantly shorter time on mechanical ventilation
compared to patients receiving placebo. Similarly, among a subset of patients
who were less severely ill (as measured by APACHE scores) those receiving
VENTUS were able to be removed earlier from the ventilator than those on
placebo. The Liposome Company stated that it does not plan to devote its own
resources to the further development of VENTUS for ARDS, but would instead
seek to license it to another company.
The Liposome Company is a broad-based biopharmaceutical company developing
and marketing products based on its knowledge of lipid technology. ABELCET
(Amphotericin B Lipid Complex Injection) is marketed in the U.S. and other
countries for the treatment of severe systemic fungal infections. TLC D-99
and other products are being developed to treat various cancers. Research is
being conducted on new cancer therapies and biologically active lipids that
may have therapeutic applications.
Except for historical information, this press release contains
forward-looking statements that involve risks and uncertainties, including but
not limited to statements regarding the ability of ABELCET to retain its
leading position in the U.S. market, the timing of launches of ABELCET in
France and Italy, the timing of filings for marketing approval of TLC D-99,
the commencement of clinical trials of TLC ELL-12 and Bromotaxol, the
presentation of data from TLC D-99 Phase III trials, and the Company's plans
to in-license, co-promote, or out-license certain products. While these
statements reflect the Company's best current judgment, they are subject to
risks and uncertainties that could cause actual results to vary, including the
risk factors identified in the Registration Statement on Form S-3 dated
October 29, 1997 and from time to time in the Company's other SEC filings. |
