To all:
Here is just another excellent example of a press release. Hope ADVR is lurking around these threads!
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Friday November 21, 11:42 am Eastern Time
Company Press Release
SOURCE: The Liposome Company
The Liposome Company on Track to File NDA for TLC D-99 for Metastatic Breast Cancer
- 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 - news) 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. |
