4
S E C U R I T I E S A N D E X C H A N G E
C O M M I S S I O N
Washington, D. C. 20549
F O R M 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): July 6, 1995
T H E L I P O S O M E C O M P A N Y, I N C.
(Exact name of registrant as specified in its charter)
Delaware 0-14887 22-2370691
(State or other juris- (Commission File No) (I.R.S. Employer
diciton of incorpora- Identification No.)
One Research Way, Princeton Forrestal Center, Princeton,
New Jersey, 08540
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code:(609) 452-7060
None
(Former name or former address, if changed since last report.)
Item 5. Other Events.
On July 6, 1995, The Liposome Company, Inc. (the "Company") released a
press release, a copy of which is attached hereto as Exhibit 20 with respect to
the Company's filing of a new drug application for its first product,
amphotericin B lipid complex (ABLC(R)) with the U.S. Food and Drug
Administration.
SIGNATURE
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.
THE LIPOSOME COMPANY, INC.
Dated: July 26, 1995 By: /s/ Brooks Boveroux
Brooks Boveroux
Vice President, Finance,
Chief Financial Officer
and Treasurer
EXHIBIT INDEX
Exhibit Page No.
20 -Copy of the Company's press release of July 6, 1995 5
relating to the Company's filing of a new drug
application with the U.S. Food and Drug Administration.
EXHIBIT 20
THE LIPOSOME COMPANY, INC. FILES NEW DRUG APPLICATION FOR ABLC(R) WITH FDA
Princeton, NJ -- July 6, 1995 -- The Liposome Company, Inc. (Nasdaq: LIPO and
LIPOZ) has filed a New Drug Application (NDA) with the United States Food and
Drug Administration (FDA) for ABLC(R) (amphotericin B lipid complex). The NDA
was submitted to the FDA on May 24, 1995, has been accepted by the FDA for
filing and the review process is underway.
"This is the first NDA filed by The Liposome Company and the first filed in the
United States by any company for a lipid-based amphotericin product. It
represents another significant milestone in our growth as an organization
capable of developing and commercializing pharmaceutical products," said Charles
A. Baker, Chairman and Chief Executive Officer of The Liposome Company. "Based
on our studies to date, we are encouraged about the prospects for ABLC(R) to
become an important drug for the treatment of deadly fungal infections often
seen in immunocompromised patients such as those receiving cancer chemotherapy
or bone marrow transplants."
The Company is seeking approval to market ABLC(R) for the treatment of
aspergillosis, a systemic fungal infection, in patients who have failed to
respond to conventional antifungal agents or who are intolerant to such agents,
or have pre-existing renal impairment.
The Company's amphotericin B lipid complex, under its European trademark,
Abelcet(tm), was approved for marketing in the United Kingdom in February
1995 and in addition was recently approved in Luxembourg. Marketing
applications are outstanding in a number of other countries, and additional
approvals are expected in 1995 and 1996.
The Liposome Company is conducting a broad-based clinical program to develop
ABLC(R) as a treatment for severe systemic fungal infections. Studies comparing
ABLC(R) to conventional amphotericin B have been conducted in several types of
systemic fungal infections, and several hundred patients who have either failed
on or were intolerant of conventional treatment have been treated under
emergency use protocols. Results of clinical trials of ABLC(R) have been
presented at numerous medical conferences including ICAAC (Interscience
Conference on Antimicrobial Agents and Chemotherapy), ASCO (American Society of
Clinical Oncology) and ASH (American Society of Hematology), as well as at
several international conferences.
Conventional amphotericin B is a broad spectrum anti-fungal agent that is
considered to be the "gold standard" for the treatment of severe, systemic
fungal infections. However, it is particularly toxic to the kidneys, an adverse
effect that significantly restricts the amount that can be administered to a
patient.
The Liposome Company, Inc. is a leading biotechnology company dedicated to the
development and commercialization of proprietary lipid and liposome-based
pharmaceuticals for the treatment, prevention and diagnosis of inadequately
treated, life-threatening diseases such as severe systemic fungal infections,
metastatic breast and other cancers, and inflammatory and vaso-occlusive
diseases.
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