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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): November 20, 1995
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SEQUUS Pharmaceuticals, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 0-15847 94-3031834
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(State or other jurisdiction of (Commission (IRS Employer
Incorporation or organization) File Number) Identification
Number)
960 Hamilton Court
Menlo Park, California 94025
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(Address of principal executive offices) (Zip Code)
Registrant's telephone no., including area code: (415) 323-9011
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NOT APPLICABLE
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(Former name or former address, if changed since last report)
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ITEM 5 Other Events
On November 20, 1995, the registrant issued the press release attached
hereto as Exhibit 99.1, the text of which is incorporated herein by reference.
ITEM 7 Financial Statements, Pro Forma Financial Information
and Exhibits
(c) Exhibits
99.1 Press Release issued by the registrant
on November 20, 1995.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report on Form 8-K to be signed on its
behalf by the undersigned hereunto duly authorized.
Dated: November 20, 1995 SEQUUS PHARMACEUTICALS, INC.
By: /s/ L. Scott Minick
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L. Scott Minick, President and
Chief Operating Officer
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EXHIBIT INDEX
<TABLE>
<CAPTION>
Exhibit
Number Description
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<S> <C>
99.1 Press Release issued by the registrant on November 20, 1995.
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EXHIBIT 99.1
[SEQUUS PHARMACEUTICALS, INC. LETTERHEAD]
Contacts: SEQUUS Pharmaceuticals, Inc. Burns McClellan, Inc.
I. Craig Henderson, M.D. Clarence Swearngan, Jr. (Investors)
Chairman and CEO 212-505-1919
L. Scott Minick Liz Landy (Media)
President and COO 212-505-1919
Donald J. Stewart
Vice President, Finance
415-323-9011
For Immediate Release
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SEQUUS PHARMACEUTICALS RECEIVES U.S. FDA
MARKET CLEARANCE FOR DOXIL(R)
Menlo Park, Calif., November 20, 1995 - SEQUUS Pharmaceuticals, Inc.
(Nasdaq/NMS:SEQU) today announced the receipt of U.S. Food and Drug
Administration (FDA) market clearance for DOXIL (doxorubicin HC1 liposome
injection). DOXIL is indicated for the treatment of Kaposi's sarcoma (KS) in
people with AIDS whose KS disease has progressed on prior combination
chemotherapy or in patients who are intolerant to such therapy. DOXIL is a
STEALTH(R) liposome formulation of doxorubicin, an off-patent anticancer drug.
"FDA market clearance of DOXIL is a significant milestone for patients with
Kaposi's sarcoma," said Chairman and Chief Executive Officer, Dr. I. Craig
Henderson. "DOXIL is a new pharmaceutical product that provides real hope for
the people with AIDS-related Kaposi's sarcoma for whom conventional therapy --
even therapy with doxorubicin -- failed or who could not tolerate conventional
chemotherapy. Our clinical data show that DOXIL has a circulating half-life of
approximately 50 hours, as compared to about 10 minutes for free (non-liposome)
doxorubicin. It is thought that the increased half-life enables STEALTH
liposomes to concentrate encapsulated drug in areas of the body where new blood
vessels are being formed and are leaky, such as tumors."
DOXIL has received market clearance under the FDA's accelerated approval
regulations. In accord with these regulations, SEQUUS has committed to
conducting a post-marketing controlled clinical trial designed to verify and
describe the clinical benefit of DOXIL.
"In anticipation of this FDA clearance, SEQUUS has built a team of 22 sales
professionals to market DOXIL," said Scott Minick, President and Chief
Operating Officer. "This group is experienced in the sale of pharmaceutical
products to physicians, hospitals and clinics, including managed care
providers, in the United States, and in facilitating reimbursement with third
party payors. The SEQUUS sales force will immediately begin to promote DOXIL.
We are pleased that SEQUUS will join the relatively small group of
biopharmaceutical companies with products in the market."
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SEQUUS PHARMACEUTICALS
RECEIVES MARKET CLEARANCE FOR DOXIL(R)
November 20, 1995 -- Page 2
"For people with AIDS-related KS for whom current therapy has failed or who are
intolerant to such therapy, and for the medical community that treats this
patient population, DOXIL is a welcome addition to the arsenal of products
currently available to manage other debilitating effects of AIDS and its
associated opportunistic infections," noted Donald Northfelt, MD, University of
California, San Francisco, one of the Company's clinical investigators.
SEQUUS has established a Patient Assistance Program for KS patients who might
benefit from DOXIL treatment as indicated and who meet certain criteria, but do
not have private or subsidized health insurance. Further information may be
obtained by calling 1-800-375-1658.
"The entire SEQUUS team, including our clinical and scientific collaborators,
has worked long and hard for this day," said Frank Martin, Ph.D., Vice
President and Chief Scientist. "We are delighted that DOXIL is in the first
wave of liposome products cleared to market in the United States."
SEQUUS has submitted an application for European Union market clearance to the
Committee on Proprietary and Medicinal Products (CPMP). The Company expects the
CPMP to review DOXIL in February 1996. The Company is in discussions with
potential corporate partners to market and distribute DOXIL, with a primary
focus outside of the U.S.
DOXIL is to be administered intravenously at a dose of 20 mg/m(2) over 30
minutes, once every three weeks, for as long as patients respond satisfactorily
and tolerate treatment.
The U.S. Centers for Disease Control and Prevention (CDC) estimate that one
million Americans are currently infected with HIV, the virus that causes AIDS.
The World Health Organization estimates that, worldwide, 18 million adults and
over 1.5 million children are infected with HIV. Kaposi's sarcoma is the most
commonly diagnosed malignancy in people living with HIV. It is estimated that
KS affects less than 20 percent of the worldwide AIDS population, yet the total
number of AIDS-related KS patients is unknown as is the percentage of patients
requiring chemotherapy.
Established in 1981 and headquartered in Menlo Park, Calif. (with offices in
London, England), SEQUUS is developing proprietary pharmaceutical products
principally to treat cancer and infectious disease. The Company is conducting
clinical trials of DOXIL in additional indications, including ovarian cancer
(Phase II), breast cancer (Phase I/II in Europe), primary liver cancer (Phase
I/II) and prostate cancer (Phase II).
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