I just re-read the press release on the approval vote and Robinson specifically mentioned the manufacturing plant, which could be taken as a vote of approval since the plant had manufactured an effective drug, or it could have been a LGND reminder to the FDA because there were concerns about the plant. Here's the press release:
FDA ADVISORY COMMITTEE VOTES UNANIMOUSLY THAT SERAGEN'S ONTAK(TM
PR Wire
June 2, 1998, 2:26 p.m. PT
Has Clinical
Benefit in Advanced Cutaneous T-Cell Lymphoma
SAN DIEGO, Calif. and HOPKINTON, Mass., June 2 /PRNewswire/ -- Ligand
Pharmaceuticals Incorporated (Nasdaq: LGND) and Seragen, Inc.
(OTC Bulletin Board: SRGN) announced today that an expanded Oncologic Drugs
Advisory Committee (ODAC) to the U.S. Food & Drug Administration (FDA) voted
favorably and unanimously (14 to 0) on questions put to it by the FDA
regarding the efficacy and safety of ONTAK(TM) (DAB389IL-2, Interleukin-2
Fusion Protein or Denileukin diftitox) for treatment of adult patients with
recurrent or persistent cutaneous T-cell lymphoma (CTCL).
The committee was expanded to include consultants representing biologics
and dermatology as well as an expert in CTCL from the National Cancer
Institute.
Three questions were submitted to the committee for a vote. The committee
first voted 14 to 0 that the clinical results cited in the Biologic License
Application for ONTAK are "reasonably likely to predict clinical benefit in
patients with CTCL who have failed one or more systemic therapies." The
committee further voted 14 to 0 that the toxicity associated with ONTAK
treatment is "acceptable, given the response rates and durations of responses
observed." By a vote of 12 to 2, the panel also recommended that treating
physicians should decide the appropriate dose within a prescribed dose range.
The panel's votes, although not binding, will be considered by the FDA in
its final review of ONTAK. If ONTAK is cleared for marketing, it will be the
first therapeutic specifically approved by the FDA for CTCL.
"We are delighted with the panel's votes," said Jean Nichols, Ph.D.,
Seragen President and Chief Technology Officer. "We believe that ONTAK, if
approved by the FDA, will benefit patients with advanced CTCL. These people
have a disfiguring, life-threatening disease, and few, if any other options
for treatment. ONTAK will offer a therapeutic alternative with a new
mechanism of action and we look forward to working with the FDA to expedite
the remainder of the review process."
"ONTAK represents a significant advance for the treatment of late-stage,
refractory CTCL patients, patients who for the most part have very limited
options," said Ligand Chairman, President and CEO David E. Robinson. "We
congratulate the Seragen team and that of its manufacturing partner Marathon
Biopharmaceuticals on achieving such positive reinforcement from the panel."
"Overall, the outlook for patients with advanced CTCL is poor, especially
those late-stage patients with organ or lymph node involvement, whose median
survival is less than three years," said Dr. Paul Bunn, Director of the
University of Colorado Cancer Center in Denver and CTCL specialist. "Any
agent that can reduce tumor burden and/or improve symptoms in these patients,
as ONTAK does, is sorely needed."
Consolidation of Rights for ONTAK(TM) Under Ligand
On May 11, 1998, Ligand and Seragen announced that the two companies had
signed a definitive agreement under which a wholly owned subsidiary of Ligand
would merge with Seragen. Ligand announced at the same time that it had
signed a definitive asset purchase agreement to acquire substantially all the
assets of Marathon Biopharmaceuticals, LLC, which provides product
development, clinical trials and manufacturing services to Seragen under a
service agreement.
The net effect of the above agreements, if the transactions are
consummated, is to provide Ligand with worldwide rights to ONTAK, as well as
five additional fusion proteins -- DAB389EGF, DAB389IL-4, DAB389IL-6,
DAB389CD-4 and DAB389MSH, which may have implications in other disease states.
Since 1989, Ligand Pharmaceuticals Incorporated has established a
leadership position in gene transcription technology, particularly
intracellular receptor (IR) technology and STATs technology. Ligand has
applied IR and STATs technology to the discovery and development of small
molecule drugs to enhance therapeutic and safety profiles and to address major
unmet patient needs in cancer, women's and men's health, skin diseases,
osteoporosis, cardiovascular and inflammatory disease.
Seragen is a biotechnology company developing receptor-targeted fusion
proteins for cancer and dermatology. Fusion proteins consist of a toxin
fragment genetically fused to a hormone, or growth factor, that targets
specific receptors on the surface of disease-causing cells.
This news release may contain certain forward looking statements by Ligand
and Seragen and actual results could differ materially from those described as
a result of factors including, but not limited to, the following. There can
be no assurance that ONTAK or any product in the Ligand or Seragen pipeline
will be successfully developed, that final data will be consistent with
interim data, that regulatory approvals, including labeling approvals, will be
granted in a timely manner, or at all, that patient and physician acceptance
of these products will be achieved, that final results will be supportive of
regulatory approvals required to market products, that Ligand and Seragen will
be able to build and timely deploy its sales support for product launch, or
that third parties on which Ligand and Seragen will rely for crucial
components of commercialization will perform adequately. Ligand and Seragen
undertake no obligation to update the statements contained in this press
release after the date hereof.
SOURCE: Ligand Pharmaceuticals Incorporated
-0- 06/02/98
/CONTACT: Mary Kenny of Ligand Pharmaceuticals Incorporated,
619-550-7536/
(LGND SRGN)
CO: Ligand Pharmaceuticals Incorporated; Seragen, Inc.
ST: California
IN: MTC
SU:
-0- (PRN) Jun/02/98 17:11
EOS (PRN) Jun/02/98 17:11 86
-0- (PRN) Jun/02/ 98 17:26 |
