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Seragen Receives Complete Review Letter from FDA Regarding ONTAK
Application for Advanced CTCL - Additional Information Requested
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HOPKINTON, Mass. and SAN DIEGO, June 17 /PRNewswire/ -- Seragen, Inc.
(BB: SRGN) and Ligand Pharmaceuticals Incorporated
(NASDAQ:LGND) announced today that the U.S. Food and Drug Administration
(FDA) has issued a "Complete Review" letter regarding Seragen's Biologics
License Application (BLA) for 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 Center for Biologics Evaluation and Research (CBER), the center of the
FDA responsible for reviewing Seragen's application, no longer issues
"approvable" or "non-approvable" letters at the conclusion of their formal
review of license applications when the action is not an approval. Instead,
CBER issues letters signifying that a complete review of all information and
data submitted has been carried out. Per CBER's January 22, 1998
correspondence to applicants, the complete review letter "summarizes all of
the deficiencies and describes actions necessary to place the application in a
condition for approval."
The complete review letter received by Seragen fulfills the FDA's
commitment under the Prescription Drug User Fee Act to a six-month review of
Seragen's BLA for ONTAK, which was designated for priority review. The BLA
was submitted on December 9, 1997, and the complete review letter is dated
June 9, 1998. Upon issuance of the letter, the review clock is suspended and
is not reactivated until all deficiencies have been addressed by Seragen. The
letter identified certain deficiencies in the application related to safety,
efficacy, manufacturing and product characterization.
"We are pleased with the timeliness of the FDA's review of our
application," said Seragen's president and chief technology officer, Jean
Nichols, Ph.D. "We look forward to continuing to work closely with the agency
to address the issues outlined in the letter."
Seragen and Ligand announced on May 11, 1998 that they have signed a
definitive agreement under which a wholly owned subsidiary of Ligand will
merge with Seragen. The merger agreement has been approved by the board of
directors of each company, and the merger is expected to close in the third or
fourth quarter of 1998.
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.
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, and cardiovascular and inflammatory disease.
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 regulatory approvals, including
labeling approvals, will be granted in a timely manner, or at all, that
patient and physician acceptance of the companies' 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 sales support for product launch in a timely manner, 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- 06/17/98
/CONTACT: Susan Atkins of Ligand, 619-550-7687; or Lora Maurer of
Seragen, 508-435-2331/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 509313/
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