Seragen Submits Biologics License Application to FDA for Cutaneous T-Cell Lymphoma Biologic Product
HOPKINTON, Mass., Dec. 8 /PRNewswire/ -- Seragen, Inc.
(OTC Bulletin Board: SRGN) announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA). The application requests clearance to market Seragen's DAB389IL-2 (Interleukin-2 Fusion Protein or denileukin diftitox) for the treatment of recurrent or persistent cutaneous T-cell lymphoma (CTCL) despite prior therapy.
CTCL is a form of non-Hodgkin's lymphoma that manifests initially in the skin. With time, however, the disease can become systemic, involving the lymph nodes and the spleen, liver and other organs. CTCL is disfiguring and debilitating; median survival for late-stage patients with organ or lymph node involvement is less than three years. Various drugs are used in treating the disease, but no drug is specifically indicated by the FDA for its treatment.
Seragen's BLA is based on accumulated data from Phase I/II and Phase III clinical trials of DAB389IL-2 in patients with CTCL who were no longer benefiting from other therapy. Two additional trials are currently in progress to evaluate the use of the drug in earlier stage CTCL. The results of the completed Phase III trial will be presented at the meeting of the American Society of Hematology tomorrow.
"We are delighted to be submitting our first BLA," said Seragen president and chief technology officer Jean Nichols, Ph.D. "Our Phase III promgram consists of controlled studies with response measurements that quantify both tumor burden and symptomatology. The particular Phase III protocol on which this application is based consists of a randomized, double-blinded evaluation of two dose levels of DAB389IL-2 in 71 patients. We also include in the application response information from 35 patients in our earlier Phase I/II CTCL study. Safety information from 206 lymphoma patients, including 168 CTCL
patients (Some of whom are in one of the ongoing trials), is also part of the application."
Dr. Nichols said that Seragen expects to hear within the next several months whether the FDA has accepted the BLA for filing. She also said that the company has requested priority review of the application. In the case of applications for drugs intended to treat certain life-threatening illnesses, the FDA may choose to accelerate the review process.
"This is a significant technical milestone for Seragen," said CEO Reed Prior. "I am proud to be connected with the talented and dedicated team responsible for this achievement. All of us hope the results will benefit patients with CTCL."
"At the same time, it should be noted that while we have achieved this technical milestone, streamlined the company, and restructured a number of key corporate agreements, Seragen continues to face major business challenges," Mr. Prior said. "Even if the BLA is eventually approved, the CTCL indication for DAB389IL-2 (denileukin diftitox) may not be profitable or even a break-even proposition for us financially."
"First, CTCL is a relatively small market," Mr. Prior elaborated. "Larger market opportunities for the product are still in clinical development, and, as yet, no partner has been identified to support such development. At this point, we are still supporting an extensive manufacturing infrastructure developed to serve larger markets. Although we intend to sell the infrastructure pending shareholder approval, we will remain the primary customer supporting that manufacturing facility for some time."
"Our marketing partner, Eli Lilly and Company, has invested a lot in the development of DAB389IL-2 and has recently taken over a substantial portion of our obligations to Ajinomoto," Mr. Prior continued. "Through this partnership, Seragen must manufacture and provide the product for a transfer price equal to approximately one-fifth of Lilly's adjusted net sales of DAB389IL-2, with the exact percentage depending on total sales volume. With the currently projected sales levels for DAB389IL-2, the transfer price arrangement, the royalties we must pay on our technology licenses, and the
anticipated costs of manufacturing the product, we do not expect these
payments to cover our costs for the foreseeable future."
"We continue," Mr. Prior concluded, "to pursue a wide range of options to address these and the other financial issues facing the company."
Seragen is a biopharmaceutical company developing a proprietary portfolio
of therapeutic products. The company's unique receptor-active 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.
Seragen's current focus is on cancer and dermatology. In addition to the
collaboration with Lilly on the development of DAB389IL-2 (denileukin
diftitox) for CTCL, Seragen is independently conducting clinical trials of the
same molecule for psoriasis. A second product, EGF Fusion Protein, is
currently in a Phase I/II clinical trial for non-small cell lung cancer and in
pre-clinical development in collaboration with United States Surgical
Corporation for restenosis following angioplasty.
Safe Harbor Information
Some of the statements contained in this document are forward-looking,
including statements relating directly or by implication to Seragen's
products, operations, strategic partnerships, financial condition, and ability
to fund its operations. These statements are based on current expectations
and involve a number of uncertainties and risks, including (but not limited
to) Seragen's ability to proceed with successful development, testing, and
licensing of its products, to modify certain existing contractual
arrangements, to enter into additional strategic partnerships and other
collaborative arrangements, and to raise additional capital on satisfactory
terms. For further information, refer to the "Business Outlook" section in
Seragen's Form 10-K as filed with the Securities and Exchange Commission.
Actual results may differ materially from such expectations.
SOURCE Seragen, Inc.
CONTACT: Lora Maurer of Seragen, Inc., 508-435-2331 |
