Well, IDEC has finally done it! Our little R&D biotech company has filed for FDA approval on IDEC-C2B8 and matured into (well, one step away) a real drug company. Hope your seatbelts are on today!
IDEC Pharmaceuticals, Genentech, and Roche Submit
Applications for U.S. & European Approval of IDEC-C2B8;
Non-Hodgkin's lymphoma therapy would be the first
monoclonal antibody for cancer treatment in the U.S.
Business Wire - March 03, 1997 09:00
FINANCIAL GENENTECH GNE CALIFORNIA MEDICINE BIOTECHNOLOGY PHARMACEUTICAL PRODUCT V%BW
P%BW
Jump to first matched term
SAN DIEGO and SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)-- March 3, 1997--IDEC
Pharmaceuticals Corporation (NASDAQ:IDPH) and Genentech Inc. (NYSE:GNE) today announced the
submission of Biological License Applications (BLA) to the U.S. Food and Drug Administration (FDA) for
IDEC-C2B8 (rituximab) as a single agent therapy for the treatment of relapsed low grade or follicular
non-Hodgkin's lymphoma. F. Hoffmann-La Roche Ltd, Basel, Switzerland, also submitted, through one of
its subsidiaries in the European Union, a Marketing Authorization Application (MAA) with the European
Medicines Evaluation Agency (EMEA) for marketing IDEC-C2B8 in Europe.
If IDEC-C2B8 is licensed for marketing, it would be the first available therapeutic monoclonal antibody for the
treatment of cancer in the U.S. It would also be the first marketed product for IDEC. These submissions occur
less than two years after the start of the development collaboration between Genentech and IDEC.
The applications are based on Phase III results which confirmed the Phase II data of the monoclonal antibody.
These Phase III results were presented at the annual meeting of the American Society of Hematology (ASH) in
December 1996. In the Phase III study of IDEC-C2B8 used alone, 50% or 76 of the 151 evaluable patients
experienced tumor shrinkage of 50% or greater following four weekly infusions with IDEC-C2B8. Of the
responding patients, 70% were still in remission at over nine months' median follow-up. Patients continue to
be followed.
The most common adverse events associated with IDEC-C2B8 are usually infusion-related. These side effects
consist primarily of mild to moderate flu-like symptoms (e.g., fever, chills) and occur with greatest frequency
upon initial administration. The symptoms are limited in duration to the period of infusion and decrease
significantly with subsequent infusions.
"The Phase III clinical results confirmed IDEC-C2B8's potential as an effective therapy with limited toxicity
for patients with relapsed low grade or follicular B-cell lymphoma," said Antonio J. Grillo-Lopez, M.D.,
IDEC's senior vice president of medical and regulatory affairs.
"Genentech, Roche and IDEC are working in close collaboration to establish this important and novel therapy
for non-Hodgkin's lymphoma patients who have failed standard treatment regimens," said Susan Hellmann,
M.D., Genentech's vice president of medical affairs and chief medical officer. "The companies are also
committed to continued exploration of further uses of IDEC-C2B8, as a frontline therapy, in combination with
other anti-cancer treatments, and in intermediate and high grade disease."
There are approximately 240,000 patients in the U.S. with non-Hodgkin's B-cell lymphomas, which are
malignancies of the body's antibody-producing immune system cells. Two-thirds are low grade or follicular
lymphoma patients who will experience multiple relapses over the average six- to seven- year course of their
incurable disease. Currently, standard treatment consists of chemotherapy and/or radiotherapy with
accompanying toxicities.
IDEC and Genentech are developing IDEC-C2B8 in collaboration with F. Hoffmann-La Roche Ltd of
Switzerland and Zenyaku Kogyo Co. Ltd. of Japan. IDEC and Genentech will be co-promoting IDEC-C2B8
in the United States. Both companies submitted BLA applications jointly to support their shared responsibility
for product manufacture. Roche will be responsible for marketing IDEC-C2B8 in the rest of the world,
excluding Japan.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets
human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San
Francisco, California and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
IDEC Pharmaceuticals focuses on developing targeted immunotherapies for the treatment of cancer and
autoimmune diseases. IDEC's products are primarily designed to act through immune mechanisms and offer
greater specificity of action, longer therapeutic effect and lower toxicity than is typical of existing therapies. All
of IDEC's products are designed for administration in outpatients settings, providing the opportunity to reduce
overall treatment costs.
F. Hoffmann-La Roche Ltd, with headquarters in Basel, Switzerland, is a member of the Roche Group, a
world leader in research-based health care with major businesses in pharmaceuticals, diagnostics, vitamins and
fine chemicals, and fragrances and flavors. Roche has a long tradition of innovative breakthroughs in drug
development and is a pioneer in the medical applications of genetic engineering. |
