RB, While looking for the BMY press release on the FDA rec, I ran across the press release on the FDA approval. Note that the rec was given on June 23 and the approval was Aug 5. The very short time between the rec and the vote to approve, indicates that the FDA still considers this a very serious condition and is not relying on other treatments (PIs). I think that LGND's results are very good news, which is why LGND is leaping over the Phase III APL trial and moving this indication into the forefront. Current treatments leave much to be desired, and popping one pill a day should grab market share big time:
FDA Clears TAXOL for AIDS-Related Kaposi's Sarcoma
PRINCETON, N.J., Aug. 5 /PRNewswire/ -- Bristol-Myers Squibb (NYSE: BMY)
today announced that the U.S. Food and Drug Administration has cleared
TAXOL(R) (paclitaxel) Injection for use in second-line treatment of AIDS-
related Kaposi's sarcoma (KS).
Bristol-Myers Squibb (BMS) pioneered the commercial development of TAXOL
beginning in 1991. Collaborative work with the National Cancer Institute
(NCI) in 1993 led to the discovery of TAXOL activity against KS.
Subsequently, Bristol-Myers Squibb sponsored a larger independent clinical
trial to confirm the initial NCI/BMS TAXOL Kaposi's sarcoma data. BMS
continues to fund studies of TAXOL in Kaposi's sarcoma patients while pursuing
ongoing research of TAXOL in many other tumor types.
"To ensure the widest availability and reimbursement of this treatment for
Kaposi's sarcoma, we invested in the necessary clinical development of TAXOL
for KS," said Renzo Canetta, M.D., vice president, Oncology Clinical Research,
Bristol-Myers Squibb. "We published significant data in the scientific
literature on TAXOL Kaposi's sarcoma findings."
In clinical studies, a majority of KS patients treated with TAXOL, all of
whom had failed prior therapy, benefited from treatment with TAXOL. TAXOL
therapy provided tumor shrinkage and symptom reduction including reduced edema
(fluid accumulation), reduction of pain, and general improvement of the
patient's performance status. The most common side effect among patients in
the studies was myleosuppression (a reduction in bone marrow cells). Other
side effects included hair loss and muscle soreness.
Current estimates are that 202,000 people in the U.S. are living with
AIDS. About 20% or 40,000 of them will be affected by KS at some time during
their illness, according to the Centers for Disease Control and Prevention.
BMS applied for and the FDA granted orphan drug status for paclitaxel for this
indication.
"BMS is a world leader in the development of drugs for AIDS and cancer,"
said Rick Winningham, president, Bristol-Myers Squibb Oncology/Immunology
Division. "To date, BMS has sponsored more than 500 TAXOL clinical trials
involving 40,000 patients to explore new uses for the drug and thus, it
remains one of the most intensively researched anticancer drugs."
In addition to TAXOL, Bristol-Myers Squibb markets Zerit(R) (d4T,
stavudine), Videx(R) (ddI, didanosine), Megace(R) OS (megestrol acetate) and
Fungizone(R) OS (amphotericin B) for use in the treatment of HIV disease. BMS
is also currently developing two new protease inhibitors for the treatment of
HIV/AIDS.
Bristol-Myers Squibb is a diversified company whose main focus is
worldwide health and personal care. The principal businesses are
pharmaceuticals, consumer products, nutritionals, and medical devices. It is
a leading maker of innovative therapies for cardiovascular, metabolic and
infectious diseases, central nervous system and dermatological disorders, and
cancer. The company will invest about $1.5 billion in research and
development in 1997.
Visit Bristol-Myers Squibb on the World Wide Web at: bms.com
SOURCE Bristol-Myers Squibb Company
CONTACT: John Kouten of Bristol-Myers Squibb, 609-252-5456, or
pager, 888-985-7407 |
