Here comes generic paclitaxel... Ivax of Miami expects to
begin shipping generic paclitaxel in about three weeks. A federal judge in
San Francisco cleared the last legal hurdle for the company on Sept. 13 by
ordering Bristol-Myers Squibb to de-list a patent related to its Taxol.
Final FDA approval came two days later. The company says the drug will be
about 30% less expensive than brand-name Taxol.
And another in six months Mylan Pharmaceuticals of
Pittsburgh received tentative FDA approval this week for generic paclitaxel.
The approval is only for the smallest vial size (20 mg/5 ml), which Mylan
says is 15% of the paclitaxel market. Final approval, however, will not
be granted until 180 days after Ivax begins marketing the same drug. Ivax,
the first to file the generic NDA, is entitled to 180 days of
MDS agent wins orphan-drug status SangStat of Fremont,
Calif., has received orphan-drug status from the FDA for Thymoglobulin
(antithymocyte globulin) for myelodysplastic syndrome. The agent, already
approved to prevent kidney-transplant rejection, is an antithymocyte rabbit
immunoglobulin that suppresses immunity.
Phase-1 for B-cell lymphoma agent Berlex Laboratories of
Montville, N.J., is beginning phase-1 trials of Oncolym (I-131-labeled Lym-1
antibody), a MAB for relapsed and refractory B-cell lymphoma. According to
the company, there are no approved treatments for these
New indication for Bexxar? Coulter Pharmaceuticals of South
San Francisco and SmithKline Beecham of Philadelphia have filed a biologics
license application to the FDA for Bexxar (tositumomab, iodine I-131
tositumomab) for relapsed or refractory low-grade and transformed low-grade
B-cell non-Hodgkin’s lymphoma. Bexxar delivers targeted microradiation to
CD20-positive cells. The company says it is able to radiate the tumor
site while sparing normal tissue.
Phase-3 trial for nose drops for Kaposi’s Cytran of
Kirkland, Wash., has announced that patients are being recruited for a
phase-3 trial of IM862, self-administered nose drops for AIDS- related
Kaposi’s sarcoma. IM862 is a peptide that, according to the company, has
shown antiangiogenic and immune-suppression properties in lab tests. In
phase-2 trials, 37% of patients had a complete or partial response and 48%
had no disease progression while taking the drug.
Synergy against breast cancer EntreMed of Rockville, Md.,
has begun a phase-1 trial of 2ME2 (2methoxyestradiol) in combination with
Taxotere (docetaxel) for advanced breast cancer. Preclinical studies have
shown that 2ME2, an antiangiogenic drug, and taxanes in combination can
control tumor growth better than each agent separately. A phase-1 trial of
2ME2 as a single agent for advanced breast cancer has been
Phase-2 for NSCLC SmithKline Beecham of Philadelphia
presented phase-2 data on Hycamtin (topotecan HC for injection) for
non- small-cell lung cancer, showing that among 42 evaluable patients one had
a complete response and five had a partial. Seventeen patients had stable
disease for at least 56 days, according to the study revealed at the World
Congress on Lung Cancer in Tokyo last week. Hycamtin, a topoisomerase I
inhibitor, is already approved as a second-line therapy for small-cell
lung cancer. This trial is testing the agent in combination with
carboplatin as a first-line treatment for non-small-cell lung cancer.
IntraDose is an orphan Matrix Pharmaceuticals of Fremont,
Calif., has received orphan-drug status from the FDA for IntraDose
Injectable Gel (cisplatin/epinephrine) for metastatic malignant melanoma.
According to the company, IntraDose is for patients with predominantly skin
and soft-tissue disease who cannot tolerate or don’t respond to systemic
chemotherapy. In clinical trials, 48% of 25 patients treated with the drug
responded. IntraDose has already received orphan-drug status for
head-and-neck cancer, and the company is filing for FDA approval for this
Combo gets new phase-1/2 ImmunoGen of Cambridge, Mass., and
SmithKline Beecham of Philadelphia have begun a second phase-1/2 trial of
HuC242-DM1/SB-408075 for colorectal and pancreatic cancer. This additional
trial of the agent, a tumor-activated prodrug, will take place at the
University of Chicago and evaluate a weekly dosing protocol. In the first
phase-1/2 trial, patients were given a single dose and follow-up doses at
three-week intervals if needed. The company says patients with
non-small-cell lung cancer may be included in the new trial.