[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
U S Bioscience's $19 million in R&D - what did it buy?
(My thanks to Dr. Amir Attran for providing a pointer to this
information.)
How much R&D can one buy for $19 million? Quite a bit,
according to a March 19, 1999, U S Bioscience filing with the
US Securities and Exchange Commission.
The following is a description of some of the 1998 research
projects that U S Bioscience funded out of its $19 million
R&D budget.
Jamie
http://www.sec.gov
/Archives/edgar/data/847562/0000950123-99-002315.txt
<---------------from U S Bioscience 10K-------------------->
Results of Operations
1998 Compared with 1997
Research and development costs for the year ended
December 31, 1998 increased to $19,041,900 from $16,904,500 in
1997. The $2,137,400 increase is principally due to the accrual
of an approximately $1 million charge related to a research
consulting arrangement, increased U.S. clinical research costs of
$1,112,200 principally related to ongoing Phase III trials of
Ethyol and NeuTrexin and the start-up of a Phase II study of
lodenosine, and $925,300 in increased clinical and regulatory
consulting costs. These increases are partly offset by savings of
approximately $1,200,000 in European clinical research expenses
due to the reorganization undertaken in 1997.
NeuTrexin
The company is continuing to investigate NeuTrexin as an
anticancer agent. In response to data from Phase II
studies of NeuTrexin in combination with 5-fluorouracil ("5-FU")
and leucovorin in patients with metastatic colorectal cancer, the
company sponsored two randomized Phase III clinical trials of
5-FU and leucovorin with and without NeuTrexin. Both of these
studies are closed to accrual of new patients, and the company
expects to begin data analysis during 1999. Research into topical
and oral formulations of NeuTrexin also is underway. The
development of these dosage forms will facilitate clinical
research not only in patients with diseases such as AIDS and
cancer but, potentially, in patients with benign
diseases (such as psoriasis and rheumatoid arthritis).
Ethyol
The company has an ongoing clinical trial which the company
anticipates may fulfill the FDA's requirement that products
approved under the Accelerated Approval Regulations undergo
further adequate and well-controlled studies to verify and
describe clinical benefit. See "Principal Products - Ethyol -
General Description" and "Government Regulation." The company is
also continuing to investigate the use of Ethyol to protect
normal tissues from the toxic effects of certain forms of
chemotherapy, radiation therapy and radio-chemotherapy (or
combined modality therapy) in a number of tumor types, without
reducing the antitumor effects of these modalities. During 1998,
the company has been managing four Phase III trials of Ethyol,
two of which have been closed to accrual of new patients and two
of which are expected to be closed to accrual in the first half
of 1999. The company is also investigating Ethyol's potential
role as a bone marrow stimulant in myelodysplastic bone marrow
syndromes ("MDS"). MDS is a condition in which the bone marrow is
typically ineffective in its production of the major blood
elements: red blood cells, neutrophils and platelets.
Lodenosine
The company has been collaborating with the NCI on the
clinical development of lodenosine under the CRADA. The
collaborative Phase I/II clinical trials of lodenosine in adult
and pediatric patients are being conducted at the NIH Clinical
Center. The first clinical trial results from the Phase I dose
escalation study conducted under the CRADA demonstrated that
lodenosine had anti-HIV activity, defined as a reduction in HIV
viral load, even in patients who had failed other AIDS
antiretroviral therapies including AZT, 3TC and d4T. In the Fall
of 1998, the company 's multi-center Phase II clinical trial of
lodenosine cleared regulatory agencies in the United States,
Great Britain and Brazil and patients are being accrued to this
study. Lodenosine is still in the early stages of clinical
development. For a description of the steps required before a
drug may be marketed in the United States see "Government
Regulation."
<---------------end U S Bioscience 10K-------------------->
--
James Love
Consumer Project on Technology
http://www.cptech.org
love@cptech.org
202.387.8030; fax 202.234.5176