The other two products under development (actually the 3rd isn't being developed until a colaborator is found); from the 10-K:
>>CTV-05
In 1999, we acquired from GyneLogix, Inc. exclusive worldwide rights to CTV-05,
a strain of bacteria under clinical investigation for a broad range of
applications in the areas of gynecological and reproductive health. We have
entered into a clinical trial agreement with the National Institutes of Allergy
and Infectious Diseases, a division of the National Institutes of Health,
commonly referred to as
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NIH, to conduct a Phase 2 trial of CTV-05, a proprietary biotherapeutic agent
for the treatment of bacterial vaginosis, or BV. BV, the most common
gynecological infection in women of childbearing age, is an imbalance of
naturally occurring organisms in the vagina.
Bacterial Vaginosis
BV develops when certain bacteria normally present in the vagina in low levels
multiply to infectious levels. BV is associated with serious health risks such
as pelvic inflammatory disease, pre-term birth, post-surgical infection and an
increased susceptibility to sexually transmitted diseases, including AIDS. The
standard treatments currently prescribed for BV are oral or topical antibiotics
including metronidazole and clindamycin. These treatments are not optimal,
having significant recurrence rates. Moreover, antibiotic use depletes a
beneficial bacteria called lactobacilli.
CTV-05: Rationale, Product Profile and Clinical Studies
A healthy vagina is principally populated by lactobacilli. The presence of
lactobacilli in the vagina, particularly those that produce hydrogen peroxide
which is active against disease causing bacteria, has been linked to decreased
incidence of BV and other urinary tract and gynecological infections. However,
many women lack sufficient populations of hydrogen peroxide-producing
lactobacilli to maintain vaginal health, making them more susceptible to
infection.
Studies have shown that the CTV-05 strain of lactobacillus is able to restore
the natural balance of the bacteria in the vagina and produce both hydrogen
peroxide and lactic acid, substances which are active against disease-causing
bacteria and serve a protective role. Because of this, CTV-05 has the potential
to improve cure rates when used in conjunction with approved antibiotics, to
prevent BV recurrence and thus to reduce serious health risks.
In the Phase 2 safety and efficacy trial, funded by National Institute of
Health, CTV-05 is administered topically to BV patients. The study is primarily
designed to show whether CTV-05 improves cure rates of BV at 30 days. The study
is the first large trial to look at recurrence rates of BV at 90 days. To date,
we have enrolled over 200 patients in a 400 patient trial at three sites and
expect to conclude the trial in 2001.
Other Indications
Recently completed studies by GyneLogix under a Center for Disease Control and
Prevention grant, have shown that CTV-05 is active against the organisms which
cause yeast infections and gonorrhea. We plan to conduct pilot clinical studies
in these indications.
IS-159
In 1998, we acquired from Immunotech S.A. exclusive worldwide rights to IS-159,
a selective chemical that reacts with receptors found on cerebral blood vessels
and nerve terminals. We are seeking a collaborator to develop IS-159 and do not
intend to initiate further studies of IS-159 until we enter into a collaborative
arrangement.
PRODUCT ACQUISITION STRATEGY
We plan to continue to acquire, develop and commercialize late-stage product
candidates or approved products that make a clinical difference to patients
managed by focused groups of medical decision-makers. Our strategy is to acquire
late-stage development product candidates with an anticipated time to market of
four years or less and existing clinical data which provides reasonable evidence
of safety and efficacy. In addition, we aim to acquire approved products that
can be marketed by our commercial organization. In making our acquisition
decisions we attempt to select products that meet these criteria and achieve
high investment returns by:
- understanding the market opportunity for initially-targeted uses of the
drug;
- assessing the investment and development programs that will be necessary
to achieve a marketable product profile in these initial uses; and
- attempting to structure the design of our development programs to obtain
critical information relating to the clinical and economic performance of
the product early in the development process, so that we can make key
development decisions.
To date, we have implemented this strategy with Angiomax, CTV-05 and IS-159.
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We intend to acquire products and product candidates with possible uses and
markets beyond those on which our initial investment program will be focused. We
plan to acquire other products that will enhance the acute hospital product
franchise we are building around Angiomax. We are also seeking other specialty
anti-infective products and product candidates that will fit into the franchise
we expect to build around CTV-05.
We have assembled a management team with significant experience in drug
development and in drug product launches and commercialization.<<
Cheers, Tuck |
