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and aerobic bacteria, such as diabetic foot infections or post-surgery intra-abdominal infections.
Cefuroxime axetil (marketed by GSK as Ceftin® and by other companies as a generic product) is a semi-synthetic antibiotic, available as tablets and
Based on the results of our pulsatile fluoroquinolone and metronidazole
granules for oral suspension. Cefuroxime is effective for the treatment of
experiments, we believe that a combination product containing
various mild to moderate infections, including urinary tract infections and
fluoroquinolone and metronidazole may perform in a fashion superior
skin/skin structure infections. In 2002, cefuroxime had U.S. sales of
to either drug alone, particularly when one or both drugs is delivered in
approximately $365 million. Cefuroxime is generally prescribed for twice
daily dosing, for a period of seven to ten days.
We anticipate marketing this combination product through an internal sales
In our in vitro
studies, cefuroxime administered once daily in a pulsatile
force targeting gastro-intestinal surgeons.
manner demonstrated initial bactericidal activity against Staph. aureus
comparable to twice-daily, immediate release treatment.
GENERIC PRODUCT CANDIDATE
In contrast to the twice-daily treatment regimen, pulsatile cefuroxime
continued to reduce bacterial colonies for two days following the initial day of treatment.
As part of our analysis in evaluating a pulsatile clarithromycin product, we
We intend to develop a value-added formulation of cefuroxime or another
identified an opportunity to formulate a generic equivalent of Biaxin XL, which
similar drug in the cephalosporins class alone and in combination with
we believe we can commercialize without infringing upon the patents held by
other drugs, which we would market through third party collaborations.
Abbott Laboratories. We filed a patent application covering the production
method of our generic version of this product in October 2000 and are currently
in the final stages of clinical trials. In 2002, Abbott’s sales of immediate
release clarithromycin were approximately $315 million and its sales of
Ciprofloxacin (marketed by Bayer as Cipro®) is a synthetic broad-spectrum
extended release clarithromycin were approximately $335 million. Although
antibiotic, which is available as tablets and granules for oral suspension.
our generic equivalent product does not incorporate our pulsatile drug delivery
Ciprofloxacin is effective for the treatment of various mild to moderate
technology, we believe that it presents an opportunity to generate cash flow
infections, including urinary tract infections, sinusitis and lower respiratorytract infections. In 2002, ciprofloxacin had U.S. sales of approximately
to accelerate development of our pulsatile drug candidates. We have licensed
$1 billion. Ciprofloxacin is typically dosed twice daily, for a period of
to Par Pharmaceutical the distribution and marketing rights to this product.
In the fourth quarter of 2003, we received results from certain bio-equivalency
Our in vitro
studies indicate that ciprofloxacin dosed once daily in a pulsatile
studies of our generic clarithromycin product and in February 2004 received
manner is as effective as twice daily dosing of immediate release ciprofloxacin
results from a more extensive bio-equivalency study using the same
without altering the overall daily dose. We found that ciprofloxacin quickly
formulation of the product. The initial study of 40 subjects indicated that the
killed bacteria in vitro
when administered in a pulsatile fashion. This data
product satisfies all bio-equivalency standards established by the FDA when
suggests that a more convenient, once-daily alternative to twice-daily,
the product is taken with food, which is consistent with the instructions on the
immediate release ciprofloxacin could be achieved with PULSYS™.
product label. However, in an initial study of 34 subjects and the expanded
132-subject study completed in February, the product narrowly missed one of
We intend to develop a pulsatile formulation of ciprofloxacin primarily for
the bio-equivalency standards when taken in the non-recommended, "fasted"
use in combination with other antibiotic drugs, such as metronidazole, which
state. While the peak drug concentration for our product fell below the
we are also developing with the PULSYS system. We anticipate marketingour ciprofloxacin combination products through an internal sales force.
confidence interval needed to statistically meet the bio-equivalence standard
In the event we produce a pulsatile product candidate consisting solely of
under this scenario, our product demonstrated a more sustained release profile
ciprofloxacin, we anticipate marketing such product through a third party
than the branded (Abbott) counterpart. We intend to pursue a new
bio-equivalency study with an adjusted formulation of the product, designed
to modify the release profile of the product to more closely correspond to
Biaxin XL and meet the standard for bio-equivalence. We expect that the new
formulation and subsequent bio-equivalency studies will involve an expanded
We intend to develop a pulsatile fluoroquinolone/metronidazole product. We
relationship with Par, whereby Par will assume many of the commercial
believe that the combination of fluoroquinolone and metronidazole will prove
manufacturing responsibilities for the generic product and the filing of
to be effective for the treatment of infections caused by a mixture of anaerobic
Note: this document is essential reading for any prospective user of the Library. The Library and its Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . Structure of the Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Structure of the Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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