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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 andStrep. pneumoniae 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 FLUOROQUINOLONE/METRONIDAZOLE COMBINATION 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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