>>GERMANTOWN, Md., Dec. 14 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation (Nasdaq: AVNC - News), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has modified its existing collaboration with Par Pharmaceutical Companies, Inc. to include a pulsatile version of the antibiotic combination amoxicillin/clavulanate for acute otitis media (ear infections) in children.
Under the updated agreement, the Companies have incorporated a PULSYS(TM) version of a combination amoxicillin/clavulanate product for otitis media to their existing joint sales and marketing agreement for Amoxicillin PULSYS. The combination replaces the previously envisioned amoxicillin-only product for otitis media. Based on discussions with infectious disease opinion-leaders, Advancis believes that amoxicillin/clavulanate is emerging as a front-line therapy resulting from shifts in the causative pathogens associated with otitis media. As such, the Companies believe the combination represents an attractive market opportunity for an enhanced pulsatile version of the drug.
"A PULSYS product targeted at otitis media has always been part of our plans under our agreement with Par," said Edward M. Rudnic, Ph.D., chairman, president and CEO of Advancis. "However, we are very optimistic about using the amoxicillin/clavulanate combination for otitis media, as frequent recurring ear infections in children are common, and we believe a PULSYS version of this drug combination will be well-received. Our PULSYS product will be designed to deliver amoxicillin/clavulante in a once-daily format with lower drug exposure and a shorter course of therapy. If successful, we believe the product will be able to effectively compete in this market and may potentially improve convenience and compliance for children with this hard-to- treat infection."
Financial terms of the Companies' agreement have not changed; however, Advancis believes the combination PULSYS product will target a greater prescription base than that of a single drug product. According to IMS Health, a pharmaceutical research organization, amoxicillin/clavulanate prescriptions totaled 23.8 million in 2003, an increase of 10 percent from 2001. Advancis believes approximately 30 percent of current amoxicillin/clavulanate prescriptions are for acute otitis media and its usage may increase over current levels as the combination emerges as a front-line therapy.
"Par is very excited to include another product in our collaboration with Advancis," said Scott Tarriff, Par Pharmaceutical president and chief executive officer. "By modifying this agreement, we are essentially broadening our potential product portfolio without increasing our investment in research and development. We believe that adding the amoxicillin/clavulanate combination product for otitis media to our broader amoxicillin PULSYS agreement will enhance the market opportunity for pulsatile antibiotics."
Advancis reacquired the rights to develop amoxicillin/clavulanate products from the discontinuation of the Company's prior agreement with GlaxoSmithKline. Advancis anticipates beginning a Phase II clinical trial for the otitis media combination product in early 2006, and expects to begin subsequent Phase III trials in late 2006.
Advancis' Amoxicillin PULSYS product candidate is currently in Phase III clinical trials for adults with pharyngitis/tonsillitis. The study has been enrolling patients according to schedule and the Company expects to report results from the trial in the second quarter of 2005. Advancis also expects to begin a similar Phase III trial in its "sprinkle" version of Amoxicillin PULSYS for children with pharyngitis/tonsillitis early in 2005.<<
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Anyone got an interest in this one? I'm starting to get curious. Advancis fireworked yesterday on publication of study that seemed to validate their platform technology:
Message 20853433
First blush, still looks cheap. possible buy on reatracement under $4?
Cheers, Tuck |
