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<p><b>The PLIVA - Pfizer Partnership</b></p> |
<p><b>The Partnership</b></p> |
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<p>PLIVA selected Pfizer as a strategic and licensing partner because of Pfizer's |
<p>Many years of research led PLIVA to the development of a valuable drug with |
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overall capabilities and track record, and because of its international presence |
huge therapeutic and marketing potential. In 1981, PLIVA filed a patent application |
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and sales force which complemented PLIVA's presence in Central and Eastern Europe |
for azithromycin in the former Yugoslavia, which was followed by further applications |
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and the former Soviet Union. Additionally, Pfizer had a clear understanding |
worldwide, including in the United States. PLIVA's first patent for azithromycin |
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of azithromycin as a result of its own research into macrolides.</p> |
was granted in Belgium. In 1988 PLIVA registered azithromycin under the brand |
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<p>Under the agreement, Pfizer and PLIVA agreed to a territorial division of exclusive |
name Sumamed.</p> |
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rights to sell azithromycin dosage forms. PLIVA maintains the right to sell |
<p>PLIVA chose Pfizer as its strategic and licensing partner because of Pfizer's |
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its Sumamed in Central and Eastern Europe as well as some other countries (e.g. |
overall capabilities and track record and because its international presence |
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People's Republic of China). Royalties from the sales of Zithromax, Pfizer's |
and sales force complemented PLIVA's presence in Central and Eastern Europe. |
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branded version of azithromycin, in Pfizer's territory are paid to PLIVA. For |
Additionally, Pfizer had developed additional understanding of azithromycin |
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PLIVA, a small pharmaceutical company when compared to its licensee Pfizer, |
as a result of its own research in this area. For PLIVA, the licensing agreement |
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the azithromycin licensing agreement meant a huge breakthrough in terms of annual |
meant a huge breakthrough in terms of annual revenues and the expansion of research |
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revenues and these allowed PLIVA to expand its research activities.</p> |
activities.</p> |
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<p><b>The Medicine</b></p> |
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<p>Azithromycin acts by interfering with bacterial protein synthesis. Although |
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this mechanism is considered bacteriostatic, concentrations several times higher |
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than minimum inhibitory concentrations (MIC) contribute to the bactericidal |
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activity of azithromycin.</p> |
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<p>Azithromycin is rapidly absorbed and distributed throughout body tissues, reaching |
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high and sustained tissue concentrations that result in sustained antimicrobial |
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activity. Since azithromycin is a weak base, it easily penetrates the cell membrane |
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and stays within the cell, mainly in lysosomes. High concentrations of azithromycin |
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are found in infected tissues since phagocytes, polymorphonuclear leukocytes |
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and macrophages deliver azithromycin to the infection site and release it there |
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in the presence of bacteria.</p> |
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<p>Those pharmacokinetic properties of azithromycin in combination with wide antimicrobial |
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activity give the drug wide therapeutic applications. For the majority of infections, |
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azithromycin is administered once daily for three days. In the treatment of |
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sexually transmitted diseases, azithromycin is administered as a single dose |
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and in the treatment of <i>erythema migrans</i> once daily over 5 days. Azithromycin's |
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short dosing regimen is convenient for the patients and improves patient compliance.</p> |
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<p>In clinical trials, azithromycin showed itself to be either better or equally |
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well tolerated, compared to other antibiotics. The tolerability and safety profile |
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of azithromycin (Sumamed) have been assessed in 4,727 patients enrolled in clinical |
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trials carried out in Croatia, the Czech Republic, Hungary, Macedonia, Poland, |
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the Slovak Republic, Slovenia, Russia and the former Yugoslavia. In addition, |
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azithromycin, unlike the majority of macrolides, does not bind to cytochrome |
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P-450 in the liver, resulting in low potential for drug to drug interaction.</p> |
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