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1 <p><b>The Partnership</b></p>
2 <p>Many years of research led PLIVA to the development of a valuable drug with
3 huge therapeutic and marketing potential. In 1981, PLIVA filed a patent application
4 for azithromycin in the former Yugoslavia, which was followed by further applications
5 worldwide, including in the United States. PLIVA's first patent for azithromycin
6 was granted in Belgium. In 1988 PLIVA registered azithromycin under the brand
7 name Sumamed.</p>
8 <p>PLIVA chose Pfizer as its strategic and licensing partner because of Pfizer's
9 overall capabilities and track record and because its international presence
10 and sales force complemented PLIVA's presence in Central and Eastern Europe.
11 Additionally, Pfizer had developed additional understanding of azithromycin
12 as a result of its own research in this area. For PLIVA, the licensing agreement
13 meant a huge breakthrough in terms of annual revenues and the expansion of research
14 activities.</p>
15 <p><b>The Medicine</b></p>
16 <p>Azithromycin acts by interfering with bacterial protein synthesis. Although
17 this mechanism is considered bacteriostatic, concentrations several times higher
18 than minimum inhibitory concentrations (MIC) contribute to the bactericidal
19 activity of azithromycin.</p>
20 <p>Azithromycin is rapidly absorbed and distributed throughout body tissues, reaching
21 high and sustained tissue concentrations that result in sustained antimicrobial
22 activity. Since azithromycin is a weak base, it easily penetrates the cell membrane
23 and stays within the cell, mainly in lysosomes. High concentrations of azithromycin
24 are found in infected tissues since phagocytes, polymorphonuclear leukocytes
25 and macrophages deliver azithromycin to the infection site and release it there
26 in the presence of bacteria.</p>
27 <p>Those pharmacokinetic properties of azithromycin in combination with wide antimicrobial
28 activity give the drug wide therapeutic applications. For the majority of infections,
29 azithromycin is administered once daily for three days. In the treatment of
30 sexually transmitted diseases, azithromycin is administered as a single dose
31 and in the treatment of <i>erythema migrans</i> once daily over 5 days. Azithromycin's
32 short dosing regimen is convenient for the patients and improves patient compliance.</p>
33 <p>In clinical trials, azithromycin showed itself to be either better or equally
34 well tolerated, compared to other antibiotics. The tolerability and safety profile
35 of azithromycin (Sumamed) have been assessed in 4,727 patients enrolled in clinical
36 trials carried out in Croatia, the Czech Republic, Hungary, Macedonia, Poland,
37 the Slovak Republic, Slovenia, Russia and the former Yugoslavia. In addition,
38 azithromycin, unlike the majority of macrolides, does not bind to cytochrome
39 P-450 in the liver, resulting in low potential for drug to drug interaction.</p>

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