first approval for famciclovir

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22 MARKET NEWS First approval for famciclovir UK authorities have granted approval to SmithKline Beecham's famciclovir [Famvir®) for the treatment of herpes zoster (shingles), breaking the near monopoly that Wellcome's aciclovir (Zovirax®] has had in this market. The stakes are high: for the year ending 31 Aug 1993, Zovirax® had sales of £760 million. Advantages touted The greatest advantage that famciclovir may have over aciclovir is that it requires administration 3-times daily only, while aciclovir must be taken 5-times daily. But Wellcome is addressing this and valaciclovir, a follow-up to aciclovir which requires only twice-daily dosing, may be approved within the next year or so. Smith Kline Beecham has also presented data which suggest that famciclovir is more effective than aciclovir in treating the long-term pain which can occur with shingles. competition SmithKline Beecham has not released any details of its planned pricing strategy for the new antiviral, but suspicions are that an aggressive approach may be taken to undercut Zovirax®. Nevertheless, both drugs may face further competition as aciclovir's patents begin to expire. Wellcome has already moved to protect aciclovir's share of the market by launching an over-the-counter version of the antiviral for cold sores. Approval applications for famciclovir have been filed in over 20 countries, and approval is expected in the US this year. Famciclovir is also in late phase III testing for other herpes virus infections including cold sores, genital herpes and chickenpox. ."24""" 8 Jan 1994INPHARMA e 0156-2703194/0919·000221$01.000 Adlalnternatlonal Limited 1994. All rlghb..... -"eel

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Page 1: First approval for famciclovir

22 MARKET NEWS First approval for famciclovir

UK authorities have granted approval to SmithKline Beecham's famciclovir [Famvir®) for the treatment of herpes zoster (shingles), breaking the near monopoly that Wellcome's aciclovir (Zovirax®] has had in this market. The stakes are high: for the year ending 31 Aug 1993, Zovirax® had sales of £760 million.

Advantages touted The greatest advantage that famciclovir may

have over aciclovir is that it requires administration 3-times daily only, while aciclovir must be taken 5-times daily. But Wellcome is addressing this and valaciclovir, a follow-up to aciclovir which requires only twice-daily dosing, may be approved within the next year or so.

Smith Kline Beecham has also presented data which suggest that famciclovir is more effective than aciclovir in treating the long-term pain which can occur with shingles.

Fie~ competition SmithKline Beecham has not released any details

of its planned pricing strategy for the new antiviral, but suspicions are that an aggressive approach may be taken to undercut Zovirax®. Nevertheless, both drugs may face further competition as aciclovir's patents begin to expire. Wellcome has already moved to protect aciclovir's share of the market by launching an over-the-counter version of the antiviral for cold sores.

Approval applications for famciclovir have been filed in over 20 countries, and approval is expected in the US this year. Famciclovir is also in late phase III testing for other herpes virus infections including cold sores, genital herpes and chickenpox.

."24"""

8 Jan 1994INPHARMAe 0156-2703194/0919·000221$01.000 Adlalnternatlonal Limited 1994. All rlghb.....-"eel