Replies to post #73107 on Biotech Values

[DewDiligence]

Correction to Sanofi link in msg #73107:

http://en.sanofi-aventis.com/binaries/Results_2008_EN_tcm28-23943.pdf

[DewDiligence]

MNTA – Generic Lovenox in the EU:

While perusing SNY’s Form 20-F filing (similar to a 10-K), I found the expiration dates in the various EU countries for the composition-of-matter patents on Lovenox:

• Germany, UK, Italy, and all EU countries not listed here: Jun 2011;

• France: Jun 2010;

• Spain, Portugal, Finland, Norway, Greece, Eastern European countries: already expired.

Annualized Lovenox sales in Europe during 4Q08 were approximately $1.2B (#msg-35570519).

The generic-Lovenox program in the EU falls under the 2006 collaboration between NVS and MNTA (#msg-12222305), which is separate from the companies’ 2003 collaboration to develop generic Lovenox in the US.

NVS and MNTA have not disclosed when they plan to file an application for generic Lovenox in the EU. Inasmuch as Lovenox’s period of EU data exclusivity (which is separate from EU patent protection) has long since expired, an application for generic Lovenox may be filed at any time. In all likelihood, a patent challenge will not be needed because the Lovenox composition-of-matter patent in all EU countries will have expired by the time the necessary clinical studies can be completed for the EMEA to render a decision.

[DewDiligence]

Sanofi Reports 1Q09 Annualized Lovenox Sales of $4.0B

[The sales figures below are in Euros, Sanofi’s reporting currency, but the growth rates are in local currencies unless otherwise specified. (Tallying growth in local currencies is a way to track the change in volume and price irrespective of exchange rates.) The sales figures below are annualized, i.e. they are 4x the 1Q09 numbers.]


Worldwide Lovenox sales in 1Q09 rose 1% year-over-year in local currencies (+6% in Euros) to an annualized rate of €3.05B, which is $4.0B at the current exchange rate. (Relative to 4Q08, worldwide Lovenox sales in 1Q09 increased 2% in Euros.)

In the US, where MNTA and partner NVS have filed an application to sell generic Lovenox, Sanofi’s annualized 1Q09 sales were €1.87B, which is $2.5B at the current exchange rate.

The breakdown of 1Q09 sales by geography is as follows:

US: €1.87B (61% of total), -1% YoY in lc
EU: €868M (28% of total), +5% YoY in lc
RoW: €308M (10% of total), +5% YoY in lc
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Total: €3.05B, +1% YoY in lc

http://en.sanofi-aventis.com/binaries/20090429_q12009_en_tcm28-24993.pdf