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* 75 mln H1N1 vaccine doses to ship in US by Christmas

* Sanofi expects first EU H1N1 approval “shortly”
(Adds details on vaccine production, pending EU approvals)

By Ros Krasny

CAMBRIDGE, Mass., Nov 10 (Reuters) – Production of H1N1
swine flu vaccine at two U.S. facilities is “working optimally”
with output on the rise, the chief executive of Sanofi-Aventis
(SASY.PA) said on Tuesday.

The French pharmaceutical giant had shipped 14 million
doses by the end of October and expects to have shipped some 75
million doses to the U.S. market by late December, CEO
Christopher Viehbacher told reporters at a company-sponsored
biotech event in Cambridge, Massachusetts.

“We’re probably the only company that is producing reliably
right now,” he said. “We’re pretty happy with production; it
takes a while to get the thing up and running.”

Production of the vaccine runs on roughly a 15-week cycle.
While output has been coming up to speed and availability of
the vaccine has been scarce in many areas, instances of swine
flu in the United States have been spreading.

Sanofi-Aventis’ facilities in Swiftwater, Pennsylvania, are
the only sites producing the H1N1 vaccine in the United States,and are now using some 300,000 eggs a day, Viehbacher said.

Yields for H1N1 vaccine production are approaching levels
typical of seasonal flu vaccine, which can also vary from
strain to strain, he said.

Sanofi-Aventis has a 40-percent market share globally for
the seasonal flu vaccine. Production of seasonal flu vaccine
has been wrapped up at this point, although packaging the
vaccine has been under “some strain,” Viehbacher said,

Viehbacher said the company should get EU approval “fairly
shortly” to sell the Panenza vaccine for H1N1, which is similar
to the U.S. variety, in four European countries.

Approval for the Humenza adjuvanted variety for broader
distribution would probably come in mid-December, he said.

STEPPING BACK FROM THE PATENT CLIFF

In a presentation, Viehbacher said the challenge for large
pharmaceutical companies is to avoid going over the “patent
cliff” when blockbuster drugs go off-patent and are exposed to
generic competition for the first time. The “cliff” looms for
much of the industry in 2012 to 2014, he said.

Sanofi’s future efforts will include a strong focus on
emerging markets and on animal health, which in turn circles
back to a rising standard of living and changing diet in
developing countries.

“The single biggest healthcare opportunity there is, is
vaccines in the southern hemisphere,” Viehbacher said. “How do
we reach the next billion customers?”
(Editing by Maureen Bavdek)