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[IP] Article on Lantus Being Launched

Once-Daily Insulin Product Launched in US

NEW YORK (Reuters Health) May 22 - After a delay of almost 9 months, Aventis
Pharmaceuticals announced on Tuesday that it has launched its once-daily
injectable insulin product Lantus (insulin glargine) in the US. Approved by
the US Food and Drug Administration in late April 2000, Lantus is an insulin
analog with a relatively constant concentration time of 24 hours, as opposed
to the shorter duration of other types of insulin that thereby require
frequent daily dosing. The therapy is indicated for both adult and pediatric
patients with type 1 diabetes, and adults with type 2 diabetes who require
long-acting insulin to control hyperglycemia. Lantus was originally expected
to hit the US market in September 2000. However, UBS analyst Paul Major told
Reuters Health that demand for the product was so high in Germany b where
Lantus quickly captured about 30% of the long-acting insulin market b that
Aventis was unable to build the inventory levels necessary for a additional
product roll-out. An Aventis Pharmaceuticals spokeswoman denied Major's
assessment, attributing the delayed launch to the company's adoption of a new
manufacturing process that required an FDA review. Once that review was
completed, the company began building its Lantus supply for the US launch,
the spokeswoman told Reuters Health. She added that the company's
manufacturing capability ensures that "we have enough Lantus to be available
to any patient who wants access to it." "Given the uptake in Germany, we know
that this will be a widely received drug, and we [made] sure that we have
enough available," she said.
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