ELN » Topics » Azactam, cease to exist.

This excerpt taken from the ELN 6-K filed Sep 29, 2009.
Azactam, cease to exist.

We do not manufacture Tysabri, Prialt® (ziconotide), Maxipime or Azactam. Our dependence upon collaborators and third parties for the manufacture of our products may result in unforeseen delays or other problems beyond our control. For example, if our third-party manufacturers are not in compliance with current good manufacturing practices (“cGMP”) or other applicable regulatory requirements, then the supply of our products could be materially and adversely affected. If we are unable to retain or obtain replacements for our third-party manufacturers or if we experience delays or difficulties with our third-party manufacturers in producing our products, then sales of these products could be materially and adversely affected. Our supplier for Azactam has indicated it intends to cease supplying our requirements for Azactam beyond 2009. In this event, we may be unable to enter into alternative manufacturing arrangements on commercially reasonable terms, if at all. If we cannot source Azactam, our revenue from sales of Azactam will cease to exist.

Our manufacturers require supplies of raw materials for the manufacture of our products. We do not have dual sourcing of our required raw materials. The inability to obtain sufficient quantities of required raw materials could materially and adversely affect the supply of our products.

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