) has signed a master manufacturing and supply agreement with
Patheon Pharmaceuticals. As per the agreement, Patheon will
provide commercial supplies of Horizant to XenoPort.
During the term of the agreement, XenoPort will provide
Patheon with its non-binding tentative long-term requirement for
the product, and will provide Patheon periodically with binding
firm purchase orders for supply of the product.
The agreement stipulates that Patheon is not permitted to
manufacture gabapentin enacarbil, which is the active ingredient
in Horizant, or any product containing gabapentin enacarbil for
any other entity except XenoPort, XenoPort's designee or any
authorized licensee of XenoPort, during the term of the
Dec 31, 2025, is the agreed upon expiry date of the agreement,
with automatic one-year renewal periods if either party does not
provide a prior notice of non-interest to renew.
Patheon is currently approved by the U.S. Food and Drug
Administration (FDA) for manufacturing and supplying Horizant.
Patheon was a supplier of the product to XenoPort's erstwhile
) on a contractual basis.
We remind investors that Glaxo and XenoPort had a
collaboration agreement for Horizant that was terminated in Nov
2012. Glaxo had commercialization rights to the drug through the
transition period, which ended on Apr 30, 2013. On May 1, 2013,
XenoPort re-acquired all commercialization rights to Horizant.
Glaxo, however, is expected to supply Horizant to XenoPort until
Oct 30, 2013.
We note that Horizant is approved in the U.S. for the
treatment of moderate-to-severe primary restless legs syndrome
(RLS) as well as the management of postherpetic neuralgia (PHN)
In May 2013, XenoPort resumed the supply and shipment of
Horizant. The company was also successful in resolving
manufacturing issues and expects to fill in orders from
wholesalers. We note that Glaxo faced manufacturing delays for
Horizant in the U.S., leading to product shortage.
XenoPort carries a Zacks Rank #3 (Hold). Currently, companies
which look attractive include
Jazz Pharmaceuticals Public Limited Company
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),
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