The US Food and Drug Administration (FDA) recently granted
orphan drug designation to
Teva Pharmaceutical Industries Ltd
) and Xenon Pharmaceuticals Inc. for their pain management
candidate, XEN402. Orphan drug status was granted for the
treatment of pain associated with erythromelalgia (EM).
XEN402 is in a phase II study for a variety of pain-related
disorders. XEN402 is being studied in both topical and oral
Oral XEN402 was shown to relieve pain related to EM, a rare
neuropathic pain condition. A phase II trial on topical XEN402,
which evaluated its effectiveness in reducing pain related to
post herpetic neuralgia, showed statistically significant
In Dec 2012, Teva entered into an exclusive worldwide license
agreement with Xenon for XEN402.
Financial terms of the deal include an upfront payment of $41
million to Xenon from Teva. Additionally, Teva will make
development, regulatory and sales-based milestone payments up to
$335 million. Xenon is eligible to receive royalties on sales and
also has an option to commercialize the drug in the US.
Teva is working on streamlining its pipeline and expects to
move 10 new therapeutic entities (NTEs) into development in 2013.
Meanwhile, as far as generics are concerned, Teva intends to
pursue first-to-file and first-to-market opportunities and seek
approval for complex generics which are likely to face less
Teva currently carries a Zacks Rank #4 (Sell). The company is
going through a transition period. Headwinds include EU pricing
pressure, potential new competition for branded products
(especially Copaxone) and fewer generic product launches compared
Currently, companies like
) look more attractive with a Zacks Rank #2 (Buy).
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