) announced that the FDA has granted orphan drug status to its
epilepsy candidate, pharmaceutical cannabidiol, for treating Dravet
syndrome, a rare form of intractable epilepsy that commences in
We note that the FDA grants orphan designation to candidates being
developed to treat rare diseases/disorders (affecting less than
200,000 people in the U.S.). Moreover, the status makes the
candidate eligible for seven years of marketing exclusivity in the
U.S. following approval. This designation also makes Insys eligible
for certain other benefits aimed at recovering the costs of
developing pharmaceutical cannabidiol, as this catastrophic
epilepsy form has a small target population.
Insys stated in its press release that its epilepsy candidate
provides an alternative to cannabinoids derived from plants. We
remind investors that Insys had received a similar designation from
the FDA for the candidate for treating another rare form of
pediatric epilepsy - Lennox-Gastaut syndrome. The company is also
evaluating the candidate in several other indications including
adult epilepsy and chemotherapy-induced peripheral neuropathy.
Insys' primary marketed product is Subsys. The product was
responsible for 96.5% of the company's total sales in 2013. The
drug is available for the treatment of breakthrough cancer pain in
patients who are opioid-tolerant. We remind investors that the
shares of the specialty pharmaceutical company declined
significantly in May this year following news on Subsys'
prescribing patterns (Read more:
Insys in Focus on Subsys Worries
Insys carries a Zacks Rank #4 (Sell). Better-ranked healthcare
), Biogen Idec
The Medicines Company
). All three stocks sport a Zacks Rank #1 (Strong Buy).
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