) announced that the FDA has granted orphan drug status to its
pharmaceutical cannabidiol (CBD), for the treatment of glioblastoma
multiforme (GBM). Glioblastoma multiforme is the most common and
aggressive form of malignant primary brain tumor.
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.). 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 financial benefits for developing pharmaceutical
We remind investors that Insys already has orphan drug
designation for pharmaceutical CBD for treating Dravet syndrome (a
rare form of intractable epilepsy that commences in infancy) and
Lennox-Gastaut syndrome (a rare form of pediatric epilepsy).
The company is evaluating the possibility of developing the
candidate for several additional indications, which include adult
epilepsy, chemotherapy-induced peripheral neuropathy and addiction
in cocaine, amphetamines and opioids. Insys expects to seek orphan
drug status for these additional indications if they qualify.
Insys continues to progress with its pharmaceutical cannabinoid
program. Earlier this month, the company submitted a New Drug
Application (NDA) seeking FDA approval for its proprietary
dronabinol oral solution for anorexia associated with weight loss
in AIDS patients and nausea and vomiting caused by chemotherapy in
patients who have not responded sufficiently to conventional
Insys carries a Zacks Rank #4 (Sell). Some better-ranked stocks
in the health care sector include ICU Medical, Inc. (
), SurModics, Inc. (
) and Eagle Pharmaceuticals Inc. (
). While ICU Medical holds a Zacks Rank #1 (Strong Buy), SurModics
and Eagle Pharmaceuticals are Zacks Rank #2 (Buy) stocks.
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