Salix Pharmaceuticals, Ltd.
) and Pharming Group NV's Ruconest gained FDA approval for the
treatment of acute angioedema attacks in adults and adolescents
suffering from hereditary angioedema (HAE). This makes Ruconest the
first recombinant replacement therapy for C1 inhibitor deficiency
to gain FDA approval.
HAE is a rare inherited genetic condition, which according to Salix
affects 1 out of 10,000 people to 1 out of 50,000 people. Ruconest
has orphan drug designation in the U.S. for the treatment of acute
angioedema attacks in patients suffering from HAE. This should
allow Ruconest to enjoy seven years of marketing exclusivity in the
Ruconest can be self-administered by a patient once training is
obtained. Due to the unpredictability of HAE attacks, patients
remain uncertain about the occurrence of the next attack. This
makes it important to have a drug that patients can administer
themselves to resolve a sudden attack.
We remind investors that Salix has a license agreement with
Pharming for the commercialization of Ruconest in the U.S., Canada
and Mexico for HAE. Salix intends to launch Ruconest in the latter
part of 2014.
Some other drugs approved for the treatment of HAE are
) Firazyr (for patients aged 18 years and more) and
Meanwhile, Salix is looking to merge with Cosmo Technologies Ltd.,
a subsidiary of Cosmo Pharmaceuticals. Following the merger, Salix
will become a wholly-owned subsidiary of Irish domiciled Cosmo
We are positive on the upcoming merger. The change of base will
allow the company to enjoy a tax efficient corporate structure,
thereby allowing it to obtain lower tax rates on licensing
agreements to be signed in the future. Additionally, Cosmo, which
has expertise in the field of gastrointestinal diseases such as
inflammatory bowel disease, colon infections and diagnostics, will
help to strengthen Salix's position in the market for
gastrointestinal disease and disorders. Salix expects this
transaction to be modestly accretive to 2016 earnings and boost the
bottom line further thereafter.
Salix carries a Zacks Rank #1 (Strong Buy). Another stock looking
equally good in the health care sector is
Synergy Pharmaceuticals, Inc.
), carrying a Zacks Rank #1.
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