Isis Pharmaceuticals, Inc.
) recently provided an update on its pipeline. Isis Pharma boasts
of a robust pipeline. The company believes 5 of its pipeline
candidates can get approval within the next five years. Isis
Pharma expects data (phase II or phase III) on nine of its
pipeline candidates in 2013.
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Isis Pharma's lead pipeline candidate, Kynamro (mipomersen), is a
second generation compound being developed in collaboration with
) for the treatment of familial hypercholesterolemia (FH). Isis
Pharma received a major boost in October 2012 when the Food and
Drug Administration's (FDA) Endocrinologic and Metabolic Drugs
Advisory Committee voted (9 - 6) in favor of approving the
company's lead pipeline candidate, Kynamro. A response from the
FDA should be out by Jan 29, 2013.
However, we note that in Dec 2012, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) rendered a negative opinion on the approval of Kynamro.
Another interesting candidate at Isis Pharma is ISIS-TTRRx. The
candidate is being co-developed with
) for the treatment of transthyretin (TTR) amyloidosis. The
companies plan to initiate a registration-directed phase II/III
study evaluating the efficacy of ISIS-TTRRx on neurological
dysfunction and quality-of-life in patients with familial amyloid
polyneuropathy (FAP), a type of TTR amyloidosis, shortly. The
candidate received fast track designation from the FDA.
Other promising candidates in Isis Pharma's pipeline include
oncology drug, OGX-011 and EXC 001 for unwanted scarring. For
OGX-011, the company has partnered with
). Data from a phase III trial evaluating OGX-011 in prostate
cancer is expected to be released at the end of 2013.
EXC 001, developed in collaboration with
), advanced into a phase II study in November 2012.
Isis Pharma carries a Zacks Rank #3 (Hold) in the short run.
Though impressed by Isis Pharma's pipeline, we expect investor
focus to remain on the FDA's decision on Kynamro.
Pharma stocks, which currently look more attractive, are
). Both these companies carry a Zacks Rank #1 (Strong Buy).