Isis Pharmaceuticals, Inc. (ISIS) 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.
Isis Pharma’s lead pipeline candidate, Kynamro (mipomersen), is a second generation compound being developed in collaboration with Sanofi (SNY) 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 GlaxoSmithKline (GSK) 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 OncoGenex (OGXI) and Teva Pharmaceuticals (TEVA). 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 Pfizer (PFE), 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 Biocryst Pharmaceuticals (BCRX) and Valeant Pharmaceuticals (VRX). Both these companies carry a Zacks Rank #1 (Strong Buy).
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