Achillion Pharmaceuticals Inc.
) recently announced that the U.S. Food and Drug Administration
(FDA) has decided to retain the clinical hold on its hepatitis C
viral infection (HCV) candidate, sovaprevir. We expect investors
to react negatively to the news.
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We note that the FDA had placed a clinical hold on sovaprevir
after observing elevations in ALT liver enzymes in a phase I
healthy subject drug-drug interaction study in Jun 2013. The
phase I study was being conducted to evaluate the effects of
concomitant administration of sovaprevir with Norvir
(ritonavir)-boosted Reyataz (atazanavir).
While imposing the clinical hold, the FDA had requested Achillion
to submit reports from two drug-drug interaction studies along
with an integrated safety analysis of ongoing sovaprevir studies.
Despite submitting the requisite data and addressing all issues
raised by the FDA, the regulatory authority decided not to lift
the clinical hold on the candidate.
Meanwhile, Achillion announced interim data from a 12-week phase
II study evaluating sovaprevir plus ACH-3102 and ribavirin in
treatment-naive patients with genotype 1 HCV. The combination
regime demonstrated promising efficacy, safety and tolerability.
We note that
) Incivek and
) Victrelis are approved for the treatment of HCV among others.
Moreover, many large cap companies are developing drugs for the
treatment of HCV
Achillion primarily focuses on developing therapies for HCV and
other infections. Pipeline candidates for the treatment of HCV at
Achillion include sovaprevir (phase II), ACH-3102 (phase II),
ACH-2684 (completed phase I) and ACH-3422 (phase I expected to be
initiated in the first half of 2014). Additionally, the company
also plans to initiate a study evaluating ACH-3102 in combination
with ACH-2684 with results expected next year.
Achillion carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).