Conatus Pharmaceuticals Inc.
) announced that its pipeline candidate emricasan has been
granted orphan drug status. Conatus is developing emricasan for
treating liver transplant patients with reestablished fibrosis.
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The designation is granted by the FDA to indications being
developed to treat rare diseases (affecting less than 200,000
people in the U.S.) having significant unmet medical needs.
Moreover, the status makes emricasan eligible for seven years of
marketing exclusivity in the U.S. following approval for the
Additionally, this status also provides several other benefits
such as tax credits to Conatus on the candidate's development
costs and exemption of prescription drug user fee. We expect
investors to react positively to the news, facilitating the
development of Conatus' lead pipeline candidate for the above
We note that Conatus is currently developing emricasan for
treating patients with acute-on-chronic liver failure (phase
IIb). The placebo-controlled, double blind, multi-center study
(n~60), initiated in Sep 2013, is evaluating pharmacokinetics,
pharmacodynamics and the safety of emricasan in patients with
acute-on-chronic liver failure (ACLF). Conatus expects initial
data from the study in the first half of 2014.
Moreover, the candidate is also undergoing phase II development
for treating patients suffering from severe alcoholic hepatitis.
While releasing its third quarter 2013 results last month, the
company announced that the study was initiated by the
translational research and evolving alcoholic hepatitis treatment
consortium. Furthermore, the company stated on the third quarter
2013 conference call that it intends to commence a phase IIb
study in patients with chronic liver failure in the second half
of 2014 following completion of the phase IIb study in ACLF
patients. We expect investor focus to remain on the company's
pipeline development efforts.
Conatus carries a Zacks Rank #3 (Hold). Some other stocks worth
AMAG Pharmaceuticals, Inc.
). While Actelion holds a Zacks Rank #1 (Strong Buy), AMAG and
Amgen carry a Zacks Rank #2 (Buy).