Pipeline updates by pharma/biopharma companies are of immense
value to investors interested in the sector. Investors, more
often than not, make their decisions on whether to invest in a
particular stock from the above sector based on such updates.
Tetraphase Pharmaceuticals, Inc.
) is working hard to develop its pipeline. Eravacycline is the
lead pipeline candidate at Tetraphase. Eravacycline, an
antibiotic, is being evaluated for multiple indications.
The company, while providing an update on eravacycline last week,
said that the enrollment process for the phase III study (IGNITE
1) on eravacycline in the complicated intraabdominal infections
(cIAI) indication is in progress. The company has completed
enrolling 50% of the targeted 536 patients for the study, which
commenced in the second quarter of 2013. The randomized,
multi-center, double-blind, double-dummy study is designed to
evaluate the efficacy and safety of eravacycline in comparison to
Merck & Co. Inc.
) Invanz (ertapenem) in cIAI patients. Top-line data from the
study is expected in the first quarter of 2015.
Tetraphase has also started enrolling patients for another phase
III study (IGNITE 2) on eravacycline. The two part study is
designed to evaluate the safety and efficacy of intravenous and
oral versions of the candidate for treating patients suffering
from complicated urinary tract infections (cUTI). Data from the
lead-in portion of the study is anticipated in mid-2014. The
company expects top-line data from the IGNITE 2 study in mid-2015
and seek U.S. approval for the candidate for both indications by
the end of that year.
We note that eravacycline enjoys qualified infectious disease
product (QIDP) designation from the U.S. Food and Drug
Administration (FDA) for the cIAI and cUTI indications. The QIDP
designation is a part of the Generating Antibiotic Incentives Now
(GAIN) Act, which falls under the 2012 FDA Safety and Innovation
With eravacycline being designated a QIDP, Tetraphase will
benefit from incentives such as priority review. Eravacycline
will also be eligible for the FDA's "fast track" status and will
enjoy an additional five years of exclusivity once it is
approved. Apart from Tetraphase, companies such as
) have also benefited from the signing of the GAIN act.
We expect investor focus to stay on the development of
Tetraphase carries a Zacks Rank #4 (Sell).
Questcor Pharmaceuticals, Inc.
) is a better-ranked stock with a Zacks Rank #1 (Strong Buy).
CUBIST PHARM (CBST): Free Stock Analysis
MERCK & CO INC (MRK): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
TETRAPHASE PHAR (TTPH): Free Stock Analysis
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