Heightened FDA Scrutiny Threatens Zalicus and AEterna Zentaris
September 19 2011 - 8:16AM
Marketwired
The Paragon Report examines investing opportunities in the
Biotechnology Industry and provides equity research on Zalicus,
Inc. (NASDAQ: ZLCS) and AEterna Zentaris, Inc. (NASDAQ: AEZS) (TSX:
AEZ). Access to the full company reports can be found at:
www.paragonreport.com/ZLCS
www.paragonreport.com/AEZS
In recent years the FDA has been heavily scrutinized for making
the approval process more difficult for drug developers. A
groundbreaking study released this year by the BIO and
BioMedTracker finds that the overall success rate for drugs moving
through clinical trials to FDA approval from late 2003 to the end
of 2010 is a mere ten percent. Previously the rate of approval was
one in five to one in six. Oncology drugs faced the toughest road
to approval despite the fact that the disease area is the most
closely studied in all of drug development.
Janet Woodcock, the head of the FDA's drug division, is quick to
dismiss concerns regarding the FDA's approval process. This summer
in testimony before the House Energy and Commerce's health
subcommittee, Woodcock explained the agency meets more than 90% of
deadlines that are part of the drug-review process. She also said
so-called first cycle approvals are at a 20-year high with and said
more than two-thirds of new drugs being approved within the
six-to-10-month time frames given to new drug applications.
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Zalicus is a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain and
immuno-inflammatory diseases. The company recently posted a $4.4
million increase in research and development expenses, which were
due primarily to an increase in expenses related to the clinical
development of Synavive and preclinical program expenses related to
our Ion channel product candidates.
Aeterna Zentaris is a late-stage oncology drug development
company currently investigating potential treatments for various
cancers including colorectal, multiple myeloma, endometrial,
ovarian, prostate and bladder cancer. Recently the company reported
positive late-stage results for its product used to diagnose adult
growth hormone deficiency.
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that all investment entails inherent risks. Please view the full
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