Published: November 23, 2009
Zacks Analyst Blog Highlights: Pozen, Sanofi-Aventis, Bristol-Myers, AstraZeneca and ADC Telecommunications Inc.
CHICAGO - (BUSINESS WIRE) - Zacks.com announces the list of stocks featured in the Analyst Blog.
Every day the Zacks Equity Research analysts discuss the latest news and
events impacting stocks and the financial markets. Stocks recently
featured in the blog include: Pozen (Nasdaq: POZN),
Sanofi-Aventis (NYSE: SNY),
Bristol-Myers (NYSE: BMY),
AstraZeneca (NYSE: AZN)
and ADC Telecommunications Inc. (Nasdaq: ADCT).
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Here are highlights from Friday's Analyst Blog:
Pozen Initiates New Phase III
This morning, Pozen (Nasdaq: POZN)
initiated phase III studies on PA-325/40, a fixed-dose combination of
325mg enteric coated aspirin and 40mg of immediate release omeprazole.
The phase III program will consist of two pivotal trials conducted under
a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and
one long-term safety study.
The two pivotal programs will enroll approximately 500 patients per
study at over 100 sites around the U.S. The primary endpoint of the
pivotal studies is the cumulative incidence of gastric ulcers over the
six-month treatment period for PA32540 versus 325 mg of enteric-coated
aspirin. The long-term study will enroll approximately 400 patients and
assess safety over a period of one year.
Pozen is developing PA-325/40 for use in the secondary prevention of
heart attacks and strokes in patients at risk for associated gastric
ulcers. Aspirin is the No. 1 recommended agent for at-risk patients,
with some 50 million Americans take daily aspirin therapy for secondary
prevention of heart attacks and strokes.
However, according to data presented at the American College of
Gastroenterology and at the American Heart Association meeting, the use
of low-dose aspirin for cardiovascular disease prophylaxis is associated
with a 2- to 4-fold increase in gastro-intestinal (GI) complications,
including gastric ulcers. Enteric coating is not a sufficient to reduce
the risk of GI bleeding, and thus the majority of patients that should
be taking 325mg aspirin are non-compliant or taking suboptimal low-dose
(81mg) "baby" aspirin instead.
Pozen's PA-325/40 is designed to provide immediate-release omeprazole as
a GI-protectant for patients taking full-dose 325mg daily aspirin
therapy. If the phase III trials meet the primary endpoint of reduction
in cumulative incidence of gastric ulcers, we expect PA-325/40 to be
approved by the U.S. FDA with the full cardiovascular label claims of
regular enteric-coated aspirin. This is a significant market opportunity
in our view, considering less than 15% of the 50 million Americans on
daily aspirin therapy are taking a GI-protectant such as omeprazole.
Recently, data from a retrospective analysis of patients that use Sanofi-Aventis
(NYSE: SNY)
/ Bristol-Myers' (NYSE: BMY)
Plavix (clopidogrel) showed an increased risk of major adverse
cardiovascular events (MACE) by as much as 50% while taking a proton
pump inhibitor (PPI) such as AstraZeneca's (NYSE: AZN)
omeprazole (Prilosec) or esomeprazole (Nexium). The data included
analysis of outcomes from 16,700 patients who underwent percutaneous
coronary intervention and continued Plavix for 12 months after the
procedure.
ADC Dips on Weak Outlook
Yesterday, after market close, ADC Telecommunications Inc.
(Nasdaq: ADCT)
declared financial results for the fourth quarter of fiscal 2009.
Earlier, the Board of Directors of ADC had taken a decision to change
its fiscal year from Oct 31 to Sep 30. As a result, fiscal year 2009
ended on Sep 30, 2009, which means the company got only two months as
its fourth quarter. The fourth quarter of fiscal 2009 would, therefore,
not be comparable to either the prior-year quarter or the previous
quarter. For this reason, management has presented pro forma results for
the three month period ending Sep 30 and its comparable quarter.
Actual revenue of fourth quarter 2009 was $183.9 million, below the
Zacks Consensus Estimate of $189 million. Quarterly pro forma revenue
was $293.6 million, down 17.5% year-over-year. This significant decline
in revenue is the result of the global economic recession across all the
three business segments.
On a GAAP basis, net loss in the quarter was $19.8 million or a loss of
20 cents per share compared to a net loss of $5.6 million or a loss of 5
cents per share in the prior-year quarter. However, adjusted net income
(excluding $25.5 million special charges and $0.6 million loss from
discontinued operations, net of taxes) in the reported quarter was $6.3
million or an income of 6 cents per share, higher than the Zacks
Consensus Estimate of an income of 4 cents per share.
Pro forma gross margin for the quarter was 34.6% compared to 33% in the
year-ago quarter. This reflects the aggressive cost cutting measures
taken by management during the past one year. Pro forma quarterly
operating expenses were $113 million compared to $106.2 million in the
prior-year quarter.
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