CHICAGO, March 14, 2011 /PRNewswire/ -- Zacks.com Analyst
Blog features: Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN),
Eli Lilly and Company (NYSE: LLY), Alkermes, Inc.
(Nasdaq: ALKS), Novo Nordisk (NYSE: NVO) and The Dow
Chemical Co. (NYSE: DOW).
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Here are highlights from Friday's Analyst Blog:
Positive Data for Amylin Candidate
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly
and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq:
ALKS) recently presented positive phase II data on a once-monthly
injectable suspension formulation of exenatide.
Results from the randomized, open-label study, which was
conducted with 121 type II diabetes patients, showed that patients
in the exenatide once-monthly arm achieved a reduction of 1.3-1.5
percentage points in A1C levels. Amylin and its partners also
evaluated Bydureon (exenatide once-weekly) which achieved 1.5
percentage point reduction in A1C levels.
Amylin, Lilly and Alkermes are now planning to meet with
regulatory authorities to determine the forward development path
for exenatide once-monthly.
The positive data comes a few days after Amylin reported
disappointing results on Bydureon from a head-to-head study.
Earlier this month, Amylin had reported that Bydureon failed to
achieve its primary endpoint of non-inferiority in the DURATION-6
study, which compared Bydureon with Novo Nordisk's (NYSE:
NVO) Victoza.
The disappointing DURATION-6 data was the latest setback faced
by Amylin and its partners in the development of Bydureon. Earlier
in October 2010, Bydureon's approval
was delayed with the US Food and Drug Administration (FDA) issuing
a second complete response letter (CRL) for the type II diabetes
candidate.
In its second CRL, the FDA asked the companies to conduct a
thorough QT (tQT) study. The FDA may have asked for this study
based on the recent concerns raised regarding the cardiovascular
safety profile of diabetes drugs.
The agency also asked Amylin and its partners to submit data
from the DURATION-5 study which was conducted to compare the safety
and efficacy of Bydureon versus Byetta (exenatide).
Amylin and its partners intend to submit a response to the
second CRL in the second half of 2011. Assuming a six-month review
period, Bydureon could gain FDA approval in mid 2012.
DOW Raises Tender Cap to $1.5B
Chemical giant The Dow Chemical Co. (NYSE: DOW) raised
the aggregate amount for its tender offer for a pool of notes to
$1.5 million from $750 million, after receiving tenders of
$1.7 billion. An offer for a second
pool of notes received $832 million
with a cap of $300 million.
Dow also under went an agreement with Solazyme Inc., a South San
Francisco-based renewable oils and bio-products company, for
bio-based dielectric insulating fluids.
Solazyme will help to develop a new class of algal oils. Dow
expects to obtain up to 20 million gallons of Solazyme's oils for
use in dielectric insulating fluids and other industrial
applications in 2013 and up to 60 million gallons in 2015. The
financial terms of the deal were not disclosed.
In the fast growing space of bio-based dielectric insulation
fluids, it is believed that Solazyme's tailor-designed algal oils
will serve as a foundation to develop a new generation of fluids
that are fire safe, environmentally sound, and that provide overall
increased performance to users of transformers and other electrical
applications.
In February, Dow reported sales of $13.8
billion for the fourth quarter of 2010, which was up 22%
year over year. The company's net earnings were 37 cents per share in the fourth quarter of 2010,
ahead of the Zacks Consensus Estimate of 35
cents as well as last year's 8
cents.
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