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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