NSPH, NYT, MYL – PennyToBuck.com Watch List For Wednesday Dec. 28th, 2011
pennytobuck Newsletter
__ MYL, Mylan Inc.
** MYL reported that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the FDA for its Abbreviated New Drug Application for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base). This product is the generic version of Abbott Laboratories` Teveten Tablets, which are used to treat hypertension.
According to MYL, Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification to the FDA for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base), and was awarded 180 days of marketing exclusivity. Mylan is shipping this product immediately.
MYL ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories.
More about MYL at www.mylan.com.
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NYT, The New York Times Company ** NYT reported that it has entered into an agreement to sell its Regional Media Group, consisting of 16 regional newspapers, other print publications and related businesses, to Halifax Media Holdings LLC for $143 million in cash, subject to certain adjustments.
The transaction is expected to close within a few weeks and upon completion of the sale, the Company will record an after-tax gain on the sale in the first quarter of 2012. The Company intends to use the net proceeds for general corporate purposes. The Company estimates the net after-tax proceeds from the sale will be approximately $150 million.
NYT, a leading media company with 2010 revenues of $2.4 billion, includes The New York Times, the International Herald Tribune, The Boston Globe, 15 other daily newspapers and more than 50 Web sites, including NYTimes.com, BostonGlobe.com, Boston.com and About.com.
More about NYT at www.nytco.com.
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NSPH, Nanosphere, Inc.
** NSPH reported that it has received 510(k) clearance from the FDA for the Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands NSPH`s infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.
The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene Gram Positive Blood Culture (BC-GP) test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.
The BC-S test provides species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours, as compared with current microbiological culture methods, which can take up to 3 days. Identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment.
The sample-to-result BC-S test automates the steps of bacterial nucleic acid extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-S test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.
NSPH develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene System, for multiplexed infectious disease, genetic, and ultra-sensitive protein testing.
More about NSPH at www.nanosphere.us.
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