http://www.straightstocks.com Leading Stock Market News, Opinions and Commentary Mon, 22 Mar 2010 12:14:14 +0000 http://wordpress.org/?v=2.9.2 en hourly 1 http://www.straightstocks.com/stock-watch/mdco-recalls-cleviprex-lots-analyst-blog/ http://www.straightstocks.com/stock-watch/mdco-recalls-cleviprex-lots-analyst-blog/#comments Fri, 18 Dec 2009 17:45:14 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/28481/MDCO+Recalls+Cleviprex+Lots+-+Analyst+Blog The Medicines Co. (MDCO) recently announced the voluntary recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion. During a routine annual inspection, the presence of visible particulate matter was observed in some vials.
 
However, The Medicines Co. stated that it has not yet received any product complaints or reports of adverse events associated with the issue. Physicians have, nevertheless, been warned to inspect the vials before using the product.
 
The Medicines Company received approval for Cleviprex in August 2008 for the short-term control of blood pressure in patients undergoing cardiac surgery. The product is an ultra-short acting calcium channel blocker (CCB) given intravenously when oral therapy is not feasible or desirable.
 
The drug acts by selectively relaxing the smooth muscle cells that line small arteries, resulting in widening of the artery and reduction of blood pressure with minimal effect on the heart rate. There are an estimated 300k cardiac surgery patients in the U.S that qualify for Cleviprex.
 
Although favorable results support the efficacy and safety of the product, Cleviprex has posted sales of only $2.5 million in the first nine months of 2009. We believe sales are being impacted by the presence of a generic version of nicardipine launched by Teva (TEVA) in the market. The presence of cheaper generic alternatives could lead to additional pricing pressure which would make it all the more difficult for the company to drive product sales.
 
We note that The Medicines Company has already reduced its 2009 sales guidance for Cleviprex to $5 - $10 million (previous guidance: $10 -$19 million). Cleviprex sales could be affected further by the product recall especially if the company recalls additional lots of the product.
 
The Medicines Company’s shares are down 3.7% on the product recall news. We currently have an Underperform recommendation on the stock.
Read the full analyst report on "MDCO"
Read the full analyst report on "TEVA"
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]]> http://www.straightstocks.com/stock-watch/mdco-recalls-cleviprex-lots-analyst-blog/feed/ 0 http://www.straightstocks.com/stock-watch/good-news-for-novartis-analyst-blog/ http://www.straightstocks.com/stock-watch/good-news-for-novartis-analyst-blog/#comments Wed, 30 Sep 2009 14:17:23 +0000 Zacks Market Commentaries http://www.zacks.com/stock/news/25342/Good+News+for+Novartis+-+Analyst+Blog Early this morning, Novartis AG (NVS) announced that data from a two year late-stage study showed that its oral drug FTY720 (fingolimod) was significantly superior to placebo in reducing relapses and disability progression in patients with relapsing-remitting multiple sclerosis (MS).

The double-blind placebo-controlled study, called FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis), involved 1,272 patients in 22 countries and assessed the efficacy, safety and tolerability of FTY720. The study revealed that FTY720, which was well tolerated in the study, reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the 1.25 mg dose compared to placebo.

Furthermore, the candidate reduced disability progression by 30% for patients on 0.5 mg and 32% for those on 1.25 mg compared to placebo over the entire duration of the study, thus meeting the primary and secondary endpoints for both the doses, with no significant difference in efficacy.

The incidence of adverse events was much lower in the 0.5 mg dosage. Consequently, the company intends to seek approval for the lower dose of the drug in the US and the European Union at the end of this year. Additionally, all further developments of FTY720 in relapsing forms of the disease will be focused on the 0.5 mg dose.

Once launched, FTY720 will compete primarily with Biogen Idec (BIIB), which is the market leader in therapies to treat MS. Biogen’s leading product is Avonex, which recorded sales of $2,203 million, up 18% from 2008. The company’s other MS product, Tysabri, continued to see an increase in patient growth despite carrying a black-box warning for the risk of progressive multifocal leukoencephalopathy (PML) and other cautionary language.

Biogen is working on consolidating its position in the MS market and has an impressive late-stage pipeline of drugs including Fampridine-SR, which is currently under review by the US Food and Drug Administration (FDA). Besides Fampridine, the company has another interesting MS candidate, BG-12, which is currently undergoing late-stage trials. The other leading candidates in the MS market are Copaxone of Teva Pharmaceutical Industries (TEVA) and Rebif of Pfizer (PFE)/Serono.

However, the market has huge potential as only about 36% of MS patients are currently treated with MS drug, this percentage is expected to increase to 56% by 2014 as new oral MS therapies are launched. MS prevalence rate is higher in women than men. It is the fourth leading cause of disability among American women.
Read the full analyst report on "NVS"
Read the full analyst report on "TEVA"
Read the full analyst report on "BIIB"
Read the full analyst report on "PFE"
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]]> http://www.straightstocks.com/stock-watch/good-news-for-novartis-analyst-blog/feed/ 0 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/exxi-vip-mdco-stock-pr-stock-headlines-september-4-2009/ http://www.straightstocks.com/small-cap-and-micro-cap-stocks/exxi-vip-mdco-stock-pr-stock-headlines-september-4-2009/#comments Fri, 04 Sep 2009 12:07:09 +0000 Stock-PR http://stock-pr.com/?p=1127 http://www.straightstocks.com/small-cap-and-micro-cap-stocks/exxi-vip-mdco-stock-pr-stock-headlines-september-4-2009/feed/ 0