The Zacks Analyst Blog Highlights: Dr. Reddy's Laboratories, Bristol-Myers Squibb, Teva Pharmaceutical, Biogen Idec and Elan
Zacks
For Immediate Release
Chicago, IL – May 21, 2012 – 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 Dr. Reddy’s Laboratories (RDY), Bristol-Myers Squibb & Co. (BMY), Teva Pharmaceutical Industries Ltd. (TEVA), Biogen Idec (BIIB) and Elan Corporation, plc (ELN).
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Here are highlights from Friday’s Analyst Blog:
Dr. Reddy's Launches Generic Plavix
Dr. Reddy’s Laboratories (RDY) recently announced the U.S. launch of a generic version of Bristol-Myers Squibb & Co.’s (BMY) blood thinner, Plavix. The U.S. Food and Drug Administration (:FDA) approved the Abbreviated New Drug Application (ANDA) for 75 mg and 300 mg formulations of the generic version of the drug. Plavix lost patent exclusivity in the U.S. on May 17, 2012.
Since Dr. Reddy’s was among the first few companies to submit an ANDA for generic Plavix, it has the 180 days of marketing exclusivity for the 300 mg formulation.
According to the IMS Health data, Plavix sales in the U.S. amounted to about $6.74 billion for the twelve months ended March 31, 2012.
Last month Dr. Reddy’s launched the generic version of Teva Pharmaceutical Industries Ltd.’s (TEVA) antipsychotic drug, Zyprexa in the U.S. The generic drug was awarded 180-day marketing exclusivity in the U.S. on October 26, 2011, following a commercial, manufacture and supply agreement with Teva.
According to the IMS Health data, the U.S. branded and generic sales of Zyprexa were about $3.28 billion for the twelve months ended January 31, 2012.
Our View
We currently have a Neutral recommendation on Dr. Reddy’s. We believe that generic launches will continue to contribute towards Dr. Reddy’s Global Generics segment’s revenues, which climbed 32% to $1.38 billion in the first quarter of 2012. Primary contribution came from North America (up 68%), Russia and other CIS (Commonwealth of Independent States) markets (up 22%) and India (up 11%). Growth was mainly driven by new generic launches and was aided by an increase in the sales volume.
However, in Europe, sales declined 2%, primarily due to exchange rate fluctuation and the pricing pressure in the German market.
Data on Elan and Biogen's Tysabri
Biogen Idec (BIIB) and Elan Corporation, plc (ELN) recently announced the publishing of research from the Tysabri risk management program in the New England Journal of Medicine.
The research was based on data from Tysabri trials, post-marketing studies and an independent Swedish registry to estimate the incidence of progressive multifocal leukoencephalopathy (PML) in patients on Tysabri.
Three risk factors, the presence of anti-JC virus antibody, prior treatment with immunosuppressants and treatment duration with Tysabri, were used in the analysis.
Patients with anti-JC virus antibody, who had taken immunosuppressant therapy before Tysabri and had been on Tysabri for 25 to 48 months, demonstrated the highest risk of PML. The number of PML cases in these patients was 11.1 per 1,000 patients.
On January 20, 2012, Biogen and Elan announced that the U.S. Food and Drug Administration (:FDA) approved a label change for Tysabri. As per the updated label, anti-JC virus antibody status is a risk factor for developing PML, a rare and life-threatening brain infection. This step will enable doctors to assess the patients’ risk benefit matrix better.
Tysabri is approved in the U.S. for relapsing forms of multiple sclerosis (MS) in patients who show inadequate response to or are unable to tolerate other treatments. In the E.U., Tysabri is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have severe RRMS or have failed with beta interferon treatment.
In the E.U., Tysabri was approved in 2006, while in the U.S.; it was initially approved in 2004. The product was withdrawn from U.S. markets in 2005 due to the PML concern. The drug was reintroduced by Biogen and Elan after a year with a strict warning regarding the occurrence of PML.
In-market net sales of Tysabri climbed 14.2% to $399 million in the first quarter of 2012. The increase was driven by higher global demand and higher price in the U.S. market. The sales of Tysabri recorded by Elan rose 17.5% to $288.2 million.
Our Recommendation
We currently have a Neutral recommendation on both Biogen and Elan. While Elan carries a Zacks #2 Rank (Buy rating) in the short run, Biogen carries a Zacks #3 Rank (short-term Hold rating).
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