For Immediate Release
Chicago, IL – March 28, 2013 – 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 Bayer (BAYRY), Johnson & Johnson (JNJ), Novo Nordisk (NVO), AbbVie Inc. (ABBV) and Astellas Pharma, Inc. (ALPMY).
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Here are highlights from Wednesday’s Analyst Blog:
Japanese Approval for Bayer Drug
Bayer’s (BAYRY) HealthCare segment recently received encouraging news as the Ministry of Health, Labour and Welfare (:MHLW) in Japan approved Stivarga (regorafenib). Stivarga is approved in Japan for the treatment of patients suffering from unresectable, advanced/recurrent colorectal cancer (CRC).
Bayer stated in its press release that CRC is the third most common cause of cancer death in Japan. More than 40,000 people die in Japan every year due to CRC.
The Japanese approval of Stivarga was based on results from the phase III CORRECT study. Results from the study showed improvement in overall survival and progression-free survival in comparison to placebo, in patients suffering from metastatic CRC (mCRC) and whose disease had progressed after approved standard therapies.
Stivarga is already approved in the US for treating patients suffering from mCRC, whose disease had progressed even after treatment with standard drugs prescribed for the disease. Stivarga is also approved for metastatic gastrointestinal stromal tumors (:GIST) indication in the US. Bayer is also seeking EU approval of Stivarga for the treatment of mCRC.
Bayer, meanwhile, received a huge setback earlier this month when the company and its partner Johnson & Johnson(JNJ) received a second complete response letter (CRL) from the US Food and Drug Administration (:FDA) for their supplemental New Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the reduction of the risk of secondary cardiovascular events in patients suffering from ACS.
The second CRL for Xarelto is a big disappointment for the company. Bayer, a large cap pharma company, currently carries a Zacks Rank #4 (Sell). Meanwhile, other large cap pharma stocks such as Novo Nordisk (NVO) and AbbVie Inc. (ABBV) are better positioned carrying a Zacks Rank #2 (Buy).
Astellas’ Acofide Approved in Japan
Astellas Pharma, Inc. (ALPMY) and Zeria Pharmaceutical Co., Ltd. recently announced that it received approval from Japan’s Ministry of Health, Labour and Welfare (:MHLW) for Acofide for the treatment of functional dyspepsia (:FD).
The regulatory application was based on a multicenter, randomized, double-blind, parallel-group and placebo-controlled phase III clinical study. The results showed statistically significant data when compared to placebo, in both the primary endpoints and several secondary endpoints.
In Mar 2008, Astellas and Zeria had entered into an agreement for the co-development and co-marketing of Acofide. Zeria had submitted the application for marketing approval to the MHLW in Japan in Sep 2010.
Acofide is the first approved product to have shown efficacy for the treatment of FD under the Rome III diagnostic criteria. Rome III is the latest version of the international classification and diagnostic criteria for functional gastrointestinal disorders.
Meanwhile, Astellas is also looking to get its type II diabetes candidate, ipragliflozin (ASP1941), approved in Japan. Earlier this month, Astellas had announced the submission of a marketing authorization application (MAA) for its sodium-glucose co-transporter 2 (SGLT2) inhibitor, ipragliflozin (ASP1941), to the MHLW in Japan. The application was based on a phase III pivotal study on ipragliflozin as monotherapy for the treatment of type II diabetes. The study showed a significant reduction in HbA1c levels. Astellas conducted six phase III studies to investigate the long-term safety and efficacy of ipragliflozin in combination with other hypoglycemic agents. Results showed effectiveness and a favorable safety profile.
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