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CommentWire
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Although the FDA's decision to delay TAK-390MR is unlikely to damage its commercial potential to replace Prevacid, the availability of cheaper generics will cap sales. Prevacid, which generated $3.6 billion in the US in 2007, faces US patent expiry in late 2009. Takeda must now ensure a rapid launch and stimulate new drug uptake in order to dampen the impact of Prevacid's generic incursion.
Published By Datamonitor
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23 Oct 2008 |
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CommentWire
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Already a leader in the monoclonal antibody sector for oncology, Roche is seeking to enhance its immunology and inflammation portfolio through its new biologic drug Actemra. However, negative results from a Japanese study are likely to affect uptake of Actemra and could even influence regulatory decisions in the US for a drug that had been regarded as a potential blockbuster.
Published By Datamonitor
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19 Mar 2009 |
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CommentWire
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The FDA-appointed Psychopharmacology Drug Advisory Committee has voted against the use of Lundbeck's Serdolect in a broad schizophrenia population due to safety concerns, recommending approval for the treatment of refractory patients only. With disappointing sales in Europe following the drug's 2005 relaunch, the return on investment for Lundbeck to enter the US with Serdolect is unclear.
Published By Datamonitor
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08 Apr 2009 |
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Expert View
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With Japan poised to receive its first biosimilar and the US moving ever closer to the establishment of an approval pathway, the biosimilars market is set for imminent expansion. Given the size of the US market and the generic erosion which characterizes it, the sector is an attractive prospect for large and established pharmaceutical companies looking to succeed in the biosimilars sector.
Published By Datamonitor
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23 Jun 2009 |
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CommentWire
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Celgene has submitted a New Drug Application in Japan for Revlimid in combination with dexamethasone for multiple myeloma patients based on positive clinical trial data. While Velcade has a larger presence in Japan following its approval for first-line use in multiple myeloma patients in 2008, Revlimid will be able to compete in the future following label expansion.
Published By Datamonitor
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08 Jul 2009 |
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CommentWire
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Having agreed to acquire Sepracor for approximately $2.6 billion, Japan's Dainippon Sumitomo Pharma will gain a presence in the US market where it plans to submit its experimental schizophrenia treatment lurasidone for regulatory approval in 2010. However, given the threat of competition from generic drugs and other pipeline treatments, lurasidone is not expected to generate significant sales.
Published By Datamonitor
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04 Sep 2009 |
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CommentWire
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Ajinomoto has announced its intention to combine its subsidiaries Ajinomoto Pharma and Ajinomoto Medica with its own pharmaceutical arm to establish a new company. The new venture will become operational in April 2010, focusing on digestive and metabolic disorders. However, Datamonitor believes that it has a tough road ahead given the strong competition in these markets.
Published By Datamonitor
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05 Oct 2009 |
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CommentWire
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The FDA has rejected SkyePharma's asthma drug Flutiform, citing a number of developmental issues. Given that the drug faces significant competition from several other marketed and pipeline products, Datamonitor believes there is little commercial potential remaining and SkyePharma is therefore unlikely to satisfy regulatory demands by initiating new trials in the US.
Published By Datamonitor
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25 Jan 2010 |
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Expert View
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Astellas has initiated legal proceedings after the board of OSI Pharmaceuticals rejected an unsolicited $3.5 billion acquisition bid by the Japanese pharmaceutical giant. With Astellas facing a slowdown in sales both domestically and internationally, the acquisition of OSI would lift its forecasts. The implications of its latest M&A efforts are, therefore, considerable.
Published By Datamonitor
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03 Mar 2010 |
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CommentWire
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In a move that mirrors earlier FDA and EMA decisions, the PMDA in Japan has granted additional approval for the use of Erbitux in combination with first-line chemotherapy for the treatment of colorectal cancer. The decision is likely to strengthen Erbitux's position in Japan, giving it an edge over rival Avastin, and marks another step in the growing trend toward personalized therapy in oncology.
Published By Datamonitor
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30 Mar 2010 |
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