Opinion on Pharmaceuticals and Healthcare in Japan

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Type Product title / description Pub Price
CommentWire
CommentWire

Takeda: TAK-390MR approval delay will not damage potential

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
23 Oct 2008
CommentWire
CommentWire

Roche: safety concerns threaten future blockbuster

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
19 Mar 2009
CommentWire
CommentWire

Lundbeck: limited last-line US positioning awaits Serdolect

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
08 Apr 2009
Expert View
Expert View

US market offers the greatest biosimilar rewards

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
23 Jun 2009
CommentWire
CommentWire

Celgene: Revlimid set to break into Japan's multiple myeloma market

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
08 Jul 2009
CommentWire
CommentWire

Dainippon: Sepracor acquisition to provide US presence

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
04 Sep 2009
CommentWire
CommentWire

Ajinomoto: new pharmaceutical business will face stiff competition

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
05 Oct 2009
CommentWire
CommentWire

SkyePharma: Flutiform potential limited following FDA rejection

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
25 Jan 2010
Expert View
Expert View

OSI's rejection of hostile takeover bid may prove costly for Astellas

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
03 Mar 2010
CommentWire
CommentWire

Erbitux: Japanese approval highlights a growing trend for personalized therapy

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
30 Mar 2010

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