2007-11-05
吸入インスリンのエクスベラ[pdf]は500mlのペットボトル程の大きな機器で吸入する。ボールペン程の大きさの注射器よりも持ち歩きは不便である。季節性のアレルギーや喫煙など安定した吸収が必ずしも保証されない。発売元は８年間の使用を通じた安全性を訴えていたが[ファイザー 日本語 2007-09-19]かならずしもマーケットは針の無い利便性を評価せず、儲からないという事でファイザーは吸入インスリンの販売を停止した[2007 Q3決算報告 2007-10-18]。
… because too few patients are taking EXUBERA and since there are other medicines available that lower blood sugar , Pfeizer will stop providing EXUBERA
インスリン療法を会社のアイデンティティーとなるコアな領域として捉えるリリーやノボが今後も吸入や点鼻のインスリンの開発を続けるかは兎も角として、幾つかの一つであるファイザーには支えきれなかったのであろう。
Safino've gotten $1.3 billion from Pfizer
売れてませんEXUBERA2006-10-26 14:07
2008-03-09
Against this background, Novo Nordisk will increase research and development activities targeted at inhalation systems for long-acting formulations of insulin and GLP-1. The activities will take place at two centres of excellence in Hayward, California, and Hillerｿd, Denmark.[Novo Nordisk refocuses its activities within inhaled insulin and discontinues the development of AERxｨ (14 January 2008)]
デテミルで商売しようと思うのに速効型の頻回打ちをアピールするものどうかと思う。一日一回ならインスリン注射で勘弁してよ。
2008-03-09
The company noted that this decision is not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.[Lilly Announces Termination of AIR Insulin Program March 7, 2008]
リリーも注射で良いとおもって止めた。
2008-04-10
まぁベータカロチンが肺がんを増やすのと同じで、インスリンも成長因子だから種があれば芽が出て膨らんで華が咲くでしょう。ということでEXUBERAではRR=5.3と肺がんが増えていたので、ファイザー以外の、サフィノなどの新しいスポンサーを捜す努力は放棄するとの事。今回観察された肺癌例は喫煙の既往のあるかたばかりだったとか。もっとも、インスリンが成長促進なら、いかなる製剤も今後登場しないでしょう。
Nektar will cease all spending associated with its inhaled insulin programs and will not incur any additional charges related to this event.
The Exubera label was updated by Pfizer to contain the following safety information warning:
"In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking." [news release 2008-04-09]
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