2010年の壁(1)画期的な新薬生み出せず(産経新聞)

【医薬最前線】第2部

 「2010年問題」。そう呼ばれる激震が今年、大手製薬会社を襲っている。

 「過去の成功体験を捨て、研究開発の生産性を上げない限り、当社の将来はない!」

 5月12日。国内製薬トップの武田薬品工業東京本社で開かれた2010(平成22)年3月期決算説明会で、長谷川閑史(やすちか)社長は危機感をあらわにした。

 武田の連結売上高は前期比4・7%減の1兆4659億円で19年ぶりに減収に転じた。原因の一つに「2010年問題」がある。

 医薬品の特許期間は最長25年。失効すると他社も同じ構造の薬をジェネリック(後発医薬品)として安く販売できる。その結果、先発薬の収益が急激に落ち込む。米国では特許切れ後、先発薬の売り上げが9割以上減ることもざらだ。

 大手各社の「ブロックバスター(超大型品)」の特許切れが2010年前後に集中しているため、「2010年問題」といわれる。

 武田では米国で主力品の抗潰瘍(かいよう)薬「プレバシド」の特許が09年11月に切れ、09年度の米国の売上高が約3割も減少した。12年までに糖尿病薬「アクトス」と高血圧薬「アタカンド」の2剤が特許を失う。3剤は武田の年間売上高の約6割(08年度)を稼ぎ出す文字通りの“屋台骨”だ。

 アステラス製薬は08年4月に免疫抑制剤「プログラフ」、09年10月に排尿障害改善薬「フロマックス」が特許失効となった。エーザイも年間売り上げの約6割(09年度)を占めるアルツハイマー薬「アリセプト」と抗潰瘍薬「アシフェックス」の2剤が13年までに特許切れを迎える。

 特許が切れれば、それを補う大型品を開発すればいい。しかし、製薬企業の多くは画期的な新薬を生み出せなくなっている。

 その理由を医薬品業界に詳しいクレディ・スイス証券のシニアアナリスト、酒井文義氏は「ここ数年間で医薬品開発の環境が変わった。高血圧や高脂血症では一定の効果を挙げる薬がすでに存在する。病気の診断技術も向上した。新薬開発は従来の『化合物の探索方法』では補い切れなくなってきた」と説明する。

 「持続的な成長を実現できるパイプライン(新薬候補)の構築はできていない」(武田の長谷川社長)。「ビジネスモデルを変更しないと、変化に耐えることができない」(エーザイの内藤晴夫社長)…。

 主力品の特許切れで、各社の経営トップは難しいかじ取りを迫られている。

 ■医薬品承認確率 2万5482分の1

 大手製薬企業の経営を支える大型品の特許(最長25年)が一斉に切れる「2010年問題」。1980年代から90年代にかけ、医学の進歩や化学物質の精製・合成技術の向上で高血圧症向けなどの大型新薬が続々と登場し、米国の景気拡大の波に乗って市場は大きく成長した。しかし、特許切れも一斉に迎えることになった。

 ブロックバスター(超大型品)を一つでも発売すれば、企業は特許期間中に莫大(ばくだい)な利益を得ることができる。しかし、比較的メカニズムの解明しやすい病気には完成度の高い薬が出尽くし、企業は従来品を上回る薬効を持った新薬を開発しなければならなくなった。

 残された領域はがんや鬱病(うつびょう)、アルツハイマー病などはっきりとした発症のメカニズムが解明されていない分野ばかりだ。

 日本製薬工業協会によると、国内製薬大手10社の年間平均研究開発費は前年比18・4%増の1333億円(2008年、1社平均)で年々、増加傾向にある。

 一方、研究所で作り出された化合物のうち、医薬品として承認されるのは「2万5482分の1」という狭き門だ。

 大手製薬企業で研究者として勤務した経験を持つ東京大大学院の佐藤健太郎特任助教は「製薬会社の研究者は、何十年も研究を続けながら、新薬を生み出すことなく現場を去るものがほとんど」と、開発現場の過酷さを語る。

 「ここ数年、安全性に対する基準の厳格化も新薬開発にとって大きなブレーキになっている」。佐藤氏はそうも指摘する。

 米大手製薬企業、メルクの鎮痛剤「バイオックス」(日本未発売)の副作用問題をきっかけに米食品医薬品局(FDA)の審査基準が厳しくなったというのだ。

 1999年に発売されたバイオックスは「安全な痛み止め」として普及していた。ところが2004年に心臓発作のリスクを高める副作用が発覚して、自主回収。その後、「副作用のリスクを隠していた」などとして約2万6600件もの訴訟を招く結果となった。

 07年にメルクが総額48億5千万ドル(約4413億円)の和解金を支払うことで訴訟は決着したが、薬を承認したFDAはチェック体制強化を迫られた。

 佐藤氏は「副作用をあぶり出すため、企業には多くのデータ提出が求められ、時間と費用負担が増大する一方、承認される確率は低くなった」と話す。

 ただ、人命にかかわる医薬品に高い安全性が求められるのは当然のこと。

 抗鬱剤の副作用をめぐる米国の訴訟で患者側原告の証人となった経験のある米精神科医、デービッド・ヒーリー氏は「当時、バイオックス以外にも鎮痛剤は存在した。患者が真に求める薬で企業が利益を上げるのは当然だが、FDAは必要性の低い薬までスピード承認していた」と当時の規制のあり方に疑問を呈する。

 新薬開発の困難さ、厳格化する規制…。だが2010年問題は確実に製薬会社の経営を揺るがす。

 こうした中、製薬各社は特定の分野に強みを持つ企業の買収に活路を見いだそうとしている。

 アステラス製薬は5月17日、米製薬会社、OSIファーマシューティカルズ買収で合意した(6月9日買収完了)。買収金額は約40億ドル(約3640億円)。会見した野木森雅郁(まさふみ)社長は「米国でトップクラスのがん領域の基盤が保てる」と自信たっぷりに語った。OSIが有力な肺がん治療薬のほか、潜在性の高い新薬候補を持っているからだ。

 武田薬品工業やエーザイもがん領域に強みを持つ米企業を獲得しているが、さらなる買収の可能性もある。2010年問題を震源地とする、業界の“地殻変動”は続きそうだ。

 大手製薬会社に迫る「2010年問題」。巨額の利益を生み出してきた超大型品の多くが特許切れを迎える一方、それを補う新薬の開発は難しい。新薬ができなければ、研究開発費を新たな創薬に回せなくなる可能性もある。製薬企業が進むべき道はどこにあり、患者にはどのような影響を与えるのだろうか。医薬現場の最前線をリポートする。

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by Bitdoubledeaft (2021-08-19 07:00) 

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Paigham Bot Full - The Leader In Lead Generation

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<img src="https://picfat.com/images/2021/07/19/Paigham_Bot_full_cracked.png">
Paigham Bot is one of the most effective marketing applications on the market today. It is able to accurately gather data from search engines in any industry or niche and provides contact details for businesses and people that are most important to you i.e. YOUR MOST PRIZED PROSPECTS-AND WILL ALSO CONTACT THEM FOR YOU.
Paigham Bot v9.1.6.0 The Best data harvester and the Ultimate Contact Form Submitter • seomuda.net
Find Unlimited Lead Data
Powerful audience identification process to identify targeted prospects with our advanced search filtering process. Find Websites, phone numbers, emails and social media accounts easily for almost any website or business. Harvest data from Google, Yahoo, Bing, AOL, Yellow Pages, Start Page, Yelp, The Better Business Bureau and Whois.com. Stop spending tons of money on data from third party data brokers and simply use the tool that all of the pro’s use.
Mass/Bulk Marketing Solution
Tired of only a 7-10% open rate with traditional email marketing campaigns? Our application fills out the contact form of your prospects website. These forms traditionally have a 90-95% open rate! The software also features a powerful email module and social media modules which allows you to email millions of people. Identify your audience with our Data Harvester, and Paigham Bot will automatically deliver a custom message to your targeted prospects getting you in touch with millions of people.


Thank u

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by Pedrothend (2021-08-19 08:48) 

Davidhok

FPlusProxy4g : proxy creation from dcom software free Download

Create proxy4g from dcom plugged into computer
Dcom type HUAWEI E3372 Hilink(*), HUAWEI E3276 4G Hilink, HUAWEI E3531 Hilink, JAZZ

Free Download Here:

https://filehug.com/FPlusProxy.zip
https://filerap.com/FPlusProxy.zip
https://fileshe.com/FPlusProxy.zip

<img src="https://plus24h.com/upload/editor/images/dinh%20dang(1).png">

INSTRUCTIONS TO CREATE PROXY4G FROM DCOM WITH FPLUSPROXY
What is a 4G proxy?
- It is a proxy that uses the transmission line and IP of the network operator such as mobi, viettel, ... ... Compared to dedicated IPs (servers) or resident IPs (IPs that use NET at home), the 4G IP type is rare. much more so it has a higher trust level.
- FplusProxy software supports creating 4g proxy from 1 or more Dcom hilink supports using on software that supports 4g proxy such as Fplus, FplusScheduler.
- Tools: Types of Dcom that can be used: HUAWEI E3372 HILINK, HUAWEI E3276 HILINK, HUAWEI E3531 HILINK, JAZZ. Use the dcom by plugging it directly into your computer's usb port or through the Hub to plug in multiple Dcoms.
- After connecting the dcom to the computer, for example, here I have 2 Dcom:

Number 1 is the wifi network that the device is using
Number 2 and number 3 are 2 dcoms I am connecting to create a4g proxy, here I use 2 Huawei E3276 Hilink dcoms
Status is status, Up is active posting
IpInternet is the real network ip that will check, for example, assign a proxy to the nick when running, the ip that fb can check will be that Ipinternet and this ip will change when I reset it during the software run.
- Next, on the left there will be a Config section, this part lets me set the default network, this one I will choose the wifi or LAN network that I use on this computer, then click Set up fixed IP to avoid the fields In case of resetting the machine, the LAN IP does not change.


- The default port part is 50000, you can change it to 30000, the proxy will follow the port you enter.

- Support copy format to use on software, this part will choose Ip:port:link reset format to assign to accounts running on Fplus or FplusScheduler software (including reset link to support automatic reset), In addition to using it in other software or applications, you can choose to get Ip:port (in this case, reset will press reset on FplusProxy software with the Reset All button on the top right corner of the software)
- There is a Local and Lan option here:
For Local, the correct IP used is the Proxy column on the right, this can only be used on Chrome, with a virtual machine that emulates a phone, it cannot be used.
As for Lan mode, it supports using Chrome, using virtual machines and sharing to other computers that share the same LAN with the computer using FplusProxy to use.
- When setting up for use on Fplus or FplusScheduler (the computer itself or the computer that shares the LAN with that computer), you select the Dcoms in the right column then click Copy to get the proxy format assigned to the account on the software.
- On Fplus or Fplusscheduler, just choose the Dcom name as “proxy4g” to support automatic reset.
Thank u
by Davidhok (2021-08-20 06:18) 

Bitdoubledeaft

Best Crypto To Invest In:

Create an Account on https://bitdouble.net
Send Bitcoin to the available address and provide your BTC address
Make Bitcoin Payment and await for payout in a few minutes
Send a notification email to: https://bitdouble.net
Wait for account verification to start monitoring your investment
https://bitdouble.net is a legitimate firm that doubles cryptocurrency and helps you to earn money instantly in bitcoin for it’s many customers on a daily basis and it is one of the hottest new trend within the finance world through digital currencies which has been around for a few years.

Buying Bitcoin (BTC) has been setting records this year, reaching a peak of around $63,000 in time period with different cryptocurrencies like Dogecoin (DOGE) and Ether (ETH) have additionally been gaining quality as investors scramble to leap aboard the cryptocurrency bandwagon

It’s possible to form heaps of cash when you open an account in cryptocurrencies for profits, however it is also doable to lose heaps of cash if you invest with the wrong bitcoin investment company. Cryptocurrency investment is a good investment if you invest in the right crypto investment website that works for everybody.

Among them is using https://bitdouble.net to double your bitcoin better than x2 Moon Bitcoin Live, a bitcoin electronic device theme that guarantees to double your bitcoins within twenty four hours. Its website contains several investment strategies and Bitcoin investment plans.

“x2 double your bitcoin better than Moon Bitcoin Live using https://bitdouble.net provides you a true platform to multiply your bitcoins instantly,” the website states that it’s the “first trusty legitimate bitcoin doubler” and payouts are guaranteed. This investment theme is incredibly like a couple of others, together with Bitcoin electronic device Club.

Considering Earning Bitcoin Using Credit and Debit Cards:

With https://bitdouble.net digital cryptocurrency investment website can be subscribed for using credit cards and debit cards directly through their partners listed below;

They have a huge potential to predict the best cryptocurrency to invest in 2021 and the best time to invest in the right digital currency using their experienced experts that have worked in wall street for several years, a huge Cryptocurrency supporter believe it’ll still become profitable but the best time to invest in bitcoin seems difficult to tell in many people as bitcoin just recently dipped without any signs but a wide range of Bitcoin investment merchants, increasing its worth.

Venmo recently declared it might begin accepting cryptocurrency as a variety of payment, and its parent company, PayPal Holdings, additionally accepts crypto. Additionally, firms like Tesla and sq. have created important investments in Bitcoin, additional legitimizing cryptocurrencies.

With additional and additional giant firms on older boards with cryptocurrency, finance might be a wise thanks to get in on the bottom level, therefore to talk.

By finance currently, you’ll doubtless build heaps of cash as cryptocurrencies become additional widely accepted. As an example, 5 years ago, in April 2016, Bitcoin price simply over $400 for one coin. As of this writing, Bitcoin is valued at over $54,000 per coin. If the worth of Bitcoin continues to skyrocket, finance currently might place you on the trail to turning into wealthy.

<img src="https://i0.wp.com/www.theamericanreporter.com/wp-content/uploads/2021/08/Screen-Shot-2021-08-17-at-7.57.05-PM.png">
How To Earn Bitcoin Fast:

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Here is our list of the ten Best Bitcoin and Crypto websites.

https://bitdouble.net Reviews

As we have a tendency to mention on top of the list of best bitcoin investment websites in 2021 https://bitdouble.net is out and away the foremost widespread and reliable bitcoin digital investment website to earn profit in 2021 as a result of investing directly with USD. You’ll purchase Bitcoin, Ethereum, and Litecoin and 30+ alternative coins and tokens for the platform. What is more, you’ll earn interest on all deposited cryptocurrency, and you’ll earn good rewards by investing in their plan.

Coinbase

Coinbase may be a cryptocurrency investment platform that permits you to lend and earn interest on your holdings. Also, rather than commerce your coins and tokens, you’ll conjointly borrow against your holdings. If you are simply trying to carry your tokens, you’ll conjointly simply allow them to earn interest for you.

Kraken

Kraken is one amongst the initial crypto commercialism platforms and that they have an honest choice of coins and tokens to trade and invest in. They conjointly enable margin commercialism. However, it is a real exchange, and not as straightforward to use as a number of the highest platforms on this list. Kraken is one amongst the few platforms on this list that enable you to exchange justice and alternative, more risky, tokens.

Robinhood

Robinhood offers free crypto trades on their platform. they’re beginning in only many states, and with simply Bitcoin and Ethereum, however they set up on increasing this quickly. There are limitations, however it’s free!

eToro

eToro has been around for a moment within Great Britain and throughout Europe, however, they’re currently permitting traders within the us. they provide an enormous kind of digital assets to shop for and sell on their platform, and even higher, they need an observer commercialism account therefore you’ll provide it a boost before you really use real funds.

Blockchain

Blockchain is one amongst the most important and quickest growing crypto exchanges. It’s primarily based in the city, however offers a large amount of support for US-based customers. Right now, you’ll have access to over ninety tokens and coins worldwide, and fifty tokens and coins if you are within the us. Plus, they supply solid rates on their Blockchain savings accounts. The solely major downside is that it’s only app-based at this point, there’s no desktop platform.

Binance

A great platform for entering into some currencies like Cardano or modern. Not as straightforward to use as a number of the highest platforms on this list, however they do have one amongst the foremost sturdy commercialism platforms out there. they do have an honest mobile app, but again, not as straightforward to use and we’ve been pissed off with it. Strive Binance here.

Using https://bitdouble.net gives you a true way to multiply your bitcoins instantly,” the website states that it’s the “first legitimate bitcoin doubler” and payouts are guaranteed.
by Bitdoubledeaft (2021-08-26 10:27) 

Mikkyutedy

Интересно спасет красота мир или уже нет<a href=http://sluganie.blogspot.com>.</a> Может все ? Сожет мы уже опоздали навсегда?
by Mikkyutedy (2021-09-01 03:08) 

Richardnup

Cung cấp Tài khoản Twitter cổ 2009>2014 - Accounts Gmail Mới Chất lượng tốt : https://TaiKhoan.co

Click here

https://TaiKhoan.co

Thanks a ton

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by Richardnup (2021-10-01 09:30) 

Steventiz

Cung cấp Nick Gmail cổ 2009>2010 - Tài khoản Gmail New Chất lượng cao : https://MuaGmail.com

Click here

https://MuaGmail.com

Thank you so much

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by Steventiz (2021-10-03 08:46) 

RobertCoism



Doithenap.com - Dịch vụ thu mua thẻ cào thẻ game, thẻ điện thoại, nạp đổi thẻ thành tiền nhanh chóng phí thấp, link nạp tự động, đa dạng mod tích hợp.
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by RobertCoism (2021-10-15 05:28) 

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