S5. E21. 並肩作戰，加速新抗生素問世 WORKING TOGETHER TO PREVENT THE NEXT CRISIS

 

傳統的抗生素無法對微生物抗藥性（Antimicrobial Resistance；簡稱AMR）起作用，世界需要新的物質；可惜的是，目前正在研發的新抗生素很少。為了加快研究進展，百靈佳殷格翰等20多家生物製藥公司聯手，並投資近10億美元，用以加速新抗生素的問世。

 

自 2020 年初，COVID-19 新型冠狀病毒肺炎不只佔據世界各地的頭條新聞版面，也霸佔了全球研究領域的所有精力。然而，地球正在同時面對另一場健康威脅：微生物抗藥性（Antimicrobial Resistance；簡稱AMR）。因為細菌已經對常規藥物、物質產生抗藥性，使用現有的抗生素治療細菌的難度愈來愈高。世界衛生組織（WHO）總幹事譚德賽形容抗微生物抗藥性是「可能摧毀過去一整個世紀所累積的醫學成就的、緩慢的海嘯。」因為缺乏可靠的抗生素用以避免感染，如人工膝關節置換術這類一般手術可能會危及患者生命— 19 世紀的情節將會重演。

AMR是什麼？為什麼會發生？

AMR：微生物抗藥性將有愈來愈多的細菌感染症狀，很難或無法用現有的抗生素進行治療。全世界每年都有約700,000人因AMR喪失性命

 

 

為何會出現抗藥性？

抗藥性是演化的自然成果。當使用抗生素進行治療時，總會有一些細菌存活，這些對特定藥物具有免疫的細菌會再傳播、發生感染。

 

 

為什麼開發中的抗生素那麼少？

現有藥物、物質依然可以使用，也能應用於治療「超級細菌」；目前尚未迫切的需要新型抗生素。為了保持新型抗生素的有效性，必須謹慎使用藥物。新藥物的物質研發，也需要耗費漫長並且昂貴的基礎研究歷程。

 

 

抗生素市場正陷於矛盾的市場規則中

世界急需新型抗生素，欠缺創新性物質。但，目前只有非常少數正在進行研發的新物質，原因是：新抗生素物質的研究，在科學界仍屬於非常複雜並且耗費鉅資的領域 ， 研究成果也充滿不確定性。目前，多數的細菌性疾病仍可使用一般、現有的抗生素進行治療。為了保持抗藥性，少數已被獲准使用的新型抗生素，也必須謹慎挑選使用時機。有些專門從事抗生素研究的生物科技公司因此退出抗生素市場（有時甚至是已破產的狀況）；即便抗生素具有長期性的市場需求，他們的產品卻無處可售。百靈佳殷格翰董事會主席 Hubertus von Baumbach 形容：「許多珍貴的專業知識、資源，因此失傳。」

 

聯合基金入場支援

製藥產業意識到了抗生素危機以及問題癥結點；百靈佳殷格翰等 20 間生物製藥公司聯合成立了 AMR 行動基金會。AMR 行動基金會已募得近十億美元，為新創生物科技公司提供風險資金。行動基金會也跟政府單位合作。Hubertus von Baumbach 表示：「我們希望可以提供獎勵措施，在 2030 年時可以讓二到四種新抗生素問市。AMR 行動基金會可以幫助我們，產出具永續性的新抗生素產品，對抗這場面對超級細菌的戰役。」抗微生物抗藥性是一個很重要，卻時常被忽視的重要議題。

 

AMR行動基金會

Who?

成員有百靈佳殷格翰、拜耳、默克等20間製藥公司。

How much?

投入約10億美金資金

What?

行動方案：投資開發創新抗生素的小型生物科技公司。於藥物開發與臨床應用、申請銷售許可、行銷等必要關鍵步驟，提供不可或缺的資金支持。

Why?

動機：目標是促進新抗生素的開發。到 2030 年，至少要研發二到四種針對抗微生物抗藥性細菌的新抗生素。

 

 

 

WORKING TOGETHER TO PREVENT THE NEXT CRISIS

Conventional antibiotics are ineffective against multi-resistant bacteria. The world needs new substances, but few new anti- biotics are currently in development. To speed up the research process, 20 pharmaceutical companies – including Boehringer Ingelheim – are jointly investing nearly a billion US dollars.

Since early 2020, the COVID-19 pandemic is not only dominating headlines; it also seems to be oc cupying all the energy of the international research community. Yet the world is on the verge of another health cri- sis: antimicrobial resistance (AMR). It is increasingly difficult or even impossible to treat bacterial infections with today’s antibiotics be- cause the germs have developed resistance to conventional substances. Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), has referred to antibiotic resistance as a “slow tsunami that threatens to undo a century of medical progress.” Routine procedures such as knee operations could become life-threatening – like they used to be in the 19th century – for want of reliable antibiotics to prevent infections.

 

WHAT IS AMR, AND HOW DOES IT OCCUR?

ANTIMICROBIAL RESISTANCE

An increasing number of bacterial infections can hardly be treated or are untreatable with today’s antibiotics.

about 700,000 people worldwide die annually as a result of antibiotic resistance(AMR)

 

 

HOW DOES RESISTANCE DEVELOP?

Resistance is a natural consequence of evolution. It develops because a few bacteria always survive whenever antibiotics are used. These bacteria are immune against that particular medicine and can thus spread.

 

 

WHY ARE SO FEW NEW ANTI¬ BIOTICS BEING DEVELOPED?

Substances are still available, even for treatment of “superbugs”, so there is not yet an acute need for new antibiotics. New antibiotics are used sparingly in order to preserve their effectiveness. Moreover, new substances require lengthy and expensive basic research.

 

The Antibiotics Market Follows Paradoxical Rules

Innovative substances are lacking, and the world urgently needs new antibiotics. Yet only a few are currently in the pipeline. There are several reasons for this: Research in the field of new antibiotic substances is scientifically complex and very expensive – and the outcome of such projects is very uncertain. At the moment, most bacterial diseases can still be treated with conventional antibiotics. The few new anti- biotics that are available are being used sparingly in order to preserve their effectiveness. Paradoxically, this has prompted a number of biotechnology companies specializing in antibiotics research to withdraw from this field. Some have even gone bankrupt: Though there is long-term demand, there has been no market for their products. “Valuable expertise and important re- sources have thus been lost,” remarks Hubertus von Baumbach, Chairman of the Board of Managing Directors of Boehringer Ingelheim.

 

Joint Fund Will Provide Help

The pharmaceutical industry is aware of the problem and mindful of the impending crisis. Therefore, 20 pharmaceutical companies have established the joint “AMR Action Fund”. The fund has been endowed with nearly a billion US dollars of risk capital for biotechnology companies – and Boehringer Ingelheim is also participating in it. “The objective is to create incentives and help bring at least two to four novel antibiotics to the market until 2030,” says von Baumbach. “We see this initiative as a stim- ulus for the global community.” The fund is also working with governments. “This will help us ensure that a sustainable pipeline of new antibiotics is available in the fight against so-called superbugs,” comments von Baumbach. The issue is important, even though it rarely makes the headlines.

AMR Action Fund

Who?

20 major pharmaceutical companies including Boehringer Ingelheim, Bayer, and Merck.

How much?

Around one billion US dollars.

What?

The AMR Action Fund invests in small biotechnology companies and supports them by contributing expertise in clinical re- search, production, approval procedures, and marketing.

Why?

The goal is to promote the development of new antibiotics. By 2030, at least two to four new antibiotics against resistant germs are to be developed.