百靈佳殷格翰 2021年上半 業績穩健成長並取得研發巨幅進展

2021年上半年，百靈佳殷格翰為全球人類和動物帶來更多創新藥物。會有如此成就，是因我們以豐富的研究發展及產品組合為基礎，專注於未被滿足的醫療需求。人類處方用藥的研發包含了約6個新化合物、約100個臨床試驗以及臨床前項目，至2025年，預計會有15種新藥物取得上市許可。

 

•　在心衰竭極具挑戰的治療領域部分取得突破性成果

7月，百靈佳殷格翰報告empagliflozin（市售名稱JARDIANCE^®）治療心衰竭的突破性進展。全世界有超過6,000萬心衰竭患者，其中約一半為分型的heart failure with preserved ejection fraction，HFpEF，因左心室無法正常舒張，心臟收縮、導回的血液減少，導致心臟衰竭。最新實驗證明，empagliflozin可以明顯降低成年HFpEF患者因心衰竭或心血管疾病死亡、住院的風險。若成功取得上市許可，百靈佳殷格翰的empagliflozin將成為此疾病的第一也是唯一經過臨床試驗驗證的醫療方案；無論射血分數（ejection fraction）為何，都能有效改善心衰竭患者的處境。另，歐洲聯盟委員會（European Commission）6月時已授與JARDIANCE^®可用於另一型（HFrEF）慢性心衰竭成年患者的適應症許可。

百靈佳殷格翰執行董事會主席 Hubertus von Baumbach說：「即便過去數十年來，醫學發展已經取得巨大的進步，仍有許多疾病尚未取得足夠的醫療方案，這就是百靈佳殷格翰始終堅持，專注於醫療創新高需求領域的原因。我們強大的醫療研究努力，已經在2021年上半年度取得了更超前且更具決定性的進展，更有可能改變全球數百萬患者的生活。」

 

•　心理健康產品線強勢進展

百靈佳殷格翰在神經精神疾病（neuropsychiatric disorders）領域也取得進展，包含兩項進行中的第二期臨床試驗。5月底時，百靈佳殷格翰已宣佈取得美國食品藥品監督管理局（FDA）授予 BI 425809突破性治療方案認定（Breakthrough Therapy Designation，BTD）。這是百靈佳殷格翰心理健康研發計畫的關鍵部分，用於治療思覺失調症伴隨的認識功能障礙（Cognitive Impairment Associated With Schizophrenia，CIAS）。百靈佳殷格翰也宣布啟動新CONNEX 第三期臨床試驗計劃，評估BI 425809（一種新型Gly-T1 inhibitor）用於改善思覺失調症成年患者認知能力的安全性及有效性。

百靈佳殷格翰更進一步強化自身的研發能力與醫療研發取向廣度，與量子電腦運算（quantum computing）和數據科學（data science）領域的夥伴進行合作與結盟。6月，百靈佳殷格翰成為量子技術與應用聯盟（Quantum Technology and Application Consortium，簡稱 QUTAC）的創始成員，十間德國引導業界發展的企業聯手，探索量子電腦運算的工業應用技術。量子電腦運算具有藥物研發的巨大潛力，對百靈佳殷格翰這類具有高水準專業知識的早期研究過程，更是有卓越的成效。

百靈佳殷格翰也將持續致力於尋找針對SARS-CoV-2病毒的潛在醫療方案。7 月時，百靈佳殷格翰宣布將COVID-19醫療方案研究重點聚焦於研發alteplase藥物，作為治療患有急性呼吸窘迫症候群（Acute respiratory distress syndrome，簡稱 ARDS）的COVID-19患者的潛在治療方案。此項決議乃是以TRISTARD 2/3期臨床試驗研究中期為基礎，完成包含62名患者的2b臨床試驗研究，分析安全性是否良好及有效數據後，方進行定案。為能更專注於研究 alteplase 藥物，百靈佳殷格翰決定終止BI 767551 SARS-CoV-2 中和抗體研發計畫。

 

•　即便受到COVID-19疫情影響，在各領域發展皆有良好表現

在2020年展現傑出、成功的財務表現之後，百靈佳殷格翰在2021年上半年度，依然保有積極並且亮眼的表現。前六個月，公司的淨銷售額為98億歐元，同比增長5.8 %（因匯率變動調整）。人類處方用藥、動物保健和生物製劑製造等三個業務領域，都對淨銷售額的增長有所貢獻。

負責財務的董事會成員Michael Schmelmer表示：「在所有同仁的努力之下，即便COVID-19 疫情未褪，我們在上半年依然保有穩健的績效表現。我們發現，因為COVID-19，就算病情已經迫切的需要就醫、診斷並接受治療，人們依然不敢去看醫生，在世界上許多國家皆是如此。這種現象導致了相當嚴重的醫療問題。在對抗疫情之時，我們必須將這個問題考量進去。」

 

人類處方用藥：JARDIANCE^® 和OFEV^® 驅動成長

在人類處方用藥領域，百靈佳殷格翰上半年實現了71億歐元的淨銷售額，與去年同期持平。依匯率影響調整，淨銷售額同比增長5%。

人類處方用藥的成長來自於 SGLT-2 抑制劑 JARDIANCE^®和呼吸道藥物 OFEV^® 的驅動。JARDIANCE^® 的淨銷售額增長 17.2%（同期相比，並依匯率影響調整），達到14億歐元。JARDIANCE^® 由百靈佳殷格翰與禮來共同開發並銷售。呼吸道藥物OFEV^® 的銷售額增長了28.9%（同期相比，並依匯率影響調整），達到12億歐元。OFEV^®於80多個國家獲准用於治療特發性肺纖維化（IPF），於70多個國家用於治療全身性硬化症有關之間質性肺病（SSc-ILD），於60多個國家用於治療纖維化間質性肺病（PF-ILD）。

 

動物保健事業在寵物和家禽領域取得亮眼成績

百靈佳殷格翰擁有完整的研發規劃，專為寵物和家禽開發具創新性的解決方案。

Velagliflozin臨床試驗計劃為範例之一；velagliflozin是一種SGLT2抑制劑，具備治療貓咪糖尿病的潛力。最初研發velagliflozin的目的，乃是用於降低血糖，治療人類第二型糖尿病，現在有機會在動物保健領域應用。為了拓展藥物研發組合，百靈佳殷格翰在動物保健事業領域增加了許多有發展性的新合作夥伴。2021 年上半年，與PetMedix合作，開發新的、具有革命性的寵物抗體良法；與Lifebit Biotech合作，運用AI人工智慧檢測，及早預告可能於全球爆發的傳染性疾病。

2021 年上半年，百靈佳殷格翰動物保健事業達成約23億歐元的淨銷售額（依匯率影響調整）。在這個競爭激烈的市場中，達成同比增加 9.6％ 的成長。

犬用抗寄生蟲藥劑 NEXGARD^® 全能狗^® 依然是最暢銷的產品，淨銷售額同比增長 16.4%（依匯率影響調整）至4.88億歐元。用於治療和預防貓狗跳蚤、鉤蟲、 嚼蝨的FRONTLINE^® 蚤不到^®，淨銷售額為2.67億歐元，同期增長8.9%（依匯率影響調整）。

預防犬心絲蟲藥劑HEARTGARD^® 犬新寶^® 的淨銷售額略下降0.2% （同比並依匯率影響調整）至1.73億歐元。豬隻疫苗INGELVAC CIRCOFLEX^® 的銷售在許多國家逐漸攀升。非洲豬瘟疫情隨之趨緩， INGELVAC CIRCOFLEX^® 的銷售額增長了 18.1%（同比並依匯率影響調整）達到 1.45 億歐元。

 

生物製劑製造：新生產基地將於10月在奧地利維也納落成

生物製劑製造的需求依然相當高，淨銷售額增長1.1%（同比並依匯率影響調整）達到3.22億歐元。百靈佳殷格翰正在進一步擴大生物製劑製造能力，因應持續增長的需求。並將於10月完成在奧地利維也納新建設的大型生物製劑生產基地（Large-Scale Cell Culture，簡稱 LSCC）；這個生產基地具備高達 150,000 公升的生產力，足以同時因應百靈佳殷格翰本身產品以及同業委託生產的需求。

 

 

First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development

• Breakthrough results in the treatment of a type of heart failure, which is extremely difficult to manage
• Strong progress in mental health pipeline
• Good business performance in all areas, despite ongoing impact of COVID-19

 

Ingelheim, August 3, 2021 – In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. The company’s success is based on its rich R&D portfolio with a focus on diseases with high unmet medical need. The R&D pipeline in Human Pharma comprises more than 60 new substances and around 100 clinical and pre-clinical projects. This pipeline has the potential to deliver up to 15 medicines for approval by 2025.

In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE^®). More than 60 million patients worldwide suffer from this disease, approx. half of them from heart failure with preserved ejection fraction (HFpEF). Heart failure with left ventricular preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. If approved, empagliflozin from Boehringer Ingelheim would become the first and only clinically proven therapy to improve outcomes across the full spectrum of heart failure patients regardless of ejection fraction. In June, the European Commission granted marketing authorization for JARDIANCE^® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

“Despite all the medical progress made in recent decades, there are still many diseases for which there is yet no adequate treatment available. That is why we at Boehringer Ingelheim focus on areas where the need for medical innovation is high,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors. “Our strong R&D pipeline has made further, decisive progress in the first half of 2021. These medical successes have the potential to improve the lives of millions of patients worldwide.”

 

Progress in mental health pipeline

Boehringer Ingelheim also made progress in the area of neuropsychiatric disorders, including two ongoing phase II trials. At the end of May, Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for BI 425809, a key component of the company’s mental health research program, for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). Boehringer Ingelheim also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809, a novel glycine transporter-1 (Gly-T1) inhibitor, for improving cognition in adults with schizophrenia.

The company supplemented its own research and development capabilities and medical pipeline with further high-profile partnerships, among others in the fields of quantum computing and data science. In June, Boehringer Ingelheim became a founding member of the Quantum Technology and Application Consortium (QUTAC), which unites ten of the leading German companies in exploring industrial applications for quantum computing. Quantum computing holds enormous potential for pharmaceutical research and development, particularly for early research processes in which Boehringer Ingelheim has a high level of expertise.

Boehringer Ingelheim also remains committed to the search for potential therapeutics against the SARS-CoV-2 virus. In July, the company announced, that it will focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, called acute respiratory distress syndrome (ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the TRISTARDS Phase 2/3 study, following completion of the Phase 2b part of the study including 62 patients. Due to its focus on alteplase, Boehringer Ingelheim decided to discontinue its BI 767551 SARS-CoV-2 neutralizing antibody development program.

 

Solid business performance despite ongoing pandemic effects

Following a successful financial year 2020, Boehringer Ingelheim continued its positive trend in the first half of 2021. In the first six months, the company generated net sales of 9.8 billion EUR, up 5.8 percent (year on year and adjusted for currency effects). All three business areas (Human Pharma, Animal Health, Biopharmaceutical Contract Manufacturing) contributed to the net sales growth.

“Together with our employees, we achieved solid financial results in the first half of the year, even when the COVID-19 pandemic continues to have an impact,” said Michael Schmelmer, member of the Board of Managing Directors with responsibility for Finance & Group Functions. “We see that in a lot of countries, people avoid seeing their doctors because of COVID-19, even if they are in urgent need of diagnosis and treatment. This non-treatment poses a serious medical problem, which we must take into consideration even more when fighting the pandemic.”

 

Human Pharma: JARDIANCE^® and OFEV^® growth drivers

In Human Pharma, Boehringer Ingelheim achieved net sales of 7.1 billion EUR in the first half of the year, equal to the high level of last year. Adjusted for currency effects, net sales increased by 5 percent year on year.

Growth in Human Pharma continues to be driven by the SGLT-2 inhibitor JARDIANCE^® and the respiratory medicine OFEV^®. Net sales generated by JARDIANCE^® increased by 17.2 percent (year on year and adjusted for currency effects) to 1.4 billion EUR. Boehringer Ingelheim has co-developed and markets JARDIANCE^® together with Eli Lilly and Company. Net sales of the respiratory product OFEV^® increased by 28.9 percent (year on year and adjusted for currency effects) and amounted to 1.2 billion EUR. OFEV^® is approved for the treatment of people living with idiopathic pulmonary fibrosis (IPF) in more than 80 countries, for systemic sclerosis-associated ILD (SSc-ILD) in more than 70 countries, and for other chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILDs) in more than 60 countries.

 

Animal Health shows good results in pet and livestock business

Boehringer Ingelheim has a full pipeline of R&D projects to develop innovative solutions for the health of pets and livestock. One example is the clinical trial on velagliflozin, a SGLT2-inhibitor with therapeutic potential to treat diabetes in cats. Velaglilozin has been developed primarily for use in treating Type 2 diabetes in humans by lowering blood sugar and now provides an opportunity for application in animal health. To complement its own R&D portfolio, Boehringer Ingelheim has entered into promising new partnerships in the area of animal health. In the first half of 2021 this included partnerships with PetMedix for the development of new and transformative antibody therapeutics for pets, and with Lifebit Biotech to detect and early-report global infectious disease outbreaks by using Artificial Intelligence.

In the first half of 2021, Boehringer Ingelheim generated strong net sales of around 2.3 billion EUR in the Animal Health business area. Adjusted for currency effects, year-on-year sales were up 9.6 percent in this highly competitive market.

The antiparasitic medicine NEXGARD^® for dogs remained the best-selling product with net sales up 16.4 percent (year on year and adjusted for currency effects) to 488 million EUR. FRONTLINE^®, which is indicated for the treatment and prevention of fleas, ticks and chewing lice in dogs and cats, generated net sales of 267 million EUR, up 8.9 percent (year on year and adjusted for currency effects).

Net sales of HEARTGARD^®, the heartworm prevention product for dogs, declined slightly by 0.2 percent (year on year and adjusted for currency effects) to 173 million EUR. Net sales of the swine vaccine INGELVAC CIRCOFLEX^® continued to recover in many countries with the decline of African swine fever. INGELVAC CIRCOFLEX^® sales grew by 18.1 percent (year on year and adjusted for currency effects) to 145 million EUR.

 

Biopharmaceutical Contract Manufacturing: Inauguration of new production facility in Vienna, Austria, in October

Demand in Biopharmaceutical Contract Manufacturing remains high. Net sales rose 1.1 percent (year on year and adjusted for currency effects) to 322 million EUR. Boehringer Ingelheim is further expanding its biopharmaceutical production capacity to continue to meet growing demand. The company will inaugurate its large-scale cell culture (LSCC) facility in Vienna, Austria, in October, including up to 150,000L manufacturing capacities for Boehringer Ingelheim products and contract manufacturing.