On April 17, 2024 Circio Holding ASA (OSE: CRNA), a biotechnology company developing next generation circular RNA vector technology for gene therapy and cancer vaccines, reported that it has terminated the exclusive TG01 KRAS cancer vaccine license option agreement with IOVaxis therapeutics in Greater China and Singapore (Press release, Circio, APR 17, 2024, View Source [SID1234642133]).

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On 1 March 2024, IOVaxis Therapeutics´ IND-application to initiate TG01 clinical development in China was approved, triggering a USD 3 million license fee to Circio. Circio initially granted IOVaxis a six-month payment extension following an immediate USD 300,000 down-payment. However, despite multiple exchanges with IOVaxis, the agreed USD 300,000 down-payment has not been made and no plan has been provided to do so.

"IOVaxis has not met the first financial payment milestone and Circio has therefore decided to terminate the TG01 license agreement in China. The three collaborative clinical studies in the USA and EU are proceeding according to plan and remain the primary TG01 development priority," said Dr. Erik Digman Wiklund, CEO at Circio. "Circio will now seek alternative partnering options in China for the TG01 program. Should IOVaxis demonstrate in the future that it has secured the required capital to cover its obligations and initiate TG01 clinical development, then discussions can potentially be reactivated to find a path forward."

Circio currently has three ongoing collaborative TG01 clinical trials with industry and academic partners in the USA and Europe in RAS-mutated multiple myeloma, pancreatic and lung cancer, which are unaffected by this license termination in China.

On April 17, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported a poster presentation on apheresis center efficiency and CXCR4 antagonists including APHEXDA (motixafortide) in patients with multiple myeloma (Press release, BioLineRx, APR 17, 2024, View Source [SID1234642132]). The poster will be presented at the American Society for Apheresis (ASFA) 2024 Annual Meeting, taking place April 17-19, 2024, in Las Vegas, Nevada.

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Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3

The model in the poster at ASFA analyzed the number of apheresis days needed to collect ≥6 million CD34+ cells/kg using different mobilization regimens based on product-specific Phase 3 studies. A direct comparison was used between daily filgrastim alone and in combination with APHEXDA based on the Phase 3 GENESIS trial that supported the U.S. Food and Drug Administration (FDA) approval of APHEXDA. In the absence of head-to-head Phase 3 studies, an indirect comparison was made between daily filgrastim, plerixafor in combination with filgrastim, and APHEXDA in combination with filgrastim. The calculations were based on data from the MOZOBIL (plerixafor) US Prescribing Information and local laboratory assessments in the GENESIS trial.4

"Variability in the time to mobilize sufficient stem cells for ASCT is a significant operational challenge for apheresis centers that can cause suboptimal experiences for patients, as well as delays in care and cost impact," said Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University. "Research of this type supports clinical and institutional decision making and we look forward to presenting the model at the poster session at ASFA."

Poster Presentation at the ASFA 2024 Annual Meeting
The Resorts World, Las Vegas, NV
Poster Session Details
Poster: Number P-28. See abstract in Journal of Clinical Apheresis.
Title: Enhancing Apheresis Center Efficiency with CXCR4 Antagonists: Evidence from the Phase 3 Trials
Authors: Edmund K. Waller, MD, PhD, FACP, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA
Date: April 17-19, 2024

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.

About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study. The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session. The study showed that APHEXDA combined with filgrastim (G-CSF) significantly enhanced the rate of mobilizing ≥6 × 106 CD34+ cells/kg in up to 2 apheresis days compared to placebo + filgrastim. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions.

About APHEXDA
APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.6

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.

WARNINGS AND PRECAUTIONS

Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
ADVERSE REACTIONS
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).

USE IN SPECIFIC POPULATIONS

Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.

Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.

Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.

Please see the accompanying full Prescribing Information.

On April 17, 2024 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2024 (Press release, Abbott, APR 17, 2024, View Source [SID1234642131]).

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First-quarter GAAP diluted EPS of $0.70 and adjusted diluted EPS of $0.98, which excludes specified items.
Abbott narrowed its full-year 2024 EPS guidance range. Abbott projects full-year diluted EPS on a GAAP basis of $3.25 to $3.40 and projects adjusted diluted EPS of $4.55 to $4.70, which represents an increase at the midpoint of the range.
Abbott narrowed its full-year 2024 organic sales growth guidance range, excluding COVID-19 testing-related sales, to 8.5% to 10.0%, which represents an increase at the midpoint of the range2.
In January, Abbott launched the Protality brand, a new high-protein nutrition shake to support the growing number of adults interested in pursuing weight loss while maintaining muscle mass.
In February, Insulet’s Omnipod 5 Automated Insulin Delivery System received CE Mark approval to be offered as an integrated solution with Abbott’s FreeStyle Libre 2 Plus sensor for treating diabetes.
In March, Abbott completed enrollment in the company’s Volt CE Mark clinical study, which is designed to evaluate the Volt Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib). Enrollment in the company’s VOLT-AF IDE clinical study was initiated in April.
In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of TriClip, a first-of-its-kind, minimally invasive treatment option for patients with tricuspid regurgitation, or a leaky tricuspid heart valve.
In April, Abbott announced FDA approval of the i-STAT TBI test, which helps assess a suspected traumatic brain injury (TBI) or concussion in just 15 minutes. This new test can be performed outside of traditional hospital settings, making it more accessible and convenient for patients.
"Our first-quarter results reflect a strong start to the year, and we are raising our full-year sales and EPS guidance," said Robert B. Ford, chairman and chief executive officer, Abbott. "This was the fifth consecutive quarter that we delivered double-digit organic sales growth in our underlying base business, which included particularly strong results in Medical Devices and Established Pharmaceuticals."

FIRST-QUARTER BUSINESS OVERVIEW

Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied ordivided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied ordivided, as appropriate, by the prior year average foreign exchange rates.

Total Company

First Quarter 2024 Results (1Q24)

Sales 1Q24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

3,846

878

931

—

2,034

International

6,118

1,190

1,283

1,226

2,419

Total reported

9,964

2,068

2,214

1,226

4,453

% Change vs. 1Q23

U.S.

(2.1)

8.1

(30.3)

n/a

14.4

International

5.2

3.0

(5.1)

3.1

14.0

Total reported

2.2

5.1

(17.6)

3.1

14.2

Impact of foreign exchange

(2.9)

(2.6)

(2.1)

(10.6)

(1.2)

Impact of CSI acquisition

0.4

—

—

—

1.1

Organic

4.7

7.7

(15.5)

13.7

14.3

Impact of COVID-19 testing sales

(6.1)

—

(20.9)

—

—

Organic (excluding COVID-19 tests)

10.8

7.7

5.4

13.7

14.3

U.S.

10.0

8.1

7.0

n/a

12.1

International

11.3

7.4

4.4

13.7

16.1

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

Nutrition

First Quarter 2024 Results (1Q24)

Sales 1Q24 ($ in millions)

Total

Pediatric

Adult

U.S.

878

514

364

International

1,190

495

695

Total reported

2,068

1,009

1,059

% Change vs. 1Q23

U.S.

8.1

12.0

3.0

International

3.0

6.4

0.8

Total reported

5.1

9.2

1.5

Impact of foreign exchange

(2.6)

(1.3)

(3.8)

Organic

7.7

10.5

5.3

U.S.

8.1

12.0

3.0

International

7.4

8.9

6.4

Worldwide Nutrition sales increased 5.1 percent on a reported basis and 7.7 percent on an organic basis in the first quarter.

In Pediatric Nutrition, global sales increased 9.2 percent on a reported basis and 10.5 percent on an organic basis. In the U.S., sales growth of 12.0 percent was primarily driven by market share gains in the infant formula business. International sales increased 6.4 percent on a reported basis and 8.9 percent on an organic basis, which was led by strong growth in Canada and several countries in Asia Pacific and Latin America.

In Adult Nutrition, global sales increased 1.5 percent on a reported basis and 5.3 percent on an organic basis, which was led by growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

Diagnostics

First Quarter 2024 Results (1Q24)

Sales 1Q24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

931

310

42

98

481

International

1,283

895

87

41

260

Total reported

2,214

1,205

129

139

741

% Change vs. 1Q23

U.S.

(30.3)

7.3

(10.6)

5.6

(46.9)

International

(5.1)

0.2

(12.5)

(0.6)

(18.3)

Total reported

(17.6)

2.0

(11.9)

3.7

(39.5)

Impact of foreign exchange

(2.1)

(3.9)

(0.2)

0.1

(0.8)

Organic

(15.5)

5.9

(11.7)

3.6

(38.7)

Impact of COVID-19 testing sales

(20.9)

(0.3)

(10.9)

—

(44.3)

Organic (excluding COVID-19 tests)

5.4

6.2

(0.8)

3.6

5.6

U.S.

7.0

7.7

6.2

5.6

6.9

International

4.4

5.7

(3.6)

(0.8)

3.5

As expected, Diagnostics sales growth in the first quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $204 million in the first quarter of 2024 compared to $730 million in the first quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 2.7 percent on a reported basis and 5.4 percent on an organic basis.

Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales increased 2.2 percent on a reported basis and 6.2 percent on an organic basis, led by continued strong adoption of Abbott’s Alinity family of diagnostics systems and testing portfolios.

Established Pharmaceuticals

First Quarter 2024 Results (1Q24)

Sales 1Q24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,226

928

298

Total reported

1,226

928

298

% Change vs. 1Q23

U.S.

n/a

n/a

n/a

International

3.1

1.7

7.6

Total reported

3.1

1.7

7.6

Impact of foreign exchange

(10.6)

(13.7)

(0.6)

Organic

13.7

15.4

8.2

U.S.

n/a

n/a

n/a

International

13.7

15.4

8.2

Established Pharmaceuticals sales increased 3.1 percent on a reported basis and 13.7 percent on an organic basis in the first quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 1.7 percent on a reported basis and 15.4 percent on an organic basis, led by growth in several geographies and therapeutic areas, including respiratory, women’s health, and central nervous system/pain management.

View News Release Full Screen
Medical Devices

First Quarter 2024 Results (1Q24)

Sales 1Q24 ($ in millions)

Total

Rhythm
Management

Electro-
physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,034

271

269

237

254

233

181

589

International

2,419

291

318

68

435

282

45

980

Total reported

4,453

562

587

305

689

515

226

1,569

% Change vs. 1Q23

U.S.

14.4

4.5

13.1

8.7

16.4

10.8

16.8

22.8

International

14.0

9.0

18.9

7.7

9.1

12.5

9.8

17.6

Total reported

14.2

6.8

16.2

8.5

11.7

11.7

15.3

19.5

Impact of foreign exchange

(1.2)

(0.7)

(2.2)

0.1

(1.0)

(1.3)

(2.1)

(1.2)

Impact of CSI

1.1

—

—

—

6.9

—

—

—

Organic

14.3

7.5

18.4

8.4

5.8

13.0

17.4

20.7

U.S.

12.1

4.5

13.1

8.7

(1.8)

10.8

16.8

22.8

International

16.1

10.3

23.0

7.1

9.9

14.8

19.6

19.6

Worldwide Medical Devices sales increased 14.2 percent on a reported basis and 14.3 percent on an organic basis in the first quarter, including double-digit growth in both the U.S. and internationally.

Sales growth was led by double-digit growth in Diabetes Care, Electrophysiology, Neuromodulation, and Structural Heart. Several recently launched products and new indications contributed to the strong performance, including Amplatzer Amulet, Navitor, TriClip, and AVEIR.

In Electrophysiology, internationally, sales grew 18.9 percent on a reported and 23.0 percent on an organic basis, which included organic sales growth of 20.4 percent in Europe.

In Diabetes Care, FreeStyle Libre sales were $1.5 billion, which represents sales growth of 22.4 percent on a reported basis and 23.3 percent on an organic basis.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2024 diluted earnings per share under GAAP of $3.25 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.30 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.55 to $4.70 for the full-year 2024.

Abbott projects second-quarter 2024 diluted earnings per share under GAAP of $0.69 to $0.73. Abbott forecasts specified items for the second-quarter 2024 of $0.39 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $1.08 to $1.12 for the second quarter 2024.

ABBOTT DECLARES 401ST CONSECUTIVE QUARTERLY DIVIDEND
On February 16, 2024, the board of directors of Abbott declared the company’s quarterly dividend of $0.55 per share. Abbott’s cash dividend is payable May 15, 2024, to shareholders of record at the close of business on April 15, 2024.

Abbott has increased its dividend payout for 52 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On April 17, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha ("efti") for first line treatment of metastatic non-small cell lung cancer (1L NSCLC) (Press release, Immutep, APR 17, 2024, View Source [SID1234642110]).

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Immutep SVP, Regulatory & Strategy, Christian Mueller commented: "We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS. Spain, a member of the EMA’s Committee for Medicinal Products for Human Use (CHMP), represents an important region given the relatively large number of institutions that participated in our TACTI-002 Phase II study evaluating efti in combination with anti-PD-1 therapy in first line non-small cell lung cancer."

The AEMPS is supportive of Immutep moving into a registrational trial in 1L NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy. Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and statistics, and the specificities of the patient population.

Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On April 16, 2024 Boehringer Ingelheim reported a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned (Press release, Boehringer Ingelheim, APR 16, 2024, View Source [SID1234642327]). Research & Development (R&D) investments increased by 14.2% to EUR 5.8 billion. R&D investments were substantial, at 22.5% of net sales. Group net sales rose by 9.7%* to EUR 25.6 billion in 2023, driven by 10.3%* growth in Human Pharma and 6.9%* growth in Animal Health. Both businesses outperformed their markets.

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In 2023, regulators awarded five additional FDA fast-track designations and one FDA breakthrough therapy designation in the US, as well as one EMA PRIME scheme acceptance in Europe. With a focus on therapeutic research areas in cardiovascular, renal and metabolic diseases (CRM), oncology, respiratory diseases, immunology, mental health, and retinal health, the company is a pioneer in breakthrough treatments in areas of high unmet patient needs.

"I am excited to see how balanced and healthy our pipeline looks today," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "We are determined to accelerate the development of our range of new treatments and make them available to patients in the best and fastest ways. In doing so, it is our mission to not only help patients, but also to help make healthcare systems fairer and better."

Human Pharma portfolio shows strong growth
JARDIANCE, which is used to treat type 2 diabetes and heart failure, continued its strong momentum in 2023, as sales rose by 31.0%* to EUR 7.4 billion. Sales of OFEV, a medicine for the treatment of patients with idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases, increased 12.8%* to EUR 3.5 billion.

JARDIANCE also received regulatory approval in Europe and the United States for a third indication, the treatment of chronic kidney disease. Some 850 million people are estimated to suffer from this chronic disease worldwide. JARDIANCE can now potentially help manage cardiovascular-renal-metabolic conditions of more than 1 billion people.

Continued high investments in Human Pharma R&D
Compounds in the late-stage portfolio accelerated significantly in oncology, CRM and mental health. Brigimadlin advanced into the key trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of zongertinib was accelerated, based upon positive early clinical data. Survodutide showed groundbreaking Phase II results in liver disease due to metabolic dysfunction-associated steatohepatitis (MASH), and also moved into Phase III obesity trials.

R&D investments in Human Pharma rose to EUR 5.2 billion in 2023, 25.1% of Human Pharma net sales (EUR 20.8 billion). Additionally, Boehringer Ingelheim also stepped up its investments in digital technologies and IT for R&D to seize new opportunities, including the use of Artificial Intelligence.

"Our 2023 investments rank us among the top R&D investors in the industry," said Michael Schmelmer, Member of the Board of Managing Directors with responsibility for Finance & Group Functions. "We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives."

Animal Health: strong growth from new product launches
With 6.9%* growth in net sales to EUR 4.7 billion in 2023, the Animal Health business strengthened its market share in the pets, equine and livestock business segments. Growth was driven by increased demand across its diverse portfolio, including pet parasiticides, pet therapeutics and vaccines. NEXGARD, a soft chew for flea and tick protection in dogs and the company’s largest product in the Animal Health portfolio, rose by 17.2%* to EUR 1.2 billion.

In 2023, Boehringer Ingelheim launched four new major products: SENVELGO for cats with diabetes, NexGard PLUS to protects dogs against fleas, ticks, heartworm disease, roundworms and hookworms, NexGard COMBO that protects against fleas and ticks, prevents heartworm disease, and treats and controls roundworms, hookworms, and tapeworms and FRONTPRO, a non-prescription chewable tablet for the control of fleas and ticks on dogs. The new products all contributed to sales growth.

Ongoing high Capital Expenditure
To support the company’s growth, Boehringer announced a 5-year, EUR 7 billion capital investment plan last year. In 2023, Capital Expenditure reached EUR 1.2 billion under this program. Prominent investments in Germany include the Chemical Innovation Plant and the biomass power plant in Ingelheim, as well as the Biologicals Development Center in Biberach. Over the past five years, Boehringer’s capital investments reached EUR 6.0 billion, of which EUR 2.9 billion in Germany alone.

Sustainable Development
Boehringer also further evolved its sustainability program to deepen the focus on health equity in areas where it can make the most relevant contribution to society and environment. Important initiatives include support for the public-private Defeat-NCD Partnership which aims for health coverage for non-communicable diseases in less developed regions and the "Angels" initiative, which has become the largest stroke community in the world and helped 16 million stroke patients in 155 countries receive optimized care. "STOP Rabies" last year provided 43.2 million vaccine doses in endemic countries, 8,000 of these via drone delivery to rural communities in Kenya.

In 2023, Boehringer received the German Sustainability Award for its global efforts in pioneering sustainable transformation in the pharmaceutical industry and its decarbonization strategy was validated by the Science Based Target initiative to be in alignment with the 2015 Paris Climate Accord.

Outlook
The company plans to start ten new phase II and III trials in the next 12-18 months, aiming for 25 new treatment launches in Human Pharma until 2030. In Animal Health, 20 additional launches are expected across markets until 2026, including product updates, indication expansion and new products. For 2024, Boehringer Ingelheim expects a slight year-on-year increase in revenues on a comparable basis, adjusted for currency and extraordinary effects.

* sales growth numbers are adjusted for currency effects

Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at www.boehringer-ingelheim.com.

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