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Boehringer Ingelheim reaches more patients in 2024 and prepares new medicine launches

On April 2, 2025 Boehringer Ingelheim reported a continued rise in the number of patients it reached, 66 million in 2024, up 8.0% from the previous year (Press release, Boehringer Ingelheim, APR 2, 2025, View Source [SID1234654046]). Development of its current product pipeline is well on track, as the company prepares multiple new product launches, starting in 2025. Research & Development (R&D) investments rose to EUR 6.2 billion, or 23.2% of group net sales. Group net sales rose by 6.1%* to EUR 26.8 billion.

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"As our current pipeline continues to mature and more products come closer to a potential market introduction, we have entered a pivotal phase of high investments," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "It is important that we use every opportunity to bring these new treatments to patients as fast as possible – this is our number one priority."

Human Pharma: investing in existing products and new launches
Human Pharma sales rose by 7.0%* to EUR 21.9 billion, led by JARDIANCE and OFEV. Sales of JARDIANCE, which is now also available for treatment of chronic kidney diseases, in addition to type 2 diabetes and heart failure, rose 14.6%* to EUR 8.4 billion. OFEV, which is used to treat idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases, grew 8.9%* to EUR 3.8 billion.

The Human Pharma pipeline includes over ten new Phase II and III trials over the next 12 to 18 months, which will potentially result in a range of significant launches in the next five years. Human Pharma R&D spending rose to EUR 5.7 billion, or 27.6% of the business unit’s net sales.

"If we look at the past five years, Boehringer Ingelheim has invested approximately EUR 25 billion in R&D," said Frank Hübler, Member of the Board of Managing Directors with responsibility for Finance. "With the innovations currently in our pipeline we will further increase investments in R&D in the years to come."

After positive data from pivotal studies, the company is preparing multiple new product launches, starting this year with potential launches of zongertinib and nerandomilast.

Nerandomilast has the potential to advance care for patients with Idiopathic Pulmonary Fibrosis (FIBRONEER-IPF) and Progressive Pulmonary Fibrosis (FIBRONEER-ILD). Full data from both phase III FIBRONEER-trials, which met their primary endpoint, will be presented in the coming months.

If approved, zongertinib would be the first orally administered, targeted therapy for previously treated HER2-mutated lung cancer patients. Zongertinib’s development was accelerated due to positive Phase 1b Beamion LUNG-1 trial data, which showed a response rate of 71% (95% CI, 60–80), p<0.0001**, and disease control rate of 93%. It was generally well tolerated, with a low toxicity-related discontinuation rate (3%). Additional studies in HER2-altered solid tumors are ongoing.

Both zongertinib and nerandomilast have been submitted to regulatory authorities globally and first launches in the US are anticipated in the second half of this year, pending approval.

Animal Health: rapid response against transboundary animal diseases
Animal Health sales rose 1.9%* to EUR 4.7 billion in 2024, mainly driven by Pet Parasiticides and Therapeutics, Poultry and Ruminant. The parasiticides NEXGARD continued to strengthen its position as the top-selling brand in the industry, growing 14.0%* to EUR 1.4 billion.

Last year, Boehringer Ingelheim supported livestock producers and governments by quickly providing vaccines and technical assistance for outbreaks of transboundary animal diseases (TADs), such as avian influenza, bluetongue virus and foot-and-mouth disease. These diseases pose a significant risk to animal health, impede global trade, and constrain food supply.

Sustainable Development
Boehringer Ingelheim is on track in its target to become carbon neutral in its company operations (Scope 1 and 2) by 2030. It increased global renewable electricity purchases to around 75% in 2024, primarily due to transitioning to renewable solutions at various sites, including Japan and China. A new biomass power plant was also commissioned at its Ingelheim site in Germany to boost on-site renewable energy generation to 95% of its energy needs.

As part of its global effort to stop rabies, the company provided 46 million rabies vaccine doses and supported vaccination campaigns in endemic countries. The "Angels" initiative, which aims to optimize the quality of treatment in existing stroke centers, added over 1,000 organizations to the network. It is the largest stroke community in the world, now encompassing 237,000 healthcare professionals from more than 9,000 hospitals in 158 countries and has helped 19 million stroke patients to date.

Outlook
The general trends and developments of the past year are expected to continue to impact 2025. The company expects a continued rise in the number of patients reached, and a slight year-on-year increase in net sales, adjusted for currency and extraordinary effects.

* sales growth numbers are adjusted for currency effects

**one-sided p-value from a z-test of the null hypothesis ORR ≤30%

Entry into a Material Definitive Agreement

On April 2, 2025, Akoya Biosciences, Inc. ("Akoya") entered into a securities purchase agreement (the "Securities Purchase Agreement") with Quanterix Corporation ("Quanterix"), pursuant to which Akoya will issue and sell to Quanterix from time to time, in a private placement, one or more convertible promissory notes having an aggregate principal amount of up to $30,000,000 (the "Convertible Notes") (Filing, Akoya Biosciences, APR 2, 2025, View Source [SID1234651803]). Akoya may draw on the Convertible Notes between May 15, 2025 and the earlier of (a) the closing of the transactions contemplated by the Agreement and Plan of Merger, dated as of January 9, 2025, as it may be amended from time to time, by and among Quanterix, Akoya and Wellfleet Merger Sub, Inc. (the "Merger Agreement") and (b) July 9, 2025 if the Merger Agreement is lawfully terminated pursuant to its terms on or prior to such date; provided, however, that if the closing of the transaction contemplated by the Merger Agreement occurs on or prior to May 15, 2025, Akoya may not draw the Convertible Notes. Additionally, if the initial termination date of July 9, 2025 is extended to January 9, 2026 in accordance with the terms of the Merger Agreement, Akoya may draw on the Convertible Notes until January 9, 2026.

Any Convertible Notes issued under the Securities Purchase Agreement will mature on the earliest to occur of (i) the 91st day following the earlier of (a) November 1, 2027 and (b) the date that Akoya’s indebtedness under the Credit and Security Agreement, dated October 27, 2020, by and among Akoya, Midcap Financial Trust, as a lender and as agent ("MidCap"), and the other lenders named therein (the "Akoya Existing Loan Agreement") is repaid in full and all commitments under such documents have been terminated and (ii) subject to the terms of the Subordination Agreement (as defined below), any acceleration of the Convertible Notes. Any Convertible Note issued under the Securities Purchase Agreement will bear interest at a rate per annum equal to the SOFR interest rate plus an applicable margin specified in the Convertible Note to, but excluding, the date of repayment or conversion of the Convertible Note. Interest on the Convertible Notes will be paid in arrears on the first day of each month and on the maturity date of the Convertible Notes. Subject to the terms of the Subordination Agreement, any interest payments will be made exclusively to Quanterix in cash.

If drawn, the Convertible Notes will be convertible at the election of Quanterix during the period beginning on the date, if any, that the Merger Agreement is terminated and ending on the maturity date of the Convertible Notes into shares of common stock, par value $0.00001, of Akoya ("Akoya Common Stock"), at a conversion price equal to the product of (i) the exchange ratio set forth in the Merger Agreement, as it may be adjusted pursuant to the terms of the Merger Agreement, and (ii) the VWAP of Quanterix’s common stock for the 10 consecutive trading days ending on the trading day prior to the entry into the Merger Agreement, subject to adjustment.

The Convertible Notes prohibit conversion if it would result in the issuance of more than 19.99% of Akoya Common Stock in the aggregate prior to obtaining stockholder approval. The Convertible Notes will also contain customary anti-dilution provisions to adjust the conversion price from time to time based upon certain issuances of securities by Akoya. The Securities Purchase Agreement contains customary representations and warranties and events of default as well as certain operating covenants applicable to Akoya until the closing of the transaction contemplated by the Merger Agreement.

Registration Rights Agreement

At such time as Akoya draws any funds and thereby issues any Convertible Notes, Akoya and Quanterix will enter into a registration rights agreement (the "Registration Rights Agreement"), pursuant to which, among other things, Akoya must prepare and file with the U.S. Securities and Exchange Commission (the "SEC") no later than August 13, 2025 a registration statement with respect to the resale of shares of Akoya Common Stock issuable upon conversion of the Convertible Notes.

Subordination Agreement

At such time as Akoya draws any funds and thereby issues any Convertible Notes, Quanterix, Akoya and MidCap will enter into a subordination agreement (the "Subordination Agreement"), pursuant to which Quanterix and Akoya will agree, among other things, that the Convertible Notes will be subordinate to any debt outstanding and obligations owing under the Akoya Existing Loan Agreement.

Huonslab Announces Significantly Enhanced Bioavailability of SC Infliximab Co-formulated with HyDIFFUZE™ in Sprague-Dawley Rats; Abstract Selected for Presentation at AACR 2025

On April 2, 2025 Huonslab Co., Ltd. ("Huonslab"), a subsidiary of Huons Global (KOSDAQ: 084110), reported that its abstract titled "The Role of HyDIFFUZE in Co-formulation with Subcutaneous Infliximab" has been selected for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place on April 28, 2025 (Press release, Huons Global, APR 2, 2025, View Source [SID1234651773]).

The study demonstrated that HyDIFFUZE (rHuPH20) significantly improves the relative bioavailability of co-formulated infliximab compared to infliximab without rHuPH20 when administered subcutaneously.

These findings suggest that co-formulation with HyDIFFUZETM (rHuPH20) may reduce the required dose of infliximab while maintaining equivalent therapeutic efficacy and potentially extending dosing interval in the maintenance regimen.

Huonslab previously validated the role of HyDIFFUZE (rHuPH20) as a locally acting, transient permeation enhancer for subcutaneous delivery of high-dose, high-volume biotherapeutics, supported by dye dispersion studies in nude mice and in vivo comparative pharmacokinetic (PK) studies in Sprague-Dawley rats.

In parallel, Huonslab is currently conducting a pivotal Phase 1 clinical trial in South Korea for Hydizyme, a stand-alone recombinant human hyaluronidase (rHuPH20) drug product, with the goal of obtaining product approval from the Ministry of Food and Drug Safety (MFDS) by 2026.

"Huonslab is committed to converting high-dose, high-volume antibody-based biotherapeutics from intravenous (IV) infusion to subcutaneous (SC) injection using human hyaluronidase PH20," said Dr. Young Sun Lee, Chief Business Officer of Huonslab.

Lee added, "Our HyDIFFUZE (rHuPH20) drug delivery technology is redefining the landscape of SC antibody development and expanding patient access to more convenient and effective subcutaneous antibody therapies."

Nuvation Bio to Present at the Jones Healthcare and Technology Innovation Conference

On April 2, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at the Jones Healthcare and Technology Innovation Conference on Wednesday, April 9, 2025, at 10:00 a.m. PT/1:00 p.m. ET in Las Vegas, NV (Press release, Nuvation Bio, APR 2, 2025, View Source [SID1234651772]).

An audio replay of the fireside chat will be available following the event on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

Landmark Bio Acquired by Artis BioSolutions to Expand Manufacturing and Commercialization of Advanced Therapies

On April 2, 2025 Landmark Bio reported it has been acquired by Artis BioSolutions ("Artis"), a newly launched company dedicated to streamlining the discovery, process development, and manufacturing of genetic medicines (Press release, Landmark Bio, APR 2, 2025, View Source [SID1234651771]). The acquisition enables Landmark Bio to continue to deliver on its mission of translating groundbreaking research into life-changing therapies, while scaling its capabilities to accelerate development and manufacturing of advanced therapies.

"Landmark Bio was born from a bold vision shared by our founding partners – to remove barriers in the manufacturing of advanced therapies and accelerate the development of life-changing medicines. In just a few short years, we’ve built a world-class team and capabilities that have become a vital force in the life sciences innovation ecosystem. Joining Artis BioSolutions marks an exciting new chapter for Landmark Bio. Together, we will stay true to our mission as we scale our operations to bring breakthrough therapies to more patients," said Ran Zheng, chief executive officer (CEO) of Landmark Bio.

Since its founding in 2021, Landmark Bio has built a robust platform to address persistent bottlenecks in advanced therapy development, serving as a partner to academic institutions, biotechnology companies, and global biopharma firms. The organization was established by leaders from academia, industry, and Boston’s leading research hospitals. Together with Artis BioSolutions, Landmark Bio will enhance its ability to provide integrated, end-to-end solutions that span preclinical development through commercialization, with expanded capabilities in process, analytical and formulation development, GMP manufacturing and QC testing, CMC consulting and IND enabling services, and manufacturing technology development.

"This next chapter for Landmark Bio is a testament to the vision, science, and dedication of its founding partners," said John Shaw, vice provost for research at Harvard University and chair of Landmark Bio’s board of directors. "Landmark Bio plays an important role in the development of new therapies, and we are confident that this transition will strengthen its position as a cornerstone of the advanced therapy ecosystem."

"Ran and the team at Landmark Bio have established an outstanding foundation built on scientific excellence, operational precision, and a strong collaborative mission," said Brian Neel, CEO of Artis BioSolutions. "We are thrilled to join forces with such a talented team and look forward to driving transformative progress together – expanding access, accelerating innovation, and ultimately enabling our partners to deliver life-changing medicines to patients more efficiently."

As part of Artis, Landmark Bio will continue to operate as a distinct entity, providing critical services in translational research, process development, and manufacturing for clinical and commercial cell and gene therapy products. The acquisition by Artis supported by initial funding from Oak HC/FT, marks a significant step toward expanding access to high-quality development and manufacturing capabilities across the advanced therapy ecosystem. Landmark Bio will remain headquartered in Watertown, MA, and continue to operate its state-of-the-art facility and teams in place.