On April 17, 2025 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, reported it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen (Press release, Hikma, APR 17, 2025, View Source [SID1234651975]). Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.

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Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.

"Hikma’s Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans."

"As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen’s innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma’s strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."

According to IQVIA, US sales of trametinib, sold under the brand name Mekinist (trametinib) Tablets, were approximately $436 million in the 12 months ending December 2024.

Hikma’s Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US1.

1IQVIA MAT December 2024, volumes by eaches

Mekinist is a registered trademark of Novartis Pharma AG

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

On April 17, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported that an abstract regarding the Company’s next-generation anthracycline, Annamycin, has been selected for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Convention Center in Chicago, IL (Press release, Moleculin, APR 17, 2025, View Source [SID1234651974]).

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Details of the presentation are as follows:

Title: Combining Annamycin, a Non-cardiotoxic Potent Topo II Poison, with Azacitidine, Cytarabine, Gemcitabine, Ifosfamide, Trabectedin, or Vincristine to Synergize Anticancer Effects and Identify Potential Clinical Applications
Track: Experimental and Molecular Therapeutics
Session: PO.ET02.03. Drug Combination Strategies for Cancer Treatment
Abstract Number: 1683/ 14
Presenter: Rafal Zielinski, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center
Date and Time: April 28, 2025, 9:00 AM – 12:00 PM ET
Location: Section 19

For more information and to view the abstract, visit the AACR (Free AACR Whitepaper) Annual Meeting website.

On April 17, 2025 Interius BioTherapeutics, a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, reported that it will present at several upcoming scientific meetings (Press release, Interius BioTherapeutics, APR 17, 2025, View Source [SID1234651973]).

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Cellicon Valley ’25: The Future of Cell and Gene Therapies
Philadelphia, PA
April 30 – May 2, 2025

Plenary Session: Are In Vivo Cell Therapies the Key to the Future of Medicine?
Presentation Title: Cell-specific in vivo gene delivery: A pipeline dream no longer
Presenter: Philip Johnson, M.D., Chief Executive Officer, Interius BioTherapeutics
Presentation Date and Time: Thursday, May 1, at 3:50 pm EDT
International Society for Cell and Gene Therapy (ISCT) 2025 Annual Meeting
New Orleans, LA
May 7 – 10, 2025

Scientific Session: In Vivo Cell Engineering: Breaking Through the Manufacturing Bottleneck
Presentation Title: INVISE: A first-in-human Phase 1 clinical trial evaluating the safety of INT2104 for in vivo generation of CAR T and CAR NK cells in adults with relapsed/refractory B cell malignancies
Presenter: Dr. David Bishop, Haematologist, Westmead Hospital, Sydney, Australia
Presentation Date and Time: Friday, May 9, at 9:15 am CT
American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting
New Orleans, LA
May 13 – 17, 2025

Scientific Symposium: The Coalition of International Gene Therapy Societies Showcases: Moving from ex vivo Cell Therapies to in vivo
Presentation Title: Investigational in vivo CAR-T therapy designed to treat B-cell malignancies
Presenter: Philip Johnson, M.D., Chief Executive Officer, Interius BioTherapeutics
Presentation Date and Time: Thursday, May 15, from 3:45 – 5:30 pm CT
Location: Room 265-268

On April 17, 2025 GSK plc (LSE/NYSE: GSK) reported the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide (Press release, GlaxoSmithKline, APR 17, 2025, View Source [SID1234651972]). This UK regulatory authorisation marks the first in the world for Blenrep in this treatment setting.

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Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHRA authorisation of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.2,3

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse."

Currently, most patients with multiple myeloma experience relapse, and in the UK only 55% remain alive five years after diagnosis.5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation.

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation and Professor, Translational Genomics Research Institute, City of Hope Cancer Center, said: "As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival. We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated."

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.2,3 In DREAMM-7, the Blenrep combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).2 DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023).4 The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the Blenrep combination compared to 12.7 months in the bortezomib combination.3

Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators.2,3

Eye-related side effects, a known side effect of treatment with Blenrep, were generally resolvable, manageable with extended time between infusions and dose reductions while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials.2,3 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep combination arm of DREAMM-8.

Blenrep combinations are currently under review in 14 countries, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025,6 European Union,7 Japan (with priority review),8 China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),9 Canada, and Switzerland (with priority review for DREAMM-8).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.10,11 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.12 Multiple myeloma is a significant concern in the UK, which ranks fifth in incidence rate of all European countries. There are approximately more than 6,500 new cases of multiple myeloma diagnosed each year and an expected 5-year prevalence of over 19,400 cases in the UK.13,14 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.15,16

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. Results were first presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine.2

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes. Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

On April 17, 2025 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported its financial results for FY 2024, provided guidance for FY 2025 and outlook for 2028 reflecting the path to sustainable profitable growth, following the completion of its strategic review process (Press release, Evotec, APR 17, 2025, View Source [SID1234651971]).

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Dr Christian Wojczewski, Chief Executive Officer of Evotec, said:

"Evotec’s ambitious new direction paves the way for sustainable profitable long-term growth. We are refocusing Evotec on its core strengths: technology and science leadership, where we deliver maximum impact for customers and patients. By combining cutting-edge technology platforms, disruptive science, and AI-driven innovation, we are accelerating the journey from concept to cure with our partners. We delivered on 2024 financial guidance, and I am excited about the opportunities that lie ahead of us. Together with our talented teams, we are writing the next chapter of Evotec’s success story as a drug discovery pioneer."

Evotec unveils new strategy to refocus on core strengths and define clear roadmap to sustainable profitable growth

· Technology and science leadership – refocusing on our strong, unique heritage

· Two pillars: Drug Discovery & Pre-clinical Development (Shared R&D) and Just – Evotec Biologics

· Drug Discovery & Pre-clinical Development will leverage automation, industrialisation, next generation platforms and AI to accelerate our customers journey and to increase their success rates

· Business model simplified: focus on high-value services and therapeutic areas, asset portfolio streamlined by ~30%, R&D supporting next-generation technology development. Exiting equity participations

· Just – Evotec Biologics growth underpinned by existing partnerships and further strengthened by leveraging its capabilities as a scalable technology and service provider, anticipating pivot to an asset lighter model

· Beating market growth via our scientific and operational expertise, focus, and differentiated technology

· Commitment to operational excellence for a step-change in performance. Driving operational leverage through our backbone with higher focus on automation. Anchored cost-out initiatives via refined footprint, optimised COGS and SG&A delivering > € 50 m gross savings by 2028 on top of Priority Reset (€ 40 m)

2024 revenue and EBITDA within guidance. Priority Reset on track. Q4: Second highest quarterly revenues ever amid challenging market environment

· Group revenues increased by 2% to € 797.0 m (2023: € 781.4 m); Q4 2024 revenues increased by 10% to € 221.2 m from € 201.3 m in Q4 2023

· Evotec’s Just – Evotec Biologics segment saw impressive growth, with revenues rising by 71% year-over-year, contributing € 185.6 m (2023: € 108.4 m) to the overall topline

· Total Shared R&D revenues decreased by 9% to € 611.4 m (2023: € 673.0 m); Demand still affected by temporary Pharma restructuring and selective funding for Biotech

· Adjusted Group EBITDA totalled € 22.6 m (2023: € 66.4 m) driven by a mismatch between revenues and cost base in the Shared R&D segment

· Priority Reset on track to secure an annualised adjusted EBITDA improvement of over € 40 m. One-off costs recognised at € 54.9 m, vs. initial provision of € 68.5 m

· Net debt leverage ratio significantly improved to 1.9x net debt / EBITDA

Strengthened partnerships in 2024 paving the way for 2025 growth in soft market environment

· Group revenue growth expected to accelerate vs. 2024, driven by Just – Evotec Biologics, while Shared R&D revenues expected to remain around 2024 levels

· Tariffs & US government funding development are expected to have a limited impact on Evotec’s business

· Expansion of technology partnership with Sandoz and new customers for long-term development and commercial manufacturing in Biologics

· Progress and extension of multi-year collaboration with Bristol Myers Squibb ("BMS") in neuroscience and targeted protein degradation

· New technology development partnership with Novo Nordisk to support next-generation cell therapies

· New multi-year master research collaboration with Pfizer, initially focusing on early discovery research for metabolic and infectious diseases

Guidance for full-year 2025

· Group revenues expected in the range of € 840 – 880 m (2024: € 797.0 m)

· R&D expenditures are expected in a range of € 40 – 50 m (2024: € 50.8 m)

· Adjusted Group EBITDA is expected to reach € 30 – 50 m (2024: € 22.6 m)

Outlook 2028

· Group revenues CAGR2024-2028 targeted to be in a range of 8 – 12 %

· Adj. EBITDA margin 2028 expected to be above 20%

CAGR: Compound annual growth rate

More detailed information and financial tables are available in the annual report published on the Evotec website under the following link: View Source

Webcast/Conference Call

The Company is going to host a conference call to discuss 2024 results as well as to provide an update on the concluded strategic review process. The conference call will be held in English.

Webcast details

Date: Thursday, 17 April 2025

Time: 2.00 pm CEST (1.00 pm BST, 8.00 am ET)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com.

Conference call detail

To join via phone, please pre-register via this link

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.