PharmaShots' Key Highlights of Third Quarter 2024
Shots:
- The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B
- This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity
- Our team at PharmaShots has summarized and compiled the insights of Q3'2024
Eli Lilly to Acquire Morphic Holdings for an Aggregate of ~$3.2B
Date: July 08, 2024
Product: N/A
Shots:
- Eli Lilly has entered into a definitive agreement to acquire Morphic Holding to strengthen its immunology portfolio by adding oral integrin therapies
- The company will buy Morphic’s outstanding shares for $57 per share in cash making it a total deal value of ~$3.2B. The transaction is anticipated to conclude in Q3’24, pending customary closing conditions
- The acquisition will add Morphic’s MORF-057 (α4β7 integrin inhibitor) being assessed under three P-II trials (2 for ulcerative colitis & 1 for Crohn's disease) and various preclinical candidates for treating autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases & cancer to Lilly’s portfolio
Date: July 12, 2024
Product: Tagrisso
Shots:
- Health Canada has approved Tagrisso + pemetrexed and platinum-based chemotherapy as a 1L treatment of locally advanced or metastatic EGFRm NSCLC, based on P-III (FLAURA2) study
- The P-III (FLAURA2) study of Tagrisso (80mg, oral, QD) + CT [pemetrexed (500mg/m^2) + cisplatin (75mg/m^2) or carboplatin (AUC5), Q3W] followed by Tagrisso with pemetrexed maintenance (Q3W) in locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC patients (n=557)
- Study depicted 38% PFS & 25.5mos. vs 16.7mos. mPFS as per investigator evaluation. OS evaluation is underway
Roche Reports the P-I (CT-996-201) Study Data of CT-996 for Treating Obesity
Date: July 17, 2024
Product: CT-996
Shots:
- The P-I (CT-996-201) study assesses SAD & MAD of CT-996 vs PBO in otherwise-healthy adults, with part 1 involving 40 obese subjects (completed), part 2 involving 25 obese subjects without T2D (completed) & part 3 involving 30 obese subjects with T2D (anticipated in Q4’24)
- Topline data from the 2 arms depicted a mean weight loss of -6.1% among obese individuals without T2D in 4wks. while a weight loss of -7.3% vs -1.2% was observed post 4wks. with PK data suggesting QD oral dosing
- Safety was well-tolerated, aligned with incretin drugs & did not lead to treatment discontinuations; blood levels of CT-996 were stable regardless of fasting or high-fat meals. It will advance to P-II based on these results
Date: July 18, 2024
Product: Altuviiio
Shots:
- Sanofi has published results from the pivotal P-III (XTEND-Kids) trial evaluating Altuviiio (50IU/kg, QW) prophylaxis in treatment-experienced patients (n=74; <12yrs.) with severe hemophilia A for 52wks. in the NEJM
- Study reached its 1EPs & 2EPs, demonstrating zero factor VIII inhibitor development; median annualized bleed rate (ABR) was 0.00 with an estimated mean ABR of 0.61 in 73 patients. 82% of children experienced zero joint bleeds, suggesting Altuviiio’s potential of long-term joint health preservation
- Additionally, an ongoing XTEND-ed extension study is assessing the long-term safety & efficacy of Altuviiio in severe hemophilia A patients (up to 4yrs.)
Date: July 18, 2024
Product: N/A
Shots:
- GE HealthCare has agreed to acquire the clinical AI software business of Intelligent Ultrasound Group for ~$51M, with a cash on hand funding. The transaction is anticipated to close in Q4’24
- Through the acquisition, the company will integrate these AI solutions to expand its ultrasound portfolio, enhancing workflows and patient care quality
- The company will also incorporate R&D experts of Intelligent Ultrasound, enabling AI-based image recognition & innovation for GE HealthCare Women’s Health ultrasound devices and a broader portfolio
Date: Aug 02, 2024
Product: Steqeyma
Shots:
- Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis
- Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate of change in the psoriasis area & severity index for skin symptoms after 52wks. The efficacy was similar in patients who switched to Steqeyma at wk.16
- Steqeyma, an IL-12 & -23 antagonist, is accessible in both IV [130mg/26 mL (5mg/mL) solution in a single-dose vial] & SC (45mg/0.5mL or 90mg/1mL solution in a single-dose, prefilled syringe) formulations
Date: Aug 12, 2024
Product: CN201
Shots:
- Merck has signed a definitive agreement with Curon to acquire CN201 (bispecific antibody) that was well-tolerated & showed its ability to induce significant & sustained B-cell reduction in early studies
- As per the agreement, Curon will receive $700M upfront in cash plus $600M development & regulatory milestones and Merck will receive full worldwide rights of CN201. The transaction is set to close in Q3’24 & will be treated as an asset acquisition
- CN201 is currently under P-I study to treat r/r non-Hodgkin’s lymphoma & P-Ib/II study to treat r/r B-cell acute lymphocytic leukemia. Merck aims further to explore CN201 for B-cell malignancies & autoimmune diseases
Stryker Reports the Acquisition of care.ai, Strengthening its Medical Device Portfolio
Date: Aug 13, 2024
Product: N/A
Shots:
- Stryker has entered into a definitive agreement for the acquisition of care.ai to enhance its IT offerings in healthcare & strengthen its medical technology portfolio
- The acquisition adds care.ai’s complementary technology to be combined with the Vocera platform and Stryker’s devices to create an ecosystem for delivering clinical workflows and advancing smart care facilities
- care.ai's platform and sensors will allow AI-assisted workflows for personalized care. This partnership helps Stryker accelerate its IT offerings in healthcare, providing real-time, smart, and connected decision-making tools, improving patient care
Carlyle to Acquire Baxter International’s Vantive Kidney Care Segment for $3.8B
Date: Aug 14, 2024
Product: N/A
Shots:
- Baxter International and Carlyle have entered into a definitive agreement as per which Carlyle will acquire Baxter's Vantive Kidney Care segment for an aggregate of $3.8B. The transaction is anticipated to conclude in H2’24 or H1’25
- As per the agreement, Baxter will get ~$3.5B in cash from the deal, estimated ~$3B after-tax proceeds, and remaining will be used for working capital and debt adjustment
- Vantive Kidney Care segment provides products and services for peritoneal dialysis, hemodialysis and organ support therapies such as continuous renal replacement therapy (CRRT)
AstraZeneca’s Lynparza Plus Imfinzi Receives the EC’s Approval to Treat Endometrial Cancer
Date: Aug 14, 2024
Product: Lynparza & Imfinzi
Shots:
- Following the CHMP’s positive opinion, the EC has approved Imfinzi + CT followed by Lynparza with Imfinzi and Imfinzi alone as a 1L treatment of pMMR & dMMR disease, respectively, based on P-III (DUO-E) study assessing the combination vs CT in patients (n=699) with advanced/recurrent endometrial cancer
- Study showed reduced disease progression or death risk by 43% (mPFS: 15mos. vs 9.7mos.) pMMR disease population and by 58% (mPFS: not reached vs 7mos.) in dMMR disease population. Data was published in Journal of Clinical Oncology
- Further submissions are being reviewed across Japan & other regions for the same. It is approved in the US for dMMR disease
Date: Aug 14, 2024
Product: ATSN-201
Shots:
- The US FDA has granted RPDD to ATSN-201 for treating X-linked retinoschisis (XLRS). The company will receive a priority voucher on approval that could be sold or used for developing other internal product
- ATSN-201 is currently being assessed under the dose escalation & expansion P-I/II (LIGHTHOUSE) study for treating XLRS caused due to RS1 gene mutations in male patients (≥6yrs.). Recruitment is underway
- ATSN-201, a gene therapy, uses AAV.SPR (novel spreading capsid) for therapeutic gene expression in central retinal photoreceptors without the risks of foveal detachment. Preclinical studies in non-human primates showed that AAV.SPR induces transgene expression beyond subretinal injection areas
Johnson and Johnson to Acquire V-Wave, Expanding and Strengthening J&J MedTech Segment
Date: Aug 21, 2024
Product: N/A
Shots:
- J&J entered into a definitive agreement to acquire V-Wave for an upfront of $600M, and approx. $1.1B regulatory and commercial milestones. The acquisition will be concluded in H2’24
- Under US GAAP, this transaction will be treated as an asset acquisition, leading to a non-tax deductible in-process R&D charge of about $600M at closure. J&J projects a diluted adjusted EPS impact of roughly $0.24 in 2024 and $0.06 in 2025. The full-year financial outlook will be presented in Q3’24 results
- The acquisition will make V-wave a part of J&J’s Medtech segment in the cardiovascular area
Stryker Reports the Acquisition of Vertos Medical, Strengthening its Pain Management Portfolio
Date: Aug 23, 2024
Product: N/A
Shots:
- Stryker has entered into a definitive agreement for the acquisition of Vertos Medical to enhance its minimally invasive treatment options to manage chronic lower back pain resulting from lumbar spinal stenosis
- With this acquisition Stryker aims to further deepen its reach to ambulatory surgery centers using Vertos’ minimally invasive pain management solutions
- This Vertos’ mild procedure is a pain relief solution with possibility of improving mobility without major surgery & helps Stryker target patients seeking minimally invasive treatment options because of reduced recovery time and quicker return to daily life.
Siemens Healthineers to Acquire Novartis’ Radiodiagnostic Manufacturing and Distribution Network
Date: Aug 27, 2024
Product: N/A
Shots:
- Siemens Healthineers has agreed to acquire Novartis' Advanced Accelerator Applications (AAA) diagnostic division for over $223M (€200M)
- The acquisition will enhance Siemens Healthineers’ spot in medical imaging sector (specifically in radioactive chemicals production for PET scans) to improve cancer, heart & neurological disorder diagnostics plus expand its European market presence
- The transaction will conclude in Q4’24, contingent upon regulatory approval and negotiations with Novartis’s works council. Siemens Healthineers will continue partnering with Novartis in radioligand therapy
Date: Aug 29, 2024
Product: Keytruda
- Merck is discontinuing the P-III (KEYNOTE-867) study of Keytruda + SBRT for NSCLC (stage I or II) based on DMC recommendation. Interim analysis showed no improvement in EFS or OS and the combination had a higher AE rate, incl. deaths
- Based on DMC’s recommendation, the company is also stopping the P-III (KEYNOTE-630) study of Keytruda for high-risk cSCC post-surgery & radiation. Study did not show improvement in RFS; OS was not formally evaluated, but interim data did not favor Keytruda; safety was consistent with previous findings
- Analysis of both studies is underway and data will be presented to the scientific community and regulatory agencies
Date: Sep 03, 2024
Product: Sebetralstat
Shots:
- The US FDA has accepted NDA for sebetralstat to treat HAE (PDUFA: Jun 17, 2025), with EMA validating its MAA for the same. Further filings across the UK, Japan & other regions are planned in H2’24
- Submission was based on P-III (KONFIDENT) study of sebetralstat (300mg & 600mg) vs PBO in HAE patients (≥12yrs.), showing faster symptom relief & ongoing KONFIDENT-S open label extension study, showing early attack treatment with a median time of 9mins. & a median time to symptom relief for laryngeal attacks of 1.3hrs.
- KalVista’s KONFIDENT-KID study assessing the safety, PK & efficacy of sebetralstat using pediatric oral disintegrating tablet (ODT) formulation in children (n=24; 2 to 11yrs.) for 1yr. has begun
Valneva and Pfizer Present P-II (VLA15-221) Study Data of VLA15 Vaccine for Lyme Disease
Date: Sep 03, 2024
Product: VLA15
Shots:
- The P-II (VLA15-221) trial assessed VLA15 vs PBO in pediatric participants (5-17yrs.). A total of 560 healthy participants received either VLA15 (180µg) in two schedules (mos.0-2-6 or mos.0-6) or PBO
- Study showed a strong anamnestic antibody response in all 6 serotypes among individuals (5-65yrs.) & over 90% seroconversion rates 1mos. after the second booster. Geometric Mean Titers were comparably high after both the 1st & 2nd boosters
- The P-III (VALOR) trial of VLA15 in subjects (≥5yrs.) across the US & EU has begun, with primary vaccination series concluded in Jul 2024. Another P-III (VLA15-1012) trial focusing on pediatric safety is underway. Pfizer will submit BLA & MAA to the US FDA & EMA in 2026, based on P-III results
Date: Sep 03, 2024
Product: N/A
Shots:
- Merck & EyeBio (Merck’s subsidiary) have commenced the P-IIb/III (BRUNELLO) study of Restoret as a treatment of DME, supported by the P-I/II (AMARONE) trial data in DME & neovascular age-related macular degeneration
- The P-IIb/III (BRUNELLO) study will investigate the safety & efficacy of two Restoret dose levels (intravitreal, Q4W) vs ranibizumab among DME patients, in ratio 1:1:1, for 1 yr. followed by a personalized treatment interval in the 2nd yr. The dual 1EP include safety & mean change in BCVA at wk.52
- Restoret is FIC tetravalent Wnt Ab that aims to restore the blood-retinal barrier and reduce vascular leakage by activating the Wnt pathway, as demonstrated in non-clinical studies
Date: Sep 06, 2024
Product: Filspari
Shots:
- The US FDA has granted full approval to Filspari (400mg) for treating IgAN, based on the P-III (PROTECT) trial assessing the drug vs irbesartan (300mg) in subjects (n=404) aged ≥18yrs. It received accelerated approval in Feb 2023
- Final 2yrs. ITT analysis showed reduction in the rate of kidney function decline at wk.110. The mean eGFR slope was -3.0 mL/min/1.73 m2/year vs -4.2 mL/min/1.73 m2/year, with a significant treatment effect of 1.2 mL/min/1.73 m²/year; additional benefits showed improved eGFR over time, with a 3.8 mL/min/1.73 m² greater mean change
- Safety was well-tolerated and consistent in all the studies. An sNDA to the US FDA is planned for a potential modification to the liver-monitoring REMS
Date: Sep 06, 2024
Product: Efsitora Alfa
Shots:
- QWINT-1 study assessed the safety & efficacy of efsitora (QW) vs insulin glargine (QD) for 52wks. in insulin-naïve T2D adults (n=796) while QWINT-3 trial compared the same b/w efsitora & insulin degludec for 78wks. in T2D adults (n=986) currently on basal insulin
- QWINT-1 reaching its 1EP, depicting non-inferior A1C reduction of 1.31% vs 1.27% (A1C of 6.92% & 6.96%, respectively) in efficacy estimand and 1.19% vs 1.16% (A1C of 7.05% & 7.08%, respectively) in treatment-regimen estimand at wk.52
- QWINT-3 also met its 1EP, showing reduced A1C of 0.86% vs 0.75% (A1C of 6.93% & 7.03%, respectively) in efficacy estimand and 0.81% vs 0.72% (A1C of 6.99% & 7.08%, respectively) in treatment-regimen estimand at wk.26
Date: Sep 09, 2024
Product: Ifinatamab Deruxtecan
Shots:
- The P-II (IDeate-Lung01) study is assessing ifinatamab deruxtecan in ES-SCLC patients previously treated with 1-3L of therapies, to receive 8mg/kg or 12mg/kg (part 1), & at least 2L of therapy, to receive the recommended 12mg/kg (part 2)
- Results showed cORR: 54.8% with 23 PRs (12mg/kg) & 26.1% with 1 CR and 11 PRs (8mg/kg), mDoR: 4.2mos. & 7.9mos., DCR: 90.5% & 80.4%, mPFS: 5.5mos. & 4.2mos. and mOS: 11.8mos. & 9.4mos. The 12mg/kg dose is selected for the expansion phase
- In patients with brain target lesions intracranial ORRs were 50.0% with 3 PRs (12mg/kg, n=10) & 66.7% with 2 PRs (8mg/kg, n=6), 2 CRs were found in each cohort. Stable disease was observed in 5 (12mg/kg) & 2 cases (8mg/kg)
Organon to Acquire Dermavant for an Aggregate of ~$1.2B
Date: Sep 18, 2024
Product: N/A
Shots:
- Organon has signed a definitive agreement to acquire Dermavant (a Roivant company), extending its international dermatology capabilities across the US
- The acquisition will add Dermavant’s VTAMA (tapinarof) cream, 1% intended for topical treatment of mild, moderate & severe plaque psoriasis in adults with its sNDA for AD in adults & children (≥2yrs.) under US FDA’s review (PDUFA: Q4’24). Dermavant holds global rights of the product (excl. China) and has out licensed Japan rights
- Under the agreement, Dermavant will receive a total of ~$1.2B which includes $175M upfront, $75M regulatory milestones for VTAMA cream in AD & $950M commercial milestones plus net-sales based royalties. Closing is anticipated during Q4’24
Telix to Expand its US Operations Through the Acquisition of RLS Radiopharmacies
Date: Sep 23, 2024
Product: N/A
Shots:
- Telix has agreed to acquire RLS from RLS Group Ltd. to expand its North American manufacturing footprint and set up a next-gen. radiometal production network
- Telix will acquire RLS for $230M upfront in cash plus up to $20M in deferred cash based on performance milestones during the four-quarters. The acquisition is anticipated to conclude during Q1’25
- The acquisition will expand Telix’ US footprint through RLS’ 31 licensed radiopharmacies that will be used to set up a radiometal production & distribution network. The network will support key therapeutic & diagnostic isotopes plus will utilize Telix’s ARTMS QUANTM Irradiation System (QIS) cyclotron technology for efficient radiometal production
Trinity Biotech Reports the Acquisition of Metabolomics Diagnostics for $1.3M
Date: Sep 23, 2024
Product: N/A
Shots:
- Trinity has acquired Metabolomics Diagnostics for an enterprise value of ~$1.3M. The deal includes over 270,000 Trinity Biotech ADS shares, cash & the assumption of liabilities
- The acquisition adds PrePsia test, intended to predict the risk of preeclampsia as early as the 12th week of pregnancy for effective treatment, to Trinity’s portfolio. Its commercialization in the US is anticipated during 2025 through Immco reference laboratory, with in-house manufacturing of its test-reagents
- The test employs mass spectrometry to detect metabolites in blood samples that is combined using ML algorithm with patient-specific clinical data for a preeclampsia risk score. Trinity aims to use this technology to develop additional diagnostic tests in maternal health
Genentech Reports the Acquisition of Regor's CDK Inhibitors Portfolio Targeting Breast Cancer
Date: Sep 30, 2024
Product: N/A
Shots:
- Regor Pharmaceuticals and Genentech have signed a definitive purchase agreement under which the former will acquire a portfolio of next-generation CDK inhibitors targeting breast cancer
- As per the agreement, Genentech will pay $850M upfront in cash and additional milestones on attaining predetermined development, regulatory and commercial success. The transaction is anticipated to close during Q4’24, pending customary closing conditions
- Genentech will handle global clinical development, manufacturing & commercialization, while Regor will complete the two ongoing P-I studies and continue advancing its other assets focused on oncology, metabolic diseases & autoimmunity
Tags
Eli Lilly
AstraZeneca
Roche
Sanofi
GE HealthCare
Ono Pharmaceutical
Dechra Pharmaceuticals
Sun Pharma
Mankind Pharma
Boehringer Ingelheim
Celltrion
Stryker
Carlyle
Atsena Therapeutics
Johnson and Johnson
Siemens Healthineers
Merck
KalVista
Valneva
Travere Therapeutics
Daiichi Sankyo
Organon
Telix
Trinity Biotech
Genentech
Bharat is a data whiz who collate and analyzes the data to generate valuable insights, contributing to both our monthly reports and the extraction of key information from press releases. Through his work, Bharat plays a crucial role in ensuring Pharmashots delivers the most relevant and up-to-date information to our readers.
