PharmaShots' Key Highlights of Fourth Quarter 2023
Shots:
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The Fourth quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, BMS acquired Mirati Therapeutics for ~$5.8B and AbbVie acquired ImmunoGen for $10.1B
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The Fourth quarter of the year also showcases multiple clinical trial results from Regeneron’s Two-Year (PULSAR) Trial of Eylea HD (aflibercept) for Wet Age-Related Macular Degeneration and Pfizer & BioNTech’s P-I/II Study of mRNA-Based Combination Vaccine Program Against Influenza and COVID-19
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Our team at PharmaShots has summarized and compiled the insights of Q4'2023
Date - October 03, 2023
Product - Rivfloza
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The US FDA has approved Rivfloza (80/128/160mg, qm) in children aged ≥9yrs. & adults with PH1 and relatively preserved kidney function. The approval was based on the P-II trial (PHYOX 2) trial evaluating Rivfloza vs PBO in 35 patients with PH1 or PH2 and an eGFR ≥30 mL/min/1.73 m2 along with interim data from P-III extension study (PHYOX 3)
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The (PHYOX 2) trial met its 1EPs & showed a reduction from baseline in 24hr.-urinary oxalate (Uox) excretion from Day 90-180, LS mean difference of AUC24-hour Uox was 4976 significant b/w both groups over 90 days
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In the (PHYOX 3) extension study, reductions in 24hr. Uox excretion was maintained in 13 patients who had received an additional 6mos. of treatment. Rivfloza is an RNAi therapy designed to lower urinary oxalate levels & is expected to be available in early 2024
Date - October 06, 2023
Product - Eylea HD
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The first presentation of positive 2yr. (96wks.) results from the (PULSAR) trial evaluating Eylea HD (8mg) with 12 & 16wk. dosing regimens vs 8wk. dosing regimen for Eylea. The results were presented with the 60wk. results at the 23rd EURETINA Congress
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The trial met its 1EPs i.e., patients achieved clinically equivalent vision gains to Eylea at 48wks. & demonstrated sustained visual and anatomic improvements through 2yrs., 88% & 78% were on a ≥12 & ≥16wk. dosing interval at the end of 2yrs. with 71% meeting the extension criteria for ≥16wk. dosing intervals & 53% eligible for ≥20 dosing week intervals
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The safety was consistent with the known safety profile of Eylea, rate of intraocular inflammation (1.3% vs 2.1)
BMS to Acquire Mirati Therapeutics for ~$5.8B
Date - October 09, 2023
Product - MRTX1719
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BMS to acquire all of the outstanding shares of Mirati common stock for $58.00 per share in cash representing a 52% premium to the 30-day VWAP making a total equity value of $4.8B. The transaction is expected to close in H1’24
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Mirati stockholders will also receive 1 non-tradeable CVR for each Mirati share in $12.00 per share in cash representing an additional $1.0B of the total value if MRTX1719 is successfully submitted to the US FDA for approval within 7 years of deal closure. The acquisition is part of BMS’s strategy to expand its portfolio & innovative pipeline in the oncology field
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BMS will incl. Krazati in its commercial portfolio & will gain rights to other assets at the clinical stage. Mirati’s promising pipeline incl. MRTX1719 & a KRAS and KRAS-enabling program incl. MRTX1133 & MRTX0902
Date - October 10, 2023
Product – Liraglutide
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Biocon & Juno Pharmaceuticals collaborated to commercialize a vertically integrated, complex formulation, Liraglutide for the treatment and management of Type 2 diabetes and obesity
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Biocon will be responsible for obtaining regulatory approval for Liraglutide along with manufacturing and supply of the product in the Canadian market
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The Juno’s goal is to provide the patient access to a cost-effective and efficacious treatment & improving healthcare affordability and innovation for all Canadians through this collaboration. Biocon also has a pipeline of promising novel assets in immunotherapy
Date - October 13, 2023
Product - BRAF V600E
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The US FDA has approved Braftovi + Mektovi for metastatic NSCLC with a BRAF V600E mutation. The approval was based on the P-II trial (PHAROS) of Braftovi + Mektovi in treatment-naïve & prior treated patients with BRAF V600E-mutant metastatic NSCLC
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The study met its major efficacy outcome measures of ORR & DoR. For treatment-naïve & previously treated patients, ORR (75% & 46%), and patients responded for 12mos. (59% & 33%), m-DoR was not estimable & 16.7mos. The results were presented at ASCO 2023 & published in the JCO
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Patients experienced an adverse reaction resulting in permanent discontinuation of Mektovi & Braftovi (17% & 16%) & serious adverse reactions (38%). Braftovi + Mektovi was approved in the US for unresectable or metastatic melanoma with a BRAF V600E or V600K mutatio
Novo Nordisk to Acquire Ocedurenone from KBP Biosciences for ~$1.3B
Date - October 17, 2023
Product – Ocedurenone
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Novo Nordisk will acquire ocedurenone (non-steroidal mineralocorticoid receptor antagonist) for ~$1.3B to treat uncontrolled hypertension with potential application in cardiovascular & kidney disease. The transaction is expected to close before the end of 2023
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The acquisition expands Novo Nordisk's drug portfolio in chronic disease. Ocedurenone is being studied in the P-III trial (CLARION-CKD) for uncontrolled hypertension & advanced CKD
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The P-III trials of ocedurenone are expected to initiate additional cardiovascular and kidney disease indications in the coming years. The (BLOCK-CKD) trial showed an improvement in systolic blood pressure from baseline to day 84 for stage 3b/4 CKD & uncontrolled hypertension with no reports of sev. hyperkalemia or acute kidney injury
Date - October 20, 2023
Product - DXd ADCs
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Daiichi Sankyo will receive $4B up front ($1.5B for ifinatamab deruxtecan due upon execution; $1.5B for patritumab deruxtecan (HER3-DXd) where $750M is due upon execution and $750M is due after 12mos.; $1B {$500M each for patritumab deruxtecan & ifinatamab deruxtecan (I-DXd)} in addition to $1.5B in continuation payments over the next 24mos. for raludotatug deruxtecan (R-DXd).
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Daiichi Sankyo is eligible for ~$16.5B incl. $5.5B for each product upon achievement of sales milestones, a total potential consideration of ~$22B. Both companies will develop & commercialize 3 DXd ADC candidates: HER3-DXd, I-DXd & R-DXd globally ex. Japan
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Daiichi Sankyo will maintain exclusive rights & will lead the manufacturing & supply. All 3 DXd ADCs are in various stages of clinical development for multiple solid tumors as monotx. & incombination with other treatments
Date - October 23, 2023
Product - NT-proBNP
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With AstraZeneca & Everton, LumiraDx intends to initiate a community-based heart & lung screening Hub across Merseyside, England for the early detection of heart failure, COPD, asthma & other chronic conditions. Liverpool University Hospitals NHS Foundation Trust, Lenus Health, Us2.ai, ArtiQ & Pumping Marvellous are also associated with this initiative
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LumiraDx’s NT-proBNP test leverages AI & eliminates the requirement of phlebotomy. The NT-proBNP test uses a fingerstick sample of blood to detect chronic conditions
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The initiative will also offer lifestyle reviews & advice to those in need. LumiraDx expects to launch the heart & lung screening Hub in November 2023
Date - October 23, 2023
Product - Zymfentra
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The approval was based on the P-III clinical trials (LIBERTY-UC) & (LIBERTY-CD) evaluating the safety & efficacy of Zymfentra vs PBO as maintenance therapy in patients (n=438 & 343) with UC & CD following treatment with an infliximab
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The results from both studies depicted a greater clinical remission at 54wks. with Zymfentra (43.2% & 62.3%) vs PBO (20.8% & 32.1%) whereas the endoscopic response rate evaluated in the (LIBERTY-CD) trial was also seen to be greater in Zymfentra (51.1%) vs PBO (17.9%). The safety for both studies was similar to PBO during the maintenance period
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Zymfentra is a subcutaneous version of Celltrion’s infliximab biosimilar which blocks the action of TNF-alpha
Amgen Presents P-III Data for Lumakras and Vectibix in Metastatic Colorectal Cancer at ESMO 2023
Date - October 23, 2023
Product - Lumakras + Vectibix
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The P-III (CodeBreak 300) clinical trial evaluates Lumakras (960 & 240mg) + Vectibix in patients with chemorefractory KRAS G12C-mCRC. The 1EP of the study includes PFS & 2EPs incl. ORR & DCR
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The results depicted a statistically significant PFS of 5.6mos. & 3.9mos. following a median follow-up of 7.8mos. whereas among the 2EPs higher ORR (26% & 6% vs 0%) & DCR (72% & 68% vs 46%) were observed in patients treated with the combination therapy vs investigator's choice of care
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Amgen’s sNDA for Lumakras’ full approval was accepted by the US FDA & has set a PDUFA date of December 24, 2023. Lumakras previously received accelerated approval from the US FDA in May 2021 for the treatment of NSCLC
Date - October 26, 2023
Product - MaaT013
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The Independent DSMB has recommended the continuation of P-III (ARES) development for MaaT013, targeting acute GvHD patients (n=75, Grade II-IV), refractory to steroids and resistant to ruxolitinib
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This positive outcome is based on interim data from 30 patients on Day 28, demonstrating improved efficacy and no safety concerns. The study maintains a positive benefit-risk ratio and boasts a superior Overall Response Rate
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MaaT013, a donor-derived microbiome ecosystem therapy (MET technology) features Butycore, a bacterial species producing anti-inflammatory short-chain fatty acids and has obtained ODD from both the US FDA and EMA
Mithra Signs a License and Supply Agreement with Searchlight for Donesta in Canada
Date - October 27, 2023
Product - Donesta
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Mithra will receive a ~$1.58M milestone & is expected to receive an additional ~$16.42M in regulatory & sales milestones along with tiered royalties on annual net sales
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Searchlight is responsible for receiving & maintaining the regulatory approvals to market and distribute Donesta in the country. Both companies focus on providing innovative solutions to women by partnering on Myring, Estelle & Donesta
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Donesta is the next-generation medicine that contains Estetrol to treat menopause symptoms. Mithra highlighted the promising topline safety results from the P-III trial of Donesta in North America where results will support marketing authorization filings in the US in H2’23 and in Canada in 2024
Date - October 27, 2023
Product - MB-109
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The US FDA has accepted the IND application to initiate a P-I trial evaluating the safety, tolerability & efficacy of MB-109, a novel combination of MB-101 and MB-108 at the City of Hope & the University of Alabama at Birmingham in adult patients with recurrent GBM and high-grade astrocytomas
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The study is expected to begin enrolling patients in 2024. The preclinical data supported the combination therapy to optimize results to treat recurrent GBM, presented at AACR 2022 and ongoing P-I trial have shown both to be well tolerated separately
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MB-109 {MB-101 (IL-13Rα2 targeted CAR-T cells) + MB-108 oncolytic virus} is designed to leverage MB-108 to make cold tumors “hot” and improve the efficacy of MB-101 CAR-T cell therapy
Date - October 27, 2023
Product - mRNA-based combination vaccine
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The P-I/II study evaluating the safety, tolerability & immunogenicity of mRNA-based combination vaccine candidates in healthy adults aged 18-64yrs. with influenza & COVID-19
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The results showed robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains while the mRNA-based vaccines showed their ability to induce robust Ab & T-cell responses. The safety profile was consistent with the COVID-19 vaccine, immunogenicity results showed point estimates for Geometric Mean Titer ratios
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The results will be published in a peer-reviewed journal & the P-III trial is expected to be initiated in the coming months. mRNA-based combination vaccine candidate received FTD from the US FDA for influenza & COVID-19
Date – November 01, 2023
Product – Jylamvo
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Shorla Oncology entered into an agreement with Therakind under which Shorla has acquired Jylamvo (oral methotrexate solution) for the US market, a US FDA-approved (Nov 2022) therapy for the treatment of various indications incl. lymphoblastic leukemia, mycosis fungoides, r/r non-Hodgkin lymphoma, rheumatoid arthritis & severe psoriasis
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The acquisition was made by Shorla after raising $35M in Series B funding in order to accelerate the growth of its oncology portfolio by commercializing therapies that have faced shortages in the market
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Jylamvo, a folate analog metabolic inhibitor indicated for the treatment of various indications, has faced a shortage in the US market in other dosage forms
Date – November 03, 2023
Product – SPN-830
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The US FDA has accepted to review the resubmitted NDA of SPN-830, apomorphine infusion device, for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD) with the decision expected in Apr 2024
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The NDA was resubmitted following the initial refusal to file (RTF) due to inadequate data, which had occurred after the original NDA submission in Sep 2020
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The original NDA was based on data from the P-III (TOLEDO) trial that demonstrated a significant reduction in OFF time, with an improvement of 1.89hrs. per day vs PBO. These improvements were observed within 1wk. of initiating the therapy
Merck to Acquire Caraway Therapeutics for ~$610M
Date – November 22, 2023
Product – N/A
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Merck has signed a definitive agreement to acquire Caraway Therapeutics, through subsidiary, for ~$610M, which includes an undisclosed upfront payment & contingent milestone payments. Merck will expense upfront payment in Q4’23 included in non-GAAP results
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As per the deal, Merck will purchase all of Caraway's outstanding shares with earnout milestones linked to the progress of some pipeline candidates
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This acquisition utilizes Merck’s research & development capabilities to accelerate discovery & preclinical programs
Boehringer Ingelheim Acquires T3 Pharma for $508.2M
Date – November 23, 2023
Product – N/A
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The company announces the acquisition of T3 Pharma to expand its immuno-oncology Pipeline for the amount of $508.2M
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The purchase of T3 Pharma is complementary to several ongoing R&D initiatives & will greatly broaden the pipeline portfolio for immuno-oncology. This will get the company one step closer to realizing its goal of bringing about a paradigm change in the way that cancer is treated
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T3 Pharma has a novel platform that delivers bioactive proteins directly and selectively into the tumor microenvironment while protecting healthy tissues. This is achieved by employing genetically modified Yersinia enterocolitica bacteria
Innovent Reports NMPA Approval to the NDA for IBI351 & Grants Priority Review Designation
Date – November 23, 2023
Product – IBI351
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The NDA approval and Priority Review Designation were based on the P-II study (NCT05005234) evaluating the safety & efficacy of IBI351 monotx. on NSCLC patients (n=264) with KRAS G12C mutation & was intolerant to standard treatment
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Previously, the P-I study data depicted an ORR of 61.2% & DCR of 92.5%, additionally, mDOR was not met yet, the 6-month DoR rate was 75.4% & patients treated with 600mg BID showed better efficacy with ORR of 66.7% & DCR of 96.7%. The median PFS was 8.2mos. & 6 & 9 mos. PFS rate was 58.9% & 47.3%
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IBI351, a KRAS G12C inhibitor, works by covalently and permanently altering the cysteine residue of the KRAS G12C protein
AbbVie to Acquire ImmunoGen for $10.1B
Date – December 01, 2023
Product – Elahere
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AbbVie announces the acquisition of ImmunoGen, including its Elahere antibody-drug conjugate (ADC) for platinum-resistant ovarian cancer in a $10.1B deal
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As per the deal, AbbVie will purchase all outstanding shares of ImmunoGen at a rate of $31.26 per share. Additionally, the agreement provides AbbVie access to Elahere (mirvetuximab soravtansine-gynx), which received FDA accelerated approval last year
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The deal, expected to close in mid-2024, & ImmunoGen's subsequent pipeline of ADCs will be made available to AbbVie
Date – December 04, 2023
Product – LYTACs
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Nona Biosciences & Lycia Therapeutics have entered into a collaboration to advance the extracellular protein degradation technology platform
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Under the collaboration, Nona will utilize Lycia's lysosomal targeting chimeras (LYTACs) platform to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins that drive a range of difficult-to-treat diseases
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Furthermore, Lycia will utilize Nona's exclusive Harbour Mice HCAb fully human antibody transgenic mice platform to explore new antibodies for its LYTAC protein degrader therapeutics
Roche to Acquire Carmot Therapeutics for ~$3.1B
Date – December 04, 2023
Product – CT-388 & CT-996
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Roche announces the acquisition of Carmot Therapeutics providing access to Carmot's portfolio, incl. CT-388 & CT-996, offering treatments for obesity in patients with & without diabetes
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Under the agreement Carmot is qualified to receive an up front of $2.7B in cash & with potential milestone payments of up to $400M. Moreover, Roche gains access to Carmot's R&D assets, incl. clinical and pre-clinical portfolios. The transaction is expected to close in Q1’24
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Upon finalizing the agreement, Roche will secure exclusive rights to Carmot's innovative Chemotype Evolution discovery platform, strengthening Roche's R&D capabilities & expanding its portfolio in cardiovascular and metabolic diseases
Date – December 05, 2023
Product – N/A
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GE Healthcare and AirStrip's collaboration integrates innovative ECG, cardiac output, and patient monitoring products with advanced data visualization on mobile devices and the web. Clinicians benefit from various functionalities, incl. cardiac rhythm strips, 12-lead ECGs, STEMI notifications
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The agreement puts remote collaboration to forefront, enabling clinicians to efficiently view patient data and prioritize multiple patients on a single screen. With a focus on streamlining in-patient care solutions, this partnership aims to enhance clinical staff productivity, collaboration, and communication
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AirStrip Cardiology and Patient Monitoring solutions will be exclusively distributed in the US by GE Healthcare providing healthcare systems with the opportunity to acquire data visualization technology collectively
AbbVie to Acquire Cerevel Therapeutics for ~$8.7B
Date – December 07, 2023
Product – Tavapadon
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Both AbbVie and Cerevel Therapeutics have signed a definitive agreement as per which AbbVie will acquire Cerevel for its neuroscience pipeline containing multiple clinical-stage & preclinical candidates as a potential treatment for various indications incl. Schizophrenia, Parkinson's Disease & Mood Disorders
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As per the terms of the agreement, AbbVie will acquire all outstanding shares of Cerevel for $45/share in cash, aggregating to an equity value of ~$8.7B. The transaction is expected to close by mid-2024
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Cerevel's lead assets include Emraclidine, currently undergoing P-II trial for the treatment of schizophrenia, and Tavapadon, currently under P-III evaluation for Parkinson's Disease management
Date – December 13, 2023
Product – Zynlonta
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The P-II study evaluating Zynlonta (loncastuximab-tesirine-lpyl) + rituximab in patients (aged 47 to 89yrs) with r/r FL who are treated with ≥1 line of systemic therapy & meet GELF criteria or POD24 at baseline
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The 1EP of the study includes a complete response (CR) by week 12 on PET/CT. The result of the study depicted an ORR of 96.3% & CR rate of 85.2% along with a PFS of 92.3% with a median follow-up of 12mos. Additionally, the median PFAS was not met
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Zynlonta functions as ADC that targets CD19. When it binds to a cell expressing CD19, the cell internalizes it, & enzymes subsequently release a drug payload containing pyrrolobenzodiazepines (PBD)
AstraZeneca to Aquire Icosavax for ~$1.1B
Date – December 13, 2023
Product – IVX-A12
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As per the deal, AstraZeneca will pay $800M as an up front payment at $15.00 per share in cash at a 43% one-day premium to buy all outstanding shares of Icosavax
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Additionally, Icosavax is eligible to receive a non-tradable CVR at $5.00 per share as regulatory and commercial milestones for a total of $300M. AstraZeneca will also acquire Icosavax's cash & marketable securities totaling $229M
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The acquisition will strengthen AstraZeneca's expertise in addressing RSV by adding Icosavax's lead vaccine candidate, IVX-A12 to the late-stage pipeline. IVX-A12 is a P-III ready vaccine that uniquely targets both RSV & hMPV
Zenex to Acquire Ayurvet to Enhance its Animal Health Business
Date – December 15, 2023
Product – N/A
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Zenex has signed an agreement to acquire Ayurvet, a subsidiary of Dabur India for an undisclosed amount to strengthen its animal health portfolio & to meet customer requirements locally & across the globe
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With the acquisition, Zenex gets hold of Ayurvet’s broad spectrum of animal health products, research capabilities, sales and management team along with an access to Ayurvet’s global presence
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Earlier, In Jul 2021, Zenex and Zydus signed a Business Transfer Agreement wherein Zenex would purchase Zydus' animal healthcare business. Zydus proposed a wish to sell its animal health business to companies in India and other countries for an aggregate of ~$369.98M
BMS Acquires Karuna Therapeutics for ~$14B
Date – December 25, 2023
Product – KarXT
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BMS signed a definitive merger agreement to acquire Karuna to strengthen its neuroscience portfolio by gaining the rights over Karuna’s lead neuroscience assets incl. KarXT, an antipsychotic
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As per the terms of the agreement, BMS will acquire all the outstanding shares of Karuna common stock for $330/share in cash for a total equity value of ~$14B or $12.7B net of estimated cash acquired. The transaction is expected to close by H1’24
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The US FDA has accepted Karuna's NDA filing for KarXT to treat schizophrenia (PDUFA date Sep 26, 2024). Moreover, KarXT is also being assessed in a registrational trial for adjunctive therapy to existing SoC agents in schizophrenia & to treat psychosis in patients with Alzheimer’s disease
AstraZeneca to Acquire Gracell Biotechnologies for ~$1.2B
Date – December 27, 2023
Product – GC-012F, GC-502, GC-509 and GC-506
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AstraZeneca has signed a definitive agreement to acquire Gracell Biotechnologies with an expectation to enhance its cell therapy pipeline with the acquisition of Gracell’s lead assets
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As per the agreement, Gracell’s stakeholders will receive $2/share in cash at a 62% one-day premium adding to a total up front of ~$1B & are also eligible to receive up to $200M at $0.3/share CVRs upon achieving regulatory milestones. The transaction is expected to close by Q1’24
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Gracell’s lead assets acquired by AstraZeneca include GC-012F (MM & Non-Hodgkin's lymphoma), GC-502 (B-cell lymphoblastic leukemia), GC-509 (acute myeloid leukemia), GC-508 (MM), GC-506 (solid tumors) & other technology platforms incl. FasTCART & TruUCART
BMS to Acquire RayzeBio for ~$4.1B
Date – December 27, 2023
Product – RYZ101
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BMS expects to acquire RayzeBio to enhance its oncology portfolio with the addition of RayzeBio’s actinium-based radiopharmaceutical platform to develop therapies for the treatment of solid tumors incl. GEP-NETs, SCLC & hepatocellular carcinoma
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As per the agreement, BMS will acquire all outstanding shares of RayzeBio common stock at $62.50/share in an all-cash transaction worth an equity value of ~$4.1B. Moreover, BMS will acquire all remaining shares of RayzeBio through a second-step merger after the tender offer's successful closure for the same price
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The transaction is expected to close by H1'24. RayzeBio’s portfolio includes RYZ101 (225Ac-DOTATATE), targeting SSTR2 & RYZ801, a peptide targeting glypican-3
Related Post: PharmaShots' Key Highlights of Third Quarter 2023
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
