Pharmaceutical Market Europe • January 2025 • 6-7
NEWS
Novartis and PTC agree on $2.9bn Huntington’s programme
Novartis will be gaining exclusive global rights to PTC Therapeutics’ mid-stage Huntington’s disease (HD) programme in a deal worth up to $2.9bn.
The candidate, PTC518, was discovered from PTC’s splicing platform and is currently being evaluated in the phase 2 PIVOT-HD trial.
Approximately one in every 10,000 to 20,000 people in the US is affected by HD, a fatal genetic disorder of the central nervous system caused by a defective gene that produces a mutated protein called HTT.
There is no cure for HD and, while there are therapies approved for specific disease symptoms, there is none that delays the onset or slow disease progression.
Under the global licence and collaboration agreement, Novartis will assume responsibility for PTC518’s development, manufacturing and commercialisation, following the completion of the ongoing placebo-controlled portion of the study, expected to occur in the first half of 2025.
In exchange, PTC will receive an upfront payment of $1bn and will be eligible for up to $1.9bn in development, regulatory and sales milestones, a 40% share of profits and losses in the US, as well as royalties on sales outside the US.
GSK and DualityBio agree
on ADC deal worth over $1bn
GSK and Duality Biologics have entered into an exclusive option agreement worth over $1bn for DualityBio’s preclinical antibody-drug conjugate (ADC).
The deal gives GSK an exclusive option to obtain a licence to develop and commercialise DB-1324 globally, except in mainland China, Hong Kong and Macau.
The candidate leverages DualityBio’s Duality Immune Toxin Antibody Conjugate (DITAC) platform against a gastrointestinal cancer target.
Gastrointestinal cancers account for one in four cancer cases and one in three cancer-related deaths globally.
ADCs are a relatively new class of cancer treatment that combine the selectivity of antibodies with the cell-killing properties of chemotherapy or other anti-cancer agents.
DB-1324 has the potential to “unlock multiple combination therapy opportunities to strategically complement” GSK’s oncology portfolio, according to DualityBio.
Under the terms of the agreement, DualityBio will initially receive $30m upfront and additional pre-option milestone payments and, if GSK exercises its option, the biotech will be in line for an option exercise fee as well as potential development, regulatory and commercial milestone payments totalling up to $975m, plus tiered royalties on net sales in GSK’s territories.
Merck and Hansoh in GLP-1 partnership
worth $2bn
Merck & Co – known as MSD outside the US and Canada – will be gaining exclusive global rights to Hansoh Pharma’s preclinical GLP-1 candidate in a deal worth over $2bn.
The agreement gives Merck a global licence to develop, manufacture and commercialise the investigational oral small molecule GLP-1 receptor agonist, HS-10535.
The company will aim to evaluate the drug and its “potential to provide additional cardiometabolic benefits beyond weight reduction,” according to Dean Li, president of Merck Research Laboratories.
In exchange, Hansoh will receive an upfront payment of $112m and will be eligible for up to $1.9bn in milestone payments, as well as royalties on sales. Hansoh may also co-promote or solely commercialise HS-10535 in China, subject to certain conditions.
GLP-1 receptor agonists are a relatively new class of drugs that can be used to treat type 2 diabetes, promote weight loss and reduce the risk of cardiovascular events. They work by mimicking the hormone GLP-1, which is produced in the small intestine.
Merck’s pipeline already includes efinopegdutide, an investigational GLP-1/glucagon receptor co-agonist that has demonstrated promising results in non-alcoholic fatty liver disease.
Pfizer’s Braftovi regimen receives FDA accelerated approval
Pfizer’s Braftovi (encorafenib) regimen has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat metastatic colorectal cancer (mCRC).
The drug has been authorised for use in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat mCRC in patients with a
BRAF V600E mutation.
Until now, there were no approved biomarker-driven therapies specifically indicated for patients with previously untreated BRAF V600E-mutant mCRC.
Braftovi is an oral small molecule kinase inhibitor designed to target BRAF V600E. Pfizer has exclusive rights to the drug in the US, Canada, Latin America, the Middle East and Africa, while licences are also held by Ono Pharmaceutical, Medison and Pierre Fabre.
The FDA’s decision was supported by phase 3 results from the ongoing BREAKWATER, which demonstrated an overall response rate of 61% for Braftovi in combination with Erbitux and mFOLFOX6 versus 40% for chemotherapy, with or without bevacizumab.
The median duration of response was 13.9 months for the Braftovi regimen versus 11.1 months for chemotherapy, and the safety profile of the combination was consistent with the known safety profile of each respective agent.
AstraZeneca’s Tagrisso granted EC approval in lung cancer
AstraZeneca’s Tagrisso (osimertinib) has been approved by the European Commission (EC) to treat a new subset of lung cancer patients.
The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) has been authorised to treat locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express EGFR exon 19 deletions or exon 21 substitution mutations.
Eligible patients will also have not experienced disease progression during or following concurrent or sequential platinum-based chemoradiation therapy.
More than 450,000 people are diagnosed with lung cancer each year in Europe, with NSCLC accounting for up to 85% of all cases.
As many as 15% of NSCLC patients in Europe have EGFR mutations and, as a result, are particularly sensitive to treatment with an EGFR-TKI.
The EC’s latest decision on Tagrisso follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the late-stage LAURA trial.
Tagrisso was shown to reduce the risk of disease progression or death by 84% compared to placebo, and median progression-free survival was 39.1 months in Tagrisso-treated patients versus 5.6 months for those receiving placebo.
Amgen’s Blincyto approved by MHRA for acute lymphoblastic leukaemia
Amgen’s Blincyto (blinatumomab) has been granted a licence extension by the Medicines and Healthcare products Regulatory Agency (MHRA) in acute lymphoblastic leukaemia (ALL).
The immunotherapy has been authorised for use in adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.
Approximately 300 new adult cases of ALL, a type of blood cancer, are diagnosed in the UK every year, with B-cell ALL accounting for approximately 75% of cases.
Already approved in the UK to treat certain cases of B-ALL, Blincyto is a bispecific T-cell engager molecule designed to target CD19 surface antigens on B cells.
The MHRA’s latest decision on Blincyto was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group.
With a median follow-up of 4.5 years, the five-year overall survival was 82.4% in the Blincyto plus chemotherapy cohort versus 62.5% in the chemotherapy group, while the five-year relapse-free survival was 77% in the Blincyto/chemotherapy arm versus 60.5% for chemotherapy alone.
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