Pharmaceutical Market Europe • June 2024 • 6-7
NEWS
Takeda and AC Immune in $2.1bn deal for Alzheimer’s drug
Takeda and AC Immune have entered into a worldwide option and licence agreement worth over $2.1bn for an investigational Alzheimer’s disease (AD) drug.
AD is the most common form of dementia, which currently affects about 982,000 people in the UK.
The deal gives Takeda an exclusive option to license global rights to AC’s ACI-24.060, an active immunotherapy designed to generate a robust antibody response against the toxic forms of amyloid beta believed to drive plaque formation and AD progression.
The candidate is being evaluated in the phase 1b/2 ABATE trial of patients with prodromal AD, a potentially progressive stage of the disease characterised by signs of mild cognitive decline, and in adults with Down’s syndrome.
AC will be responsible for completing the study and, following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities and worldwide commercialisation.
In exchange, AC Immune will receive an upfront payment of $100m and will be eligible to receive an option exercise fee and additional milestone payments of up to approximately $2.1bn plus tiered royalties on worldwide net sales.
Sanofi and Novavax agree $1.2bn COVID-19 vaccine licensing deal
Sanofi and Novavax have announced a licensing agreement worth over $1.2bn to co-commercialise Novavax’s COVID-19 vaccine and develop combination vaccines for COVID-19 and influenza.
The deal gives Sanofi a co-exclusive licence to co-commercialise Novavax’s current standalone adjuvanted COVID-19 vaccine globally, except in countries that Novavax has existing partnership agreements with, including Japan, India and South Korea, as well as those with advance purchase agreements.
Sanofi will also receive a sole licence to Novavax’s adjuvanted COVID-19 vaccine for use in combination with its own flu vaccines, along with a non-exclusive licence to use the company’s Matrix-M adjuvant in vaccine products, and a less than 5% stake in Novavax.
In exchange, Novavax will receive an upfront payment of $500m and up to $700m in development, regulatory and launch milestones, as well as tiered royalties on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines.
Novavax will also be entitled to additional launch and sales milestone opportunities of up to $200m plus royalties for each additional Sanofi vaccine product developed under a non-exclusive licence with its Matrix-M adjuvant technology.
Biogen acquires HI-Bio in $1.8bn deal for immunology and rare diseases
Biogen has announced that it has entered into a definitive agreement to acquire Human Immunology Biosciences (HI-Bio) in a deal worth more than $1.8bn.
Anticipated to close in the third quarter of 2024, the acquisition will expand Biogen’s immunology portfolio while also addressing the serious unmet needs of three renal diseases.
Under the terms of the agreement, HI-Bio will receive an upfront payment of £1.15bn and will be eligible for additional payments of up to $650m contingent on certain development milestones.
As part of the deal, Biogen will gain access to HI-Bio’s lead asset, felzartamab, an investigational fully human anti-CD38 monoclonal antibody that has been shown to selectively deplete CD38+ cells in a broad range of immune-mediated diseases, as well as its izastobart/HIB210, an anti-C5aR1 antibody in development to treat a range of complement-mediated diseases.
Felzartamab has already received Breakthrough Therapy Designation and Orphan Drug Designation (ODD) from the US Food and Drug Administration to treat primary membranous nephropathy and has received ODD to treat antibody-mediated rejection in kidney transplant recipients.
Phase 2 studies have been completed in both indications and remain ongoing in IgA nephropathy.
Pfizer shares positive
five-year results for Lorbrena in advanced lung cancer
Pfizer has shared positive longer-term follow-up results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Lorbrena (lorlatinib) in advanced non-small cell lung cancer (NSCLC).
The phase 3 CROWN trial has been comparing the drug to Pfizer’s tyrosine kinase inhibitor Xalkori (crizotinib) in patients with previously untreated ALK-positive disease.
Results, presented at this year’s American Society of Clinical Oncology Annual Meeting, showed that 60% of patients treated with Lorbrena were alive without disease progression after five years compared to 8% of those in the Xalkori cohort.
The updated results also demonstrated an 81% reduction in the rate of disease progression or death and a 94% reduction in the risk of developing intracranial progression in the Lorbrena treatment arm compared to the Xalkori group.
ALK-positive tumours occur in up to 5% of NSCLC cases, translating to approximately 72,000 people who are diagnosed worldwide every year.
Lorlatinib, which already holds approvals to treat certain adults with ALK-positive NSCLC, is designed to inhibit tumour mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.
Sobi’s Aspaveli receives expanded EC approval for rare blood disorder
Sobi’s C3 therapy Aspaveli (pegcetacoplan) has been approved by the European Commission (EC) as a first-line treatment for paroxysmal nocturnal haemoglobinuria (PNH) in adults with haemolytic anaemia.
PNH is a rare and severe blood disorder characterised by persistently low haemoglobin. The condition can result in frequent transfusions and symptoms such as severe fatigue caused by anaemia.
Aspaveli, which is designed to regulate excessive activation of the complement cascade, is already approved in Europe to treat adults with PNH who are anaemic following treatment with a C5 inhibitor for at least three months.
The EC’s latest authorisation is supported by data from the APL2-308 study, which enrolled PNH patients who had not been treated with any complement inhibitor within three months prior to enrolment and with haemoglobin levels less than the lower limit of normal, and lactate dehydrogenase levels of at least 1.5 times the upper limit of normal.
Sobi has exclusive commercialisation rights for systemic pegcetacoplan outside the US, where Apellis Pharmaceuticals has exclusive rights. Apellis also holds global commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.
Amgen’s Imdelltra given FDA accelerated approval for small cell lung cancer
Amgen’s Imdelltra (tarlatamab-dlle) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat extensive-stage small cell lung cancer (SCLC).
The immunotherapy has been specifically authorised for use in adults with disease progression on or after platinum-based chemotherapy.
More than 234,000 new cases of lung cancer are expected to be diagnosed in the US this year, with SCLC accounting for approximately 15% of all diagnoses.
The DLL3 protein is expressed on the surface of SCLC cells in the majority of patients and is minimally expressed on healthy cells, which Amgen says makes it an “exciting target”.
Imdelltra is the first and only DLL3-targeting bispecific T-cell engager therapy that activates the patients’ own T cells to attack DLL3-expressing tumour cells.
The FDA’s decision was supported by positive results from the mid-stage DeLLphi-301, which evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment.
A 10mg dose of Imdelltra every two weeks demonstrated an objective response rate of 40%, a median duration of response of 9.7 months, and a median overall survival of 14.3 months.
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