Pharmaceutical Market Europe • May 2023 • 6-7

NEWS

Merck to acquire Prometheus Biosciences for almost $11bn

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Merck – known as MSD outside the US and Canada – has said it will acquire Prometheus Biosciences for around $10.8bn, marking a significant boost to its immunology pipeline.

The deal will grant Merck access to the California-based biotech’s lead candidate, PRA023, being developed for ulcerative colitis, Crohn’s disease and other autoimmune conditions.

Prometheus announced positive results from a phase 2 study of the candidate in ulcerative colitis late last year, with 26.5% of patients in the PRA023 cohort achieving clinical remission, compared to 1.5% on placebo.

The company also reported positive results from a single-arm study evaluating the antibody in Crohn’s disease at the same time.

Commenting on the deal, Robert Davis, chairman and chief executive officer of Merck, said: “The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need.”

“This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade,” he added.

Under the terms of the agreement, Merck will pay $200 per share. The transaction is expected to close in the third quarter of 2023.


GSK to acquire Bellus Health for around $2bn

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GSK has said it will acquire Bellus Health for approximately $2bn in a deal that is set to expand the British drugmaker’s specialty medicines and respiratory pipeline.

The acquisition will grant GSK access to the Canadian biotech’s experimental drug, camlipixant, currently in phase 3 development for refractory chronic cough (RCC).

Current clinical data shows that by selectively inhibiting P2X3 receptors, camlipixant may reduce cough frequency with a relatively low incidence of dysgeusia – the taste disturbance associated with other medicines that broadly target the P2X2/3 receptor.

Bellus initiated a pair of phase 3 trials evaluating camlipixant in recent months, with data from the studies expected in the second half of 2024 and 2025.

Under the terms of the agreement, GSK will pay $14.75 per share in cash. The transaction is expected to close in the third quarter of this year.

Camlipixant is up against a rival RCC candidate, gefapixant, from Merck – known as MSD outside the US and Canada. The drug, which is also a P2X3 receptor antagonist, was denied US approval at the beginning of 2022, with the US Food and Drug Administration requesting additional efficacy information. Merck is expected to submit the information later this year.


Novo Nordisk and Aspect partner in deal worth up to $2.6bn

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Novo Nordisk and Aspect Biosystems have announced a partnership to develop a new class of disease-modifying treatments for diabetes and obesity in a deal potentially worth up to $2.6bn.

The collaboration will utilise Aspect’s proprietary bioprinting technology, as well as Novo Nordisk’s capabilities in stem cell differentiation and cell therapy development and manufacturing to develop bioprinted tissue therapeutics designed to replace, repair or supplement biological functions in the body.

Under the terms of the agreement, Novo Nordisk will receive an exclusive, worldwide licence to use Aspect’s bioprinting technology to develop up to four products for the treatment of diabetes, obesity or both.

In exchange, Aspect will receive initial payments of $75m and will also be eligible for up to $650m in milestone payments per product, as well as tiered royalties on future product sales.

The partnership will initially focus on developing bioprinted tissue therapeutics designed to maintain normal blood glucose levels without the need for immunosuppression in patients with type 1 diabetes, the companies said.

The deal comes after Novo’s weight-loss drug was recommended by the European Medicines Agency’s human medicines committee for use in adolescents aged 12 years and older with obesity and a minimum weight of 60kg.


Astellas to acquire Iveric Bio for approximately $5.9bn

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Astellas Pharma is set to acquire Iveric Bio for approximately $5.9bn, marking a notable boost to its ophthalmology pipeline.

The acquisition will grant Astellas access to the US drugmaker’s lead asset, Zimura (avacincaptad pegol), which was recently filed for approval in the US to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

AMD is a major cause of moderate and severe loss of central vision in ageing adults, affecting both eyes in the majority of patients.

GA is the advanced stage of AMD and leads to irreversible loss of vision. It is estimated that approximately 1.6 million people in the US have GA in at least one eye.

Zimura works by targeting the C5 protein suspected to play a critical role in the development and growth of scarring associated with the disease.

The US Food and Drug Administration granted priority review of the drug in February, and if approved, the treatment could be commercialised by the end of this year.

Under the terms of the agreement, Astellas will pay $40 per share in cash, a premium of 64% to Iveric’s closing price at the end of March. The transaction is expected to close in the third quarter of this year.


BioNTech and Duality Biologics partner in deal worth over $1.5bn

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BioNTech and Duality Biologics have announced an agreement to co-develop and commercialise two antibody-drug conjugates (ADCs) for solid tumours.

Under the terms of the agreement, DualityBio will receive upfront payments totalling $170m and will be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn.

ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents.

As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, which targets HER2-expressing solid tumours. DB-1303 has already received Fast Track designation from the US Food and Drug Administration and is currently being assessed in a phase 2 clinical trial.

The second ADC candidate, DB-1311, is yet to enter human studies but has demonstrated ‘potent antitumour activity in a range of tumour models representing multiple cancer types and has been well tolerated in preclinical studies’, the companies said.

BioNTech will hold commercial rights for both assets globally, while DualityBio will retain commercial rights for Mainland China, the Hong Kong Special Administrative Region and the Macau Special Administrative Region. DualityBio also has the right to co-commercialise DB-1311 in the US.


Eli Lilly to sell Baqsimi to Amphastar in deal worth over $1bn

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Eli Lilly will sell its severe hypoglycaemia treatment, Baqsimi, to Amphastar Pharmaceuticals in a deal worth over $1bn, the two companies announced.

Under the terms of the definitive agreement, Amphastar will pay Lilly $500m at closing and an additional $125m after one year, with Lilly also eligible to receive sales-based milestone payments of up to $450m.

Baqsimi is the first and only nasally administered glucagon that can be used to treat severe hypoglycaemia – very low blood sugar – in diabetes patients aged four years and older.

Classed as a diabetic emergency, severe hypoglycaemia is a complication that can occur in diabetes patients who take insulin and certain anti-diabetic tablets.

The condition is characterised by altered mental or physical functioning, including confusion and disorientation, convulsions, loss of consciousness and coma.

Lilly launched Baqsimi in 2019 and it is currently available in 27 international markets, with worldwide sales totalling over $139m in 2022.

Amphastar, which is focused on developing, manufacturing and marketing injectable, intranasal and inhalation products, said it expects to provide ‘dedicated commercial investment’ to expand access to the treatment.

The transaction has been approved by the boards of directors of both companies and is expected to close in the second or third quarter of 2023.