Pharmaceutical Market Europe • September 2024 • 6-7

NEWS

GSK and Flagship agree on $7bn drug discovery partnership

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GSK and Flagship Pioneering have entered into a partnership worth up to $7bn to discover and develop novel medicines and vaccines for a range of conditions.

Bringing together GSK’s expertise in disease and development capability via Flagship’s ecosystem of bioplatform companies, the collaboration aims to develop a portfolio of up to ten future medicines and vaccines, beginning in respiratory and immunology, which will each be subject to an exclusive option by GSK for further clinical development.

As part of the deal, both companies will initially fund up to $150m upfront to support an exploration phase to identify the most promising concepts for further research and development utilising Flagship’s bioplatform companies, which will be eligible to receive up to $720m in upfront, development and commercial milestones from GSK, as well as preclinical funding for each acquired programme plus tiered royalties.

Most recently, GSK entered into a new licensing agreement worth over €1.4bn with CureVac to restructure their current collaboration to develop mRNA vaccines for infectious diseases, to allow both companies to prioritise investment and focus on their respective mRNA development activities.


Boehringer Ingelheim acquires Nerio for $1.3bn to expand immuno-oncology pipeline

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Boehringer Ingelheim has announced its acquisition of Nerio Therapeutics for up to $1.3bn, marking a significant boost to the German drugmaker’s immuno-oncology pipeline.

The deal gives Boehringer access to the US-based drug discovery and development company’s small molecules designed to inhibit the protein tyrosine phosphatases N1 and N2 (PTPN1 and PTPN2).

PTPN1 and PTPN2 act as immune checkpoints, and inhibiting them can activate the body’s immune system to fight cancer cells.

Boehringer said it hopes to develop the preclinical programme as a potential “key centrepiece component” of its immuno-oncology portfolio, with the company adding that the inhibitors could be used as both single agents and in combination with its own cancer therapies.

Paola Casarosa, member of the board of managing directors at Boehringer, said that gaining the rights to Nerio’s inhibitors “creates a broad panel of exciting new cancer treatment combination opportunities”.

The acquisition came just over a week after Boehringer and artificial intelligence specialist Brainomix entered into a partnership aimed at improving the care of patients with fibrosing lung disease in the US.


Eli Lilly acquires Morphic in $3.2bn chronic disease pipeline expansion

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Eli Lilly has announced that it will be acquiring Morphic Therapeutics for approximately $3.2bn, marking a notable boost to the company’s chronic disease pipeline.

The deal gives Lilly access to Morphic’s lead programme, MORF-057, a selective oral small molecule inhibitor of α4β7 integrin for inflammatory bowel disease (IBD).

The candidate, which Lilly said “has the potential to improve outcomes and expand treatment options for patients”, is currently in mid-stage clinical development to treat ulcerative colitis and Crohn’s disease.

An estimated 3.1 million adults in the US are affected by IBD, a term for conditions characterised by chronic inflammation of the gastrointestinal tract, including Crohn’s disease and ulcerative colitis.

The exact cause of IBD is unknown, and symptoms include persistent diarrhoea, abdominal pain, rectal bleeding/bloody stools, weight loss and fatigue.

The acquisition also includes Morphic’s preclinical pipeline of other molecules for autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases and cancer.

Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Morphic for a purchase price of $57 per share in cash.


Roche’s subcutaneous Ocrevus granted MHRA approval for MS

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Roche’s subcutaneous (SC) formulation of Ocrevus (ocrelizumab) has been approved by the Medicines and Healthcare products Agency (MHRA) to treat adults with relapsing and primary progressive multiple sclerosis (MS).

The ten-minute injection maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, providing an additional treatment option for patients and enabling them to spend less time in hospital.

Affecting more than 150,000 people in the UK, MS is a neurological disease that causes symptoms such as blurred vision, unsteadiness, memory problems and fatigue.

Roche’s Ocrevus is a disease-modifying therapy designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in people with MS.

The MHRA’s latest decision was supported by clinical trial results showing that the SC formulation is just as effective as the IV treatment, with 97% of patients experiencing no relapses in their condition and no development of brain lesions over 48 weeks.

Alongside reducing treatment time, it is hoped that Ocrevus SC will save time for clinicians and help free up capacity in hospitals.


Merck’s Keytruda recommended
by NICE for gastric cancer

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Merck & Co – known as MSD outside the US and Canada – has received a recommendation from the National Institute for Health and Care Excellence (NICE) for the use of Keytruda (pembrolizumab) in a subset of advanced gastric cancer patients.

The anti-PD-1 therapy has been recommended for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat untreated locally advanced unresectable or metastatic human epidermal growth factor 2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of one or more.

More than 6,500 new diagnoses of gastric cancer are made in the UK every year and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases.

The agency’s decision, which provides the first immunotherapy-chemotherapy combination treatment option for patients whose tumours express PD-L1 with a CPS of one to four, was supported by positive results from the late-stage KEYNOTE-859 trial.

Results showed that the Keytruda/chemotherapy combination led to statistically significant improvements in overall survival, progression-free survival and objective response rate compared to placebo plus chemotherapy.


Pfizer’s haemophilia B gene therapy Durveqtix approved by EC

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Pfizer’s haemophilia B gene therapy has been granted conditional marketing authorisation by the European Commission (EC) to treat adults with severe and moderately severe cases of the rare bleeding disorder.

Durveqtix (fidanacogene elaparvovec) has been specifically authorised for use in patients without a history of both factor IX (FIX) inhibitors and detectable antibodies to variant adeno-associated virus serotype Rh74.

Affecting more than 42,000 people globally, haemophilia B is a genetic condition resulting from a deficiency in blood-clotting FIX.

Pfizer’s Durveqtix, which is already approved in the US as Beqvez, is administered as an intravenous infusion and designed to enable patients to produce FIX themselves after a one-time dose.

The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by positive results from the late-stage BENEGENE-2 clinical trial of men aged 18 to 62 years with moderately severe or severe haemophilia B.

The trial met its primary efficacy endpoint of non-inferiority and demonstrated a statistically significant decrease in annualised bleeding rate for total bleeds post-Durveqtix infusion compared to a routine FIX prophylaxis regimen, administered as part of usual care.