Merck buys Prometheus for US$ 10.8 bn; FDA grants full approval to Roche’s Polivy for lymphoma

By PharmaCompass

2023-04-20

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This week, Phispers brings you news about two M&A deals. Merck is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. And GSK is buying Canada-based drug developer Bellus Health for US$ 2 billion in a bid to expand its respiratory portfolio.

In approvals, the US Food and Drug Administration (FDA) has granted full approval to Roche’s Polivy as a first-line therapy for diffuse large B-cell lymphoma. The agency has also expanded the approval of AbbVie’s Qulipta (atogepant) as a preventive treatment for chronic migraine in adults. And Gamida’s cell therapy – Omisirge – has bagged FDA approval as a treatment for reducing the risk of infection in patients aged 12 years or older with blood cancer who are undergoing stem cell transplantation.

FDA, however, rejected Alvotech’s Humira biosimilar – AVT02 – for a second time citing deficiencies at its manufacturing plant in Iceland. It also issued a complete response letter to Lilly’s drug for ulcerative colitis – mirikizumab – citing manufacturing issues.

GSK’s experimental oral antibiotic drug – gepotidacin – has successfully met its goals in two late-stage trials for treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. Vaxcyte’s experimental 24-valent pneumococcal vaccine – VAX-24 – has succeeded in a second mid-stage trial on adults 65 years and older.

Eli Lilly said it will invest an additional US$ 1.6 billion at its two new manufacturing sites in Indiana, US. And the ruling on restricted access to the abortion pill mifepristone has been temporarily halted by the US Supreme Court.

Merck strengthens immunology pipeline with US$ 10.8 billion Prometheus purchase

Merck is set to acquire San Diego-based biotech Prometheus Biosciences in an all-cash deal worth US$ 10.8 billion to strengthen its immunology pipeline. Merck will acquire the autoimmune diseases drugmaker through a subsidiary. The purchase will give Merck access to Prometheus’ experimental lead drug, PRA023, which has shown promise in the treatment of ulcerative colitis and Crohn’s disease.

GSK acquires Bellus Health for US$ 2 billion in bid to expand respiratory portfolio

GSK is acquiring Canada-based drug developer Bellus Health for US$ 2 billion in an all-cash deal, in order to expand its respiratory portfolio. The acquisition will provide GSK access to Bellus’ experimental drug – camlipixant – which is currently in late-stage development for refractory chronic cough (RCC).

Meanwhile, 750 workers across six GSK sites in the UK are planning to go on strike after the company offered a six percent pay raise, which the workers have found to be “significantly below” the rate of inflation.

Lilly to invest US$ 1.6 billion in US: Eli Lilly is investing an additional US$ 1.6 billion at its two new manufacturing sites in Indiana, US. The drugmaker has now committed US$ 3.7 billion to build the facilities, which are expected to employ around 700 people. The sites will expand Lilly’s production capacity for active pharmaceutical ingredients (APIs) and support next-generation therapeutics like genetic medicines.

FDA grants full approval to Roche’s Polivy as first-line treatment of lymphoma

Roche’s Polivy has received full approval from the FDA for the treatment of certain types of previously untreated diffuse large B-cell lymphoma (DLBCL). It is to be used in combination with Rituxan, cyclophosphamide, doxorubicin and prednisone. The approval is based on a phase 3 trial that showed the drug cocktail reduced the risk of progression or death by 27 percent compared to the standard regimen.

The Polivy combo is the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. The drug had received accelerated approval in 2019 to treat DLBCL after at least two prior therapies.

GSK’s experimental oral antibiotic shows promise in late-stage trials for UTI

GSK’s experimental oral antibiotic drug – gepotidacin – has successfully met its primary goals in two late-stage trials for treating uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The drug demonstrated effectiveness on par with or better than nitrofurantoin, the current standard of care. If approved, gepotidacin could become the first new antibiotic in over 20 years to treat uUTIs.

Vaxcyte’s 24-valent pneumococcal shot succeeds mid-stage trial in older adults: Vaxcyte’s experimental 24-valent pneumococcal vaccine – VAX-24 – has succeeded in a second mid-stage trial for adults 65 years and older. The vaccine produced a strong immune response against all 24 bacterial strains tested. Its effectiveness was comparable to Pfizer’s Prevnar 20.

FDA rejects Alvotech’s Humira biosimilar yet again due to manufacturing issues

Last September, the FDA had rejected Alvotech’s application to approve a biosimilar to AbbVie’s blockbuster drug Humira citing deficiencies at the drugmaker’s manufacturing plant in Reykjavik, Iceland. Last week, the agency rejected the Humira biosimilar – AVT02 – for a second time citing deficiencies at the same plant during a reinspection in March.

Lilly’s colitis drug fails to bag FDA nod: FDA has issued a complete response letter to Eli Lilly’s experimental drug for ulcerative colitis – mirikizumab – citing manufacturing issues. However, the agency did not raise any concerns about the drug’s clinical data or safety, Lilly said.

AbbVie’s Qulipta gets FDA’s add-on nod for chronic migraine prevention in adults

FDA has expanded the approval of AbbVie’s Qulipta (atogepant) as a preventive treatment for chronic migraine in adults, making it the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the condition.

Meanwhile, Gamida Cell’s cell therapy – Omisirge – has received FDA approval as a treatment for reducing the risk of infection in patients aged 12 years or older with blood cancer who are undergoing stem cell transplantation. The treatment is administered intravenously as a single dose.

FDA panel votes in favor of Otsuka-Lundbeck’s Alzheimer’s drug: An FDA advisory committee voted 9-1 in favor of Otsuka and Lundbeck’s drug Rexulti (brexpiprazole) for treating agitation associated with Alzheimer’s dementia.

Another panel of external advisers to the FDA unanimously voted 12-0 in favor of Innoviva’s intravenous drug sulbactam -durlobactam to treat serious hospital-acquired and ventilator-associated bacterial pneumonia caused by strains of the Acinetobacter baumannii-calcoaceticus complex. FDA is slated to decide on the drug’s approval by May 29.

Temporary halt on abortion pill ruling: The US Supreme Court has temporarily halted a lower court ruling that restricted access to the abortion pill mifepristone, allowing time for the court to consider a challenge by anti-abortion groups against the drug. Meanwhile, a manufacturer of a generic form of mifepristone — GenBioPro — is suing the FDA in a bid to prohibit the agency from taking any action that would disrupt access to the abortion pill.

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