Roche, Sarepta collaborates; FDA approval for Merck’s Ervebo, and Allergan’s Ubrelvy

Roche has entered into a licensing partnership with Sarepta Therapeutics worth USD 1.15 Billion. 

Roche has agreed to license in Sarepta’s gene therapy ‘SRP-9001’ for Duchenne muscular dystrophy (DMD), though which Roche will gain access to exclusive rights to it globally except in the US. 

As per the DelveInsight analysis, there were 4769 patients in the age group 8–13 years followed by 14–the 19-year age group with 4726 patients in 2017 in the United States.

The goal of Duchenne Muscular Dystrophy (DMD) treatment is to control the symptoms of DMD and related complications caused by severe progressive muscle weakness and loss to maximise the quality of life. Various therapies have been developed for treating DMD. However, companies are testing the potential of gene therapies to tackle DMD treatment challenges like the product gene size, the origin of dystrophin gene expression, transport effectiveness, and immunological rejection.

Under the agreement, Roche will pay Sarepta an amount of USD 750 Million upfront, and remaining USD 400 million in stocks and equity. Furthermore, Sarepta on receiving regulatory and sales milestones will receive royalties on net sales. 

However, the companies have decided to share the developmental expenses equally.

The US FDA has given its recommendations to Merck’s Ervebo vaccines for the prevention of Ebola virus disease (EVD).

Ebola virus disease (EVD), also known as Ebola hemorrhagic fever (EHF) or simply Ebola, is caused by virus species Zaire ebolavirus. Ebola virus cases have a mortality rate of up to 90%. EVD cases are relatively rare in the USA, and recent outbreaks took place in Central and West Africa, near tropical rainforests.

The vaccine is a single-dose injection and is bioengineered as a live, attenuated injection containing protein from the virus. 

Ebola virus disease is rare but severe and is contagious. EVD spreads to the healthy population through infected blood, secretions, fluids, and other body fluids of infected animals like a chimpanzee, gorilla, fruit bats, monkeys, forest antelopes and porcupines.

The company has received the approval from the European Commission, and this is the second regulatory milestone Merck has achieved. However, Ervebo remains unapproved in the most affected areas, i.e., Africa. The company has filed for the approval to African regulators in collaboration with the African Vaccine Regulatory Forum.

The US FDA has approved Ubrelvy, a drug of Allergan, for the immediate treatment of migraine with or without aura in adults.

The drug belongs to the class of oral calcitonin gene-related peptide receptor antagonists recommended for the acute migraine treatment. 

As per the World Health Organization’s disability rating, Migraine is recognised as the 19th most common reason for disability and is three times more common in women. According to the US Centers for Disease Control, self-reported migraine prevalence in the United States increased by 60%, from 25.8 to 41 per 1000 person-years between 1981 and 1989.

Ubrelvy is the first oral calcitonin gene-related peptide receptor (CGRP) and is not indicated for the preventive treatment of migraine. It is the first drug in the class of CGRP receptor antagonists approved for the acute treatment of migraine.