Authors: Martha Powell, Future Science Group
Take a look at this month’s industry headlines including new clinical trial results for zoliflodacin and an EMA recommendation for fexinidazole, an oral treatment of sleeping sickness, .
- FDA grants priority review for controversial dengue vaccine, Dengvaxia®
- EMA recommends fexinidazole, the first all-oral treatment for sleeping sickness
- Merck cuts back on rotavirus vaccine commitment to West Africa
- Antibiotic-developer Achogen makes more cuts
- Entasis’ novel antibiotic effective in the treatment of uncomplicated gonorrhea
- AstraZeneca sells US rights to RSV therapy to Sobi
- Access to Medicine Foundation reports that pharmaceutical companies have failed to develop two-thirds of urgently needed treatments
FDA grants priority review for controversial dengue vaccine, Dengvaxia®
The US FDA has accepted a Biologics License Application for Sanofi Pasteur’s (Lyon, France) dengue vaccine, Dengvaxia, despite its controversial past.
The vaccine would represent the first and only medical prevention tool against dengue – a considerable unmet need. However, last November Sanofi reported in post-marketing research that the vaccine appeared to increase the risk of severe disease in children vaccinated before they’d had a dengue infection.
A decision from the FDA must be filed within 6 months; in addition, the European Commission is expected to grant marketing authorization for Dengvaxia in December 2018.
EMA recommends fexinidazole, the first all-oral treatment for sleeping sickness
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive scientific opinion of fexinidazole – the first oral treatment shown to be effective for both stages of sleeping sickness.
The recommendation is a result of clinical trials led by DNDi (Geneva, Switzerland), and an application submitted by Sanofi. The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.
Bernard Pécoul, DNDi Executive Director, commented: “Fexinidazole is an entirely new chemical entity that has been developed through an alternative non-profit R&D model. It is the first new chemical entity to be developed by DNDi. This therapeutic breakthrough is testament to the unique partnership between DNDi and Sanofi to discover, develop, and register a treatment for a severely neglected disease.”
Merck cuts back on rotavirus vaccine commitment to West Africa
Merck & Co (NJ, USA) will fall short of its promise to provide the rotavirus vaccine to children in West Africa, potentially leaving half a million children unprotected.
The company originally agreed with non-profit organization Gavi to supply RotaTeq – its rotavirus vaccine – to four low-income countries at a reduced price. However, it has now been announced that Merck will be scaling its rotavirus shipments back by a third for 2018 and 2019, with Gavi reporting that more than half a million children could miss out on vaccination due to this shortfall.
The decision comes after Merck won an approval in China this April, putting a strain on its supply of the vaccine.
Antibiotic-developer Achogen makes more cuts
Achaogen (CA, USA) is making its second set of cuts in under 4 months, according to reports, with the latest restructuring aiming to cut 40% of the company’s expenses.
The news comes after the US FDA approved Achaogen’s antibiotic plazomicin for one indication but rejected it for another, while partly validating the drug this also initiated a strategic review that could see Achaogen put up for sale. The restructuring, which is expected to be complete by the end of 2018, follows shortly after Achaogen making deep cuts to its R&D department.
Entasis’ novel antibiotic effective in the treatment of uncomplicated gonorrhea
New Phase II clinical trial results indicate the promise of zoliflodacin, a novel antibiotic that inhibits DNA synthesis, as a well-tolerated and successful treatment for uncomplicated gonorrhoea.
Given this positive outcome, The Global Antibiotic Research & Development Partnership (GARDP, Geneva, Switzerland) in partnership with Entasis (MA, USA), will begin to conduct a Phase III clinical trial of zoliflodacin in the Netherlands, South Africa, Thailand and the USA in 2019.
AstraZeneca sells US rights to RSV therapy to Sobi
AstraZeneca (Cambridge, UK) announced on November 13 an agreement to sell US rights to their RSV therapy, Synagis (palivizumab), to Swedish Orphan Biovitrum (Sobi; Stockholm, Sweden). The total upfront consideration is US$1.5 billion, and under the deal AstraZeneca will receive $500 million in shares of Sobi upon completion, representing an 8% stake.
AstraZeneca has an agreement with AbbVie (IL, USA) for the distribution of Synagis outside the US, which the company noted will not be impacted by the proposed deal with Sobi.
“We continue to streamline our portfolio, allowing AstraZeneca to allocate resources more effectively,” remarked AstraZeneca CEO Pascal Soriot.
Access to Medicine Foundation report that pharmaceutical companies have failed to develop two-thirds of urgently needed treatments
A new report by the Access to Medicine Foundation has stated that two-thirds of the 139 urgently needed treatments for developing countries (identified by the WHO) are not being developed by pharmaceutical companies.
The report monitors the 20 major drug companies and the availability of their medicines, the most recent edition suggested that most firms focus on infectious diseases such as HIV, malaria and tuberculosis but fail to look at other conditions. It reports the 91 of the 136 drugs, vaccines or diagnostics have yet to be developed, with 16 prioritized diseases with no projects at all.