Authors: Martha Powell, Future Science Group
Take a look at this month’s industry headlines including a new partnership for antibiotic development, approval for HIV drugs and authorization for a cytomegalovirus test.
- Genetically modified mosquito pilot abandoned
- FDA authorizes first test for the detection of cytomegalovirus in newborns
- RedHill Biopharma’s pylori antibiotic on track for 2019 launch
- Melinta cuts costs in a difficult industry
- GARDP, Eisai and Takeda partner in the search for new antibiotics
- European Commission approves Merck’s DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1
Genetically modified mosquito pilot abandoned
A pilot being carried out by Oxitec (Oxford, UK) releasing genetically-modified mosquitoes whose offspring can’t grow into adulthood has been halted in the British Overseas territory of Grand Cayman.
The pilot has been ongoing for 2 years but it will cease this month and the results will be analyzed. This comes after a Freedom of Information Request by campaign group Genewatch suggested that there had been “no significant reduction in the abundance of mosquitoes in the released area.”
FDA authorizes first test for the detection of cytomegalovirus in newborns
The US FDA has permitted the marketing of a new diagnostic test to aid in the detection of cytomegalovirus (CMV) in newborns less than 21 days of age.
The Alethia CMV Assay Test System, developed by Meridian Bioscience, Inc. (OH, USA), is used as an aid in the diagnosis of congenital CMV infection by the detection of viral DNA from a saliva swab. Tim Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health, commented: “This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”
RedHill Biopharma’s H. pylori antibiotic on track for 2019 launch
RedHill Biopharma’s (Tel-Aviv, Israel) lead asset, the antibiotic cocktail RHB-105 has had positive results from Phase III trials, setting the company up for an FDA filing in the first half of 2019 and potentially a launch by the end of the year.
RHB-105, a combination of rifabutin and amoxicillin and omeprazole, was demonstrated to be superior to an amoxicillin combination in the recent trials, with an 84% reduction in H. pylori infection. However, RedHill have commented their efficacy will probably decline over time in the face of growing resistance to antibiotics.
Melinta cuts costs in a difficult industry
It has been reported that antibiotic-developer Melinta (CT, USA) is laying off 22 of 25 staff at its flagship New Haven office as it carries out a cost-cutting plan. In an emailed statement to local paper the New Haven Biz, Melinta commented: “In the face of an extremely challenging time for the antibiotics industry, Melinta has made the difficult decision to significantly reduce our investment in discovery research and are currently looking for strategic partners to take on these activities, located at our New Haven facility.”
However, also this month Melinta has received European Commission Marketing Authorization for Vabomere® (meropenem and vabrobactam) for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, bacteremia that occurs in association with any of these infections, and infections due to aerobic Gram-negative organisms where treatment options are limited.
GARDP, Eisai and Takeda partner in the search for new antibiotics
The Global Antibiotic Research and Development Partnership (GARDP; Geneva, Switzerland), Eisai and Takeda (both Tokyo, Japan) have signed an agreement for GARDP to access and screen components of Eisai and Takeda’s chemical libraries.
Both libraries will be tested by the Institut Pasteur Korea (Seoul, South Korea) against bacteria on the WHO’s global priority pathogen list in the hope of discovering new antibacterial compounds.
Dr. Seamus O’Brien, Research and Development Director at GARDP, commented: “GARDP is very excited about this partnership. Not only can partnerships like this accelerate the discovery of new antibiotics, they can also support the pharmaceutical sector in staying engaged in antibiotic R&D.”
European Commission Approves Merck’s DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1
The European Commission has approved DELSTRIGO™, a once-daily fixed-dose combination tablet, and PIFELTRO™, a NNTRI, for the treatment of HIV-1 infection, both developed by Merck (NJ, USA). The approvals are based on Phase III trial results from the DRIVE-AHEAD and DRIVE-FORWARD studies evaluating the efficacy and safety of both drugs over 96 weeks. Both drugs were approved in the USA in August 2018; availability in the EU is expected in early 2019.
George Hanna, Vice President and Therapeutic Area Head of infectious diseases, Merck Research Laboratories, commented: “We are very pleased that the European Commission has approved DELSTRIGO and PIFELTRO, as this approval marks another important milestone in Merck’s unwavering commitment to the global HIV community. These medicines bring new treatment options with demonstrated efficacy that could potentially address unmet needs for people in Europe living with HIV.”