FDA approves Merck & Co.’s Ebola vaccine Ervebo: January’s industry headlines

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Take a look at the industry headlines from the last 2 months, including the FDA approval of Ebola vaccine Ervebo, US $11M granted to Emergex for novel drug development and QuantuMDx and Ontera collaboration to improve sepsis diagnosis.

Merck & Co.’s HIV-1 treatment doravirine approved for NHS use

At the end of 2019, Merck & Co (NJ, USA) announced that its new treatment for HIV-1 infection, doravirine, has been recommended for NHS use in England. The once-daily fixed-dose combination will be known as DELSTRIGO and the single entity tablet PIFELTRO.

“Advances in HIV medication have led to dramatic improvements in life expectancy,” commented Chloe Orkin, clinical professor of HIV medicine at Queen Mary University of London (UK). “We need to continue to develop new treatments that enable us to effectively treat the virus, whilst having minimal side effects, thus enabling a better quality of life. This is why I welcome today’s news granting reimbursement for doravirine. It offers clinicians and people living with HIV in England another effective treatment option that has few side effects.”

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ViiV Healthcare files submissions to the US FDA and EMA for a dispersible formulation of DTG

ViiV Healthcare (NC, USA) filed submissions to the US FDA and EMA in December for the first-ever dispersible formulation of dolutegravir (DTG), as well as a simplified dosing regimen to optimize use of the existing DTG tablet for children living with HIV.

These submissions are based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which investigate the respective safety and efficacy of DTG regimens and treatment in pediatric patients.

Deborah Waterhouse, CEO of ViiV Healthcare commented: “By submitting these files to regulators for approval, we believe that we are on the cusp of delivering against our promise to develop dolutegravir in a tablet that can be dispersed simply in water. We will then aim to make this available, via partnerships, as quickly as possible to children living with HIV worldwide.”

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QuantuMDx and Ontera collaborate to improve sepsis diagnosis

QuantuMDx Group Limited (Newcastle, UK) and Ontera Inc (CA, USA) are collaborating to develop a next-generation solution for blood stream infection and drug resistance detection. The technology will be based on QuantuMDx’s Capture-XT and Ontera’s nanopore biosensor technology.

“Our early prototype testing has already shown sensitivity in the range required for this kind of test and performed in minutes from spiked bacteria in whole blood,” commented Jonathan O’Halloran, Chief Scientific Officer at QuantuMDx. “We haven’t even pushed the technology yet, but it has the potential to become a paradigm-shifting, powerful device. And, by including drug resistance in the assay to enable right first time prescribing, the impact of this partnership could be profound.”

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Iterum’s shares take a hit after failure of Phase III study for investigational antibiotic sulopenem

Shares in Iterum Therapeutics (Dublin, Ireland) fell by 46% in December after reports that the Phase III SURE 3 trial, which investigated the antibiotic sulopenem in patients with complicated intra-abdominal infections (cIAI), failed to meet its primary endpoint.

Iterum CEO Corey Fishman commented: “If we obtain positive results in the first quarter of 2020 from our Phase III complicated and uncomplicated urinary tract trials, we believe that the overall safety and efficacy results from this cIAI trial would be supportive in an FDA filing for oral and intravenous sulopenem and that sulopenem’s market potential remains robust.”

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Teva announces launch of a generic version of Reyataz® in the US

Teva Pharmaceutical Industries (Petah Tikva, Israel) have announced the exclusive launch of a generic version of Reyataz® (atazanavir), which is to be used for treatment of HIV-1.

“The exclusive launch of our generic version of Reyataz marks our fifth generic product offering for the treatment of HIV-1 infection,” commented Brendan O’Grady, Executive Vice President, North America Commercial at Teva. “Antiviral medications continue to be a focus for Teva Generics, and this is an important addition to our portfolio.”

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Antibiotic developer Melinta files for bankruptcy

Melinta Therapeutics (CT, USA) filed for bankruptcy at the end of December due to financial difficulties. This news came 2 months after the FDA approved the company’s application for delafloxacin for treatment of community-acquired bacterial pneumonia, the launch of which was delayed because of financial problems.

The company stated that the filing is part of a restructuring agreement with lenders, and that it plans to continue operating while working through the process.

Jennifer Sanfilippo, Melinta’s interim CEO commented: “We are confident that this process will secure new ownership of the business with the financial resources to support the company’s antibiotics portfolio and ensure these potentially life-saving products continue to get to patients in need.”

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FDA rejects GSK’s combined cabotegravir and rilpivirine HIV regimen

In December it was announced that the FDA have rejected a filing for the two-drug regimen of cabotegravir and rilpivirine for HIV treatment, developed by GSK (Brentford, UK) subsidiary ViiV Healthcare (NC, USA) and Johnson & Johnson (NJ, USA), respectively. The submission was based on the Phase III studies ATLAS and FLAIR, which involved over 1100 adults with virologically suppressed HIV, demonstrating the injectable regimen was as effective as the standard-of-care throughout the 48-week study period. The companies recently reported that the combination also met the main goal of the Phase III ATLAS-2M.

The two-drug regimen is also under review in Canada and Europe.

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FDA approves Merck & Co.’s Ebola vaccine Ervebo

The FDA have announced the approval of Ervebo, the first FDA-approved Ebola vaccine. Also known as V920, this vaccine was developed by Merck & Co (NJ, USA) and received positive responses from the European Commission and the WHO in November 2019.

The approval of Ervebo is supported by a study conducted in Guinea during the 2014–2016 outbreak.

The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher, as well as Breakthrough Therapy designation in order to accelerate its development and review.

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China approves domestic pneumococcal and HPV vaccines, rivalling Pfizer

China has approved a pneumococcal vaccine developed by a unit of Walvax Biotechnology (Kunming, China) as an alternative option for children up to 5 years old, as well as backing Cecolin, a HPV vaccine for women aged 9 to 45 developed by Xiamen Innovax (China).

Walvax has stated that their new product will be competitively priced to rival Pfizer’s (NY, USA) already established pneumococcal vaccine Prevnar 13.

Innovax’s Cecolin is set to compete with GSK’s (London UK) older Cervarix and Merck’s (NJ, USA) Gardasil.

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VBI reveal promising data from second hep B trial

VBI Vaccines (MA, USA) have unveiled data from a second pivotal vaccine trial for hepatitis B. Last year’s trial failed to meet the standard in comparison to GSK’s established Engerix-B.

The new vaccine, Sci-B-Vac, is already approved in Israel and ten other countries. It has been engineered to imitate the three surface antigens of the hep B virus and is being developed to work at lower doses than existing hep B vaccines.

The second study, known as CONSTANT, met its primary endpoints in the evaluation of Sci-B-Vac’s safety, immunogenicity and manufacturing consistency compared with Engerix-B. VBI plans to use CONSTANT data in their submission of marketing applications in the US, Canada and Europe later on this year.

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Emergex granted $11M to tackle infectious diseases

Emergex Vaccines (Abingdon, UK) have secured US $11M in Series A funding, led by Vickers Venture Partners, to fight infectious disease vaccines using its novel T-cell vaccine technology, which is designed to trick the immune system into thinking it’s already had the infection.

The company’s lead experimental product is for dengue, with three studies to test the product being carried out this year. Tom Rademacher (University College London, UK), founder of Emergex, estimates that there will be at least two readouts in 2020.

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FDA approves Merck’s DIFICID for treatment of C. difficile diarrhea

The US FDA have approved Merck’s (NJ, USA) DIFICID (fidaxomicin) for oral suspension and tablet form for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in children aged 6 months and older.

Both applications received a priority review classification by the FDA.

Larry Kociolek associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children’s Hospital (IL, USA) commented: “C. difficile is an important cause of healthcare- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children… I am very excited to have a new C. difficile infection treatment option for my pediatric patients.”

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