US FDA approvals for antibiotic Xenleta™ and tuberculosis drug Pretomanid: August’s industry headlines


Take a look at this month’s industry headlines including US FDA approvals for two drugs – Xenleta™ and Pretomanid – in addition to an EMA decision for Zerbaxa®, partnerships for vaccine development and results on Ebola therapeutics.

First new antibiotic with novel mechanism of action approved in nearly two decades

The FDA have approved New Drug Applications for Nabriva Therapeutics’ (Dublin, Ireland) oral and intravenous formulations of Xenleta™ (lefamulin) to treat adult patients with community-acquired bacterial pneumonia (CABP).

The approval was based on two pivotal clinical trials, LEAP 1 and LEAP 2, demonstrating that Xenleta was comparable with moxifloxacin in terms of efficacy, and that the antibiotic was well tolerated. Ted Schroeder, Chief Executive Efficer of Nabriva Therapeutics, commented: “Today’s approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP.”

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Nabriva plans to resubmit Contepo™ (fosfomycin) to FDA

Following the FDA rejecting Nabriva’s antibiotic Contepo for complicated urinary tract infections in May this year, the company have announced plans to resubmit a New Drug Application in quarter four of 2019. The announcement followed a meeting conducted to obtain clarity on the FDA’s Complete Response Letter, which raised concerns over manufacturing deficiencies at one of Nabriva’s contract manufacturers.

Ted Schroeder, Chief Executive Officer, commented: “With the official minutes from the FDA in hand, we have identified a path forward for resubmission of the Contepo New Drug Application in the near future. We look forward to the opportunity to bring this important treatment to patients as quickly as possible and providing clinicians an urgently needed early and appropriate therapeutic option to manage patients at risk of resistant infections with limited available treatment options for complicated urinary tract infections.”

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Discover more about the rejection in May’s industry headlines >

Sales surge for triple combination HIV drug Biktarvy

Gilead Sciences (CA, USA) has announced its quarter two results, with total HIV sales rising from US $3.7 billion in the previous year to $4 billion, fueled mainly by high sales volumes of Biktarvy. Biktarvy sales were at $1.1 billion, up from $185 million in the prior year, however, sales for Truvuda, Genvoya and Odefsey were down.

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Positive EMA opinion for Zerbaxa® 3g dose

Merck (NJ, USA) have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending a 3g dose of Zerbaxa (ceftolozane and tazobactam) for the treatment of ventilator-associated and hospital-acquired pneumonia in adults.

The recommendation will now be considered by the European Commission. Nicholas Kartsonis, Senior Vice President of Infectious Diseases and Vaccines at Merck Research Laboratories, commented: “We are pleased with the CHMP’s positive opinion recommending approval of Zerbaxa for the treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, which marks an important step towards providing a new option for medical professionals treating critically ill patients in the hospital setting.”

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Want to discover more about the clinical trial behind this recommendation? Take a look at our piece on the ASPECT-NP study >

FDA approves Pretomanid tablets for drug-resistant tuberculosis

The FDA has announced an approval for Pretomanid tablets in combination with bedaquiline and linezolid for the treatment of specific types of drug-resistant pulmonary tuberculosis.

The drug has been approved for the treatment of adults with extensively drug-resistant, treatment-intolerant or non-responsive multidrug-resistant pulmonary tuberculosis, which make up approximately 490,000 new cases of tuberculosis globally each year.

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Two Ebola treatments prove effective in DRC outbreak

A clinical trial assessing four Ebola treatments has highlighted two drugs that significantly improved survival rates: REGN-EB3 from Regeneron Pharmaceuticals (NY, USA) or mAb114 from Ridgeback Biotherapeutics (FL, USA). The results have led to the trial being halted early and these two therapeutics being recommended for the treatment of all future cases.

The two treatments, mAb114 and REGN-EB3, will now continue to be assessed as part of the study’s extension phase, which will further evaluate safety. However, Mike Ryan, Executive Director of the WHO Emergencies Programme, commented in a statement on August 12: “We are seeing outstanding results for those individuals who reach care early. The results for those who don’t reach care, or who reach care very late are still very poor.”

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Find out more about the DRC outbreak so far and the challenges facing the response >

Merck partner with Themis Bioscience for vaccine development

Themis Bioscience (Vienne, Austria) have announced a research collaboration and exclusive license agreement with Merck for the development of undisclosed vaccines using Themis’ virus vector platform.

Themis will develop vaccine candidates against an undisclosed disease target, with Merck providing funding. Themis will be eligible to receive development and sales milestone payments up to the potential value of approximately US $200 million as well as royalties on any approved products.

Erich Tauber, MD, Chief Executive Officer of Themis Bioscience, commented: “We are excited to collaborate with MSD (tradename of Merck) and to develop a vaccine that has the potential to provide a significant benefit to a great number of patients worldwide.”

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Pulmocide Ltd announce in vitro data for novel antifungal PC945 against Candida auris

Pulmocide Ltd (London, UK) has announced in vitro data published in the Journal of Antimicrobial Chemotherapy, highlighting the potential of its novel antifungal candidate PC945 in the treatment of Candida auris.  PC945 was discovered to be a more potent inhibitor of the fungi than posaconazole, voriconazole and fluconazole, with the company stating that the compound warrants further investigation.

Garth Rapeport, Chief Executive Officer of Pulmocide, commented: “We are pleased to report these promising data. Pulmocide is very aware of the growing concern around C. auris and we are delighted to be able to contribute to the growing body of research characterizing this newly identified pathogen.”

“PC945 is the first antifungal triazole specifically designed as a once-daily, topical/aerosolized treatment for upper airway fungus colonization. Although the transmission route of C. auris has not been fully identified, these in vitro data of PC945 indicate that it is a promising drug to prevent or treat C. auris infection.”

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Sabin Institute acquires rights for Ebola and Marburg viruses from GSK

The non-profit organization, the Sabin Vaccine Institute (DC, USA) has acquired the rights to develop vaccines against two species of Ebola and the related Marburg virus from GlaxoSmithKline (GSK; Brentford, UK). This transfer will put the vaccines back into development after GSK ceased operations at the end of the 2014–2016 Ebola outbreak. No money is involved in the transaction – GSK is giving the rights to the Sabin Institute.

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Want to find out more about the Sabin Institutes work on vaccines? Take a look at our piece on Vaccine confidence in the ‘post-truth’ world with President of Global Immunization, Bruce Gellin >

 Northern Antibiotics scouting for commercial partner to develop polymyxin derivative

Northern antibiotics (Espoo, Finland) have announced their work on a new antibiotic molecule, which is a derivative of polymyxin. The company states that the molecule has shown promise in preclinical tests, with activity against carbapenem-resistant bacteria, moreover, the molecule has been reported to be less nephrotoxic than polymyxin itself.

The company is currently searching for a commercial partner – as development will require additional funding – stating that this antibiotic could be in-use by the mid-2020s.

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ViiV Healthcare reports positive Phase III study results for long-acting, injectable HIV treatment

ViiV Healthcare (Brentford, UK) has reported that the ATLAS-2M study has met its primary endpoint, demonstrating that long-acting, injectable HIV treatment cabotegravir and rilpivirine administered every 8 weeks was comparable to administration every 4 weeks.

Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, commented: “We are excited to report that for the first time since the AIDS epidemic started more than 30 years ago, our ATLAS-2M study has demonstrated that it is possible to maintain suppression of the HIV virus with an injectable regimen containing two drugs administered every 2 months.”

“This is further progress in our efforts to reduce the number of medicines a person living with HIV must take while also reducing the frequency of treatments. The ATLAS-2M study results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year. Approval of this regimen would mark a significant change in the HIV treatment paradigm.”

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Learn more about the future of long-acting formulations for HIV in our interview with expert, Jose Arribas >

 The Native Antigen Company introduces Rubella virus-like particles

The Native Antigen Company (Oxford, UK) has announced the release of its Rubella virus-like particles at the 71st AACC Annual Scientific Meeting & Clinical Lab Expo (4–8 August 2019, Anaheim, CA, USA). The product is an addition to the Company’s current selection of recombinant virus-like particles.

Andy Lane, Commercial Director, The Native Antigen Company, commented: “We are committed to expanding our product portfolio of reagents to facilitate cutting-edge vaccine and diagnostics research for infectious disease.”

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Missed last month’s headlines? You can catch up here:

US FDA approves RECARBRIO™ for complicated UTIs and complicated intra-abdominal infections: July’s industry headlines >


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