Data Presented at ASM Microbe 2017 Highlight Progress on New Antibiotics: Business Watch Report

Welcome to the first edition of the Contagion^® Weekly Business Watch. As we wait to learn the fate of the Affordable Care Act (ACA) and the introduction and make-up of the American Health Care Act (AHCA), we have begun providing our readership with a Public Health Watch each week, bringing a snapshot of the latest news in public health. To this end, we feel that it is important to provide our readers with the latest information on new drugs, medical devices, and tests coming out of industry and so each week we will be publishing a Business Watch Report. In this week’s report, we include information on the latest data presented at the recent American Society for Microbiology (ASM) Microbe 2017 conference, June 1-5, 2017 in New Orleans, Louisiana.

Shionogi Presents Further Evidence on Efficacy of Cefiderocol Against MDR Gram-Negative Pathogens

Shionogi & Co., Ltd. (Shionogi) presented results from several studies on cefiderocol (S-649266), a late-stage investigational parenteral siderophore cephalosporin at ASM Microbe 2017. Findings from epidemiological, molecular mechanism, and global surveillance studies showed that cefiderocol demonstrated potent activity against Pseudomonas aeruginosa, Acinetobacter baumannii, Enterobacteriaceae, and Stenotrophomonas maltophilia, including carbapenem-resistant strains of these pathogens harboring both serine and metallo-type beta-lactamases. Clinical development of cefiderocol for the U.S. is ongoing with a phase 3 trial in patients with carbapenem-resistant pathogens at various infection sites (CREDIBLE-CR). Also scheduled to start in 2017 is a phase 3 trial in patients with hospital-acquired/ventilator-associated/healthcare-associated pneumonia HAP/VAP/HCAP† (APEKS*-NP‡). Shionogi plans to submit a new drug application (NDA) to the FDA in 2017 with data from a recently completed registrational study in patients with cUTI (APEKS*-cUTI).

ASM Microbe 2017 Presentations:

• In Vitro Antibacterial Activity of Cefiderocol against Gram-Negative Clinical Strains Collected in North America and Europe: SIDERO-WT-2015
• Cefiderocol Susceptibility against Globally Isolated Meropenem Non-Susceptible Gram-Negative Bacteria Containing Serine and Metallo-Carbapenemase Genes
• Anti-Acinetobacter Activity of Cefiderocol (S-649266), a Novel Siderophore Cephalosporin: Bactericidal Activity Due to Penicillin-binding Proteins Inhibition and Antibacterial Activity against Globally Collected Clinical Isolates
• Stenotrophomonas maltophilia in United States Hospitals between 2010 and 2015

Nabriva Therapeutics Showcases Data on Pleuromutilin Class of Antibiotics

Nabriva Therapeutics AG (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, presented data at ASM Microbe 2017 last weekend. The company showcased 4 poster presentations on lefamulin’s in vitro activity against key pathogens commonly causing respiratory tract infections. These data are part of a growing body of evidence supporting lefamulin’s profile as a potential first-line, empiric treatment for the key pathogens, including multidrug resistant strains, that are known to cause community-acquired bacterial pneumonia (CABP). The data presented at ASM Microbe 2017 are supportive of Nabriva's ongoing Phase 3 clinical development program and the company will report top-line results from its first pivotal trial, known as LEAP 1, in the third quarter of 2017.

ASM Microbe 2017 Presentations:

• In Vitro Activity of Lefamulin against Bacterial Pathogens Collected from Patients with Community-Acquired Bacterial Pneumonia (CABP) - SENTRY 2015 US Data
• In Vitro Antibacterial Activity of Lefamulin against Bacterial Pathogens Commonly Causing Pneumonia Collected from Patients in Asia (2015)
• In Vitro Activity of Lefamulin against a Collection of Respiratory Pathogens from Pediatric Patients in US (SENTRY Surveillance 2015)
• In Vitro Antibacterial Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in US

Theravance Biopharma Presents New Data on VIBATIV

Theravance Biopharma reported new data from multiple studies of VIBATIV (telavancin), the Company’s proprietary FDA-approved antibiotic, at ASM Microbe 2017. Study results highlighted greater in vitro potency for VIBATIV against difficult-to-treat Staphylococcus aureus (S. aureus) pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and those considered to be multidrug-resistant (MDR), as compared to other commercialized antibiotics. Frank Pasqualone, Chief Commercial Operations Officer at Theravance Biopharma, said, “In an environment clouded by the challenges of antibiotic resistance, we believe that the in vitro potency of VIBATIV, coupled with its demonstrated bactericidal activity, provides clinicians an important antibiotic treatment option for some of their most challenging cases, where indicated.”

ASM Microbe 2017 Presentations:

• Activity of Telavancin (TLV) against Staphylococcus aureus (SA) Causing Pneumonia or Skin and Skin Structure Infections (SSSI) with Concomitant Bloodstream Infections (BSI) in United States (US Hospitals (2012-2016)
• Evaluation of Telavancin Alone and Combined with Ceftaroline or Rifampin against Methicillin-Resistant Staphylococcus aureus (MRSA) in an In Vitro Biofilm Model

Hennepin Life Sciences Presents Pre-Clinical Data on Broad-Spectrum Topical Gel

Hennepin Life Sciences, a clinical-stage biotechnology company, highlighted its pre-clinical data at this year’s ASM Microbe 2017. The data demonstrated that their proprietary broad-spectrum topical gel with bactericidal activity against pathogenic bacteria, eradicates multi-drug resistant urinary tract infection bacteria in vitro and in vivo. Catheter-associated urinary tract infections (CAUTI) account for one of the top four healthcare costs in the United States.

ASM Microbe 2017 Presentations:

• Glycerol Monolaurate Eradicates Multi-Drug Resistant Urinary Tract Infection Bacteria In Vitro and In Vivo

TECHLAB Showcases Its C. DIFF QUIK CHEK COMPLETE

TECHLAB Inc., a leading developer and manufacturer of rapid, non-invasive diagnostic tests for gastrointestinal disease, attended this year’s ASM Microbe 2017 meeting where they showcased the Company’s C. DIFF QUIK CHEK COMPLETE. It’s the only complete test for Antigen and Toxins A&B on a single device. C. DIFF QUIK CHEK COMPLETE allows healthcare professionals to treat the right patients and improve infection prevention measures by differentiating colonized carriers from patients with true disease—molecular tests are unable to make this critical distinction which can lead to overdiagnosis, overtreatment, and increased costs.

Norvir Oral Powder Formulation Approved by FDA

The US Food and Drug Administration (FDA) approved an oral powder formulation (100 mg packet) of AbbVie Inc.’s antiviral Norvir (ritonavir) on June 7, 2017. According to information released by the FDA, “This approval provides for the use of Norvir (ritonavir) oral powder (only for >100 mg dose increments) in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection.” Of note is the fact that this oral powder dosage of Norvir is, “free of alcohol and propylene glycol, both of which are present in the currently marketed Norvir oral solution, making it safer for use in the pediatric population.” The complete revised labeling will be available at DailyMed.

Ready-to-Use Clindamycin in Saline from Baxter Approved by FDA

Baxter International Inc. (NYSE: BAX), a global leader in sterile medication production and delivery announced today that the FDA has approved their ready-to-use clindamycin injection in saline for 3 commonly prescribed formulations (300mg/50mL, 600mg/50mL, 900mg/50mL). According to a press release put out by Baxter, “clindamycin injection in saline provides an alternative to administer to patients for whom the use of dextrose is contraindicated or undesirable.”