Paratek publishes positive PhIII data on approved Nuzyra; Allergan settles opioid lawsuits in two Ohio counties
→ Paratek Pharmaceuticals‘ $PRTK Nuzyra (omadacycline) has met all primary and secondary clinical study endpoints in their OASIS-2 Phase III clinical trial, according to results published in The Lancet Infectious Diseases. In the study, involving 735 adults with ABSSSI, Nuzyra was shown to be as effective as Pfizer‘s $PFE twice-daily oral-only Zyvox (linezolid). Nuzyra is currently available in the US as a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and ABSSSI. The drug is also being studied for the treatment of urinary tract infections.
→ Wrapping a week of big opioid lawsuit news, Allergan $AGN disclosed that it’s settled with two Ohio counties, avoiding a multi-defendant trial scheduled for October. The drugmaker — which contends that it has not actively marketed or promoted any opioid products since 2013 and that it does not have liability for generic claims — said it’s seeking indemnification from other parties in the federal litigation. Per the settlement, Allergan is paying $1.9 million to Summit County and $3.1 million to Cuyahoga County.
→ On the heels of a fast track designation, Akari Therapeutics has added orphan status to its lead drug nomacopan’s credentials. The C5 inhibitor is being positioned as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy in pediatric patients. The biotech plans to commence a pivotal trial in the fourth quarter this year, said COO Clive Richardson, who was installed as interim CEO more than a year ago after David Horn was ousted amid a scandal.