Biotechnology Events

Home

Ligand Pharmaceuticals, Inc.

Partner : Melinta Therapeutics

.

LIGAND PARTNER MELINTA THERAPEUTICS SUBMITS BAXDELA NEW DRUG APPLICATION FOR HOSPITAL-TREATED SKIN INFECTIONS

October 24, 2016
SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48-to-72 hours. In addition, Baxdela met the primary endpoint, the investigator assessment of clinical cure, for the European Medicines Agency (EMA) in both studies. Baxdela was shown to be well-tolerated among Phase 3 study participants, with less than 1% of patients discontinuing for treatment-related adverse events. With the submission, Ligand has earned a $1.5 million milestone payment. If approved, Ligand is entitled to receive a 2.5% royalty on net sales of the IV formulation of Baxdela and an additional $1.5 million approval milestone payment.

“Baxdela, if approved, represents a potentially attractive treatment option for the nearly 3 million patients hospitalized annually in the U.S. with serious skin infections,” stated Eugene Sun, M.D., Melinta’s Chief Executive Officer. “These patients have a high rate of treatment failure, and frequently have underlying medical conditions that pose challenges to the choice of antibiotic. Baxdela has been tested in over 2,600 patients to date, and was well-tolerated with fewer than 1% of Baxdela-treated patients discontinuing due to treatment-related adverse events.”

Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. FDA, which provides for priority review. According to Melinta’s press release, Melinta could receive a regulatory decision by mid-year 2017 consistent with Prescription Drug User Fee Act (PDUFA) priority review timelines.

“Baxdela has demonstrated in clinical trials a broad spectrum of activity and the ability to treat patients with serious co-morbidities, both of which are compelling characteristics sought by physicians according to our market research. We believe that Baxdela’s ability to treat challenging patients in hospitals will be a major driver of adoption,” concluded John Temperato, Melinta’s President and Chief Operating Officer. “If approved, we plan to support the introduction of Baxdela for the treatment of ABSSSI with a focused acute-care hospital sales force. We believe we can further leverage the resources of such a sales team in the future as we seek to complete clinical studies and file applications to market Baxdela in additional indications such as community-acquired bacterial pneumonia and complicated urinary tract infections.”
More
Source: press release, 10/24/16. http://investor.ligand.com/press-releases/detail/306

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Delafloxacin Infectious DiseaseAcute bacterial skin and skin structure infections (ABSSSI)Topoisomerase II InhibitorTopoisomerase II

Mechanism of action: Delafloxacin is a novel, broad spectrum fluoroquinolone intended for use as an effective and convenient first-line therapy primarily in hospitals prior to the availability of a specific diagnosis. Fluoroquinolones inhibit the topoisomerase II ligase domain, leaving the two nuclease domains intact. This modification, coupled with the constant action of the topoisomerase II in the bacterial cell, leads to DNA fragmentation via the nucleasic activity of the intact enzyme domains.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-10-24

Results: Completed