Willkie represents Melinta Therapeutics, Inc. and Vatera Healthcare Partners, Melinta’s majority shareholder, in the transaction, which will form a leading, vertically integrated commercial-stage anti-infectives company.
On August 9, Willkie client Melinta Therapeutics, Inc., a privately held company focused on discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, announced that it has entered into a definitive agreement to merge with Cempra, Inc., a publicly traded NASDAQ company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Melinta’s shareholders, including its majority shareholder and Willkie client Vatera Healthcare Partners, will own a majority of the combined company. The merger is expected to create a NASDAQ-listed company committed to discovering, developing and commercializing important anti-infective therapies for patients and physicians in areas of significant unmet need.
In June 2017, the U.S. Food and Drug Administration (FDA) approved Melinta product Baxdela in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is indicated to start patients on either intravenous (IV) or oral formulations. Baxdela has been designated a Qualified Infectious Disease Product (QIDP) by the FDA and as such, qualifies for an additional five years of marketing exclusivity to be added to the five year exclusivity period provided by the Food, Drug, and Cosmetic Act. Melinta is also evaluating Baxdela in an ongoing Phase 3 study in patients with community-acquired bacterial pneumonia (CABP) and plans to initiate a clinical trial in patients with complicated urinary tract infections (cUTI). Baxdela is not currently FDA approved for the treatment of CABP or cUTI. The merger lays a strong foundation for the launch of Baxdela.
Vatera Healthcare Partners is the dedicated healthcare venture capital and private equity investing arm of Vatera Holdings LLC. Vatera Healthcare Partners seeks to identify and develop best-in-class therapies to treat unmet medical needs and improve patients’ lives.
The multidisciplinary Willkie deal team was led by partners Gordon Caplan and Sean Ewen and included partners Michael Katz, Thomas Meloro, Christopher Peters and Jeffrey Goldfarb, and associates Jeffrey Daniel, David Blassberger, Richard Hevier, Andrew Marmer, Karolina Majewski, Rose Ohanesian, Rachel Dooley, Alexandra Awai and Yaniv Maman.