PARSIPPANY, N.J.—In December, The Medicines Company acquired San Diego-based Rempex Pharmaceuticals Inc., a company with multiple potential new therapies focused on multi-drug resistant gram-negative bacteria, including Carbavance, Minocin IV, RPX-602, and a preclinical developmental program of novel investigational agents. In January, the U.S. Food and Drug Administration (FDA) designated one of those new therapies, Carbavance, as a qualified infectious disease product (QIDP).
The Medicines Company, which focuses on 3,000 leading acute/intensive care hospitals worldwide, offers solutions for acute cardiovascular care, surgery and perioperative care and serious infectious disease care. According to Dr. Clive Meanwell, chairman and CEO of The Medicines Company, “Acute and intensive care hospitals around the world face rapid and increasing antibacterial resistance, especially to gram-negative pathogens. The assets of Rempex, particularly Carbavance, will allow us to intensify our efforts to save lives, alleviate suffering and contribute to the economics of healthcare by serving leading hospitals.”
“We believe that combining The Medicines Company’s outstanding track record of developing and commercializing innovative hospital solutions with the antibiotic drug discovery and development capabilities at Rempex creates a team that is ideally positioned to address the complex problems associated with multidrug resistant infections,” said Daniel Burgess, president and CEO of Rempex. “The combined product pipeline has the potential to offer clinicians and patients a suite of innovative new antibiotic approaches to tackle many of the most vexing problems in infectious disease today.”
In a transaction worth $474 million, The Medicines Company gave Rempex equity holders $140 million in an upfront payment at the closing of the deal. Additionally, The Medicines Company has agreed to pay Rempex equity holders milestone payments after the closing, including certain development and regulatory approval milestones totaling $214 million, and commercial milestones totaling $120 million.
Carbavance is Rempex’s investigational agent that combines a novel beta-lactamase inhibitor (RPX7009) with a carbapenem for intravenous treatment of hospitalized patients with serious infections. RPX7009 is the first of a novel class of beta-lactamase inhibitors designed by Rempex to inhibit the KPC (Klebsiella pneumoniae carbapenemases) enzyme, the primary resistance mechanism to carbapenems. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) globally and are classified by the U.S. Centers for Disease Control and Prevention to be an urgent antimicrobial resistance threat. Carbavance has completed Phase 1 dose-escalation studies in normal subjects, and is expected to enter registration studies in 2014.
The QIDP designation gives Carbavance priority review by the FDA, eligibility for the FDA’s “fast track” status and an additional five years of exclusivity upon approval of the product for intravenous use in the indications of complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia and febrile neutropenia. This designation was granted pursuant to the Generating Antibiotic Incentives Now Act, included in the FDA Safety and Innovation Act that was signed into law in 2012.
“We believe that a priority review and approval will help us bring the novel Carbavance to patients with serious gram-negative infections more quickly,” said Meanwell. “Advancing Carbavance serves our purpose to save lives, alleviate suffering and contribute to the economics of healthcare by serving leading hospitals.”
According to Dr. Michael Dudley, senior vice president of research and development and chief scientific officer of Rempex, “Carbapenems are among the most potent and safe antibiotics and are now regarded as one of the last lines of defense following worldwide dissemination of cephalosporin resistance. We anticipate that Carbavance will profile better than any antibiotic on the market or currently in clinical development for multidrug resistant gram-negative infections.”
In addition, The Medicines Company will market Minocin IV (Minocycline for Injection) in the United States for resistant infections due to Acinetobacter, which is frequently isolated in hospitals and is especially prevalent in intensive care units. The company expects to submit a novel, improved formulation of Minocin IV (RPX-602) for U.S. approval in 2014 and to continue Rempex’s ongoing discovery program to identify other novel beta-lactamase inhibitor-based combination products designed to provide versatility in overcoming resistance mechanisms.
“The most serious gram-negative infections are in seriously ill hospitalized patients, and the most common pathogens are Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter. Rempex has given us leading programs for all three,” concluded Dr. Matthew Wikler, vice president, infectious disease care of The Medicines Company.