The Medicines Company said today it acquired Rempex Pharmaceuticals for up to $474 million, creating a combined company that expands the buyer’s pipeline by adding Rempex’ numerous drug candidates focused on fighting drug-resistant gram-negative bacteria.
Among those candidates is Carbavance™, a broad-spectrum antibiotic combination agent designed to treat intravenously serious bacterial infections in hospitalized patients due to gram-negative bacteria. Carbavance combines a carbapenem antibiotic with a second drug (RPX7009) that is the first of a novel class of beta-lactamase inhibitors designed by Rempex to inhibit the KPC (Klebsiella pneumoniae carbapenemases) enzyme, the primary drug resistance mechanism to carbapenems. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) globally and have been classified by the CDC to be an urgent antimicrobial resistance threat.
Carbavance is expected to enter registration studies in 2014, having completed Phase I dose-escalation studies in normal subjects. Last year, Rempex presented preclinical data in which Carbavance showed promising activity against key gram-negative pathogens, including E. coli, Klebsiella sp., Acinetobacter sp., and Pseudomonas aeruginosa.
"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," Michael Dudley, PharmD, Rempex’ SVP of research and development and CSO, said in a statement.
In addition to Carbavance, Rempex’ pipeline has included Minocin IV, RPX-602, and a preclinical developmental program of new investigational agents.
The Medicines Company said it 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 CDC says about 63% of Acinetobacter is considered multidrug-resistant, and thus a serious threat in the United States.
Also next year, the Medicines Company expects to submit for U.S. approval RPX-602, a new, improved formulation of Minocin IV.
The company will also continue Rempex' ongoing discovery program to identify other novel beta-lactamase inhibitor-based combination products designed to provide considerable versatility in overcoming resistance mechanisms such as extended-spectrum beta-lactamase (ESBL), serine carbapenemase, and metallo beta-lactamase (MBL) production in gram-negative organisms.
The Medicines Company agreed to shell out $140 million up front for Rempex once the deal closed, plus up to $214 million tied to development and regulatory milestones, and another $120 million tied to achieving commercialization milestones. Boards of directors of both companies have unanimously approved the agreement.
“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," said Clive Meanwell, M.D., Ph.D., chairman and CEO of the Medicines Company.