The Medicines Company Reports Discovery of New Series of Beta-Lactamase Inhibitors at ICAAC/ICC 2015

CDC estimates two million people in the U.S. are sickened every year with antibiotic-resistant infections, with at least 23,000 dying as a result

Newly discovered Broad-spectrum Carbapenemase Inhibitors (BCIs) could be significant advancement in the war against multi-drug resistant infections

PARSIPPANY, N.J.--()--Researchers at The Medicines Company presented data today on a new series of Beta-Lactamase Inhibitors (BLIs) at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, CA. The new series of investigational compounds, termed Broad-spectrum Carbapenemase Inhibitors, or BCIs, are the only known agents that have shown in vitro to inhibit both families (serine and metallo types) of beta-lactam enzymes produced by some multidrug resistant bacteria that inhibit the effectiveness of certain antibiotics.

“Growing resistance to our current arsenal of antibiotics is causing widespread concern among the infectious disease community,” said Karen Bush, PhD, Professor of Practice in Biotechnology, Indiana University, and noted global expert in beta-lactamases. “The possibility of having a compound which can work against both families of beta-lactam enzymes could be a significant advancement in the war against multi-drug resistant infections.”

The U.S. Centers for Disease Control and Prevention estimates that more than two million people are sickened every year with antibiotic-resistant infections in the US, with at least 23,000 dying as a result2. Beta-lactam antibiotics are considered to be first line agents for the treatment of serious hospital-acquired gram-negative infections. Unfortunately, resistance to these agents has grown rapidly over the past decade, leaving clinicians with limited choices for treating critically ill patients in the hospital3.

“We are excited about rapidly advancing these newer broad-spectrum carbapenemase inhibitors towards the clinic as they could potentially provide a novel weapon against resistant, gram-negative bacterial strains, where few options exist,” said Michael Dudley, PharmD, Senior Vice President and Head of Health Science R&D and Co-Leader of the Infectious Diseases Global Innovation Group at The Medicines Company. “These compounds exceed the in vitro profile of currently available beta-lactamase inhibitor combinations by inhibiting carbapenem-inactivating enzymes (carbapenemases) of both families (serine and metallo types) that are responsible for resistance to beta-lactam antibiotics.

Reliance upon the carbapenem class of antibiotics to treat hospital-acquired infections in critically-ill patients has increased greatly in the wake of the dissemination of cephalosporin-hydrolyzing extended-spectrum beta-lactamases (ESBLs)1. Resistance to carbapenems is growing worldwide due to serine carbapenemases such as KPC and OXA, and metallo carbapenemases like NDM. Few treatment options are available to treat these often multidrug-resistant infections.

The same Medicines Company team that discovered the BCI compounds is also developing the investigational beta-lactamase inhibitor combination product CARBAVANCE® (meropenem/RPX7009), currently in Phase 3 clinical trials. CARBAVANCE® as well as products from this new series of molecules have the potential to resurrect the usefulness of existing carbapenem agents against resistant bacteria.

“The Medicines Company is committed to discovering new solutions for multidrug resistant bacteria and improving the arsenal to provide clinicians with effective options to improve patient outcomes,” said Olga Lomovskaya, PhD, Vice President of Microbiology at The Medicines Company. “While still at an early stage, broad-spectrum carbapenemase inhibitors (BCIs) hold exciting possibilities to restore the activity of our most powerful antibiotics.”

About CARBAVANCE® (meropenem/RPX7009)

CARBAVANCE®, an investigational combination not approved for commercial use in any market, is a combination of meropenem and RPX7009 administered as a fixed combination by IV infusion and is being developed to treat serious gram-negative infections, such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.

CARBAVANCE® was designed to address gram-negative bacteria that produce new beta-lactamase enzymes that have spread in the US and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of carbapenem-resistant Enterobacteriaceae (CRE) in the US and are classified by the US Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat. CARBAVANCE® is designated as a qualified infectious disease product (QIDP) by the US FDA and thus eligible for benefits under the GAIN Act.

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “hopes,” and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether our product candidates, including the BCIs and CARBAVANCE®, will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

References
1 Clin Infect Dis 2011; 52 (suppl 5): S397-S428.
2 CDC. Antibiotic Resistance Threats in the United States, 2013. http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed Aug. 27, 2015.
3 Ruppe E, Woerther, PL, Barbier, F. Ann Intensive Care 2015;5:21

Contacts

The Medicines Company
Media:
Bob Laverty, 973-290-6162
Mobile 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
973-290-6400
Investor.Relations@themedco.com

Contacts

The Medicines Company
Media:
Bob Laverty, 973-290-6162
Mobile 609-558-5570
Vice President, Communications
Robert.Laverty@themedco.com
or
Investor Relations:
973-290-6400
Investor.Relations@themedco.com