Corporate News Blog – FDA Grants Approval to The Medicines Co.’s VABOMERE(TM)

Research Desk Line-up: SteadyMed Post Earnings Coverage

LONDON, UK / ACCESSWIRE / September 1, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for The Medicines Co. (NASDAQ: MDCO), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=MDCO. The Company announced on August 30, 2017, the approval for VABOMERE™ injection by the US Food and Drug Administration (FDA), for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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VABOMERE™ is likely to be available in Q4 2017. The drug’s approval prompted a milestone payment obligation of $40 million, to be paid to the former security holders of Rempex Pharmaceuticals, Inc., which was acquired by The Medicines on December 04, 2013.

VABOMERE™ Represents a Significant Advancement in Addressing KPC-Producing Enterobacteriaceae

Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines, stated that the Company is grateful to the FDA for advancing the development and approval of VABOMERE™ for cUTI on an accelerated basis to make this important treatment available to physicians, and patients carrying significant risks of death and mortality. VABOMERE™ represents a significant new advancement in addressing KPC-producing Enterobacteriaceae, for which there are currently limited treatment options. Clive added that the Company looks forward to a successful US launch of VABOMERE™, leveraging its established, fully dedicated commercial infrastructure, and to expanding VABOMERE™ into other global markets.

Approval Supported by TANGO-1 Study

Approval of VABOMERE™ was followed by the evaluation of data from TANGO-1, a Phase-III, multi-center, randomized, double-blind, and double-dummy study to evaluate the efficacy, safety, and tolerability of VABOMERE™ compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults. The trial enrolled 550 adult patients each for up to 10 days. Overall success was observed in around 98.4% patients in the meropenem-vaborbactam group and in 94.3% patients in the piperacillin-tazobactam group.

The Medicines Collaborated with BARDA for VABOMERE™’s Rapid Development

Michael Dudley, Senior Vice President, Head of R&D and Co-Leader for The Medicines’ Infectious Disease Business, expressed his gratefulness for the support of patients, families, and investigators that contributed to the rapid development of VABOMERE™ as it progressed from discovery in the laboratories to availability for patients in under eight years. This unprecedented speed has been due to the Company’s outstanding collaboration with the Biomedical Advanced Research and Development Authority (BARDA).

BARDA Awarded Cost-Sharing Contract to The Medicines for Supporting VABOMERE™’s Development

As per the news release in February 2014, The Medicines’ Infectious Disease Business was awarded a cost-sharing contract by the BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services (HHS), of which $55.8 million in federal funds were obligated to support the development of VABOMERE™.

On September 21, 2016, The Medicines entered into a partnership with the BARDA, pursuant to which the former was provided with up to $132 million for supporting the development of new antibiotics to fight drug-resistant, gram-negative infections. It was awarded $32 million in initial funding to support further development of VABOMERE™ and advancement of the Company’s early stage pipeline.

About VABOMERE™

VABOMERE™ is indicated for the treatment of patients of 18 years of age and older with cUTI. VABOMERE™ was developed by The Medicines’ Infectious Disease Business. It is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE™ and other antibacterial drugs, VABOMERE™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

The most common adverse reactions seen with VABOMERE™ were headache, infusion site reactions, and diarrhea. Serious risks associated with VABOMERE™ treatment include allergic reactions and seizures.

Last Close Stock Review

At the closing bell, on Thursday, August 31, 2017, Medicines Co.’s stock slightly advanced 0.71%, ending the trading session at $36.69. A total volume of 1.39 million shares have exchanged hands, which was higher than the 3-month average volume of 1.16 million shares. The stock gained 8.10% since the start of the year. The stock currently has a market cap of $2.59 billion.

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