The Medicines Company
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The Medicines Company is a biopharmaceutical company, selected for having a pipeline that targets priority pathogens. At the end of 2017, the company announced that it would divest its infectious disease business to Melinta, another biopharmaceutical company in scope of the Benchmark. The divestment was completed in January 2108. The Medicines Company was evaluated in the area of Research & Development only, although it has a number of antibiotics on the market. It performs well compared to other biopharmaceutical companies in scope. The Medicines Company received FDA approval for its meropenem/vaborbactam combination in August 2017. The company engages in public- private partnerships to develop its antibiotic candidates. The company reports no information on access or stewardship provisions for its recently FDA-approved antibiotic. The Medicines Company was not evaluated in the Manufacturing & Production area; however, it is the only company in scope to disclose identities of third-party manufacturers of its antibiotics.
Sales & operations
The Medicines Company is a US-based biopharmaceutical company with core therapeutic areas in infectious disease care, cardiovascular care, surgery and perioperative care. The company’s revenues in the past three years have come primarily from the US sales of its cardiovascular medicine bivalirudin (Angiox® or Angiomax®), a direct thrombin inhibitor. These revenues include approximately USD 71.2 million in royalties derived from the authorised sale of the generic version of bivalirudin (Angiomax®) by Sandoz. In August 2017, the company received FDA approval to commercialise its intravenous formulation of meropenem/vaborbactam (Vabomere™), which is active against multidrug- resistant gram-negative bacteria, for the treatment of complicated urinary tract infections. The compound was developed with funding from BARDA, first under a contract of USD 90 million and, starting in 2016, under a new five-year contract of up to USD 132 million. At the end of 2017, The Medicines Company announced that it would divest its infectious disease business to Melinta, another biopharmaceutical company in scope of the Benchmark. The divestment was completed in January 2018 and included three marketed antimicrobial medicines: meropenem/vaborbactam (Vabomere™), minocycline (Minocin®) and oritavancin (Orbactiv®). The company’s two other marketed antimicrobial medicines (azithromycin and clindamycin) are generic medicines comercialised via a licensing and supply agreement with APP Pharmaceuticals, LLC.
According to publicly available data, The Medicines Company’s portfolio of antimicrobial medicines consists of five antibiotics. One of these antibiotics, clindamycin, is listed on the WHO EML (Section 6), in the Access group. The remaining four medicines are the recently approved meropenem/vaborbactam (Vabomere™), azithromycin (for intravenous administration) and powder-for-injection formulations of two other antibiotics: the broad-spectrum agent minocycline (Minocin®), approved to treat Acinetobacter species infections, and the antibiotic oritavancin (Orbactiv®), active against gram-positive pathogens and indicated for the treatment of acute bacterial skin and skin structure infections in adults, including those due to methicillin-resistant S. aureus (MRSA).
A. Research & Development
1 projects, 1 target priority pathogens
A.2.1-2.2 One antibiotic recently approved.
Biopharmaceutical companies in scope were selected based on their pipelines that target priority bacteria. The Medicines Company received FDA approval for its meropenem/vaborbactam (Vabomere™, formerly Carbavance™) in August 2017. Vaborbactam is a β-lactamase inhibitor (BLI) with a novel chemical structure. Meropenem is an existing carbapenem β-lactam. Vaborbactam restores susceptibility to meropenem in carbapenem-resistant Enterobacteriaceae (CRE).
A.3 One R&D project being developed with public partners.
The Medicines Company developed meropenem/vaborbactam (Vabomere™) in partnership with BARDA, which began with a five-year contract in 2014, followed by a new five-year contract in 2016 (≤ USD 132 million).
A.4 No information on access or stewardship provisions.
The Medicines Company reports no information on access or stewardship provisions for its recently FDA-approved antibiotic. It has signed the Davos Declaration, which includes a general commitment to ensuring access to antimicrobial medicines and vaccines, and to support the appropriate and responsible use of these products.
Pipeline targeting priority pathogens
B. Manufacturing & Production
The Medicines Company is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market, and notable practices relevant to this area are mentioned.
B.2 Only company to disclose identities of third-party suppliers.
On reviewing publicly available information, the Benchmark found that The Medicines Company has disclosed the identities of third-party manufacturers of its antibiotics, per product, in its annual report. It is the only company to publish this information.
C. Appropriate Access & Stewardship
The Medicines Company is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market.
* In January 2018, The Medicines Company completed the divestment of its infectious disease business to Melinta Therapeutics, Inc.
† EML Section 6: Anti-Infective Medicines
§ Net revenues; FYE 31 December 2016