Melinta Therapeutics, Inc.

Stock Exchange: XNAS Ticker: MLNT HQ: New Haven, CT, USA Employees: 50 Signatory to Davos Decl: Yes Signatory to Industry Roadmap: No
Performance by research area
How Melinta Therapeutics, Inc. was evaluated
1 2.1 2.2 2.3 3 4
R&D A
1 2 3
M&P B
1 2 3 4 5 6 7
AA&S C
Applicable indicator Not applicable

Performance

Melinta is a biopharmaceutical company, selected for having a pipeline that targets priority pathogens. At the end of 2017, Melinta merged with Cempra and, in January 2018, acquired The Medicines Company’s infectious disease business. The company was evaluated in the area of Research & Development only. It is a mid-performing company compared to the biopharmaceutical companies in scope. The company has five projects in its antimicrobial R&D pipeline, four of which target priority pathogens. Melinta has one antibiotic approved by the FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSI), and has licensed the commercialisation and co-development rights of this product to partners in various geographic areas.

Sales & operations

Melinta is a US-based biopharmaceutical company focussing on the development of antibiotics for infections caused by drug-resistant bacteria. The company was founded in 2000 (as Rib-X Pharmaceuticals), by Yale University faculty, including a co-winner of the 2009 Nobel Prize for Chemistry for studies on the function of the ribosome, a cellular structure responsible for protein synthesis. Based on these studies, the company’s drug discovery platform allows for atomic-level analysis of interactions between drug candidates and their bacterial targets at the ribosome, thereby aiding the design of antibiotics capable of bypassing resistance mechanisms. Melinta has used this platform to establish its preclinical research programme targeting the ‘ESKAPE’ pathogens: E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and Enterobacteriaceae. The company’s only antimicrobial medicine on the market, delafloxacin (Baxdela™), was acquired from Wakunaga Pharmaceutical in 2006 and approved by the FDA for the treatment of ABSSSI in 2017. It is available in both intravenous and oral formulations. The latter is expected to offer advantages in terms of administration and reduced hospital admission rates. Recent funding rounds for the company have been led by Vatera Holdings LLC (e.g., USD 67 million in 2015), together with Quadrant Capital Advisors, Inc., Arisaph Pharmaceuticals, Inc. and Malin Corporation plc. At the end of 2017, Melinta merged with Cempra and announced the acquisition of the infectious disease business of The Medicines Company, both biopharmaceutical companies in scope of the Benchmark. The latter acquisition was completed in January 2018 and included three antimicrobial medicines marketed by The Medicines Company: the recently launched meropenem/vaborbactam (Vabomere™) and established products oritavancin (Orbactiv®) and minocycline (Minocin®). On merging with Cempra, Melinta became listed on the NASDAQ stock exchange with ticker MLNT.

Antimicrobial Portfolio

Melinta has one antibiotic on the market, delafloxacin (Baxdela™), currently not included in the WHO EML (Section 6). Delafloxacin was approved by the US FDA in June 2017 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is available in both intravenous and oral formulations. The oral formulation is expected to offer advantages in terms of ease of administration and reduced hospital admission rates.

Opportunities

Develop access and stewardship plans for products on the market. Regarding products on the market, e.g., meropenem/vaborbactam (Vabomere™), part of The Medicines Company’s acquisition, Melinta can plan for access and stewardship provisions, e.g., through partnerships. Regarding delafloxacin (Baxdela™), Melinta has signed licensing agreements to help ensure access to a range of countries in scope.* Melinta can develop a strategy for ensuring appropriate use of the product in all countries.

Plan ahead for access and stewardship during R&D. Melinta merged with Cempra in 2017 and now has a total of three antibiotic candidates in late-stage clinical development. The company can ensure access and stewardship provisions are in place for these candidates, for example, through partnerships.

A. Research & Development

Indicators scored on
  • 1
  • 2.1
  • 2.2
  • 2.3
  • 3
  • 4
Antimicrobial pipeline
5 projects, 4 target priority pathogens

A.2.1-2.2 Four R&D projects that target a priority pathogen. 

Biopharmaceutical companies in scope were selected based on their pipelines that target priority bacteria. Melinta has five projects in its antimicrobial R&D pipeline, four of which target priority bacteria. Its antibiotic, delafloxacin (Baxdela™), is a fluoroquinolone targeting both gram-negative and gram-positive bacteria (including methicillin-resistant S. aureus), many of which are resistant to other quinolones. The compound was approved by the FDA in 2017 for the treatment of ABSSSI, in both oral and intravenous formulations. It is currently in Phase III clinical trials for community-acquired bacterial pneumonia. Additionally, Melinta has two preclinical R&D projects for the development of new drug classes (such as pyrrolocytosines) through its ESKAPE pathogen programme, and one macrolide discovery programme.

A.3 No public-private partnerships reported. 

Melinta conducts R&D in-house and with private-sector partners. It does not participate in public-private partnerships, or in partnerships with non-profit organisations, for antimicrobial R&D.

A.4 Access provision in place, but no information regarding stewardship. 

Melinta reports that it has an access provision in place for its recently approved antibiotic, but reports no information on stewardship provisions. In 2017, Melinta licensed the commercialisation and co-development rights of delafloxacin (Baxdela™) to the Menarini Group in 68 countries in Europe, Asia-Pacific, and the Commonwealth of Independent States (CIS). Additionally, Melinta and Malin Corporation plc entered into an agreement for the commercialisation and distribution of the drug in certain countries in the Middle East and Africa. The company has also entered into a similar agreement with Eurofarma Laboratórios, one of the largest pharmaceutical companies in Brazil, for the development and commercialisation of the medicine in Brazil and other Latin American countries where Eurofarma operates. For this indicator, countries in scope are 106 low- and middle-income countries where access to medicine is likely limited. Regarding stewardship provisions, Melinta signed the Davos Declaration, which includes a general commitment to support the appropriate and responsible use of antimicrobial medicines and vaccines.

Pipeline targeting priority pathogens

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B. Manufacturing & Production

Melinta is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market.

C. Appropriate Access & Stewardship

Melinta is a biopharmaceutical company that did not meet the criteria for evaluation in this Research Area. It does, however, have products on the market.


* Countries in scope are 106 low- and middle-income countries where access to medicine is likely limited.



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