São Paulo, March 2022 – Eurofarma, one of the most innovative pharmaceutical companies in Brazil, is launching Delabaxi®—an innovative medication indicated for the treatment of complicated skin and soft tissue infections—in Latin America. It is the product with the highest spectrum among quinolones and has shown efficacy and safety in monotherapy, with no need for dose adjustment in patients frequently affected by these infections, such as obese and diabetic individuals^1,2.

The new medication, which is already available in Brazil, Argentina, Chile, Peru, and Uruguay, is intended for hospital use and comes to market due to a demand for new antimicrobial therapies to combat severe bacterial infections. Delabaxi®, whose active ingredient is delafloxacin meglumine, shows great potential, especially due to its efficacy and safety in complicated infections.

“The launch of this product in several countries where we operate confirms our motivation to bring real innovation to patients. With this move, our goal is to expand our share in the market for innovative molecules and continue Eurofarma’s growth and expansion process,” said Martha Penna, Vice President of Innovation at Eurofarma.

Advantages and Administration

Delabaxi® is an intravenous antimicrobial medication indicated for the treatment of complicated skin and soft tissue infections (cSSTI) in adults. It is a member of the class of quinolones—antimicrobial medications that have bactericidal action, as they prevent bacterial replication. The product is innovative, because its molecule combines important attributes for combating infections:

1. It is the only medication in the broad-spectrum quinolone category, i.e., medications that combat gram-positive³ and gram-negative⁴ bacteria, including MRSA (Methicillin-resistant Staphylococcus aureus), a bacterium that became highly resistant to several antimicrobials over the years and accounts for 30% to 60% of all skin infections, or even 80% according to some studies^5,6,7,8.
2. In acidic environments, i.e., those that most affect skin and tissue wounds, the action of the medication is enhanced⁹.
3. Because of its molecular structure, the product does not require serum monitoring, i.e., it does not require dose adjustment, as is common with several medications for complicated skin infections. This allows for greater safety in medication management and requires less human resources during treatment^9,10.

It is also worth mentioning that the arrival of the new product brings together a consistent profile of safety and tolerability, even in patients with challenging comorbidities. The medication has a low level of adverse events: One of its trials recorded a discontinuation rate of only 0.9%, lower than the 2.8% rate of one of its main competitors. This contributes to treatment continuity, a lower potential for drug interactions, and the possibility of reducing hospital costs².

History and Approvals

Eurofarma has been seeking to bring delafloxacin to the Latin American market since 2015, when it acquired an equity interest in Melinta, the American pharmaceutical company responsible for the product (under another name) in the United States. Since then, Eurofarma has obtained the right to market, sell, and distribute the molecule in Brazil and Latin America, in addition to receiving a technology transfer, which enabled the company to develop the medication at its main production plant in Itapevi, SP.

According to the partnership, Eurofarma is responsible for obtaining regulatory approval for Delabaxi® in 14 countries, in addition to those where the product is already being marketed: Belize, Bolivia, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, and Venezuela.

 
Sources:
 
1.    Giordano PA, Pogue JM, Cammarata S. Analysis of Pooled Phase III Efficacy Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Apr 8;68(Suppl 3):S223-S232. doi: 10.1093/cid/ciz006. PMID: 30957167; PMCID: PMC6452004.
2.    Bassetti M, Hooper D, Tillotson G. Analysis of Pooled Phase 3 Safety Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections. Clin Infect Dis. 2019 Apr 8;68(Suppl 3):S233-S240. doi: 10.1093/cid/ciy1080. PMID: 30957169; PMCID: PMC6451993.
3.     Gram-positive: Staphylococcus aureus (strains resistant to methicillin [MRSA] and susceptible to methicillin [MSSA]), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis.

4.     Gram-negative: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

5.     DataSus. In: http://tabnet.datasus.gov.br/cgi/deftohtm.exe?sih/cnv/niuf.def

6.     Gelatti LC, Bonamigo RR, Inoue FM, Carmo MS, Becker AP, Castrucci FM, Pignatari AC, D' Azevedo PA. Community-acquired methicillin-resistant Staphylococcus aureus carrying SCCmec type IV in southern Brazil. Rev Soc Bras Med Trop. 2013 Jan-Feb;46(1):34-8.

7.    Bonesso MF, Marques SA, Camargo CH, Fortaleza CM, da Cunha Mde L.Community-associated methicillin-resistant Staphylococcus aureus in non-outbreak skin infections. Braz J Microbiol. 2015 Mar 4;45(4):1401-7
8.    Paternina-de la Ossa R, Prado SID, Cervi MC, Lima DAFDS, Martinez R, Bellissimo-Rodrigues F. Is community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) an emerging pathogen among children in Brazil? Braz J Infect Dis. 2018 Sep - Oct;22(5):371-376.
9.     Bambeke FV.  Delafloxacin, a non-zwitterionic fluoroquinolone in Phase III of clinical development: evaluation of its pharmacology, pharmacokinetics, pharmacodynamics and clinical efficacy.  Future Microbiol. (2015) 10(7), 1111–1123

10.   Hoover et al. Delafloxacin Pharmacokinetics in Subjects With Varying Degrees of Renal Function. The Journal of Clinical Pharmacology 2018, 58(4) 514–521

*INSTITUTIONAL MATERIAL NOT INTENDED FOR COMMERCIAL/ADVERTISING PURPOSES
 

About Eurofarma Group

The Eurofarma Group has been operating in the healthcare industry since its establishment in 1972, producing and marketing innovative products and services to improve people’s quality of life. The company operates in all major segments, such as Prescription, Non-Prescription, Generic, Hospital, and Oncology.

Present in 20 countries and with 10 production plants in Latin America, it generated net sales of BRL 7 billion in 2021 and employs more than 7,600 people.

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G&A – Public Relations – Eurofarma

Priscilla Rosa +55 11 98654-0104 - priscilla@gaspar.com.br

Guilherme Gaspar - +55 11 98285-6000 - guilherme@gaspar.com.br