Published in: February 26, 2018
and updated in: February 2, 2022
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The agreement with Melinta Therapeutics is expected to cover all countries in Latin America and Caribbean
São Paulo, February 26th, 2018 - Eurofarma Laboratórios S.A, one of the largest companies in the pharmaceutical market, 100% Brazilian-owned multinational, submitted this month the first Latin American authorization application for Delabaxi® (delafloxacin) in Argentina. The process should be finalized in the end of the year, and sales should start in the end of 2018 or beginning of 2019.
Launched in February 2018 as Baxdela™ in the USA, this is the first application out of the North American market. "Meeting unmet medical demands through innovative products, with special attention to anti-infectives, coupled with our ambitious international expansion plan, continue to drive our growth. Having a growing investment in R & D, which is expected to reach 10% of our revenues in the next few years, and maintaining a successful partnership with an avant-garde company such as Melinta, is a source of pride and certainty that we are on the right track " , reinforces Martha Penna, vice president of Innovation of Eurofarma.
Lyn Baranowski, Melinta’s SVP of corporate development and strategy, added, “Eurofarma has been a strong and motivated partner to date, and we are excited to report on their regulatory submission in Argentina, the first for delafloxacin outside of the United States. Eurofarma plans to complete additional submissions within their Latin American territories in the coming months, specially in Chile, Mexico and Uruguay, with expectations to launch in late 2018.”
Under an agreement initiated in 2015 and expanded in 2017, Eurofarma Laboratórios is responsible for obtaining regulatory approval for delafloxacin in 19 countries: Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela. Melinta received an undisclosed upfront payment upon signing of the agreement and will receive milestones and royalties on future sales.
About Delafloxacin
Delafloxacin tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections). It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Delabaxi® for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
Delabaxi® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
IMPORTANT SAFETY INFORMATION:
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
Tendinitis and tendon rupture
Peripheral neuropathy
Central nervous system effects
Discontinue Delabaxi® immediately and avoid the use of fluoroquinolones, including Delabaxi®, in patients who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Delabaxi® in patients with known history of myasthenia gravis.
Contraindications
Delabaxi® is contraindicated in patients with known hypersensitivity to Delabaxi® or other fluoroquinolones.
Warnings and Precautions
Risk of tendinitis, tendon rupture, peripheral neuropathy and central nervous system effects is increased with use of fluoroquinolones. Discontinue Delabaxi® immediately at the first signs or symptoms of any of these serious adverse reactions.
Avoid Delabaxi® in patients with known history of myasthenia gravis.
Hypersensitivity Reactions may occur after first or subsequent doses of Delabaxi®. Discontinue Delabaxi® at the first sign of hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in users of nearly all systemic antibacterial drugs, including Delabaxi®. Evaluate if diarrhea occurs.
Prescribing Delabaxi® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in patients treated with Delabaxi® were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).
Use in Specific Populations
In patients with severe renal impairment (eGFR of 15-29 mL/min/1.73 m2) dosing of Delabaxi® should be dosed at 200 mg IV every 12 hours or 450 mg orally every 12 hours. Delabaxi® is not recommended in patients with End Stage Renal Disease (eGFR of <15 mL/min/1.73 m2) due to insufficient information to provide dosing recommendations.
About the Eurofarma Group
As the first 100% Brazilian-owned multinational pharmaceutical company, Eurofarma has been in existence for 45 years, has 6,500 employees, and has operations in 20 Latin American countries.
With 12 manufacturing plants in the region, the company has more than 280 products in its portfolio. In 2016, it produced more than 290 million units and reached revenues of R$3.3 billion, 15.7% higher than the previous year. The Group invests approximately 5.5% of its net sales in Research & Development and maintains a pipeline of more than 175 projects.
About Eurofarma Brazil
Considered one of the best companies to work for, Eurofarma Brazil is also considered the most sustainable pharmaceutical company in the country based on an analysis by the Exame Sustainability Guide. With operations in all main pharmaceutical segments including Medical Prescriptions, Generics, Hospital, Oncology, Veterinary, and Bids and Services to Third Parties, Eurofarma has the largest medical advertising salesforce in Brazil with more than 2,000 representatives that together perform 450,000 medical contacts per month. The company has the 4th largest pharmacy system in the country and has a portfolio of medicines that is the 2nd largest by prescription volume.
For more information, visit www.eurofarma.com.br
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new and better therapeutic solutions. Its four marketed products include Baxdela™ (delafloxacin); Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
For more information
Eurofarma
G&A Relações Públicas -
Juliana Guerra | (11) 3065-3045 | 5090-8600 r.8369 juliana@gaspar.com.br
Guilherme Gaspar | (11) 3065-3049 | guilherme@gaspar.com.br
São Paulo, February 26th, 2018 - Eurofarma Laboratórios S.A, one of the largest companies in the pharmaceutical market, 100% Brazilian-owned multinational, submitted this month the first Latin American authorization application for Delabaxi® (delafloxacin) in Argentina. The process should be finalized in the end of the year, and sales should start in the end of 2018 or beginning of 2019.
Launched in February 2018 as Baxdela™ in the USA, this is the first application out of the North American market. "Meeting unmet medical demands through innovative products, with special attention to anti-infectives, coupled with our ambitious international expansion plan, continue to drive our growth. Having a growing investment in R & D, which is expected to reach 10% of our revenues in the next few years, and maintaining a successful partnership with an avant-garde company such as Melinta, is a source of pride and certainty that we are on the right track " , reinforces Martha Penna, vice president of Innovation of Eurofarma.
Lyn Baranowski, Melinta’s SVP of corporate development and strategy, added, “Eurofarma has been a strong and motivated partner to date, and we are excited to report on their regulatory submission in Argentina, the first for delafloxacin outside of the United States. Eurofarma plans to complete additional submissions within their Latin American territories in the coming months, specially in Chile, Mexico and Uruguay, with expectations to launch in late 2018.”
Under an agreement initiated in 2015 and expanded in 2017, Eurofarma Laboratórios is responsible for obtaining regulatory approval for delafloxacin in 19 countries: Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela. Melinta received an undisclosed upfront payment upon signing of the agreement and will receive milestones and royalties on future sales.
About Delafloxacin
Delafloxacin tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections). It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Delabaxi® for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
Delabaxi® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
IMPORTANT SAFETY INFORMATION:
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
Tendinitis and tendon rupture
Peripheral neuropathy
Central nervous system effects
Discontinue Delabaxi® immediately and avoid the use of fluoroquinolones, including Delabaxi®, in patients who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Delabaxi® in patients with known history of myasthenia gravis.
Contraindications
Delabaxi® is contraindicated in patients with known hypersensitivity to Delabaxi® or other fluoroquinolones.
Warnings and Precautions
Risk of tendinitis, tendon rupture, peripheral neuropathy and central nervous system effects is increased with use of fluoroquinolones. Discontinue Delabaxi® immediately at the first signs or symptoms of any of these serious adverse reactions.
Avoid Delabaxi® in patients with known history of myasthenia gravis.
Hypersensitivity Reactions may occur after first or subsequent doses of Delabaxi®. Discontinue Delabaxi® at the first sign of hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in users of nearly all systemic antibacterial drugs, including Delabaxi®. Evaluate if diarrhea occurs.
Prescribing Delabaxi® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in patients treated with Delabaxi® were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).
Use in Specific Populations
In patients with severe renal impairment (eGFR of 15-29 mL/min/1.73 m2) dosing of Delabaxi® should be dosed at 200 mg IV every 12 hours or 450 mg orally every 12 hours. Delabaxi® is not recommended in patients with End Stage Renal Disease (eGFR of <15 mL/min/1.73 m2) due to insufficient information to provide dosing recommendations.
About the Eurofarma Group
As the first 100% Brazilian-owned multinational pharmaceutical company, Eurofarma has been in existence for 45 years, has 6,500 employees, and has operations in 20 Latin American countries.
With 12 manufacturing plants in the region, the company has more than 280 products in its portfolio. In 2016, it produced more than 290 million units and reached revenues of R$3.3 billion, 15.7% higher than the previous year. The Group invests approximately 5.5% of its net sales in Research & Development and maintains a pipeline of more than 175 projects.
About Eurofarma Brazil
Considered one of the best companies to work for, Eurofarma Brazil is also considered the most sustainable pharmaceutical company in the country based on an analysis by the Exame Sustainability Guide. With operations in all main pharmaceutical segments including Medical Prescriptions, Generics, Hospital, Oncology, Veterinary, and Bids and Services to Third Parties, Eurofarma has the largest medical advertising salesforce in Brazil with more than 2,000 representatives that together perform 450,000 medical contacts per month. The company has the 4th largest pharmacy system in the country and has a portfolio of medicines that is the 2nd largest by prescription volume.
For more information, visit www.eurofarma.com.br
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new and better therapeutic solutions. Its four marketed products include Baxdela™ (delafloxacin); Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
For more information
Eurofarma
G&A Relações Públicas -
Juliana Guerra | (11) 3065-3045 | 5090-8600 r.8369 juliana@gaspar.com.br
Guilherme Gaspar | (11) 3065-3049 | guilherme@gaspar.com.br