Date: 2016-08-17
Type of information: Distribution agreement
Compound: Zevtera® (ceftobiprole medocaril) Cresemba® (isavuconazole)
Company: Basilea Pharmaceutica (Switzerland) Hikma Pharmaceuticals (UK)
Therapeutic area: Infectious diseases
Type agreement: licensing - distribution
Action mechanism:
- antibiotic/cephalosporin. Ceftobiprole belongs to the class of antibacterial agents known as cephalosporins. Its broad spectrum activity encompasses Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. The rights for ceftobiprole have been transferred back to Basilea from Cilag GmbH International, a Johnson & Johnson company, in February 2011.
- systemic antifungal agent. Isavuconazole is an intravenous and oral broad-spectrum antifungal. It has a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of the enzyme lanosterol 14 alpha demethylase. In collaboration with Astellas Pharma , isavuconazole is being investigated in phase 3 clinical studies for the treatment of severe invasive fungal infections. The drug demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such asCandida species) and molds (such as Aspergillus species) as well as in-vitro activity against less prevalent but often fatal molds including those that cause mucormycosis. In clinical studies to date, isavuconazole achieved predictable drug levels supporting reliable dosing and a switch from intravenous administration to a once-daily oral dose. The intravenous formulation of isavuconazole, which is water-soluble, does not contain potentially kidney damaging solubilizers and has the potential to be given also to patients with pre-existing renal impairment.
Disease: severe community-acquired and hospital-acquired pneumonia, invasive aspergillosis, mucormycosis
Details:
- • On October 15, 2015, Hikma Pharmaceuticals announced that it has entered into an exclusive licensing, supply and distribution agreement with Basilea Pharmaceutica International for its new generation cephalosporin Zevtera® (ceftobiprole medocaril). Under the terms of the agreement, Hikma will have the exclusive rights to register, distribute and market Zevtera® in the Middle East and North Africa (MENA) markets leveraging Hikma’s strong local presence, sales and marketing capabilities and regulatory expertise. Zevtera® has received approvals in 13 European countries and Canada for the treatment of adult patients with community- and hospital-acquired pneumonia (CAP, HAP), excluding ventilator-associated pneumonia (VAP), and has been launched in Germany, France, Italy and the UK.
Financial terms: The financial terms of the agreement were not disclosed.
Latest news:
- • On August 17, 2016, Hikma Pharmaceuticals announced that its wholly owned subsidiary Hikma Pharmaceuticals LLC has extended its current exclusive licensing, supply and distribution agreement with Basilea Pharmaceutica for its anti-infective product Zevtera® (ceftobiprole), to also include Basilea’s injectable and oral anti-fungal product Cresemba® (isavuconazole). Under the terms of the amended agreement, Hikma will have the exclusive rights to register, distribute and market Cresemba® in all its MENA markets leveraging Hikma’s strong local presence, sales and marketing capabilities and regulatory expertise.
- Cresemba® has received approvals across Europe and the US. In March 2015, the product was approved by the US Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European marketing authorisation was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
Is general: Yes
