January 10, Ceftobiprole
Positive results of second phase III study
Top-line results of a second pivotal phase III trial in complicated skin and skin structure infections (cSSSI) demonstrated that ceftobiprole monotherapy was as effective as standard two drug combination therapy covering Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA) infections, Gram-negative infections and difficult-to-treat diabetic foot infections.
February 19, Alitretinoin
Positive results of phase III study
Results of the pivotal phase III study demonstrated that alitretinoin was highly effective in treating patients suffering from severe refractory chronic hand eczema (CHE).
April 25, Alitretinoin
Positive results of second phase III study
Results of the second pivotal phase III study showed that patients suffering from severe CHE with its relapsing
nature benefited from re-treatment after successful initial response to alitretinoin. In addition, patients with an initial incomplete response benefited from an extended treatment period.
May 18, Ceftobiprole
US Regulatory filing
A New Drug Application (NDA) for ceftobiprole was sub mitted to the U.S. Food and Drug Administration (FDA) for the proposed treatment of cSSSI including diabetic foot infections.
May 30, Ceftobiprole
Accelerated assessment by Swissmedic
The Swiss health authority Swissmedic granted ceftobiprole an accelerated assessment of the planned market
authorization application.
June 18, Ceftobiprole
Regulatory filing with European health authorities
A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) for the proposed treatment of complicated skin and soft
tissue infections (cSSTI) including diabetic foot infections.
July 17, Ceftobiprole
Regulatory filing to Canadian health authorities
A New Drug Submission (NDS) for ceftobiprole was filed with the Therapeutic Products Directorate (TPD) of Health Canada for the proposed treatment of cSSSI including diabetic foot infections.
August 23, Ceftobiprole
Regulatory filing to Swiss health authorities
A market authorization application for ceftobiprole was submitted to Swissmedic for the proposed treatment of cSSTI including diabetic foot infections.
September 11, Alitretinoin
Regulatory filing to EU health authorities
Marketing authorization applications were filed in the EU for alitretinoin for the treatment of severe refractory chronic hand eczema (CHE).
September 14, Ceftobiprole
Positive results of first phase III study in pneumonia
Top-line results of phase III trial in community-acquired pneumonia (CAP) requiring hospitalization showed that ceftobiprole monotherapy was as effective as the standard combination therapy covering Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA) infections, and Gram-negative infections.
September 28, Alitretinoin
Regulatory filing to Swiss health authorities
Marketing authorization application for alitretinoin was submitted to Swissmedic for the treatment of severe
refractory chronic hand eczema (CHE).
October 9, Ceftobiprole
Positive results of second phase III study in pneumonia
Top-line results of phase III trial in hospital-acquired pneumonia (HAP) showed that ceftobiprole monotherapy was as effective as the standard combination therapy covering Gram-positive, including methicillin-resistant Staphylococcus aureus (MRSA) infections, and Gram-negative infections.
December 21, Alitretinoin
Regulatory filing to Canadian health authorities
A New Drug Submission (NDS) for alitretinoin was filed with the Therapeutic Products Directorate (TPD) of Health Canada for the treatment of severe refractory hand eczema (CHE).
Balanced Late-stage Product Portfolio
Three late-stage clinical programs allow Basilea to create critical mass for a commercialization organization and future growth. Basilea has multiple assets to build long-term growth through portfolio synergies in addition to innovative
pre-clinical programs progressing to the clinic.
