Anonymous
08-09-2007, 09:25 PM
Basilea Maintains Global Commercialization Rights for BAL8557, its Novel
Broad-Spectrum Antifungal Agent and Third Compound Entering Phase III
Basel, Switzerland, 19 December 2005
Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that it maintains global
marketing and manufacturing rights to BAL8557 following Roche's decision not to
exercise its opt-in right. BAL8557 will be Basilea’s third compound to enter phase III
clinical development, planned to commence in 2006.
"We are very excited by this opportunity. Our recently announced positive phase II clinical
results confirm BAL8557 as the third key product in our late-stage portfolio. Owning all rights
to BAL8557, including both marketing and manufacturing rights, gives us full control to
maximize product value with a partner or alone. BAL8557 will be a highly attractive and
complementary product to our antibiotic ceftobiprole for the hospital anti-infectives market.
We have a solid financial position with no royalties or other payments on BAL8557 to Roche
and are enthusiastic about moving this promising compound into phase III clinical
development to join our other two phase III compounds; ceftobiprole, Basilea’s first-in-class,
broad-spectrum antibiotic effective against resistant bacteria, and alitretinion, our vitamin A
derivative for refractory chronic hand dermatitis. This is a great opportunity for us to
capitalize on our success and opens the possibility to add commercialization capabilities to
our fully integrated research and development organization. Basilea is uniquely positioned in
anti-infectives as an emerging biopharmaceutical company with a significant research base
plus a late stage development portfolio of competitively profiled products", said Dr. Anthony
Man, Basilea's CEO.
Positive BAL8557 Phase II Results
In September this year Basilea released positive phase II results on BAL8557. The phase II
study compared three dosing regimens of BAL8557 to fluconazole in the treatment of
esophageal candidiasis to demonstrate antifungal efficacy in patients. All three BAL8557
dosing regimens were highly effective for the stringent primary endpoint of endoscopically
confirmed complete clinical cure. Endoscopically confirmed clinical cure at the end of therapy
was achieved in 95%, 95% and 98% of patients treated with BAL8557 for the 100 mg daily,
50 mg daily and 400 mg weekly doses, respectively, and in 95% of patients treated with
100 mg fluconazole. Statistical non-inferiority to comparator was confirmed for all three
BAL8557 dosing regimens. Excellent activity was also confirmed in secondary endpoints,
including microbiological cure, therapeutic responses and follow-up assessments at two and
four weeks. In the trial, BAL8557 was safe and well tolerated with an adverse event profile
comparable to fluconazole. Planned phase III trials will target severe invasive yeast (candida)
and mold infections (including aspergillus and zygomycetes).
The Need for New Antifungal Therapies
The expansion of the immunocompromised patient population including cancer patients with
chemotherapy induced neutropenia, transplant recipients receiving immunosuppressive
therapy and HIV infected patients has led to an increased incidence of invasive fungal
infections. In major markets alone, an estimated nine million patients are at risk for invasive
fungal infection with more than two million patients treated. Currently available antifungal
drugs are reported to fail in more than 50% of patients with acute invasive aspergillosis and
in 20-30% of patients with candidemia. There is a high medical need to address the
limitations of current therapy, most importantly the gaps in the antifungal spectrum, unwanted
side effects, dosing flexibility as well as the development of resistance.
About BAL8557
BAL8557 is a novel extended spectrum, water-soluble anti-fungal from the azole drug class.
It has in vitro activity across a wide variety of pathogenic yeasts and molds causing serious
infections in immuno-compromised patients including fluconazole resistant candida strains
and zygomycetes. In addition, it has activity against dermatophytes, including terbenafine
resistant strains, causing chronic nail infections. BAL8557 is being developed in clinical trials
with both intravenous and oral dose forms that can be administered once weekly or once
daily.
Broad-Spectrum Antifungal Agent and Third Compound Entering Phase III
Basel, Switzerland, 19 December 2005
Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that it maintains global
marketing and manufacturing rights to BAL8557 following Roche's decision not to
exercise its opt-in right. BAL8557 will be Basilea’s third compound to enter phase III
clinical development, planned to commence in 2006.
"We are very excited by this opportunity. Our recently announced positive phase II clinical
results confirm BAL8557 as the third key product in our late-stage portfolio. Owning all rights
to BAL8557, including both marketing and manufacturing rights, gives us full control to
maximize product value with a partner or alone. BAL8557 will be a highly attractive and
complementary product to our antibiotic ceftobiprole for the hospital anti-infectives market.
We have a solid financial position with no royalties or other payments on BAL8557 to Roche
and are enthusiastic about moving this promising compound into phase III clinical
development to join our other two phase III compounds; ceftobiprole, Basilea’s first-in-class,
broad-spectrum antibiotic effective against resistant bacteria, and alitretinion, our vitamin A
derivative for refractory chronic hand dermatitis. This is a great opportunity for us to
capitalize on our success and opens the possibility to add commercialization capabilities to
our fully integrated research and development organization. Basilea is uniquely positioned in
anti-infectives as an emerging biopharmaceutical company with a significant research base
plus a late stage development portfolio of competitively profiled products", said Dr. Anthony
Man, Basilea's CEO.
Positive BAL8557 Phase II Results
In September this year Basilea released positive phase II results on BAL8557. The phase II
study compared three dosing regimens of BAL8557 to fluconazole in the treatment of
esophageal candidiasis to demonstrate antifungal efficacy in patients. All three BAL8557
dosing regimens were highly effective for the stringent primary endpoint of endoscopically
confirmed complete clinical cure. Endoscopically confirmed clinical cure at the end of therapy
was achieved in 95%, 95% and 98% of patients treated with BAL8557 for the 100 mg daily,
50 mg daily and 400 mg weekly doses, respectively, and in 95% of patients treated with
100 mg fluconazole. Statistical non-inferiority to comparator was confirmed for all three
BAL8557 dosing regimens. Excellent activity was also confirmed in secondary endpoints,
including microbiological cure, therapeutic responses and follow-up assessments at two and
four weeks. In the trial, BAL8557 was safe and well tolerated with an adverse event profile
comparable to fluconazole. Planned phase III trials will target severe invasive yeast (candida)
and mold infections (including aspergillus and zygomycetes).
The Need for New Antifungal Therapies
The expansion of the immunocompromised patient population including cancer patients with
chemotherapy induced neutropenia, transplant recipients receiving immunosuppressive
therapy and HIV infected patients has led to an increased incidence of invasive fungal
infections. In major markets alone, an estimated nine million patients are at risk for invasive
fungal infection with more than two million patients treated. Currently available antifungal
drugs are reported to fail in more than 50% of patients with acute invasive aspergillosis and
in 20-30% of patients with candidemia. There is a high medical need to address the
limitations of current therapy, most importantly the gaps in the antifungal spectrum, unwanted
side effects, dosing flexibility as well as the development of resistance.
About BAL8557
BAL8557 is a novel extended spectrum, water-soluble anti-fungal from the azole drug class.
It has in vitro activity across a wide variety of pathogenic yeasts and molds causing serious
infections in immuno-compromised patients including fluconazole resistant candida strains
and zygomycetes. In addition, it has activity against dermatophytes, including terbenafine
resistant strains, causing chronic nail infections. BAL8557 is being developed in clinical trials
with both intravenous and oral dose forms that can be administered once weekly or once
daily.