Basel, Switzerland, February 1, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces 2009 financial results reflecting first full year of Toctino® sales in its initial launch countries, and focused investments to support phase III development of isavuconazole globally and U.S. alitretinoin (Toctino®) trials. Combined cash and short-term investments amount to CHF 178.4 million as of December 31, 2009.
Basel, Switzerland, January 29, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that based on a futility analysis of the isavuconazole phase III trial for the treatment of invasive Aspergillus infections, the Independent Data Safety Monitoring Board (IDSMB) has recommended the continuation of the study.
Basilea Pharmaceutica Ltd. announces that
the U.S. Food and Drug Administration (FDA) issued to the sponsor, Johnson
& Johnson Pharmaceutical Research and Development, L.L.C. (Johnson &
Johnson PRD), a Complete Response Letter on ceftobiprole for the treatment of
complicated skin and skin structure infections (cSSSI).
Basilea
Pharmaceutica Ltd. announces that Toctino® (alitretinoin) was
recommended for regulatory approval under the Repeat-use Procedure in 13
additional European Union (EU) Member States as well as in Norway and Iceland. Toctino® is a
new once-daily oral treatment for adults with severe chronic hand eczema (CHE)
unresponsive to potent topical corticosteroids.
Basilea
Pharmaceutica Ltd. (SIX:BSLN) presents new research data on its innovative
antitumor drug candidate BAL27862 at the international conference on Molecular
Targets and Cancer Therapeutics in Boston
(MA). BAL27862 is a novel, intravenous
and orally bioavailable small molecule. It disrupts the microtubule network, a
well established intracellular target in oncology, through a unique mechanism
of action. The new data suggest that BAL27862 has the potential for a distinct
anticancer profile in a wide range of
cancer types, including those resistant to current treatment options.
Basel, Switzerland, November 18, 2009 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.
Basilea Pharmaceutica Ltd. announces that Toctino®
(alitretinoin), a new once-daily oral treatment for adults with severe chronic
hand eczema (CHE) unresponsive to potent topical corticosteroids, has been
approved by the Swiss regulatory authority Swissmedic.
Data on Basilea Pharmaceutica Ltd.’s anti-infective compounds
ceftobiprole, isavuconazole and the novel antibiotic BAL30072 were presented at
the Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
in San Francisco.
The data demonstrate that the in-vitro
potency of BAL30072 translates into high efficacy in in-vivo models for respiratory tract infection (RTI), urinary tract
infection (UTI), septicemia and for soft tissue infection (STI) involving
multi-resistant Gram-negative "superbugs".
Basilea Pharmaceutica Ltd. announces that the U.S. Food
and Drug Administration (FDA) has accepted the response submitted by the
sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (PRD) as complete. The
Complete Response submission addresses the FDA Complete Response Letter issued in
November 2008 concerning the ceftobiprole NDA for complicated skin and skin structure
infections.
Basilea Pharmaceutica Ltd.
(SIX:BSLN) announces that the National Institute for Health and Clinical
Excellence (NICE) today issued its final guidance recommending the use of
Toctino®
(alitretinoin) within its licensed indication, as a treatment option for adults
with severe chronic hand eczema that has not responded to potent topical
corticosteroids.