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News Article | February 20, 2017
Site: globenewswire.com

Basel, Switzerland, February 20, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced its financial results for 2016 today with product sales from Cresemba® (isavuconazole) and Zevtera®/Mabelio® (ceftobiprole) of CHF 7.1 million in Europe, royalties on US Cresemba sales of CHF 7.3 million, total revenue of CHF 66.0 million, a year-end cash and financial investment position of CHF 289.0 million and a reduced operating loss of CHF 43.9 million. Basilea's CEO Ronald Scott said: "We've launched Cresemba addressing severe fungal infections in the first European markets and made substantial progress in the commercialization of both Cresemba and our antibiotic Zevtera/Mabelio. We are pleased to announce that we achieved sales for the full year of CHF 7.1 million in Europe. The Cresemba launch is also going well in the USA, where our license partner Astellas Pharma US reported 2016 sales of USD 46 million, on which we received CHF 7.3 million in royalties." He continued: "We plan to initiate a ceftobiprole clinical phase 3 development program under our agreement with BARDA in mid-2017 to support a potential future US regulatory filing and we continue to make good progress on our oncology development programs addressing tumor resistance. We were able to expand our BAL101553 oral phase 1/2a study to include brain cancer patients according to plan." Anti-infectives: Cresemba and Zevtera/Mabelio marketed by Basilea in first European countries with partnerships in place for important additional markets Basilea is marketing Cresemba and Zevtera/Mabelio in Germany, Italy, the UK, France and Austria; Zevtera is also marketed in Switzerland. Basilea's licensing partner Astellas Pharma US markets Cresemba in the United States. In 2016, Basilea entered into distribution agreements for isavuconazole and ceftobiprole with Grupo Biotoscana S.L. in nineteen Latin American countries and with Unimedic Pharma AB for the Nordics. The distribution agreement with Hikma Pharmaceuticals LLC for the Middle East and North Africa (MENA) region was extended to include isavuconazole in addition to ceftobiprole. In addition, Basilea concluded a license agreement with Asahi Kasei Pharma Corporation for the development and commercialization of isavuconazole in Japan. Basilea's existing partnerships cover more than forty countries around the world in addition to the countries that Basilea is directly serving. The latest guideline issued by the European Conference on Infections in Leukaemia (ECIL) recommends Cresemba for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients. The guideline states that isavuconazole is as effective as voriconazole with a better safety profile.1 This recommendation in one of the most relevant treatment guidelines in Europe underscores the potentially important clinical role of Cresemba in the treatment of patients with these life-threatening infections. Contract with BARDA to support ceftobiprole phase 3 development for US market Basilea entered into a contract in 2016 with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US, the largest market value-wise for branded hospital antibiotics. BARDA provides initial funding of approximately USD 20 million for the preparation of the phase 3 program. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Basilea submitted clinical study protocols to the US Food and Drug Administration (FDA) for two phase 3 studies, one in Staphylococcus aureus bacteremia (SAB) and one in acute bacterial skin and skin structure infections (ABSSSI). Basilea will initiate the phase 3 clinical development program once it completes the FDA Special Protocol Assessment (SPA) process. Two oncology drug candidates in clinical development: tumor checkpoint controller BAL101553 and panRAF/SRC kinase inhibitor BAL3833 In 2016 Basilea further strengthened its oncology pipeline, the second pillar of its hospital-focused strategy, by broadening BAL101553's clinical development program. A separate study arm for patients with glioblastoma was added to the ongoing phase 1/2a clinical study with oral BAL101553, based data in preclinical glioblastoma tumor models demonstrating activity of the drug candidate in this often lethal brain cancer. Potential patient-selection biomarkers have also been identified and will be assessed in BAL101553-treated glioblastoma patients. In addition, a further phase 1/2a clinical study was initiated to explore continuous intravenous infusion. Dose-escalation in the phase 1 study with orally administered BAL3833 in patients with solid tumor cancers, including metastatic melanoma, is continuing with the aim to determine the maximum tolerated dose. Preclinical data on BAL3833 presented at the American Association for Cancer Research (AACR) annual meeting showed that the drug candidate has anti-cancer activity in KRAS-driven in vitro and in vivo tumor models via inhibition of the RAF and SRC family kinases. This indicates that BAL3833 may also be effective in non-melanoma KRAS-mutant cancers such as pancreatic, colorectal and non-small-cell lung cancer, potentially providing a new therapeutic option in these indications. Focus 2017 on growing product sales and progress in pipeline Basilea's CEO Ronald Scott stated: "In 2017, we expect to further grow our product sales as we continue to execute on our commercialization and partnering strategy. We anticipate seeing initial contributions from our current distributors as their first marketing authorizations are granted. We are also working towards further agreements with potential partners to cover remaining commercially relevant markets including Asia Pacific, Russia/CIS, and certain European countries. In addition, we anticipate that Swissmedic will complete its review of our isavuconazole marketing authorization application in 2017." He added: "An important goal for us this year is to finalize the Special Protocol Assessment process with the US FDA in order to start the clinical phase 3 program for ceftobiprole under our BARDA contract. Our initial focus will be on skin and bloodstream infections, two areas of high medical need." Ceftobiprole will have a total of ten years of market exclusivity in the US from potential approval based on its Qualified Infectious Disease Product designation granted by the FDA. Upon successful completion of the studies, the phase 3 data could be used to support supplemental marketing authorization applications for ceftobiprole in Europe and other territories, potentially resulting in label extensions for ceftobiprole. In 2017, Basilea will further advance the clinical development of its oncology drug candidates and expects to complete dose-escalation in BAL101553's phase 1/2a studies and BAL 3833's phase 1 study. Notes: Consolidated figures in conformity with US GAAP; rounding was consistently applied. The consolidated financial statements of Basilea Pharmaceutica Ltd. for the financial year 2016 can be found on the company's website at http://annualreport.basilea.com. Full-year product revenue 2016 amounted to CHF 7.1 million (2015: none). Contract revenue 2016 amounted to CHF 57.7 million (2015: CHF 51.2 million), including CHF 37.7 million (2015: CHF 37.6 million) related to the global agreement for Toctino® and CHF 19.3 million (2015: CHF 13.6 million) related to the license agreement with Astellas for isavuconazole. Total operating income in 2016 including sales amounted to CHF 66.0 million (2015: CHF 52.8 million). Research and development net expenses in 2016 amounted to CHF 48.4 million (2015: CHF 60.1 million) and were mainly related to activities for the phase 1/2a development of oncology drug candidate BAL101533, phase 1 clinical development of oncology drug candidate BAL3833, costs for the pediatric program for ceftobiprole and activities related to isavuconazole. The decrease of CHF 11.7 million as compared to 2015 is mainly due to 2015 isavuconazole pre-launch activities. Selling, general and administration expenses in 2016 amounted to CHF 56.1 million (2015: CHF 54.2 million), and included costs related to the commercialization of Cresemba and Zevtera/Mabelio and stock-based compensation of CHF 4.2 million (2015: CHF 4.6 million). In 2016, the operating loss was reduced by 29% to CHF 43.9 million from CHF 61.5 million in 2015 and net loss 2016 was reduced to CHF 51.3 million (2015: CHF 61.6 million), resulting in a lower basic and diluted loss per share of CHF 5.07 (2015: CHF 6.09). The net cash used for operating activities in 2016 amounted to CHF 75.0 million as compared to CHF 67.8 million in 2015. The increase in comparison to 2015 is mainly due to the milestone payment from Astellas in 2015 upon approval of isavuconazole in the US, which reduced the net cash used in the previous period. Combined cash and financial investments amounted to CHF 289.0 million as of December 31, 2016, compared to CHF 364.7 million as of December 31, 2015. Basilea continues to focus on growing sales of its two marketed products while at the same time advancing its clinical development pipeline. Basilea anticipates total annual product sales of approximately CHF 15 million in 2017, a more than 100% increase over 2016, and a participation in US sales through royalties of approximately CHF 14 million. Total operating expenses after anticipated BARDA reimbursements for 2017 are estimated at approximately CHF 10 million on average per month with an operating loss of approximately CHF 3 million on average per month. Cresemba (isavuconazole) - an i.v. and oral azole antifungal for the treatment of invasive mold infections Isavuconazole is an i.v. and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.3 The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria. In the United States Cresemba is marketed by Basilea's licensee Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. The European Conference on Infections in Leukaemia (ECIL) recommends isavuconazole in its current guideline for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients.1 Zevtera/Mabelio (ceftobiprole) - a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. Ceftobiprole (European trade name Zevtera or Mabelio, depending on the country) is approved for sale in 13 European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4 Basilea is currently marketing the drug in Germany, Italy, the UK, France, Austria and Switzerland. Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the US FDA for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The drug is not approved in the United States. In 2016, Basilea entered into a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Initial studies are planned in acute bacterial skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB). BAL101553 - a tumor checkpoint controller in phase 1/2a clinical testing in patients with advanced solid tumors including recurrent or progressive glioblastoma The small molecule oncology drug candidate BAL101553 (prodrug of BAL27862) is being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. The drug is currently undergoing clinical phase 1/2a evaluation (oral and continuous infusion) in patients with advanced solid tumors. In December 2016, the oral study was extended by adding a separate arm for patients with recurrent or progressive glioblastoma after prior radiotherapy. The drug candidate has shown evidence of clinical anti-tumor activity in a phase 1/2a study with weekly 2-hour i.v. infusion, during which the maximum tolerated dose and the recommended phase 2 dose for this administration regimen was established.5 BAL3833 (also known as CCT3833) is an orally administered small-molecule panRAF/SRC kinase inhibitor targeting cell proliferation signaling pathways that are associated with tumor growth and resistance development to current therapies. It is the lead compound of a series of kinase inhibitors in-licensed by Basilea in April 2015 under an agreement with The Institute of Cancer Research, Cancer Research Technology, the Wellcome Trust, and The University of Manchester. BAL3833 is currently being investigated in a phase 1 study in adult patients with advanced solid tumors including metastatic melanoma. The compound originates from the renowned UK cancer research institution, The Institute of Cancer Research, where it was developed by scientists funded by Cancer Research UK and the Wellcome Trust. Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Monday, February 20, 2017, 4 p.m. (CET), during which the company will discuss today's press release. A playback will be available 1 hour after the conference call until Wednesday, February 22, 2017, 6 p.m. (CET). Participants requesting a digital playback may dial: and will be asked to enter the ID 19991 followed by the # sign. The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary General Meeting of Shareholders of Basilea Pharmaceutica Ltd. for the business year 2016 will take place on Thursday, April 27, 2017 at 2 p.m. at the Radisson Blu Hotel in Basel, Switzerland. The invitation will be published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the share register with voting rights on April 13, 2017 will be entitled to participate and exercise their voting rights. Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical problem of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com. 1  F. Tissot et al. ECIL-6 guidelines for the treatment of invasive candidiasis, aspergillosis and mucormycosis in leukemia and hematopoietic stem cell transplant patients. Haematologica 2016 (101), published online ahead of print; www.haematologica.org/content/early/2016/12/20/haematol.2016.152900 [Accessed February 17, 2017] 2  Cresemba US prescribing information [Accessed: February 17, 2017] 3  European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: February 17, 2017] 4  UK Summary of Product Characteristics (SPC) Zevtera®: http://www.mhra.gov.uk/ [Accessed: February 17, 2017] 5  J. Lopez et al. Phase 1/2a trial of intravenous BAL101553, a novel tumor checkpoint controller (TCC), in advanced solid tumors. American Society of Clinical Oncology (ASCO) annual meeting 2016, abstract 2525, poster board #225


Page M.G.,Basilea Pharmaceutica International Ltd | Bush K.,Indiana University
Current Opinion in Pharmacology | Year: 2014

Multidrug-resistant Gram-negative bacteria continue to pose a threat, with many infections caused by these pathogens being virtually untreatable. A number of new antibacterial agents are in late stage clinical development to treat these infections. Drugs in known classes such as new quinolones, aminoglycosides, tetracyclines, and β-lactams have been designed to evade many of the known resistance mechanisms, whereas newer drug classes include novel β-lactamase inhibitors in combination with new or approved β-lactams, and a peptidomimetic that have entered full clinical development. The establishment of public-private partnerships and an increase in pharmaceutical interest in antibacterial R&D are encouraging signs for the future. © 2014 Published by Elsevier Ltd.


Page M.G.P.,Basilea Pharmaceutica International Ltd. | Dantier C.,Basilea Pharmaceutica International Ltd. | Desarbre E.,Basilea Pharmaceutica International Ltd.
Antimicrobial Agents and Chemotherapy | Year: 2010

BAL30072 is a new monocyclic β-lactam antibiotic belonging to the sulfactams. Its spectrum of activity against significant Gram-negative pathogens with β-lactam-resistant phenotypes was evaluated and was compared with the activities of reference drugs, including aztreonam, ceftazidime, cefepime, meropenem, imipenem, and piperacillin-tazobactam. BAL30072 showed potent activity against multidrug-resistant (MDR) Pseudomonas aeruginosa and Acinetobacter sp. isolates, including many carbapenem-resistant strains. The MIC90s were 4 μg/ml for MDR Acinetobacter spp. and 8 μg/ml for MDR P. aeruginosa, whereas the MIC90 of meropenem for the same sets of isolates was >32 μg/ml. BAL30072 was bactericidal against both Acinetobacter spp. and P. aeruginosa, even against strains that produced metallo-β-lactamases that conferred resistance to all other β-lactams tested, including aztreonam. It was also active against many species of MDR isolates of the Enterobacteriaceae family, including isolates that had a class A carbapenemase or a metallo-β-lactamase. Unlike other monocyclic β-lactams, BAL30072 was found to trigger the spheroplasting and lysis of Escherichia coli rather than the formation of extensive filaments. The basis for this unusual property is its inhibition of the bifunctional penicillin-binding proteins PBP 1a and PBP 1b, in addition to its high affinity for PBP 3, which is the target of monobactams, such as aztreonam. Copyright © 2010, American Society for Microbiology. All Rights Reserved.


Page M.G.P.,Basilea Pharmaceutica International Ltd
Annals of the New York Academy of Sciences | Year: 2013

There has been considerable effort expended in the investigation of the potential of siderophore conjugates of antibiotics to circumvent the permeability barrier imposed by the outer membrane of Gram-negative bacteria. There is also a small group of natural conjugates, the sideromycins. Among the synthetic analogues that have been investigated are conjugates of nucleosides, glycopeptides, macrolides, fluroquinolones, and, above all, β-lactams. Despite this effort, few compounds have progressed beyond experimental studies. One compound, the siderophore monosulfactam BAL30072, is in early clinical studies. © 2013 New York Academy of Sciences.


Dreier J.,Basilea Pharmaceutica International Ltd. | Ruggerone P.,University of Cagliari
Frontiers in Microbiology | Year: 2015

Pseudomonas aeruginosa infections are becoming increasingly difficult to treat due to intrinsic antibiotic resistance and the propensity of this pathogen to accumulate diverse resistance mechanisms. Hyperexpression of efflux pumps of the Resistance-Nodulation-Cell Division (RND)-type multidrug efflux pumps (e.g., MexAB-OprM), chromosomally encoded by mexAB-oprM, mexCD-oprJ, mexEF-oprN, and mexXY (-oprA) is often detected in clinical isolates and contributes to worrying multi-drug resistance phenotypes. Not all antibiotics are affected to the same extent by the aforementioned RND efflux pumps. The impact of efflux on antibiotic activity varies not only between different classes of antibiotics but also between members of the same family of antibiotics. Subtle differences in physicochemical features of compound-pump and compound-solvent interactions largely determine how compounds are affected by efflux activity. The combination of different high-resolution techniques helps to gain insight into the functioning of these molecular machineries. This review discusses substrate recognition patterns based on experimental evidence and computer simulations with a focus on MexB, the pump subunit of the main RND transporter in P. aeruginosa. © 2015 Dreier and Ruggerone.


Neuhaus C.M.,ETH Zurich | Liniger M.,ETH Zurich | Stieger M.,Basilea Pharmaceutica International Ltd. | Altmann K.-H.,ETH Zurich
Angewandte Chemie - International Edition | Year: 2013

Key steps in this total synthesis of the antimitotic natural product WF-1360F (3) include the formation of the macrocycle through ring-closing alkyne metathesis and the subsequent conversion of the ensuing alkyne moiety into an E-configured double bond. As illustrated by the synthesis of 4, the macrocyclic vinyl iodide 2 can also serve as a common precursor for the synthesis of side-chain-modified rhizoxin analogues (see scheme; TIPS=triisopropylsilyl). Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Page M.G.P.,Basilea Pharmaceutica International Ltd
Handbook of Experimental Pharmacology | Year: 2012

There has been an enormous increase in our knowledge of the fundamental steps in the biosynthesis and assembly of the outer membrane of Gram-negative bacteria. Lipopolysaccharide is a major component of the outer membrane of Gram-negative bacteria as is peptidoglycan. Porins, efflux pumps and other transport proteins of the outer membrane are also present. It is clear that there are numerous essential proteins that have the potential to be targets for novel antimicrobial agents. Progress, however, has been slow. Much of the emphasis has been on cytoplasmic processes that were better understood earlier on, but have the drawback that two penetration barriers, with different permeability properties, have to be crossed. With the increased understanding of the late-stage events occurring in the periplasm, it may be possible to shift focus to these more accessible targets. Nevertheless, getting drugs across the outer membrane will remain a challenge to the ingenuity of the medicinal chemist. © 2012 Springer-Verlag Berlin Heidelberg.


News Article | November 15, 2016
Site: globenewswire.com

Basel, Switzerland, Nov. 15, 2016 (GLOBE NEWSWIRE) -- Basel, Switzerland, November 15, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announces that it has launched its antifungal Cresemba® (isavuconazole) in France and that it has sponsored a symposium on current challenges and recent opportunities in the treatment of invasive mold infections. The event was held on November 10, 2016 in Paris, France, and was co-chaired by Professor Élie Azoulay, Medical Intensive Care, Saint-Louis Teaching Hospital, Paris; Professor Jean-Pierre Gangneux, Laboratory of Parasitology and Mycology, University Hospital Rennes, and Professor Olivier Lortholary, Department of Infectious Diseases, Necker - Enfants Malades Hospital, Paris. David Veitch, Basilea's Chief Commercial Officer, commented: "We are excited to have launched Cresemba in France. The symposium provided an opportunity both for clinicians to discuss important clinical data and to share their experiences in the management of patients with potentially life-threatening invasive mold infections. Cresemba addresses an important medical need for these patients." Isavuconazole was approved by the European Commission in October 2015 for the treatment of adults with invasive aspergillosis and the treatment of adults with mucormycosis for whom amphotericin B is inappropriate. Invasive aspergillosis and mucormycosis are life-threatening fungal infections that often affect immunocompromised patients, such as patients with cancer and after transplantation. Invasive aspergillosis is often fatal. Mucormycosis (also known as zygomycosis) is a rapidly progressive invasive fungal infection, often affecting the nose and sinuses with high mortality. Professor Raoul Herbrecht, Department of Oncology and Hematology, Hautepierre University Hospital Strasbourg, stated: "There is a significant medical need in invasive aspergillosis and mucormycosis. They can cause severe morbidity and rapid deterioration in a patient's condition and may be associated with mortality rates approaching 100% if untreated or if effective treatment is delayed. Isavuconazole's safety and tolerability profile can be beneficial for highly vulnerable patients with invasive mold infections, as for instance patients with comorbidities or the need for long-term use, or high-risk patients receiving concomitant medications such as immunosuppressants." Professor Jean-Pierre Gangneux added: "There are gaps in the spectrum of various currently available antifungal drugs. Isavuconazole is characterized by a broad spectrum with activity against filamentous fungi such as Aspergillus spp. and Mucorales." Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.1 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2 Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria and is seeking national pricing and reimbursement in additional EU countries. In the US, the drug is marketed by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is currently not approved for commercial use. The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. About the isavuconazole invasive aspergillosis and mucormycosis studies The approval of Cresemba is based on results from the isavuconazole development program. The safety and efficacy profile of isavuconazole in adult patients with invasive aspergillosis was demonstrated based on data from two phase 3 clinical studies: SECURE, a randomized, double-blind, active-control study in 516 patients (intent-to-treat population, ITT) with invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient study (ITT) of isavuconazole in the treatment of invasive aspergillosis patients with renal impairment, or invasive fungal disease (IFD) caused by emerging molds, yeasts or dimorphic fungi, including invasive mucormycosis. In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population. All-cause mortality through Day 42 was 19% in the isavuconazole treatment group and 20% in the voriconazole treatment group.3 In the SECURE study, similar rates of non-fatal adverse events were observed for isavuconazole and the comparator, voriconazole. Further, the percentage of study drug-related adverse events in invasive aspergillosis patients was 42% for isavuconazole and 60% for voriconazole. In addition, the percentage of treatment-emergent adverse events in the system organ classes of hepatobiliary disorders was 9% for isavuconazole versus 16% for voriconazole; skin or subcutaneous tissue disorders was 33% for isavuconazole versus 42% for voriconazole; and eye disorders was 15% for isavuconazole versus 27% for voriconazole.3 The safety and efficacy profile of isavuconazole in patients with mucormycosis was demonstrated based on data from the VITAL study, which included a subpopulation of 37 patients with proven or probable mucormycosis, of whom 21 received isavuconazole as primary treatment for their infection. All-cause mortality at Day 42 was 38% which is similar to mortality rates reported in literature for the treatment of mucormycosis. In this trial the rate of overall response against mucormycosis at the end of therapy was 31%, with an additional 29% exhibiting a stable response. For patients receiving isavuconazole as primary therapy, this number was 32%, with an additional 32% having stable disease.4 The efficacy of isavuconazole for the treatment of mucormycosis has not been evaluated in concurrent, controlled clinical trials. The most frequent adverse events for patients treated with isavuconazole in clinical phase 3 studies were nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (17%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%). Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com.


Basel, Switzerland, Dec. 02, 2016 (GLOBE NEWSWIRE) -- Basel, Switzerland, December 02, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the expansion of its ongoing oncology drug candidate BAL101553 clinical phase 1/2a oral formulation study. The first patient has been dosed in an additional arm containing adult patients with recurrent or progressive glioblastoma (brain cancer) after prior radiotherapy with or without chemotherapy. Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "We are excited to explore BAL101553 in a separate glioblastoma study arm to our ongoing phase 1/2a clinical study. Glioblastoma is a cancer indication associated with high medical need. There are limited treatment options for glioblastoma patients due in part to the challenge of getting medication into the brain through the blood brain barrier. BAL101553 has been shown to enter the brain and has demonstrated anticancer activity with oral dosing in various preclinical models of glioblastoma, including models refractory to or with reduced sensitivity to standard therapies." In addition to the activity in glioblastoma tumor lines, BAL101553 was shown to have potent anticancer activity against glioblastoma stem-like cells in a pre-clinical model as reported in a recent publication co-authored by Basilea and the research group of Prof. Diane Braguer of Aix-Marseille University, France. Tumor stem-like cells contribute to glioblastoma regrowth as well as brain invasion, a phenomenon which also occurs in the pre-clinical model used. The publication further reported the observation that BAL101553 promoted the loss of stem-cell properties. These published data further support the potential of BAL101553 to target glioblastoma, a tumor often associated with poor prognosis for patients.1 Glioblastoma is the most common primary brain tumor and one of the most lethal types of cancer. The incidence of glioblastoma is approximately 3 patients per 100,000 in the United States.2 Median survival of about 15 months from diagnosis has been reported for adult glioblastoma patients receiving standard-of-care treatment,3 with a 5-year survival rate of 5%.2 The ongoing phase 1/2a study includes patients with advanced or recurrent solid tumors who have failed standard therapy or for whom no effective standard therapy was available. Phase 1 dose escalation to determine the maximum tolerated dose (MTD) of daily oral dosing is currently ongoing. A subsequent phase 2a extension of the study is planned to further evaluate the safety, tolerability and the pharmacokinetic profile of oral BAL101553 at the MTD, and to assess its anti-tumor activity. Furthermore, biomarkers are assessed in both the phase 1 and phase 2a parts of the study to determine their utility in identifying patients who are most likely to respond to treatment, including biomarkers with potential relevance to glioblastoma. Basilea's small molecule oncology drug candidate BAL101553 (the prodrug of BAL27862)4 is being developed as a potential therapy for diverse cancers. BAL101553 is currently undergoing clinical phase 1/2a evaluation (oral and continuous infusion) in patients with advanced solid tumors. In preclinical studies, the drug candidate demonstrated in-vitro and in-vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.5, 6, 7 BAL101553 efficiently distributes to the brain, with anticancer activity in glioblastoma (brain cancer) models.1, 8, 9 The active moiety BAL27862 binds the colchicine site of tubulin with distinct effects on microtubule organization,10 resulting in the formation of the "spindle assembly checkpoint" which promotes tumor cell death.11 Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com.


News Article | February 27, 2017
Site: globenewswire.com

Basel, Switzerland, February 27, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its Board of Directors proposes Dr. Nicole Onetto for election as a non-executive member of the Board at its Annual General Meeting of Shareholders to be held on April 27, 2017. Domenico Scala, Chairman of Basilea's Board of Directors, said: "Basilea has successfully brought to market two hospital anti-infectives, the antifungal Cresemba and the antibiotic Zevtera/Mabelio. As we are also progressing toward important decision points in our oncology portfolio, the Board has decided to further strengthen its expertise in oncology. We are therefore very pleased that Dr. Onetto has agreed to be nominated to join our Board. She has a distinguished career with a wealth of experience operationally and strategically in developing and bringing novel and innovative oncology drugs to patients." Dr. Nicole Onetto, a French and Canadian citizen, currently serves as an independent consultant for oncology, drug development and translational research in Vancouver, Canada. Prior to that, from 2009 to 2016, she was Deputy Director & Chief Scientific Officer at the Ontario Institute for Cancer Research (OICR) in Toronto, Canada. From 2005-2009 she was Senior Vice President and Chief Medical Officer at ZymoGenetics Inc. Between 2002 and 2005, she served at OSI Pharmaceuticals, Inc., first as Executive Vice President-Oncology and then as Chief Medical Officer and Executive Vice President. Her career in the pharmaceutical industry also includes senior management positions at Bristol-Myers Squibb and Nexstar Pharmaceuticals, which was acquired by Gilead Sciences, Inc. She is currently on the board of ProNAi Therapeutics, a Vancouver-based oncology hematology company, and previously served for eleven years as a member of the board of ImmunoGen Inc. and a number of other public and private pharmaceutical companies in the oncology sector. Dr. Onetto obtained her MD from the University of Paris and holds a Master of Pharmacology from the University of Montréal. If Dr. Onetto is newly elected and all current Board members are re-elected, Basilea's Board of Directors will consist of seven members: Prof. Daniel Lew, Dr. Martin Nicklasson, Dr. Thomas M. Rinderknecht (current Vice-Chairman), Domenico Scala (current Chairman), Dr. Nicole Onetto, Steven D. Skolsky and Dr. Thomas Werner. Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical problem of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com.

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