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Thermo Fisher Scientific to develop and then commercialize its assay for measuring the concentration of plazomicin SOUTH SAN FRANCISCO, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that they have achieved a strategic milestone in their ongoing efforts to develop an assay enabling therapeutic drug management (TDM) of plazomicin. Achaogen is developing plazomicin for the potential treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). In Achaogen’s Phase 3 CARE trial in patients with serious infections due to CRE, an investigational assay enabling plazomicin TDM was used to help ensure that targeted exposures of plazomicin were achieved in the critically ill patients enrolled in the trial. If plazomicin is approved, Achaogen and Thermo Fisher plan to develop and have a commercial assay for plazomicin available at product launch. Achaogen plans to submit a New Drug Application (NDA) for plazomicin to the Food and Drug Administration (FDA) in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. “Thermo Fisher is a world leader in developing and providing high-quality commercial assays to achieve precise and accurate quantitative results crucial for monitoring drug levels. We are pleased with the progress made in our collaboration with Thermo Fisher and with achieving this important milestone of demonstrating assay feasibility, a key step toward enabling therapeutic drug management of plazomicin for those patients most likely to benefit from TDM,” said Blake Wise, Achaogen’s Chief Operating Officer. “In certain high-risk patient populations, such as the critically ill, we believe TDM has the potential to provide significant utility in optimizing plazomicin dosing.” The two companies have been collaborating on assay development since 2015. Under terms of their collaboration agreement, Thermo Fisher leads the development, regulatory approval, and commercialization of an assay for measuring plazomicin drug levels. Achaogen brings plazomicin expertise to the collaboration, including the discovery of plazomicin-specific antibodies utilizing their state-of-the-art antibody discovery platform. “The agreement reflects our mutual commitment to providing a broadly-available plazomicin assay at launch so that healthcare providers can measure plazomicin drug levels in critically ill patients with bacterial infections,” said John Kody, Vice President/General Manager Clinical Diagnostics - Niche Products at Thermo Fisher Scientific. “During the feasibility period, our two teams have developed an assay that compares very well to traditional analytical chemistry techniques. Thermo Fisher’s QMS™ TDM assays are conveniently ready-to-use, with excellent precision and accuracy, and are optimized for performance on a wide range of analyzers.” In December 2016, Achaogen announced positive results from its plazomicin Phase 3 clinical trials in complicated urinary tract infections (cUTI) and infections due to CRE. In the Phase 3 EPIC registration trial in patients with cUTI and acute pyelonephritis (AP), plazomicin met the objective of non-inferiority compared to meropenem for FDA-specified primary efficacy endpoints, and achieved superiority for the EMA-specified primary efficacy endpoints. In addition, in the Phase 3 CARE trial in patients with serious infections due to CRE, a lower rate of mortality or serious disease-related complications was observed for plazomicin-treated patients compared with those on colistin therapy. In the Phase 3 CARE trial, TDM with an investigational assay helped to confirm that the targeted-exposure of plazomicin was achieved in these critically ill patients. About Therapeutic Drug Management and Plazomicin Therapeutic Drug Management is the practice of measuring the concentration of medication in blood and adjusting the dose of that drug based on the results. Healthcare providers routinely use TDM for certain drugs to help improve patient care by individually adjusting the dose as appropriate.  Critically ill patients with bacterial infections often have abnormal and fluctuating renal function as well as an altered volume of drug distribution in the body. This can lead to these patients being either under or over-dosed with what are potentially life-saving therapies. Initial data from Achaogen’s plazomicin CARE study in critically ill patients with CRE infections confirmed drug concentration variability within and among patients and importantly, showed that TDM helped to ensure that the targeted-exposure of plazomicin was achieved in these patients. About Achaogen Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s new drug application (NDA) filing for Carbavance® (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTIs). The FDA does not currently plan to hold an advisory committee meeting to discuss the application. The NDA filing is based on results from the pivotal Phase III TANGO 1 clinical trial in patients with cUTIs. As previously announced, the TANGO 1 trial met both FDA and European Medicines Agency (EMA) pre-specified primary endpoints. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients. Supporting the NDA are interim data from the ongoing TANGO 2 Phase III trial, which compares the safety, tolerability and efficacy of Carbavance with best available therapy in patients with selected serious infections due to confirmed or suspected carbapenem-resistant Enterobacteriaceae (CRE). The TANGO 2 trial is ongoing and the Company expects results to be available before the end of the third quarter of 2017. “The exceptionally rapid development of Carbavance demonstrates the strong product discovery and development capabilities of The Medicines Company’s Infectious Disease Business, and reflects our commitment to making innovative antimicrobial products available to patients with the most serious drug-resistant infections,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We believe that Carbavance could be a promising and highly-differentiated treatment option for these patients and we look forward to continuing our dialogue with the FDA during its review process.” Tony Kingsley, President and Chief Operating Officer of The Medicines Company added, “Reaching this point in the development of Carbavance reflects the focus, commitment and expertise of our Infectious Disease Business. Multiple studies support the potential for Carbavance to make a meaningful difference in the treatment of serious infections. If approved by the FDA, we will leverage our existing sales and distribution infrastructure to launch Carbavance in the U.S. market.” Carbavance, an investigational agent not approved for commercial use in any market, is a combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (formerly known as RPX7009), administered as a fixed combination by IV infusion. It is being developed to treat serious gram-negative infections, such as cUTI, including those infections caused by bacteria resistant to currently-available carbapenems. Carbavance has been granted Fast Track status by the FDA for the treatment of cUTI and has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act. Carbavance was designed to address gram-negative bacteria that produce new beta-lactamase enzymes that have spread in the United States and Europe, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of CRE in the United States and are classified by the U.S. Centers for Disease Control and Prevention (CDC) to be an urgent antimicrobial resistance threat. In February 2014, the Company’s Infectious Disease Business was awarded a cost-sharing contract from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS), of which $55.8 million in federal funds have been obligated to date to support the development of Carbavance. In September 2016, The Medicines Company entered into a new strategic partnership with BARDA that will provide the Company with up to $132 million to support the development of new antibiotics to fight drug-resistant, gram-negative infections. The partnership was established under HHS’s Other Transactional Authority (OTA) and is a distinctive, flexible, portfolio-based approach to funding drug development. The Medicines Company was awarded $32 million in initial funding, and up to an additional $100 million (pending the availability of funding) over approximately five years, if all options to extend the partnership are exercised by BARDA. The initial $32 million award support a Phase IIIb trial of the Carbavance, for the treatment of gram-negative infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The initial award, as well as funding provided under any subsequent options exercised by BARDA, will also support the advancement of additional antibiotics in The Medicines Company’s leading portfolio of new antibiotic drug candidates targeting drug resistant bacteria. The Medicines Company’s Infectious Disease Business is committed to bringing life-saving antimicrobial products to patients with the most serious drug-resistant infections – infections caused by “super bugs” which are no longer treatable with available antibiotics. The Infectious Disease Business encompasses basic research and drug discovery focused on bacterial mechanisms of drug resistance; drug development focused on the most threatening bacterial diseases; and a distribution and commercial infrastructure that serves the leading hospitals and healthcare facilities in the United States. The business is currently developing Carbavance to treat serious gram-negative infections, such as complicated urinary tract infections, including those infections caused by bacteria resistant to currently available carbapenems. A pivotal Phase III clinical trial for Carbavance was successfully completed in 2016. Since 2014, our team has successfully developed and launched two antibiotics against serious infections: Orbactiv® (oritavancin) for treatment of acute bacterial skin and skin-structure infections in adults, including those due to methicillin-resistant Staphylococcus aureus (MRSA), and a new formulation of Minocin® (minocycline) for Injection, which is among the few FDA-approved agents for the treatment of infections due to Acinetobacter sp., a serious antimicrobial resistance threat. For more information on these products, including their respective prescribing information, please see www.orbactiv.com and www.minociniv.com. The Infectious Disease Business also has a leading pipeline of novel agents directed towards existing and emerging multidrug-resistant bacteria. The Medicines Company is a biopharmaceutical company driven by an overriding purpose – to save lives, alleviate suffering and contribute to the economics of healthcare. The Company’s mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in three critical therapeutic areas: serious infectious disease care, cardiovascular care and surgery and perioperative care. The Company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland. Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include: whether the Company will make regulatory submissions for Carbavance on a timely basis, or at all; whether the Carbavance NDA and other regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all; whether clinical trials for Carbavance will advance in the clinical process on a timely basis, or at all, or succeed in achieving their specified endpoints; whether physicians, patients and other key decision makers will accept clinical trial results; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission, including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 27, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


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


-- Plazomicin NDA submission planned for the second half of 2017 -- -- Plan to initiate clinical trial of orally-administered antibacterial candidate for ESBL+ infections, C-Scape, in 2017 -- -- Advances in research expand unique pipeline of therapeutic candidates targeting the most critical priority pathogens -- SOUTH SAN FRANCISCO, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, held an R&D Day to provide an overview of its Research and Development programs including the Company's new orally-administered antibacterial candidate, C-Scape. The meeting consisted of presentations from members of Achaogen’s leadership team and medical community key opinion leaders. "We aspire to solve the growing issue of antimicrobial resistance and we are very pleased to announce that we now have two potential development candidates to further this vision,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. "We believe that with plazomicin, a pre-NDA candidate, and C-Scape, a 2017 Phase 1 candidate with potential for rapid development, we are positioned to advance our leadership in discovering, developing, and commercializing innovative antibacterials to treat the critical priority pathogens that cause highly resistant gram-negative infections.” The Achaogen R&D Day focused on the Company's antibacterial development pipeline to support the following corporate objectives: Plazomicin: The R&D Day provided an overview of the plazomicin program, including a review of the Phase 3 results, progress towards the planned New Drug Application (NDA) submission and preparation for commercialization: C-Scape: An overview of Achaogen’s newly announced, orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, was provided. Key highlights were as follows: Research Discovery and Development: Achaogen’s research and early development overview focused on novel approaches to address infections caused by MDR gram-negative pathogens. The early stage pipeline consists of the following research candidates: An audio webcast of the 2017 Achaogen R&D Day is available in the "Investors" section of Achaogen’s website, www.achaogen.com. A replay of the presentation will be available until April 2, 2017. About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen's lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen's plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen's gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. All product candidates are investigational only and have not been approved for commercialization.  For more information, please visit www.achaogen.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA or NIAID could terminate Achaogen's contract for the funding of the plazomicin or LpxC inhibitor development programs, respectively; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.


News Article | February 22, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) Therapeutics™ to create a new generation of transformative medicines for patients, announced today the appointment of Israel Ruiz, Executive Vice President and Treasurer of the Massachusetts Institute of Technology (MIT), to the company’s Board of Directors, where he will serve as Audit Committee Chair. Mr. Ruiz serves as MIT’s Chief Financial Officer and, as a Trustee of the MIT Corporation and a member of its Executive Committee, is the chief steward of over $17 billion of financial assets, $3.4 billion in operating revenues and is responsible for administering MIT’s $5 billion capital plan through 2030. In addition, Mr. Ruiz currently serves as Audit Committee Chair on the Board of Directors of Fortive (NYSE: FTV), a diversified industrial growth company with 24,000 global employees and more than $6 billion in annual revenue. In 2015, Fortive was spun out from Danaher (NYSE: DHR), a Fortune 150 company and global science and technology innovator. “We are delighted to welcome Israel to Moderna’s Board of Directors. His progressive leadership at MIT has helped ensure the continued, unparalleled contributions of the Institute on a regional, national and global scale, through education, innovation and entrepreneurship,” said Noubar Afeyan, Ph.D., co-founder and Chairman, Moderna Therapeutics, and CEO of Flagship Pioneering. “We look forward to leveraging Israel’s insights as Moderna evolves into a leading, clinical stage biotechnology company by harnessing the promise of messenger RNA science to improve lives.” With a strong understanding of MIT’s innovation ecosystem and future technology trajectories, Mr. Ruiz was instrumental in leading the re-zoning efforts of Kendall Square in Cambridge, Mass. in 2013 to enable mixed-use development and accelerate the process of moving ideas from lab to market. Mr. Ruiz continues to actively co-lead the development of the process through its complex execution phase, expected to last beyond 2020. “A critical component of Moderna’s success to date has been our ability to tap into a breadth of viewpoints and guidance from leading experts across the corporate and academic worlds. To that end, we are thrilled that Israel is joining the Moderna board,” said Stéphane Bancel, Chief Executive Officer at Moderna. “Israel’s proven track record at MIT, one of the world’s leading incubators of innovation, as well as his active role in advancing Kendall Square as a world-class innovation hub, afford him a unique perspective on how Moderna can drive innovation on behalf of patients, and also advance change through broader contributions to society. In addition, Israel’s experience as Audit Committee Chair on Fortive’s Board of Directors well positions him to help us continue to ensure Moderna’s financial strength and establish a framework for long-term success.” “At MIT, we are driven to bring knowledge to bear on the world’s great challenges, and I see this same spirit of intellect and impact embodied by the Moderna team. They are working with rigor and intensity to drive breakthroughs in both science and technology with the goal of delivering a new class of medicines to address significant medical challenges and unmet needs around the world,” said Mr. Ruiz. “I am extremely honored to join Moderna’s Board, and look forward to lending my support to help further advance the mission and vision of this unique and immensely exciting company.” At MIT, Mr. Ruiz is responsible for financial and debt strategy development, budget and capital planning, and the integrity of financial information. His other areas of responsibility include human resources, information systems, campus facilities, security and safety, compliance, government relations, international support, sustainability and medical. Prior to becoming Executive Vice President and Treasurer in 2011, Mr. Ruiz held several roles of increasing responsibility at MIT, most recently serving as Vice President of Finance. Involved since the early 2000s with digital education, Mr. Ruiz was instrumental in launching a group to evaluate e-learning opportunities in 2009-2010 in response to the global financial crisis. The work of this group ultimately led MIT to launching its online efforts, MITx in 2011 and edX in 2012, in partnership with Harvard University. In 2014, Mr. Ruiz co-led the Task Force that published the “Future of MIT Education” outlining the tremendous opportunities that digital learning technologies bring to residential education and to the global market for education. Mr. Ruiz previously held management and engineering roles at Hewlett-Packard and Nissan Automotive. Mr. Ruiz serves on the MIT-related Board of Directors of edX (an MIT and Harvard on-line learning initiative), MIT Endicott House and MIT Technology Review. He is a director of Fortive (NYSE: FTV). He is also a director of the Governing Board of the Eliot Innovation School and very active in the Boston Public Schools. Mr. Ruiz holds a master’s degree from the MIT Sloan School of Management and a six-year degree in industrial and mechanical engineering from the Polytechnic University of Catalonia, in his native Barcelona. Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. With its breakthrough platform, Moderna is developing mRNA vaccines and therapeutics to address currently undruggable targets and deliver a new class of medicines for a wide range of diseases and conditions. Moderna is developing its innovative mRNA medicines for infectious diseases, cancer (immunooncology), rare diseases, cardiovascular disease and pulmonary disease, through its ecosystem of internal ventures and strategic partners. Founded by Flagship Pioneering, Cambridge-based Moderna is privately held and has strategic agreements with AstraZeneca, Merck, Alexion Pharmaceuticals and Vertex Pharmaceuticals, as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS); and the Bill & Melinda Gates Foundation. To learn more, visit www.modernatx.com.


News Article | February 22, 2017
Site: www.accesswire.com

MISSION VIEJO, CA / ACCESSWIRE / February 22, 2017 / Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose‑escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amytrophic Lateral Sclerosis ("ALS"), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the BARDA contract supports the drug's potential as a therapy for IPF. Upon completion of the phase 1 single dose study, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer. Data from all of these studies will support the development of AEOL 10150 as a medical countermeasure for Lung-ARS and sulfur mustard exposure, as well as the IPF and cancer clinical indications. "We are very pleased to have addressed the FDA's comments and received their concurrence to test AEOL 10150 in healthy subjects. The new formulation of AEOL 10150 has reduced the cost of the drug by approximately 90 percent and the additional toxicology work cleared the way for testing in healthy subjects," stated John L McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This phase 1 study will give us important safety and pharmacokinetic data that will allow us to accelerate and expand the development of AEOL 10150 in both large commercial and in biodefense indications that represent major unmet medical needs. We are grateful to BARDA for their support of the program, which enabled us to achieve the improvements in the cost and consistency of manufacturing AEOL 10150 and the elimination of the toxicology concerns that had previously limited our potential clinical targets." AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas. Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus' corporate website at www.aolsrx.com. The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


News Article | February 22, 2017
Site: www.marketwired.com

MISSION VIEJO, CA--(Marketwired - February 22, 2017) - Aeolus Pharmaceuticals, Inc. ( : AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amyotrophic Lateral Sclerosis ("ALS"), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the BARDA contract supports the drug's potential as a therapy for IPF. Upon completion of the phase 1 single dose study, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer. Data from all of these studies will support the development of AEOL 10150 as a medical countermeasure for Lung-ARS and sulfur mustard exposure, as well as the IPF and cancer clinical indications. "We are very pleased to have addressed the FDA's comments and received their concurrence to test AEOL 10150 in healthy subjects. The new formulation of AEOL 10150 has reduced the cost of the drug by approximately 90 percent and the additional toxicology work cleared the way for testing in healthy subjects," stated John L McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This phase 1 study will give us important safety and pharmacokinetic data that will allow us to accelerate and expand the development of AEOL 10150 in both large commercial and in biodefense indications that represent major unmet medical needs. We are grateful to BARDA for their support of the program, which enabled us to achieve the improvements in the cost and consistency of manufacturing AEOL 10150 and the elimination of the toxicology concerns that had previously limited our potential clinical targets." AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas. Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus's corporate website at www.aolsrx.com. The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


News Article | February 17, 2017
Site: www.accesswire.com

MISSION VIEJO, CA / ACCESSWIRE / February 17, 2017 / Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today financial results for the three months ended December 31, 2016. "During the quarter we made the necessary filings to initiate a phase 1 single dose study in healthy subjects, which we plan to initiate shortly. FDA clearance to allow testing of AEOL 10150 in healthy subjects is a tremendous step forward for the Company and is yet another example of the valuable public-private partnership between Aeolus and the Biomedical Advanced Research and Development Authority ("BARDA")," stated John L McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "Upon completion of the single dose study, we plan to move into multiple dose studies in Idiopathic Pulmonary Fibrosis and non-small cell lung cancer, which will provide the human safety data for the Lung Acute Radiation Syndrome indication as well as advance two significant commercial programs for the Company." The Company reported a net loss of $1,087,000 for the three months ended December 31, 2016, versus a net loss of $1,260,000 for the three months ended December 31, 2015. Revenue for the three months ended December 31, 2016 was approximately $83,000, compared to $305,000 revenue for the three months ended December 31, 2015. The revenue is from the cost-plus contract with BARDA for the development of AEOL 10150 as a medical countermeasure for the pulmonary and delayed effects of acute radiation exposure. Since being awarded the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, based on allowable costs incurred during the period, plus any recognizable earned fee. We consider fixed fees under cost-plus fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. Revenue was higher in the prior year primarily due to the timing of work related to the BARDA contract. Research and development expenses decreased by $3,000, or 1%, to approximately $489,000 for the three months ended December 31, 2016 from approximately $492,000 for the fiscal year ended December 31, 2015. R&D expenses were lower during the three months ended December 31, 2016 versus December 31, 2015 due to the timing of work related to the BARDA Contract. G&A expenses increased approximately $120,000, or 21%, to approximately $681,000 for the three months ended December 31, 2016 from about $561,000 for the three months ended December 31, 2015. The increase is primarily attributable to higher accounting and legal fees related to SEC filing requirements. Net loss for the three months ended December 31, 2016 was $1,087,000 or ($0.01/share) as compared to $1,613,000 or ($0.01/share) for the three months ended December 31, 2015. Aeolus has filed today with the SEC its quarterly report on Form 10-Q for the three months ended December 31, 2016. Aeolus urges its investors to read this quarterly filing as well as its amended Annual Report on Form 10-K/A, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the amended Annual Report on Form 10-K/A are also available on the Company's website, at www.aolsrx.com. AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce tissue damage in patients with idiopathic pulmonary fibrosis. Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus's corporate website at www.aolsrx.com The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


News Article | February 17, 2017
Site: www.eurekalert.org

Vaccine developers have successfully protected mice against Zika by injecting synthetic messenger RNA that encodes for virus proteins into the animals. The cells of the mice then build parts of the virus, training the immune system to recognize a future infection. The research, published February 17 in Cell, follows a February 2 Letter in Nature (doi:10.1038/nature21428) that showed similar positive results for a messenger RNA vaccine for Zika in mice and monkeys. "We measured virus in the blood, virus in the brain, virus in the spleen, virus in the uterus for the female mice, and in one group of our vaccines we saw no viral replication at all in 95% of the mice," says study senior co-author Michael Diamond, infectious disease researcher at the Washington University School of Medicine in St. Louis. Instead of training the immune system with weakened viruses or viral fragments, RNA vaccines trick cells into building pieces of virus, much the way viruses coerce cells into building more viruses. "Zika viruses inject their RNA into the cytoplasm and then they hijack the cell's translation machinery to produce their antigen," says study co-senior author Giuseppe Ciaramella, the Chief Scientific Officer at Valera LLC, a Moderna Venture focusing on the development of therapeutic approaches for infectious diseases. "With our vaccines, we direct cells to do exactly the same." While viruses inject RNA instructions to build an entire virus, the vaccine contains RNA with instructions for just two Zika proteins. When the vaccine RNA enters the mouse cells, the ribosomes pick it up, build the protein, and release it. The two proteins can't infect any other cells, but they're enough for the immune system to learn to recognize Zika and build immunity. Researchers have been hesitant to use weakened viruses of Zika to immunize against the virus, because Zika viruses can enter the brain. Even with weakened Zika, some scientists are concerned that attenuated viruses might still cause some damage in the brain. However, with RNA vaccines, cells quickly uptake the RNA, which never reaches the brain. Another key advantage of using RNA vaccines is their adaptability. Biologists have had a lot of practice at altering RNA strands, making it easier to customize the vaccine. The researchers demonstrated the vaccine's flexibility by addressing one possible concern in the Zika vaccine development community. Zika virus looks an awful lot like its close relative, the dengue virus. In fact, they look so much alike that the immune system's antibodies against Zika might latch onto dengue viruses without actually killing the dengue virus. If that occurred, anti-Zika antibodies might worsen dengue infections. However, slightly modifying the RNA in the vaccine allowed the researchers to induce a Zika-killing antibody that minimized its ability to bind to dengue. The researchers stressed that there haven't been epidemiological studies reporting especially vicious dengue infections in people who have had Zika. "It is a theoretical concern. We do not know yet if it's going to be a major concern or not. Because you need to have Zika first and then get dengue," says Diamond. Lots of people have gotten dengue first and later caught Zika, but since Zika is a relatively new addition to most locales, there haven't been enough Zika-first, dengue-second cases to lay the concern to rest. "We just don't know yet," says Diamond. Next steps for the Zika RNA vaccines include a human clinical trial (which is currently recruiting) and mouse studies that test whether the vaccine can prevent mother-to-fetus transmission. This work was supported by grants from the NIH-NIAID and by a research grant from Moderna. Michael Diamond is a consultant or scientific advisor for several pharmaceutical companies, including Moderna. Giuseppe Ciaramella and two co-authors are employees of Valera LLC, a Moderna venture. Pre-clinical funding for Moderna's development of its Zika mRNA vaccine was provided by the Defense Advanced Research Projects Agency (DARPA). Funding for the clinical trials of Moderna's Zika mRNA vaccine is provided by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Cell, Richner and Himansu et al.: "Modified mRNA vaccines protect against Zika virus and minimize antibody enhancement of dengue virus infection" http://www.cell.com/cell/fulltext/S0092-8674(17)30195-2 Cell (@CellCellPress), the flagship journal of Cell Press, is a bimonthly journal that publishes findings of unusual significance in any area of experimental biology, including but not limited to cell biology, molecular biology, neuroscience, immunology, virology and microbiology, cancer, human genetics, systems biology, signaling, and disease mechanisms and therapeutics. Visit: http://www. . To receive Cell Press media alerts, contact press@cell.com.


News Article | February 22, 2017
Site: marketersmedia.com

MISSION VIEJO, CA / ACCESSWIRE / February 22, 2017 / Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose‑escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amytrophic Lateral Sclerosis ("ALS"), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the BARDA contract supports the drug's potential as a therapy for IPF. Upon completion of the phase 1 single dose study, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer. Data from all of these studies will support the development of AEOL 10150 as a medical countermeasure for Lung-ARS and sulfur mustard exposure, as well as the IPF and cancer clinical indications. "We are very pleased to have addressed the FDA's comments and received their concurrence to test AEOL 10150 in healthy subjects. The new formulation of AEOL 10150 has reduced the cost of the drug by approximately 90 percent and the additional toxicology work cleared the way for testing in healthy subjects," stated John L McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This phase 1 study will give us important safety and pharmacokinetic data that will allow us to accelerate and expand the development of AEOL 10150 in both large commercial and in biodefense indications that represent major unmet medical needs. We are grateful to BARDA for their support of the program, which enabled us to achieve the improvements in the cost and consistency of manufacturing AEOL 10150 and the elimination of the toxicology concerns that had previously limited our potential clinical targets." AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas. Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus' corporate website at www.aolsrx.com. The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MISSION VIEJO, CA / ACCESSWIRE / February 22, 2017 / Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose‑escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amytrophic Lateral Sclerosis ("ALS"), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the BARDA contract supports the drug's potential as a therapy for IPF. Upon completion of the phase 1 single dose study, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer. Data from all of these studies will support the development of AEOL 10150 as a medical countermeasure for Lung-ARS and sulfur mustard exposure, as well as the IPF and cancer clinical indications. "We are very pleased to have addressed the FDA's comments and received their concurrence to test AEOL 10150 in healthy subjects. The new formulation of AEOL 10150 has reduced the cost of the drug by approximately 90 percent and the additional toxicology work cleared the way for testing in healthy subjects," stated John L McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "This phase 1 study will give us important safety and pharmacokinetic data that will allow us to accelerate and expand the development of AEOL 10150 in both large commercial and in biodefense indications that represent major unmet medical needs. We are grateful to BARDA for their support of the program, which enabled us to achieve the improvements in the cost and consistency of manufacturing AEOL 10150 and the elimination of the toxicology concerns that had previously limited our potential clinical targets." AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. We are developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas. Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus' corporate website at www.aolsrx.com. The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

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