Shire Human Genetic Therapies
Shire Human Genetic Therapies
News Article | May 17, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, today announced the appointment of David Brooks, M.D., Ph.D., to Senior Vice President, Clinical Development. Dr. Brooks will be responsible for the execution of Eleven’s ongoing and planned clinical trials. He will report to Arthur DeCillis, M.D., Chief Medical Officer. “Eleven is at a pivotal inflection point, as we progress our Phase 3 registration trial of Vicinium™ and prepare to advance our second program, Proxinium™, into a Phase 1/2a study in combination with a checkpoint inhibitor,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “We are pleased to welcome David to the Eleven team as we continue to build out our clinical development organization. David brings a highly-relevant skillset, including experience overseeing the simultaneous development of multiple oncology programs as monotherapies and in combination with immuno-oncology agents. We look forward to his contributions as we continue to evaluate the potential of our locally- and systemically-administered TPTs and work to bring new medicines that improve upon existing therapeutic options to patients.” Dr. Brooks joins Eleven Biotherapeutics from Deciphera Pharmaceuticals, where he served as Vice President, Clinical Research and Translational Medicine. In this role, Dr. Brooks led the clinical development of four oncology product candidates, set clinical strategy for assets entering testing in direct anti-tumor and immune combination therapy, and planned clinical trials evaluating the combination of immunotherapies with novel myeloid cell checkpoint blockers. Prior to joining Deciphera, Dr. Brooks was Senior Director Physician, Oncology Early Clinical Development at AstraZeneca, where he led the clinical development of a dual specificity PI3K inhibitor across multiple oncology indications and managed a portfolio of external alliances and investigator-sponsored studies. Earlier in his career, Dr. Brooks served as Medical Head, Translational Medicine at TESARO Inc., as Chief Medical Officer and Senior Vice President at Generation Health, Inc., and as Medical Director, Global Clinical Medicine at Abraxis Bioscience, Inc. He also worked at Shire Human Genetic Therapies, Inc. and Merck & Co., Inc. Dr. Brooks holds a M.D. and Ph.D. in Molecular Biology from Cornell University. He completed his residency in Internal Medicine at the University of Pennsylvania and a fellowship in Medical Genetics at the Children’s Hospital of Philadelphia/Hospital of the University of Pennsylvania. He also served as an Instructor in Medicine in the Division of Medical Genetics at the University of Pennsylvania. “I am pleased to join the Eleven team at such an important time,” said Dr. Brooks. “The Company’s lead drug candidates have demonstrated promising anti-tumor activity and safety as single agents. I am eager to work with Eleven’s team to further demonstrate the potential of Vicinium in the clinic. I am particularly excited to progress the ongoing Phase 3 registration trial of Vicinium for patients with high-grade non-muscle invasive bladder cancer, a disease which has not seen meaningful advancements in approximately forty years.” Dr. Brooks is the third recent addition to Eleven’s clinical development group in recent months. In the first quarter, Eleven appointed Gary Conboy as Executive Director, Clinical Sciences and Mary Rohrer as Associate Director, Clinical Operations. Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's TPT platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing ADC technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than are achievable with small molecule payloads that require tumor cell proliferation and face multi-drug resistance mechanisms. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immuno-oncology drugs such as checkpoint inhibitors. For more information please refer to the Company's website at www.elevenbio.com. Any statements in this press release about future expectations, plans and prospects for the Company, the Company's strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company's product candidates and other factors discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.
News Article | May 8, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Agilis Biotherapeutics, Inc. (Agilis), a biotechnology company advancing innovative gene therapy products for the treatment of rare genetic diseases that affect the central nervous system (CNS), announced today that the Company has expanded its commercial and medical teams, hiring Markus Peters, Ph.D., as Chief Commercial Officer, Kirsten Gruis, M.D. as Chief Medical Officer, and Anne Marie Conway, M.H.A, R.N., as Vice President Clinical Operations. “We are pleased to welcome these three talented individuals to our leadership team. Each brings a wealth of experience to Agilis that is directly aligned with our mission to help patients with rare CNS diseases, advance our clinical pipeline, and lay the foundation for future approval and commercialization of our promising gene therapy product candidates,” said Dr. Mark Pykett, President and CEO of Agilis. Dr. Markus Peters will lead Agilis’ commercial, business development and business analytics activities, and will spearhead market efforts for the company’s aromatic L-amino acid decarboxylase (AADC) deficiency gene therapy globally. He brings a significant background to Agilis in the commercialization of rare disease therapeutics and specialty pharmaceuticals. Most recently, he was an Associate Partner with the consulting group Alacrita. Dr. Peters was previously Vice President, Global Marketing/Commercial with Synageva, where he led the cross-functional global launch team for first-in-class enzyme replacement therapy Kanuma to develop and implement the global strategy and launch plan for the product in ultra-rare LAL deficiency. He was also responsible for the commercial assessment of the Synageva pipeline. Before Synageva, he was Head of Global Marketing Nephrology and Transplant Therapeutic Area at Alexion, leading the global launch of the ultra-orphan Soliris aHUS (atypical hemolytic uremic syndrome) franchise. Dr. Peters previously worked at Merck where he led the global launch of recombinant biologic Elonva, and at Sepracor, Wyeth, Bayer and Boehringer Ingelheim in the US, Japan and Europe in business and commercial roles of increasing responsibility. He holds a Ph.D. in Biochemistry from Heinrich-Heine Universität. Kirsten Gruis, M.D., is an accomplished physician scientist, board certified neurologist, and rare disease specialist, with a broad background in the development of innovative therapeutics. She has worked in Friedreich’s ataxia, Spinal Muscular Atrophy (SMA), Amyotrophic Lateral Sclerosis (ALS) and Duchenne Muscular Dystrophy (DMD), among others, across a range of development stages, including pre-clinical, Phase I, Phase II and Phase III programs. Dr. Gruis was most recently at WAVE Life Sciences leading their clinical development plans in DMD. Previously, she was at Idera Pharmaceuticals where she lead the team to initiate a global, phase II trial in dermatomyositis and, before that, she was at Alnylam Pharmaceuticals as the clinical lead of a global, phase III program of patisiran in the rare disease familial amyloidotic polyneuropathy and, before that, was with Pfizer managing pre-clinical and phase I-II assets in the Rare Disease Research Unit focused on Friedreich’s ataxia, SMA, ALS, and DMD. Dr. Gruis held academic appointments as an Associate Professor of Neurology at both the University of Michigan and SUNY Upstate Medical University. She received her MD from the University of Iowa and did her residency training at the University of Michigan, where she subsequently joined the faculty. While at SUNY Upstate Medical University, she served as the Director of the MDA clinic, Co-Director of the ALS Clinic, and prior to that was Director of the Motor Neuron Disease Center/ALS Clinic at the University of Michigan. Dr. Gruis is a member of the American Academy of Neurology and World Muscle Society, as well as a Fellow American Association of Neuromuscular & Electrodiagnostic Medicine with additional board certification in Neuromuscular Disorders. She has served on multiple NIH Scientific Review Panels for the NINDS and Neurotechnology study groups as well as a principal investigator of several clinical studies for ALS. Anne Marie Conway, M.H.A., R.N., brings extensive experience in clinical operations to Agilis’ clinical development programs. Most recently, she was Principal at AMC Consulting, providing clinical operations services to a range of drug development organizations including Rhythm Pharmaceuticals, bluebird bio and Lantheus Medical Imaging, among others. Before that, she worked at Ziopharm Oncology as head of Clinical Operations and Data Management. While there, she managed the start-up of the gene therapy program for high grade gliomas. Prior to that, she was at Shire Human Genetic Therapies (now integrated into Shire, plc) as Vice President, Development Operations, providing management oversight for the global filing and approval of VPRIV™ for Gaucher disease, running a global Phase III trial and subsequent approval of Firazyr™ for hereditary angioedema and, leading global clinical operations, data management and registry group for eight rare disease pipeline products in Phases I through IV studies. Prior to its acquisition by Shire, Ms. Conway worked at Transkaryotic Therapies and led the integrated development team for the clinical sections of the BLA/MAA filing and subsequent approval in the United States, European Union, and Japan for elaprase™. Before moving into industry, Ms. Conway worked at Tufts Medical Center as a Clinical Trials Manager, Outpatient Nurse Coordinator, and Staff Nurse. She has an M.H.A. from Suffolk University and a B.S. from Boston University, is a licensed nurse, and holds an adjunct faculty position at Suffolk University. Agilis is advancing innovative gene therapies designed to provide long-term efficacy for patients with debilitating, often fatal, rare genetic diseases that affect the central nervous system. Agilis’ gene therapies are engineered to impart sustainable clinical benefits by inducing persistent expression of a therapeutic gene through precise targeting and restoration of lost gene function to achieve long-term efficacy. Agilis’ rare disease programs are focused on gene therapy for AADC deficiency, Friedreich’s ataxia, and Angelman syndrome, all rare genetic diseases that include neurological deficits and result in physically debilitating conditions. We invite you to visit our website at www.agilisbio.com Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.
News Article | May 9, 2017
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today the appointment of several experienced industry leaders to key leadership roles including: Manmeet S. Soni, Chief Financial Officer; Theresa Heggie, Senior Vice President, Head of Europe and Canada; Peter Smith, Ph.D., Senior Vice President, Early Development; and Alan Eisenberg, Vice President, Global Public Policy and Government Relations. "We are thrilled to welcome Manmeet, Theresa, Peter, and Alan to Alnylam at an exciting moment in our history. Each of these individuals brings a critical set of skills to the organization as we transition from a late-stage research and development company to a multi-product, commercial-stage company with a robust and sustainable pipeline of innovative medicines,” said John Maraganore, Ph.D. Chief Executive Officer of Alnylam. "This expansion of our leadership team solidifies and strengthens our path forward." “I couldn’t imagine a more exciting time to join Alnylam,” said Mr. Soni. “It’s an honor to have the opportunity to work with such a talented group of individuals focused on bringing forward a new class of medicines for the betterment of lives of patients in need. I look forward to using my experience in building and leading commercial finance teams and capabilities to help Alnylam execute on its strategy, goals and transition towards an independent commercial-stage company.” In this role Mr. Soni will provide strategic leadership in the overall financial management of Alnylam, including for the global finance, investor relations and communications teams. Manmeet is the former Chief Financial Officer and Treasurer of ARIAD Pharmaceuticals, Inc., where he played a central role in the strategic review, turnaround and subsequent acquisition of ARIAD Pharmaceuticals, Inc. by Takeda Pharmaceuticals Company Limited. Before joining ARIAD Pharmaceuticals, Inc., Manmeet worked at Pharmacyclics, Inc., where he served most recently as Chief Financial Officer and Treasurer. Mr. Soni also played a vital role in the acquisition of Pharmacyclics, Inc. by Abbvie, Inc. for $21 billion. Previously, Mr. Soni worked at ZELTIQ Aesthetics Inc., and PricewaterhouseCoopers San Jose, in the Life Science and Venture Capital Group. Prior to that, he worked at PricewaterhouseCoopers, India. Mr. Soni is currently a board member and audit committee chair at Genoscience Pharma. He graduated from Hansraj College at Delhi University in India. He is a Certified Public Accountant, licensed in the state of California and a Chartered Accountant from India. "Expanding Alnylam’s operations into Europe and Canada is being done in recognition of the broad commercial rights we have in these regions and the important role they will play in our global commercial strategy," commented Ms. Heggie. "Drawing on my expertise from numerous European and global leadership roles, I look forward to advancing this important phase of the Company’s commercial evolution and bringing new treatments to patients in Europe and Canada." In this role Ms. Heggie will be responsible for the strategic direction and activity of all of Alnylam’s operations in Europe and Canada including building the go-to-market strategy across multiple products and therapeutic areas. Most recently she served as the Chief Marketing and Strategy Officer at The British United Provident Association (Bupa). Previously, Ms. Heggie held various senior commercial positions at Shire Human Genetic Therapies (and formerly TKT) including the roles of Vice President and General Manager of EMEA, Chief Executive Officer of Jerini AG (a Shire acquisition), and Senior Vice President of Global Commercial Operations. Earlier, at Baxter Healthcare she held numerous roles including Vice President of Global Marketing. Early in her career, Ms. Heggie held a variety of sales and marketing positions at Janssen Pharmaceuticals. She formerly served as a member of the board of directors of Swedish Orphan Biovitrum AB. Theresa received a BSc from Cornell University. Ms. Heggie will report to Barry Greene, President and will be based at Alnylam’s European headquarters in Zug, Switzerland. “Having the ability to work at an organization with a product engine as productive as Alnylam’s is a very special opportunity,” added Dr. Smith. “The ability to grow and develop the Early Development team across the pipeline of RNAi therapeutics at Alnylam will be paramount as we advance the translation of promising science toward new medicines for patients.” In this role, Dr. Smith will be responsible for all aspects of non-clinical safety, drug metabolism and pharmacokinetics, bioanalysis and biomarker programs, providing both scientific and drug development leadership. Dr. Smith brings more than 30 years of pharma industry experience to Alnylam, most recently joining from Moderna, where he was Head of R&D Non-Clinical. He joined Moderna from Millennium Pharmaceuticals, where he most recently served as co-head of R&D and a member of the company’s management team. In this role, he was responsible for management of all Non-Clinical groups and Pharmaceutical Sciences. His extensive experience in drug discovery and development spans multiple therapeutic areas and therapeutic modalities. Over the course of Dr. Smith’s career, he has had oversight of the non-clinical development of multiple, currently marketed therapeutics including CELEBREX®, INSPRA®, VELCADE® and ENTYVIO®, and also deep involvement in the development of numerous other products. Dr. Smith has a B.S. in biology from Fairfield University and a Ph.D. in Pharmacology and Toxicology from the University of Arizona. His postdoctoral fellowship in biochemical toxicology was undertaken at SmithKline. He has published and presented extensively in the pharm/tox area as well as in the area of drug development. Dr. Smith will report to Akshay Vaishnaw, Executive Vice President of Research and Development. “In an era of intense scrutiny around value and access to innovation, I look forward to drawing on my political and policy experience both in the private and public sectors to help Alnylam achieve its objectives,” said Mr. Eisenberg. “I’m deeply aligned with the mission and vision of Alnylam and look forward to working on behalf of the company with our governmental stakeholders globally.” In this role, Alan will lead federal, state and local government affairs and public policy initiatives globally. Alan joins Alnylam from Celgene where he was the Vice President for Federal Government Relations. In this role, he led Celgene’s Federal Government Relations function and had direct responsibility for the Company’s public policy engagement with Congress, relevant Executive Branch agencies and other Washington, D.C. based stakeholders. Prior to Celgene, Mr. Eisenberg was Executive Vice President for Emerging Companies & Business Development at the Biotechnology Innovation Organization (BIO), leading BIO’s services and advocacy efforts for BIO’s pre-market and early stage commercial companies, in addition to serving in other senior leadership roles at BIO. Previously, Mr. Eisenberg served as Health and Economics Policy Advisor to Congressman Jim Greenwood and prior to that, he served on the staff of the Senate HELP Public Health Subcommittee, and also was a legislative assistant for Congressman John Shadegg. Earlier in his career he spent four years with Ford Motor Company. Mr. Eisenberg holds a Master in Public Policy degree from Harvard University, a Master of Science in Finance degree from George Washington University, and a Bachelor of Science degree from Union College. Mr. Eisenberg will report to Laurie Keating, Senior Vice President and General Counsel. Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically-validated approach for the treatment of a wide range of debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including three product candidates that are in late-stage development or will be in 2017. Looking forward, Alnylam will continue to execute on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam. Various statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylam's views with respect to the potential for RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam's ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, including actions by regulators concerning product candidates, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam's ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam's and others developing products for similar uses, Alnylam's ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam's dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.
News Article | February 16, 2017
AUSTIN, Texas, Feb. 16, 2017 (GLOBE NEWSWIRE) -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer, today announced the appointment of Suzanne L. Bruhn, Ph.D. to its Board of Directors. Dr. Bruhn previously served as chief executive officer, president and director at Promedior, Inc., a clinical-stage biotechnology company, from 2012 to 2015. “Suzanne’s depth of experience in the early-stage biotechnology space and expertise in orphan diseases will be a valuable addition to our Board,” said David G. Lowe, Ph.D., co-founder, president and chief executive officer of Aeglea. “Her insights and guidance will be a tremendous asset as we further our clinical programs in order to pursue our mission of developing treatments for patients with rare genetic diseases and cancer.” During her time at Promedior, Dr. Bruhn focused the company’s strategy on clinical development for orphan diseases and negotiated the grant of an exclusive option to acquire Promedior to Bristol-Myers Squibb Company in 2015. Prior to Promedior, Dr. Bruhn held a number of roles in strategic and portfolio planning, program management and regulatory affairs at Shire Human Genetic Therapies, formerly known as Transkaryotic Therapies, between 1998 and 2012. She also served on the board of directors of Raptor Pharmaceuticals Corp., a biotechnology company focused on treating rare metabolic disorders, from 2011 until it was sold to Horizon Pharma plc in October 2016. Dr. Bruhn earned her bachelor’s degree in chemistry from Iowa State University of Science and Technology and her Ph.D. from Massachusetts Institute of Technology. About Aeglea BioTherapeutics Aeglea is a biotechnology company committed to developing enzyme-based therapeutics in the field of amino acid metabolism to treat rare genetic diseases and cancer. The company’s engineered human enzymes are designed to modulate the extremes of amino acid metabolism in the blood to reduce toxic levels of amino acids in inborn errors of metabolism or target tumor metabolism for cancer treatment. AEB1102, Aeglea’s lead product candidate, is currently being studied in two ongoing Phase 1 clinical trials in patients with advanced solid tumors and acute myeloid leukemia/myelodysplastic syndrome (AML/MDS). Additionally, Aeglea is recruiting patients into its ongoing Phase 1/2 trial of AEB1102 for the treatment of patients with Arginase I deficiency. The company is building a pipeline of additional product candidates targeting key amino acids, including AEB4104, which degrades homocystine, a target for an inborn error of metabolism, as well as two potential treatments for cancer, AEB3103, which degrades cysteine/cystine, and AEB2109, which degrades methionine. For more information, please visit http://aegleabio.com. Safe Harbor / Forward Looking Statements This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, the potential therapeutic benefits and economic value of our product candidates. Further information on potential risk factors that could affect our business and its financial results are detailed in our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.