Monthly Archives

September 2019

AstraZeneca, Learning Undefeated and Discovery Education Launch New Generation Health Program to Encourage Healthy Living Through Science-Based Learning

By | News | No Comments

New STEM Program Inspires Middle School Students to Connect Science and Healthy Living Through Experiential Learning Resources

Silver Spring, Md., Sep. 12 /CSRwire/ –  AstraZeneca, Learning Undefeated and Discovery Education, the leading provider of standards-aligned digital curriculum resources, engaging content and professional learning for K-12 classrooms, today launched Generation Health: How Science Powers Us, a dynamic program designed to make the connection between students’ health and the science behind the prevention and treatment of disease. This program offers standards-aligned experiential learning resources for students in grades 6-8, where students investigate both preventative measures, and innovative solutions to key health concerns with a focus on the following areas: oncology, cardiovascular and respiratory.

The Generation Health: How Science Powers Us program will launch with a Virtual Field Trip premiere on Tuesday, October 8, 2019 at 1:00 p.m. ET/10:00 a.m. PT and will give students a behind-the-scenes look at pharmaceutical labs at AstraZeneca. During the Generation Health Virtual Field Trip, students will get a chance to meet real scientists and learn about the importance of failure as a way to learn and grow, especially when it comes to innovating new medicines. Educators, parents and students are welcomed to register for the virtual event here. Participants are encouraged to join @DiscoveryEd@AstraZenecaUS, and @LearningUNDFTD for a live Twitter chat during the premiere by submitting questions and sending pictures using #GenerationHealthVFT.

“AstraZeneca is committed to educating and empowering the next generation of scientists, and our partnership with Discovery Education is designed to help students explore some common diseases and how we aim to combat them,” said José Baselga, executive vice president, Oncology R&D, AstraZeneca. “In addition, this program will help students understand the importance of scientific discovery and innovation, while showcasing some of the many STEM careers available in the healthcare field.”

Click here to read the entire release.

Kinexum’s Dr. Zan Fleming, M.D. and Thomas Seoh join Rich Bendis on BioTalk

By | BioTalk, News | No Comments

Dr. Zan Fleming, M.D. and Thomas Seoh of Kinexum join Biotalk host Rich Bendis to discuss the company, Metabesity, and their upcoming 2019 Conference in Washington, DC

Listen now on Google Podcasts http://bit.ly/2kaI8Xt, iTunes https://apple.co/2kc7jsG, and TuneIn http://bit.ly/2lMk79l

Dr. Alexander Fleming is Founder and Executive Chairman of Kinexum, a company with diverse expertise in developing drugs, biotech products, medical devices and digital health technologies. He is also Executive Vice-President of Tolerion, a biotechnology company developing disease-modifying treatments for type 1 diabetes and other autoimmune diseases. Dr. Fleming received his M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow.

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications.  He led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication and represented FDA on the expert working groups for Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonisation (ICH) and participated on other ICH committees including the Common Technical Document working group.

Dr. Fleming remains active in supporting the development of diabetes-related preventions, treatments, devices, and digital technologies.  He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.
Thomas Seoh is President and CEO of Kinexum, a strategic advisory firm that provides regulatory, clinical, CMC and other translational guidance for life science product development.  He is an entrepreneur/executive who has held senior leadership positions in public and private pharmaceutical, biotech and medical device companies for over 25 years.

Mr. Seoh began his career as a corporate attorney in New York and London, then assumed legal management positions with the Consolidated Press group in Livonia, MI, then the ICN Pharmaceuticals group in Costa Mesa, CA.  He next became VP, General Counsel and Secretary, and later, SVP Corporate and Commercial Development, of Guilford Pharmaceuticals, a NASDAQ-listed company in Baltimore which commercialized GLIADEL® wafer for glioblastoma multiforme and developed the propofol pro-drug LUSEDRA® and small molecules for Parkinson’s disease.  He then became CEO of venture-backed Faust Pharmaceuticals in Strasbourg, France, with a repurposed compound in Phase II for Parkinson’s patients, a re-positioned molecule for Duchenne muscular dystrophy and a GPCR drug discovery platform.

Mr. Seoh subsequently served in leadership positions of medical device startups developing an ex vivo liver dialysis device, a novel mechanical thrombectomy device for Deep Vein Thrombosis and stroke and a state-of-the-art neurocatheter, and a plant-based skin substitute wound dressing.  He has served on industry-university advisory boards at Johns Hopkins School of Medicine and the University of Maryland Baltimore County.  He holds an AB in Philosophy and History and a JD from Harvard University.

Viela Bio Announces Publication in The Lancet of Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder

By | News | No Comments

GAITHERSBURG, Md.–(BUSINESS WIRE)–Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.

The N-MOmentum trial, the largest global, placebo-controlled study in NMOSD with 231 enrolled patients, met its primary endpoint and a majority of secondary endpoints. The study results, which were presented at a plenary session of the annual meeting of the American Academy of Neurology (AAN), demonstrated significant reduction in risk of NMOSD attack and reduced disability scores as measured by expanded disability status scale, hospitalizations and new central nervous system MRI lesions.

The paper, entitled “Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmemtum): a double-blind, randomised placebo-controlled phase 2/3 trial,” is now available and will be published in a future print edition of The Lancet.

“We’re pleased that these important results are now fully available to the greater neuroinflammatory and autoimmune disease communities,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “This study provided key information on the safety and efficacy profile of inebilizumab monotherapy in NMOSD. Inebilizumab is the first and only biologic to use CD19 as a target for B cell depletion in this devastating disease.”

Click here to read the entire press release.

Regenxbio, Clearside enter option and license agreement for SCS Microinjector

By | News | No Comments

Regenxbio and Clearside Biomedical announced an option and license agreement that will give Regenxbio exclusive worldwide rights to Clearside’s SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space.

RGX-314 includes the NAV AAV8 vector encoding an antibody fragment to inhibit VEGF. Regenxbio is evaluating RGX-314 using the SCS Microinjector for in-office, nonsurgical delivery to the suprachoroidal space while also advancing its subretinal delivery program for the treatment of wet age-related macular degeneration and diabetic retinopathy, according to a press release.

“We are pleased to partner with Clearside in evaluating the use of the SCS Microinjector to deliver RGX-314 to the suprachoroidal space in the eye. We believe this approach can potentially allow for the treatment of an expanded population of patients with wet AMD and DR by providing access to gene therapy treatment in all settings of patient care,” Kenneth T. Mills, president and CEO of Regenxbio, said in the release. “Delivery into the suprachoroidal space, which in clinical trials has demonstrated minimal associated procedural risks, may allow physicians to treat patients with diseases like DR earlier in the disease course with RGX-314.”

Click here to read more via healio.com

Emergent BioSolutions Awarded 10-Year HHS Contract to Deliver ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) Into the Strategic National Stockpile

By | News | No Comments
  • Reaffirms ACAM2000 as a key component of the U.S. preparedness stance against the threat of smallpox as a biologic weapon
  • Supports the government’s continued efforts and long-term strategy to maintain sufficient quantities of smallpox vaccine to provide a response capability to vaccinate every American during a smallpox emergency

GAITHERSBURG, Md., Sept. 03, 2019 (GLOBE NEWSWIRE) — In support of the U.S. government’s policy to maintain a stockpile to be able to protect every American from smallpox, Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $2 billion over 10 years for the continued supply of ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (SNS). The actual number of ACAM2000 doses to be procured is dependent on certain timing and tiered-pricing terms that are subject to the discretion of ASPR. ACAM2000 vaccine is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, stated, “Emergent applauds the U.S. government’s continued focus on national security demonstrated through its long-term stockpiling strategy, which ensures a sustainable supply of critical medical countermeasures such as ACAM2000 vaccine, and its investment in a stable domestic manufacturing infrastructure to help protect the U.S. population against  smallpox in the event of an attack. Awarded on the heels of our recently announced contract to supply our Vaccinia Immune Globulin Intravenous or VIGIV therapeutic, this contract solidifies our role as a solutions provider supporting the government’s smallpox preparedness efforts and helping fulfill their needs with our smallpox franchise. It is one of the unique ways we live out our mission – to protect and enhance life.”

This contract for the procurement of ACAM2000 vaccine consists of a one-year base period of performance, valued at approximately $170 million, and nine option years. The company expects to deliver into the SNS a majority of the doses under the base year by year end 2019, the effect of which is already included in the company’s full year financial forecast, which was recently reaffirmed on August 1. This multiple year contract is intended to support the replacement of the smallpox vaccine stockpile and follows the conclusion of a prior 10-year, $425 million contract to establish domestic warm-base manufacturing capabilities and procure smallpox vaccines issued by the U.S. government April 1, 2008. ACAM2000 continues to be one of the lowest priced vaccines that the U.S. government procures across all relevant vaccine programs.

Abbey Jenkins, SVP and vaccines business unit head at Emergent, said, “The U.S. government’s long-term commitment to smallpox preparedness and the role ACAM2000 vaccine serves have been reinforced in guidance and legislation within the last two decades. As the only smallpox vaccine administered in one dose, ACAM2000 vaccine remains the primary smallpox vaccine for general population use in the event of a smallpox emergency.i We are proud of our employees, especially those at our Canton, Massachusetts and Rockville, Maryland locations, who are dedicated to producing this critical countermeasure. Because of their work, Emergent stands ready to continue our partnership with HHS in fulfilling this contract.”

Smallpox vaccines have been foundational to the U.S. government’s preparedness and response efforts as documented in the Project BioShield Act of 2004 (https://www.govtrack.us/congress/bills/108/s15/text) and its predecessor the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (https://www.congress.gov/bill/107th-congress/house-bill/3448). In 2015, the Centers for Disease Control and Prevention (CDC) issued clinical guidance for smallpox vaccine use in a post-event scenario (https://www.cdc.gov/mmwr/pdf/rr/rr6402.pdf) stating that surveillance and containment activities including vaccination with replication-competent smallpox vaccine such as ACAM2000 will be the primary response strategy for achieving epidemic control. Persons exposed to smallpox virus are at high risk for developing and transmitting smallpox and should be vaccinated with a replication-competent smallpox vaccine unless severely immunodeficient.

Contract 75A50119C00052 is funded by the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

About ACAM2000 Vaccine
ACAM2000 vaccine is the primary smallpox vaccine designated for use in a bioterrorism emergency, with almost 269 million doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000 vaccine is also licensed in Australia and Singapore and is currently stockpiled both in the U.S. and internationally.

ACAM2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

The labeling for ACAM2000 contains a contraindication for individuals with severe immunodeficiency. Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000. The risk for experiencing severe vaccination complications must be weighed against the risk for experiencing a potentially fatal smallpox infection.

Additionally, there are warnings and precautions for myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson Syndrome), eczema vaccinatum resulting in permanent sequelae or death, ocular complications; blindness and fetal death have occurred following either primary vaccination or revaccination with live vaccinia virus smallpox vaccines. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequalae and/or death.

Please see full Prescribing Information for full boxed warning and additional safety information.

About Smallpox
Smallpox is a highly contagious disease caused by the variola virus, a member of the Orthopox virus family. According to the CDC, it is one of the most devastating diseases with a mortality rate as high as 30%. Smallpox is classified by the CDC as a Category A bioterrorism agent and the U.S. government continues to invest in countermeasures to protect the nation from this threat. Governments around the world are also taking precautionary measures to be ready to deal with a potential smallpox outbreak.

About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats. We aspire to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values. Additional information about the company may be found at www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the total potential realizable value of the contract, the timing of ACAM2000 deliveries and their impact on the company’s full year financial forecast, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the availability of funding for our U.S. government grants and contracts, decisions by HHS to exercise options under the contract and our manufacturing capabilities and strategy. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Lynn Kieffer
Vice President, Corporate Communications
240-631-3391
KiefferL@ebsi.com

i CDC. Clinical Guidance for Smallpox Vaccine Use in a Postevent Vaccination Program. MMWR Recomm Rep 2015;64 (No. 2).

emergent logo.jpg

Join our Mailing List