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Personal Genome Diagnostics and Fox Chase Cancer Center Announce Partnership to Broaden Liquid Biopsy Applications in Oncology Clinical Research

BALTIMORE, Md.–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, today announced a strategic collaboration with Fox Chase Cancer Center in Philadelphia for the PGDx elio™ plasma resolve liquid biopsy panel.

The strategic collaboration combines the world-class Fox Chase research and clinical expertise in the community healthcare setting with PGDx leadership in the development of comprehensive genomic products that can be distributed and used in laboratories worldwide, wherever patients seek treatment for their cancer. Both organizations are driven by the overall goal of bringing the highest standards of care to patients in communities across the globe.

“We are proud to enter into this collaboration with Fox Chase Cancer Center, which shares our vision for advancing access to the most innovative technologies that enable precision medicine in oncology. As an NCI designated Comprehensive Cancer Center, Fox Chase is known for advanced treatments, highly experienced teams, and bold discoveries in oncology. Their leadership in clinical care and research will provide valuable insights to PGDx as we continue our quest to empower each patient’s fight against cancer by decentralizing comprehensive tumor profiling capabilities,” said PGDx CEO Megan Bailey.

Don A. Baldwin, Ph.D., Associate Professor of Pathology and Director of Molecular Testing Enterprise at Fox Chase Cancer Center, commented, “Through this partnership with PGDx, we seek to advance the current standards of care to include genomic monitoring during and after cancer treatment. Our goal is early identification of tumor responses to therapy, drug resistance mutations, and metastasis or recurrence, enabling rapid revision of the patient’s treatment plan informed by changes in the molecular status of their disease. This molecular status is often reflected by tumor DNA shed into the bloodstream, and our clinical research will use the PGDx elio plasma resolve platform to sequence circulating tumor DNA.”

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to improving clinical insight, speed of results, and healthcare economics by delivering a portfolio of regulated tissue-based and liquid biopsy genomic products for health systems worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. For additional information, visit www.pgdx.com.

About Fox Chase Cancer Center

The Hospital of Fox Chase Cancer Center and its affiliates (collectively “Fox Chase Cancer Center”), a member of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence five consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship and community outreach. It is the policy of Fox Chase Cancer Center that there shall be no exclusion from, or participation in, and no one denied the benefits of, the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.

For more information, visit www.foxchase.org.

Contacts

W2O Group:
Aulani Capuchin
559-355-2673
acapuchin@w2ogroup.com

Eyedea Medical Joins Baltimore’s LaunchPort™ Medtech Venture Center

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The LaunchPort™ announced today that Eyedea Medical (https://www.eyedeamedical.com/) joined the Venture Center and will make the Port Covington, Baltimore location their HQ and engineering site.

Eyedea Medical is an early-stage, ophthalmic medical device company that was spun out of the Wilmer Eye Institute and the Center for Bioengineering Innovation & Design at Johns Hopkins University. Eyedea Medical was formed by a group of ophthalmologists and biomedical engineers in 2019 to alleviate the burden of corneal blindness globally through development and commercialization of a series of devices with potential to improve outcomes and access to vision-restoring corneal procedures.

Eyedea was awarded a Small Business Innovation Research (SBIR) grant from the National Science Foundation to complete development and validation of its first product, DescePrep™, a corneal graft preparation device. In a study presented at the recent Eye Bank Association of America annual meeting, Eyedea Medical demonstrated that DescePrep™ can process human donor corneas extremely efficiently (< 5 mins), at high success rates (97%+), and of suitable quality for clinical use.

Robert Storey, Managing Partner of The LaunchPort™, commented, “We’re extremely happy that Katie Solley, Eyedea’s CEO, selected LaunchPort for their Baltimore home. I’ve known Katie since her days at Johns Hopkins CBID and through her journey in Abell Foundation’s Fellow program. She is a shining example of the next generation of bright and motivated Medtech leaders emerging from the Baltimore ecosystem.”

About Eyedea Medical (Baltimore, MD)
Eyedea Medical (http://www.eyedeamedical.com), founded in 2019, is a women-owned, ophthalmic medical device company working to reduce the burden of corneal blindness globally.

About The LaunchPort™ (Port Covington, Baltimore, MD)
The LaunchPort™ (http://www.thelaunchport.com) is a Medtech venture center that allows Medtech start-ups and emerging technology developers the ability to co-locate at an experienced, regulated manufacturing center. Located at the “City Garage” in Baltimore’s Port Covington, it is in close proximity to two of the Country’s premier medical schools (Johns Hopkins and University of Maryland) and at the center of one of the world’s largest urban revitalization projects.

Cartesian Therapeutics Initiates Phase 2 Clinical Trial of First RNA-Engineered Cell Therapy for Frontline Cancer

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  • Descartes-11 specifically designed to integrate into standard treatment regimen for newly diagnosed multiple myeloma without requiring lymphodepleting chemotherapy
  • Cartesian plans to enroll up to 30 patients in a single arm, open-label, multicenter study

Gaithersburg, MD, Feb. 22, 2021 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company pioneering mRNA-engineered cell therapy in and beyond oncology, today announced that it has initiated a Phase 2a clinical trial of its mRNA chimeric antigen receptor (CAR) T-cell therapy, Descartes-11, in patients with newly diagnosed, high-risk multiple myeloma.  Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for a frontline cancer. Descartes-11 is the third product candidate to be evaluated in clinical trials resulting from Cartesian’s RNA Armory℠ engineering platform.

“Patients newly diagnosed with high-risk multiple myeloma seldom achieve deep, durable responses after frontline therapy,” said Kenneth Anderson, MD, Kraft Family Professor of Medicine at Harvard Medical School and Program Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics.  “Integrating a CAR T-cell therapy into our standard of care, without using lymphodepleting chemotherapy, would be a welcome addition to our toolkit for treating this currently incurable disease.”

Descartes-11 is engineered with Cartesian’s RNA Armory℠ platform to express its CAR molecules transiently instead of permanently, thereby reducing both short-term and long-term risks inherent with conventional CAR T-cell therapies. Descartes-11 is manufactured in-house at Cartesian’s wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.

A Phase 1 study of Descartes-11 in patients with advanced myeloma showed no evidence of typical CAR T-cell toxicities such as cytokine release syndrome (CRS) of neurotoxicity.  Tens of billions of cells are mRNA-engineered with the CAR molecule so that the full therapeutic dose can be administered with each infusion.  This eliminates the need for preconditioning chemotherapy required by conventional CAR T-cell therapies.

Murat Kalayoglu, MD, PhD, President and Chief Executive Officer at Cartesian Therapeutics added, “We are hopeful that this study will validate the preliminary safety and efficacy of Descartes-11 in newly diagnosed myeloma, bringing us one step closer to offering a new frontline cell therapy treatment for multiple myeloma patients.  Descartes-11 is one of six wholly-owned cell therapy programs being developed using our proprietary RNA-based cell engineering platform, the RNA Armory℠.  Our vision is to cure disease by mRNA-engineering any cell, to target to any tissue, any combination of therapies.  Our approach enables us to potentially impact a broad range of indications beyond oncology, including respiratory and autoimmune conditions.”

About the Phase 1/2a Clinical Trial

The Phase 2a study (NCT04436029) is enrolling patients with newly diagnosed, high-risk multiple myeloma at multiple centers in the United States.  This study aims to determine the safety and preliminary efficacy of Descartes-11 in patients with newly diagnosed multiple myeloma who complete a pre-transplant anti-myeloma drug combination treatment but have residual disease after therapy.  The study aims to enroll approximately 30 patients.  For more information visit cartesiantherapeutics.com/Descartes-11-NDMM.

About Multiple Myeloma

Multiple myeloma, a cancer of plasma cells, is the second most common blood cancer in the world with over 150,000 new cases diagnosed yearly worldwide.  The malignant myeloma cells accumulate in the bone marrow, crowding out healthy cells and increasing risk of bone fractures.  The disease can also affect the kidneys and immune system.  For more information visit https://themmrf.org/.

About the RNA ArmorySM

The RNA Armory℠ is Cartesian’s proprietary cell therapy platform that enables mRNA-engineering any cell, to target to any tissue, any combination of therapies.  Unmodified donor cells enter the RNA Armory℠ in the millions; a battle-ready cell army leaves the RNA Armory℠ in the tens of billions. Each cell is equipped with a combination of therapeutics rationally chosen to have a synergistic effect on the disease.  In the body, the cells deliver a precision-targeted treatment regimen directly to the site of disease. The cells express therapeutics with a defined half-life, enhancing their safety profile and making repeat dosing and outpatient administration possible. The platform is agnostic to cell type; we choose the best cell for the job, whether autologous or off-the-shelf. For more information visit cartesiantherapeutics.com/rna-armory.

About Cartesian Therapeutics

Founded in 2016 and with three assets currently in clinical trials, Cartesian is the leader in mRNA-engineered cell therapy.  Cartesian’s vision is to cure disease by mRNA engineering any cell, to deliver to any tissue, any combination of therapies.  The company is pioneering mRNA cell therapies in and beyond oncology, with products in development for respiratory, autoimmune, and oncologic disorders.  All investigational therapies are manufactured at Cartesian’s wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD. For more information visit www.cartesiantherapeutics.com.

Media Contacts:

Maggie Beller for Cartesian Therapeutics
Russo Partners, LLC
maggie.beller@russopartnersllc.com

646-942-5631

John Mumm, CEO of Deka BioSciences, joins Rich Bendis on BioTalk

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Deka BioSciences CEO, John Mumm, CEO of Deka BioSciences, virtually guests on BioTalk to discuss his history in the BioHealth Capital Region, Precision Medicine, and Funding Strategies.

Listen now via Apple http://apple.co/3aIy6Ew, Google http://bit.ly/3sfEysd, Spotify http://spoti.fi/3aJq8ei, and Tunein http://bit.ly/2Me25ut.

John has spent 24 years researching and developing various technologies associated with IL-10. His work experience included various leadership roles at Anergen, Introgen Therapeutics, Bacterial BarCodes, Schering-Plough, Merck, Targenics, ARMO BioSciences, ACIR BioSciences, and MedImmune/AstraZeneca. John’s primary focus has been on discovery research at the interface between cancer biology and the adaptive immune response. Visit https://www.dekabiosciences.com/ to learn more about them today.

Click here to view the transcript.

Phlow Corp. and USP announce strategic alliance focused on Pharmaceutical Continuous Manufacturing to increase supply of essential medicines for U.S. patients

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Richmond, VA., February 22, 2021 – Phlow Corp., a public benefit essential medicines solutions provider, and the United States Pharmacopeia (USP) today announced a strategic alliance to develop a new laboratory that will certify and validate Pharmaceutical Continuous Manufacturing processes resulting in affordable, high-quality, U.S.-manufactured essential medicines. Throughout its 200-year history of setting standards for medicine quality, USP has been providing validated scientific methods used by manufacturers and regulators to determine what “good quality” looks like. The methods developed through this strategic alliance will be available for use by other domestic generics manufacturers to encourage broader adoption of Pharmaceutical Continuous Manufacturing in order to strengthen the U.S. drug supply.

USP, a global, scientific not-for-profit organization located in Rockville, Maryland, develops public standards that establish the quality expectations for medicines, collaborating with scientific experts from the academic, industry, and healthcare practitioner communities along with the U.S. FDA. The alliance will facilitate Phlow’s application of “flow” chemistry and other continuous advanced manufacturing processes to produce the crucial ingredients that enable domestic, end-to-end drug manufacturing of essential medicines that have been or are at risk of being in shortage thereby contributing to a more resilient medicines supply chain.

“Phlow has embarked on a bold mission to provide access to affordable, high-quality essential medicines for every American,” said Eric Edwards, M.D., Ph.D., co-founder, president and CEO of Phlow. “We are fixing the broken essential medicines supply chain by creating a solution that is 100% U.S.-based and fully integrated. Our success, which is made possible by partners like USP, is achieved only when every human being has access to the most important medicines necessary to sustain life and conquer disease.”

“When crises such as natural disasters, geopolitical strife including barriers to trade and pandemics like COVID-19 arise, major interruptions in the global supply of quality medicines have an impact on American patients,” said Ronald T. Piervincenzi, Ph.D., CEO of USP. “Pharmaceutical Continuous Manufacturing poses several advantages over traditional batch manufacturing, especially during supply disruptions. These include the availability and use of real-time data to accelerate manufacturing scale-up and help improve medicine quality, enabling more efficient and nimble production of essential medicines and strengthening the overall supply chain. In addition, we hope that USP’s work with Phlow will help pave the way for the pharmaceutical industry to apply continuous manufacturing more broadly for the generic medicines so many patients rely upon.”

As part of the alliance, USP scientists will be employed at a new laboratory facility operated by USP that will be developed onsite at the Virginia Biotechnology Research Park, which includes Virginia Commonwealth University’s Medicines for All Institute. Phlow currently leverages the advanced manufacturing processes developed by Virginia Commonwealth University’s Medicines for All Institute to produce active pharmaceutical ingredients for essential medicines that are in short supply. The new USP laboratory will be co-located with the R&D Laboratories at Phlow and the Virginia Commonwealth University’s Medicines for All Institute to support analytical process development and testing designed to improve efficiency in cost and time to produce essential medicines. Laboratory facilities and instruments in USP’s Rockville laboratory will also be used to expand capabilities and capacity for other analytical and testing projects.

“Phlow’s partnership with the USP, working alongside the Virginia Commonwealth University’s Medicines for All team represents another key resource in our efforts to strengthen our supply chain for essential medicines,” said Frank Gupton, Ph.D., co-founder of Phlow, chair of Virginia Commonwealth University’s (VCU) Department of Chemical and Life Science Engineering and CEO of the Medicines for All Institute. “USP is the recognized leader in quality standards for pharmaceuticals and their commitment to this effort underscores the importance that we all place on delivering medicines that are of the highest quality.  We look forward to our collaboration with USP and Phlow in this important initiative to secure onshore manufacturing in the U.S.”

The anticipated impact of the partnership includes the development of early scientific and regulatory guidelines for high-quality continuous manufacturing processes. The partnership will also create a foundation for successful product development, tech transfer, and drug application filings and will guide the post tech transfer verification of active pharmaceutical ingredients, intermediates, and dosage forms. As a result, the partnership will provide validation of U.S.-based advanced manufacturing processes to increase local production capacity and reduce the over-dependance on exports from just a few countries.

“Through this partnership with USP, the leading independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, Phlow will help assure the essential medicines being developed and manufactured meet the highest quality standards. We hope the USP and Phlow program will serve as a catalyst for industry change as we work together to apply pioneering flow chemistry, advanced manufacturing and novel analytical  approaches to these critical medicines,” said Edwards. “We believe the essential medicines we make at Phlow today, in partnership with USP, will save countless American lives tomorrow.”


About Phlow

Phlow Corp. is a trailblazing, essential medicines impact company that is reimagining essential medicines from start to finish through the use of flow chemistry. Everything Phlow does is designed to promote access to affordable, high-quality essential medicines for all Americans. Phlow provides a solution to the broken essential medicines supply chain by offering a resilient end-to-end solution that is U.S.-based, comprehensive, and fully integrated. With the support of a world-class team, strategic partners, and established relationships at the policy, regulatory, and federal levels, Phlow will manufacture active pharmaceutical ingredients (API) and finished pharmaceutical products, domestically for essential medicines critical to the Nation’s healthcare. Through the use of continuous-flow technology and green chemistry, Phlow is able to reduce costs and waste, improve quality and yield, and offer a more environmentally friendly alternative to batch manufacturing.

About USP

USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP’s standards are used in the U.S. and other countries to ensure the quality of thousands of products including cardiovascular, oncology, endocrine and antibiotic drugs. Through its standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide. For more information, visit usp.org.

 

Phlow Contact
Debby Betz: dbetz@phlow-usa.com
Office: +1-804-207-4893
Mobile: +1-804-219-9232

USP Contact
Anne Bell: adb@usp.org
Office: +1-301-998-6785
Mobile: +1-240-701-3242

BioBuzz – AstraZeneca’s Joe Sanchez Shares Vision for Growing the BioHealth Capital Region

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When AstraZeneca (AZ)  announced in 2019 that it was officially retiring the MedImmune brandquestions naturally arose about whether the U.K. pharma giant would continue the legacy MedImmune support for the BioHealth Capital Region’s (BHCR) life science ecosystem.

Since its founding in 1998, MedImmune had been an anchor life science company in the region, and starting around 2014, it was a key force behind the creation of BHCR brand, as well as the region’s collective push to be a top-three biotech cluster by 2023.

AstraZeneca recognized the impact the MedImmune brand retirement would have on the ecosystem. Shortly after this announcement, AZ reconfirmed its commitment to the BHCR brand and the region at the 2019 BioHealth Capital Region Forum. This confirmation ensured that MedImmune’s BCHR legacy would live on through AZ’s ongoing efforts to support and engage the region’s life science community.

 Click here to read more via BioBuzz.

Vigene Biosciences Plans Major Expansion in Montgomery County

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Global leader in gene therapy and vaccine manufacturing taking additional space in Rockville

Rockville, Md. — Vigene Biosciences, a global leader in gene therapy development, has announced plans to expand into a new facility in Montgomery County to accommodate industry demand for its gene and cellular therapy products. In addition to its existing headquarters, R&D and manufacturing locations in Rockville, the company will lease 52,000 square-feet of manufacturing space at 14200 Shady Grove Road, bringing the total lab and manufacturing space of the company to 110,000 sq ft. Vigene will retain its current 125 employees and add up to 245 new jobs by the end of 2025.

“Vigene serves over 4,000 clients worldwide, including our recently announced collaboration with Gaithersburg’s Altimmune to manufacture its single-dose intranasal vaccine candidate for COVID-19,” said Dr. Zairen Sun, Vigene’s President and CEO. “This new facility will allow us to support our customers as they move beyond clinical development into commercial scale manufacturing.”

Founded in 2012, Vigene Biosciences’ mission is to make gene therapy affordable for patients with cancer and serious genetic disorders. The company develops, manufactures and distributes state-of-the-art adeno-associated viruses (AAV), lentivirus, retrovirus, adenovirus and plasmid viral vectors for gene delivery. In 2016, Vigene acquired Omnia Biologics with its significant clinical manufacturing experience to respond to growing product demand as gene therapy candidates progressed to clinical trials. The company’s global clientele includes pharmaceutical and biotech companies, governmental agencies, non-profit organizations and academic institutions.

“As the field of gene therapy continues to advance and becomes more affordable, we are pleased to support the expansion of Vigene Biosciences in Maryland and the addition of 245 new jobs,” said Governor Larry Hogan. “It is a testament to our state’s outstanding business climate and wealth of resources that we have seen so many life sciences companies expand and add thousands of new jobs in recent years.”

“Vigene Biosciences is known as an award-winning world leader in the life science industry, and contributes to Montgomery County’s ability to provide the entire spectrum of gene and cell capabilities,” said Montgomery County Executive Marc Elrich. “We are so proud that this company started here and continues to commit to our community as it develops these life-saving products.”

To assist with project costs related to the expansion, the Maryland Department of Commerce has approved a $1,225,000 conditional loan contingent on job creation and capital investment. In addition, the state has approved a $100,000 Partnership for Workforce Quality training grant, and the company is eligible for several tax credits, including the Job Creation Tax Credit and More Jobs for Marylanders. Montgomery County has approved a $125,000 Economic Development Fund conditional grant contingent on job creation and capital investment.

“Vigene’s expansion project shows once again why Montgomery County is a leading life sciences hub,” Montgomery County Council President Tom Hucker said. “Only Montgomery County has the unique mix of federal agencies, the proximity to our nation’s capital, the highly educated talent and the support that enables these mission-driven companies to achieve extraordinary things.”

“Vigene is at the forefront of developing products for gene and cellular therapy for people around the world battling cancer and other life-threatening disorders, and we are very excited that they are continuing to do that important work right here in Maryland,” said Maryland Commerce Secretary Kelly M. Schulz. “Together with our partners in Montgomery County, we look forward to working with Vigene to ensure they continue to grow and thrive here in our state.”

“It was just a year ago that we cut the ribbon at Vigene’s new custom-built headquarters and already the growing demand for its gene and cellular therapy products requires additional physical expansion,” said Benjamin H. Wu, President and CEO of Montgomery County Economic Development Corporation. “Vigene’s growth as a global innovation leader has been fueled by its local collaborations and access
to a robust talent pipeline.”


ABOUT MARYLAND COMMERCE

The Maryland Department of Commerce stimulates private investment and creates jobs by attracting new businesses, encouraging the expansion and retention of existing companies, and providing financial assistance to Maryland companies. The Department promotes the State’s many economic advantages and markets local products and services at home and abroad to spur economic development and international investment, trade and tourism. Because they are major economic generators, the Department also supports the Arts, film production, sports and other special events. For more information, visit commerce.maryland.gov.

ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on TwitterFacebook and LinkedIn.

ABOUT VIGENE BIOSCIENCES

Vigene Biosciences is an award-winning world leader in plasmid and viral vector development and manufacturing. Vigene features integrated plasmid and viral vector production and analytical service offerings from its 110,000 sq ft of state-of-the-art facility with over 15 GMP cleanroom suites. Vigene’s mission is to make gene therapy affordable. On basic research side, Vigene is developing, manufacturing, and distributing state-of-the-art AAV, lentivirus, retrovirus, adenovirus, and plasmid-based reagents including HHMI/Janelia Research Campus AAV Biosensors. On the cGMP clinical production side, Vigene combines the proven production technologies with rigorous regulatory compliant cGMP production to meet the needs and expectations of clinical and commercial clients. Vigene offers FDA and EMA compliant cGMP production for AAV, lentivirus, adenovirus, retrovirus, and plasmids to global pharmaceutical and biotech companies, governmental agencies and non-profit organizations. For more information on Vigene, please visit www.vigenebio.com.

CONTACTS
Kristin O’Keefe
VP of Communications & Marketing
240-641-6703
kristin@thinkmoco.com

Jeffrey Hung, Ph.D.
Vigene Biosciences, Chief Commercial Officer
301-251-6638
jhung@vigenebio.com

Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization

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  • Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada

GAITHERSBURG, Md., February 4, 2021 — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.

“The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide,” said Gregory M. Glenn, MD, President of Research and Development, Novavax. “We appreciate the agencies’ confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination.”

To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.

Novavax’ recombinant protein-based vaccine candidate is currently in Phase 3 clinical development in both the U.K. and U.S. for the prevention of COVID-19. It was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

About Matrix-M™
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:     

Investors

Novavax, Inc.

Erika Schultz | 240-268-2022

ir@novavax.com

Solebury Trout
Jennifer Porcelli | 617-974-8659
jporcelli@soleburytrout.com
Media
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755
media@novavax.com
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BioBuzz – 5 People in the BioHealth Capital Region You Should Know In 2021

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2020 brought about a lot of growth across the BioHealth Capital Region (BHCR) as dozens of organizations responded with urgency to address the COVID-19 pandemic.  With 20% of the world’s vaccine leaders residing in the region, the BHCR has played a critical role in the pandemic response.  In Maryland, nearly $8 Billion in federal, private, and foundational funding has been invested in life sciences companies for coronavirus vaccine research and other immunotherapeutic developments.

The past year has seen several new leaders step into roles that will impact our biotech ecosystem’s growth and direction. Just as we highlighted 2020’s new leaders in the BHCR, we want to recognize the people in the Biohealth Capital Region that you should know in 2021

These new leaders are sure to help the many companies across our region raise capital, establish their growth plans, attract new talent, build collaborations, and help attract even more companies to our diverse ecosystem. Diversity is one of Maryland’s greatest assets

So, who are these people you should know in BHCR in 2021?

We’ve identified five new faces that we believe will play prominent roles that will influence and shape the future of the BHCR.

Click here to read more via BioBuzz.

Horizon Therapeutics plc to Acquire Viela Bio, Inc. to Significantly Expand Development Pipeline and Grow Rare Disease Medicine Portfolio

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DUBLIN & GAITHERSBURG, Md.–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) and Viela Bio, Inc. (Nasdaq: VIE) today announced the companies have entered into a definitive agreement under which Horizon will acquire all of the issued and outstanding shares of Viela Bio, Inc. common stock for $53.00 per share in cash, which represents a fully diluted equity value of approximately $3.05 billion, or approximately $2.67 billion net of Viela’s cash and cash equivalents. As previously announced, Horizon had $2.08 billion in cash and cash equivalents at December 31, 2020. The transaction is expected to close by the end of the first quarter of 2021.

“This acquisition represents a significant step forward in advancing our strategy – to expand our pipeline in order to accelerate our growth over the long term,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “Adding Viela’s research and clinical development capabilities along with its deep, mid-stage biologics pipeline to our seasoned R&D and commercial teams, advances our transformation to an innovation-driven biotech company where we will build on the success of TEPEZZA and KRYSTEXXA to bolster our long-term growth trajectory. We intend to maximize the full potential of Viela’s pipeline, including the pursuit of additional future indications.”

Strategic Rationale

  • Adds to commercial rare disease medicine portfolio with UPLIZNA® (inebilizumab-cdon)
    • UPLIZNA is the first and only FDA-approved B-cell-depleting humanized monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, autoimmune disease that attacks the optic nerve, spinal cord and brain stem, which leads to loss of vision and paralysis, in adults who are anti-aquaporin-4 (AQP4) antibody positive.
  • Strengthens current R&D capability by adding a team with early-stage research, translational and clinical development capabilities along with deep scientific knowledge in autoimmune and severe inflammatory diseases.
  • Adds deep, mid-stage biologics pipeline focused primarily on autoimmune and severe inflammatory diseases.
    • The current Viela pipeline includes four therapeutic candidates currently in nine development programs.
      • UPLIZNA
        • Phase 3 trials in myasthenia gravis, a chronic, rare autoimmune neuromuscular disease and in IgG4-related disease, a group of disorders marked by tumor-like swelling and fibrosis of affected organs.
        • Phase 2 trial for kidney transplant desensitization (paused due to COVID-19).
      • VIB4920
        • Investigational fusion protein designed to block a key co-stimulatory pathway involved in many autoimmune and inflammatory diseases.
        • Phase 2b trial in Sjögren’s syndrome and Phase 2 trials for kidney transplant rejection and rheumatoid arthritis.
      • VIB7734
        • Investigational human monoclonal antibody designed to deplete plasmacytoid dendritic cells (pDCs), a cell type believed to be critical to the pathogenesis of multiple autoimmune diseases.
        • Phase 2 trial for systemic lupus erythematosus (SLE) expected to begin in the first half of 2021.
        • Phase 1 study for the treatment of COVID-19-related acute lung injury.
      • VIB1116
        • Monoclonal antibody for autoimmune diseases expected to begin Phase 1 first-in-human trial in mid-2021.

“We are pleased that Horizon recognizes the value of our robust R&D pipeline, our commercial medicine UPLIZNA, which is an important treatment option for patients with NMOSD, and our talented team,” said Bing Yao, Ph.D., chairman and chief executive officer, Viela Bio, Inc. “We believe that the combined pipeline, including the pursuit of additional potential indications, has the potential to yield innovative new medicines to treat autoimmune and severe inflammatory diseases. Our collective R&D expertise coupled with Horizon’s commercial capabilities, has the potential to provide benefit to more patients with high unmet treatment needs.”

Financial Impact

Horizon anticipates the transaction will reduce its adjusted EBITDA by approximately $140 million in 2021, nearly all of which is attributable to increased R&D investment.

Transaction Terms and Approvals

The acquisition is structured as a two-step cash tender offer for all the issued and outstanding shares of Viela Bio, Inc. common stock at a price of $53.00 per share. Following successful completion of the tender offer, Horizon will acquire all remaining shares not tendered in the offer through a second step merger at the same price per share as in the tender offer. The transaction has been unanimously approved by Horizon’s and Viela’s boards of directors and is subject to the satisfaction of customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976. Stockholders holding approximately 54% of the outstanding shares of common stock of Viela, including AstraZeneca UK Limited, have agreed to tender their shares in the offer pursuant to support agreements.

Financing

Horizon intends to finance the transaction through $1.3 billion of external debt along with cash on hand. Horizon has put in place fully committed financing with Citigroup Global Markets Inc. and Morgan Stanley Senior Funding, Inc.

Advisors

Morgan Stanley & Co. LLC is the sole financial advisor to Horizon in the transaction. Horizon’s legal advisor is Cooley LLP.

Goldman Sachs & Co. LLC is the sole financial advisor to Viela in the transaction. Viela’s legal advisor is Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

TEPEZZA Supply Update

Last week, Horizon submitted a prior approval supplement to the U.S. Food and Drug Administration (FDA) to support increased scale production of TEPEZZA drug product for the treatment of Thyroid Eye Disease (TED). The submission includes data to support more product output with each manufacturing slot than is currently approved by the FDA. Horizon will continue to discuss potential additional data requirements and approval timeline with the FDA. Horizon continues to anticipate the disruption could last through the first quarter of 2021.

As previously announced on December 17, 2020, this increased production scale is necessary due to government-mandated COVID-19 vaccine production orders pursuant to the Defense Production Act of 1950 (DPA) related to manufacturing that dramatically reduced the number of drug product production slots available to Horizon at the drug product contract manufacturer of TEPEZZA.

Conference Call Today at 8 a.m. EST

At 8 a.m. EST/1 p.m. IST today, Horizon will host a live webcast to review this acquisition. The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to Horizon’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

About Neuromyelitis Optica Spectrum Disorders (NMOSD)

NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and brain stem. Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.

These AQP4 autoantibodies are produced by CD19+ B cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4 antibodies to central and peripheral nervous system cells is believed to trigger attacks, which can damage the optic nerve, spinal cord and brain. Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease. Each NMOSD attack can lead to further damage and disability. NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

About KRYSTEXXA

INDICATIONS AND USAGE

KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to infusions, and healthcare providers should consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

Patients should be screened for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA should not be administered to these patients.

GOUT FLARES

An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

CONGESTIVE HEART FAILURE

KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials with KRYSTEXXA were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

Please see Full Prescribing Information and Medication Guide for more information.

About UPLIZNA

INDICATION

UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

For additional information on UPLIZNA, please see Prescribing Information at www.UPLIZNA.com.

About Horizon

Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on TwitterLinkedInInstagram and Facebook.

About Viela Bio, Inc.

Viela Bio, Inc., headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases. For more information, please visit www.vielabio.com.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will be” and similar expressions. These forward-looking statements include, without limitation, statements related to the anticipated consummation of the acquisition of Viela Bio, Inc. (“Viela”) and the timing and benefits thereof, Horizon Therapeutics plc’s (“Horizon”) strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio, development programs, the timing of the initiation of clinical trials, the potential benefits and applications of inebilizumab, patent terms and other statements that are not historical facts. These forward-looking statements are based on Horizon’s and Viela’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Horizon Therapeutics USA, Inc.’s ability to complete the transaction on the proposed terms and schedule; whether the tender offer conditions will be satisfied; whether sufficient stockholders of Viela tender their shares in the transaction; the final terms and conditions of Horizon’s financing for the transaction; the outcome of legal proceedings that may be instituted against Viela and/or others relating to the transaction; the failure (or delay) to receive the required regulatory approvals relating to the transaction; the possibility that competing offers will be made; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks related to future opportunities and plans for Viela and its products, including uncertainty of the expected financial performance of Viela and its products; risks related to the uncertainty of the research, development and regulatory approval process for product candidates; disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the occurrence of any event, change or other circumstance that could give rise to the termination of the acquisition agreement, and the possibility that if Viela does not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of Horizon’s shares could decline, the risk that further TEPEZZA manufacturing run cancellations, whether as a result of additional government orders or other issues at Horizon’s third party manufacturers, or failed manufacturing runs could exacerbate and prolong TEPEZZA supply disruptions; whether the FDA approves Horizon’s prior approval supplement for TEPEZZA and the timing for any approval, as well as other risks related to Horizon’s and Viela’s businesses detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s and Viela’s respective Securities and Exchange Commission (“SEC”) filings and reports, including their respective Annual Reports on Form 10-K for the year ended December 31, 2019 and subsequent quarterly and current reports filed with the SEC. The risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. The extent to which the COVID-19 pandemic impacts Horizon’s and Viela’s businesses, operations, and financial results, including the duration and magnitude of such effects, will depend on numerous factors, which are unpredictable, including, but not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions can resume. Horizon and Viela undertake no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in their expectations, except as required by law.

Additional Information and Where to Find It

The tender offer described in this press release (the “Offer”) has not yet commenced, and this press release is neither a recommendation, nor an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Viela or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the SEC by Horizon, Horizon Therapeutics USA, Inc. and Teiripic Merger Sub, Inc., and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Viela. The offer to purchase shares of Viela common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR COMMON STOCK, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Investors may also obtain, at no charge, the documents filed or furnished to the SEC by Viela under the “Investors/Media” section of Viela’s website at www.vielabio.com.

Contacts

Horizon contacts:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com

Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com

U.S. Media Contacts:
Geoff Curtis
Executive Vice President, Corporate Affairs & Chief Communications Officer
media@horizontherapeutics.com

Ireland Media Contact:
Gordon MRM
Ray Gordon
ray@gordonmrm.ie

Viela Bio contacts:
Investors:
Solebury Trout
Chad Rubin
646-378-2947
crubin@soleburytrout.com

Media:
Solebury Trout
Amy Bonanno
914-450-0349
abonanno@soleburytrout.com

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