Monthly Archives

June 2020

Emergent BioSolutions Signs Agreement to Be U.S. Manufacturing Partner for AstraZeneca’s COVID-19 Vaccine Candidate

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  • Emergent will provide contract development and manufacturing services and secure large-scale manufacturing capacity through 2020 to support AstraZeneca’s COVID-19 vaccine candidate
  • Agreement valued at approximately $87 million

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced it will deploy its molecule-to-market contract development and manufacturing (CDMO) services to support the manufacturing of AstraZeneca’s vaccine candidate for COVID-19, AZD1222, a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein, developed by Oxford University’s Jenner institute working with the Oxford Vaccine Group.

AstraZeneca’s AZD1222 is one of several candidates supported by Operation Warp Speed (OWS), the U.S. government’s program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures that aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021. As part of OWS, Emergent will provide development and manufacturing services and capacity to innovators of leading COVID-19 vaccine candidates selected by the U.S. government, such as AstraZeneca.

“By partnering with leading innovators like AstraZeneca, Emergent is playing a critical role in increasing the world’s chances of having a safe and effective COVID-19 vaccine,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “We are proud to provide our CDMO services to advance AstraZeneca’s COVID-19 vaccine candidate. With this agreement, we bring to our facilities two of the five leading candidates being developed with U.S. government funding.”

Under the agreement, valued at approximately $87 million, Emergent will provide development services, technology transfer, analytical testing, drug substance process and performance qualification and will reserve certain large-scale manufacturing capacity through 2020.

“As both a manufacturer of our own vaccines and a service provider, Emergent is uniquely equipped to take on the integral role of development and manufacturing partner to companies like AstraZeneca with lead vaccine candidates for COVID-19,” said Syed T. Husain, senior vice president and CDMO business unit head at Emergent. “We have spent decades establishing a strong, integrated CDMO network that allows us to dependably and consistently produce life-saving medicines for our company and for others worldwide.”

Development services will be provided out of Emergent’s Gaithersburg product development facility. Large-scale manufacturing of drug substance will be done at the Baltimore Bayview facility, an HHS-designated Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

Emergent’s Bayview facility has unique capabilities across four independent suites to produce at clinical scale to get candidates rapidly into the clinic, while at the same time scaling up to enable large-scale manufacturing to up to 4000L to prepare for production of commercial volumes to meet customer demand. The CIADM has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used.

Financial Considerations
The company will provide an update to its 2020 financial outlook incorporating expectations related to this agreement and any other relevant information when it reports its second quarter financial results.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Emergent’s Response to COVID-19
Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.

Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments – COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding and will be evaluated in at least one of the studies of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in Phase 2 clinical studies in Q3 2020. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.

Emergent is deploying its CDMO capabilities, capacities, and expertise to support the U.S. government’s Operation Warp Speed to pave the way for innovators to advance COVID-19 programs. Prior to the launch of Operation Warp Speed, the company had announced earlier collaborations with three innovators to develop and manufacture COVID-19 vaccine candidates. For the COVID-19 vaccine response, Emergent’s integrated CDMO network provides development services from its Gaithersburg facility, drug substance manufacturing at its Baltimore Bayview facility, and drug product manufacturing at its Baltimore Camden and Rockville facilities, all in Maryland.

For 22 years Emergent has focused on advancing public health, and its multi-pronged approach to tackling COVID-19 demonstrates its commitment to its mission – to protect and enhance life.

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 our ability to produce viable COVID-19 vaccine candidates at the prescribed scale and on the anticipated timeline and pave their potential pathway to licensure, as well as the negotiation of another contract related to the second phase of the collaboration and deployment of capacity toward future commercial manufacturing, 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 success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; and our commercialization, marketing and manufacturing capabilities. 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.

Media Contact:
Miko B. Neri
Senior Director, Corporate Communications
240-631-3392
NeriM@ebsi.com

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

Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (Inebilizumab-Cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)

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UPLIZNA™ is the first and only B cell depleter approved for the treatment of NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive

GAITHERSBURG, MD, USA I June 11, 2020 I Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of all patients with NMOSD test positive for anti-AQP4 antibodies.

“NMOSD is an extremely challenging disease to treat. Patients experience unpredictable attacks that can lead to permanent disability from blindness and paralysis. In addition, each subsequent attack may result in a cumulative worsening of disability. In the pivotal N-MOmentum trial, UPLIZNATM—a humanized CD19-directed monoclonal antibody—significantly reduced the risk of attacks and also reduced hospitalizations when given as a monotherapy,” said Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum trial and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences. “UPLIZNATM is an important new treatment option that provides prescribing physicians and patients living with NMOSD a therapy with proven efficacy, a favorable safety profile and a twice-a-year maintenance dosing schedule.”

NMOSD is a rare, severe, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and brain stem. In addition to potentially irreversible blindness and paralysis, patients may also experience loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure. It is estimated that there are approximately 10,000 people in the U.S. suffering from NMOSD2. Multiple lines of evidence suggest that NMOSD is a B-cell-mediated disorder.

“As an organization that understands and represents the struggle of patients and their loved ones affected by NMOSD, we are pleased that now there is another treatment option that could reduce their attacks, which can lead to devastating and irreversible disability,” said Victoria Jackson, co-founder of the Guthy-Jackson Charitable Foundation, a non-profit organization dedicated to funding research and raising awareness about NMOSD. “We have been proud to partner with Viela Bio and congratulate them and the NMOSD community on this important milestone.”

The approval of UPLIZNATM—which previously received Breakthrough Therapy and Orphan Drug designations from the FDA—is based in part on results from the pivotal N-MOmentum trial, the largest study ever conducted in a real-world spectrum of adults with NMOSD. The global, placebo-controlled study—which enrolled 213 anti-AQP4 antibody positive patients and 17 anti-AQP4 antibody negative patients—met its primary endpoint by demonstrating a statistically significant reduction in risk of NMOSD attacks. Specifically, 89% of patients in the anti-AQP4 antibody positive group remained relapse-free during the six-month period post-treatment, compared to 58% of the patients taking placebo. UPLIZNATM also demonstrated statistically significant benefits in key secondary endpoints, including reductions in NMOSD-related hospitalizations. Additionally, UPLIZNATM demonstrated a favorable safety and tolerability profile. Across both the randomized and open-label treatment in Study 1, the most common adverse reactions (greater than 10%) were urinary tract infection (20%), nasopharyngitis (13%), infusion reaction (12%), arthralgia (11%), and headache (10%). The results from the N-MOmentum trial were published in the peer-reviewed journal, The Lancet, in September 2019 (“Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial”).

Commented Bing Yao, Ph.D., Chief Executive Officer at Viela Bio: “We are proud that Viela Bio’s first approved medicine has the potential to help thousands of patients with NMOSD, a progressive and debilitating neuroinflammatory disease. We are incredibly grateful to the patients, families and care partners who participated in and supported our research.”

Viela anticipates product launch in June.

Study Design Overview and Efficacy Results Summary

Patients in the N-MOmentum trial were randomized 3:1 (UPLIZNATM to placebo) to receive two introductory doses of 300 mg of UPLIZNATM monotherapy or placebo at Day 1 and Day 15. The patients were followed for a total of 197 days. Following that randomized-controlled period (RCP), patients were given the option to enter an open-label extension period, in which every participant received 300 mg of UPLIZNATM monotherapy every 6 months. The study was concluded early on the recommendation of the independent data monitoring committee, based on evidence of efficacy. Results from the anti-AQP4 antibody positive patient subgroup are shown in the chart below.

Treatment Group
UPLIZNATM
N = 161
Placebo

N = 52

Time to Adjudication Committee-Determined Relapse (Primary Efficacy Endpoint)
Number (%) of patients with relapse 18 (11.2%) 22 (42.3%)

a Cox regression method, with placebo as the reference group.

1Jarius S, Wildemann B. Aquaporin-4 antibodies (NMO-IgG) as a serological marker of neuromyelitis optica: a critical review of the literature. Brain Pathol. 2013;23(6):661-683.
2 Flanagan EP. Ann Neurol. 2016;79(5):775-783.

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 can be fatal. 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 N-MOmentum
N-MOmentum, the largest clinical study ever conducted in NMOSD, was a double-blind, placebo-controlled clinical trial of 213 patients who are anti-AQP4 antibody positive and 17 who are anti-AQP4 antibody negative (n=230). In the trial, patients were randomized to receive two intravenous doses of UPLIZNATM (inebilizumab-cdon) monotherapy or placebo and followed for 6.5 months. Patients were subsequently given the option to enter into an open-label extension in which all patients receive inebilizumab every 6 months. The primary endpoint was time from treatment initiation to occurrence of an NMOSD attack, which was reviewed by an independent, blinded external Adjudication Committee. NMOSD attack diagnosis was standardized using 18 clinically meaningful criteria that were developed for the study. The open-label extension portion of the study is ongoing. More information can be found on clinicaltrials.gov (Study NCT02200770).

Additional Clinical Investigation

A Phase 2 trial with inebilizumab is ongoing in kidney transplant desensitization, with an additional Phase 3 trial planned in myasthenia gravis and a Phase 2b trial planned in IgG4-related disease. For more information on ongoing clinical trials, please visit www.clinicaltrials.gov and enter the search term “Viela.”

About Viela Bio
Viela Bio, 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.

Adaptive Phage Therapeutics Enters Agreement With Mayo Clinic to Commercialize a Phage Susceptibility Test

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Mayo Clinic and Adaptive Phage Therapeutics (APT) today announced a collaboration to advance and commercialize a phage susceptibility test (PST) linked exclusively to APT’s PhageBank™ investigational therapy. At launch, the PST will be offered as a laboratory developed test for worldwide commercial availability by Mayo Clinic Laboratories (MCL). The PST will enable rapid identification of patient-specific precision therapy for challenging bacterial infections, including, but not limited to, those that are antimicrobial resistant (AMR) or complicated with biofilms.

“One of the most difficult lessons we are all learning from the COVID-19 pandemic is that pharmaceutical approaches need to be able to rapidly adapt to new and more virulent diseases and infections”

The phage susceptibility test is being developed to simultaneously test hundreds of phage candidates selected from APT’s PhageBank, against bacteria isolated from a patient. The PST will identify one or more phage that may be deployed to treat the infection.

“One of the most difficult lessons we are all learning from the COVID-19 pandemic is that pharmaceutical approaches need to be able to rapidly adapt to new and more virulent diseases and infections,” said Greg Merril, chief executive officer and co-founder, Adaptive Phage Therapeutics. “Our PhageBank investigational therapy, made from an ever-expanding and diverse collection of therapeutic agents, combined with susceptibility testing, will allow for a rapid, precise and adaptive approach to dealing with infectious diseases. Our ability to adapt to emerging resistance is the key to combat these diseases in a long-term, durable therapeutic way. The problem of antibiotic resistance will continue to grow as bacteria continue to evolve. PhageBank is designed to adapt to change and therefore remains effective as bacteria continue to evolve.”

“We have now treated several patients with PhageBank under FDA emergency allowance. In each of these cases, APT successfully matched its investigational PhageBank therapy to bacteria we isolated from patients suffering advanced and chronic prosthetic joint infections,” said Gina A. Suh, M.D., Infectious Disease expert at Mayo Clinic.

Working closely with Mayo Clinic Laboratories, Adaptive Phage Therapeutics will have an opportunity to accelerate worldwide access to PhageBank therapy. “At Mayo Clinic, we have put significant effort into developing strategies to overcome antibacterial resistance, and we are pleased to collaborate with Adaptive Phage Therapeutics,” said Robin Patel, MD, Chair of the Division of Clinical Microbiology and Director of the Infectious Diseases Research Laboratory, Mayo Clinic.

Mayo Clinic, Dr. Patel and Dr. Suh have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

About Antimicrobial Resistance (AMR)

According to the Centers for Disease Control, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result.1 The World Health Organization estimates that superbugs will kill up to 10 million people globally each year by 2050.2 Thirty-five percent of common human bacterial infections are already resistant to currently available medicines in some high-income countries.3

According to the World Health Organization, there is a US $100 trillion potential cost in terms of lost global production between now and 2050.4 The indirect costs of drug-resistant infections to the individual and society from morbidity, disability, premature deaths and reduced effective labor supply are estimated to cause a decrease in the global economic output of 1–3% by 2030, with estimated losses ranging from US $1 trillion to US $3.4 trillion annually if no action is taken.5

About Biofilms

Bacterial biofilms are densely packed communities of microbial cells that grow on living or inert surfaces and surround themselves with secreted polymers. Biofilms have significance for public health because biofilm-associated microorganisms exhibit decreased susceptibility to many antimicrobial agents. Many bloodstream infections and urinary tract infections are associated with indwelling medical devices and, therefore, (in most cases) biofilm-associated.7 In American hospitals alone, thousands of deaths are attributed to biofilm-related surgical site infections and urinary tract infections.6

About Phage

Bacteriophage (“phage”) are viruses that host on bacteria. Phage have evolved to become the most prolific killers of bacteria on earth. Phage have been used for clinical applications since their initial discovery at the beginning of the twentieth century. The ability of phage to replicate exponentially and kill bacteria suggests that they could play a vital role in our armamentarium for the treatment of infectious diseases.8 There are an estimated 10 phage for each bacteria on earth, and each phage strain has evolved to eradicate a narrow range of bacteria. The introduction of penicillin in the 1940s displaced interest in commercial development of phage. With the growing crisis of bacterial resistance to antibiotics, there has been renewed interest in phage therapy.

About PhageBank

PhageBank is an ever-expanding collection of genetically diverse, carefully screened, and purified phage that are collectively broad spectrum, negating the effects of bacterial resistance that increasingly diminish the effectiveness of antibiotics. In 2017, APT acquired world-wide exclusive commercial rights to PhageBank from the biodefense program of the U.S. Department of Defense. APT is advancing the technology through innovation in bioinformatics, rapid phage-bacteria matching and phage purification methods in an approach capable of providing a precision-matched therapy based upon the diagnosis of a specific bacterial pathogen.

About Adaptive Phage Therapeutics (APT)

APT is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 23 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.

BioBuzz: The Top Biotech Companies That Are Hiring

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Despite the uncertainty created by the COVID-19 pandemic, companies across the BioHealth Capital Region (BHCR) continue to hunt for talented life science professionals to advance their technologies, produce their commercial products for the patients that need them, and for many they are also supporting COVID-19 vaccine and diagnostic efforts that the whole world is counting on.

If you are looking for biotech jobs in Maryland or across the BioHealth capital region, now is a great time to start your search. Three of the top companies listed are located in Frederick, Maryland which has become an advanced BioManufacturing hub within the region and is seeing continued growth in this sector.

Here’s a roundup of the top companies hiring for biotech jobs in Maryland and are hiring across a wide array of functions and experience levels.

Click here to read more via BioBuzz

Anthony D. Saleh, Ph.D., CEO of miRecule, joins Rich Bendis on BioTalk

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miRecule CEO Anthony D. Saleh, Ph.D. guests on BioTalk to discuss his company, his many roles in startup companies, and being an Entrepreneur in Residence with BHI

Anthony is a biotech entrepreneur and having served in a variety of roles in startup companies. He is currently the CEO of miRecule, Inc., but also helped found MIMETAS US, and Birich Technologies. As an “Entrepreneur in Residence” at BioHealth Innovation, he has consulted for over a dozen biotech companies. In this role, he led technology diligence, market analysis and business and product development efforts. He also participated in funding raises for two companies, and performed scouting efforts for Roche and MedImmune, leading to several academic collaborations. As the President of MIMETAS US (a startup affiliate of the Dutch company Mimetas BV), he raised over $4.5 M in non-dilutive funding and over $1 M in commercial partnerships to develop organ-on-a-chip based drug discovery models. Dr. Saleh has more than 15 years of experience in microRNA research, nucleic acid chemistry and the design of therapeutic oligonucleotides at Johns Hopkins University, The National Institutes of Health, and in the private sector. Dr. Saleh has raised about $5 M in dilutive and no-dilutive funding directed to gain IND approval for miRecule’s lead therapeutic MC-30.

Listen now via via Apple https://apple.co/2Y8VRxQ, Google https://bit.ly/3cJVC1i, Spotify https://spoti.fi/3dKuaSG, and TuneIn https://bit.ly/3h27j7f. BioHealth Capital Region #Podcast

Click here to download the transcript. 

Supernus Completes Acquisition of CNS Portfolio From US WorldMeds

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Creates leading CNS portfolio with five marketed products, two product candidates in late-stage development, and robust pipeline

ROCKVILLE, Md., June 09, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced the closing of the acquisition of the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. This transaction builds on Supernus’ experience in CNS diseases and expands its marketing and development efforts into Parkinson’s disease.

“This acquisition significantly expands our business in CNS and increases and diversifies our revenue and earnings streams, while continuing to maintain a strong balance sheet,” said Jack Khattar, President and CEO of Supernus. “We welcome our US WorldMeds’ colleagues who are joining Supernus and look forward to working with them on building our leadership position in CNS across numerous diseases.”

For additional details relating to the acquisition, please see the press release HERE issued by Supernus on April 28, 2020 announcing the acquisition.

About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy, Apokyn® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson’s disease (PD), Myobloc® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults, and Xadago® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, apomorphine infusion pump for hypomobility in PD, SPN-820 (NV-5138) for treatment-resistant depression, and SPN-817 for the treatment of epilepsy.

APOKYN Pen and apomorphine infusion pump product candidate are under a license from Britannia Pharmaceuticals Limited
XADAGO is under a license from Zambon S.p.A
All trademarks are the property of their respective owners

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management’s current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to successfully incorporate and integrate the acquired products and product candidate, technologies, sales force and organization into its current infrastructure, the Company’s ability to achieve the anticipated revenues and benefits from the acquired products; the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Gregory S. Patrick, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

or

INVESTOR CONTACT:
Peter Vozzo
Westwicke, an ICR Company
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com

Source: Supernus Pharmaceuticals, Inc.

BioHealth Innovation Leading Five Digital RESI Conference Virtual Panels

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With the LSN Digital RESI Conference approaching quickly, Event Gold Sponsor, BioHealth Innovation (BHI), is stepping up to help lead five panels with some heavy hitters from the BioHealth Capital Region (BHCR) on June 8-10, 2020.
Great Investment Opportunities in the BioHealth Capital Region
While we adjust to a COVID-19 world, there continue to be great investment opportunities in the BioHealth Capital Region. Join BHCR CEOs as they make short introductions about themselves and companies. Join CEOs from American Gene Technologies International Inc., miRecule, Adaptive Phage, Healion Bio, KaloCyte, Emocha, Tailored Therapeutics, Inc., DEKA, and Ashvattha Therapeutics, Inc.
Raising Early Stage Capital in Difficult Times
Companies are still working to raise capital while we remain socially distant. Join us as we discuss how to best adjust and continue attracting investors to your business. Moderator, Rich Bendis, Founder, President and CEO of BioHealth Innovation, is joined by investment experts from Alexandria Venture Investments, The BioHealth Capital Fund, Boston Millennia Partners, and JP Morgan.
Collaborating for Growth in the BioHealth Capital Region
Being able to collaborate with your business partners is as important today as it ever has been. This panel demonstrates the strong collaboration taking place in the BioHealth Capital Region. Led by Jarrod Borkat, Senior Director, External Partnerships & Collaborations, Emergent BioSolutions, Inc., the panel includes experts from Children’s National Hospital, George Mason University, AstraZeneca, and Immunomic Therapeutics.
International BioHealth Companies Entering the U.S. Market
Also known as “Soft Landing”, the ability for International BioHealth Companies to be able to successfully enter the U.S. Market and grow is a constant challenge. Having a partner in the U.S. to help with this process is critical to your business. Moderator, Rich Bendis, Founder, President and CEO of BioHealth Innovation, discusses the topic with representatives from BHI, Gentian Diagnostics (Norway), Mimetas (Netherlands), and OnDosis (Sweden).
Advancing your Technology Through Non-Dilutive Grants
Keeping ownership of your company and technology, while raising growth capital, is an important topic for many entrepreneurs. Join our panel led by BioHealth Innovation Inc.’s Managing Director – Economic Development, Judy Costello, as she covers the in’s and out’s with participants who have successfully navigated these waters. Industry experts from Aperiomics, miRecule, Mimetas, SpineAlign, and TEDCO join the discussion to share their experiences.
Learn more about the Digital RESI – Three Day Conference Registration on June 8-10, 2020 ONLINE.

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