iBIO is excited to release our 2019 State of the Industry Report, titled Meeting the Future Needs of a Changing Community. 

This report provides an overview of the life sciences innovation community, benchmarks our recent growth, identifies key trends shaping the community and provides recommendations to ensure the continued growth of the Illinois Life Science Industry.

By several metrics, the Illinois life sciences industry is large, growing and recognized as a national leader. More than 41,000 people are employed at life science companies statewide and increases in the number of life sciences workers at Illinois companies from 2014 – 2016 (latest statistics available) have outperformed national averages.

Second, the annual economic output of the life sciences industry in Illinois was $98 billion in 2016. Annual pay for the life sciences community was $129,866 in 2016, and with strong wage growth in all segments, the life sciences industry remains a major contributor to state and local taxes.

Third, the life sciences innovation ecosystem in Illinois has grown significantly over the past couple years. Our state’s companies reported over $14 billion in R&D expenditures in 2017, and our research-based universities have increased R&D investment and secured numerous NIH grants and awards. Recent key indicators of startup activity have also shown an upward trend, including patent products and venture capital (VC) investment.

Despite these positive developments, continued growth in the Illinois life sciences community is not guaranteed. Recent major acquisitions of Illinois companies reduced the number of large companies and related employment in the state. Meanwhile, an increase in commercialization activities at Illinois universities and the growth in the number of smaller R&D-stage companies will drive the future expansion of the Illinois life sciences industry.

To support the future growth of our community, state and local governments will need to realign policy and community resources to support a startup- and growth-oriented ecosystem.

Read the 2019 iBIO State of the Industry: Meeting the Future Needs of a Changing Community.

NCATS has released a new SBIR contract solicitationto support small businesses interested in developing innovative health technologies. The standard deadlines to submit an application for open NCATS SBIR and STTR Omnibus Solicitationare April 5, 2019; September 5, 2019; and January 5, 2020.

For more information about NCATS, its SBIR and STTR programs, and upcoming funding opportunities, visit the Small Business Opportunitiespage. If you have general questions about the NCATS SBIR and STTR program or want to discuss potential project ideas and related questions, email NCATS-SBIRSTTR@mail.nih.gov.

Every month we will release a comprehensive list of non-dilutive government funding opportunities. We will also be offering regular updates and webinars for new funding sources, agency priorities, conferences where companies can present and meet program managers, advice on how to build those relationships and insights on the process.

To stay updated on these opportunities and other community programs and news, subscribe to iBIO’s Daily NewsBrief:

Last week, iBIO organized a trip to Washington for Illinois medical technology (MedTech) companies to meet with lawmakers and discuss how they can work together to provide patients greater access to next generation, life-saving products.

The fly-in participants met with 10 congressional members and both senate offices. Thank you to Endotronix, Flow-FX and Bob Brutvan for participating in the 2019 Medtech Flyin.

Over the past couple years Illinois has outpaced the national average for employment growth and establishment growth in the Medtech industry.

The growth of the community has been fueled by a surge of patent production and our universities. Over the past 5 years 1,714 patents for medical and surgical devices have been filed in Illinois.

It is important to understand where scientific or policy issues may impact the medtech community’s ability to continue to innovate and bring new medical products to the market.

Eliminating taxes on innovative products and providing clarity on review timeline and coverage decisions were major topics of discussion at the medtech flyin this year.

There are currently two bills waiting to be introduced in DC to address both of these issues.

Breakthrough Pathway

The breakthrough pathway proposal would establish a program of accelerated transitional coverage and payment for new technologies that offer breakthroughs in the treatment or diagnosis of serous illnesses affecting Medicare beneficiaries.

The FDA would designate a new therapy as a breakthrough product if it meets the following conditions:

• Provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions;
• Has no approved alternatives;
• Offers significant advantages over existing approved alternatives; or
• Avalibility is in the best interest of patients.

If the products meets the threshold it would qualify for expedited FDA review. If the therapy were ultimately approved by FDA, CMS would provide temporary coverage for three years. During the three years the therapy would receive a guarenteed level of payment, and CMS could specify the additional data needed to continue coverage after the three-year period under its statutory “reasonable and necessary” standard.

The proposal also improves the existing NTAP program. These improvements are designed to reduce coverage and payment disincentives that limit prompt patient access to innovative but more costly technologies. These changes would both stimulate development of important new diagnostics and treatment and assure prompt availability of those treatments to patients. The Ensuring Patient Access to Critical Breakthrough Products Act of 2019 will be introduced soon.

Medical Device Tax Repeal

The Protect Medical Innovation Act is expected to be introduced soon, which would repeal the medical device tax.

The medical device tax is a 2.3% excise tax on the sale of most medical technologies that was enacted as part of the Affordable Care Act. Given that this tax applies to revenues, not profits, it is extremely punitive to medical technology innovators. Since the inception of the medical device tax, there has been growing bipartisan support to end this tax on innovation and it has been suspended multiple times by Congress. In 2018, the House passed a bill to repeal the tax 283-132, but the Senate failed to act.

If Congress does not act this year, the medical device will be reinstated in 2020, and billions of dollars will be diverted away from research and development for cures and therapies. Perhaps most concerning, the short term suspensions limit the ability of companies to make longer term investments in new technologies and treatments without the certainty of a full repeal.

Large bipartisan majorities in Congress agree that the medical device tax is bad policy and have suspended the tax twice for a total of four years. Additionally, Congress has suspended the tax longer than it has allowed it to be in effect, with no measurable impact on coverage. While these suspensions have had no measurable impact on health care coverage, the relief has enabled medical device makers to invest in important research and development projects and new hires.

If the tax is allowed to go back into effect, it will exacerbate job losses sustained when the tax was in effect. During that period, the U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 according to data from the U.S. Department of Commerce. In Illinois these workers earn on average $125,715.

Over the past 7 years we have offered Stellar Girls after-school STEM programming for more than 2,100 girls in high-needs, underserved communities in the Chicagoland area. Stellar Girls combines interesting hands-on activities with speakers working in STEM industries. Girls learn by working together on lab activities presented in the context of solving real-world problems concerning feeding, fueling, healing and saving the world.

The partnership with SIUE on the NSF grant provides a great opportunity to expand the impact of the program and incorporate the resources and thought leadership at SIUE to improve the curriculum. The partnership also provides us with the opportunity to expand the StellarGirls program outside of the Chicagoland area.

Read STEM+C After-School Initiative inspires minority girls to solve global challenges

iBIO & Bio Business Solutions Program

Through its partnership with the Biotechnology Innovation Organization (BIO), the international organization that represents the biotechnology industry, iBIO offers its members the opportunity to take advantage of several of the BIO Business Solutions^® programs. With more than $400 million in annual sales, BIO Business Solutions^® aggregates the purchasing power of over 3,700 biotech companies from North America. Companies of all sizes save substantial money each year through its group savings program. Learn More about the program.

Stellar Girls introduces girls to “Big Ideas” in STEM fields. Through weekly hands-on after-school activities, students explore how science, technology, engineering, and mathematics are used to feed, fuel, heal and save the world. Students have the opportunity to interact with STEM professionals to learn about STEM careers, apply STEM skills to real-world problems, and employ critical thinking skills through collaborative inquiry.

The Stellar Girls curriculum is divided into 4 units: Feeding, Fueling, Healing, and Saving. The entire program consists of up to 20 hour-and-a-half long lessons.

Since 2011, Over 2100 girls have participated in Stellar Girls programming. School-level data from 2012-2018 show that 69% of girls are underrepresented minority and 66% of participants are from low-income homes that qualify for free and reduced lunch at school.

The Stellar Girls program has a significant impact on girls’ STEM content knowledge. Stellar Girls gain an average of 21 percentage points in STEM content from pre-test to post-test.

Pictures from the StellarGirls Program

Proceeds from the Acuitas investment will be used to pay for the treatment of the final 3 refractory ascites patients with BIV201 (continuous infusion terlipressin) needed to complete the ongoing Phase 2a clinical trial, the analysis of the results and their presentation to the FDA, augmentation of the Company’s intellectual property (IP) estate, and other general corporate purposes. Additionally, BioVie will retire its accumulated debt at negotiated discounts and emerge virtually debt-free.

About BioVie                                                                                                               

BioVie Inc. is a clinical-stage company pursuing the development and commercialization of innovative drug therapies for liver disease. Prior to the Acuitas investment the Company had treated one-half of the patients to be enrolled in a mid-stage (Phase 2a) clinical trial of its new drug candidate, BIV201 (continuous infusion terlipressin). BIV201 has an Orphan Drug designation for the treatment of ascites, FDA Fast Track status, and US patent protection.

BIV201 represents a potential new treatment for thousands of patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis. The FDA has never approved a drug specifically for treating ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information about BioVie, please visit our website: www.biovieinc.com.

About Liver Cirrhosis and Ascites

More than 600,000 Americans and millions worldwide suffer from liver cirrhosis. Cirrhosis is the 12th-leading cause of death due to disease in the US, killing more than 30,000 people each year. The condition results primarily from hepatitis, alcoholism, and nonalcoholic steatohepatitis (NASH) linked to fatty liver disease and obesity. Ascites is a common complication of advanced liver cirrhosis. Certain drugs approved for other uses may provide initial relief, but patients often fail to respond to them as the ascites worsens. With no medications approved by the FDA specifically for the treatment of ascites, an estimated 40% of patients die within two years of initial diagnosis. In addition to patient suffering, US medical costs for liver cirrhosis, including ascites and other complications, are estimated at more than $4 billion annually.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. BioVie has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are BioVie’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; and the risks that BioVie’s compounds may experience delays or difficulties in commencing or completing clinical studies, may not successfully complete pre-clinical or clinical testing, or may not be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission under its former name. In addition to the risks described above and in BioVie’s filings with the SEC, other unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. BioVie cannot guarantee the approval of patents or Orphan-drug applications, nor the completion or success of its clinical trials.

“It was a great night celebrating the many advancements that the Illinois life sciences community has experienced over the last year, as well as the contributions of educators, researchers and entrepreneurs,” said John Conrad, president and CEO of iBIO and the iBIO Institute. “We were not only able to honor some true trailblazers in the field, but we also raised funds that allow us to continue providing STEM learning opportunities to students and teachers across the state.”

The 2018 Civic iCON Award was presented to The Stanley Manne Children’s Research Institute. Thomas Shanley, MD, Chairman of Pediatrics at Lurie Children’s Hospital and Chief Research Officer at The Manne Research Institute, accepted the award on behalf of the organization. For more than 30 years, the research at Ann & Robert H. Lurie Children’s Hospital of Chicago has been conducted through The Stanley Manne Children’s Research Institute, which focuses on improving child health and transforming pediatric medicine to ensure healthier futures for patients. The Manne Institute actively innovates in STEM by implementing community health programs in Chicago’s underserved neighborhoods.

The iBIO Institute introduced a new award this year called the iCON Community Award, which was created to honor an iBIO member organization that has demonstrated outstanding commitment to the communities it serves in Illinois. Tonight, the award was presented to Horizon Pharma.

Horizon launched its corporate social responsibility function in 2015 and as a small to mid-size company, has emerged as a trailblazer for giving. Since then, Horizon has partnered and supported more than 40 organizations, including Perspectives Charter Schools’ IIT Math and Science Academy. Through this partnership, Horizon employees work with more than 600 students from underserved communities in Chicago to help them excel in the STEM field.

Horizon has also partnered with Mount Sinai Hospital to create a new Access to Care Fund that underwrites the cost of prescriptions for low-income patients discharged from the emergency room. Other organizations Horizon supports includes Women in Bio and the Red Cross.

The 2018 iCON Entrepreneurial Award, which recognizes a pioneering entrepreneur who is a risk taker and visionary leader, was presented to Sean Nolan, CEO of AveXis, a leading gene therapy company developing treatments for rare and life-threatening neurological genetic diseases.

Nolan has served as the CEO of AveXis since 2015 and recently led the company through Phase 3 clinical trials for its lead product that treats patients suffering from Type 1 Spinal Muscular Atrophy (SMA), the number one genetic cause of infant mortality. Prior to joining AveXis, Nolan worked for InterMune in San Francisco as the company’s Executive Vice President and Chief Business Officer where he was responsible for building and leading the North American commercial organization and preparing for the anticipated U.S. launch of pirfenidone, a treatment for Idiopathic Pulmonary Fibrosis, a devastating orphan disease.

The 2018 iCON Innovator Award was given to Dr. Maryellen Giger, the A.N. Pritzker Professor of Radiology, the Committee on Medical Physics and the College Vice-Chair for Basic Science Research in the Department of Radiology at the University of Chicago.

Dr. Giger is considered to be one of the pioneers in the development of computer-aided diagnosis (CAD). She has authored or co-authored more than 180 peer-reviewed journal articles, is an inventor on over 35 U.S. patents and serves as a reviewer for various national and international granting agencies including the National Institute of Health and the U.S. Army.She is a member of the National Academy of Engineering (NAE) and was awarded the William D. Coolidge Award from the American Association of Physicists in Medicine, the highest award given by the AAPM. In 2013, she was named by the International Congress on Medical Physics (ICMP) as one of the 50 medical physicists with the most impact on the field in the last 50 years.

The iCON Knowledge Builder Award was presented to Allison Hennings, a biology teacher at Oak Park River Forest High School in Oak Park, Illinois, where she leads the school’s award-winning independent research program. For the last six years, Ms. Hennings has actively encouraged her students to participate in iBIO’s annual Illinois BioGENEius Competition, and every year OPRF students represent a significant majority of BioGENEius participants based on selection and quality of their projects. Last year, one of her students won the statewide competition and went on to compete in the international competition in Boston over the summer. Before becoming a high school teacher, Ms. Hennings was an intensive care nurse at Loyola University’s Medical Center for 12 years.