Viela Bio

Viela Bio Announces Pricing of Initial Public Offering

Viela Bio, Inc., a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases, today announced the pricing of its initial public offering of 7,900,000 shares of its common stock at a price to the public of $19.00 per share. The gross proceeds to Viela Bio from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $150 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 3, 2019 under the symbol “VIE.” The offering is expected to close on October 7, 2019, subject to customary closing conditions. In addition, Viela Bio has granted the underwriters a 30-day option to purchase up to an additional 1,185,000 shares of common stock at the initial price to the public less underwriting discounts.

Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, and Cowen and Company, LLC are acting as the joint book-running managers for this offering. Guggenheim Securities, LLC is acting as lead manager for this offering.

The offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from:

  • Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, email: prospectus-ny@ny.email.gs.com, telephone: 1-866-471-2526, fax: 1-212-902-9316;
  • Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, NY 10014; or
  • Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, email: PostSaleManualRequests@broadridge.com, telephone: 1-833-297-2926.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 2, 2019. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory diseases.

Contacts

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

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

Viela Bio today announced that data from the N-MOmentum trial—the largest global, placebo-controlled study conducted in patients with neuromyelitis optica spectrum disorder (NMOSD)—have been selected for an oral plenary session presentation as well as poster presentations at the upcoming 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The congress will be held in Stockholm, Sweden, September 11-13, 2019.

“We are pleased that results from our N-MOmentum trial were selected for presentation at ECTRIMS—the largest global congress dedicated to research advances in neurological diseases—providing a platform to further share data regarding inebilizumab as a potential therapy for patients with NMOSD,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “Among the highlights to be presented at the congress are the long-term results from our open-label extension study, building on the previously reported data which demonstrated a reduction in risk of NMOSD attack and reduced disability scores as measured by expanded disability status scale, hospitalizations and new central nervous system MRI lesions when compared to placebo.” The U.S. Food and Drug Administration recently accepted for review Viela Bio’s Biologics License Application for inebilizumab for the treatment of patients with NMOSD.

Oral Plenary Presentation
Title: The N-MOmentum Study–A Randomised, Placebo-Controlled, Double-Blind Trial of Inebilizumab for Neuromyelitis Optica Spectrum Disorder: Randomised Controlled Period and Open-label Extension Results
Date: Thursday, September 12, 2019
Time: 08:30 – 08:42 CEST

Late-Breaking Poster Presentations
Title: Sensitivity Analyses of Time to Adjudicated Attacks in the N-MOmentum Study, a Randomized, Placebo-Controlled, Double-Masked Trial in Patients with Neuromyelitis Optica Spectrum Disorder
Date: Friday, September 13, 2019
Time: 12:15 – 14:15 CEST

Title: Elevated Serum Glial Fibrillary Acidic Protein (sGFAP) is Associated with Increased Risk of Neuromyelitis Optica Spectrum Disorder Attacks in the N-MOmentum Randomised, Masked, Placebo-Controlled Clinical Trial of Inebilizumab
Date: Friday, September 13, 2019
Time: 12:15 – 14:15 CEST

Additional Poster Presentations
Title: Inebilizumab Reduces Worsening of Disability in Neuromyelitis Optica Spectrum Disorder: Outcomes from the N-MOmentum Randomized, Placebo-Controlled, Double-Masked Trial

Title: Diagnosis, Severity, and Recovery of Attacks in the N-MOmentum Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

Title: Characterization of B-Cell Subset Changes Following Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) with Inebilizumab: Results from the N-MOmentum Study Randomized Control Period

About Inebilizumab
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization.

About N-MOmentum
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab monotherapy or placebo and followed for 6.5 months. Patients were subsequently given the option to enter into 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).

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans, objectives of management, and the timing and progress of clinical development of our product candidates, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

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

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

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

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

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

“We’re pleased that these important results are now fully available to the greater neuroinflammatory and autoimmune disease communities,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “This study provided key information on the safety and efficacy profile of inebilizumab monotherapy in NMOSD. Inebilizumab is the first and only biologic to use CD19 as a target for B cell depletion in this devastating disease.”
Continued Dr. Drappa: “The results from this pivotal study are very encouraging, demonstrating the potential impact on patient care if inebilizumab is approved by the U.S. Food and Drug Administration.”

The FDA granted inebilizumab Orphan Drug Designation in 2016 and Breakthrough Therapy Designation in 2019. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017. The FDA accepted for review Viela’s Biologics License Application for inebilizumab in August 2019.

Efficacy Results from N-MOmentum Study
Below is a summary of the study results, as presented at AAN:

  • Inebilizumab met the primary efficacy endpoint with a 77% reduction in risk of developing an NMOSD attack when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment (HR: 0.227; p < 0.0001)i.
  • Similar effect on attack risk (73% reduction) was seen in the total inebilizumab-treated patient population, inclusive of AQP4-IgG seronegative patients, (HR: 0.272; p < 0.0001).
  • At the end of the randomized-controlled period (RCP), 89% of AQP4-IgG seropositive patients treated with inebilizumab were attack-free, versus 58% in the placebo group.
  • Inebilizumab demonstrated statistically significant benefits in key secondary endpoints, including:
    • Reduction in worsening from baseline in Expanded Disability Status Scale (EDSS) scores: inebilizumab-treated patients (15.5%), versus placebo (33.9%, p=0.0049)
    • Reduction in NMOSD-related hospitalizations: inebilizumab-treated patients (10/174 subjects) versus placebo (8/56 subjects) (p=0.01; rate ratio: 0.286)
    • Reduction in frequency of cumulative total active MRI lesions: inebilizumab-treated patients (79/174 subjects) versus placebo (32/56 subjects) (p=0.0034; rate ratio: 0.566)

Visual acuity, also a secondary endpoint, did not demonstrate a statistically significant difference.

[i] Data on File. Viela Bio. Gaithersburg, MD. March 2019.

About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a recently proposed unifying term for neuromyelitis optica (NMO) — also known as Devic’s disease — and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. In NMOSD, about 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4-IgG antibodies to central 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 leads to further damage and disability. NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent. There is currently no cure for NMOSD.

About Inebilizumab
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization.

About N-MOmentum
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab 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)

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, product candidates, future operations, prospects, plans, objectives of management, the timing and progress of clinical development of our product candidates, and the benefits of inebilizumab to patients with NMOSD are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

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

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

Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for inebilizumab, an investigational anti-CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.

“The acceptance of our first BLA filing for review represents a huge milestone for inebilizumab and another important step in delivering this novel therapy to patients in need,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “We believe that inebilizumab can play a critical role in reducing the risk of developing an NMOSD attack, thereby contributing to the health of patients with this devastating and debilitating disease. We look forward to working closely with the FDA to move this therapy toward approval.”

The safety and efficacy results provided in the application are from the pivotal N-MOmentum trial, the largest global, placebo-controlled study in NMOSD. The study, which enrolled 231 patients with and without the AQP4-IgG antibody—a key biomarker for the disease—met its primary and a majority of the secondary endpoints. Results demonstrated that inebilizumab reduced the risk of developing an NMOSD attack by 77% when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment. In addition, inebilizumab impacted measurements of worsening disability, hospitalizations and new central nervous system MRI lesions.

These study results were presented at the plenary session of the recent American Academy of Neurology (AAN) annual meeting.

About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a recently proposed unifying term for neuromyelitis optica (NMO) — also known as Devic’s disease — and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. In NMOSD, about 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4-IgG antibodies to central 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 leads to further damage and disability. NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent. There is currently no cure for NMOSD.

About Inebilizumab
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization.

About N-MOmentum
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab 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)

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, product candidates, future operations, prospects, plans, objectives of management, the timing and progress of clinical development of our product candidates, and the benefits of inebilizumab to patients with NMOSD are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

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

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

Viela Bio today announced the appointment of Chris Nolet to its Board of Directors. Mr. Nolet brings more than 38 years of financial leadership experience in the Life Sciences industry. In his most recent role, he served as the West Region Life Sciences Industry Leader and Partner at Ernst & Young LLP (EY).

“We are pleased to welcome Chris to our Board of Directors,” said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. “From rapidly growing VC backed start-ups to Fortune 100 companies, Chris has been an integral player in the development and growth of numerous life science companies, in addition to working with federal legislators in support of improving patient access to innovative new therapies. We look forward to his many contributions to Viela as we prepare for the commercialization, if approved, of our lead asset, inebilizumab.”

Mr. Nolet spent 18 years at Ernst & Young, in various roles of increasing responsibility including leading the West EY Life Sciences Industry Group, while also serving as a Director and member of the Executive Committee and Chair of the Audit Committee of the California Life Sciences Industry Association (and its predecessor CHI). Previously, he was a member of the Finance & Investment Committee and Emerging Companies Selection of the Biotechnology Innovation Organization (BIO) and was also active in supporting the need for patient access to innovative new therapies. During his time at EY, Mr. Nolet was a member of the Global EY Life Sciences Executive Leadership Group, a member of the EY Americas Advisory Council, and a co-author and editor of EY’s leading Annual Biotechnology Industry Report.

Throughout the course of his career, Mr. Nolet has led the audit engagements for many life science companies, including Amgen, Applied Biosystems, Genentech/Roche, Gilead, Eli Lilly, Allogene Therapeutics and Denali Therapeutics, and has gained extensive experience in capital structuring and other strategic financial transactions.

Mr. Nolet is a CPA (California) and member of the AIPCA and the California Society of CPAs. He served on the School of Accountancy Advisory Board at his alma mater San Diego State University.

About Viela Bio

Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans, objectives of management, and the timing and progress of clinical development of our product candidates, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

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

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

Viela Bio today announced the appointment of Mitchell Chan as Chief Financial Officer, effective July 1. In this role, he will be responsible for leading corporate financing, financial operations, treasury, investor relations, corporate communications and corporate strategy. Previously, Mr. Chan served as Viela’s Vice President, Head of Finance & Corporate Strategy.

“We are pleased to announce Mitch’s appointment to the CFO position,” said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. “Mitch brings a deep understanding of capital markets and the life sciences industry. He has a proven track record of successful financial leadership and was integral in supporting Viela in raising capital, including our recent Series B financing. We look forward to his continued contributions as we approach our first regulatory milestone with inebilizumab and advance the entirety of our pipeline in autoimmune and inflammatory disease.”
Mr. Chan has more than 15 years of finance experience. Prior to joining Viela in 2018, he served as Director of Investor Relations for AstraZeneca, North America. Previously, Mr. Chan held various roles of increasing responsibility at Genentech-Roche, including in BioOncology Commercial Finance, R&D Finance, and Mergers & Acquisitions.

Mr. Chan is the recipient of Executive Certifications from Stanford University, University of California (Haas), and University of Pennsylvania (Wharton) and earned his BSc, MSc and MBA (Rotman School of Management) from the University Toronto.

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Contacts

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

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

Viela Bio today announced the successful completion of a $75 million private placement of its Series B preferred stock, bringing the total capital raised since the Company’s launch in February 2018 to more than $300 million. The financing round was led by HBM Healthcare Investments, and additional new investors participating included Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs, and Barer & Son Capital. Existing investors participating included Temasek.

“We are pleased that our ongoing development of our clinical programs continues to attract capital from leading healthcare investors. This financing will support our upcoming regulatory milestone—the anticipated filing of our Biologics License Application with the U.S. FDA for our lead product candidate, inebilizumab, for the treatment of neuromyelitis optica spectrum disorder, or NMOSD,” said Bing Yao, Ph.D. Executive Chairman and Chief Executive Officer. “NMOSD is a severe, debilitating, and sometimes fatal neurological disease for which there is currently no approved treatment. While our priority is to serve this patient population through the successful approval and launch of inebilizumab, we believe this financing also puts us in a strong position to pursue additional new indications with inebilizumab. Furthermore, we believe this financing will allow us to advance the entirety of our clinical pipeline, which is comprised of several additional clinical candidates for a range of rare autoimmune and inflammatory diseases.”

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Contacts

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

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

Viela Bio, Inc. (“Viela”) and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”) today announced a collaboration focused on development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in China for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential inflammation/autoimmune and hematologic malignancy indications.

“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “Their significant commercial, regulatory and clinical development infrastructure gives us a strong strategic partner in China and also may provide support for our global product expansion and lifecycle plans.”

Under terms of the collaboration, Viela will receive an up-front collaboration fee and additional payments contingent on certain development, regulatory, and commercial milestones, totaling potentially more than $220 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China.

“We are thrilled to partner with Viela. They have shown that targeting CD19 to achieve sustained B cell depletion is a compelling monotherapy strategy that brings profound benefits to patients with NMOSD, for whom there is no approved therapy,” said Aifeng Lyu, Ph.D., President of Hansoh Pharma. “Viela is a leader in researching and developing breakthrough treatments for inflammation and autoimmune diseases. Together, we will endeavor to advance inebilizumab as quickly as possible for patients in China, as well as seek to broaden the potential of inebilizumab via combination therapies.”

Viela recently presented positive results from a pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) – a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Inebilizumab is not yet approved for sale in either the United States or China. Viela expects to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) in mid-2019.

ABOUT INEBILIZUMAB
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization in the United States or China.

ABOUT HANSOH PHARMACEUTICAL GROUP LIMITED
Hansoh Pharma is a leading biopharmaceutical company in China committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, together with its 8,800 employees.

Founded in 1995, Hansoh has fully integrated research and development, manufacturing and commercial capabilities, supporting a leadership position in CNS, oncology, infectious diseases, and diabetes, among others. With 1,400 professionals across R&D, Hansoh ranks top 2 in innovation among all biotech and pharmaceutical companies in China based on new molecular entity INDs submitted for clinical development since 2011.

Hansoh Pharma’s 2018 revenue was US$1.1 billion, representing a year-over-year growth of 25%. For more information, please visit www.hansoh.cn/en/

ABOUT VIELA BIO
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Contacts

For Viela Bio:

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

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

For Hansoh Pharma:

Investor/Media
communications@hspharm.com

Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.

The N-MOmentum trial, the largest global, placebo study in NMOSD, achieved the primary and key secondary endpoints, demonstrating significant reduction in risk of NMOSD attack, and impacting measurements of worsening disability, hospitalizations and new central nervous system MRI lesions.

“The N-MOmentum trial demonstrated the statistically significant and clinically meaningful treatment effect of inebilizumab across both the primary endpoint and key secondary endpoints. Inebilizumab is the first and only biologic in NMOSD to use CD19 as a target for B cell depletion without the confounding effects of background drug therapies,” said Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum study and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences. “Inebilizumab substantially reduced the risk of attacks when given as a monotherapy, successfully measuring a strong treatment effect in both attacks and worsening disability.”

Efficacy Results

  • Inebilizumab met the primary efficacy endpoint with a 77% reduction in risk of developing an NMOSD attack when compared to placebo in AQP4-IgG seropositive patients after 28 weeks of treatment (HR: 0.227; p < 0.0001)i.
  • Similar effect on attack risk (73% reduction) was seen in the total inebilizumab-treated patient population, inclusive of AQP4-IgG seronegative patients, (HR: 0.272; p < 0.0001).
  • At the end of the randomized-controlled period (RCP), 89% of AQP4-IgG seropositive patients treated with inebilizumab were attack-free, versus 58% in the placebo group.
  • Inebilizumab demonstrated statistically significant benefits in key secondary endpoints, including:
    • Reduction in worsening from baseline in Expanded Disability Status Scale (EDSS) scores: inebilizumab-treated patients (15.5%), versus placebo (33.9%, p=0.0049)
    • Reduction in NMOSD-related hospitalizations: inebilizumab-treated patients (10/174 subjects) versus placebo (8/56 subjects) (p=0.01; rate ratio: 0.286)
    • Reduction in frequency of cumulative total active MRI lesions: inebilizumab-treated patients (79/174 subjects) versus placebo (32/56 subjects) (p=0.0034; rate ratio: 0.566)

Visual acuity, also a secondary endpoint, did not demonstrate a statistically significant difference.

Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo. Rates of serious and/or ≥ Grade 3 severity adverse events were similar in the inebilizumab (10.3%) and placebo (14.3%) groups.

“NMOSD is a devastating disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain. There is currently no approved treatment, and patients today are relegated to off-label therapies with uncertain benefit,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “The results of the N-MOmentum study are promising, and have the potential to reshape the treatment paradigm in NMOSD. We look forward to working with the regulatory agencies to understand how inebilizumab can become part of a dedicated therapeutic regimen for people living with this devastating disease.”

The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without the AQP4-IgG antibody, a key biomarker for the diseaseii. Patients were randomized 3:1 (inebilizumab to placebo) to receive either two introductory doses of 300 mg of inebilizumab monotherapy or placebo at Day 1 and Day 15.The patients were followed for a total of 28 weeks, after which time the RCP was stopped early for efficacy. Following the RCP, patients were given the option to enter an open-label extension period, in which they receive 300 mg of inebilizumab every 6 months.

Based on the safety and efficacy data from this pivotal study, the company plans to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) mid-2019. The FDA granted inebilizumab Orphan Drug Designation for the treatment of NMOSD in 2016 and Breakthrough Therapy Designation in 2019 for the treatment of NMOSD. The European Medicines Agency (EMA) granted inebilizumab Orphan Drug Designation in 2017.

Investor Event 
Viela Bio will host a live investor event on May 9, 2019 at 5:30 p.m. EDT in New York City, which will feature the N-MOmentum lead investigator, Dr. Bruce Cree, as well as Viela Bio senior management.

[i] Data on File. Viela Bio. Gaithersburg, MD. March 2019.
[ii]Cree BA, Bennett JL, Sheehan M, Cohen J, Hartung HP, Aktas O, Kim HJ, Paul F, Pittock S, Weinshenker B, Wingerchuk D, Fujihara K, Cutter G, Patra K, Flor A, Barron G, Madani S, Ratchford JN, Katz E. Placebo-controlled study in neuromyelitis optica-Ethical and design considerations. Mult Scler. 2016 Jun;22(7):862-72. doi: 10.1177/1352458515620934. Epub 2015 Dec 14., Data on File. Viela Bio. Gaithersburg, MD. March 2019.

About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a recently proposed unifying term for neuromyelitis optica (NMO) — also known as Devic’s disease — and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. In NMOSD, about 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4-IgG antibodies to central nervous system cells is believed to trigger attacks, which can damage the optic nerves, the 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 leads to further damage and disability. NMOSD occurs more commonly in women and it may be more common in non-Caucasians. There is currently no cure or approved treatment for NMOSD.

About Inebilizumab
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation. Inebilizumab is an investigational new drug for which there is no marketing authorization in the U.S.

About N-MOmentum
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab monotherapy or placebo and followed for 6.5 months. Patients were subsequently given the option to enter into 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 study is ongoing. More information can be found on clinicaltrials.gov (Study NCT02200770).

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

Forward-Looking Statements
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Contacts

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

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

Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, life-threatening autoimmune disease affecting the central nervous system.

“The Breakthrough Therapy Designation for inebilizumab is based on results from the largest monotherapy study ever conducted in NMOSD,” said Jorn Drappa, M.D., Ph.D., Chief Medical Officer and Head of Research & Development at Viela Bio. “Inebilizumab is a humanized monoclonal antibody designed to bind with high affinity to CD19 and deplete a broad range of B cells, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells. We continue our efforts to bring inebilizumab to patients suffering from this devastating disease for which there are currently no approved medicines.”

Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines intended to treat a serious condition that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. The designation for inebilizumab is based on data from the pivotal N-MOmentum study evaluating inebilizumab as monotherapy.

The FDA and the European Medicines Agency granted Orphan Drug Designation for inebilizumab for the treatment of patients with NMOSD in March 2016 and March 2017, respectively.

NMOSD is a rare, life-threatening autoimmune disease of the central nervous system in which the body’s immune system attacks healthy cells, most commonly in the optic nerves and spinal cord, resulting in severe damage. NMOSD may cause severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function and neuropathic pain.1 There is currently no cure or approved treatment for NMOSD.

[1] National Institute of Neurological Disorders and Stroke, National Institutes of Health https://www.ninds.nih.gov/Disorders/All-Disorders/Neuromyelitis-Optica-Information-Page

About Breakthrough Therapy 
Breakthrough Therapy Designation (BTD) is a U.S. FDA program designed to expedite the development and review of drugs intended for serious or life-threatening conditions. In order to receive a BTD, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of BTD include more intensive guidance from FDA on an efficient drug development program, access to a scientific liaison to help accelerate review time and organizational commitment from FDA.

About Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD is a recently proposed unifying term for neuromyelitis optica (NMO)—also known as Devic’s disease—and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal. In NMOSD, about 80% of patients have autoantibodies to a water channel protein called aquaporin-4 (AQP4). These AQP4-IgG autoantibodies are thought to be produced by plasmablasts and plasma cells and bind primarily to astrocytes in the central nervous system. Binding of AQP4-IgG antibodies to central nervous system cells is believed to trigger attacks, which can damage the optic nerves, 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 leads to further damage and disability. NMOSD occurs more commonly in women and it may be more common in non-Caucasians. There is currently no cure or approved treatment for NMOSD.

About Inebilizumab
Inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and some plasma cells. After binding to CD19, these cells are rapidly depleted from the circulation.

About N-MOmentum
The N-MOmentum study enrolled 231 NMOSD patients, including patients with and without AQP4-IgG antibodies. Patients were randomized to receive two intravenous doses of inebilizumab monotherapy or placebo and followed for 6.5 months. Patients were subsequently placed into open label extension in which all patients received inebilizumab every 6 months. The primary endpoint was time from treatment initiation to occurrence of an NMOSD attack. NMOSD attack diagnosis was standardized using 18 clinically meaningful criteria that were developed for the study. These criteria were defined and established prospectively. An independent, blinded external adjudication committee reviewed all NMOSD attacks. An open-label study is ongoing, with patients receiving an inebilizumab infusion every 6 months. More information can be found on clinicaltrials.gov

About Viela Bio
Viela Bio, headquartered in Gaithersburg, Maryland, is a clinical-stage biotechnology company pioneering and advancing treatments for severe inflammation and autoimmune diseases by selectively targeting shared critical pathways that are the root cause of disease.

For more information, please visit www.vielabio.com

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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