Breaking News
September 26, 2018 - DFG establishes nine new Research Units
September 26, 2018 - Companies stepping up efforts to ensure medicine supply post Brexit
September 26, 2018 - Extracellular RNA in urine may provide useful biomarkers for muscular dystrophy
September 26, 2018 - Horwitz Prize Awarded for Work on Hormones
September 26, 2018 - Study reveals structure of potential drug target in neurological conditions
September 26, 2018 - Micronic introduces better alternative to traditional cryo tubes
September 26, 2018 - Epidural stimulation and locomotor training helps patients with spinal cord injury to walk
September 26, 2018 - RTI’s TETRAfuse 3D Technology wins 2018 Spine Technology Award
September 26, 2018 - Researchers discover novel targeting agents to prevent cancer metastasis
September 26, 2018 - Researchers develop molecule that makes cancer cells sensitive to radiotherapy
September 26, 2018 - American Cancer Society releases new cookbook for cancer patients
September 26, 2018 - Relmada Therapeutics Provides Enrollment Update in Phase 2 Study of REL-1017 (dextromethadone) in Patients with Major Depressive Disorder
September 26, 2018 - Many doctors in India miss TB signs: study
September 26, 2018 - Horwitz Prize Awarded for Work on Hormones
September 26, 2018 - Genomic ‘islands’ evolved from viruses can be converted into ‘anti-bacterial drones’
September 26, 2018 - Who is Your Possible Self?
September 26, 2018 - Most running injuries may be influenced by simple technique errors, finds study
September 26, 2018 - Optimizing dopaminergic treatment improves non-motor symptoms and quality of life
September 26, 2018 - NIRS-IVUS imaging identifies patients and plaques vulnerable to subsequent adverse cardiac events
September 26, 2018 - New insights into what drives organ transplant rejection
September 26, 2018 - Tiny Device Is a ‘Huge Advance’ for Treatment of Severe Heart Failure
September 26, 2018 - Research shows possibility to postpone cumbersome treatment for low-risk MDS patients
September 26, 2018 - CSU chemists may help in making extracorporeal life support devices more effective
September 26, 2018 - Brain marker linked with aggression in toddlers identified
September 26, 2018 - Blood-brain barrier can be important biomarker for early diagnosis of Alzheimer’s disease
September 26, 2018 - PCORI, AHRQ announce awards to support patient-centered outcomes research in learning health systems
September 26, 2018 - Scientists discover and characterize human skeletal stem cells
September 26, 2018 - Repeat CT Common in Peds Traumatic Epidural Hematoma
September 26, 2018 - Genetics Home Reference: bunion
September 26, 2018 - Increase observed in hearts from drug-intoxicated donors
September 26, 2018 - For Heart Failure Patients, Mitral Valve Procedure Improved Outcomes
September 26, 2018 - TINY cancer detection device shows promise as point-of-care detector of KSHV
September 26, 2018 - Women with non-small cell lung cancers live longer than their male counterparts
September 26, 2018 - KTU researchers engineer experimental bone to help treat osteoarthritis patients
September 26, 2018 - Foundation for a Smoke-Free World calls for proposals to implement Smoke-Free Index
September 26, 2018 - Functional Imagery Training helps lose five times more weight than talking therapy
September 26, 2018 - Fewer American Teens Having Sex, Most Using Birth Control
September 26, 2018 - We are predisposed to forgive, new research suggests
September 26, 2018 - Insomnia Exacts Heavy Toll on Quality of Life
September 26, 2018 - Clinical study shows efficacy, safety of novel drug-eluting stent with improved radiographic visibility
September 26, 2018 - Cytox, AIBL announce expanded agreement to assess genetic risk for Alzheimer’s
September 26, 2018 - Study finds persistent rate of lawnmower injury-related emergency department visits
September 26, 2018 - Researchers find molecule that halts, reverts neurodegeneration caused by Parkinson’s disease
September 26, 2018 - Novartis announces winners of 2018 eXcellence in Ophthalmology Vision Award
September 26, 2018 - New spinout company to tackle drug-resistant infections with novel antibiotics
September 26, 2018 - In depression the brain region for stress control is larger
September 26, 2018 - Smuggling RNA into cells can activate the immune system to fight cancer
September 26, 2018 - Special Focus Issue takes wide view of complementary and integrative medicine in cancer
September 26, 2018 - Researchers now confirm that genome duplication drives evolution of species
September 25, 2018 - Study provides evidence of beta lactamase producing, antimicrobial resistant E. coli in U.S. retail meat
September 25, 2018 - UCI study finds new cause of cerebral microbleeds
September 25, 2018 - Researchers propose mechanism by which ASTN2 protein defects lead to brain disorders
September 25, 2018 - Chinese and German researchers to cooperate more closely in future for better food
September 25, 2018 - Recent study helps predict probability of pregnant mothers to have child with autism
September 25, 2018 - New online, sound matching tool offers tinnitus sufferers potential treatment options
September 25, 2018 - UC Davis researchers take critical step in developing more effective Salmonella vaccine
September 25, 2018 - Antibiotics best paediatric treatment for children’s chronic wet cough
September 25, 2018 - Looking beyond opioids: Stanford pain psychologist briefs Congress
September 25, 2018 - Organs actively fighting back against autoimmune diseases, finds study
September 25, 2018 - Lancaster professor aims to understand how genes affect smoking cessation
September 25, 2018 - Human-oriented perspective needed to better understand Parkinson’s disease
September 25, 2018 - Physical activity may have beneficial effects for people with rare Alzheimer’s disease
September 25, 2018 - FDA Updates on Valsartan Recalls
September 25, 2018 - 3-D-printed tracheal splints used in groundbreaking pediatric surgery
September 25, 2018 - Who is the designated driver, or proxy, for your health decisions?
September 25, 2018 - New chemo-optogenetic method enables multi-directional activity control of cellular processes
September 25, 2018 - Study explores link between genetic predisposition to Alzheimer’s and cardiometabolic risk factors
September 25, 2018 - NeoTract presents new clinical data from studies of UroLift System for patients with BPH
September 25, 2018 - Patients with paralysis manage to walk thanks to new technology
September 25, 2018 - Statins Improve Long-Term Survival After AAA Repair
September 25, 2018 - Novel brain network linked to chronic pain in Parkinson’s disease
September 25, 2018 - Researchers reassess negative pressure wound therapy as its benefit and harm remain unclear
September 25, 2018 - Older adults with ‘fall plan of care’ less likely to suffer fall-related hospitalizations
September 25, 2018 - FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials
September 25, 2018 - IME Medical Electrospinning establishes state-of-the-art manufacturing lab facilities
September 25, 2018 - Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results
September 25, 2018 - How to Protect Your Eyesight
September 25, 2018 - Novel approach allows researchers to define how cells in the retina respond to diabetes
September 25, 2018 - Columbia University announces winners of 2018 Louisa Gross Horwitz Prize
September 25, 2018 - New model enables anyone to run powerful simulations, complex calculations easily
Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

image_pdfDownload PDFimage_print

revefenacin

Treatment for Chronic Obstructive Pulmonary Disease

Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Jan. 29, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ, TASE: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA). If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the NDA.

“The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy. With positive results in our Phase 3 program, we believe that revefenacin is well positioned to fill this important need,” said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma. “I commend the team at Theravance Biopharma and Mylan for producing a high quality submission, and we look forward to working with the FDA in its review of our application.”

“Today, patients with moderate to severe COPD do not have access to a nebulized LAMA as a treatment option yet. We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan’s robust and growing respiratory portfolio,” said Mylan President Rajiv Malik. “We are extremely pleased that the revefenacin NDA has been accepted for FDA review, as it demonstrates the success of our collaboration with Theravance Biopharma, our collective expertise in complex products and the quality of the revefenacin development program.”

Theravance Biopharma and Mylan previously reported that in two replicate pivotal Phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing.1 Both doses of revefenacin had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, were exacerbations, cough, dyspnea and headache. Additionally, the companies have previously announced positive results from the 12-month Phase 3 safety study, which did not identify new safety issues. Rates of AEs and SAEs in the study were low and comparable to those seen in the standard of care treatment arm.

Theravance Biopharma and its affiliates have partnered with Mylan and its affiliates on the development and commercialization of nebulized revefenacin products for COPD and other respiratory diseases. The companies are developing revefenacin as a once-daily, nebulized bronchodilator for the treatment of patients with COPD that will be compatible with a range of jet nebulizers.

About Theravance Biopharma and Mylan Strategic Collaboration

Theravance Biopharma and Mylan N.V. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Under the terms of the agreement, Theravance Biopharma is leading the US development program for the revefenacin inhalation solution product, with all costs related to the registrational program reimbursed by Mylan up until the approval of the first new drug application, after which costs will be shared. Mylan is responsible for ex-US development and commercialization. Theravance Biopharma is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on US sales and double-digit royalties on ex-US sales. Additionally, Theravance Biopharma retains worldwide rights to revefenacin delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI), and the rights to nebulized revefenacin in China.

About COPD

COPD is a growing and devastating disease that is the third leading cause of death in the U.S.2 Nearly 15.7 million Americans (6.4%) report that they have been diagnosed with COPD and more are believed to be undiagnosed.3 There were more than 700,000 hospital discharges related to COPD in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly $50 billion in 2010, including $29.5 billion in direct healthcare expenditures, $8 billion in indirect morbidity costs and $12.4 billion in indirect mortality costs.3

About Revefenacin

Revefenacin (TD-4208) is a novel investigational once-daily nebulized LAMA under FDA review for the treatment of moderate to very severe COPD. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the U.S. use nebulizers for ongoing maintenance therapy.4 LAMAs are a cornerstone of maintenance therapy for COPD and, if approved, revefenacin has the potential to be a best-in-class once-daily single-agent product for COPD patients who require, or prefer, nebulized therapy. Revefenacin’s stability in both metered dose inhaler and dry powder device formulations, suggest that this LAMA could also serve as a foundation for novel handheld combination products.

About Theravance Biopharma

Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that help improve the lives of patients suffering from serious illness.

Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases, such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and intestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop intestinally restricted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases.

In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain drug development programs, including Trelegy Ellipta (the combination of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA® inhaler, previously referred to as the Closed Triple), currently approved in the US for the treatment of appropriate COPD patients and in development for the treatment of COPD in several other countries. The product is also currently in development for the treatment of asthma.

For more information, please visit www.theravance.com.

THERAVANCE®, the Cross/Star logo and VIBATIV® are registered trademarks of the Theravance Biopharma group of companies. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s strategies, plans and objectives, the Company’s regulatory strategies and timing of clinical studies, the potential benefits and mechanisms of action of the Company’s product and product candidates, the Company’s expectations for product candidates through development, potential regulatory approval and commercialization (including their potential as components of combination therapies) and the Company’s expectations for product sales. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company’s product candidates are unsafe or ineffective (including when our product candidates are studied in combination with other compounds), the feasibility of undertaking future clinical trials for our product candidates based on FDA policies and feedback, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize product and product candidates, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure. Other risks affecting Theravance Biopharma are described under the heading “Risk Factors” contained in Theravance Biopharma’sForm 10-Q filed with the Securities and Exchange Commission (SEC) on November 8, 2017and Theravance Biopharma’s other filings with the SEC. In addition to the risks described above and in Theravance Biopharma’s filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma’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 these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

This press release includes statements that constitute “forward-looking statements,” including with regard to the target action date; that, if approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of COPD; that the acceptance of the NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy; that with positive results in the Phase 3 program, we believe that revefenacin is well positioned to fill this important need. We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan’s robust and growing respiratory portfolio; and that revefenacin’s acceptance by FDA demonstrates the success of Mylan’s collaboration with Theravance Biopharma, our collective expertise in complex products and the quality of the revefenacin development program. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: success of clinical trials and our or our partners’ ability to execute on new product opportunities; any regulatory, legal or other impediments to our or our partners’ ability to bring products to market; other risks inherent in product development; the scope, timing, and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings on our or our partners’ businesses; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; the impact of competition; strategies by competitors or other third parties to delay or prevent product introductions; the effect of any changes in our or our partners’ customer and supplier relationships and customer purchasing patterns; any other changes in third-party relationships; changes in the economic and financial conditions of the businesses of Mylan or its partners; uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

References

1 “Clinically meaningful” is defined by industry established Minimal Clinically Important Difference (MCID) for lung function (100 mL improvement in FEV1).

2 American Lung Association. “Chronic Obstructive Pulmonary Disease (COPD)” http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd. Accessed on September 29, 2016.

3 Center for Disease Control, COPD https://www.cdc.gov/copd/index.html. Accessed on January 3, 2018.

4 TBPH market research (N = 160 physicians); Refers to US COPD patients

SOURCE Theravance Biopharma, Inc.

Posted: January 2018

Related Articles

revefenacin FDA Approval History

Tagged with:

About author

Related Articles