Theravance, Mylan to Present New Data at 2018 CHEST Annual Meeting

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V.(NASDAQ: MYL) (“Mylan”) today announced that data from studies of YUPELRI^™ (revefenacin) will be presented at the 2018 CHEST annual meeting, being held in San Antonio, Texas on October 6-10, 2018. Multiple presentations will report new results from the previously completed Phase 3 program of YUPELRI in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Researchers will also report data from a new study comparing outcomes for YUPELRI and tiotropium (Spiriva^® HandiHaler^®) in COPD patients with suboptimal peak inspiratory flow rates (PIFR).

YUPELRI is an investigational long-acting muscarinic antagonist (LAMA) currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of COPD. The Prescription Drug User Fee Act (PDUFA) date for YUPELRI is November 13, 2018. If approved, YUPELRI would be the first and only once-daily, long-acting nebulized bronchodilator for the treatment of COPD. YUPELRI is designed to be compatible with any standard jet nebulizer.

Details of the presentations at CHEST 2018 are as follows:

Efficacy of Revefenacin by Nebulization and Tiotropium by Handihaler^® in Subjects with COPD and Suboptimal Peak Inspiratory Flow Rates (PIFR)

• Poster Number: 153
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Efficacy of Revefenacin, a Long-Acting Muscarinic Antagonist for Nebulized Therapy, in Chronic Obstructive Pulmonary Disease Patients with Markers of More Severe Disease

• Poster Number: 147
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

Cardiovascular Safety of Revefenacin for Nebulization: a Review of Randomized Controlled Trial Data

• Poster Number: 146
• Date/time: Wednesday, October 10, 2018, 1:00 – 2:00 p.m. Central Time
• Session: 4285 – Obstructive Lung Diseases 2
• Location: Exhibit Hall

About YUPELRI

YUPELRI (revefenacin) inhalation solution 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.¹ LAMAs are a cornerstone of maintenance therapy for COPD and, if approved, YUPELRI would be the first and only once-daily, long-acting single-agent product for COPD patients who require, or prefer, nebulized therapy. YUPELRI’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.

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.

https://www.biospace.com/article/releases/theravance-biopharma-and-mylan-to-present-new-data-from-studies-of-yupelri-revefenacin-at-the-2018-chest-annual-meeting/

Ironwood Presenting at the American College of Gastroenterology Meet

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, today announced the presentation of clinical data for IW-3718 and linaclotide from the company and its collaborators during the American College of Gastroenterology 2018 Annual Scientific Meeting in Philadelphia, PA, October 5 through October 10, 2018.

IW-3718 is being evaluated in Phase III clinical trials for the treatment of persistent gastroesophageal reflux disease (GERD). Persistent GERD is a condition affecting an estimated 10 million Americans who continue to suffer from heartburn and regurgitation despite receiving treatment with proton pump inhibitors, the current standard of care. Researchers will present analyses of Ironwood’s Phase IIb data on the effect of IW-3718 on health-related quality of life in patients with persistent GERD, as well as data on the effect of IW-3718 on esophageal erosions in this patient population.

Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that acts by a mechanism pioneered by Ironwood scientists. Linaclotide is marketed in the United States as LINZESS^® and is the U.S. branded prescription market leader for adults with Chronic Idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C). It is also marketed in Japan as LINZESS for the treatment of adults with IBS-C and adults with chronic constipation, and in Europe as CONSTELLA^® for the treatment of adults with moderate to severe IBS-C. Researchers will present an analysis of clinical data focusing on the impact of linaclotide on constipation symptoms and quality of life in patients with IBS-C or CIC. An additional presentation will focus on treatment patterns in patients with IBS-C or CIC.

The data via poster presentations is as follows:

Treatment Impact on Patients with IBS-C or CIC

• Treatment Patterns, Over-the-Counter (OTC) Use, and Outcomes among Patients with Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation: Results from the CONTOR Study (poster session #P0331), by Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 7, 5:15 p.m. to 6:30 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
• Impact of Linaclotide on Patient-Reported Constipation Symptoms and Quality of Life: Results from the CONTOR Study (poster session #P0332), by Douglas C.A. Taylor, MBA, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 7, 5:15 p.m. to 6:30 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.

Effect of IW-3718 on Patients with Persistent GERD

• Clinical Response is Associated with Improvement in Health-Related Quality of Life in Patients with Persistent GERD Symptoms (poster session #P2019), by Hancheng Jiang, M.S., Ironwood Pharmaceuticals, Inc., Cambridge, MA, will be presented on Tuesday, October 9, 1:00 p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.
• Effects of a Gastric-Retentive Extended-Release Bile Acid Sequestrant on Esophageal Erosions in Patients with Persistent GERD; Exploratory Analysis from a Phase IIb Study of IW-3718 (poster session #P2026), by Peter Kahrilas, M.D., Northwestern University Feinberg School of Medicine, Chicago, IL, will be presented on Tuesday, October 9, 1:00 p.m. to 2:15 p.m., in Exhibit Halls DE of the Pennsylvania Convention Center.

https://www.biospace.com/article/releases/ironwood-pharmaceuticals-presenting-iw-3718-and-linaclotide-data-at-the-american-college-of-gastroenterology-2018-annual-scientific-meeting/

Bausch Health approval of Bryhali largely expected, says Wells Fargo

Bausch Health announced this morning that final approval of Bryhali Lotion for the treatment of plaque psoriasis in adults is pending the expiration of exclusivity for a related product, which is expected to occur in early November, Wells Fargo analyst David Maris tells investors in a research note. The analyst reiterates his belief that the market largely expected Bausch would receive approval for Bryhali since the active ingredient is already available as a generic and other similar products are already approved using this active ingredient. While unaware the approval would be held up based on the exclusivity of another product, Maris does not consider the one or two month delay as significant. He currently models Bryhali sales of $17M in 2019, and peak sales of approximately $75M. Maris keeps an Underperform rating on shares of Bausch Health, which are trading up 4% to $27.37 in early trading.
https://thefly.com/landingPageNews.php?id=2801019

Lannett Engages Advisors To Explore, Evaluate Debt, Capital Alternatives

Lannett Company, Inc. (NYSE: LCI) today announced that it has engaged and/or expanded the role of existing advisors to assist in evaluating a range of alternatives regarding the company’s debt and capital structure.

“We welcome the specialized expertise our advisors bring to the table, as we look to add revenues, reduce costs and more closely analyze financing options,” said Tim Crew, chief executive officer of Lannett. “Following the recent announcement that our distribution agreement with Jerome Stevens Pharmaceuticals, which expires on March 23, 2019, will not be renewed, we ramped up our efforts to address this eventuality and ultimately grow our business. I am pleased to report that we are making solid progress and our plans continue to proceed, as evidenced by the launch of five new products in our recently completed fiscal 2019 first quarter.”

Crew added that the company continues to expect to remain in compliance with its debt covenants through at least the end of fiscal 2019.

The company said Kirkland & Ellis LLP and Lazard Ltd. will serve as advisors.

https://www.marketscreener.com/LANNETT-COMPANY-INC-15227635/news/Lannett-Engages-Advisors-To-Explore-And-Evaluate-Debt-And-Capital-Structure-Alternatives-27386544/

Menlo says serlopitant fails to demonstrate efficacy in Refractory Chronic Cough

Menlo Therapeutics announced top-line results from TUSSIX, its Phase 2 clinical trial of serlopitant for the treatment of refractory chronic cough. In this 185 patient study, treatment with serlopitant failed to demonstrate benefit versus placebo on the primary and key secondary endpoints. In the primary endpoint analysis of change from baseline in 24-hour cough frequency after 12 weeks of treatment, the serlopitant group had 31% less reduction than the placebo group. In a key secondary analysis of response rates, 54% of placebo treated patients and 44% of serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline. Serlopitant was well-tolerated in this study. Treatment related adverse events occurred at comparable rates in the serlopitant and placebo treated groups. “Based upon the results of this trial, we do not anticipate further development of serlopitant for the treatment of refractory chronic cough. We sincerely thank the patients and investigators who participated in this trial. We are continuing the clinical development of serlopitant for pruritus associated with various conditions given the two successful Phase 2 clinical trials in which serlopitant demonstrated a reduction in chronic pruritus and pruritus associated with prurigo nodularis,” stated Steve Basta, CEO of Menlo Therapeutics. The Phase 2 clinical trial of serlopitant to treat pruritus associated with psoriasis is fully enrolled, and data is expected in December 2018, said the company, which added that it is currently enrolling patients in two Phase 3 clinical trials – one in the U.S. and one in Europe – to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected in the first half of 2020.
https://thefly.com/landingPageNews.php?id=2800955

Theravance Reports Positive New Data from Multiple Studies of Anti-infective

Data from TOUR™ Observational Patient Registry Demonstrate 77.1% Clinical Response Rate for VIBATIV® (telavancin) in Patients with Monomicrobial Staphylococcus aureus Infections with Vancomycin MIC ≥ 1 µg/mL
Additional TOUR Data Demonstrate Unchanged Renal Function in 68.7% of Patients Who Received VIBATIV Treatment for More Than 21 Days and Had CrCl Measured at Baseline and End of Treatment   

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) today announced that positive new data from multiple studies of VIBATIV^® (telavancin) were presented at IDWeek^™ 2018, which was held in San Francisco, CA, on October 3 – 7, 2018. Two presentations were made reporting new data from the ongoing Telavancin Observational Use Registry (TOUR^™) study, which is designed to report how VIBATIV^® (telavancin) is being used by healthcare practitioners to treat patients in real-world clinical settings. Presented findings from one study reported a positive clinical response following VIBATIV treatment in 77.1% of registry patients diagnosed with monomicrobial infections caused by Staphylococcus aureus (S. aureus) with vancomycin minimum inhibitory concentration (MIC) ≥ 1 µg/mL. Positive clinical response was defined as cure or improvement leading to step-down oral therapy. Results from a second study demonstrated that renal function was unchanged in 68.7% of TOUR patients who received treatment with VIBATIV for more than 21 days and had creatinine clearance (CrCl) measured at baseline and end of treatment.

https://www.biospace.com/article/releases/theravance-biopharma-reports-positive-new-data-from-multiple-studies-of-vibativ-telavancin-at-idweek-2018/

Teva to Present New Data at European Multiple Sclerosis Conference

Teva Pharmaceutical Industries Limited (NYSE and TASE: TEVA) today announced that new data on COPAXONE^® (glatiramer acetate injection), a product for relapsing forms of multiple sclerosis (RMS), will be presented at the 34^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, October 10-12, 2018.

“We are honored to contribute data spanning more than 25 years of research on COPAXONE^®at this year’s ECTRIMS Congress,” Danny McBryan, M.D., Senior Vice President of Global Medical Affairs and Pharmacovigilance at Teva. “Teva’s COPAXONE^® remains an important treatment option for RMS patients and this research highlights our understanding of the established therapeutic profile and complexity of COPAXONE^®.”

Teva-sponsored data include:

COPAXONE^® (glatiramer acetate injection)

P589: Twenty-five years of continuous treatment of multiple sclerosis with glatiramer acetate: long-term clinical results of the US open-label extension study (Poster Session 1, October 10, 2018, 5:00 – 7:00 p.m. CET) C. Ford, J. Cohen, A. Goodman, J. Lindsey, R. Lisak, C. Luzzio, A. Pruitt, J. Rose, H. Rus, T. Vollmer, J. Wolinsky, J. Alexander, O. Barnett-Griness, Y. Stark, US Open-Label Glatiramer Acetate Study Group

EP1358: A descriptive study of switching patterns among MS patients who started on Glatopa therapy: a claims database analysis (ePoster) J. Alexander, J. Kasturi, S. Melamed-Gal, K. Bibeau, R. Ariely, M. Vardi, Y. Wu, Z. Su, T. Brecht, A. Bryant, E. Hulbert, D. Liassou

EP1664: Genomic profiling and in vivo rat toxicity characterization of Copaxone and the Synthon European follow-on glatiramer acetate product (ePoster) S. Kolitz, N. Ashkenazi, B. Timan, J. Zhang, J. Funt, O. Beriozkin, A. Konya, J. Alexander, P. Loupe, M. Vardi, V. Weinstein, S. Melamed-Gal, I. Grossman, B. Zeskind, S. Nock, M. Hayden

https://www.biospace.com/article/releases/teva-to-present-new-data-at-34th-european-committee-for-treatment-and-research-in-multiple-sclerosis-congress-in-berlin/