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/

LeMaitre upgraded to Outperform from Market Perform at Barrington

Barrington analyst Michael Petusky upgraded LeMaitre Vascular to Outperform with a $34 price target. Friday’s 21% on the disappointing preliminary Q3 results was overdone and provides investors with an attractive entry point, Petusky tells investors in a research note. He believes the shares are “no longer priced for perfection.”
https://thefly.com/landingPageNews.php?id=2800893

Novavax analyst commentary at B. Riley FBR

Novavax added to Alpha Generator list at B. Riley FBR. B. Riley FBR analyst George Zavoico added Novavax to his firm’s Alpha Generator list based on the upcoming top-line results of two key clinical trials expected in early Q1. If a Phase III trial of ResVax delivers positive results, Novavax will seek FDA approval in 2020, the analyst points out. Further, if a Phase II trial of NanoFlu delivers positive results, Novavax could commence pivotal Phase III trial in the second half of 2020, the analyst adds. These are multi-billion-dollar markets, and positive results could make Novavax an acquisition target by a major pharmaceutical company, Zavoico tells investors in a research note. He keeps a Buy rating on the shares with a $10 price target.
https://thefly.com/landingPageNews.php?id=2800923

WellCare partners with agilon health

WellCare Health Plans announced it has expanded its network of providers by signing a new value-based care agreement with agilon health, a leading national organization which brings a complete operating platform for global risk to primary care physicians, to help improve access to care and drive greater health outcomes for its members in Texas.
https://thefly.com/landingPageNews.php?id=2800935