Onsolis (BEMA fentanyl) / Viatris, Collegium Pharma - LARVOL DELTA

An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain (clinicaltrials.gov) - P=N/A | N=37 | Completed | Sponsor: Mackay Memorial Hospital | Recruiting ➔ Completed

Trial completion • Oncology • Pain

"Adalvo Acquires Its First Branded Product, Onsolis® https://t.co/kYmLRWpL8D" (@NewsFromBW)

An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Mackay Memorial Hospital

New trial • Oncology • Pain

A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. (PubMed, Cancer Rep (Hoboken)) - "Individualized dose titration is recommended for BTP management for patients' benefit. Overall, FBSF was effective and well tolerated and was positively correlated with patients' background opioid dose for persistent pain management."

Journal • Oncology • Pain

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (AATD) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: University of Florida; Trial primary completion date: Apr 2016 ➔ Apr 2017

Trial primary completion date • Biosimilar • Fibrosis • Immunology • Inflammation

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (AATD) (clinicaltrials.gov) - P1; N=109; Active, not recruiting; Sponsor: University of Florida; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Fibrosis • Immunology

FDA to approve shared system REMS for TIRF products (FDA) - FDA approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products; This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system; TIRF medicines includes the brand-name drugs Abstral, Actiq, Fentora, Lazanda, and Onsolis

REMS approval • Pain

Pharmacological and clinical differences among transmucosal fentanyl formulations for the treatment of breakthrough cancer pain. A review article (Minerva Anestesiol) - "Clinical data on efficacy and safety were compared. In parallel, we report the differences in delivery systems, bioavailability, maximum plasma concentration (Cmax), plasma half-life, and time to reach Cmax (tmax). Considerable variability emerged between formulations."

Review • Pain

Onsolis relaunch postponed pending product modification (PRNewswire) - BioDelivery Sciences International, Inc today announced that the U.S. relaunch of Onsolis (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the FDA following a recent inspection of the Aveva manufacturing facility where Onsolis is produced

Launch update • Pain

US Patent Office rejects All 191 claims in key MonoSol patent asserted against BioDelivery Sciences (PRNewswire) - The USPTO's action is a significant and positive development for BDSI as the '588 patent is a key element of claims first asserted in a litigation filed by MonoSol in Nov 2010 against BDSI and its commercial partners for BDSI's Onsolis

Patent update • Pain

Investor Presentation (Biodelivery Sciences) - Onsolis® (BEMA® Fentanyl) / Biodelivery sciences; Anticipated launches in Q2 ’11 in Canada and Q3 ’11 in EU

Anticipated product launch • Pain

BioDelivery Sciences announces regulatory approval of Onsolis in Taiwan (PRNewswire) - "BioDelivery Sciences International...announced the regulatory approval of ONSOLIS in Taiwan for the management of breakthrough cancer pain in opioid tolerant, adult patients with cancer....In Taiwan, BDSI has licensed the commercialization rights to TTY Biopharm, where the product will be marketed under the brand name PAINKYL."

Licensing / partnership • Non-US regulatory • Pain

Piper Jaffray Healthcare Conference (Biodelivery Sciences) - Onsolis (fentanyl) / Biodelivery Sciences; Onsolis approved in Canada May ’10 and EU Oct ’10 (to be marketed as BREAKYL); $22M in cash royalty made ending Q3 ’10;

Product update

BioDelivery on track for mid-year NDA filing (SeekingAlpha) - "BioDelivery and Meda have submitted a proposal to the FDA to reintroduce Onsolis into the U.S. If approved, the original Onsolis formulation may be on the market during the second half of 2013, while stability data is collected on a newly formulated version of Onsolis. The new data could be submitted to the FDA before the end of 2013 and, if approved, could allow for the introduction of the new formulation during 2014."

Anticipated FDA event • Anticipated launch US • Pain

Drug approval reports (FDA) - Manufacturing change or addition for Onsolis on 11th Aug, 2015.

FDA event • Pain

Investor Presentation (Biodelivery Sciences) - Onsolis / Biodelivery Sciences; Anticipated launch in H2 2012 in EU

Anticipated EU product launch • Pain

Biodelivery Sciences International: Ladenburg - BDSI: BEMA Buprenorphine Top-line results expected September 2011; 2Q 2011 results a non-event. Reiterating Buy rating and maintaining price target of $8.00. (Ladenburg, Thalmann & Co) - The launch of Onsolis in the EU is expected H2 '11

Financial analyst: Regulatory • Pain

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD) (clinicaltrials.gov) - P=N/A; N=109; Completed; Sponsor: University of Florida; Active, not recruiting ➔ Completed; Trial completion date: Oct 2020 ➔ Sep 2019; Trial primary completion date: May 2020 ➔ Sep 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date • AAT

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD) (clinicaltrials.gov) - P=N/A; N=109; Active, not recruiting; Sponsor: University of Florida; Trial primary completion date: Dec 2019 ➔ May 2020

Clinical • Trial primary completion date • AAT