Bunavail (buprenorphine/naloxone transmucosal) / Collegium Pharma - LARVOL DELTA

"Had clients switch to Bunavail because of the taste issue and liked it much better. Pineapple candy type flavor." (@jeff_deeney)

SUBLOCADE Rapid Initiation Study (clinicaltrials.gov) - P4; N=26; Completed; Sponsor: Indivior Inc.; N=49 ➔ 26

Clinical • Enrollment change

BioDelivery Sciences provides corporate update and reports second quarter 2015 financial results (PRNewswire) - "Nearly 14,000 prescriptions dispensed for BUNAVAIL during second quarter 2015; 27% increase over first quarter. BUNAVAIL prescriber base expanded to 1,728 physicians, with 684 new prescribers added during the second quarter....BELBUCA (buprenorphine HCl) buccal film for treatment of chronic pain: PDUFA date of October 23rd. Clonidine Topical Gel for treatment of painful diabetic neuropathy...New study planned to commence in the fourth quarter of this year with a budget of $3-5 million."

Anticipated new trial • Anticipated PDUFA date • Commercial • Pain

BioDelivery Sciences to present at the 6th Annual Credit Suisse Small & Mid Cap Conference and the Ladenburg Thalmann 2015 Healthcare Conference (PRNewswire) - "BioDelivery Sciences International...announced that the company will present at two upcoming healthcare conferences...BDSI will be discussing progress with the commercial launch of BUNAVAIL® (buprenorphine and naloxone buccal film), including the recently secured exclusive preferred formulary status with Tennessee Medicaid. Also discussed will be BELBUCA™ (Buprenorphine HCL buccal film)...The presentation will also provide an update on the status of Clonidine Topical Gel being studied for the treatment of painful diabetic neuropathy..."

Anticipated conference • Pain

BioDelivery Sciences provides business review and update in conjunction with filing of its 2013 annual report (PRNewswire) - "...anticipated third quarter 2014 launch of BUNAVAIL. Additionally, data from clinical studies of BUNAVAIL will be presented at the American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida. BEMA Buprenorphine for Chronic Pain. BDSI anticipates the second database lock from the Phase 3 trial for opioid experienced patients and subsequent $10 million milestone payment from Endo, to occur in mid-year 2014, and the potential filing of the NDA in late 2014 or early 2015. Clonidine Topical Gel for Painful Diabetic Neuropathy. A Phase 3 study will be initiated by the end of first quarter 2014 with the potential for interim data by year-end."

Anticipated clinical data • Anticipated financing • Anticipated launch US • Anticipated NDA • Anticipated new P3 trial • Pain

BioDelivery Sciences to present at the Rodman & Renshaw 18th Annual Global Investment Conference and the 7th Annual Credit Suisse Small and Mid Cap Conference (PRNewswire) - "Dr. Sirgo will discuss strategic initiatives supporting BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and the launch of BELBUCA™ (buprenorphine) buccal film (CIII) by BDSI's commercial partner, Endo Pharmaceuticals. Also covered will be an update on the development of Clonidine Topical Gel for painful diabetic neuropathy and the buprenorphine 30-day injection for opioid dependence and chronic pain."

Anticipated conference • Anticipated pipeline update • Demo Pain • Pain

BioDelivery Sciences to present at the Stifel 2016 Healthcare Conference (PRNewswire) - "Dr. Sirgo will discuss strategic initiatives supporting BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) and the launch of BELBUCA® (buprenorphine) buccal film (CIII) by BDSI's commercial partner, Endo Pharmaceuticals. Also covered will be an update on the development of Clonidine Topical Gel for painful diabetic neuropathy and the buprenorphine 30-day injection for opioid dependence and chronic pain."

Anticipated pipeline update • Demo Pain • Pain

BioDelivery on track for mid-year NDA filing (SeekingAlpha) - "BioDelivery Sciences...is on track to file a new drug application with the FDA this summer for its Bunavail treatment for opioid dependence... 'If all goes according to plan, in mid-2014, we should have an FDA decision on the approvability of Bunavail and be preparing a submission for an NDA on our chronic pain product, BEMA buprenorphine,'...He expects a launch of Bunavail in 2014 and BEMA buprenorphine for chronic pain in 2015."

Anticipated FDA event • Anticipated launch • Anticipated NDA • Pain

BioDelivery Sciences to present at the Stifel Nicolaus 2012 Healthcare Conference (PRNewswire) - Anticipated clinical and commercial update on BEMA buprenorphine/naloxone (BNX) and BEMA buprenorphine

Anticipated conference • Pain

BioDelivery Sciences to present at the 26th Annual ROTH Conference (PRNewswire) - "BioDelivery Sciences International...announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the 26th Annual ROTH Conference. The presentation is scheduled for Monday, March 10, 2014 at 8:00 a.m. Pacific Time...Dr. Sirgo will be providing an update on BUNAVAIL commercial options...with the ongoing Phase 3 clinical program for BEMA Buprenorphine for the treatment of chronic pain. The update will include the recently announced positive topline results from the Phase 3 clinical study of BEMA Buprenorphine in opioid naïve patients."

Anticipated conference • Pain

BioDelivery Sciences provides business update and summary of third quarter results of operations (PRNewswire) - "Based on the positive outcome of its pivotal PK study, BDSI anticipates it will submit an NDA to the FDA for BNX during the latter part of the second quarter of 2013...BDSI and Endo expect to continue recruitment in two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups. The opioid experienced trial is expected to be completed with data read out before the end of 2013 and the opioid naive trial by early 2014"

Anticipated NDA • Anticipated P3 data • Pain

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (clinicaltrials.gov) - P2; N=35; Completed; Sponsor: Paolo Mannelli; Recruiting -> Completed ; N=20 -> 35

Enrollment change • Trial completion • Biosimilar

Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers (clinicaltrials.gov) - P1; N=47; Completed; Sponsor: INSYS Therapeutics Inc; Recruiting ➔ Completed; N=24 ➔ 47

Enrollment change • Trial completion • Biosimilar

BioDelivery Sciences reports third quarter 2017 financial results and provides corporate update (PRNewswire) - "Total net revenue for BELBUCA and BUNAVAIL in the third quarter was $6.4 million and $1.7 million respectively, versus $6.6 million and $1.3 million in the second quarter of 2017. ....Net revenue for the nine months ended September 30, 2017, was approximately $49.5 million, compared to $11.6 million in the same period of 2016. Total net sales of BELBUCA and BUNAVAIL in the first nine months of 2017 were $17.6 million and $6.2 million, respectively....Opportunities for new managed care contracts for BUNAVAIL and BELBUCA in 2018"

Commercial • Addiction (Opioid and Alcohol) • CNS Disorders

BioDelivery Sciences: Investor Presentation (Biodelivery Sciences) - Anticipated approval for induction claim related to expanded labeling in Q3 2016

Anticipated regulatory • Pain

BioDelivery Sciences initiates confirmatory pharmacokinetic study of BEMA buprenorphine/naloxone compared to suboxone (PRNewswire) - NDA submission targeted for late 2012 or early 2013

Anticipated NDA submission • Pain

BioDelivery Sciences announces $40 million registered financing (Biodelivery Sciences) - "BioDelivery Sciences...has received definitive commitments from institutional investors (including existing investors of the company) for an at market registered direct financing yielding gross proceeds of $40 million to BDSI....Proceeds from this financing are expected to be used to fund completion of the Phase 3 clinical development program for BEMA Buprenorphine for chronic pain and progress BEMA Buprenorphine/Naloxone (BNX) for opioid dependence to the submission of a New Drug Application (NDA)"

Financing • Pain

BioDelivery Sciences provides business review and update in conjunction with filing of its 2012 annual report (PRNewswire) - "Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, BDSI anticipates it will submit a New Drug Application (NDA) to the FDA for BUNAVAIL in mid-2013...BDSI will continue to evaluate its strategic options for the commercialization of BUNAVAIL, which include partnership, internal approaches or a combination of these. BDSI expects to finalize its strategy in the second half of 2013."

Anticipated commercial • Anticipated NDA • Pain

BioDelivery Sciences announces submission of NDA for Bunavail (BDSI Press Release) - "BioDelivery Sciences...announced that yesterday it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence. Under the 505(b)(2) regulatory statute, BUNAVAIL will be subject to a ten month review."

NDA • Pain

US Patent Office institutes inter partes review brought by MonoSol Rx against all claims in key BDSI BEMA patent (GlobeNewswire) - "The...(USPTO) has granted MonoSol Rx, LLC's (MonoSol Rx) petition for inter partes review (IPR) of all claims of US Patent...('the '019 patent') and has instituted the IPR....Based on information provided by MonoSol Rx in its IPR petition, the USPTO's decision to institute the post-grant USPTO trial was based on the USPTO's agreement that MonoSol Rx established a reasonable likelihood that all of the claims in the '019 patent are invalid. The trial is now proceeding, with a final decision by the USPTO... expected by August 2015."

Corporate lawsuit • Pain

BioDelivery sciences announces results from phase 3 efficacy study for BEMA buprenorphine in chronic pain (PRNewswire) - P3, N=334; The primary endpoint of the study, overall pain intensity difference between BEMA buprenorphine & PBO, was not achieved, however BDSI believes that totality of study results favors BEMA buprenorphine; Company plans to initiate a second efficacy study in near future that will take approximately nine months to complete; BDSI further plans to initiate pivotal bioequivalence trial of other product BEMA buprenorphine/Naloxone by end of this year with data expected in Q1 '12

Anticipated initiation of additional P3 trials • Anticipated pivotal study initiation • Anticipated study results • P3 results • Pain

Bunavail- Market exclusivity expiry (Orange Book) - Market exclusivity expiry date listed in Orange Book as Jun 6, 2017

Commercial • Addiction (Opioid and Alcohol) • CNS Disorders

BioDelivery Sciences to present at the 25th Annual ROTH Conference (PRNewswire) - "BioDelivery Sciences...announced that Dr. Mark A. Sirgo , President and Chief Executive Officer of BDSI, will present at the 25th Annual ROTH Conference...Dr. Sirgo will focus on the development status, timeline and market opportunity for BEMA Buprenorphine/Naloxone (BNX), which BDSI recently announced will now be referred to by its brand name BUNAVAIL, for the management of opioid dependence. Additionally, Dr. Sirgo will discuss progress made by BDSI and its commercial partner, Endo Health Solutions, with the ongoing Phase 3 clinical program for BEMA Buprenorphine for the treatment of chronic pain."

Anticipated conference • Pain

The introduction of buprenorphine-naloxone film in opioid substitution therapy in Australia: Uptake and issues arising from changing buprenorphine formulations. (PubMed) - "The introduction of BNX film in Australia varied across States. A perception of restricted choice in medication may have undermined initial acceptance in SA.

Journal • Biosimilar • Pain

Biodelivery Sciences announces positive results supporting BEMA buprenorphine/naloxone formulation for opioid dependence (PRNewswire) - Reported positive preliminary P1 study result; Expect to initiate the pivotal bioequivalence trial in Dec 2011 with results expected during Q1 '12; NDA for BEMA buprenorphine/naloxone expected in H2 '12; Results of study demonstrated ability of BEMA formulation to meet key pharmacokinetic goal of delivering plasma concentrations of buprenorphine in range needed to treat opioid dependence while minimizing exposure of naloxone

Anticipated adjuvant study • Anticipated NDA submission • P1 data • Pain