Bausch’s Salix arms its GI salesforce with 2nd liver treatment in Dova co-promotion

Salix Pharmaceuticals continues to roll up partners in bid to broaden its reach. Its latest deal not only beefs up its own portfolio, but gives Dova Pharmaceuticals a co-promotional boost for its chronic liver disease drug Doptelet, which just won FDA approval.

The deal gives Dova access to Salix’s bigger sales force with established physician connections, while Salix gets another liver medicine to market to doctors. Salix’s Xifaxan, better known for its IBS-D indication, is also approved to treat hepatic encephalopathy, a complication of liver cirrhosis.

The GI arm of Bausch Health, Salix plans to deploy 100 of its gastroenterology sales reps already working in liver disease and add Doptelet by mid-October. Dova will continue its separate sales efforts, which specifically target hepatologists and interventional radiologists. Doptelet is approved to treat thrombocytopenia in adults with chronic liver disease who are scheduled for a medical or dental procedure.

Thrombocytopenia is a platelet deficiency that can increase risks for bleeding in chronic liver disease patients. Patients with CDL typically receive a platelet transfusion before procedures, but Doptelet is designed to circumvent that.

Mark McKenna, Salix’ senior VP and general manager, said adding first-in-class Doptelet makes Salix “more relevant to physicians.”

“Dova has started initial marketing efforts, and they’ll continue to own the marketing end of the collaboration; however, we’ll offer a lot of assistance in regard to day one access to physicians, and knowledge and know-how on the market access side, he said. “And on the medical side, to change the way physicians think about how they treat these patients.”

This summer, Salix struck a deal with US WorldMeds to co-promote its opioid withdrawal drug Lucemyra, boosting a pain medicine franchise built around opioid-induced constipation drug Relistor. It also announced in August a team-up with Cedars Sinai to research new therapies related to the gut microbiome. McKenna said the latter is a bid to invest in earlier-stage treatments to accelerate its pipeline.

While Bausch Health, formerly Valeant, once spent heavily to promote Xifaxan through direct-to-consumer ads, it lately has concentrated more on a sales-force drive. Beginning in 2016, it ramped up its sales force for both Xifaxan and Relistor, a big investment; those additional sales resources, along with increased promotional spending, cost more than $50 million in 2017, according to its most recent financial report. Those were “amounts well spent,” the report said, as sales increased 37% for Xifaxan and 48% for Relistor for the six months ended in June 2018 versus the same time period in 2017.

While Bausch Health doesn’t break out individual drug sales, Salix’ total sales for the first six months of 2018 were $863 million, a 25% increase from $688 million during the same period in 2017.

https://www.fiercepharma.com/marketing/salix-inks-deal-dova-for-2nd-liver-treatment-looks-to-development-and-research-deals-to

Biogen Neurology Presentations at Parkinson’s, Movement Disorders Meet

Biogen Inc. (Nasdaq: BIIB) announced it will present data from its movement disorders portfolio at the upcoming International Congress of Parkinson’sDisease and Movement Disorders (MDS) in Hong Kong (Oct. 5-9, 2018).

Data being presented are from Biogen’s research programs evaluating potential treatments for progressive supranuclear palsy (PSP) and Parkinson’s disease (PD) as part of its larger neurology pipeline.

‘The data being presented at MDS are a testament to Biogen’s commitment to its goal of delivering innovative therapies for people living with complex, neurodegenerative conditions like PSP and PD,’ said Kate Dawson, M.D., vice president of late-stage clinical development at Biogen. ‘PSP and PD both have significant unmet need, especially for disease modifying therapies, so we look forward to advancing the clinical development programs to help better understand these challenging conditions.’

Biogen PSP presentations will focus on safety data from the Phase 1 long-term extension study and baseline demographics from the Phase 2 PASSPORT study. The company’s BIIB092 program has recently met milestones, including recruitment completion for the Phase 2 PASSPORT study and fast track designation by the U.S. Food and Drug Administration for PSP. PSP is a rare neurodegenerative disease, considered to be a primary tauopathy, characterized by rapidly progressing physical impairments, such as difficulty speaking, swallowing and walking, as well as cognitive/behavioral impairments, such as apathy and dementia.

PD presentations will feature an overview of the design of the BIIB054 SPARK Phase 2 study, which is the most advanced program in Biogen’s PD pipeline. PD is the second most common neurodegenerative disease after Alzheimer’s disease. Motor symptoms of PD include bradykinesia, muscular rigidity, rest tremor and postural and gait impairment.1

https://www.marketscreener.com/BIOGEN-4853/news/BIOGEN-TO-PRESENT-DATA-FROM-ITS-NEUROLOGY-PIPELINE-AT-THE-2018-INTERNATIONAL-CONGRESS-OF-PARKINSON-27375480/

CymaBay: Additional Positive Results of Phase 2 Liver Disease Study

CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that two late-breaking presentations describing new long-term data from its ongoing Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC) will be featured on November 12, 2018 during The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, CA (November 9-13, 2018).

Seladelpar is an orally administered, potent and selective peroxisome proliferator-activated receptor delta (PPAR) agonist currently in development for PBC and nonalcoholic steatohepatitis (NASH).

The first presentation, abstract LB-3, titled ‘Efficacy and Safety of Seladelpar, a Selective Peroxisome Proliferator-Activated Receptor Delta Agonist, in Primary Biliary Cholangitis: 52-Week Analysis of an Ongoing International, Randomized, Dose Ranging Phase 2 Study’ will be delivered by Professor Chris Bowlus, MD, Division Chief of Gastroenterology and Hepatology, University of California at Davis Health. The 52-week analysis from this ongoing Phase 2 study may provide some insight into the primary efficacy outcome of the upcoming pivotal Phase 3 seladelpar PBC study. The Phase 3 primary efficacy outcome is a composite responder rate measured at 52 weeks that comprises an alkaline phosphatase

https://www.marketscreener.com/CYMABAY-THERAPEUTICS-INC-16725724/news/CymaBay-Therapeutics-Announces-Additional-Positive-Results-from-its-Ongoing-Phase-2-Study-of-Selad-27375488/

Omeros: Additional Positive Data for OMS721 in IgA Nephropathy

Omeros Corporation (NASDAQ: OMER) today announced positive data from the company’s ongoing Phase 2 clinical trial of OMS721 for the treatment of renal diseases.

The data are from study patients with immunoglobulin A (IgA) nephropathy, a progressively worsening kidney disease and the most common glomerulonephritis worldwide, responsible for 10 percent of all people on dialysis globally. Patients in this cohort had IgA nephropathy with high risk of progression but none received corticosteroid treatment immediately prior to or during the study – different than the cohort reported last year in which all patients initiated the study while on steroid therapy. Reductions in protein levels in urine collected over a 24-hour duration (the ‘gold-standard’ in assessing proteinuria) in this steroid-free OMS721-treated group were of similarly large magnitude to those seen in the earlier cohort. In IgA nephropathy, proteinuria is the most reliable prognostic factor for loss of kidney function – the greater the proteinuria reduction, the better the prognosis. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system’s lectin pathway. In addition to an ongoing Phase 3 clinical trial in IgA nephropathy, OMS721 is in Phase 3 clinical programs for hematopoietic stem cell-associated thrombotic microangiopathy (HSCT-TMA) and for atypical hemolytic uremic syndrome. OMS721 has been granted breakthrough therapy designations by FDA for both IgA nephropathy and HSCT-TMA.

‘We now have results of treatment with OMS721 in IgA nephropathy patients both with and without concomitant steroid therapy,’ stated Jonathan Barratt, Professor of Renal Medicine at the University of Leicester and Honorary Consultant Nephrologist at Leicester General Hospital. ‘In contrast to the previously reported cohort who were enrolled while on steroid therapy, the patients in this study were steroid-free, and yet the magnitude of proteinuria reduction across both groups is consistent and likely to indicate a significant renoprotective effect of OMS721 in IgAN, with a legacy effect again seen for months beyond cessation of OMS721 treatment. Notably, the current study’s patients are at very high risk of progressive renal disease and generally have long-standing, established disease with multiple comorbidities, representing a difficult-to-treat population. Despite that, almost all of the OMS721-treated patients responded to the first 12-week course of treatment. Collectively, these data further confirm the rationale for lectin pathway inhibition as a promising future option for the treatment of patients with IgAN.’

The current cohort study was designed to evaluate the safety and tolerability of once-weekly intravenous (IV) dosing of OMS721 and to describe the effect of the drug on 24-hour proteinuria in patients with IgA nephropathy. Twelve patients were enrolled. Per protocol, patients are required (i) to not receive corticosteroids during the study duration or for at least three months prior to screening and (ii) to be stable on an optimized dose of ACE inhibitors/ARBs (i.e., renin-angiotensin system [RAS] blockade) before enrollment. In a double-blind design, study patients were randomized 1:1 to receive either OMS721 or placebo for 12 weeks, and then both groups could receive extended OMS721 dosing at investigator discretion. Three patients were excluded from the analysis: two for unstable RAS blockade with at least a 50 percent change in dosing of RAS-blockade medication during the study, and one for untreated gastrointestinal disease that persisted throughout a substantial majority of the study duration. These conditions are known to affect proteinuria levels markedly, and results from these patients were determined by IgA nephropathy expert review to be unevaluable.

For the nine evaluable patients, median reductions in proteinuria following the initial 12-week course of treatment were 18.4 percent and 18.0 percent for the OMS721 and placebo groups, respectively. The one OMS721-treated patient whose proteinuria level remained elevated after the initial treatment course subsequently reached a 67.8-percent reduction from baseline following an additional course of OMS721 dosing.

After the initial 12-week treatment with OMS721 or placebo, all patients rolled into a dosing-extension period during which time a patient could receive, at investigator discretion, treatment with OMS721 if his/her respective 24-hour proteinuria level remained above 1 gram or the proteinuria response was less than a 50-percent reduction from baseline. Eight patients received OMS721 in this extension period, after either first receiving 12 weeks of OMS721 or placebo. Comparison with baseline of the proteinuria data after at least 18 weeks in the study (i.e., after the first course of OMS721 or placebo treatment and six-week follow-up) shows a median proteinuria reduction for this group of 55.7 percent. Four patients in this OMS721 dosing-extension period have reached between 9 and 12 months beyond baseline, and show reductions in proteinuria of 53.9 percent, 57.4 percent, 65.3 percent, and 67.8 percent. At most recent assessment, two of these four patients have continued to demonstrate sustained reductions in proteinuria for 2.5 and 5 months, respectively, after cessation of treatment with OMS721; the other two patients just recently completed treatment courses.

For the evaluable patients in the OMS721-treated and placebo groups, respectively, median ages at study start were 50 vs 33 years old; median time since diagnosis was 19 vs 9 years and median baseline proteinuria was 2.9 vs 2.5 g/day. Forty-four percent of these patients had nephrotic-range proteinuria at baseline, ranging from approximately 4.5 to 12 g/day, and most patients had multiple comorbidities.

Consistent with all other studies conducted with OMS721, the drug was well tolerated and no safety concerns were seen in this cohort of patients. Across all 12 patients, no treatment-related serious adverse events were observed, and most reported adverse events were mild or moderate.

The OMS721 treatment-extension period in this cohort study remains ongoing. Omeros plans to report additional data from this Phase 2 cohort at a future medical congress.

https://www.marketscreener.com/OMEROS-CORPORATION-5628248/news/Omeros-Corporation-Announces-Additional-Positive-Data-for-OMS721-in-IgA-Nephropathy-27375495/

Cytokinetics price target lowered to $21 from $24 at H.C. Wainwright

H.C. Wainwright analyst Joseph Pantginis lowered his price target on Cytokinetics shares to $21 from $24 after partner Astellas reported that both primary and secondary endpoints were not met in a trial of reldesemtiv in COPD patients and another trial testing reldesemtiv in elderly frailty was discontinued. However, omecamtiv drives the “lion’s share” of his valuation of Cytokinetics shares, said Pantginis. The analyst, who noted that the omecamtiv mecarbil pivotal
https://thefly.com/landingPageNews.php?id=2800479

Tweed, Uber, MADD Canada in national campaign on risks of driving when high

With the legalization of recreational cannabis coming to Canada in just over one week, Tweed, Uber, and MADD Canada are launching a national awareness campaign focused on informing Canadians on the risks of driving high.

On Wednesday, October 10, the advocacy partnership will be launched with an event inviting media for an early look at the education focused campaign, including its interactive features.

Tweed’s President and Co-CEO, Mark Zekulin, will unveil the campaign and media in attendance will also have the opportunity to discuss this new approach to informing Canadians about issues and perceptions around cannabis use and impaired driving.

Date: October 10, 2018 (Yes, one week before legalization.)

Time: 09:00 am ET – 10:30 am ET (We’ll have coffee and snacks don’t worry.)

Location: Artscape Sandbox, 301 Adelaide Street West, Toronto, ON (We’ll have lots to showcase at the venue.)

RSVP: If you’re planning on attending, please RSVP to Caitlin O’Hara by Tuesday, October 9, 2018.

ABOUT TWEED
Tweed is a globally recognized cannabis brand and subsidiary of Canopy Growth Corporation (TSX:WEED, NYSE:CGC). It has built a large and loyal following by focusing on quality products and meaningful customer relationships. Tweed doesn’t just sell cannabis, it facilitates a conversation about a product we’ve all heard about but haven’t met intimately yet. It is approachable and friendly, yet reliable and trusted. As cannabis laws liberalize around the world, Tweed will expand its leading Canadian position around the globe. Learn more at www.tweed.com.

ABOUT UBER CANADA
Co-founded by Calgarian entrepreneur Garrett Camp in 2009, Uber is evolving the way the world moves. Present in communities across Canada, Uber has revolutionized transportation and offers Canadian driver-partners a new way to earn income in their spare time by offering an affordable transportation alternative to riders across the country. For more information, visit uber.com.

ABOUT MADD CANADA
MADD Canada is a national, charitable organization that is committed to stopping impaired driving and supporting the victims of this violent crime. With volunteer-driven groups in more than 100 communities across Canada, MADD Canada aims to offer support services to victims, heighten awareness of the dangers of impaired driving and save lives and prevent injuries on our roads. To learn more, visit www.madd.ca.

https://www.biospace.com/article/releases/media-advisory-tweed-uber-and-madd-canada-to-launch-national-campaign-on-the-risks-of-driving-high/

Tilray Inc. Upsizes and Prices Offering of US$450 Million Convertible Senior Notes

Tilray Inc. (NASDAQ:TLRY), a global leader in cannabis research, cultivation, production and distribution, today announced the pricing of US$450 million aggregate principal amount of Convertible Senior Notes due 2023 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Any notes sold in Canada will only be sold to accredited investors pursuant to an exemption from the prospectus requirements of Canadian securities laws. Tilray also granted the initial purchasers of the notes an option to purchase up to an additional US$67.5 million aggregate principal amount of notes. The offering was upsized from the previously announced US$400 million aggregate principal amount.

The sale of the notes to the initial purchasers is expected to settle on October 10, 2018, subject to the satisfaction of customary closing conditions, and is expected to result in approximately US$435.0 million in net proceeds to Tilray (or approximately US$500.5 million if the initial purchasers exercise their option to purchase additional notes in full) after deducting the initial purchasers’ discount and estimated offering expenses payable by Tilray.

Tilray intends to use the net proceeds from this offering for working capital, future acquisitions and general corporate purposes, and to repay the approximately US$9.1 million existing mortgage related to its facility in Nanaimo, British Columbia.

The notes will be senior unsecured obligations of Tilray and will bear an interest at a rate of 5.00% per year, payable semiannually in arrears on April 1 and October 1 of each year, beginning on April 1, 2019. The notes will mature on October 1, 2023, unless earlier repurchased, redeemed or converted.

The initial conversion rate for the notes is 5.9735 shares of Class 2 common stock per US$1,000 principal amount of notes (which is equivalent to an initial conversion price of approximately US$167.41 per share). Conversions of the notes will be settled in cash, shares of Tilray’s Class 2 common stock or a combination thereof, at Tilray’s election. The initial conversion price represents a conversion premium of approximately 15% over the last reported sale price of US$145.57 per share of Tilray’s Class 2 common stock on the Nasdaq Global Select Market on October 4, 2018.

Prior to the close of business on the day immediately preceding April 1, 2023, the notes will be convertible at the option of the holders only upon the satisfaction of specified conditions and during certain periods. On and after April 1, 2023 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their notes at their option regardless of these conditions.

Holders may require Tilray to repurchase their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a cash purchase price equal to the principal amount thereof plus accrued and unpaid interest, if any.

Tilray may not redeem the notes prior to October 1, 2021. On or after October 1, 2021 and on or before the 30th scheduled trading day immediately before the maturity date, Tilray may redeem for cash all or part of the notes if the last reported sale price of Tilray’s Class 2 common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which Tilray provides a notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which Tilray provides notice of redemption. The redemption price for the notes will equal the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any.

Neither the notes, nor any shares of Tilray’s Class 2 common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, or qualified for distribution by prospectus in Canada, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws, or sold in Canada absent an exemption from the prospectus requirements of Canadian securities laws.

https://www.biospace.com/article/releases/tilray-inc-upsizes-and-prices-offering-of-us-450-million-convertible-senior-notes/