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Monday, January 7, 2019

Sandoz, Pear Launch reSET-OTM to Help Treat Opioid Use Disorder in US


  • reSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic for patients with Opioid Use Disorder
  • Cleared by the FDA in December, reSET-O is available immediately
  • As part of a broader focus on digital healthcare solutions at Novartis, Sandoz aims to increase patient engagement and improve access to treatment through digital solutions
Sandoz Inc., a Novartis division, and Pear Therapeutics, Inc., announced today the US commercial launch of reSET-O(TM) for patients with Opioid Use Disorder (OUD). reSET-O, cleared by the US Food and Drug Administration (FDA) in December, is immediately available.
The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician.
“The launch of reSET-O provides an important technology-based treatment option for patients with Opioid Use Disorder and may fundamentally change how they interact with their therapies,” said Richard Francis, CEO, Sandoz. “At Sandoz, we are proud and excited to push the frontiers of medical innovation.”
“Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment,” said Corey McCann, M.D., Ph.D, President and CEO of Pear Therapeutics. “We believe prescription digital therapeutics can transform the way clinicians treat addiction by providing a way for patients to access treatment when and where it’s needed. reSET-O has been clinically proven to increase the likelihood that a patient will remain in treatment, while also providing a way for patients to access treatment anytime, anywhere, under clinician supervision.”
The efficacy of reSET-O was evaluated in a pivotal, randomized trial of 170 patients seeking treatment for OUD, who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of the Therapeutic Education System (TES), which had equivalent content to reSET-O. The clinical trial showed that reSET-O therapeutic content had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.
reSET-O also serves as a training, monitoring and reminder tool for healthcare providers by leveraging the Clinician Dashboard.  The dashboard helps clinicians gain deeper insights into their patients’ progress toward recovery, including patient-reported buprenorphine adherence to allow for more transparency during in-person therapy sessions.
When a healthcare provider prescribes reSET-O, the patient is contacted by a patient care specialist and is provided with an access code. The patient then downloads and installs reSET-O on their smartphone or tablet and enters the access code to unlock treatment. After that, the patient can begin working and learning with reSET-O by completing lessons, answering quiz questions, reporting medication usage and reporting substance use, cravings and triggers. All the while, the patient continues to see the clinician in therapy sessions and progress on reSET-O is tracked via the Clinician Dashboard.
Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET®*, Pear’s prescription digital therapeutics for the treatment of Substance Use Disorder and Opioid Use Disorder, respectively. Sandoz launched reSET in November 2018 and now has made reSET-O available to patients in the U.S.
High attrition and relapse rates represent a significant obstacle to providing care to patients with OUD. Therefore, it is important to retain patients in treatment. Retention in treatment is a well-established indicator of successful treatment outcomes for OUD patientsi. The study data demonstrate that reSET-O significantly improved OUD patient retention rates in outpatient treatment.
For more information about reSET-O, go to http://www.resetforrecovery.com. To help patients get started with reSET-O, call 1-833-MY-RESET (1-833-697-3738) Monday-Friday, 8am-6pm ET or go to www.resetconnect.com.
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Spero Licenses Everest to Develop Med in Asia, Initiates Phase 1 Trial


Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections, and Everest Medicines announced today that they have entered into a collaboration to develop, manufacture and commercialize SPR206 in Greater China, South Korea and certain Southeast Asian countries (the “Territory”), along with an exclusive option to rights to SPR741 in the Territory.
SPR206 and SPR741, two intravenous (IV)-administered product candidates from Spero’s Potentiator Platform, are being developed as innovative options to treat MDR Gram-negative bacterial infections.  Based on microbiological and in vivo testing, Spero believes that SPR206 has the potential to offer a broad-spectrum of activity, including against extensively drug-resistant (XDR) bacterial strains, together with improved safety and tolerability compared with other molecules in its class. Spero initiated a Phase 1 clinical trial of SPR206 in December 2018, designed as a double-blind, placebo-controlled, ascending dose, multi-cohort study in healthy subjects, and expects top-line data from this trial in the second half of 2019.  Data from investigational new drug (IND)-enabling studies, together with data presented at the ESCMID/ASM Conference in September 2018, collectively demonstrate SPR206’s favorable safety profile and in vitroactivity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa. SPR741 is a novel compound designed to expand the spectrum and enhance the potency of existing antibiotics.  SPR741 completed a Phase 1b drug-drug interaction clinical trial in July 2018, which demonstrated safety and pharmacokinetic compatibility of SPR741 when co-administered with beta-lactam antibiotics.
Spero, through certain of its wholly owned subsidiaries, has granted Everest an exclusive license to develop, manufacture, and commercialize SPR206 in the Territory.  Everest also has a 12-month exclusive option to rights to SPR741 in the Territory.  A Joint Development Committee will be established between the companies to coordinate and review the development, manufacturing and commercialization plans with respect to SPR206 in the Territory. Spero will receive an upfront payment of $2 million and is eligible to receive milestone payments of up to an additional $59.5 million upon achievement of specified clinical, regulatory and commercial milestones related to SPR206, of which Spero anticipates receiving at least $2 million in near-term milestones during 2019. Furthermore, Spero will be eligible to receive high single-digit to low double-digit royalties on any sales of SPR206 products in the Territory following regulatory approval.  Everest will also pay Spero a $1 million upfront fee for its exclusive 12-month option to rights to SPR741.
“We look forward to working with Everest Medicines to further develop and bring SPR206 to market in Greater China, South Korea and Southeast Asia in an effort to address the growing, global problem of antibiotic resistance,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “Everest shares our passion and commitment to developing these important, novel medications. Having a local partner who understands the market dynamics and reimbursement landscape will significantly assist Spero’s efforts to develop and commercialize these product candidates in Asia.  Additionally, funding from this transaction will provide additional resources to advance our robust pipeline of products that address unmet medical needs.”
“Bacterial drug resistance is a critical health issue and innovative new classes of antibiotics is an area of urgent unmet need,” said Sean Cao, Interim CEO at Everest Medicines. “We partner with companies that develop innovative medicines and have large commercial potential in Asia. Development of safer polymyxins with a broad spectrum of antimicrobial activity including extensively resistant bacteria may provide a life-saving treatment to patients with limited or no alternative treatment options.”
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Canopy Growth: Rivers Announces $80 Million Bank Debt Facility at PharmHouse

Canopy Rivers Inc. (“Canopy Rivers” or the “Company”) (TSXV: RIV) today announced that its 49%-owned joint venture PharmHouse Inc. (“PharmHouse”) has entered into a syndicated credit facility (the “Credit Facility”) with the Bank of Montreal (“BMO”), as agent and lead lender, and with Canadian Imperial Bank of Commerce and Concentra Bank as lenders (together with BMO, the “Lenders”). Under the terms of the Credit Facility, the Lenders will provide PharmHouse up to C$80 million of secured debt financing at a rate of interest that is expected to average in the mid-to-high 5% per annum range over its three-year term.
“We are proud to be entering the new year with a significant financial development for PharmHouse, a joint venture we consider well-positioned to pursue the increasingly global cannabis opportunity. Having secured what we believe to be the largest bank debt to a private company in the cannabis industry, one that is supported by a syndicate of three Schedule I banks, PharmHouse has gained substantial momentum,” said Bruce Linton, Chairman and Chief Executive Officer of Canopy Rivers. “We believe the commitment made by these leading Canadian financial institutions demonstrates confidence in PharmHouse and sheds meaningful light on the quality of the infrastructure, the level of expertise of the joint venture partners, and the anticipated significant near-term cash flow of this platform,” continued Linton.
The Credit Facility will be used to finalize the acquisition of the 1.3 million square foot modern greenhouse facility and further fund necessary project equipment and ongoing construction costs as the production and distribution platform ramps up. The Credit Facility is being secured by the Company and its wholly-owned subsidiary, Canopy Rivers Corporation, and contains customary financial and restrictive covenants. Additional details on the Credit Facility can be found in the Company’s documents, which will be filed under the Company’s profile on SEDAR at http://www.sedar.com.
“Closing this credit facility is a major milestone for both PharmHouse and Canopy Rivers,” said Eddie Lucarelli, Chief Financial Officer of Canopy Rivers. “This strategic and non-dilutive financing is a testament to the dedication of our team in identifying and optimizing the most attractive sources of capital at both the portfolio partner and corporate levels.”
The PharmHouse joint venture operates out of an ultramodern greenhouse facility in Leamington, Ontario, constructed in 2017 using the latest in commercial agriculture technology and featuring state-of-the-art automation systems. PharmHouse has already secured multiple offtake agreements, with purchase orders in place for an aggregate 30% of the production capacity upon licensing.
Canopy Rivers and its PharmHouse joint venture partner, a company formed by the leading principals and operators of a North American agriculture conglomerate, seek to leverage their relationship networks and respective strengths in cannabis, global commercial agriculture, marketing, and distribution to pursue regulated cannabis opportunities together on a global scale. The Leamington facility represents the first stage of a planned global strategic relationship between the joint venture partners.
“With $140 million of fully funded capital, modern infrastructure that is being converted for cannabis cultivation, and operators with tier one agriculture and distribution expertise, we believe this initial platform will produce a significant amount of cannabis for distribution within the Canopy Rivers ecosystem and beyond,” said Olivier Dufourmantelle, Chief Operating Officer at Canopy Rivers and a director of PharmHouse. “The development of the PharmHouse platform has been on time and on budget. As economic activity and regulatory reform continues in North America and in new jurisdictions globally, we look forward to building on this success and leveraging the benefits of our global cannabis exclusivity with our joint venture partners,” continued Dufourmantelle.
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Meridian Bioscience sees Q1 revenue $51M-51.5M, consensus $53.5M


https://thefly.com/landingPageNews.php?id=2845031
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Diplomat downgraded to Market Perform from Outperform at William Blair


https://thefly.com/landingPageNews.php?id=2844939
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Sarepta’s ‘unfounded’ weakness a buying opportunity, says RBC Capital


RBC Capital analyst Brian Abrahams believes there has been some confusion coming out of an investor presentation this morning on Sarepta’s limb girdle muscular dystrophy data and on the regulatory path for microdystrophin gene therapy. After talking with the company, he believes timelines and prospects for both remain intact, views the weakness as “‘unfounded” and would use the pullback today as a buying opportunity. Abrahams maintains an Outperform rating on Sarepta shares.
https://thefly.com/landingPageNews.php?id=2844941
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Syndax initiated at B. Riley FBR


Syndax resumed with a Buy at B. Riley FBR. B. Riley FBR analyst Polishetty resumed coverage on Syndax with a Buy and $40 price target.
https://thefly.com/landingPageNews.php?id=2844949
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