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Thursday, January 2, 2020

Adamas settles Gocovri patent dispute with Sandoz

Adamas Pharmaceuticals (ADMS +5.5%) has settled its patent infringement litigation with Novartis’ (NVS +0.1%) Sandoz unit related to Parkinson’s disease dyskinesia med Gocovri (amantadine).
Sandoz will be allowed to launch its generic version on March 4, 2030 or earlier under certain circumstances.

INmune Bio up on potential of lead candidate in Alzheimer’s

Thinly traded nano cap INmune Bio (INMB +3.9%) perks up on 50% higher volume, a modest 29K shares, on the heels of positive data on lead candidate XPro1595, a protein biologic that it says has the potential to lower the risk of Alzheimer’s disease (AD) in obese people.
Results from the study, published in Alzheimer’s Research & Therapy, showed that XPro1595 blocked soluble tumor necrosis factor signaling-dependent pathways in mice fed a high-fat high-carb diet for 14 weeks.
The company says such diets raise the risk of neurodegenerative disorders like AD via their effects on insulin signaling and immune-metabolic interactions, increasing inflammation in the brain. XPro1595 is an anti-inflammatory agent that can cross the blood-brain barrier.
An Australia-based 18-subject Phase 1 study in patients with mild-to-moderate AD who have biomarkers of neuroinflammation has been initiated.

New insulin affordability options from Novo now available in U.S.

Novo Nordisk (NVO +0.4%launches its My$99Insulin Program, generic insulin brands and an Immediate Supply option for U.S. diabetes patients.
My$99Insulin provides up to three vials or two packs of FlexPen/FlexTouch/PenFill pens of any combination of Novo insulins.
Generic offerings and wholesale prices per package: Insulin Aspart vial ($144.68), Insulin Aspart PenFill cartridge – 5×3 mL ($268.73), Insulin Aspart FlexPen – 5×3 mL ($279.41), Insulin Aspart Mix 70/30 10 mL vial ($150.06) and Insulin Aspart 70/30 FlexPen – 5.3 mL ($279.41).
Potential for immediate shipment of up to three vials or two packs of pens at no-charge under Immediate Supply option for patients with a prescription.
Related tickers: Sanofi (SNY +0.7%), Eli Lilly (LLY -0.1%)

Select Medical ups stake in Concentra to 65%

Select Medical Holdings (SEM -1.9%) has agreed to purchase ~17.2% of the outstanding ownership interests in joint venture subsidiary Concentra held by other investors for ~$338.4M, raising its ownership stake to ~65.2%.

Durect’s DUR-928 flunks psoriasis study; shares down

DURECT (DRRX -31.8%) slumps on more than double normal volume in early trade in reaction to unsuccessful results from a Phase 2a clinical trial evaluating a topical formulation of DUR-928 in 22 patients with mild-to-moderate plaque psoriasis.
DUR-928 failed to demonstrate a treatment effect compared to placebo as measured by a scale called IGA (primary endpoint). All secondary endpoints were missed as well.
On a positive note, DUR-928 was safe and well-tolerated.
The company has terminated development for the indication.
Development is ongoing for oral formulations in alcoholic hepatitis and primary sclerosing cholangitis.

MediWound +10% premarket on distribution deal for NexoBrid

MediWound (NASDAQ:MDWD) is up 10% premarket on signing a distribution agreement granting Balance Medical Pty Ltd. the exclusive rights to market and distribute NexoBrid in Australia, New Zealand and Singapore for the treatment of severe burns.
Commercialization of NexoBrid in these territories will commence after receipt of the respective local regulatory authorities approval, which is expected within two years.
NexoBrid is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns, which is approved in the European Union and other international markets.

Opiant inks collaboration deal to develop OPNT004 for acute cannabinoid overdose

Opiant Pharmaceuticals (NASDAQ:OPNT) has signed a Letter of Intent with NIH’s National Center for Advancing Translational Sciences (NCATS) to collaborate on the development of OPNT004 (drinabant) for the treatment of acute cannabinoid overdose (ACO).
The company in-licensed exclusive global rights to the candidate for ACO from Sanofi in December 2018. The latter is responsible for manufacturing under an expanded agreement inked in July 2019.
ACO, accounting for an estimated 1M emergency room visits last year, is most often linked to the ingestion of edible products containing large amounts of THC. Symptoms include panic and anxiety, feelings of paranoia, agitation, visual and auditory hallucinations, and nausea.