Wednesday, January 16, 2019
Adamis announces partner Sandoz’s U.S. launch of Symjepi
Adamis announces partner Sandoz’s U.S. launch of Symjepi Adamis Pharmaceuticals Corporation () announced that its marketing and commercial partner, Sandoz, a Novartis (NVS) division, has launched Symjepi 0.3 mg Injection in the U.S. market for the emergency treatment of allergic reactions, including anaphylaxis. Sandoz is launching this medicine as an affordable, single-dose, pre-filled syringe alternative to epinephrine auto-injectors. Symjepi will be rolled out via a phased launch and will initially be available in the institutional setting, an established channel where Sandoz has significant experience and knowledge, followed by introduction into the retail market.
https://thefly.com/landingPageNews.php?id=2849915
Accusation Ligand is lying to investors ‘simply false,’ STAT’s Feuerstein says
STAT’s Adam Feuerstein said in a series of tweets regarding a short report published earlier today about Ligand by Citron Research: “What I found most disappointing (and fundamentally dishonest) about Andrew’s work is the accusation that $LGND is lying to investors about its royalty-based business model…That’s simply false. There are few pharma companies that disclose more information about their business in a fully transparent manner than $LGND…Now, you may dislike $LGND royalty-based model or believe the company is over-valued. Nothing wrong there. But instead of making the bear case in a strong, fundamental way, @CitronResearch just screams “Fraud” with no substance…That’s sensationalism, not research.”
FDA advisors vote in favor of approval for Amgen’s Evenity
An FDA Advisory Committee voted that the overall benefit/risk profile of Amgen’s Evenity was acceptable to support approval, with 15 voting yes for Amgen’s proposed indication, 3 voting yes, but for a different indication, and 1 voting no, according to various press reports of the committee meeting.
https://thefly.com/landingPageNews.php?id=2849869
Neurocrine: New analysis of INGREZZA in Journal of Affective Disorders
Neurocrine announced that a new analysis of INGREZZA capsules, published in the Journal of Affective Disorders, demonstrated sustained improvement in tardive dyskinesia symptoms in patients with primary mood disorders. In the post-hoc analysis, INGREZZA significantly reduced involuntary movements associated with TD in patients with a primary mood disorder, such as bipolar and major depressive disorder, and was generally well tolerated with no clinically meaningful changes to psychiatric stability. INGREZZA is the first U.S. FDA approved treatment for adults with TD, a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts.
Anika Therapeutics to showcase Hyalofast at ICRS
Anika Therapeutics announced plans to showcase HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, at the 2019 International Cartilage Repair Society Summit. The 2019 ICRS Summit, which will be focused on Bio-Orthopaedics in Sports Medicine, will be held in San Diego, CA at the Hyatt Regency Mission Bay on January 17-18, 2019. At the 2019 ICRS Summit, Dr. Alberto Gobbi, world-renowned specialist in arthroscopic surgery, cartilage repair and regenerative medicine, will present findings from a 10-year follow-up study of patients treated with HYALOFAST HA scaffold with Bone Marrow Aspirate Concentrate in a one-step surgery. The session will also provide a comparative review of HYALOFAST in comparison to ACI, or Autologous Chondrocyte Implantation, and MACI, or Matrix Autologous Chondrocyte Implantation, two-step surgeries requiring cell cultivation.
United Neuroscience Positive Top-Line Results in Phase 2a Alzheimer’s Vax Study
United Neuroscience (UNS), a clinical-stage biotech company pioneering a new class of medicine to treat and prevent brain disorders, today announced positive top-line results from its Phase 2a clinical study of UB-311, a novel synthetic peptide vaccine targeting beta amyloid (Aβ) in the treatment of Alzheimer’s disease.
The top-line Phase 2a data met the primary aims of safety and immunogenicity with a 96% response rate. All secondary endpoints – including Amyloid PET burden, CDR-SB, ADCS-ADL, ADAS-Cog and MMSE – pointed directionally in favor of UB-311, though not statistically significant with the study sample size.
“The positive results show that we can safely raise and maintain anti-Aβ antibody titers in a predictable and sustained manner,” said Peter Powchik, Executive Vice President of Research and Development at UNS. “High response rates, reproducibility of response and generation of antibodies directed to relevant toxic protein species are key elements of an effective therapeutic vaccine for neurodegenerative conditions. The UNS platform is proving that it can deliver on these requirements.”
Chief Executive Officer Mei Mei Hu added, “These early results suggest a clinical response and support the continued and rapid development of UB-311. The intent of this Phase 2a study was to acquire directional information on the safety, tolerability and therapeutic potential of UB-311 in patients with Alzheimer’s disease. UNS is committed to transforming the lives of patients and families affected by Alzheimer’s by tackling the seemingly impossible and bringing an end to Alzheimer’s through a safe, effective and accessible active immunotherapy that can treat and ultimately prevent the disease.”
The Phase 2a double blinded, placebo-controlled study evaluated the safety and immunogenicity of prolonged dosing with two different dosing regimens of UB-311. Subjects from the completed Phase 2a study will roll over into a long-term extension study and will be offered continued treatment with UB-311.
Additional results, including future analysis of secondary endpoints and other data, are expected to be presented at upcoming medical meetings, such as the 14th International Conference on Alzheimer’s and Parkinson’s Diseases, and published in peer reviewed medical journals.
About UB-311 in Alzheimer’s Disease Active vaccination of human individuals against Aβ has yet to be safely and effectively achieved. Other active vaccine efforts have either reported low antibody titers and responder rates or significant safety issues such as T-cell mediated encephalitis. The most advanced Alzheimer’s vaccine in all clinical development, UB-311 is a novel UBITh™ active vaccine targeting the N-terminus of Aβ peptides and is designed to induce high B-cell specific responses while avoiding T-cell inflammation. In the Phase I study, UB-311 vaccination safely elevated anti-Aβ antibodies in all patients with a suggestion of cognitive stabilization.
Aspirin and N-Acetylcysteine as Adjunctive Treatments for Bipolar
Objective: Neuroinflammation has been implicated in the pathophysiology of bipolar disorder. Some evidence shows that nonsteroidal anti-inflammatory drugs (NSAIDs) have promising antidepressant effects. The antioxidant N-acetylcysteine (NAC) may enhance the effects of NSAIDs. No study has, however, tested the adjunctive therapeutic benefits of an NSAID and NAC in bipolar disorder.
Methods: The sample included 24 medicated patients diagnosed with DSM-IV-TR bipolar disorder who were aged 18–65 years and had a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20. Participants were randomly assigned to receive either aspirin (1,000 mg), NAC (1,000 mg), combined aspirin and NAC (1,000 mg each), or placebo. Data were collected between 2013 and 2017. The primary outcome was a ≥ 50% reduction in MADRS scores. Participants completed mood and global functioning questionnaires. They also underwent blood tests prior to and following 8 and 16 weeks of treatment. A Bayesian analytic method was adopted, and posterior probability distributions were calculated to determine the probability of treatment response.
Results: Following the first 8-week treatment phase, individuals on treatment with placebo and NAC + aspirin had a similar probability for successful treatment response (about 70%). Following a 16-week treatment period, NAC + aspirin was associated with higher probability of treatment response (67%) compared to placebo (55%), NAC (57%), and aspirin (33%). There was no treatment effect on interleukin-6 and C-reactive protein levels at either 8 or 16 weeks.
Conclusions: The coadministration of NAC and aspirin during a period of 16 weeks was associated with a reduction in depressive symptoms. The adverse effects were minimal. These preliminary findings may serve as a starting point for future studies assessing the efficacy, tolerability, and safety of anti-inflammatory and antioxidant agents in the treatment of bipolar depression.
Trial Registration: ClinicalTrials.gov identifier: NCT01797575
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