New treatments are offering hope for successfully treating Parkinson's disease. With more than 10 million people around the world living with it, with nearly a million living with it in the U.S., according to the Parkinson's Foundation, that's certainly welcome news. Potential treatments could also cut down on the multi-billion-dollar healthcare costs in the U.S. In fact, according to the Parkinson's Foundation, the "combined direct and indirect cost of Parkinson's, including treatment, social security payments and lost income, is estimated to be nearly $52 billion per year in the United States alone. Medications alone cost an average of $2,500 a year and therapeutic surgery can cost up to $100,000 per person." Some of the top companies racing to help treat Parkinson's, including XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF), Pfizer Inc. (NYSE:PFE), AstraZeneca PLC (NYSE:AZN), Biogen Inc. (NASDAQ:BIIB), and ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD).
XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF) BREAKING NEWS: XPhyto Therapeutics Corp.,a next generation bioscience company, announced an update on its transdermal delivery system for the neurologic drug Rotigotine.
Further to the Company's press release dated, June 8, 2020, regarding formula finalization, Vektor Pharma TF GmbH, a wholly owned German subsidiary of XPhyto, has now completed process implementation for the manufacture of its Rotigotine patches. With process implementation complete, clinical sample manufacturing and analytical work will commence in Vektor's EU GMP laboratory and manufacturing facility based in Baden-Württemberg, Germany. Human bioavailability studies in Europe are scheduled for Q3 2020 with results expected in Q4 2020. Updates to the Rotigotine drug delivery program will be provided periodically as it proceeds.
Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. Rotigotine, the active pharmaceutical ingredient, is a generic "off-patent" drug that is typically formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Global and European sales of Rotigotine patches in 2019 were approximately $500MM and $250MM CAD respectively.
"Our goal is the commercialization of a low-cost Rotigotine patch with superior bioavailability and adhesion properties," said Hugh Rogers, XPhyto's CEO. "Incorporating Rotigotine into Vektor's novel transdermal drug delivery system platform is a major accomplishment. With the formula locked and manufacturing soon to commence, we look forward to the upcoming clinical studies."
Other related developments from around the markets include:
Pfizer Inc. (NYSE:PFE) shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. The newly released manuscript describes key safety and immunogenicity data from the U.S. Phase 1 trial for the BNT162b2 vaccine candidate, which at30μg recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants. As previously announced, these data informed the companies' decision to advance a 2-dose regimen of the 30µg dose level of BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), into a Phase 2/3 evaluation. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, as compared to the BNT162b1 candidate, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein that is not contained in the BNT162b1 vaccine candidate.
AstraZeneca's (NYSE:AZN) Imfinzi (durvalumab) has been approved in Japan for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the Phase III CASPIAN trial, showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone.
Biogen Inc. (NASDAQ:BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer's disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer's disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes. "The FDA's acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer's disease," said Michel Vounatsos, Chief Executive Officer at Biogen. "We look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey. We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer's disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease."
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2020. "In the first half of 2020 we drove robust growth of NUPLAZID®. With the FDA filing of our sNDA for dementia-related psychosis we are one step closer to potentially delivering the first and only approved treatment for this devastating condition," said Steve Davis, ACADIA's Chief Executive Officer. "Building upon the successful development of our PDP and DRP programs, our clinical team is focused on advancing our innovative early- and late-stage pipeline."
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