Aquavit Pharmaceuticals, Inc | March 22, 2022
Aquavit Pharmaceuticals, Inc continues to succeed in its intellectual property cases against counterfeiters both domestically and abroad.
Following a recent win against counterfeiter U-BioMed, Inc. across the European Union, the U.S. Southern District Court of New York adopted Judge Lehrburger's recommendations that any sanctions related to U-BioMed's deletion of its Instagram account, which blatantly exploited Aquavit's AQUAGOLD product illegally, be folded into the pre-existing sanctions requiring U-BioMed to pay Aquavit's reasonable legal fees and costs associated with the sanctions-related motions. The Court further reinforced Lehrburger's preview award ordering U-BioMed to pay attorney fees and costs to Aquavit in compensatory damages.
U-BioMed's continuous violation of the court's order in 2019 has to date accumulated the court's coercive sanction to millions of dollars.
"The depths to which counterfeiters have gone to exploit Aquavit's patented technology, confuse customers, and attempt to trick the legal system(s) is criminal, especially with FDA regulated medical devices. It is of the utmost importance that we protect our physicians from liability and misinformation and continue to keep our patients safe."
Sobin Chang, CEO of Aquavit
Aquavit's victorious claim against U-BioMed with the European Union Intellectual Property Office (EUIPO) has set a significant milestone. The court acknowledged that U-BioMed knowingly and intentionally filed an infringing trademark application with the EUIPO for the mark "AQUAGOLD Fine Touch".
"The counterfeits appear almost identical to the naked eye; however, they do not contain the microchannels as they claim and are often made of regular steel that are not biocompatible under the FDA's medical device material guidelines. Furthemore, they infringe on our 'repeated motion' drug delivery utility patent (U.S. Patent No . 10,980,865) for any drugs, components or biologics." says Dr. David Shafer, Aquavit's Chief Medical Technology Officer.
The EUIPO has declared U-BioMed's actions to be willful and done purposefully in an effort to confuse consumers with Aquavit's already existing AQUAGOLD products being sold globally. The EUIPO issued a cancellation of U-BioMed's infringing mark, upheld Aquavit's application for a declaration of invalidity, and held U-Biomed accountable for the legal costs in the European Union.
Aquavit is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech and medical device technologies. Aquavit focuses on personalized medicine to improv.
Alpha Cognition Inc. | February 23, 2022
Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI.
“These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.”
Denis Kay, the Company’s Chief Scientific Officer
In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison.
Compared to vehicle treatment, ALPHA-1062
Demonstrated statistically significant reduction in lesion size measured at 35 days after injury.
Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression.
Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment.
Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation.
Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.”
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options.
ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.
Ankura | March 09, 2022
Ankura Consulting, LLC a leading global expert services and advisory firm announced the expansion of its Pharmaceutical and Biopharma Regulatory Compliance offering with the addition of a Pharmaceutical Data Integrity solution within the Data and Technology practice, bolstering its comprehensive client advisory capabilities.
With this solution, Ankura has enhanced its team of experts to support pharmaceutical clients' compliance with the Data Integrity guidelines of multiple regulators through advanced digital technology. The offering includes Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, and import alert.
"In the endeavour to embrace industry 4.0, the pharmaceutical industry should explore giving up manual and fragmented means of managing compliance procedures and implement digital technologies in the quality control laboratories to proactively identify any data integrity (DI) gaps in real-time. EWS enables this transition and allows for early identification of any anomaly, falsification activities, and DI deviations from a regulatory compliance perspective,"
Amit Jaju, Senior Managing Director in Ankura's Data & Technology practice
The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organization.
"The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organizations to gain back the trust of regulators once breached. Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity," said Paul Walker, Senior Managing Director in Ankura's Data & Technology practice. In light of this, Ankura's Data Integrity investigation and remediation offering is a pivotal tool to support clients in performing comprehensive data integrity analysis using big data and advanced analytical approach on 100% of the data as compared to the sample manual review approach followed in the industry."
Ankura Consulting Group, LLC is an independent global expert services and advisory firm that delivers services and end-to-end solutions to help clients at critical inflection points related to change, risk, disputes, finance, performance, distress, and transformation. The Ankura team consists of more than 1,700 professionals serving 3000+ clients across 55 countries who are leaders in their respective fields and areas of expertise. Collaborative lateral thinking, hard-earned experience, expertise, and multidisciplinary capabilities drive results and Ankura is unrivaled in its ability to assist clients to Protect, Create and Recover Value.
Virpax® Pharmaceuticals, Inc. | December 29, 2021
Virpax® Pharmaceuticals, Inc. "Company" achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below.
“I believe that Virpax has made significant progress this past year toward our stated goalsThese accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022.
Anthony P. Mack, Chairman and CEO of Virpax
“Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope Technology delivery platform licensed from Nanomerics, Ltd. has enabled the development of product candidates for central nervous system and anti-viral indications. In the second half of 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter anti-viral product candidate formulated to prevent the spread of respiratory infections like influenza, SARS-CoV-2 and rhinovirus. We added VRP324 which is an intranasally delivered cannabidiol formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences as a part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver which we believe reduces drug-to-drug interaction concerns for treatments using this technology.
“On the corporate front, we strengthened our Board by appointing two new members adding expertise in commercialization and financial strategy. Additionally, in 2021 we raised approximately $58 million in aggregate gross proceeds from our initial public offering and an underwritten follow-on public offering. These funds are being used for research and development activities of our product candidates. We are on track to add accomplishments in 2022 and I remain confident that we have the significant financial strength to continue advancing our pipeline,” concluded Mr. Mack.
Epoladerm is a diclofenac topical spray film product candidate that is being developed for pain associated with osteoarthritis of the knee. Virpax recently reported successful results of a Charles River Laboratories single dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation observed. The maximum plasma concentration was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24-hour post-dose for all animals.
Upon completion of all the required IND enabling studies and subsequent review by the FDA, Virpax intends to conduct a Phase 1 study to evaluate the relative bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Altasciences Company, Inc., to conduct this study in Canada. Virpax anticipates enrollment of the first patient by early second quarter of 2022.
Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional pre-clinical trials are being conducted with Lipocure, the product developer, to improve the formulation to potentially enhance manufacturing efficiencies, prolong duration and extend patent protection. Once completed, we plan to perform seven preclinical animal studies as part of required FDA IND enabling trials.
Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. This product leverages Nanomeric’s MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal delivery enabling the enkephalin to permeate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS.
Virpax recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the research, development and manufacturing of Envelta. These contracts are to support Good Manufacturing Practices production of drug substance and drug product, as well as to support Good Laboratory Practices toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and has procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin, the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to promptly suppress pain.
AnQlar is a high-density intranasal molecular masking spray in development as an anti-viral OTC product for protection against respiratory infections, such as SARS-CoV-2 and influenza, that Virpax anticipates will be used as an adjuvant to barrier-based personal protective equipment. Virpax recently announced a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar.
Additionally, Virpax engaged Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in early 2022.
Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children and adults.
Under this agreement, Virpax has the global rights to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare CNS diseases considered serious epileptic encephalopathies that cause epileptic seizures, as well as cognitive and behavioral changes, and are generally resistant to treatment. Preclinical studies of VRP324 have been initiated by Nanomerics which it anticipates will be completed in the first quarter of 2022. Upon completion, Virpax will collaborate with RRD International, a clinical drug development company which Virpax has engaged, to prepare the pre-IND briefing documents for the FDA.
About Virpax Pharmaceuticals
Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.