FDA grants Sandoz approval for Ziextenzo in oncology care

PharmaTimes | November 06, 2019

The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this year. The drug is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The Novartis division revealed that the the FDA approval was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study. In the study, Sandoz pegfilgrastim and US-sourced reference pegfilgrastim were compared with Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.

Spotlight

The Legatum Institute, a London-based research institute released its 10th annual global Prosperity Index in November, a huge survey that ranks the most prosperous countries in the world. The organization compares 104 variables to come up with its list, splitting those variables into nine subindexes. One of the big components of the ranking is how healthy a country's people are.


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PHARMACY MARKET

Veneno Technologies, a Novel DRP Drug Discovery Company, Raises $2Million (¥200M Yen) in Seed Funding Round

Veneno Technologies Co. Ltd. | January 27, 2022

Veneno Technologies Co. Ltd. is pleased to announce that it has completed fundraising of 200 million yen through a third-party allocation of new shares to SBI Investment Co., Ltd., Tsukuba Institute of Research, Ltd., and SBI regional activation support Co., Ltd. The funds raised will be used to strengthen the recruitment and organizational structure, to further develop the Company's proprietary peptide drug discovery platform technology, and invest in the research and development of the Company's own drug discovery pipeline using DRP functional peptides as basic molecules to further promote DRP drug discovery. Objective of the Fund Procurement Veneno Suite™ is the Company's proprietary integrated DRP drug discovery technology. The Veneno Suite™ consists of a large gene library that is created by artificially accelerating the evolution of natural DRPs using them as templates, a screening system that enables the search for target DRPs from the library in a fast and efficient manner, and technology that enables the efficient production of various DRPs in a short period of time. With this funding, we will further refine these technologies and accelerate DRP drug discovery. Our mission is to contribute to the advancement of medicine by providing new drugs for targets such as membrane proteins that have been difficult to discover, and for intractable diseases related to these targets. In order to fulfill this mission, we will strengthen the following points through this fundraising. Appointment of high-level researchers and opening of new laboratories to advance DRP drug discovery. Expansion of the DRP focused library (DRP Space™). Strengthen and expand the pipeline of the DRP rapid search system (PERISS™) (promote joint research). Development of DRP manufacturing technology (Super Secrete™) including establishment of high-efficiency, low-volume, high-mix manufacturing technology. This funding will enable us to further refine our proprietary large-scale library, high-speed screening technology, and high-efficiency DRP manufacturing technology to accelerate our goal of DRP drug discovery. We expect that we will be able to take a concrete step toward the establishment of a new paradigm using DRP as a new drug discovery platform molecule following antibody drugs. Investor Comments Mr. Makoto Hasegawa, Manager, Investment Division, SBI Investment Co. noted, "Veneno Technologies has developed an innovative technology to turn functional peptides, called DRPs, into pharmaceuticals. We have decided to invest in Veneno Technologies because we see the potential in their technology and want to take on the challenge of developing new modalities together. We hope that our technology will lead to the development of many innovative new drugs in the future." "Veneno Technologies is a drug discovery venture that uses this technology to develop drugs that target ion channels, which remain untapped as drug targets." Mr. Masato Suzuki, Senior Researcher, Consulting Department, Tsukuba Research Institute, Inc About Veneno Technologies, Inc. Veneno Technologies was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. The company was established to accelerate the research and development of DRP functional peptides and to contribute to advanced and sustainable medicine and society. By integrating innovative DRP discovery technologies that have been researched for many years at the National Institute of Advanced Industrial Science and Technology (AIST) and DRP manufacturing technologies that are currently being researched and developed, we will lead the research and development of various DRP drug discovery technologies such as new drugs, research reagents, agrochemicals and biostimulants.

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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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PHARMA TECH

Aquavit Further Prevails Against Counterfeiters in U S Following its Recent Victory in Europe

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. About Aquavit 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.

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BUSINESS INSIGHTS

Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. | June 27, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function. “Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors (AChEIs, e.g., donepezil), and explore fosgonimeton’s effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. “The study was intended to show differences on the biomarker ERP P300 latency. This primary endpoint was not met by protocoled analysis, however a pre-specified subgroup analysis indicated a potential diminished effect of fosgonimeton when given in combination with AChEIs. A subsequent post hoc analysis of the data from patients on fosgonimeton monotherapy showed a meaningful improvement in both ERP P300 latency and cognitive performance compared to placebo at 26 weeks. “These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study,” Dr. Moebius “The data from the fosgonimeton monotherapy analysis are encouraging and show biologic activity that may support the potential role of the HGF/MET pathway in neurodegenerative diseases,” said Marwan Sabbagh, M.D., FAAN, professor of neurology at Barrow Neurological Institute, Phoenix, AZ. “ACT-AD adds to the body of literature suggesting ERP P300 latency as an important biomarker for cognitive status.”

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Spotlight

The Legatum Institute, a London-based research institute released its 10th annual global Prosperity Index in November, a huge survey that ranks the most prosperous countries in the world. The organization compares 104 variables to come up with its list, splitting those variables into nine subindexes. One of the big components of the ranking is how healthy a country's people are.

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