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Daily Archives: January 15, 2021

Regulatory Expert Henrietta Ukwu, M.D. Appointed Novavax Chief Regulatory and Quality Officer

GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company’s development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

“Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We welcome her medical perspective and intricate knowledge of the regulatory process at this extraordinary time for the company and the race against the global pandemic.”

Dr. Ukwu most recently served as Chief Regulatory Officer and Global Head of Quality and Regulatory at Otsuka Pharmaceuticals. While there, she globalized and led the regulatory and quality organizations with a focus on compliance excellence, inspection readiness, engagement with health authorities and regulatory agencies and successful outcomes. Prior to Otsuka, she held senior leadership roles at PPD as Senior Vice President and Head of Global Regulatory Affairs, where she had responsibilities for regulatory services across all PPD lines of business; Wyeth Pharmaceuticals, Inc. (Pfizer), where she was Vice President, Regulatory Affairs, with responsibility that spanned vaccines, biologics and pharmaceuticals across all regions; and at Merck & Co., Inc., as Head of Vaccine Regulatory Development, Vice President of Global Regulatory Affairs and Global Regulatory Policy. Dr. Ukwu has led approval of many products, including for Varivax®, a chickenpox varicella vaccine, and Crixivan®, (indinavir), an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.

Dr. Ukwu’s significant contributions to medicine, science and the pharmaceutical industry include developing and enriching the regulatory and quality profession, as well as serving as a mentor to others who have progressed into senior leadership positions. These contributions have been recognized with numerous prestigious awards.

Dr. Ukwu earned her medical and surgical degrees from the University of Jos School of Medicine in Nigeria. She completed her residency in internal medicine at Baptist Hospital, and a fellowship in infectious diseases at Vanderbilt University, both in Nashville, Tennessee. She is a Fellow of both the American College of Physicians (FACP) and the Regulatory Affairs Professional Society (FRAPS) and is a pioneer professor at the Graduate School of Pharmacy at Temple University in Ambler, Pennsylvania.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should consider these risks and uncertainties.

Contacts:         
Investors
Erika Trahan
ir@novavax.com
240-268-2022

Media
Edna Kaplan
media@novavax.com
617-974-8659

Pacific Green Signs Battery Energy Storage System Strategic Manufacturing Framework Memorandum of Understanding with Shanghai Electric Gotion New Energy Technology CO., LTD.

DOVER, DE / ACCESSWIRE / January 14, 2021 / Pacific Green Technologies, Inc. (the “Company” or “PGTK,” (OTCQB:PGTK)) announces the signing of a Battery Energy Storage System Strategic Manufacturing Framework Agreement Memorandum of Understanding (the “Framework Agreement”) with Shanghai Electric Gotion New Energy Technology Co., Ltd. (“SEG”).

Under the terms of the Framework Agreement, the parties will work together towards the development of various lithium-ion Battery Energy Storage System (BESS) projects around the world. PGTK, through its wholly-owned subsidiary, Pacific Green Energy Storage Technologies, Inc., will manage each project’s overall execution, including system design, integration, and commercial optimization, while SEG will produce the battery technology as the equipment manufacturer.

Scott Poulter, PGTK’s Chief Executive, commented: “The BESS sector around the world is developing at an exponential rate and with the signing of this Framework Agreement, we have now combined PGTK’s existing capabilities following the acquisition of UK BESS technology company Innoergy Limited with SEG’s capacity, technology, and expertise, to ensure we can meet the demand in this rapidly expanding sector.”

James Gratton, Pacific Green Energy Storage Technologies, Inc.’s Technical Director, noted: “SEG has established itself as one of the largest and most reputable BESS technology integrators in the world, and with multiple certified production centers, we are confident that they have the capacity necessary to meet the needs of our project pipeline.”

Gareth Dauley, Vice President of Pacific Green Energy Storage Technologies, Inc., commented: “Lithium-ion batteries, which we have identified as best suited for our projects due to their high-energy density, safety track-record, and long service life, are the cornerstone of state-of-the-art BESS developments. This Framework Agreement will combine our existing experience and industry-knowledge with SEG’s long track-record of lithium-ion battery production to ensure commercially optimized and technologically bankable projects.”

SEG, which is a joint-venture between Shanghai Electric Group Co., Ltd. (“Shanghai Electric”) and Guoxuan High-tech Co., Ltd., operates among the largest and most advanced production and supply-chain management centers in the world. Shanghai Electric (SHA: 601727), which has 70,000 employees and over US$20b in operating revenue, provides a strong industrial backing and decades of experience in power equipment manufacturing and integration.

About Pacific Green Technologies, Inc.

Pacific Green Technologies, Inc. is focused on addressing the world’s need for cleaner and more sustainable energy. The Company offers BESS and Concentrated Solar Power (CSP) energy solutions to complement its marine environmental technologies and emissions control divisions.

For more information, visit PGTK’s website:
www.pacificgreentechnologies.com

About Shanghai Electric Gotion New Energy Technology Co., Ltd.

Shanghai Electric Gotion New Energy Technology Co., Ltd. is a joint-venture between Shanghai Electric Group Co., Ltd. and Guoxuan High-tech Co., Ltd. With multiple production facilities and a long-established history in technology manufacturing and supply-chain management, SEG is well-positioned to provide lithium-ion BESS technology around the world.

Notice Regarding Forward-Looking Statements:
This news release contains “forward-looking statements,” as that term is defined in Section 27A of the United States Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this news release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements include, among other things, the ongoing effects of the pandemic on delays and orders regarding PGTK’s technologies, potential business developments around the world, and future interest in our green technologies.

Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, general economic and political conditions, the continuation of the Framework Agreement with SEG, and the ongoing impact of the pandemic. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that the beliefs, plans, expectations, and intentions contained in this news release are reasonable, there can be no assurance that such beliefs, plans, expectations, or intentions will prove to be accurate. Investors should consult all the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q, and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

CONTACT:
Scott Poulter, Chairman & CEO
Pacific Green Technologies
T: +1 (302) 601-4659

SOURCE: Pacific Green Technologies, Inc.

 

Relay Medical and Glow LifeTech Report on Successful Phase II Clinical Results For COVID-19 Treatment Candidate Based On Its MyCell Technology™

  • Glow LifeTech has the exclusive rights for MyCell Technology™ in the United States, Canada and Mexico for one of the primary ingredients used in ArtemiC™, a COVID-19 Treatment Candidate with successful Phase II Clinical Results
  • The formulation statistically significantly improved the clinical recovery of COVID-19 patients in the treatment group in comparison with placebo and 100% of the patients in the treatment group fully recovered within 15 days
  • Positive results from a phase II double blind randomized controlled clinical trial show the MyCell Technology™ ArtemiC™ formulation, successfully met the primary and secondary endpoints for safety and efficacy1
  • ArtemiC™ is a natural anti-inflammatory formulation by Glow partner Swiss PharmaCan and MGC Pharma, intended to suppress cytokine storm and clinical deterioration prevention to support the recovery of COVID-19 patients
  • These results demonstrate the major health impact offered by MyCell Technology™ and open potential market opportunities for ArtemiC™, and it’s component MyCell ingredients to a wide range of diseases related to cytokine storm such as influenza, autoimmune diseases, inflammatory GI diseases and chemotherapy patients

TORONTO, Jan. 14, 2021 (GLOBE NEWSWIRE) — Relay Medical Corp. (“Relay” or the “Company”) (CSE: RELA, OTC: RYMDF, Frankfurt: EIY2), a developer of MedTech innovation, and Glow LifeTech Ltd. (“Glow”), a private company in which Relay holds a significant equity interest, are pleased to report on developments related to Glow’s MyCell Technology™ (“MyCell”).

Glow LifeTech partner Swiss Pharmacan AG, and MGC Pharma (“MGC”) have announced the full results of Phase II double-blind, placebo-controlled clinical trial for anti-inflammatory treatment ArtemiC™, powered by MyCell Technology™, on persons diagnosed with COVID-19, has successfully met all the Phase II primary and secondary endpoints and demonstrated to improve the clinical recovery of COVID-19 patients.

MGC has completed its phase II randomized controlled clinical trial on ArtemiC™ involving 50 patients and the results show ArtemiC™ statistically significantly improved the clinical recovery of COVID-19 patients in comparison with the Placebo Group. The results deliver a full safety and efficacy profile, demonstrating to improve and expedite the clinical recovery in moderate COVID-19 patients, with no drug-related adverse events. None of the patients supported by ArtemiC™ required additional oxygen, mechanical ventilation or intensive care, compared to 23.4% in the placebo group requiring further assistance. Full Trial results can be viewed at www.mgcpharma.com.au.

ArtemiC™ is a natural anti-inflammatory formulation by MGC Pharma, which is powered by Mycell Technology™, the same delivery system technology that Glow LifeTech has the exclusive North American (US, Canada, Mexico) license to manufacture, sell and market for cannabis and certain nutraceutical ingredients. The natural formulation, jointly developed by Glow partner Swiss PharmaCan, is based on four MyCell™ enhanced ingredients: Artemisinin, Curcumin, Vitamin c, and Boswellia Serrata, which are well-known natural active ingredients with anti-inflammatory properties. The formulation is intended to suppress the cytokine storm and clinical deterioration to support the recovery of COVID-19 patients. Glow LifeTech owns the exclusive rights for the sale, manufacturing and distribution of MyCell™ curcumin in the United States, Canada and Mexico.

“These are very exciting results for Glow’s MyCell Technology™ and the ArtemiC™ formulation. We are pleased that our innovative MyCell Technology™ is helping to power a natural formulation that shows promising ability to improve and expedite the recovery of COVID-19 patients. It demonstrates the long term potential of MyCell Technology™ to power next generation natural health products with science-backed efficacy and safety,” said Clark Kent, Chief Executive Officer, Glow LifeTech.

MGC completed its trial on ArtemiC™ on 50 COVID-19 infected patients across 3 independent hospital sites in Israel. The Trial met all the FDA requirements for a COVID-19 study. These results now open potential market opportunities for ArtemiC™ to a wide range of diseases related to cytokine storm such as influenza, autoimmune diseases, inflammatory GI diseases and chemotherapy patients.

Following the successful Phase II results, MGC plans to develop and commence a Phase III clinical trial in the first half of 2021. The Phase III trial is anticipated to be an international multicentre study to encompass a wide range of inflammatory indications for the use of ArtemiC™ as a treatment.

“Relay and Glow are critical partners of ours in commercializing MyCell Technology™ in North America and beyond. We look forward to building on our relationship as we roll-out breakthrough innovations like ArtemiC™. With Glow preparing to list on the CSE, they will positioned well to support our mission of bringing innovative health products to the market,” said Michel Fässler, Managing Director, Swiss PharmaCan AG.

On November 25, 2020 Glow Lifetech announced that it had received conditional approval to list its common shares on the Canadian Securities Exchange (“CSE”) pursuant to an amalgamation transaction with Ateba Resources Inc. Glow’s conditional approval to list its common shares on the CSE is subject to the completion of a financing raise of an additional $2.5 million and the completion of the amalgamation with Ateba.

Glow and Swiss PharmaCan have initiate a regulatory assessment to determine the best path forward for the commercialization of ArtemiC in North America.

SUBSCRIBE: For more information on Relay or to subscribe to the Company’s mail list visit: https://www.relaymedical.com/news

About Relay Medical Corp.
Relay Medical is a MedTech innovation Company headquartered in Toronto, Canada focused on the development of novel technologies in the diagnostics and AI data science sectors.

Website: www.relaymedical.com

About Glow LifeTech Ltd.
Glow LifeTech is a Canadian-based biotechnology company focused on producing nutraceutical and cannabinoid-based products with dramatically enhanced bioavailability, absorption and effectiveness. Glow has rights to the groundbreaking, plant-based MyCell Technology® delivery system, which transforms poorly absorbed natural compounds into enhanced water-compatible concentrates that unlock the full healing potential of the valuable compounds.

Website: www.glowlifetech.com

About Swiss PharmaCan AG/Micelle Technology AG
Micelle Technology AG, parent company of Swiss PharmaCan is a dynamic organization dedicated to R&D using natural active ingredients (i.e. vitamins and minerals) to improve human health. As one of the leading innovators of plant-based micelle concentrates, Micelle Technology AG offers a unique technology, which enables the company to harness the full potential of herbal active ingredients.

Website: www.swisspharmacan.ch

About MGC Pharmaceuticals Ltd.
MGC Pharma is a biopharma company with a “Nature to Medicine” strategy at the forefront of the emerging phytocannabinoid and plant derived medicine markets. The company’s mission is to build an innovative, global bio-pharma company providing standardised, affordable plant derived medicines of the highest regulatory compliance for targeted global markets.

Website: www.mgcpharma.com.au

Contact:
W. Clark Kent
President
Relay Medical Corp.
Office. 647-872-9982 ext. 2
TF. 1-844-247-6633 ext. 2
investor.relations@relaymedical.com

Bernhard Langer
EU Investor Relations
Office. +49 (0) 177 774 2314
Email: blanger@relaymedical.com

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the commercialization plans for the technology described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which filings are available at www.sedar.com

1 ArtemiC™ Full Trial Results: https://wcsecure.weblink.com.au/pdf/MXC/02322300.pdf

Police nab 11 allegedly involved in stealing catalytic converters

The police have arrested 11 members of a syndicate including the mastermind known as ‘Adik’, believed to be involved in stealing catalytic converters from vehicles around Melaka.

Melaka Tengah police chief ACP Afzanizar Ahmad said the suspects, comprising 10 men and a woman aged 23 to 43, were arrested in areas around Melaka, Johor and Selangor from Jan 5 to Jan 13.

He said the first round of arrests involved two men – including the 33-year-old Adik – as well as a woman in Johor on Jan 5, while three others were on the same day in Merlimau.

“Following the arrest, the police managed to arrest a man who acted as a middleman or a buyer of a catalytic converter that was stolen in Tanjung Kling on Jan 6,” he said adding that another four men were arrested in Selangor and Johor between Jan 7 and 13.

Afzanizar said the syndicate which targeted catalytic converters of continental vehicles believed to be processed to produce white gold abroad, had allegedly committed 11 such theft cases in the state since last November, involving losses of about RM30,000.

“The group’s leader, ‘Adik’ who is unemployed, has seven criminal records including six which are drug-related, and the suspect is believed to be using the money to purchase drugs,” he added.

Source: BERNAMA News Agency

Solar project: CIDB sues Jepak Holdings, to claim RM1.65 mln levy

— The Construction Industry Development Board (CIDB) has filed a lawsuit against Jepak Holdings Sdn Bhd to seek an order for the company to pay more than RM1.65 million in outstanding levy to CIDB involving a hybrid solar project for 369 rural schools in Sarawak.

The hybrid solar project is linked to a corruption case involving the wife of former prime minister, Datin Seri Rosmah Mansor who is being tried.

CIDB as the plaintiff filed the suit through Messrs. Hazura Yusoff & Partners on Dec 2, by naming Jepak Holdings as the sole defendant. The media obtained a copy of the document today through a search in e-filing.

According to the list of court cases, the case is set for online mention (e-Review) before High Court deputy registrar Maslinda Selamat on Jan 18.

In its statement of claim, CIDB said based on the provisions under the Malaysian Construction Industry Development Board (LPIPM) Act 1994, the plaintiff is entitled to impose a levy on any registered contractor before starting construction work with a total contract of RM500,000 and above, namely for a quarter per cent of the total contract price.

According to CIDB, on Nov 10, 2016, Jepak Holdings received the award appointment to carry out contract work known as “Proposed Implementation Through Direct Negotiations for Hybrid Photovoltaic (PV) Solar System Integrated Project and Maintenance and Operation of Diesel Gen-sets for 369 Sarawak Rural Schools” worth RM1.25 billion.

CIDB said, in accordance with the provisions of Section 34 (2) of the LPIPM Act and Regulations 7 and 10 of the Construction Industry (Levy Collection) Regulations 1996, the plaintiff issued a Levy Imposition Notification Form starting from June 12, 2019 for a total levy of RM1,656,250.00.

“Defendant has also declared the solar project to the plaintiff through an online system and as a result of the declaration, the plaintiff’s system has automatically generated a levy imposition form on the defendant.

“Therefore, the defendant is liable to pay to the plaintiff the amount of levy charged amounting to RM1,656,250.00 and the defendant’s failure to settle the whole or the balance of payment of the levy for the contract is an offence under the LPIPM Act,” according to CIDB in its statement of claim.

According to the plaintiff, a notice of claim dated Aug 16, 2019 was issued to the defendant to claim the payment of the outstanding levy amount which must be paid by the defendant to the plaintiff, but until now the defendant still failed to settle the payment of the levy.

Therefore, the plaintiff is demanding that the defendant pay the remaining outstanding levy amounting to RM1,656,250.00 as of Aug 16, 2019 with interest, costs and other relief as the court deems fit.

Source: BERNAMA News Agency

Vessel said to be centuries-old found in Lipis after floods

— The wreck of an old vessel said to be hundreds of years old was discovered at Sungai Lipis, near the Sungai Kampung Pagar Penjom suspension bridge in Kuala Lipis around 220 kilometres from here yesterday.

Lipis district police chief Supt Azli Mohd Noor said the vessel, made of wood and metal, was believed to have been revealed by the floods that hit the district on Jan 3, before receding almost a week later.

Azli said the police were informed of the discovery of the wreck by a villager at around 5 pm and a team was dispatched to the site to confirm the information.

“Initial investigations revealed that there was a metal object with the words VIVIA AND SONS SHEATING on the wreck. There were also 16 digits believed to be referring to the weight or density of copper.

“However, we are still waiting for the Malaysia Heritage Department to conduct further checks and for the time being, the area around the wreck is under police supervision,” he said, adding that there were several components on the wreck that were missing.

Based on police interviews with nearby residents, the components were believed to have been taken by some villagers.

He advised those who had done so to return the components immediately as it was an offence to keep heritage items under the National Heritage Act 2005.

“The act stipulates that any member of the public who discovers a heritage item should immediately report it to the relevant authorities and not take the component or any part of the item to keep or as a collection.

“Objects found after the act came into effect is also the absolute property of the federal government and compensation can be paid to the owner of the land if it was found on private land,” he said, adding that those who are believed to have damaged, deformed, disposed or alter heritage objects without permission can be arrested.

Source: BERNAMA News Agency

Man abducted, beaten by three men after failing to settle debt

— An unemployed man was abducted by three men and sustained serious injuries after being beaten for failing to settle a debt in an incident at a traffic light intersection of Jalan Sungai Nyior, Butterworth yesterday.

Seberang Prai Utara district police chief ACP Noorzainy Mohd Noor said the police received a report from a woman, 48, who witnessed the incident that occurred at 5.38 pm.

“According to the complainant, a man ran out of a Proton Wira shouting for help, before two other suspects came out of the vehicle and dragged the victim back into the car, which then accelerated away,” he said in a press conference here today.

He said based on the police report, the police conducted an investigation before raiding a flat in Mak Mandin at 11.30 pm and arrested three men involved in the incident.

The victim, 38, was saved during the raid and was found to have suffered serious injuries to the head and bruises all over his body from being beaten.

Noorzainy said investigations found the three men, aged 24 to 40, initially met the victim around Sungai Nyior at 5.30 pm because he promised to pay RM2,300 that he owed to one of the suspects’ wife.

The victim failed to withdraw any money when they were at the bank because there was no money in his account.

“The suspect got angry and took the victim in the car till they reached the intersection, at which the victim tried to escape. The 40-year-old suspect had just been released from prison three months ago and claimed that the victim had an affair with his wife, 32, who is an online trader,” he said.

The victim and the three men were acquaintances and police investigations revealed all possessed prior records relating to criminal and drug offences. They also tested positive for drugs.

He said the three men had been remanded for five days beginning today and the cause would be investigated under Section 367 of the Penal Code for kidnapping.

Source: BERNAMA News Agency