Connect with us

Technology

SIFI Receives European Commission Approval for AKANTIOR®

Published

on

AKANTIOR® (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis

CATANIA, Italy, Aug. 26, 2024 /PRNewswire/ — SIFI, a leading international ophthalmic company, today announced the European Commission has approved AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age, confirming the orphan status of the product. AKANTIOR is the first and only approved therapy for people suffering from AK in Europe. 

AK is an ultra-rare, severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. AK is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers.

“Today’s approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development,” said Fabrizio Chines, Chairman and CEO of SIFI. “For the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA.”

“AKANTIOR, when used as monotherapy with the trial’s treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease,” stated Professor John Dart, of Moorfields Eye Hospital and the UCL Institute of Ophthalmology, who was Principal Investigator of the Phase III ODAK trial. “After 15 years of research and effort development by SIFI, culminating in the pivotal Phase III clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis. This breakthrough offers significant improvement over current treatment options and has the potential to prevent blindness and save eyes. As the only approved therapy, it has been recommended for use with the detailed treatment delivery protocol used in the Phase 3 trial, which eliminates the need for the variable individualized treatment delivery currently used for patients, providing an effective standardized approach that can be followed by any clinician and which has been shown to be effective, not only in the Trial, but also in the current compassionate use program outside the more stringent Trial setting.”

“With the approval of AKANTIOR, AK patients (also known as AK Warriors) are now one step closer to having access to the best possible treatment in the EU. This milestone represents a significant step towards providing fair healthcare to all AK Warriors, giving them hope for a brighter future,” commented Juliette Vila Sinclair Spence, a rare disease patient advocate and the Chairwoman and Founder of AK Eye Foundation – the first global foundation dedicated exclusively to this condition.

In Europe, SIFI plans to initiate its first commercial launch in Germany during the last quarter this year, followed by additional markets based on local regulatory, healthcare technology assessment and reimbursement process timelines, including France, Italy, Romania, Spain, United Kingdom and Turkey addressing a total population of 430 million, and by Avanzanite, its commercial partner, in other European Countries addressing an additional population of 180 million. Based on scientific publications, the incidence of acanthamoeba keratitis is estimated at 1 to 4 patients per million inhabitants.

ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. The European Commission confirmed the orphan status of the product. The FDA granted SIFI Orphan Drug Designation for the treatment of acanthamoeba keratitis.

ABOUT Acanthamoeba Keratitis (AK): AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. 

ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research and development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people’s lives through meaningful innovation in eye care. SIFI exports to more than 40 countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at www.sifigroup.com.

View original content:https://www.prnewswire.co.uk/news-releases/sifi-receives-european-commission-approval-for-akantior-302229445.html

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

Hyundai Motor Group Announces 2024 Second Half Key Executive Appointments

Published

on

By

Jaehoon Chang is promoted to Vice Chair of Hyundai Motor Group – Automotive DivisionJosé Muñoz appointed as CEO of Hyundai Motor CompanySung Kim appointed as President of Hyundai Motor CompanyJun Young Choi is promoted to President of Kia Corporation; and Kyoo Bok Lee is promoted to President of Hyundai GlovisAppointment of new CEOs for the Group’s affiliates, including Cheol Seung Baek, Hyundai Transys; Joon Dong Oh, Hyundai KEFICO; Hanwoo Lee, Hyundai E&C; Woo Jeong Joo, Hyundai Engineering

SEOUL, South Korea, Nov. 14, 2024 /PRNewswire/ — Hyundai Motor Group (the Group) today announced key executive appointments for the year 2024 as part of its aims to solidify sustainable growth and better prepare for uncertainties in the global business environment.

This appointment reflects its commitment to a performance-based approach that aligns with outstanding achievements. By consolidating the Group’s core competencies and strategically placing proven leaders with verified track records in key positions, the Group aims to strengthen organizational foundations and accelerate our future transformation.

Jaehoon Chang is promoted to Vice Chair of Hyundai Motor Group – Automotive Division, effective Jan. 1st, 2025, to further strengthen the future competitiveness of the Group’s mobility business.

Looking ahead, Chang will oversee the entire value chain, including product planning, supply chain management manufacturing, and quality assessment. He will optimize business operations across the automotive business while securing internal synergies and building foundational systems for cost and quality innovation to ensure sustainable future competitiveness.

José Muñoz is appointed President and CEO of Hyundai Motor Company to advance global management framework and solidify customer-focused mobility innovation through diverse powertrain offerings, including electric, hybrid, ICE and hydrogen technologies, effective Jan. 1st, 2025.

As a result, Muñoz is appointed as the first non-Korean CEO of Hyundai Motor – identified as the ideal fit to further enhance the company’s performance thanks to his merit-based management philosophy and his commitment to recruiting top global talent. Going forward, he is expected to enhance the company’s global management systems and further elevate its stature as a leading global brand.

Sung Kim is appointed as President of Hyundai Motor Company to manage the business effectively through global economic uncertainties, effective Jan. 1st, 2025.

As part of his appointment to enhance the company’s Think Tank capabilities and better navigate various geopolitical challenges, Kim will oversee global external affairs, analyze and research domestic and international policy trends, and lead communications and PR initiatives. He will focus on increasing synergies across the company’s intelligence functions, strengthening external networking and advancing global protocol capabilities.

Jun Young Choi is promoted to President of Kia Corporation from Head of Domestic Production Division and Chief Safety Officer (CSO). Kyoo Bok Lee, CEO of Hyundai Glovis, is promoted to President.

To strengthen sustainable management and accelerate business transformation, the Group has appointed Cheol Seung Baek as CEO of Hyundai Transys and Joon Dong Oh as CEO of Hyundai KEFICO.

To address challenges in the construction industry and accelerate fundamental improvements, the Group has appointed Hanwoo Lee as CEO of Hyundai Engineering & Construction Co., Ltd. (Hyundai E&C) and Woo Jeong Joo as CEO of Hyundai Engineering Co., Ltd.

* Editor’s note: Appointment of all CEOs referenced are subject to approval by the relevant Group affiliate’s Board of Directors

About Hyundai Motor Group

Hyundai Motor Group is a global enterprise that has created a value chain based on mobility, steel, and construction, as well as logistics, finance, IT, and service. With about 250,000 employees worldwide, the Group’s mobility brands include Hyundai, Kia, and Genesis. Armed with creative thinking, cooperative communication and the will to take on any challenges, we strive to create a better future for all.

More information about Hyundai Motor Group can be found at:

http://www.hyundaimotorgroup.com or Newsroom: Media Hub by Hyundai, Kia Global Media Center (kianewscenter.com), Genesis Media Center.

SOURCE Hyundai Motor Group

Continue Reading

Technology

GreenPower Provides Business Update and Reports Second Quarter Fiscal 2025 Results

Published

on

By

Shareholder Call Scheduled for November 15, 2024 at 10 a.m. EST/7 a.m. PST

VANCOUVER, BC, Nov. 14, 2024 /PRNewswire/ — GreenPower Motor Company Inc. (Nasdaq: GP) (TSXV: GPV) (“GreenPower” and the “Company”), a leading manufacturer and distributor of all-electric, purpose-built, zero-emission medium and heavy-duty vehicles serving the cargo and delivery market, shuttle and transit space and school bus sector, today reported its second quarter fiscal year 2025 results and provided an update on its manufacturing operations.

“GreenPower spent the quarter advancing the school bus production process at its West Virginia facility by setting up an oversized paint booth and establishing production stations to increase throughput in order to meet customer orders and demands,” said GreenPower President Brendan Riley. “The increase in production coupled with manufacturing process improvements is expected to result in higher gross profit margins and cost reductions on a per unit basis as throughput improves.”

Riley said that the Company has been systematically increasing its production workforce to provide for its growing production. “Putting the workforce in place and validating the manufacturing process is key to our efficiency, and production growth which is expected to drive cost savings on a per unit basis. With these in place, GreenPower will be able to attain its longer-term manufacturing goal of producing 20 school buses per month,” he said, noting that steady, measured growth, a foundation of GreenPower’s model, is critical for maintaining quality throughout the production process.

“The growth in production complements GreenPower’s sales strategy of focusing on states where there are money and mandates for electric school buses,” added Fraser Atkinson, CEO of GreenPower. “While we continue to manufacture and sell EV school buses for current orders and contracts under both state and federal programs, the future is more focused on states that have put policies and plans in place to provide a cleaner, healthier ride for students through the deployment of electric school buses. States like California and New York, and regions like the Southwest.”

During the second quarter of GreenPower’s fiscal year 2025, the manufacturing process was exhibited when the Company produced the first Type D BEAST all-electric, purpose-built, zero-emission school bus for the 37 BEAST order from the state of West Virginia from its South Charleston plant, which was delivered at the beginning of our current quarter.  That was the second BEAST produced in the facility following the production of the Kanawha County bus purchased directly by the school district outside of the state order. Additional deliveries to fulfill the state order are planned to take place in the third and fourth quarters.

Second Quarter 2025 Highlights:

Generated revenues of $5.3 million for the three months ended September 30, 2024, an increase of 78% over the previous quarter.Delivered 11 BEAST Type D all-electric school buses, six EV Star Cargo and EV Star Cargo Plus and five EV Star Passenger Vans.Deferred revenue increased to $10.4 million, including the current portion of $7.5 million, which is expected to be realized over the next year.At the end of the quarter GreenPower had working capital of $10.1 million including inventory of $31.7 million consisting of $9.3 million of finished goods, $18.6 million of work-in-process and $3.8 million of parts and components.Received order for school buses under EPA’s Clean School Bus Program from the RWC Group for Arizona.

In October the Company completed an underwritten offering of 3,000,000 common shares raising gross proceeds of $3 million. The net proceeds from this offering are intended for the production of all-electric vehicles, including BEAST school buses and EV Star commercial vehicles, product development, with the remainder, if any, for general corporate purposes.  

For additional information on the results of operations for the periods ended September 30, 2024 review the interim financial statements and related reports posted on GreenPower’s website as well as on www.sedar.com or filed on EDGAR.

Shareholder Call Information

Date: Friday November 15, 2024 
Time: 7 a.m. PST/10 a.m. EST

Participant dial-in: (US) 1-844-739-3982 (Canada); 1-866-605-3852; (International) 1-412-317-5718. Ask to be joined into the GreenPower Motor Company Inc. conference call.

Webcast Link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=pVZ0NwpL

Replay: (US) 1-877-344-7529; (Canada) 1-855-669-9658; (International) 1-412-317-0088
Replay access code: 4413647

For further information contact:

Fraser Atkinson, CEO
(604) 220-8048

Brendan Riley, President
(510) 910-3377

Michael Sieffert, CFO
(604) 563-4144

About GreenPower Motor Company Inc.
GreenPower designs, builds and distributes a full suite of high-floor and low-floor all-electric medium and heavy-duty vehicles, including transit buses, school buses, shuttles, cargo van and a cab and chassis.  GreenPower employs a clean-sheet design to manufacture all-electric vehicles that are purpose built to be battery powered with zero emissions while integrating global suppliers for key components. This OEM platform allows GreenPower to meet the specifications of various operators while providing standard parts for ease of maintenance and accessibility for warranty requirements. GreenPower was founded in Vancouver, Canada with primary operational facilities in southern California. Listed on the Toronto exchange since November 2015, GreenPower completed its U.S. IPO and NASDAQ listing in August 2020. For further information go to www.greenpowermotor.com

Forward-Looking Statements
This document contains forward-looking statements relating to, among other things, GreenPower’s business and operations and the environment in which it operates, which are based on GreenPower’s operations, estimates, forecasts and projections. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “upon”, “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. A number of important factors including those set forth in other public filings (filed under the Company’s profile on www.sedar.com) could cause actual outcomes and results to differ materially from those expressed in these forward-looking statements. Consequently, readers should not place any undue reliance on such forward-looking statements. In addition, these forward-looking statements relate to the date on which they are made. GreenPower disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. All amounts in U.S. dollars. ©2024 GreenPower Motor Company Inc. All rights reserved.

View original content to download multimedia:https://www.prnewswire.com/news-releases/greenpower-provides-business-update-and-reports-second-quarter-fiscal-2025-results-302306496.html

SOURCE GreenPower Motor Company

Continue Reading

Technology

Announcing the Launch of “JPxData Portal (beta version)”, a Portal Site Comprehensively Covering Data Provided by JPX Group, etc.

Published

on

By

TOKYO, Nov. 14, 2024 /PRNewswire/ — The JPX Market Innovation & Research, Inc., a leading global provider of Japan’s financial market data, promptly began provision of “JPxData Portal (beta version)” (hereinafter referred to as “Website”), a portal site that comprehensively introduces data provided by Japan Exchange Group, Japan Exchange Group companies and partner companies (hereinafter referred to as “JPX Group, etc.”), as of August 2024.

What is JPxData Portal?
JPX Group, etc. currently provide over 200 types of data, which are used by a wide range of users, including investors, brokerage firms, and listed companies. However, JPXI received feedback that it is difficult for users to search through due to the overwhelmingly large amount of data and know what kind of data can be used for what. This feedback led us to the launch of Website providing users with easy access to data they seek and showing how to use the data.

“JPxData Portal” is named after “a data portal site of JPX Group, etc.” and “a place where “Japan (JP)” and “data(Data)” are combined” with the letter “x.” JPXI will aim to develop Website further to make it an easy-to-use site, where any data on the Japanese market are accessible in the future.

Click here for JPxData Portal (beta version): https://clientportal.jpx.co.jp/ClientPortalEN/s/

JPxData Portal Main Features
Product List

Users can search over 200 types of data by using simple keywords such as “stock price,” “derivatives,” “margin trading,” and “ESG.”Users can check the frequency and timing of updates, the period of historical data available, file formats (PDF, CSV, Excel, etc.), and if such data are provided via an API.For some data, sample data and articles on how to use them are also provided.

Use cases

Users can find articles introducing how to use data, including examples of analysis using the data, and the differences among similar data such as stock price data and issue master data with comparison of them.Users can discover related data from an article about data users initially searched for.

Company search

Users can check basic information, timely disclosure information, filing information, corporate governance, and other information about each issue.In addition to company names and codes, users can also search by using keywords such as “cloud” and “digital transformation” based on generative AI technology.The current list of listed issues is available for free download.

Disclosure search

Users can search TDnet disclosures published for the past one year*.
* The latest one is for two business days prior.Users can leverage browser machine translation easily for financial statements and other information disclosed in HTML format. An article on how to use browser’s machine translation features and detailed usage notes is also provided.English tags are attached to Japanese documents to facilitate primary extraction of information so that users easily search for information in English.

Useful links

Users can check a list of useful websites related to the securities market*.
* Currently, only websites managed by JPX Group or related companies are available.)

About JPX Market Innovation & Research
JPX Market Innovation & Research, Inc. (JPXI) was established as a subsidiary of Japan Exchange Group, Inc. (TOKYO:8697) in 2022. It consolidates JPX Group’s data/index services and system-related services, and leads further business enhancement of JPX Group by leveraging IT technologies and new business partnerships.

Contact
Frontier Development Department,
JPX Market Innovation & Research, Inc.
E-mail: inf_dev@jpx.co.jp
Inquiry form: https://clientportal.jpx.co.jp/ClientPortalEN/s/InquiryFormEn

View original content:https://www.prnewswire.com/news-releases/announcing-the-launch-of-jpxdata-portal-beta-version-a-portal-site-comprehensively-covering-data-provided-by-jpx-group-etc-302306517.html

SOURCE JPX Market Innovation & Research, Inc.

Continue Reading

Trending