Novotech Presented with Cell & Gene Excellence Award 2022 at 6th Cell & Gene Therapy World Asia Conference

SYDNEY, AU, Sep 15, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Cell & Gene Therapy Clinical Trials award at the 6th Cell & Gene Therapy World Asia 2022 conference.



Novotech has extensive experience in cell & gene therapy clinical trials across Asia Pacific. The Asia Pacific accounts for over a third of cell & gene therapy trial activity with China being the leading location in APAC. In addition, APAC has nearly a 50% faster growth rate in cell & gene therapy trials than ROW. Blood cancers (ALL, NHL, DLBCL, lymphomas), solid tumors, viral infections, liver and gastrointestinal tract cancers are the top indications in China-based cell & gene therapy trials between 2016 and 2021.

Watch our recent Endpoints News webinar for more information:
EVOLUTION OF CELL & GENE THERAPY IN CHINA: THE CASE FOR UNIVERSAL CAR-T
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The award was presented to Novotech during the 6th Cell & Gene Therapy World Asia 2022 conference (14th – 15th September) at the Sheraton Towers, Singapore.

Novotech CEO Dr. John Moller said, "We are extremely pleased our team has been recognized with this prestigious award at the 6th Cell & Gene Therapy World Asia 2022 conference. Cell & gene therapy is driving recent innovations in biotech and it is an honour to be recognized as the CRO at the forefront in Asia-Pacific supporting this vital clinical research. Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships – which also translates to patent access – our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success."

Novotech has recently also been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.

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EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5
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About Novotech

Novotech is the leading Asia-Pacific centered, globally capable, biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Indonesia’s Bio Farma ready to produce ‘IndoVac’ Covid-19 vaccines

BANDUNG, INDONESIA, Sep 12, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in manufacturing IndoVac, its Covid-19 vaccines brand, including primary series vaccines, booster vaccines and vaccines for children, in development since November 2021.


IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)


Honesti Baasyir, President Director of Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

According to Honesti, "IndoVac uses vaccine technology platforms which are compatible with our equipment and facilities. The technology platforms for protein recombinant vaccines also offer other benefits; they can be adapted to new strains of Covid-19.

"Results from primary series Phase 1 and Phase 2 clinical trials show that IndoVac vaccines offer quality safety and efficacy, no less competitive than other Covid-19 vaccines. Now we are completing documentation to wrap up Phase 3."

Honesti said Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July to provide necessary Phase 3 primary series data, so the BPOM can release an Emergency Use Authorization (EUA) permit for the vaccine. The EUA is the permit for medical supplies, including vaccines and medications, used during a public health emergency.

In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country. BPOM's head Penny K. Lukito, during a hearing at the Indonesian House of Representatives, said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September.

Shariah Compliance

Bio Farma has also processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccine. The vaccine has passed an audit by The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product. The certificate from the Halal Certification Agency (BPJPH) of the Religious Affairs Ministry is expected to be released soon after the BPOM EUA for IndoVac.

After securing all the necessary permits, Bio Farma will be ready to move on to the next stage, mass production of the vaccine. Bio Farma plans to produce an initial 20 million doses of primary series vaccine this year, which will be further increased to 40 million doses in 2023, as the company expands its production facilities. In 2024, production may further increase to 100 million doses per year, depending on demand and the market.

Booster Vaccine and Vaccine for Children

Bio Farma also started clinical trials for its booster vaccine on September 1. Bio Farma conducted the trials for its booster vaccine at Hasan Sadikin General Hospital in Bandung (Faculty of Medicine, Padjajaran University) and Dr I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Dept, Udayana University). Trials involved 900 subjects aged 8 and above to test the booster vaccines. Next, the company plans to conduct clinical trials for children, following registration with the BPOM.

All Covid-19 vaccines made by Bio Farma, including the primary series vaccines, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.

President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said.

Made-in-Indonesia Vaccines

Honesti said IndoVac is special, as one of the few made-in-Indonesia vaccine products, developed and manufactured for the nation's children. Bio Farma handles the manufacturing process from upstream to downstream. The locally sourced content in the IndoVac vaccines, according to Bio Farma, will be around 80%.

"This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines," Honesti said.

Bio Farma hopes to capture the export market with its IndoVac vaccines. "We will not only produce them to meet domestic needs, but for the supply of global markets," said Honesti. "We registered for EUL with the World Health Organization (WHO), so the vaccine can be used in other countries through Covax Facility multilateral procurement. (The EUL assesses and lists vaccines during emergencies in non-vaccine-producing countries.)

"With our Covid-19 vaccines, we hope to contribute to the health industry, not just in Indonesia, but in the world," said Honesti.

For Bio Farma, it is not the first experience with clinical trials, having conducted more than 30 clinical trials (including Covid-19) in Indonesia. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).

Bio Farma's Success in Polio Vaccine

Honesti said apart from the Covid-19 primary series vaccines, Bio Farma previously secured EUA from BPOM and EUL from WHO for its novel Oral Polio Vaccine type 2 (nOPV2). As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. However, the Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.

Among the countries in Africa that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.

In manufacturing the nOPV2 vaccine, Bio Farma collaborated with world-class institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has since become the main supplier of polio vaccines in the world, and currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).

Bio Farma's Laboratories have been internationally acknowledged as reference labs to check samples of polio viruses, while Bio Farma's success in producing and exporting nOPV2 vaccines shows the Indonesian state-owned company contributing to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Prenetics Announces Second Quarter 2022 Financial Results and Raises Full Year Adjusted EBITDA Outlook

LONDON AND HONG KONG, Sep 9, 2022 – (ACN Newswire) – Prenetics Global Limited (NASDAQ: PRE) ("Prenetics" or the "Company"), a global leader in genomic and diagnostic testing, today announced its unaudited financial results for the second quarter ended June 30, 2022.

— Revenue of US$51.7 million in the second quarter of 2022
— Loss from operations of US$(17.9) million and adjusted EBITDA(1) of US$6.5 million in the same period
— Raises full year adjusted EBITDA guidance to the range of US$35 million to US$45 million, with corresponding full year revenue guidance in the range of US$255 million to US$275 million
— Strong cash and cash equivalents, short-term financial assets, trade receivables, deposits, prepayments and other receivables of US$215.3 million on balance sheet as of June 30, 2022
— Successfully launched two pipeline products, ColoClear and Circle SnapShot in the period, growing Prenetics beyond COVID-19 testing services
— Prenetics and Animoca Brands, the pioneer in Web3 signed an agreement to form a joint venture to create a decentralized digital health data platform on the Metaverse. Additional details to be announced in the fourth quarter of 2022

Danny Yeung, CEO & Co-founder of Prenetics, said "The current and next fiscal year are critical periods of transformative growth for Prenetics. With the full support of our management and board we have put into motion a sensible strategic plan which guides us in achieving our mission to decentralize healthcare. In doing so, we aim to further grow our business beyond diagnostic testing by penetrating prevention and personalized care segments.

At present, our genetics and diagnostics testing services continue to be our strongest offering. The diagnostics segment is a major contributor to our total revenues and places us into a strong position to execute on our diversification initiatives through M&A. Organically, we expanded our product pipeline through the launch of ColoClear, a non-invasive stool DNA test for the early detection of colorectal cancer and Circle SnapShot, an at-home painless blood test, two major initiatives in placing the control of health into consumers' hands while in the comfort of their homes. At a global level, we continue to be in deep discussions with various M&A targets, especially in the areas of telehealth, personalized care and specialized clinics. The synergies which we believe we can build upon are expected to provide us the tools needed to build the world's first global end-to-end healthcare ecosystem."

Second Quarter 2022 Financial and Operational Highlights

— Revenue was US$51.7 million for the second quarter of 2022
— Loss from operations was US$(17.9) million for the second quarter of 2022. Included in the loss were employee equity-settled share-based payment expenses of US$13.0 million and other strategic financing, transactional expense and non-recurring expenses of US$8.8 million
— Gross margin was 42% for the second quarter of 2022
— Adjusted EBITDA was US$6.5 million for the second quarter of 2022
— Maintained strong balance sheet with cash and cash equivalents, short-term financial assets, trade receivables, deposits, prepayments and other receivables of US$215.3 million to support M&A and strategic growth initiatives
— Ease of quarantine policy globally accelerated resumption of travel and continued COVID-19 testing service volumes, with further momentum into the third and fourth quarter of 2022
— Significant progress with M&A discussions and geographic expansion
— Robust organic growth – official launch of ColoClear in June 2022 and Circle SnapShot in August 2022. Pipeline product Pet DNA expected to be launched in the fourth quarter of 2022
— Prenetics has performed and delivered more than 23 million laboratory and at-home COVID-19 tests globally as of June 30, 2022

First Half 2022 Financial Highlights

— Revenue was US$143.8 million for the six months ended June 30, 2022, compared to US$136.5 million for the six months ended June 30, 2021, representing an increase of 5% year-over-year, on track to beat FY2022 guidance
— Loss from operations was US$(18.4) million for the six months ended June 30, 2022 compared to profit from operations of US$25.9 million for the six months ended June 30, 2021. Included in the loss were employee equity-settled share-based payment expenses of US$22.3 million and other strategic financing, transactional expense and non-recurring expenses of US$10.5 million
— Gross margin was 40% for the six months ended June 30, 2022 compared to 42% for the six months ended June 30, 2021
— Adjusted EBITDA was US$19.3 million for the six months ended June 30, 2022 compared to US$32.6 million for the six months ended June 30, 2021, achieving full year adjusted consensus estimates

Financial Outlook

Prenetics provides guidance based on current market conditions and expectations for revenue and adjusted EBITDA, which is a non-IFRS financial measure.

For the third quarter of 2022, we expect:

— Revenue to be in the range of US$65 million to US$70 million
— Adjusted EBITDA to be in the range of US$15 million to US$20 million

About Prenetics

Founded in 2014, Prenetics is a major global diagnostics and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars – Prevention, Diagnostics and Personalized Care – comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across 9 locations, including United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening; and provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. To learn more about Prenetics, visit www.prenetics.com.

Enquires:

Investors:
investors@prenetics.com

Media:
Strategic Public Relations Group
Vicky Lee +852 2864 4834 Email: vicky.lee@sprg.com.hk
Corinne Ho +852 2114 4911 Email: corinne.ho@sprg.com.hk
Holly Szeto +852 2864 4853 Email: holly.szeto@sprg.com.hk
www.sprg.com.hk

(1) Adjusted EBITDA (non-IFRS) represents (loss)/profit from operations under IFRS before equity-settled share-based payment expenses, depreciation and amortization, other strategic financing, transactional expense and non-operating recurring expense, and finance income, exchange gain or loss. See the section titled "Unaudited Financial Information and Non-IFRS Financial Measures" and the table captioned "Reconciliation of (Loss)/Profit from Operations under IFRS and Adjusted EBITDA (Non-IFRS)" for more details.

Forward-Looking Statements
This document contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that are based on beliefs and assumptions and on information currently available to Prenetics, and also contains certain financial forecasts and projections.

All statements other than statements of historical fact contained in this document, including, but not limited to, statements about Prenetics' future results of operations and financial position, plans for new product development and geographic expansion, objectives of management for future operations, projections of market opportunity and revenue growth, competitive position, and technological and market trends, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing," "target," "seek" or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. These statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of Prenetics, which involve inherent risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Any such estimates, assumptions, expectations, forecasts, views or opinions, whether or not identified in this document, should be regarded as indicative, preliminary and for illustrative purposes only and should not be relied upon as being necessarily indicative of future results. A number of risks and uncertainties could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to: changes in applicable laws or regulations applicable to Prenetics; developments related to the COVID-19 pandemic; the regulatory environment and changes in laws, regulations or policies in which Prenetics operate; Prenetics' ability to successfully compete in highly competitive industries and markets; Prenetics' ability to continue to adjust its offerings to meet market demand; Prenetics' ability to attract customers to choose its products and services and grow its ecosystem; political instability in the jurisdictions in which Prenetics operates; the overall economic environment and general market and economic conditions in the jurisdiction in which Prenetics operates; and Prenetics' ability to execute its strategies, manage growth and maintain its corporate culture as it grows. In addition to the foregoing factors, you should also carefully consider the other risks and uncertainties included in Prenetics' filings with the U.S. Securities and Exchange Commission (the "SEC") from time to time.

Forward-looking statements speak only as of the date they are made. Prenetics does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required under applicable law.

Website

Prenetics intends to use its website as a distribution channel of material company information. Financial and other important information regarding the Company is routinely posted on and accessible through the Company's website at https://www.prenetics.com/. Accordingly, we recommend you to monitor the investor relations portion of our website at https://ir.prenetics.com/ in addition to following our press releases, SEC filings, and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Request Email Alerts" section of our investor relations page at https://ir.prenetics.com/. However, the additional information contained on our website is not part of our SEC filings.

Basis of Presentation

Unaudited Financial Information and Non-IFRS Financial Measures has been provided in the financial statements tables included at the end of this press release. An explanation of these measures is also included below under the heading "Unaudited Financial Information and Non-IFRS Financial Measures." Unaudited Financial Information and Non-IFRS Financial Measures

To supplement Prenetics' consolidated financial statements prepared in accordance with International Financial Reporting Standards ("IFRS"), the Company is providing non-IFRS measures, Adjusted EBITDA, adjusted gross profit and adjusted profit for the period. These non-IFRS financial measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similarly-titled measures presented by other companies. Management believes these non-IFRS financial measures are useful to investors in evaluating the Company's ongoing operating results and trends.

Management is excluding from some or all of its non-IFRS operating results (1) Equity-settled share-based payment expenses, (2) depreciation and amortization, (3) finance income and exchange gain or loss, and (4) other discretionary items determined by management. These non-IFRS financial measures are limited in value because they exclude certain items that may have a material impact on the reported financial results. Management accounts for this limitation by analyzing results on an IFRS basis as well as a non-IFRS basis and also by providing IFRS measures in the Company's public disclosures.

In addition, other companies, including companies in the same industry, may not use the same non-IFRS measures or may calculate these metrics in a different manner than management or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of these non-IFRS measures as comparative measures. Because of these limitations, the Company's non-IFRS financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with IFRS. Investors are encouraged to review the non-IFRS reconciliations provided in the tables captioned "Reconciliation of Loss from Operations under IFRS and Adjusted EBITDA (Non-IFRS)", "Reconciliation of Gross Profit under IFRS and Adjusted Gross Profit (Non-IFRS)" and "Reconciliation of Loss attributable to equity shareholders of Prenetics under IFRS and Adjusted Profit for the period (Non-IFRS)" set forth at the end of this document.


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Indonesian pharmaceutical Bio Farma ready to produce IndoVac Covid-19 vaccines

Bandung, W Java, Indonesia, Sep 9, 2022 – (ACN Newswire) – PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.


IndoVac Covid-19 vaccine in production at PT Bio Farma's facilities near Bandung, Indonesia (Image: PT Bio Farma)


Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

PT Bio Farma has completed Phase 1 and Phase 2 clinical trials and is currently in the Phase 3 stage to produce the primary series vaccines or two vaccine doses for everyone aged 18 years and older.

"IndoVac uses vaccine technology platforms which are compatible with the equipment and facilities within our factories. The technology platforms for protein recombinant vaccines also offer other benefits: they can be adapted to the new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials showed that IndoVac offers quality safety and efficacy, not less competitive than other Covid-19 vaccines. Now we are completing a report to wrap up Phase 3."

Honesti said, Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July 2022 to provide the necessary data, so that BPOM can release the Emergency Use Authorization (EUA) permit for IndoVac's primary series vaccines in the near term.

The EUA, released by a country's regulatory agency, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country.

BPOM's head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac's primary series vaccines in mid-September 2022.

Shariah Compliance

Bio Farma also has processed the Halal (or Shariah compliant) certification for IndoVac's primary series vaccines to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product.

The certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry is expected to be released in the near term after BPOM release the EUA for IndoVac.

After securing all the necessary permits, Bio Farma is ready to move on to the next stage, which is producing IndoVac's primary series vaccines massively. At the first stage, Bio Farma plans to produce a maximum of 20 million doses of primary series vaccines, before this can be further increased to 40 million doses in 2023, as the company expands its production facilities.

In 2024, the company may further increase the volume to 100 million doses per year, depending on the demands and needs in the markets. Honesti said after the company has secured all the necessary permits, then IndoVac's primary series vaccines "can be massively used by people aged 18 and above."

Booster Vaccine and Vaccine for Children

At the same time, Bio Farma also started clinical trials for its booster vaccine on September 1, 2022. "We have secured approval for a clinical trial (PPUK) from BPOM for IndoVac booster vaccine," Honesti said. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM.

Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine of Padjajaran University, Bandung) and Dr. I.G.N.G Ngoerah General Hospital in Bali (Children's Health Sciences Department, Udayana University). Trials involved 900 subjects aged 8 and above to test IndoVac's booster vaccines.

BPOM requires vaccine manufacturers to conduct clinical trials to decide if a vaccine is safe and can boost immunity against Covid-19, and to determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.

All Covid-19 vaccines made by Bio Farma, including the primary series, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.

President Joko Widodo gave the IndoVac name to the vaccine. "We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma," Honesti said.

For Bio Farma, it is not the first time embarking on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes the Phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).

Made-in-Indonesia Vaccines

Honesti Basyir said IndoVac is special as one of the few made-in-Indonesia vaccine products. The vaccines (which include the primary series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for nation's children. Bio Farma handles the manufacturing process from upstream to downstream.

The local contents of IndoVac's primary series vaccines, according to Bio Farma, will be around 80%. "This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation's dependency on imported vaccines. This will also impact foreign exchange reserves," Honesti said.

In the long term, Bio Farma hopes to capture the export market with IndoVac vaccines. "We will not only produce them (the three types of vaccines) to meet domestic needs but also target the supply of global markets," he said.

"We registered for Emergency Use Listing (EUL) with the World Health Organization (for primary series), so this vaccine can be used in other countries through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not just in Indonesia, but also to the world."

Bio Farma's Success in Polio Vaccine

Honesti said apart from manufacturing Covid-19 primary series vaccines, which is currently waiting for the results of Phase 3 clinical trials and the EUA, Bio Farma has previously proven that it can secure the EUA from BPOM and the EUL from the WHO for its novel Oral Polio Vaccine type 2 (nOPV2).

The EUL, which is released by the WHO, is a procedure for assessing and listing vaccines during public health emergencies by non-vaccine-producing countries. As Indonesia hasn't had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.

Among the countries that have used Bio Farma's nOPV2's vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.

In the manufacturing of nOPV2 vaccine, Bio Farma collaborated with world-class research institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier for the polio vaccine in the world. The company currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).

Apart from producing polio vaccines, Bio Farma's Laboratories have secured international acknowledgement as the reference labs to check samples of polioviruses. The world was previously waiting for two countries, Afghanistan and Pakistan, to combat polio diseases, before a 'world-free polio' can be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East.

The nOPV2 vaccine became an important product to prevent further spread of the polio disease. Bio Farma's success in producing and exporting nOPV2 vaccine means that the Indonesian state-owned company has contributed to the world's health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

EC Healthcare Chairman Mr. Eddy Tang Further Increases Shareholding, Exhibiting Unwavering Assurance in the Future Development of the Group

HONG KONG, Sep 9, 2022 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong*, is pleased to announce that on 7 September 2022, the Group's Chairman, Executive Director and Chief Executive Officer Mr. Tang Chi Fai further acquired a total of 170,000 shares of the Company on the open market for approximately HK$854,800 at an average price of HK$5.0282 per share. Prior to this transaction, Mr. Tang had already increased his shareholding in the Company earlier this month on 1 September 2022, acquiring a total of 107,000 shares at an average price of $5.4905 per share. After the transaction, Mr. Tang holds an aggregate of 722,204,610 shares in the Company, increasing his equity stake from 61.27% to 61.29%.

Mr. Eddy Tang, Chairman, Executive Director and Chief Executive Officer of EC Healthcare said, "In spite of the current economic climate, we are confident that the medical market will remain resilient and that long-term public-private healthcare partnerships will continue to drive up investment in Hong Kong's private healthcare sector. Reaping the benefits from its ongoing investments in elevating healthcare service offerings, the Group exemplified solid business recovery by delivering first-quarter sales volume of no less than HK$860 million for the financial year that concluded on March 31, 2023. Management is still nevertheless upbeat about the Group's business success going forward. In order to continue enhancing EC Healthcare's enclosed healthcare ecosystem, the Group will go forward with its close collaboration with the major players in the technology, telecommunications, insurance, property, and pharmaceutical industries."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for years, primary care clinics jointly established with Tencent Doctorwork, chiropractic services centre New York Spine and Physiotherapy Center NYMG, health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, a comprehensive dental centre EC DENTAL CARE, a diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic SPECIALISTS CENTRAL, NEW MEDICAL CENTER and Prime Medical Centres, obstetrics and gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, specialists central, a paediatric center PRIME CARE, cardiology center HONG KONG INTERNATIONAL CARDIOLOGY CENTER, PathLab Medical Laboratories, a professional hair care center HAIR FOREST, Ophthalmology Center VIVID EYE and EC Veterinary Hospital and Imaging Center.

*According to independent research conducted by Frost and Sullivan in terms of revenue in 2020 and 2021


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Dammam Valley and Arcensus GmbH to establish Saudi-German Genomic Center in Riyadh

DAMMAM, SAUDI ARABIA, Sep 8, 2022 – (ACN Newswire) – Dammam Valley, in partnership with other investment partners, and Arcensus GmbH announce the establishment of a high-throughput Saudi-German Genomic Center in Riyadh. The Saudi-German Genomic Center will begin operations immediately, providing comprehensive genomic diagnostic services for the GCC region based on exclusive next-generation sequencing technologies.

Based on the expertise of a cross-functional, international team of geneticists, medical experts, and data scientists, the Riyadh center will reflect one of the world's most innovative genetic biotechnology organizations, provide its knowledge to clinical colleagues, collaborate with all medical decision-makers, and support the further improvement of the Saudi healthcare infrastructure in line with the Saudi Health Vision 2030. In addition, the partners believe that with the global adoption of Whole Genome Sequencing as the first line of genetic testing, the genomic era will begin in full force and conquer the molecular medicine market in a short period of time.

The initiative to establish this state-of-the-art genomic center stems from the Kingdom's goal to accelerate the implementation of genetic testing for the early diagnosis of diseases, particularly cancer and rare genetic disorders, but also address the preventive element in personalized medicine. The financial investment led by Dammam Valley will enable the partners to penetrate regional markets faster with their innovative solutions.

Dr. Abdulrahman Al-Olayan, CEO of Dammam Valley, said, "The establishment and short-term opening of a state-of-the-art genetic center is central part of the Saudi Vision 2030 and a key element to establishing knowledge and expertise in the region. Furthermore, it is a crucial element in the continuous improvement of the regional healthcare systems to the benefit of the entire population. All the knowledge we accumulate here will be used in the next step for the strategic development of a dynamic and vital pharmaceutical and biotech scene. We are pleased to have Arcensus GmbH as an internationally experienced partner at our side. Especially for the Arab world it is a great pleasure to have Dr. Arndt Rolfs, a highly accomplished, experienced and visionary multi-entrepreneur as a partner."

Dr. Arndt Rolfs, Arcensus Founder and CEO, said, "Especially after Dammam Valley's investment in the company I founded in 2020, Arcensus GmbH, it is a logical and purposeful step to go along the path of establishing a regional center for improving genomic diagnostics with such a proven and reliable partner. The Arab countries have the challenge of improving the early and targeted diagnosis of the numerous genetic diseases. But exactly this knowledge, which can be developed here with the local medical partners, can also serve to establish a dynamic and creative regional and, in a further step, international biotech scene. We are extremely pleased to be able to contribute with our knowledge to this success in the coming years."

Under the terms of the agreement, Dammam Valley along with other investors, will make a substantial investment in establishing the Saudi-German Genomic Center. The parties agree that Arcensus will fully operate the center. The integrity of the protected patient data will be maintained, as will the dedicated sales, marketing and life science business activities.

About Dammam Valley

Established in 2021, Dammam Valley is a semi-government Investment company, solely owned by Imam Abdulrahman bin Faisal University in Damman, Saudi Arabia, with a raised capital of 100,000,000 SAR. It strives to be a source and destination for biotechnology innovation and healthcare in the Middle East and is the Nation's premier hub for evaluating and incubating biotech innovations. It aims to stimulate investment, support projects, and forge quality partnerships in the fields of Health & Biotechnology, in addition to focusing on numerous other sustainable investments in various fields of interest. Please see https://dammamvalley.sa/.

About Arcensus GmbH

Arcensus GmbH is a digital healthcare and diagnostics company that empowers people to take control of their health. The company provides the highest-standard, secure, trusted, and comprehensive diagnostic service based on Whole Genome Sequencing. Arcensus analyses the complete genetic information in human DNA and identifies the predispositions and reasons for unclear symptoms with the help of cutting-edge bioinformatic technology, including artificial intelligence.

The interpretation of the genomic data suggests better treatment options and helps individuals take preventive measures to live a healthier and longer life. From offices in New Jersey, U.S., and Rostock and Berlin, Germany, a cross-functional team of genetic experts, medical doctors, and data scientists works to make the most sophisticated and best genetic interpretation with medical and health prevention applications accessible to everyone. Please visit https://arcensus-diagnostics.com/.

Contact information:
Arcensus GmbH
Ahmad Malik
Communication Manager
Email: Ahmad.malik@arcensus-diagnostics.com

Dammam Valley
Dalal Alsarawi
Communication Manager
Tel: +966 13 333366
Email: dalal.alsarawi@dammamvalley.sa

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Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

EC Healthcare and AXA Jointly Establish the FIRST AXA Medical Centre

HONG KONG, Sep 8, 2022 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong*, is pleased to announce that the Group has entered into a non-legally binding memorandum of understanding (the "MOU") with AXA Hong Kong & Macau ("AXA") for a strategic partnership, pledging to work together to provide premium and comprehensive health management services to customers.


EC Healthcare and AXA signed Memorandum of understanding today to kick start their long term collaboration. (From left: Emily Li, Chief Employee Benefits & Wellness Officer, AXA Hong Kong and Macau, Sally Wan, Chief Executive Officer of AXA Greater China, Eddy Tang, Founder, Chairman, Executive Director and CEO of EC Healthcare and Leslie Lu, Executive Director and Co-CEO of EC Healthcare)


Under the partnership, the first AXA Medical Centre was unveiled today on the 34th floor of the World Trade Centre in Causeway Bay. Together with the AXA designated Endoscopy and Day Surgery Centre in Central, it will officially start operating in November this year.

Located in the central business district of Causeway Bay, the AXA Medical Centre occupies a floor area of over 5,000 sq. ft. The center offers services include preventive medicine, body checks, vaccinations, and nutritional counselling with support from on-site medical professionals including general practitioners, Chinese medicine practitioners, dieticians and radiographers. The AXA Medical Centre provides various body check services such as chest and abdominal X-rays, ultrasound scans, gynaecological examination, electrocardiogram (ECG) with over 10 body examination rooms. Other services include allergy tests, non-invasive genetic screening tests for colorectal cancer, and all pre-insurance health screening for AXA customers.

EC Healthcare is building a one-stop, multi-disciplinary, enclosed healthcare service platform, which allows AXA's customers to obtain a seamless medical referral service after check-ups and enjoy comprehensive, high-quality medical services that covers multiple medical disciplines.

In addition to setting up dedicated medical centres, the Group and AXA will further their cooperation with a view to extending the market coverage of their services to other central business districts and residential areas.

Mr. Leslie Lu, Executive Director and Co-CEO of EC Healthcare said, "Hong Kong's private healthcare market has huge potential. The Group regards strategic partnership with insurance firms as a key strategy of building up its presence in the growing market. The Group is very honoured to form partnership with such an internationally leading insurance group as AXA. The Group believes that the strategic partnership will boost higher customer public traffic with strong synergy in the healthcare sector and enhance the organic growth of the Group's medical and healthcare business through the provision of high-quality and high-end branding medical and healthcare services. The Group will also forge ahead with its deep strategic cooperation with the key players in the technology, telecommunications, insurance, property and pharmaceutical industries so as to keep enriching EC Healthcare's enclosed healthcare ecosystem."

Ms. Sally Wan, Chief Executive Officer of AXA Greater China said, "AXA Medical Centre marks a major milestone for us in delivering exceptional health management services to our customers, providing our customers with all-round care across their life stages. The centre, offering comprehensive one-stop health management services spanning prevention, diagnosis, and treatment, not only enhanced AXA's health management ecosystem but also brought to life our ongoing commitment to become a lifelong partner to our customers. AXA and EC Healthcare share the same vision of improving our customers' holistic wellness. Through this partnership, we can bring an exclusive, innovative, and personalised healthcare experience beyond insurance to our customers leveraging our combined strength."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism. The Group is a constituent stock of the Hang Seng Composite Index and the MSCI Hong Kong Small Cap Index.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for years, a professional hair care center HAIR FOREST, primary care clinics jointly established with health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, General outpatient clinic Tencent Doctorwork, the largest one-stop pain management centre in Hong Kong New York Medical Group, the comprehensive dental centres Bayley & Jackson Dental Surgeons, EC DENTAL CARE and Health and Care Dental Clinic, an advanced diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic PREMIER MEDICAL CENTRE, SPECIALISTS CENTRAL and NEW MEDICAL CENTER, a paediatric centre PRIME CARE, a gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, PathLab Medical Laboratories, Ophthalmology Center VIVID EYE and EC Veterinary Hospital and Imaging Center.

*According to independent research conducted by Frost and Sullivan in terms of revenue in 2020 and 2021

For further information, please contact:
iPR Ogilvy Limited
Callis Lau / Lorraine Luk
Tel: (852) 2136 6952 / 2169 0467
Fax: (852) 3170 6606
Email: ech@iprogilvy.com


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Oculis announces publication and presentation of Phase 2 data showing topical OCS-01 improves macular thickness and visual acuity in patients with diabetic macular edema

LAUSANNE, Switzerland, Sep 6, 2022 – (ACN Newswire) – Oculis S.A., ('Oculis') a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, announces that the Phase 2 DX-211, a randomized, double blinded, multi-center and vehicle controlled clinical trial assessing the safety and efficacy of topical OCS-01 in patients with Diabetic Macular Edema (DME) (NCT05343156) has been published by the Acta Ophthalmologica journal. The publication is accessible on the National Institutes of Health (NIH) website here ( https://pubmed.ncbi.nlm.nih.gov/35848336/ ). In addition, a new subgroup analysis of this study was also recently presented by Pr R. Tadayoni at the 22nd EURETINA Congress on 2nd September in Hamburg, Germany.

— Positive Phase 2 data, published in journal ACTA, provides the first proof-of-concept for a topical drug effect in diabetic macular edema (DME)
— Dataset shows that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME as per the pre-defined criteria for statistical superiority in the study protocol
— Subgroup analysis, presented by Pr Ramin Tadayoni at EURETINA, suggests even greater improvement in patients with lower baseline visual acuity
— If approved, OCS-01 has the potential to provide a new and potentially the FIRST non-invasive eye drop option for DME patients

The dataset published shows OCS-01 to be superior to vehicle in the primary efficacy analysis of BCVA change from baseline with a between group difference of +1.58 ETDRS letters at the pre-specified significance level of 0.15. Mean CMT showed a statistically significant greater decrease from baseline in the OCS-01 group compared to vehicle at all post-baseline time points up to and including Week 12 (-54micrometer OCS-01 vs. -17micrometer vehicle) and reversed towards baseline when treatment stopped at 12 weeks, demonstrating the pharmacological effect of OCS-01 on retinal edema. OCS-01 was well tolerated and no significant or unanticipated ocular adverse events were observed.

Subgroup analysis in patients with BCVA baseline is less than or equal to 65 letters, presented at EURETINA 2022, showed greater improvements in both CMT (-77.4micrometer OCS-01 vs. -23.1micrometer vehicle) and BCVA (+2.9 ETDRS letters in OCS-01 vs vehicle) at week 12.

Approximately 37 million people are affected by DME worldwide, representing around 7% of the large and growing diabetes patient population. DME is the build-up of fluid (edema) in the macula (the macula is important for the sharp, straight-ahead vision that is used for reading, recognizing faces, and driving). DME is the most common cause of vision loss among people with diabetic retinopathy and a leading cause of new cases of blindness in US adults. Although treatment options currently exist, all of them are invasive (injections or implants) and represent a significant burden for patients and caregivers.

OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME. OCS-01 opens up the possibility of treating DME patients at all stages of disease with an eye drop. In addition, OCS-01 could increase the accessibility to treatment of those patients without easy access to specialists; together, this could significantly reduce the burden to the health care system and improve patient outcomes and quality of life.

OCS-01 is currently under investigation for the treatment of DME in the ongoing Phase 3 DIAMOND trial to confirm these findings in a larger patient population.

Riad Sherif, M.D., CEO of Oculis, said: "We are delighted by these data from the Phase 2 DX-211 study, which further reinforce the potential of OCS-01 to provide patients with a potentially transformative treatment of DME as the first non-invasive, eye drop, option. An effective topical treatment for DME could expand the proportion of patients treated, especially those with recent onset DME, as well as provide a treatment option to general ophthalmologists prior to referral to a retina specialist and thereby, improving access to treatment. We look forward to the results of the ongoing Phase 3 DIAMOND trial as Oculis seeks to deliver life-changing treatments that can be accessed globally for the world's most prevalent ocular diseases."

Pr Ramin Tadayoni, MD, PhD, Professor of Ophthalmology at Universite de Paris, said: "The development of effective topical eye drops for posterior segment disorders such as DME would offer easier, non-invasive options than those currently available, and could be widely adopted across all socioeconomic and geographic boundaries. This would allow earlier treatment in DME, reduce the burden on both patients and their caregivers with potentially less injections per year if combined with current standard of care, increase adherence and ultimately, improve outcomes worldwide. OCS-01 is the most developed and promising topical therapy for DME to date, and I look forward to its further development as a potentially transformative treatment for patients in need."

About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs

SYDNEY, AU, Sep 6, 2022 – (ACN Newswire) – Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.



Watch the video here: https://www.avancecro.com/avance-clinical-north-america-operations/

Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.

The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.

Avance Clinical's CEO Yvonne Lungershausen said: "Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical's expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients.

"This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. This GlobalReady model is designed to extend biotechs' investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data.

"In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

"We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

"We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.

Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions."

This seamless GlobalReady journey is designed for success whereby biotechs can:
– Take advantage of the Australian early phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalise global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

Avance Clinical's has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here: https://www.avancecro.com/the-australian-advantage/
Meet the North American leadership team here: https://www.avancecro.com/avance-clinical-north-america-operations/
For more information about the benefits of running your next study with Avance Clinical contact us https://www.avancecro.com/contact-us/

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO with operations across Australia, New Zealand and North America delivering quality clinical trials with globally accepted data for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical to Later Phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

State-of-the-art Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM and Medrio are just some of the technology partners.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Dammam Valley/KSA to acquire the majority of Arcensus GmbH/Germany to accelerate the global implementation of Whole Genome Sequencing in genetic diagnostics and delivery of breakthrough technologies in genomic bioinformatics

ROSTOCK, Germany & DAMMAM, KSA, Sep 5, 2022 – (ACN Newswire) – Dammam Valley in partnership with other investment partners, announce to acquire a majority stake in Arcensus GmbH/Germany. Arcensus, founded by Dr. Arndt Rolfs, a multi-entrepreneur in biotechnology, CEO and founder of several innovative biotech companies, is a digital health and diagnostics company providing comprehensive genomic diagnostic services based on Whole Genome Sequencing.

With a cross-functional, international team of geneticists, medical experts and data scientists, Arcensus, one of the world's most innovative genetic biotechnology companies, offers its knowledge and bioinformatic expertise in genomic interpretation together with cutting-edge medical and preventive health applications. The management of Arcensus is convinced that with the worldwide implementation of Whole Genome Sequencing as the first line of genomic testing, the genomic era will start quickly and will conquer the molecular medicine market in a short time.

The initiative for the take-over comes from the Kingdom's aim to improve the global speed in implementing genomic testing for the early diagnosis of genetic diseases, mainly in cancer and rare genetic disorders. The financial investment led by Dammam Valley will allow Arcensus to speed up the penetration of the worldwide markets with its innovative solutions. It will be the backbone for developing a comprehensive multi-omic strategy.

Dr. Abdulrahman Al-Olayan, CEO of Dammam Valley said, "This is an important step in our global healthcare strategy for KSA, as we believe that the early diagnosis and preventive testing based on real-life genomic expertise with Whole Genome Sequencing is a key ingredient to accelerate the development of, and access to, new future treatments. As a leading technology company in genomic testing, Arcensus GmbH, founded by the visionary multi-entrepreneur, Dr. Arndt Rolfs, is best positioned to provide a deep understanding of bioinformatic technologies and data analytics infrastructure needed not only for the Kingdom of Saudi Arabia but for medical research and development efforts across the globe. A key principle of this is to preserve Arcensus' autonomy. We are delighted that the founder of Arcensus, Dr. Arndt Rolfs, will continue to manage operations, sit on the board and remain a significant shareholder."

Dr. Arndt Rolfs, Arcensus founder and CEO, said, "Dammam Valley will be a tremendous partner for the global expansion to us and shares our vision for building a worldwide healthcare platform in modern preventive medicine as well as early diagnostics of all genetic diseases. This important partnership will allow us to increase the investments in our modern technology and services platform, as well as our knowledge-based data extraction of the genomic data."

Under the terms of the agreement, Dammam Valley along with other investors will make a double-digit million Euro payment on a fully diluted basis. The parties agree Arcensus to continue its current business model, a network of partnerships and overall objectives following the transaction's closing. The integrity of the proprietary patient data will be maintained, as will the dedicated sales, marketing, and life sciences business activities.

About Dammam Valley

Established in 2021, Dammam Valley is a semi-government Investment company, solely owned by Imam Abdulrahman bin Faisal University, and with a raised capital of 100,000,000 SAR. It strives to be a source and destination for biotechnology innovation and healthcare in the Middle East and is the Nation's premier hub for evaluating and incubating biotech innovations. Aiming to stimulate investment, support projects, and forge quality partnerships in the fields of Health & Biotechnology, in addition to focusing on numerous other sustainable investments in various fields of interest.

About Arcensus

Arcensus is a digital healthcare and diagnostics company that empowers people to take control of their health. The company provides the highest-standard, secure, trusted, and comprehensive diagnostic service based on Whole Genome Sequencing. Arcensus analyses the complete genetic information in human DNA and identifies the predispositions and reasons for unclear symptoms with the help of cutting-edge bioinformatic technology, including artificial intelligence. The interpretation of the genomic data suggests better treatment options and helps individuals take preventive measures to live a healthier and longer life.

From our offices in New Jersey – United States, Rostock and Berlin – Germany, a cross-functional team of genetic experts, medical doctors, and data scientists works to make the most sophisticated and best genetic interpretation with medical and health prevention applications accessible to everyone. For more information, visit https://arcensus-diagnostics.com/.

Important Notice and Disclaimer

This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws. Statements contained herein that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "continues," "expect," "estimate," "intend," "project," and similar expressions and future or conditional verbs such as "will," "would," "should," "could," "might," "can," and "may," are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Arcensus' actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our requirement for additional financing and our ability to continue as a going concern, or other factors.

Contact information:
Arcensus GmbH
Ahmad Malik
Communication Manager
Tel: +49 381 20267000
Email: Ahmad.malik@arcensus-diagnostics.com

Dammam Valley
Dalal Alsarawi
Communication Manager
Tel: 013 333366
Email: dalal.alsarawi@dammamvalley.sa
www.dammamvalley.sa

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