News
NEWS | Innovation for Life
-
Prestige Biopharma and Intas Pharmaceuticals Announce Partnership to Commercialize Bevacizumab Biosimilar in the US, Europe andSINGAPORE, July 26, 2022 – Prestige Biopharma Limited (hereafter referred to as “Prestige”) and Intas Pharmaceuticals Limited (hereafter referred to as “Intas”) today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma´s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.Prestige´s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin®, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin®.The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. As one of the key players in the global biosimilar market, Accord has a longstanding commitment to oncology with proven commercial capabilities and it currently supplies around one in three injectable oncology medicines in Europe.This collaboration represents the successful execution of the company’s strategy to expand its market reach in Europe and Canada leveraging Accord’s strong global footprint and deep commercial expertise. The global sales of bevacizumab including its biosimilars were recorded at USD 6.4 billion1) last year and the market is expected to continue growing. Prestige’s HD204 with excellent cost competitiveness based on the company’s proprietary bevacizumab production technology will be providing affordable access to more patients in need.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are delighted to establish a partnership with Intas for the key markets, the US and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.”Binish Chudgar, Vice Chairman & Managing Director of Intas Pharmaceuticals, commented: “We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally.” About Intas Pharmaceuticals Limited: Intas Pharmaceuticals Ltd. is a leading vertically integrated pharmaceutical company based in Ahmedabad, India, having end-to-end capabilities of formulation development, manufacturing and marketing along with backward integration of APIs. The organisation has more than 18,000 employees and 14 manufacturing sites worldwide and sells products in more than 85 countries. The Intas Group’s revenue amounted to USD 2.3 bn in FY 2020-21 and the compounded annual growth rate of revenue has been 19% in the past 5 years. For more information, please visit www.intaspharma.com. 1) Source: IQVIA
-
Major Shareholders of Prestige Biopharma Group Have Bought KRW 10 billion Worth of Stock in AccumulationSINGAPORE, July 14, 2022 – Major shareholders of Prestige Biopharma Group were actively defending their stock prices, while the local stock market has recently fluctuated and fallen sharply due to concerns over an economic slowdown.According to the Data Analysis Retrieval and Transfer System by Korean Financial Supervisory Service on July 14, Octava Fund Limited, a major institutional shareholder, recently purchased KRW 1.3 billion of Prestige Biopharma stock and KRW 400 million of Prestige Biologics stock, amounting to a total of KRW 1.7 billion.Chairman Lisa S. Park and Vice Chairman Michael J. Kim of Prestige Biopharma Group, the largest shareholders of the two companies, have also bought a total of KRW 7.5 billion worth of stock through Mason Partners, a joint investment company established by Chairman Park and Vice Chairman Kim. As a result, the investment that major shareholders have put in defending the stock price of Prestige Biopharma and Prestige Biologics amounts to nearly KRW 10 billion since EMA.According to the company, Octava Fund has provided support in defending the stock price to show trust and confidence as a long-term investment partner. Previously, the major institutional shareholder had purchased KRW 6.9 billion stock in December 2021.Meanwhile, Prestige BioPharma is focusing on preparing for the re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin® biosimilar HD201 that it requested European Medicines Agency (EMA) in May. The company decided to seek approval through re-examination by setting up with a global expert team, instead of choosing withdrawal and reapplication which will take more than a year. Prestige Biologics is strengthening its business with signing new contracts as a global CDMO utilizing its global-scale facilities and state-of-the-art patented technologies.NEWS
-
US FDA Approves Prestige Biopharma’s IND for Phase 1/2a trial of First-in-Class Pancreatic Cancer Treatment, PBP1510SINGAPORE, June 27, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN-Ulenistamab), for the treatment of pancreatic cancer.The clinical trial will be conducted on patients with advanced/metastatic pancreatic cancer in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center by Principal Investigators (PI) comprised of leading authorities at Harvard Medical School and UCLA School of Medicine. The study aims to identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy.Pancreatic cancer is a highly aggressive malignancy which contributes to high morbidity and mortality with an overall survival rate in the U.S. of around 11%1) at five years. Currently, the only curative options are surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15%2) of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancer patients. PAUF plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige Biopharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit to all patients affected by PAUF-positive pancreatic cancer.The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect few individuals but cause great suffering. This designation provides certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU for 10 years, in the U.S. for 7 years.PBP1510 is also expected to be eligible for FDA’s accelerated approval program if certain conditions are met. This program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. The company believes that PBP1510 will be able to apply for the accelerated approval program with the validated surrogate endpoint from its Phase 2 study.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in the world-class medical institutions in the US,” and “the company will accelerate the Phase 1/2a study of PBP1510 to demonstrate the solid evidence to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments.” 1) American Cancer Society 2022, Survival Rates for Pancreatic Cancer, accessed 27 June 2022, https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html>2) Srustidhar D. and Surinder K. B. (2015). Pancreatic Cancer Metastasis: Are we being Pre-EMTed?. Current Pharmaceutical Design, Volume 21, Issue 10, 1249 – 1255NEWS
-
Prestige Biopharma & Prestige Biologics to Present at BIO International Convention 2022SINGAPORE, June 14, 2022 – Prestige Biopharma Group, comprising Singapore-based biopharmaceutical company Prestige Biopharma Limited. and biopharmaceutical CDMO company Prestige Biologics Co., Ltd., announced that the Group is participating in the BIO International Convention 2022, taking place in San Diego from June 13 to 16, 2022.The Group aims to partner with global players for its core pipelines and secure clients for its CDEMO business at the world’s largest event for the biotechnology and pharmaceutical industries. After 2 years of online conventions, this year’s event is back in-person, thus expected to gather a high number of participants including around 3,000 companies from all over the world.At booth #1421 in Bioprocess Zone, Hall B2, Prestige Biopharma Group showcases its technological platform for bioprocessing value chain, ranging from drug discovery to commercialization, which enhances productivity and cost-effectiveness. In particular, Prestige Biopharma introduces its biosimilar and antibody portfolio and share current progress on each pipeline to discusses partnership in development or commercialization. Prestige Biologics concentrates on securing clients and business contracts of its CDEMO services that provide customized manufacturing suites as well as development and engineering solutions.Michael Ruppert, Director of International Business Development at Prestige Biopharma, said: “Our goal here is to build global network and partnership to enter the global market. In addition to biosimilars and first-in-class antibody drugs, we also look forward to discussing collaborations in research and development of vaccines against next-generation infectious diseases.”Jae-young Yang, CEO of Prestige Biologics, said: “In the competitive CDMO market, we have armed ourselves with state-of-the-art biomanufacturing facilities and patent technologies that ensures high quality and productivity. We will seize this opportunity to raise Prestige Biologics’ profile worldwide and secure new clients for CDEMO business.”NEWS
-
CEO & COO of Prestige Biopharma Group Buys Additional SharesSINGAPORE, June 2, 2022 – CEO Lisa S. Park and COO Michael J. Kim have purchased additional shares in Prestige Biopharma and Prestige Biologics to stabilize stock prices of the two companies. Through Mason Partners, a joint investment company established by CEO Park and COO Kim, the two executive directors bought 137,420 shares of Prestige Biopharma’s stock. In addition, CEO Park and COO Kim bought 19,337 shares and 19,301 shares of Prestige Biologics’ stock respectively. Including the KRW 2 billion stock purchase previously announced on May 23, the two executive directors have purchased KRW 4 billion stock in total so far, and will consider further action to protect the market value of their companies.picture: Vice Chairman, Mr. Michael Kim“We are confident with the value of our business and have been putting strenuous efforts towards the development and commercialization of our pipelines. The recent fall in stock price doesn’t reflect the potential value of our companies. We hope the in-house purchase would be a positive signal to the shareholders and help recover our market value. Prestige Biopharma and Prestige Biologics will continue to do the utmost to enhance future values,” said Dr. Lisa S. Park, CEO of Prestige Biopharma.Prestige Biopharma has requested European Medicines Agency (EMA) for re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin® biosimilar HD201. The result is expected to be announced after 120 days. Prestige Biologics is strengthening its business as a global CDMO utilizing its state-of-the-art facilities and patented technologies.NEWS
-
Prestige Biopharma announces International Non-proprietary Name for PBP1510SINGAPORE, May 31, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that its first-in-class antibody PBP1510 has acquired an International Nonproprietary Name (INN) of ‘Ulenistamab’ and was placed on the INN Recommended List by the World Health Organization (WHO).“With its INN- Ulenistamab, PBP1510 is one step closer to commercialization. Not to mention pancreatic cancer has the highest mortality rate of all major cancers, we will try our utmost with PBP1510 so that it could provide significant benefit in all patients affected by PAUF-positive pancreatic cancer,” said Lisa S. Park, CEO of Prestige Biopharma.INN-Ulenistamab, which is also known as a generic name, facilitates the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. The name is given through a thorough examination and discussion on the drug by the WHO and INN experts.PBP1510 (INN-Ulenistamab) is an anti-PAUF monoclonal antibody for pancreatic cancer treatment. It effectively counteracts the effects induced by PAUF (Pancreatic Adenocarcinoma Up-regulated Factor) which is known to play an important role in tumor growth and to be involved in the rapid progression of pancreatic cancer.In 2020, PBP1510 (INN-Ulenistamab) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Korean MFDS. Currently, it is on Phase 1/2a clinical trial in France and Spain.Meanwhile, Prestige Biopharma has recently published a research paper on Frontiers in Pharmacology revealing that PBP1510 may potentially treat ovarian cancer as well. The study showed that PAUF independently promotes tumor growth and metastasis in ovarian cancer cells, in a baseline PAUF dependent and saturable manner, thus an anti-PAUF antibody may sensitize and synchronize the anti-tumor effects of cytotoxic agents and prolong survival time for patients with ovarian cancer.
-
Prestige Biopharma Enters MOU with Vaxine for Supply of COVID-19 Vaccine and Co-development of COVID-19 / Influenza Combo VacciSINGAPORE, March 30, 2022 – Prestige Biopharma Limited and Vaxine Pty Ltd announced that the two organizations have entered into a memorandum of understanding (MOU) to collaborate on the supply of Vaxine’s COVID-19 Vaccine, Covax-19® (also known as Spikogen®) and on the co-development of COVID-19/influenza combo vaccine.Vaxine has developed a state-of-the-art recombinant protein vaccine against COVID-19 that is manufactured using insect cells and includes Vaxine’s proprietary Advax polysaccharide adjuvant. This vaccine showed efficacy against infection by the Delta variant in Phase 3 clinical trials and already is in use in the Middle East. In December 2021, the Australian Therapeutic Goods Administration (TGA) granted a provisional determination allowing an application to be lodged for a provisional approval for this COVID-19 vaccine. Regulatory submissions are similarly underway in many other countries in parallel.Industry experts remain concerned that the next pandemic might be even worse than Covid-19, creating an urgent need to develop strong and affordable pandemic vaccine platforms like the one Vaxine created for its Covid-19 and influenza pandemic vaccine production.Through this MOU, Prestige and Vaxine will be building a long-term vaccine partnership, initially focused on manufacturing and commercialization of Vaxine’s Covid-19 vaccine and then as Covid-19 enters an endemic phase development of a next generation Covid-19/influenza combo vaccine as well as other vaccine projects.The MOU will bring together Prestige’s global scale vaccine manufacturing capacity & research expertise with Vaxine’s innovative vaccine technologies including its vaccines against COVID-19, seasonal and pandemic influenza, hepatitis B, Japanese encephalitis, dengue, malaria, allergy and cancer.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are very pleased to enter into an MOU with Vaxine, given their great strengths in creating novel vaccine technologies. Vaxine’s efforts are aligned with Prestige’s ultimate aim to provide innovative vaccines for the era of endemic COVID. With this partnership, Prestige will be able to accelerate the development of more effective and accessible vaccines and at the same time contribute to the growing global demand for vaccines in response to COVID-19 and potential future pandemics.”Dr Nikolai Petrovsky, CEO of Vaxine, commented: “We are delighted to enter into an MOU with Prestige Biopharma, given their exceptional capabilities in product development and large-scale drug manufacture. Through this partnership with Prestige we look forward to accelerating all the vaccines currently in our extensive development pipeline, starting with our Covax-19 vaccine and a Covid-19/influenza combo vaccine, but also including our pre-pandemic avian H7N9 influenza and Japanese encephalitis programs. Our Japanese encephalitis vaccine is particularly relevant right now with the first major endemic outbreak in Australia that has recently results in the patient deaths in multiple Australian states.”About Prestige Biopharma Limited:PRESTIGE BIOPHARMA LIMITED is a Singapore-based biopharmaceutical company with operations in USA and Korea, specializing in the discovery and development of biosimilars, novel antibodies and vaccines. Prestige strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-Ulenistamab) that recently obtained orphan designation from FDA, EMA and MFDS. Prestige’s rich portfolio of biosimilars in various stages including HD201 trastuzumab in EU EMA’s MAA review, HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige has expanded its business into development and manufacturing of vaccines through its global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines. For more information, please visit www.prestigebiopharma.com.About Vaxine Pty Ltd:VAXINE PTY LTD is an Australian biotechnology company specializing in the research and development of novel vaccines and drugs against pathogens that pose major public health or biodefense threats. The company was founded in 2002 by Professor Nikolai Petrovsky, a world leading vaccine expert based at Flinders University in Adelaide, South Australia. Vaxine has received extensive funding support from the US government for its pandemic vaccine development programs and has worked extensively with U.S army researchers to develop vaccines against a range of exotic pathogens including Ebola, dengue, Covid-19, malaria, MERS and Hantaan hemorrhagic fever. More recently, it has seen success with its allergy and cancer vaccine programs. At the center of Vaxine’s technological prowess lies Advax™, one of the first major breakthroughs in vaccine adjuvants in almost a hundred years. For more information, please visit www.vaxine.net.NEWS
-
CEO & COO of Prestige Biopharma Buys KRW 2 billion Worth of SharesSINGAPORE, May 23, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced that its CEO Lisa S. Park and COO Michael J. Kim purchased KDR 138,206 shares of the company’s stock, worth KRW 2 billion, in total. The purchase has increased their holdings from 15.29% to 15.40% for CEO Park, and from 14.83% to 14.94% for COO Kim. The two largest shareholders are considering additional stock purchase in the future.After the European Medicines Agency (EMA)’s refusal of Marketing Authorization Application (MAA) for the company’s Herceptin® biosimilar HD201 was announced, its stock price plunged. While appealing the EMA’s decision and requesting for re-examination, the two executive directors of Prestige Biopharma bought up shares to reinforce trust and restore confidence of the shareholders. The company has confidence in long-term sustainable growth of its business.Dr. Lisa S. Park, CEO of Prestige Biopharma, commented, “We expect this in-house purchase would increase shareholder value and push up the share price. Prestige Biopharma will do its utmost to promote future value of the company.” She added, “Even though we are disappointed by the EMA’s decision, we are still confident with HD201 and its value, thus focus on preparing for the EMA’s re-examination for HD201 thoroughly.”NEWS
-
The Result of the Phase 3 Study for Prestige Biopharma’s Herceptin Biosimilar, HD201(Tuznue®), Published in JAMA OncologySINGAPORE, March 11, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical with operations in USA and South Korea, announced positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA), a biosimilar to Herceptin® (trastuzumab), published in JAMA Oncology on March 4, 2022.The publication highlights comparative efficacy and safety data for patients who received 1-year of treatment with HD201 or referent trastuzumab and completed a median follow-up of 31 months. The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the two groups was not significant at −3.8% (95% CI, −12.8% to 5.4%) and fell within the predefined equivalence margins. The results regarding secondary endpoints bpCR, overall response, and response based on mammography, ultrasonography, or clinical tumor evaluations supported the comparable efficacy between HD201 and referent trastuzumab. Similar safety, PK and immunogenicity results were reported for the two treatment arms.The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is currently ongoing. The preliminary results of the current final analysis indicate highly comparable 3-year EFS and OS rates for HD201 and reference trastuzumab.Tuznue® has secured global distribution partnerships in major markets including Europe, the Middle East, South America, and Asia. It is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.Prestige’s robust pipeline in clinical stage also includes an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe.Lisa S. Park, CEO of Prestige Biopharma, commented: “We are pleased to demonstrate HD201’s excellence through the Phase 3 study results published in JAMA Oncology” and “the company will accelerate global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”NEWS