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Merck Ltd. Renamed as Procter & Gamble Health Ltd.
Drug firm Merck Ltd recently said it has been renamed as Procter & Gamble Health Ltd following P&G’s global acquisition of the consumer health business of Merck KGaA, Germany. “The company has received approval from the Registrar of Companies, Mumbai, Maharashtra, for change of name from Merck Ltd to Procter & Gamble Health Ltd effective May 6, 2019,” Merck said in a filing to the BSE. The company is taking necessary steps to comply with the formalities and documentation, as may be required by the stock exchanges to record the said change, it added. Procter & Gamble Health Ltd Managing Director Milind Thatte said, “Our new name reflects our new identity as part of the P&G Group and signifies the coming together of strong consumer health capabilities and cultures. Together, we are working towards leveraging our combined expertise to develop categories and brands that meet today’s needs and tomorrow’s opportunities,” he added. The decision to change the name of the listed entity in India follows the successful completion of P&G’s global acquisition of the consumer health business of Merck KGaA, Darmstadt, Germany, the filing said. The consumer health business was transferred to P&G on December 1, 2018, it added. “I am delighted to announce the new name of our listed entity which will now be known as Procter & Gamble Health Ltd,” Procter & Gamble Global Personal Health Care President Tom Finn said. With India’s over-the-counter (OTC) market growing at double the global growth rate, “this is a exciting phase for all of us, as we now move forward to realise the great potential of our two health-related P&G businesses in India”, he added. Procter & Gamble Health Ltd will be a part of P&G’s Personal Health Care International Business Unit led by Uta Kemmerich-Keil (vice-president, Personal Health Care International), the company said.

 


 
Honeywell Introduces Pharma Packaging Innovation with Aclar Accel
Honeywell recently introduce Aclar Accel, a new, cost-effective thermoformable barrier film for pharmaceutical packaging that provides faster service to companies at a lower cost while maintaining patient safety through increased protection for medicines. Aclar Accel, which expands Honeywell’s line of Aclar films with two new gauges, was introduced at this year’s Pharmapack Expo in Paris. With two new clear and opaque laminated options for its high-moisture barrier films, Honeywell’s Aclar gives companies cost-effective alternatives for product packaging with shorter lead times to increase shelf life, decrease operating costs and protect drugs in climates throughout the world. While the original Aclar is clear and customizable, Aclar Accel 1700 maintains the clarity, but has a standard size that allows for faster production and delivery to companies at a lower cost. Aclar Accel 5400 is designed for opaque laminates and offers an even denser, moisture-rich barrier to companies seeking a more cost-effective solution to protect drugs than cold form foil in aluminum blister packaging, which has higher production costs and slower output. “Pharmaceutical companies are seeking new packaging technologies that allow them to get their drugs to market faster and reduce operational costs and Aclar Accel addresses those needs,” said Ken West, vice president and general manager, Packaging & Composites, at Honeywell. “Companies have trusted Aclar for more than 40 years to provide the highest quality protection for their drugs and Aclar Accel gives them new choices. Now, in addition to the customized options of the original Aclar, they can select standard sizes for packaging with these new films and receive them in half the time.” In comparison to packages made of cold form foil, Aclar enables smaller blister pack sizes that reduce shelf space, usage of raw materials and lower transportation costs. Available in many thickness grades and a wide range of moisture barriers, Aclar provides flexibility to optimize moisture protection across different climate conditions. Honeywell’s Aclar films are based on polychlorotrifluoroethylene (PCTFE) fluoropolymer technology. They are crystal clear, biochemically inert, chemical-resistant, nonflammable, and plasticizer- and stabilizerfree. The films can facilitate increased patient compliance with doctor prescriptions with see-through, portable and patient-friendly pack presentations. Today, Aclar thermoformable films are used in a broad range of markets including originator and generic pharmaceutical, over-the-counter (OTC) pharmaceutical and animal health packaging.

 


 
Glenmark Appoints Dr. Yasir Rawjee as Chief Executive Officer of Glenmark Life Sciences, Its Subsidiary for The API Business
Mumbai: Glenmark Pharmaceuticals Ltd., a research-led global integrated pharmaceutical company, recently announced that it has appointed Dr. Yasir Rawjee as the Chief Executive Officer of Glenmark Life Sciences Ltd., its subsidiary for the API (Active Pharmaceuticals Ingredients) business. Yasir joins Glenmark Life Sciences from Mylan Inc., where most recently, he was the Head of Global API Operations. He has held positions of increasing responsibility at Mylan including Senior Vice President of API Technical Operations and Senior Vice President and Head for Sales and Marketing for the API Business. Yasir started his career with SmithKline Beecham Pharmaceuticals based in the USA and has been associated with GlaxoSmithKline and Matrix Laboratories Ltd. previously. He has over 25 years of experience in the pharmaceutical industry. He has a Ph.D. in Chemistry from Texas A&M University, USA and holds a degree in B.Sc.(Tech.) from UDCT Mumbai, India. Glenmark's API business has witnessed robust growth rate of 15% CAGR over the last 5 years while maintaining its leadership position globally across several molecules. To provide a strategic focus to this business, Glenmark had earlier this year transferred the API business to a wholly-owned subsidiary Glenmark Life Sciences. "We see significant growth potential in our API business given the increasing demand for good quality and sustained supply of APIs globally. With this view, we housed our API business into a separate subsidiary, which will be run independently. We are happy that Dr. Yasir Rawjee will now spearhead the API unit and take it to greater heights with his rich experience both in the technical and marketing aspects of the business," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals. "Glenmark Life Sciences has built strong partnerships across the globe and has a very focused approach to further expand the API business. I am pleased to join the organization at a time when I believe I am getting an opportunity to contribute meaningfully in scaling up and shaping the next leg of growth for the API unit," said Dr. Yasir Rawjee.

 


 
Indoco Remedies's New Solid Dosages Facility at Baddi Receives UK-MHRA Approval
Indoco Remedies announced that it received approval from the UKMHRA (Medicines and Healthcare Products Regulatory Agency) for its new solid dosages manufacturing facility in Baddi, Himachal Pradesh (Baddi III unit). The inspection was held from 16th to 18th October, 2018. Thefacility is spread over an area of 18000 sq m, with manufacturing capacity of 4.3 billion tablets and 50 million capsules p.a.

 


 
Aurobindo Pharma Gets 10 Observations from USFDA for Its Unit 3 at Hyderabad
New Delhi: Drug firm Aurobindo Pharma on Tuesday said it has received 10 observations from the US health regulator for its Unit 3 in Hyderabad. The United States Food and Drug Administration (USFDA) conducted an inspection at company's Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad, from May 13 to May 24, 2019, Aurobindo Pharma said in a filing to the BSE. "The company has received a 'Form 483' with 10 observations," it added. None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said. The drug firm, however, did not provide any details about the observations made by the regulator. "The company will be responding to the USFDA within the stipulated time. The Form 483 will not have an impact on existing business of this facility," Aurobindo Pharma said. Shares of Aurobindo Pharma closed at Rs.654.10 per scrip on the BSE, down 0.48% from its previous close.

 


 
Zydus Pharmaceuticals Inc Among Companies Facing Lawsuit by US States: Cadila
New Delhi: Drug firm Cadila Healthcare recently said the name of its arm Zydus Pharmaceuticals Inc is included in the lawsuit filed against some generic companies by US states. Zydus Pharmaceuticals Inc is the US arm of Cadila Healthcare. According to some media reports, more than 40 US states have filed a lawsuit against Teva Pharmaceuticals and 19 other generic companies for price fixing and inflating prices of drugs. In a regulatory filing, Cadila said in its opinion this particular matter is not likely to have any material impact on the operations and financials of the company. "Zydus conducts its business with the highest degree of integrity and honesty," it added. Shares of Cadila Healthcare were trading at Rs.265.10 per scrip on BSE, down 1.41% from its previous close.

 


 
Dr. Reddy’s Launches Daptomycin for Injection
Hyderabad: Dr. Reddy’s Laboratories Ltd. recently announced the launch of Daptomycin for Injection, 500mg/vial single-dose vial, a therapeutic equivalent generic version of Cubicin for Injection, approved by the US Food and Drug Administration (USFDA). The Cubicin for Injection (daptomycin for injection) brand and generic had US sales of approximately $640.8 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health. Dr. Reddy’s Daptomycin for Injection is available in single-dose 15 ml vials containing 500 mg of daptomycin.

 


 
Dr. Reddy's Laboratories' Q4 Consolidated PAT up 44% at Rs 434 Crore
Hyderabad: Dr. Reddy's Laboratories Limited Friday said its consolidated profit after tax for the quarter-ended March 31, 2019 was up by 44 per cent at Rs 434.4 crore against Rs 302.2 crore in the third quarter of FY 18. Revenue for the quarter under discussion was up by 14 per cent at Rs 4,016.60 crore against Rs 3,534.90 crore in the same quarter last fiscal, the city-based drug-maker said in a press release. The CEO and co-chairman of the company G V Prasad said in the release it has been a good year with a significant turnaround in the financial performance and steady progress on the quality front. "Looking ahead, we will focus on profitable growth, continue the emphasis on operational excellence and drive innovation to deliver value to patients and healthcare systems worldwide," he said. For FY 19, PAT stood at Rs 1,880 crore while revenue was 15,385 crore. Revenue from global generics segment in the Q4 was reported at Rs 3,038 crore a year-on-year growth of nine per cent over the same quarter last year, primarily driven by contributions from emerging markets and Europe. Revenue from North America grew by three per cent to Rs 1,496 crore against Rs 1,449 crore in Q4 of FY18. Revenue from pharmaceutical services and active ingredients was at Rs 676.50 crore in the fourth quarter with eight per cent growth over the Q4 of FY 18, the release said.

 


 
Strides Pharma Science Q4 Profit After Tax at Rs.43.81 Crore
New Delhi: Drug firm Strides Pharma Science reported a consolidated profit after tax of Rs.43.81 crore from operations for the March 2019 quarter. The company had posted a loss of Rs.3.39 crore in the year-ago period, the company said in a BSE filing. Consolidated revenue stood at Rs.839.70 crore for the quarter under review as against Rs.669.89 crore for the same period a year ago. For 2018-19, the company posted a profit after tax of Rs.58.93 crore compared to Rs.74.27 crore in 2017-18. The company’s consolidated revenue from operations stood at Rs.3,011.68 crore for 2018-19, against Rs.2,845.12 crore in the year-ago period. “Starting the year with several challenges, we are satisfied with our FY19 exit quarter performance as most of the strategic outcomes have met our expectations,” Strides Pharma Science founder and group CEO Arun Kumar said. Moving into the new financial year, company’s emerging market and institutional business will get highest attention and priority, he added. The company said its board has proposed a final dividend of Rs.3 per equity share of face value of Rs.10 each. Shares of Strides Pharma Science closed at Rs.485.70 per scrip on the BSE, up 0.37 per cent from its previous close.

 


 
Amsterdam University Medical Center Wins MR Solutions’ Newly Launched Image of The Year Award
Guildford UK: The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular research image. Preclinical image submissions came in from most of MR Solutions’ users across the world. The winners which were presented at the ISMRM conference in May were chosen by a panel of leading academics who examined images from MRI, PET or CT – or a combination of imaging modalities. The winning submission was carried out by Amsterdam PhD researcher, Gustav Strijkers. This technique was used in cardiac research to produce a high fidelity 3D tractography of the left ventricle heart muscle fibres of a mouse. The exceptional quality and accuracy of the cardiomyopathy research significantly advances the preclinical imaging sector in the battle to better understand heart muscle disease and treatment. The submission from Sydney Imaging Core Research Facility came a close second place for the high quality MR abdominal image of a pregnant Sprague Dawley rat. The resulting image showed multiple embryonic implants and was ranked for image clarity, research interpretation and understanding. The third place submission by the Centre Georges François Leclerc centre in France was a PET-MR whole body image of an eight week old BALB/c mouse showing a CT26 xenograft tumour. This displayed a clear breakdown of the metabolic, hypoxic and necrotic regions of the tumour. Additional axial images showed further localized information on the high and low uptake areas of 18F-FMISO using a 2T signal. Nicky Doughty, CEO and Director at MR Solutions was delighted with the imaging submissions: “We want to thank our user group for all their imaging contributions. Researchers using our preclinical imaging systems are producing amazing results – this will help to progress our scientific understanding at molecular level and ultimately aid better treatment for patients in the clinic.” MR Solutions’ preclinical MRI and PET imaging systems won the prestigious Queen’s Awards for Enterprise for Innovation in 2016 and 2019. The company has over 30 years’ experience and in excess of 2000 installations across the world. Its scanners are renowned for their excellence in terms of superior soft tissue contrast and molecular imaging ability. MR Solutions operates from its global headquarters in the UK, with offices in the USA and distributors in all the major markets for maintenance and service coverage across the globe.

 


 
Strategic Collaboration Between Biotage and Yingsheng on the Chinese Market for Clinical Mass Spectrometry Applications
UPPSALA, Sweden, (B3C newswire): Biotage AB (Biotage), (NASDAQ OMX Stockholm: BIOT.ST) is pleased to announce its strategic collaboration with Shandong Yingsheng Biotechnology Co., Ltd. (Yingsheng). Yingsheng is mainly focused on independently researching, producing and selling in vitro diagnostic reagents and medical equipment, building a genetic detection platform and mass spectrometry detection platform around metabolomics and genetics. Biotage and Yingsheng have now agreed to develop Clinical Mass Spectrometry Applications in China. Biotage will provide systems and consumables within its Analytical Chemistry portfolio to be sold by Yingsheng under its own brand and together with Yingsheng’s other products and technical solutions. “This collaboration opens up a market not previously available to Biotage and we believe that Biotage together with Yingsheng have good opportunities to be successful in this market environment. Clinical MS detection can be used in varied applications like Vitamin, Hormone and New Born screening. MS detection owns clear advantages in sensitivity and accuracy compared to traditional methods. Due to cost, complexity and technical reasons, it was not widely available before. This new joint effort is to provide a complete solution for this market from instrument, consumable to technical solution. For Biotage particularly it is also a great possibility to strengthen our efforts in China within Analytical Chemistry. Biotage has been very successful with its product offering in Organic Chemistry over the years and we are now looking very much forward to accelerate the Analytical Chemistry activities.” says Torben Jörgensen, CEO & President Biotage.

 


 
Verseon Showcases Oral Candidates for Next-Generation Diabetic Eye Disease Drugs
Fremont, Calif.: Verseon presented a new class of oral candidate drugs, which could not only revolutionize the treatment of diabetic macular edema (DME), but could also be effective in preventing this increasingly common condition. The current standard of treatment for DME involves regular injections into the eye which can cause discomfort, infection, and inflammation, and is only effective in some patients. Speaking at this week’s BIO international Convention in Philadelphia Dr. Anirban Datta, Verseon’s Senior Director of Discovery Biology Diabetic Macular Edema (DME) said: “Our oral development candidate, a novel inhibitor of plasma kallikrein, has the potential to redefine how DME is treated. These drug candidates could become the first real alternative to eye injections, the current standard of care for millions of diabetics at risk of vision loss.” DME, a leading cause of adult blindness, is a complication of diabetes with over 20 million diagnosed patients worldwide. Macular edema occurs when fluid leaks from damaged blood vessels and accumulates in the central region of the retina, a process caused by chronically high blood sugar. It is estimated that about one third of long-term diabetic patients are at risk of developing DME, a group that is expected to grow significantly as the global diabetic population escalates from roughly 425 million to over 600 million over the next 25 years. The current standard of care for DME are recurring injections into the eye associated with discomfort, infection, and inflammation, and that are only effective in about half of patients. Given the risk profile and invasiveness of administration, these drugs are not appropriate for preventative treatment in chronic diabetics at risk. There is a large unmet need for better medications for treating, and ideally preventing, DME. Verseon’s oral DME program is aimed at meeting this need. To address this problem, Verseon is developing the first oral medications for DME. At the BIO International Convention, Dr. Datta presented preclinical data on the Company’s first development candidate for clinical trials. Verseon’s drug candidates target plasma kallikrein, a central mediator of the disease that is not covered by current drugs. In preclinical studies, these compounds have demonstrated excellent oral bioavailability and successfully inhibited both retinal thickening and retinal vascular leakage, two hallmarks of DME. This combination makes them promising candidates for a new generation of oral DME drugs that could potentially open up a $96 billion annual global market for treatment and prophylaxis.

 


 
Minoryx Therapeutics Announces First Patient Dosed in the FRAMES Phase 2 Trial in Friedreich’s Ataxia
Mataró, Barcelona, Spain and Charleroi, Belgium (ALA News): Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, recently announces that the first patient has been dosed with its lead candidate, leriglitazone (MIN-102), in the phase 2 FRAMES clinical trial in Friedreich’s Ataxia. This first patient was dosed at the end of April at the Hospital La Paz (Madrid) by a team headed up by Dr. Francisco Javier Rodríguez de Rivera. Additional sites, led by Prof. Alexandra Durr (ICM, Paris, France), Dr. Alexandra Darling (Hospital Sant Joan de Déu, Barcelona, Spain), Prof. Massimo Pandolfo (Hôpital Erasme-ULB, Brussels, Belgium), and Prof. Jörg Schulz (Universitätsklinikum RWTH, Aachen, Germany) are now also open for enrollment. FRAMES is a double-blind, placebo-controlled trial with the aim of assessing the efficacy and safety of leriglitazone in Friedreich’s Ataxia patients. Principal investigator is Professor Alexandra Durr from the Brain and Spine Institute of La Pitié-Salpêtrière University Hospital (ICM), Paris. The trial will enroll 36 patients aged 12 years or older with a treatment duration of one year. Several studies have shown that the PPARγ/PGC1α pathway is downregulated in Friedreich’s Ataxia, making this pathway a therapeutic target with disease modifying potential. In preclinical models leriglitazone was able to upregulate PGC1α, increase neuron survival, improve mitochondrial function and biogenesis, and restore energy production. Leriglitazone has also shown good in-vivo efficacy in models of other central nervous system (CNS) diseases and is currently in a phase 2/3 clinical trial for the treatment of adrenomyeloneuropathy (AMN), the most common phenotype of X-linked Adrenoleukodystrophy (X-ALD). This trial completed enrollment of 116 patients in 2018 and about 25% of patients have now received treatment for over one year. “We are pleased that enrollment in the FRAMES trial has started,” said Marc Martinell, CEO of Minoryx. “Based on preclinical studies there is a strong rationale for developing leriglitazone in this indication and we are currently exploring a number of additional conditions affecting the central nervous system, where leriglitazone may provide potential benefit for patients.” “I’m delighted to see that Minoryx’s leriglitazone is being assessed in multiple rare CNS diseases, an area where there is a high unmet medical need for novel treatments,” said Prof. Alexandra Durr, principal investigator at the Brain and Spine Institute of La Pitié-Salpêtrière University Hospital (ICM), Paris, and coordinator of the study. “I’m looking forward to the completion and a positive outcome of this clinical trial, which could bring a long-awaited treatment option for Friedreich’s Ataxia patients.”

 


 
apceth Will Operate as the Commercial Manufacturer in Europe for Zynteglo™, Bluebird bio’s Gene Therapy for β-Thalassemia
MUNICH, Germany, (B3C newswire): apceth Biopharma GmbH, a leading company for the manufacturing of cell and gene therapeutics, will operate as the commercial manufacturer in Europe for Zynteglo™, a product of bluebird bio. Yesterday the European Commission (EC) has granted conditional marketing authorisation for Zynteglo™, a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. “We are proud to be the commercial manufacturing partner of bluebird bio and to be part of bringing this life-changing therapy to TDT patients in Europe”, commented Dr Christine Guenther, CEO of apceth Biopharma. “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.” “We are looking forward to continue supporting bluebird bio with its other programs”, announced Dr Guenther. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for Zynteglo™, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016.

 


 
Japan’s Medical Device Market Set to Reach US$74.7bn in 2025 Making it an Attractive Space for Investment, Says GlobalData
The Japanese medical device market to reach from US$54.5bn in 2018 to US$74.7bn in 2025, growing at a compound annual growth rate (CAGR) of 4.6% says GlobalData, a leading data and analytics company. Japan stands as the world’s second-biggest medical device market, after the US. GlobalData’s latest report ‘CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Japan’, discovers that a conducive environment for improved medical products and new technological innovation for better healthcare, make Japan more open and attractive place for healthcare investment. Renuka Sreeramoju, Medical Device Analyst at GlobalData, says: “The rapidly aging Japanese population, increasing number of patients with chronic and life-style diseases, universal health insurance coverage and regulatory measures are driving the Japanese medical device market. Even though the increasing elderly population provides a unique business opportunity for many international medical device companies to innovate new products, foreign investment into the untapped Japanese market was due to lack of knowledge on domestic companies.” Against this backdrop, the Japanese government has taken new initiatives to streamline the regulatory approval review process and accelerate the launch of innovative medical products. In addition, various steps taken by the Ministry of Health, Labor and Welfare (MHLW) to improve the transparency of the approval review system substantially to accomplish a quick review process, which is equivalent to, or faster than that of North American and European markets. The government also introduced ‘Medical Information Database’ to provide access to medical records for the innovators, which has led to quicker medical device development and faster patient access. The changes to the regulatory review system resulted in increasing the number of partnerships, licensing deals and research collaborations among the medical device companies in Japan. For example, German-based KARL STORZ partnered with Medicaroid Corporation to develop robotic assisted surgery systems and Fujirebio and US-based Janssen Pharmaceuticals collaborated to develop AMYLOID β 42/40 RATIO immunoassay for Alzheimer’s dementia. FUJIFILM Corporation collaborated with Indiana University School of Medicine to develop artificial intelligence (AI) application in medical imaging diagnostic support systems. Besides traditional healthcare companies, Cyberdyne (Hybrid Assistive Limb (HAL) robotic exoskeleton unit), Cyfuse (3-D tissue fabrication system) and CureApp (medical-care applications for smartphones) are some of the medical device start-ups established in Japan which are expected to improve the healthcare outcome and patient’s experience. Sreeramoju concludes: “Favorable regulatory landscape, aging demographics, better access to medical data, innovative research and development, and increasing international collaborations will not only attract medical device start-ups, but also encourage AI and other technological start-ups to invest in healthcare sector in Japan.”

 


 
European Medicines Agency Accepts Marketing Authorisation Application for Prestige BioPharma’s Trastuzumab Biosimilar HD201 for Review
Singapore, (B3C newswire): Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue®). HD201 is Prestige’s lead development candidate biosimilar to Herceptin (trastuzumab), which is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Accordingly, if authorized by the EMA, HD201 (Prestige) would take part in the race along with Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Merck Sharp & Dohme), and Trazimera (Pfizer) to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin (Roche). Furthermore, the positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials. Dr Lisa S. Park, Chief Executive Officer of Prestige, commented: “We are very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application. It is a major step in our endeavor to become a global player focussing on biosimilars and innovative biologics. Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing.” HD201 is Prestige’s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorization from the EMA. Based on this achievement, Prestige will continue to move forward with other 8 biosimilars and innovative biologics in its portfolio, which are currently at different stages of development, from nonclinical development to advanced clinical stages.

 


 
European Venture Capital Firm Seventure Partners renews its support to Domain Therapeutics and Invests €3.5M ($3.9M) to Prepare Next Growth Phase
Strasbourg, France: Domain Therapeutics announces today that it has secured a €3.5M ($3.9M) investment from existing shareholder Seventure Partners, to accelerate its next growth phase. Since its inception in 2008, the French biopharma company has emerged as a key player in the field of discovery and early development of programs targeting membrane receptors in Central Nervous System (CNS) disorders, oncology/immuno-oncology and rare diseases. In 2018, Domain Therapeutics successfully executed on the three pillars of its business strategy, thanks to a multitarget collaboration agreement with Boehringer Ingelheim, a license granted on the bioSens-All™ technology platform to BMS and the acquisition by Lundbeck of Prexton Therapeutics, one of the asset-centric companies developing Domain’s programs. Based on this outstanding performance and successful year, Domain Therapeutics is in good position to trigger its next growth phase through a new round of financing. “Seventure Partners is proud to be a strategic financial partner for Domain Therapeutics, a company with validated breakthrough technologies,” said Sébastien Groyer, Partner, Seventure Partners. “Since our last investment in the company, Pascal Neuville and his team have significantly expanded the business and increased the value of the company.” “With Domain being a profitable biotech, the support of Seventure aims at kick-starting our acceleration phase,” said Pascal Neuville, CEO of Domain Therapeutics. “This recognition by a major shareholder of our capacity to create value is a positive signal for future investors and will pave the way for a significant investment aimed at further speeding up company growth.”.

 

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