MUNDIPHARMA CLOSES ACQUISITON OF INVENTAGES PORTFOLIO COMPANY VITAL FOOD PROCESSORS LIMITED AND SECURES GLOBAL RIGHTS TO COMMERCIALISE DIGESTIVE HEALTH SUPPLEMENT EXTRACTED FROM KIWIFRUIT, ZYACTINASE™

5 September 2018: Mundipharma has closed an asset purchase agreement with Vital Food Processors Limited,  an agricultural science company founded in New Zealand, for the global rights beyond New Zealand to commercialize Zyactinase™ – a clinically-proven gastrointestinal consumer health product. Zyactinase™ is a freeze-dried extract of Kiwifruit (Actinidia deliciosa) that has been developed as a constipation relief product as well as for long-term gut health. It contains a protease complex, fiber, pectin and fructo-oligosaccharides that stimulates increased bowel movements. Under the agreement, Mundipharma will initially focus on the commercializing Zyactinase™ to establish a foothold in the US and Canada markets, while continuing to supply existing partners. It will then look to expand its marketing and distribution footprint globally. This agreement will also enable the extension of the company’s Senokot® product range in the US, which is also an all natural, clinically proven digestive health supplement for the treatment of constipation. “We are delighted to have realized this opportunity to acquire a unique, clinically-proven differentiated formulation for commercialization on a global basis across our network,” said Mundipharma CEO, Raman Singh. “As well as providing a consumer pathway for a great product, this strategic acquisition also enables us to extend our depth and competitiveness in the digestive health category,” he added. Dr. Oliver Summerfield, Vital Foods CEO and Principal at majority investor Inventages Venture Capital, commented “We believe this deal recognizes the value created by Vital Foods’ technology platform and that Mundipharma is a strong partner for the global commercialization of the clinically-proven digestive health product developed by Vital Foods’ team” TM: ZYACTINASE is a trademark of Vital Food ®: SENOKOT... read more

AM-Pharma still on track with sepsis drug despite mixed phase 2 readout

The pharma industry doesn’t have a strong record when it comes to trying to find treatments for sepsis, but AM-Pharma has today reported what looks like a rare win. The Dutch biotech has just reported a greater than 40% reduction in mortality for its recombinant form of the enzyme alkaline phosphatase (recAP) compared to placebo in sepsis-related acute kidney injury (AKI). Kidney damage is a common early consequence of the havoc that results from the overblown immune response to infection that occurs in sepsis patients. AM-Pharma’s CEO Erik van den Berg told FierceBiotech that the intention now is to move the program into a phase 3 study in consultation with clinical investigators, regulators and, of course, Pfizer, which took out an option on the company back in 2015. In the trial, recAP—which has a fast-track designation from the FDA—was compared to placebo on top of standard therapy with antibiotics—still the primary treatment option for sepsis patients along with supportive care. The data isn’t a home run. The study in 301 patients—called STOP-AKI—missed its primary endpoint of showing an improvement in kidney function in the first week. However, it did show a “significant, progressive and sustained improvement” in renal function over the 28-day study period, without any major toxicity issues. Nevertheless, the mortality reduction coupled with renal function data suggests that the program remains on track in an indication that analysts have suggested could deliver blockbuster sales for a safe and effective product. Van den Berg said that the study “missed its primary endpoint … it met the primary objective of showing recAP could ameliorate kidney damage,” adding that it is actually more important to have... read more

AM-Pharma announces Phase II study results of recAP in sepsis-associated Acute Kidney Injury

  Bunnik, The Netherlands, March 9th 2018. AM‐Pharma B.V., an Inventages portfolio company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date. Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the STOP-AKI study said: “Acute Kidney Injury affects millions of patients each year and comes with a substantial risk of mortality. The significant improvements demonstrated in survival and kidney function are very encouraging and strongly support further development of recAP.” The STOP-AKI study demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint), it did show a significant, progressive and sustained improvement in renal function over the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without any observations of concern. The STOP-AKI data will be presented today by the principle investigator Professor Pickkers at the AKI & CRRT conference in San Diego and at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) on March 21st in Brussels. Previously, the US Food and Drug Administration granted Fast Track designation to recAP for the treatment of sepsis-associated acute kidney injury. Acute Kidney Injury involves inflammatory processes in the kidney which can... read more

Phagenesis has successfully reached the first of two milestones in its staged acquisition agreement with Nestlé Health Science

Manchester, 4 October 2017 – Phagenesis announced today that by completing a key clinical study in Europe it has reached the first milestone in its staged acquisition agreement with Nestlé Health Science (NHSc). Under the terms of the agreement, Nestlé Health Science has acquired an additional stake in Phagenesis. Reinhard Krickl, CEO of Phagenesis, said: “We are very happy to have successfully closed a key clinical study demonstrating the clinical benefit of Phagenyx®* for the treatment of post-stroke dysphagia amongst tracheostomized patients. We are looking forward to having the study results published early 2018.” Phagenesis is a medical device company that has developed a new treatment for dysphagia, the inability to swallow safely. Dysphagia is a condition with high prevalence as well as high clinical and health economic burden. It is a debilitating condition, which frequently leads to life-threatening complications, including aspiration pneumonia, malnutrition and dehydration. Furthermore, patients with dysphagia experience a dramatic reduction in Quality-of-Life1. Oern Stuge, Chairman of Phagenesis, stated: “Nestlé Health Science’s increasing stake in Phagenesis will continue to foster a strong collaboration between Phagenesis and NHSc, allowing Phagenesis to accelerate its clinical programs demonstrating the benefit of Phagenyx for this significant unmet medical need.” Gunnar Weikert, Director of Phagenesis and Founder of Inventages Venture Capital commented: “As a long-term investor in Phagenesis we are pleased about this significant achievement and look forward to working more closely with NHSc.”  Currently, the management of neurogenic dysphagia is complex. Available options can improve the status and the symptoms, but few are treating the cause. Phagenesis has developed Phagenyx, a novel medical device designed to restore the neurological control... read more

Atonomics announces CE marking of Trace Lipids Test Panel

Atonomics announces CE marking of Trace Lipids Test Panel Trace is a rapid, lab accurate self-testing device for measuring wellness and disease biomarkers Trace Lipids panel measures cholesterol markers from a finger prick of blood with quantitative lab standard results provided within minutes Lipids panel and app can assist in monitoring cardiovascular risk without need to send blood samples to central lab Atonomics A/S, a consumer medical diagnostics company providing personal central lab standard data, announced today the CE marking of its first commercial product, a Lipids test panel on its proprietary Trace platform.  Trace, a personal biomarker device, is a disruptive self-testing platform for accurate, low-cost, and easy-to-use diagnostics. The Lipids Panel determines total cholesterol, HDL (high density lipids), LDL (low density lipids) and triglycerides levels from a finger prick of blood with quantitative lab standard results provided within minutes. The simple cartridge test can be used to monitor the effectiveness of diet, lifestyle changes and medication to lower cholesterol which is a key marker of cardiovascular risk. The device will be linked to an app for convenient read-out and tracking. “We are delighted to launch our first product after having demonstrated that we can achieve central lab accuracy in a small and user friendly format ideally suited for point-of-care applications.  While the initial CE mark is for in-vitro diagnostics (IVD) professional use, a CE mark for self-testing is targeted for later this year, which will enable us to market Trace directly to consumers for home use,” said Thomas Warthoe, CEO. The company plans to roll out a range of prevention and disease marker tests with pipeline products... read more

AM-Pharma completes patient recruitment of recombinant human Alkaline Phosphatase

Recruitment of 301 patients in STOP-AKI adaptive Phase II trial marks largest ever therapeutic study in AKI AM‐Pharma B.V., an Inventages portfolio company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases, announced completion of recruitment in the adaptive Phase II trial to treat sepsis patients with Acute Kidney Injury (AKI). The trial, titled A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (STOP-AKI), completed recruitment with 301 patients, which makes it the largest interventional clinical study in AKI to date. The STOP-AKI adaptive Phase II trial is being conducted in two parts. First, data from 131 patients were evaluated to select the most effective dose of recAP. Second, an additional 170 patients were recruited into two arms, receiving either the optimal dose of recAP identified initially, or placebo. The study was conducted in more than 50 intensive care units (ICU) in Western Europe and North America. Erik van den Berg, CEO of AM-Pharma said: “We are pleased to announce that we have enrolled the last patient in the STOP-AKI trial. I would like to express my appreciation to all staff in the investigating ICUs for their dedication and diligence in supporting the trial. We will now enter a new and exciting phase of patient follow-up, data analysis and discussions with our scientific advisors. We anticipate publishing and presenting results from the trial in early 2018.” In May 2015, Pfizer Inc. (NYSE:PFE) acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon... read more

Accera Appoints Dr. Judith Walker as Chief Medical Officer

Accera, Inc., an Inventages portfolio company, today announced the appointment of Judith Walker, M.D., F.R.C.P.(C), as Chief Medical Officer. Dr. Walker joins Accera from QuintilesIMS where she held the position of Vice President of Product Development, providing leadership for the global clinical development of drugs in the areas of neurology and pain. “Dr. Walker brings to Accera over 20 years of experience in the global biopharmaceutical industry,” said Accera’s president and CEO, Charles Stacey, M.D. “Her wealth of expertise in neurology drug development will be invaluable as we advance our metabolic approach to the treatment of Alzheimer’s disease into the final stage. Dr. Walker will lead the progression of our newly formulated lead compound in Alzheimer’s and help build out our pipeline of drugs in the CNS space.” Prior to QuintilesIMS, Dr. Walker served as Senior Director of Medical Affairs at Teva Neuroscience, a division of Teva Pharmaceuticals. Before Teva Neuroscience, Dr. Walker held leadership roles in global product and global clinical development in neurology at Serono International (Merck KGaA). Dr. Walker continues to serve on the boards of Great Lakes Neuroscience and the pharmaceutical advisory board of the non-profit Accelerated Cure Project. A Fellow of the Royal College of Physicians and Surgeons of Canada, Dr. Walker received her medical degree from the University of Montréal and completed her residency in neurology at the University of Western Ontario. “Accera has one of the few drugs in late-stage development for Alzheimer’s disease which addresses a differentiated and well-validated target,” said Dr. Walker. “I am delighted to be joining Accera at this exciting time in the program.” About Accera Accera, Inc.... read more

Biosys appoints Axel Wiest to Board of Directors

London, UK (10 February 2017) – Biosys UK Limited (“Biosys” or the “Company”), a clinical-stage microbiome company dedicated to the development of targeted oral immune therapies that modulate the gut microbiome, initially focused on the treatment of C.difficile infection (“CDI”), is pleased to announce that Axel Wiest, M.D., Ph.D., M.P.H., has joined the board of the Company. The Centers for Disease Control and Prevention (“CDC”) has declared C.difficile one of three urgent public health threats as it causes life-threatening diarrhea. In 2011, there were almost half a million infections in the US alone and 29,000 CDI-associated deaths within 30 days of initial diagnosis. It has been report that CDI 30-day mortality rates are as high as 14% in some countries. C. difficile has become the most common microbial cause of healthcare-associated infections in US hospitals and results in up to $6.3 billion in excess health care costs annually. The Biosys group of companies (the “Group”) is harnessing the power of oral polyclonal IgA therapies to modulate gut microbiota composition and restore host–microbial symbiosis to treat CDI. Oral polyclonal antibodies have specificity for multiple epitopes and can be delivered directly to the site of infection or dysbiosys in the intestine. The secretory component of sIgA protects it from digestion which provides an advantage over IgG antibodies. The initial focus is on CDI where the Group’s oral polyclonal antibodies target both the C.difficile spores and bacteria that cause relapse and recurrence of infection, as well as the C.difficile toxins that cause clinical symptoms and disease pathologies. This is a targeted approach that eliminates specific pathogens and reduces the recolonization of C.difficile... read more

MSI, an Inventages portfolio company, raises US$30 million investment to advance treatment for patients suffering with Major Depressive Disorder

MSI (MSI Methylation Sciences Inc.), a clinical-stage pharmaceutical company, announced a US$30 million investment from Quark Venture Inc. to advance development of a once-daily oral, small molecule therapy for adjunctive treatment of Major Depressive Disorder (MDD). MDD is estimated to affect around 16 million Americans (Substance Abuse and Mental Health Services Administration 2013) and, according to the World Health Organization (2012), is the leading cause of disability worldwide. Among the U.S. workforce, the prevalence of MDD has been estimated at 7.6% (Birnbaum et al., 2010).  A recent study published in the Journal of Clinical Psychiatry (Greenberg et al (2015)), examined trends in costs associated with MDD and estimated that the total economic burden of MDD is $210.5 billion per year in the U.S. According to key industry analysts about one-third of patients treated with standard antidepressant therapy will end up being treatment resistant to multiple lines of therapy. This is estimated to be about 7 million patients in the U.S. alone.  Current therapy includes dosing with a-typical anti-psychotics which are estimated to have about 4.1 prescriptions into this depression patient group per year. “The currently marketed antidepressants work through similar pathways in the brain and do not adequately treat individuals with major depression.  New medicines that work in different ways represent tools for both doctors and patients in treating people who inadequately respond to marketed antidepressants,” said Karimah Es Sabar, Chief Executive Officer of Quark Venture. “MSI’s lead product, MSI-195, directly addresses this problem. MSI’s strong track record of formulation and clinical development, a strong patent portfolio and its experienced management team validated our investment in MSI. Quark Venture is... read more

Accera Appoints Jeffrey Cummings and Bruno Vellas to Scientific Advisory Board

Accera, Inc., an Inventages portfolio company focused on product development for Alzheimer’s disease, today announced the appointment of Jeffrey L. Cummings, M.D., Sc.D. and Bruno Vellas, M.D., Ph.D. to the company’s Scientific Advisory Board. “As we progress toward Phase 3 data from the NOURISH AD study later this year and the initiation of our second Phase 3 study next year, we continue to build upon our existing network and team of leading Alzheimer’s experts,” said Accera’s president and CEO, Dr. Charles Stacey. “Dr. Cummings and Dr. Vellas are both distinguished and experienced Alzheimer’s disease researchers, and we are pleased to have them join Dr. Martin Farlow and Dr. Michael Weiner on our scientific advisory board. We look forward to the board’s guidance and input as we advance the development of AC-1204 for the treatment Alzheimer’s disease.” Dr. Cummings is the director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada and Cleveland, Ohio. He is the Camille and Larry Ruvo Chair of the Neurological Institute of Cleveland Clinic and Professor of Medicine (Neurology), Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Additionally, Dr. Cummings serves as the principal investigator and director of the Center for Neurodegeneration and Translational Neuroscience. Previously, Dr. Cummings was a professor of neurology and psychiatry at UCLA where he was also the director of the Mary S. Easton Center for Alzheimer’s Disease Research and the director of the Deane F. Johnson Center for Neurotherapeutics. Dr. Cummings has authored or edited 39 books and published over 700 peer-reviewed papers. Dr. Vellas is the chairman of the Toulouse Gerontopole... read more