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Groei in omzet en winst voor Pharming over het eerste kwartaal van 2019

Het Leidse biotechbedrijf Pharming presenteerde vorige week mooie cijfers over het eerste kwartaal van 2019. De productomzet groeide ten opzichte van Q1 2018 met bijna 20% tot € 35,2 miljoen. Het aantal productverkopen in de VS steeg met 21% tot € 33,7 miljoen, vergelijkbaar met het niveau van het laatste kwartaal van 2018. Ook de nettowinst steeg met 23% tot € 6,7 miljoen. De operationele winst steeg met bijna 50%. Pharming CEO Sijmen de Vries zegt verheugd te zijn met de sterke resultaten. De omzet- en winstprestaties van Pharming bevestigen volgens hem het succes van de marktstrategie voor RUCONEST.

Het hele persbericht lees je hier.

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Erasmus MC and LUMC to co-participate in GenomeScan

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Erasmus MC (Rotterdam, The Netherlands) announced today the acquisition of shares of the fast-growing genomics service provider GenomeScan BV based in Leiden (The Netherlands). Together with the Leiden University Medical Center (LUMC), another shareholder in GenomeScan, they are joining forces in the field of molecular diagnostics and research.

In the fast-growing field of molecular diagnostics, it is critical to introduce and develop cutting-edge diagnostic technologies. One of these technologies is Next Generation Sequencing (NGS) that rapidly analyzes DNA and/or RNA of patients on a large scale.

GenomeScan is an ISO-accredited genomic service provider specialized in Next Generation Sequencing applications. The participation of Erasmus MC and LUMC in GenomeScan allows both UMCs to perform fast and sustainable molecular diagnostics under GenomeScan’s ISO-accreditation for NGS. Moreover, the collaboration will  increase the capacity to innovate, use new technologies and develop new applications for R&D and diagnostics in an international scientific environment.

GenomeScan’s expertise not only lies in molecular diagnostic, but also in developing customizable NGS solutions for pharmaceutical and biotech companies, academic centers and hospitals, mainly within Europe. In addition, GenomeScan collaborates with leading scientific institutes in a number of national and international research projects.

David Voetelink, vice-chairman of the Executive Board: “The Erasmus MC wants to drive innovation in healthcare and technology is becoming an increasingly important factor that requires consequent investments. Through our collaboration with the LUMC we optimize the use of capital equipment. As a result, not only we have access to the most advanced technologies, but also we have a chance to ensure that the healthcare costs remain affordable.”

Pancras Hogendoorn, vice-chairman of the Executive Board of LUMC: “The collaboration with GenomeScan and Erasmus MC fits perfectly with our strategy to develop cutting-edge applications to accelerate and improve diagnosis of patients in state-of-the art clinical research facilities. With the accession of Erasmus MC, we take a big step towards achieving this goal.”

Kees van den Berg, CEO GenomeScan: “Our partnership with both UMCs, allows GenomeScan to strengthen its engagement in developing new tools to diagnose genetic disorders quicker, affordably and more effectively. By sharing knowledge and regrouping facilities, this partnership helps the company to rapidly invest in costly emerging technologies, in a thoroughly sustainable manner, under ISO-accreditation for healthcare providers or academic research and under G(C)LP for the pharmaceutical market.”

Source: GenomeScan

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Alveron pharma closes series A round to advance a cyclodextrin based procoagulant medicine into the clinic

Alveron Pharma, a newly incorporated company established by Okklo Life Sciences BV and Sanquinnovate (part of Sanquin), is pleased to announce the closing of a EUR 6.5M Series A financing round led by Thuja together with Waterman Ventures and Oost NL. This investment allows Alveron Pharma to select a lead compound, conduct non-clinical studies, and complete a first clinical study to demonstrate safety and obtain a first clinical readout.

Alveron Pharma will focus on a unique class of cyclodextrin-based drugs, that have the ability to promote blood coagulation without inducing it in the absence of bleeding. Alveron’s first target is to reverse the effects of anticoagulants. Anticoagulants (“blood thinners”) are widely prescribed to patients with increased thromboembolic risk. While effective in preventing thrombosis, these drugs also inhibit blood coagulation when this is needed urgently, e.g. in patients who suffer a major bleed or in case of emergency surgery. Anticoagulant related bleedings are not uncommon, and may be serious, and difficult to treat since no or only selective reversal agents are available. Alveron’s cyclodextrins are unique in the sense that they restore coagulation independent of the type of anticoagulant used. Sales of selective reversal agents have been estimated at around $2 billion per annum.

Ben Nichols, CEO of Alveron Pharma: “There is a clear unmet clinical need for a universal anti-coagulant reversal agent, and the early pre-clinical data for Alveron’s unique cyclodextrin compounds are compelling. Having recently taken a new class of coagulant into clinical trials, I am thrilled to be joining the founders of this business,  Stephan Peters (who conceived the original idea, CSO) and Alex Zwiers (COO), with their expertise on cyclodextrins, and coagulation expert at Sanquin, Joost Meijers  (Chairman of the Scientific Advisory Board). Alex was also involved in the development of the world’s first cyclodextrin-based medicine, Bridion®.”

“Multiple factors come together in this investment that are highly attractive”, says Michel Briejer of Thuja, who led this transaction. “A highly experienced and knowledgeable team, a promising set of drug leads, and a reputable partner in the field of blood, Sanquin. We are extremely pleased to be part of this venture and are confident that Alveron will create success for doctors and patients alike.”

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Economische missie Boston – Life Sciences & Health

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Zakendoen of kennis opdoen over Life Sciences & Health, Robotics/AI of Climate Resilience in Boston, de hoofdstad van de Amerikaanse staat Massachusetts? Ga dan van 17 tot en met 19 juli mee met de economische missie in aanwezigheid van minister-president Mark Rutte, minister voor Medische Zorg en Sport, Bruno Bruins en de watergezant Henk Ovink. Rijksdienst voor Ondernemen organiseert deze handelsmissie in samenwerking met Task Force Health Care en zakelijk missieleider Hans de Boer, voorzitter van VNO-NCW. Aanmelden kan tot en met donderdag 15 mei

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DDL diagnostic laboratory and ENPICOM join forces

Two Dutch companies – DDL, a state-of-the-art laboratory specializing in molecular diagnostic testing and assay development and ENPICOM, an innovative immunomics data analysis company – Today announced that they have started a collaboration to jointly deliver immune repertoire sequencing and analysis service to organizations studying immune system related diseases or developing drugs influencing this system.

Immune repertoire sequencing is a powerful way to analyze hundreds of thousands to millions of T or B cell receptors swiftly and in a cost-effective way. This new technology is rapidly gaining interest from researchers and physicians who want to unravel the adaptive immune responses in areas like basic and translational immunology, immuno-oncology, autoimmune disorders, inflammatory and infectious diseases, vaccine research and transplantation. From target discovery to patient stratification in clinical trials with immunotherapies, repertoire sequencing is becoming an important addition to accelerate the different drug development processes and make it more cost-effective.

“DDL is very pleased to start this partnership with ENPICOM in this new and challenging field of immunomics”, says Jan Lindeman, DDL’s Chief Executive Officer. “It further expands DDL’s portfolio of tailor-made molecular diagnostic services for our (bio)pharmaceutical customers. ENPICOM’s expertise and know-how are highly complementary to DDL’s expertise and we are confident that this partnership will offer a unique opportunity to accelerate immunotherapy discovery and development.”

Jos Lunenberg, ENPICOM’s Chief Executive Officer comments: “Last month we launched our IGX platform to manage, store, analyze, visualize and interpret immune repertoire sequencing data from T and B cell receptors. Now we are also able to support organizations lacking the specific expertise or capabilities to perform repertoire sequencing with our smart new analysis and visualization methods. In DDL we have found a highly respected business partner with an excellent track record as molecular diagnostic testing laboratory for the biopharmaceutical industry. I’m very pleased to be able to go public with this partnership today.” He continues: “There are a few other kits and services for this specific form of targeted sequencing available in the market, but none or very limited data analysis is included. Clonality analysis is just a first step to bridge the existing gap between producing raw sequencing data and obtaining important insights from the data. So, in essence, we start where others stop.”

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The European Lead Factory, Europe’s largest collaborative drug discovery platform, continues its success story

The European Lead Factory (ELF) secured a total project budget of EUR 36.5 million under the second framework of the Innovative Medicines Initiative (IMI). Over the next 5 years, 20 partners in 7 countries will push forward the transformation of potential drug targets to new medicines in the new project ESCulab (European Screening Centre: unique library for attractive biology) under the European Lead Factory brand.

Jon de Vlieger, coordinator of the ESCulab consortium at Lygature, commented: “It’s truly exciting to continue the onboarding of new and innovative proposals for screening and provide high quality starting points for drug discovery to academics and SMEs throughout Europe. In an effort to broaden our scope we are not only looking for target-based approaches, but now also enable phenotypic screens.”

Proven platform for smart new ideas

Universities, research organisations and SMEs have a diverse range of potential drug targets but cannot easily access suitable compound libraries and screening facilities. Pharmaceutical companies need access to high quality targets to bring innovative therapies to the patient. The European Lead Factory combines the large high-quality compound libraries derived from the pharmaceutical industry and the Public Compound Collection and Europe’s leading screening facility with the innovative targets held by academic organisations in a public-private partnership. This offers an ideal platform to translate early-stage fundamental biological research into credible and investable starting points for drug discovery campaigns.

Stefan Jaroch, project lead of Bayer AG, confirms that: “the European Lead Factory has clearly shown how crowd sourcing and collective intelligence can indeed advance biological concepts into drug discovery projects that benefit academia, industry, society and ultimately patients.”

New ideas + New partners = New chances

Over the next five years,the European Lead Factory will initiate 185 new drug discovery projects by screening medically relevant drug targets from European researchers, small and medium-sized enterprises and pharmaceutical industry against the ELF library of 550,000 unique chemical compounds.

The successful concept of the European Lead Factory has already encouraged additional private partners to join. The ESCulab Project welcomes the two pharmaceutical companies Servier and Grünenthal as well as the Medicines for Malaria Venture (MMV), the leading product development partnership in the field of antimalarial drug research and development.

Tim Wells, Chief Scientific Officer at MMV, adds: “We are thrilled to participate as ESCulab and the European Lead Factory represent a chance for new partnerships for MMV, both with the EU through IMI and with a variety of highly creative companies. These partnerships give access to a novel, high quality chemical library that we believe is important to be screened against high priority malaria targets.”

Source: European Lead Factory

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SMS-oncology appoints Dr. Stephan Winckels as CMO

SMS-oncology, a full service CRO solely dedicated to oncology, today announces the expansion of its management team by appointing Stephan Winckels MD PhD as Chief Medical Officer (CMO).

Dr. Winckels carries over ten years of experience in cancer research and pharmaceutical industry in both big pharma as well as CROs. Trained as an MD, Dr. Winckels obtained his PhD in Medical Physiology. From 2008 onward, Stephan decided to dedicate his career to oncology and started as a resident in pathology at University Medical Center Utrecht. In 2009, Stephan joined the pharmaceutical industry following Wyeth (now Pfizer), Boehringer Ingelheim and the CRO Julius Clinical in which he fulfilled roles as a medical monitor, project manager, protocol author, safety physician, proposal writer and medical lead, focusing on phase I-III oncology studies. Throughout his career, he gained strong experience in clinical oncology drug development and operational insights.

Dr. Winckels joined SMS-oncology three years ago to head the department of Medical Affairs. Today’s promotion is the evaluation of Dr. Winckels demonstrated results, experience and leadership, which benefited the company’s strong performance.

Ms Philine van den Tol, Chief Executive Officer (CEO) at SMS-oncology: “We are pleased to have Stephan join our executive team. His strategic planning and decision-making capabilities combined with extensive industry knowledge is an excellent addition to the company’s growth and development plan. The management team is now further completed and I am confident to say that we possess the right mix of competencies to achieve SMS-oncology’s aim to become the leading oncology CRO in the world.”

Dr. Winckels is delighted to strengthen the management team in his new position as CMO and further contribute to the advancement of medical oncology: “In the upcoming years big data may be the turning point for the clinical trial industry. To ensure effective implementation and to bypass any loss or valuable information we are turning our focus to smart, adaptive and flexible study designs. By integrating our expertise with the newest advances in oncology, we can ensure our current and future clients a successful transition from an oncological compound to meaningful trial results.”

The management team now consists of: Ms. Philine van den Tol (CEO), Mr. Raymond Hoffmans PhD (CBDO), Ms. Eveline Verheijen (COO), Mr. Stephan Winckels MD, PhD (CMO), and Mr. René de Keijzer (CFO).

Source: SMS-oncology

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Ampersand Capital Partners completes Growth Equity Investment in Transplantation Diagnostic firm GenDx

Genome Diagnostics B.V. (“GenDx”) announced today that Ampersand Capital Partners has completed a minority, growth equity investment in the company. Wietse
Mulder, PhD., remains the majority shareholder and CEO of GenDx. The partnership between Ampersand and GenDx aims to foster sustainable growth, both organically and through M&A activities in the molecular diagnostic products and services market.

GenDx is a leading provider of molecular diagnostic kits and analysis software for transplantation and companion diagnostics. Dr. Mulder commented: “GenDx has been successfully organized as a fully independent organization for almost fifteen years. We are delighted to partner with Ampersand and together continue to live by our vision of ‘meaningful entrepreneurship’ by offering the best products, education, and services to the transplantation community worldwide.”

David Parker, a General Partner at Ampersand, added: “Given Ampersand’s prior experience in the transplantation and NGS markets, we were highly impressed by the differentiated product and service offering of GenDx. We are excited to partner with Dr. Mulder and the GenDx team to build on the
company’s long history of profitable growth.”

In connection with this transaction, David Parker has joined the GenDx Board of directors along with Ampersand Operating Partner Mike Evans, PhD. They join three founders on the GenDx Board: Dr. Mulder, Raoul Linschoten, LLM (Chairman), and Oscar Schoots, PhD. The board will be supported by non-director advisors Larry McCarthy, PhD and Frank Witney, PhD., both seasoned entrepreneurs and executives who serve as Operating Partners at Ampersand.

Source: GenDx

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Ophan drug designation granted to Neuroplast’s Neuro-Cells

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Neuroplast, a Dutch medical BioTech company in the growing feld of regenerative medicine stem cell-based therapeutics, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Neuro-Cells, the Company’s autologous therapy for the treatment of Traumatic Spinal Cord Injury. Orphan Drug Designation (ODD) can be granted for a product that is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than fve in 10,000 people in the European Union. With the ODD status Neuroplast takes advantage of potential incentives from the European Union such as protocol assistance, reduced fees, funding from the European Commission for clinical trials, and 10 years of market exclusivity .

Spinal cord injury

A spinal cord injury (SCI) is damage or trauma to the spinal cord which interrupts communication of the brain with body regions below the site of injury. Spinal cord injuries are mainly caused by accidents and, in most of the cases, result in life-long loss of control of motor functions and sensation. After the primary injury to the spinal cord, a cascade of events leads to progressive loss of tissue which may further deteriorate the patient’s prognosis. Current treatment approaches for neurodegenerative disorders as SCI are only symptomatic, leaving the underlying pathophysiology unaffected.

Neuro-Cells

Neuro-Cells represents a non-substantially manipulated tissue engineered product manufactured from patient’s own bone-marrow, intended to treat patients suffering from traumatic SCI. Based on these mechanisms Neuroplast focuses to develop a stem cell therapy, which can inhibit the inflammatory processes following damaged/dying neural tissue cells and sees its Neuro-Cells as a disease modifying therapy (DMT). DMT’s are defned as treatments or interventions that affect the underlying pathophysiology of the disease and have a benefcial outcome on the course of several neurodegenerative diseases such as SCI and Amyotrophic Lateral Sclerosis (ALS).

Source: Neuroplast



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Aantal investeringen Nederlandse gezondheidszorg en biotech neemt af

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Deze week publiceerde de Nederlandse Vereniging van Participatiemaatschappijen (NVP) de feiten en cijfers over het investeringslandschap anno 2018. Het was een uitstekend jaar voor een aantal toegewijde life sciences VC’s, die recordbedragen ophaalden op de markt. Tegelijkertijd tonen de cijfers een minder positieve trend: het aantal investeringen in gezondheidszorg en biotechnologie neemt al jaren op rij af in Nederland. Op dit moment werkt de overheid aan de oprichting van de nieuwe financieringsinstelling Invest-NL. Een uitgelezen kans om het teruglopende aantal investeringen een impuls te geven en zo een vliegwiel voor innovatie in de life sciences te vormen!

In totaal is er in 2018 € 6 miljard geïnvesteerd in 466 Nederlandse bedrijven. Dit omvat zowel investeringen in startende en snelgroeiende ondernemingen (venture capital) als investeringen in volwassen bedrijven (private equity). Met bijna € 5 miljard is de omvang van buyouts verreweg het grootst. Hierbij kopen private equity investeerders (een deel van) de aandelen van een onderneming op. Het in 2018 geïnvesteerde groeikapitaal nam licht af ten opzichte van 2017. Het totaal aantal investeringen door VC’s bereikte in 2018 wél een record: zij staken afgelopen jaar € 387 miljoen aan investeringen in 293 bedrijven. NVP-voorzitter Annemarie Jorritsma concludeert dan ook terecht: ”Het is zeer positief dat de fondsenwerving voor venture capital op zo’n hoog niveau ligt.”

Aantal investeringen in Nederlandse biotech neemt af

Waar de hele VC-markt record na record breekt, wijkt de biotech af van deze positieve trend. Voor het vierde jaar op rij neemt het aantal investeringen in de sector af. De omvang van de investeringen nam afgelopen jaren wel toe, een teken dat VC’s met grotere ticketomvang in een steeds later stadium van ontwikkeling investeren. Dat is ook niet verwonderlijk, want de kapitaalbehoefte in de life sciences is enorm. De ontwikkeling van een nieuw geneesmiddel duurt lang, is risicovol en kostbaar. En waar normale bedrijven bij de bank aankloppen voor een lening, is een biotech bedrijf bijna volledig afhankelijk van start- en groeikapitaal vanuit VC fondsen. Des te schrijnender is de afname in het aantal investeringen in Nederlandse biotech bedrijven. Het toont eens te meer aan dat het huidige financieringslandschap in de life sciences nog flinke gaten vertoont en dat dit marktfalen aangepakt moet worden.

Invest-NL als vliegwiel voor innovatie

Een mogelijke oplossing ligt bij een nieuwe investeringsinstelling die in oprichting is, Invest-NL. Minister Wiebes van Economische Zaken en Klimaat heeft meermaals aangegeven dat Invest-NL zich specifiek gaat richten op de financiering van start-ups en scale-ups. Op dit vlak identificeerde de NVP twee knelpunten die tot marktfalen leiden. Enerzijds komt dit door een gebrek aan kapitaal bestemd voor investeringen in hoog risicovolle seed- en start-up bedrijven, anderzijds door onvoldoende aanbod van kapitaal voor de snelle doorgroei van kapitaalintensieve scale-ups. De feiten en cijfers over 2018 van de NVP laten zien dat dit helaas ook voor de biotechnologie geldt. Invest-NL kan deze gaten in het financieringslandschap helpen overbruggen door een brug te slaan tussen de publieke regelingen en private investeerders. Zo kan het als vliegwiel dienen voor innovatie en kunnen biotech bedrijven met nog meer slagkracht blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van gezondheid en zorg.

Meer informatie

Het persbericht van de NVP lees je hier

Wil je meer weten over HollandBIO’s programma ‘Een ijzersterk innovatieklimaat’? Kijk op de website of neem contact op met Fabian.