Marc Funk

BGPartner advises Memo Therapeutics Ltd on extension of Series C financing to CHF 45 million BGPartner | Attorneys-at-law advised Memo Therapeutics AG, a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, on the successful completion of its Series C extension financing. Memo Therapeutics Ltd raised a further CHF 20 million, bringing the total amount raised in this funding round to CHF 45 million. The Series C extension financing was led by Ysios Capital and Kurma Partners and was joined by existing investors. The new funding will be used to bolster the clinical advancement of Memo Therapeutic’s lead asset, AntiBKV. There are more than 100,000 kidney transplants worldwide each year and 20,000 of these are at risk from developing BK virus associated nephropathy. With no disease modifying therapies available, there is an urgent need for a treatment. FDA fast track status has already been obtained. BGPartner assisted Memo Therapeutics Ltd in all legal and negotiation matters in this transaction and is proud to have been advising Memo Therapeutics Ltd for several years already. The team was led by Oliver Gnehm (Partner) and consisted of Victoria Marty (Senior Associate) and Barbara Meise (Associate). Click here for the complete media release: https://lnkd.in/eireTwgu More information about our legal and negotiation expertise can be found here: https://lnkd.in/eFQjD5fw BGPartner – Mastering Law and Negotiation #bgpartner #financinground #law #negotiation #lifescience

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One of our greatest ongoing challenges is ensuring that all patients everywhere have access to the latest medical innovations as quickly as possible and on equal terms.   Therefore, I’m pleased to see that year by year we see a positive change in Poland’s healthcare rankings. This month’s @EFPIA - European Federation of Pharmaceutical Industries and Associations W.A.I.T. report shows that the country has moved to 20th place in terms of access to innovative therapies, and that treatment waiting time has decreased from 827 days last year to 804 days. Similar positive developments come from another study, the Access GAP Report, in which Poland also raised its ranking.   Thus, we are moving in the right direction and, thanks to positive reimbursement decisions, catching up in terms of giving more patients in Poland access to innovative therapies.   Yet, despite these steps forward, Polish patients still face one of the longest waiting times in Europe for access to new medicines. Innovations are available somewhat faster, but unfortunately, more and more medicines are available only to limited groups of patients.   This inequality has societal implications far beyond healthcare, because a country can’t grow and thrive without a healthy population. Investing in public health by minimizing disease and reducing the risk of disability can also lead to reduced healthcare costs, worker absenteeism and pre-mature retirement. On a macroeconomic level, healthcare investments can significantly improve a country's economy, because efficient healthcare systems and innovative medical technologies increase the overall quality of life, which in turn boosts productivity and future economic potential.   I believe that we can and must continue this positive trend and improve Poland’s healthcare rankings even further. Poland has huge potential and has achieved a lot in the last 30 years. Currently it’s the fifth largest economy in the European Community, with one of the lowest unemployment rates and truly fantastic GDP growth. So why should Poland not also achieve such results for healthcare? Together we can work effectively to improve access to innovative therapies and create a better quality of life for all people in Poland. However, for this to happen, and to ensure a promising future for healthcare, we need more resources and adequate funding. #Efpia

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Lessons for Biotech Founders from Pharma: It has been a great pleasure and honor to present at Nucleate UK – The Forum on June 7, 2024 at 22 Bishopsgate in London, together with Professor David Roblin (CEO, RelationTx) and our moderator Alya Masoud (UCL) to a large group of entrepreneurs, investors, scientists from the UK about the key learnings for transiting from positions in Big Pharma (Pfizer, Bayer, Novartis, AstraZeneca, GE Healthcare) to positions in academia (Francis Crick Institute, ETH Zurich) and finally into leadership positions at Biotech startups (RelationTx, Vector BioPharma, Mayr BioMedTech Consulting). https://lu.ma/0oll972t https://lnkd.in/ePYTzjjt Here are my recommendations: 1.        Follow the science: The pace of discovery and innovation in biomedical sciences is unprecedented in history. Development of new therapies and diagnostics should be guided by strong scientific data from the lab and the hospital. 2.        Build a strong team: The success of a startup depends on the quality of the team (science, management, leadership), combined with diversity and inclusion. This requires open minds and open borders. 3.        Create a good business plan: The speed and success of company creation, will depend on creation of a strong, clear, compelling business plan. Key questions are: Why this company? Why now? Do you know your customer? 4.        Generate a viable funding strategy: Startups need a reliable source of funding throughout the full journey. This needs close alignment with a group of knowledgeable investors who have the resources, expertise and network to finance a company. 5.        Simplify your business: Many scientists build complex technologies to solve complex problems and tend to run a complex business. Biotech startups can’t afford to do that. Simply your value proposition, simplify your financing, simplify your value proposition, simplify your path to product. 6.        Embrace learning and improvement: Initial plans for company creation and business strategy are often insufficient at the beginning, might get outdated over time and often need refinement. That requires constant learning, flexibility to adapt and passion to execute. 7.        Partnering and networking: Successful companies build early on a number of good relationships to business and academic partners, tap into their unique skills and capabilities and form strong combined activities. One of the most important skills is networking with other professionals, in science, business and finance. Finally, please remember the time for company creation has never been as good as it is now. Unprecedented pace of scientific discovery, combined with a surplus of venture funding for the right ideas, provides excellent opportunities for entrepreneurs in life sciences, around the world and, in particular, in the UK.

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The new Austrian parallel-import guidelines for pharmaceutical products will come into effect on July 1, 2024 #ParallelImport plays an important role in the #AustriaHealthcareMarket across several indications. The main rules were changed by the Austrian Social Insurance (#DachverbandDerÖsterreichischenSozialversicherungsträger). Main extracts - source: www.ris.bka.gv.at: "These guidelines aim to ensure sustainable, secure, and economically feasible provision of insured individuals with pharmaceutical products according to the current state of medical science. These guidelines establish the extent to which parallel-imported pharmaceutical products may be dispensed by pharmacists and leading physicians of in-house pharmacies on behalf of social insurance carriers." "The dispensing of a #parallelimported pharmaceutical product is only permissible if, at the time of distribution, it is assigned by the Austrian social insurance umbrella organization (#DachverbandDerÖsterreichischenSozialversicherungsträger) to the same area of the #ReimbursementCodexEKO as the corresponding directly imported pharmaceutical product.   Such assignment to the same area occurs when the parallel-importing company offers the phrmaceutical product at least under the same or better economic conditions for the #DachverbandderösterreichischenSozialversicherungsträger as the directly imported pharmaceutical product listed in the reimbursement codex." Would you like to learn more and understand how this may impact your business activities in Austria? Reach out today to schedule your complimentary initial consultation! Thorsten.peske@supersonicpharma.com

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Slides from the recent keynote "Biopharma Dealmaking: Time for a Re-Think" I delivered at the Swiss Healthcare Licensing Group meeting in Montreux in May are now available on the Lumanity website. https://lnkd.in/ePi9Vwse This data rich presentation is important viewing for anyone involved with or interested in biotech corp dev strategy but especially for those pre-commercial biotech "sellers" pinning their hopes on a large pharma partnership. The historically unprecedented increase in the number of biotechs reaching or surpassing clinical PoC stage (5 x or greater over past decade) coupled with a limited number of large pharma "buyers" means odds for vast majority of would be sellers are long. Many more of these biotechs should start to see self-commercializing, especially those pursuing advanced therapeutic modalities, such as cell and gene therapy, as more of a "Plan A" than B. And for many of these companies the time to get started is now, not when they are late in P3 or beyond.

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#News: Bayer and Evotec have updated the focus of their strategic collaboration to develop #precisiontreatments for #cardiovasculardiseases (CVDs). Financial terms were not disclosed.   The collaboration aims to identify and validate #noveltargets, with the goal of building a portfolio of precision #cardiologytherapeutics by leveraging #Evotec's disease modelling capabilities using human #inducedpluripotentstemcells (iPSCs). #iPSCs provide unique opportunities to identify new disease mechanisms and pathways for novel treatments. Under the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms.   Bayer and Evotec will share responsibilities during the preclinical development of potential clinical candidates. Bayer will be responsible for any subsequent clinical development and commercialization.   “This development takes our long-standing collaboration with Evotec to a new level, and has the added benefit of lessons learned from working together the past 12 years,” said Juergen Eckhardt, M.D., Head of Business Development & Licensing at Bayer’s Pharmaceuticals Division. “We remain committed to develop innovative therapies for patients in need and to tackle the high burden of cardiovascular disease.”
 Read more from Contract Pharma 👇🏼

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We are hosts to Trillions of microbes! Neurxstem's CEO ponders the slew of credible papers that implicate microbes causing Alzheimer's and Parkinson's diseases! 🕵‍♂️ This was first noticed in autism spectrum disorders! The Impact of Gut Microbiota-Derived Metabolites in Autism Spectrum Disorders https://lnkd.in/evS-t3pk Systematic characterization of multi-omics landscape between gut microbial metabolites and GPCRome in Alzheimer’s disease https://lnkd.in/ee6jZ43k Genetic correlations between Alzheimer’s disease and gut microbiome genera https://lnkd.in/d652aj7d Virus exposure and neurodegenerative disease risk across national biobanks https://lnkd.in/ea6Gmyw4 Gut microbiota-host lipid crosstalk in Alzheimer’s disease: implications for disease progression and therapeutics https://lnkd.in/eF6qZm3N Gut Microbial Metabolites in Parkinson's Disease: Implications of Mitochondrial Dysfunction in the Pathogenesis and Treatment https://lnkd.in/e-js7AVc #neurodegeneration #microbes #gut #Alzheimers #Parkinsons #virus #bacteria #microbiota #aging #autism #enviroment #climatechange

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#News: French drugmaker Sanofi is nearing a decision to invest between 1.3 billion euros and 1.5 billion euros ($1.4-$1.6 billion) at a major production site in Frankfurt, Germany, where it makes #insulin brand #Lantus, newspaper Handelsblatt reported on Monday. The paper cited German government sources as saying Sanofi changed course after initial considerations to transfer Lantus production to France and the company is now close to committing to an upgrade of the German site in Frankfurt's Hoechst district. Sanofi did not immediately respond to a request for comment. Among recent wins by Germany's ruling coalition to attract healthcare investments, Daiichi Sankyo Europe GmbH (4568.T), said in February it would spend about 1 billion euros to boost its work on precision cancer drugs near Munich. U.S. drugmaker Eli Lilly and Company (LLY.N), in November last year pledged to invest 2.3 billion euros to make #obesity and #diabetes #drugs in Germany. Read more from Reuters 👇🏽 https://lnkd.in/eqUbmUuK

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Excellent keynote panel on the latest developments to the EU Pharma Package at #eupharmalaw. Tools such as the regulatory sandbox and the Transferable Exclusivity Voucher (TEV) must be retained as “magnets” to attract and incentivise pharmaceutical innovation in the EU, including the development of new antimicrobials Pernille Weiss Elise MELON Kristine Peers Eveline Van Keymeulen #innovation #regulatory #AMR

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Today, at USBio'24 in San Diego, 🇺🇸? If so, join the #orphan and #rare disease presentations track (Theater 4) and watch live Avanzanite Bioscience corporate presentation. Eva Cruz de Castro will emphasise what is the role of #orphan specialty pharmaceutical company and our strong beliefs to ensure that NO ONE IS LEFT BEHIND when facing monstrous #rare diseases. She will also share our view on the evolving #orphandrug market with anticipated 800+ R&D programs in the global biotechs. And options available for partners how to make their innovations available in Europe and globally. You should particularly watch Eva Cruz de Castro if you face challenges in Europe 🇪🇺 and beyond. Perhaps, there are very few patients that could use your medicine. Or the market access issues are overwhelming. Or simply, you only have a bandwith to go to to 2–3 countries at launch. At Avanzanite Bioscience, whatever is the trouble, we love challenges.

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Attention biopharmaceutical professionals! ✨ Our expert Markus Roucka, Head of Business Development at Tentamus DACH, will participate as a speaker in the Protein Analytics Online Training by the ECA Academy. 🧑‍💻 📅 When? 22 & 23 May The webinar will give the participants insights into the established and emerging assays for biopharmaceuticals. It will also focus on method validation and regulatory questions. 🔬 It aims to address the challenges faced by the complex biopharmaceutical processes, especially the challenges posed by protein-based products, that require analytical and non-analytical testing methods for comprehensive evaluation of functionality and safety. 🧬 If you have any questions about the topic, you can also contact our colleague directly: 📧 markus.roucka@tentamus.com #Biopharmaceuticals #ProteinAnalytics #ECAAcademy #Webinar

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Looking forward to the BioTech company presentations and being inspired by the high level of innovation at this level! These conferences are always great for seeing what the future holds for patient populations who still have a high unmet need. Paola Valinotti's advice is just what these assets need to understand what is required to generate a successful outcome, further down the line. And at FINGERPOST, we're happy to bring the research, data, clinical and payer experts together to support Paola and others to deliver this. #marketaccess #pricing #forwardthinking #SwissBiotechDay

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The EU Patent Package aims to modernise IP laws for Europe's pharmaceutical industry. However, it’s important to ensure that any proposals made are helping innovation rather than hurting it. Allowing pre-grant opposition for Supplementary Protection Certificates and having a broad Compulsory Licensing mechanism is one such proposal that may hinder innovation.  Removing pre-grant opposition and refining Compulsory Licensing to protect trade secrets and ensure judicial review are crucial adjustments needed to foster a stable environment for investment and innovation. Learn more in the clip below. https://lnkd.in/e7YX72Sr

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𝗕𝗶𝗼𝗡𝗧𝗲𝗰𝗵 𝗱𝗼𝘂𝗯𝗹𝗲𝘀 𝗱𝗼𝘄𝗻 𝗼𝗻 𝗔𝗗𝗖 𝗽𝗮𝗿𝘁𝗻𝗲𝗿 𝗠𝗲𝗱𝗶𝗟𝗶𝗻𝗸 𝗶𝗻 𝗻𝗲𝘄 $𝟭.𝟴𝗕 𝗯𝗶𝗼𝗯𝘂𝗰𝗸𝘀 𝗽𝗮𝗰𝘁 As BioNTech SE’s pipeline tilts back toward oncology, the German biotech is once again tapping a young Chinese partner in a bid for the next generation of the field’s hottest modality. It’s going back to MediLink Therapeutics for antibody-drug conjugates in a new deal that begins with $25 million and promises up to $1.8 billion down the road, plus tiered royalties should any of the ADCs make it to market. For that money, BioNTech snags the exclusive option for the global license to MediLink’s so-called TMALIN ADC platform for “several novel targets,” the companies said over the weekend. https://lnkd.in/d36Z2rXc

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Everyone knows that at puretransfer.com we're all about high purity know-how. But it's important to remember the other magic ingredient in everything we do: 𝐅𝐔𝐍! Take a look and have a great Tuesday! #fun #puretransfer #priorities #highpurity #magiv https://lnkd.in/euAKZ-4Z

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#EUHTA Today, the (draft) text of the first Implementing Act on Joint Clinical Assessment (#JCA) for medicinal products on which the #ComitologyCommittee expressed its positive opinion last Friday, is now available here: https://lnkd.in/ea_UqSVB The text is still a draft, awaiting formal approval by the #EUCommission. First impression is very few changes and minimal improvements. A brief insight: Art 12 : Health Tech Developer (#HTD) Dossier Submission - The time for HTD submission dossier is set at 100 days - from secretariat notification (instead of originally proposed 90 days).  - The time for HTD submission dossier in accelerated procedures and type-II variations remained unchanged, at 60 days. Art 11 : Engagement with HTD - An assessment scope explanation meeting - on the finalised scope - shall take place at the request of the HTD. - This shall take place no later than 20 days after the finalization of the assessment scope. - (in calendar days: no later than Day 150 for standard procedure, and Day 95 for accelerated procedures and type-II variations). Art 20 : Right to appeal on confidential information - The #HTA Secretariat (Commission) must provide justification to HTD on the choices of non-redaction of information considered by HTD as confidential - and inform HTD about the appeal mechanism.

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Repurposing, new drug development and generics. We - BioResearch Pharma SA - chose business model based on repurposed topical dermatological treatments. WHY? 💡High Entry Barrier: unlike generics developing a repurposed drug allows patents, carry unique know-how, and data protection, which means a lower risk of early substitution. 💡Reduced Risk and Costs: repurposed drugs are based on substances that have already been extensively tested and shown to be safe in humans, which reduces the risk of failure during clinical trials leading to a lower development costs . 💡Shorter Regulatory Pathway: in the USA, repurposing follows the 505(b)(2) regulatory pathway, and in the European Union, the hybrid pathway, which allow the use of research data not conducted by the applicant, including results from previous studies of already approved referrence drug. 💡Accelerated Timeline: as a result of the above and scientific research shows that repurposed drug can be brought to market in just 3-5 years instead of the 12-17 years typically required for a new chemical entity. The patent protection of our innovation BRP-011 covers the #EU and the #UK, while the BRP-007 patents cover the #EU, the #USA and #Australia. More information: https://lnkd.in/dq_aT9ic #pharma #dermatology

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Selenite is not equivalent to selenium. It as its own specific properties. See references in cited review article below. 1- At low dose and concentration selenite (ie less than 500 microgram/day during few days, optimal selenium intake seems between 100-150 microgram/day) is a good Se donor, which is required for key antioxidant selenoenzymes (see below reference review articles). It is therefore a pro-antioxidant is that case. 2- But, selenite (Na2SeO3) should be also classified as an active ingredient (AI) (drug) depending on concentration (=> dose and speed of intravenous injection) (see below reference review articles especially table 1 of part B). Cytotoxic concentration is above 1-5 micro mole/L of Se under the form of selenite (Na2SeO3) (see figure in joined peace, graphical abstract, figure 2 and table 1 of part B review article below). Bolus injection of high dose selenite may reach cytotoxic concentration and then should be classified as chemotherapeutic intervention. In addition, it should be clearly specify if the dose is express in mg Se as selenite or in mg of selenite (Na2SeO3). There's a ratio of two to one between these two expressions. NOAEL: 400 microgram/day). Optimal daily intake may be for Se between 100-150 microgram/day (Rayman). AI reasons: 1- Selenite has been studied since long term as chemotherapeutic agent (see text and table 1 of part B, phase I Brodin O et al, 2015; Breuer O et al 2023 and the other with key words Brodin selenitpe) 2- It’s general lethal dose is similar to arsenic salt and its margin of safety is narrowed in sepsis. 3-It’s general toxicity mimic sepsis as documented in poisoning. 4- When its administration (e.g. rapid IV) allows reaching cytotoxic concentration in blood or tissues, selenite research should follow drug development process and not be directly studied in human. 5- Selenite is teratogenic, mutagenic and maybe carcinogenic. Human body content in Se in a repleted people is only 10-15 mg. However, there is an interest for developing a traitement based on selenite cytotoxicity. But that requires to follow drug development process. More details: Selenocompounds and Sepsis-Redox Bypass Hypothesis: Part B-Selenocompounds in the Management of Early Sepsis. Antioxid Redox Signal. Xavier Forceville, Pierre Van Antwerpen, Djillali Annane, and Jean Louis Vincent, 2022 Nov;37(13-15):998-1029. Or free beta access via pubmed (HAL) Below (attached )is a copyright-free figure focusing on selenite cytotoxicity. It is adapted from part B's forum review article published in Antioxidant and Redox Signaling (Fig 2).

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With Andrew Parker at the helm, this will be a fully interactive review of the CMC and regulatory challenges we navigate when transitioning to IND with molecules presenting 'exposure limiting' characteristics. Please join the discussion. #quotientsciences, #translationalpharmaceutics, #drugproductoptimization

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