Roche forced to extend Spark tender offer as investors sue over $4.3B merger

Roche | April 03, 2019

Roche’s $114.50-per-share offer for Spark Therapeutics represents a whopping 122% premium to the gene specialist’s closing price on the last trading day before the acquisition announcement. But some Spark investors still think the price is too low. So far, Spark investors have tendered only 29.4% of the shares outstanding, which doesn't exactly inspire confidence in the deal; Roche needs more than 50% to carry out the combo. The Swiss drugmaker said it's extending its tender offer to May 2 from the previous deadline of Wednesday. The lackluster results aren't Spark's only problem with its investors. The company faces shareholder lawsuits that call the deal price too low—a “bargain,” one suit claims—and question Spark's accounting methods and deal disclosures.

Spotlight

The WHO reports the medication adherence rate only approaches 50%, even in developed nations. When compared to the top 15 most adherent countries on Medisafe, the U.S. healthcare system has some work to do in boosting its oncology adherence rate. It’s important for pharma companies to know which countries are leading the charge and which types of cancer are seeing the lowest adherence. What types of factors influence oncology drug adherence rates? How do rates vary by day and time? Condition? Number of medications taken simultaneously? Which pharma companies manufacture the top 10 most adherent cancer drugs on Medisafe.


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HKSTP and Boehringer Ingelheim Venture Fund Launch Co-Incubation Programme to Fast-track R&D in Infectious Diseases and Immunology

BIVF | June 18, 2022

Hong Kong Science and Technology Parks Corporation is partnering global research-driven biopharmaceutical leader, Boehringer Ingelheim Venture Fund Limited in a strategic co-incubation collaboration to promote and nurture startups on research and development for infectious diseases and immunology. HKSTP is dedicated to collaborating with sector leaders in building the strongest I&T eco-system to help startups via business development, mentorship and investment initiatives. In the last five years, the number of biotech companies at HKSTP have tripled from 50 to over 150, which has also synched with the Government’s strategic focus on biomedical technology with allocation of HK$10 billion to develop life and health technology as a key future growth sector for Hong Kong. This partnership between HKSTP and BIVF marks a key milestone to drive the Hong Kong’s biomedical technology development. Both local and global qualified startups in infectious diseases and immunology can apply to the incubation programme to access the full capabilities of the HKSTP ecosystem and BIVF’s extensive biotech funding network. Incubatees can access one-on-one coaching and assessment to track key research milestones, while receiving expert guidance from HKSTP on commercialisation, manufacturing, scaling-up and marketing strategy to ensure successful innovation, plus vital funding opportunities and investment insight from BI. “Hong Kong is now Asia’s largest and the world’s second largest fundraising hub for biotech. As HKSTP marks our 20th year of propelling success and innovation, our mission is to drive the growth of biotech to another level with world class leaders like BIVF. We will maximise the GBA growth opportunities for high-potential tech talents and early-stage startups to ensure the region emerges as a global I&T powerhouse.” Mr. Albert Wong, CEO of HKSTP Dr. Grace Lau, Head of Institute for Translational Research of HKSTP, said: “Our partnership with BIVF, provides early-stage startups and promising university spinoffs with vital support at the most critical stage of their long and challenging biotech innovation journey. Incubatees will have access to our Incu-Bio Programme, with total incubatees doubling up in the last five years. The startups can also access funding support of up to HK$6 million, with financial subsidies and upfront grants to cover regulatory activities such as clinical trials.” “The world has faced growing public health challenges in recent years. As Boehringer Ingelheim’s strategic investment arm, BIVF focuses on the development of new science in areas with huge unmet medical needs such infectious diseases and immunology,” said Dr. Frank Kalkbrenner, Global Head of the BIVF. “The co-incubation program jointly initiated by HKSTP and BIVF will enable us to identify more breakthrough technologies in the early stage of development. With the funding and infrastructure support offered by HKSTP and BI‘s expertise and experiences in the successful development of breakthrough mediactions for patients, we foster the startup companies and bridge the gap between science and industry for the local ecosystem. We look forward to developing together with HKSTP next-generation therapies in the fields of infectious diseases and immunology with long term partnerships.” “The innovation competency of biopharmaceuticals in Asia is rising quickly. To grab the opportunities in this market, Boehringer Ingelheim has set up the External Innovation Hub in China which brings our Research Beyond Borders, Business Development & Licensing and Venture Fund groups under one umbrella. Now we’re thrilled to see that the biopharmaceutical industry is picking up rapidly in the Guangdong–Hong Kong–Macau Greater Bay Area, it’s a great opportunity for us to partner with HKSTP to develop the local ecosystem, and further enhance China’s dual-circulation scheme. We hope to offer our continuous support to more home-grown innovations to be recognized on the global market and eventually benefit the patients worldwide.” said Mr. Felix Gutsche, President & CEO, Boehringer Ingelheim China. Programme incubatees will also benefit from HKSTP’s rapidly-growing biotech R&D capabilities including the HKSTP Institute for Translational Research (ITR), enabling biomedical startups to turn their innovative biomedical technologies to life-changing impact for patients and society. Also available to startups is HKSTP’s Incu-Bio program providing dedicated biotech mentorship, business matching, entrepreneur-in-residence, and access to R&D facilities and the Science Parks’ diverse talent pool. About Hong Kong Science and Technology Parks Corporation Hong Kong Science and Technology Parks Corporation (HKSTP) has for 20 continuous years committed to building up Hong Kong as an international innovation and technology hub to propel success for local and global pioneers today and tomorrow. HKSTP has established a thriving I&T ecosystem that is home to three unicorns and Hong Kong’s leading R&D hub with over 11,000 research professionals and over 1,000 technology companies focused on healthtech, AI and robotics, fintech and smart city technologies. Established in 2001, we attract and nurture talent, accelerate and commercialise innovation and technology for entrepreneurs on their journey of growth in Hong Kong, to the Greater Bay Area, Asia and beyond. Our growing innovation ecosystem is built around our key locations of the Hong Kong Science Park in Shatin, InnoCentre in Kowloon Tong and three modern INNOPARKs in Tai Po, Tseung Kwan O and Yuen Long. The three INNOPARKs are realizing a vision of re-industrialisation for Hong Kong. The goal is sectors like advanced manufacturing, electronics and biotechnology are being reimagined for a new generation of industry. Through our infrastructure, services, expertise and network of partnerships, HKSTP will help establish innovation and technology as a pillar of growth for Hong Kong, while reinforcing Hong Kong’s international I&T hub status as a launchpad for global growth at the heart of the GBA innovation powerhouse. About BIVF Created in 2010, the Boehringer Ingelheim Venture Fund GmbH invests in groundbreaking therapeutics-focused biotechnology companies to drive innovation in biomedical research. searching for significant enhancements in patient care through pioneering science and its clinical translation by building long-term relationships with scientists and entrepreneurs. BIVF’s focus is to target unprecedented therapeutic concepts addressing high medical needs in immuno-oncology, regenerative medicine, infectious diseases and digital health. These may include novel platform technologies to address so far undruggable targets, new generation vaccines and/or new biological entities, such as oncolytic virotherapy. About Boehringer Ingelheim External Innovation Hub China Established in 2020, Boehringer Ingelheim External Innovation Hub China unites three external innovation functions including Research Beyond Borders (RBB), Business Development & Licensing and the Boehringer Ingelheim Venture Fund. Through this innovative business model, Boehringer Ingelheim External Innovation Hub China is committed to providing one-stop solutions for biomedical innovators in China and. It is also dedicated to enriching the company's global R&D pipeline through external innovation collaborations so as to benefit more patients worldwide.

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BUSINESS INSIGHTS

Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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Qualigen Therapeutics Acquires Majority Stake in Infectious Disease Diagnostics Technology Company NanoSynex

Qualigen Therapeutics, Inc. | June 03, 2022

Qualigen Therapeutics, Inc. a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has completed the acquisition of a majority stake in NanoSynex Ltd., an Israeli-based developer of next generation diagnostics technology. NanoSynex’s award winning technology is an Antimicrobial Susceptibility Testing (AST) platform that aims to provide clinical laboratories worldwide with a rapid, accurate and personalized test for bacterial infections, especially difficult-to-treat drug resistant strains, with the goal of quickly matching the correct antibiotics at the correct concentration to treat a patient’s specific infection. Antibiotic misuse and overuse have given significant rise to more frequent and more deadly antibiotic resistant bacteria, such as Methicillin-resistant Staphylococcus aureus (MRSA). Multi-drug resistant pathogens such as these have been declared a substantial threat to U.S. public health and national security by the Institute of Medicine and a federal Interagency Task Force on Antimicrobial Resistance. According to some estimates, the global infectious disease diagnostics market is expected to reach ~$39.8 Billion by 2026 from ~$28.1 Billion in 2021. “Living through two and a half years of COVID-19 has taught us the critical role diagnostics plays in combating infectious disease, and the need to be prepared for the next wave. NanoSynex’s technology shows great promise in rapidly and accurately matching antibiotics to the target bacteria, and in doing so, quickly equipping healthcare providers with the data needed to treat their patients with the right antibiotic at the right dose at the right time. We strongly believe in the potential of this platform, and our ability to leverage our long-standing diagnostics development, regulatory and commercial expertise to help bring the NanoSynex diagnostics technology to market sooner.” Michael Poirier, Qualigen's Chairman and CEO “We are excited about beginning a new journey with Qualigen and joining forces in a common mission to develop innovative diagnostics. This partnership takes the NanoSynex AST platform to the next level," added NanoSynex Co-Founder and Chief Executive Officer, Diane Abensur Bessin. NanoSynex is led by a dynamic team of healthcare subject matter experts, microbiologists, and engineers, including its co-founders – Diane Abensur Bessin and Michelle Heymann, who were selected for Forbes’ 2020 Tech 30 Under 30 list. Qualigen’s diagnostics team, led by Shishir Sinha, Senior VP and Chief Operating Officer, will work closely alongside the Israeli-based NanoSynex team on technology development, regulatory path, and commercial preparedness. Qualigen also envisions potential synergies with its proprietary FastPack® diagnostics platform to further strengthen the Company’s diagnostics business which has seen a post-COVID-19 resurgence. Qualigen’s purchase of the controlling interest in NanoSynex was primarily accomplished via a stock-for-stock acquisition with a controlling shareholder of NanoSynex. Qualigen also provided an investment in NanoSynex at closing and will provide future milestone-based funding leading to the commercialization of this technology. NanoSynex’s Board will initially be comprised of two current NanoSynex directors – NanoSynex co-founders - and two Qualigen appointees – Mr. Poirier and Mr. Sinha. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. About NanoSynex NanoSynex is a MedTech company that aims at providing new solutions to improve testing quality, patient outcomes, and reduce healthcare costs by speeding up diagnostic processes. NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.

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NextRNA Launches with $56 Million in Funding to Bring Transformative Non-Coding RNA-Directed Medicines to Patients

NextRNA Therapeutics | March 02, 2022

NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, announces its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors. Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs. The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called “non-coding RNAs,” play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets. “NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines. We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas.” Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. “By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines,” said Dr. Novina, co-founder of NextRNA. Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology. “NextRNA is at the forefront of innovation in the field of non-coding RNAs,” said Todd Kaloudis, Managing Director at Cobro Ventures. “There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients.” About NextRNA Therapeutics NextRNA is a biotechnology company with a mission to translate pioneering science into transformative therapeutics for the benefit of patients. The company is leveraging its proprietary technology platform to systematically identify disease-relevant non-coding RNAs and their interacting proteins, and to develop selective small molecules to drug these interactions. NextRNA investors include Cobro Ventures, Lightchain Capital, Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors.

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Spotlight

The WHO reports the medication adherence rate only approaches 50%, even in developed nations. When compared to the top 15 most adherent countries on Medisafe, the U.S. healthcare system has some work to do in boosting its oncology adherence rate. It’s important for pharma companies to know which countries are leading the charge and which types of cancer are seeing the lowest adherence. What types of factors influence oncology drug adherence rates? How do rates vary by day and time? Condition? Number of medications taken simultaneously? Which pharma companies manufacture the top 10 most adherent cancer drugs on Medisafe.

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