Titan Pharmaceuticals, Inc. | December 22, 2021
Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process.
Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada.
Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.
Debiopharm International SA | January 11, 2022
Debiopharm a Swiss biopharmaceutical company, announced their co-investment in California-based start-up VeriSIM Life's $15 Million Series A Round to advance their mission to accelerate drug development via technology powered by artificial intelligence. VeriSIM Life's computational platform reduces time and cost of drug development as well as reduces the need for animal testing that, in the vast majority of cases, does not translate well to humans. Debiopharm's co-investment in VeriSIM contributes to the growth plan of the start-up and will help to expand and establish transformational partnerships with industry and academia using their first-in-class 'virtual drug development engine' BIOiSIM™. The investment aligns with Debiopharm's focus to invest in digital health solutions that improve the cancer patient journey, transform pharmaceutical R&D, and shift healthcare towards a more patient-centric approach.
With the financing round led by Morpheus Ventures, Debiopharm Innovation Fund joins new investors including Colorcon Ventures along with existing investors OCA Ventures, Intel Capital, Serra Ventures and Susa Ventures. Founded in 2017 by Jo Varshney, DVM and PhD alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts, the start-up offers a range of translational-based solutions, customized for pre-clinical and clinical programs.
"We're moving into a time where AI-based technology will play a critical role in drug development. We absolutely need to reduce the time, costs & risks of drug development in order to be more efficient – that's exactly what the BIOiSIM™ is proven to do. The value of using this AI-based platform is the potential decrease in the need for animal testing and the acceleration of the pre-clinical, translational stage, helping drug research companies to more quickly select which early-stage medicines will most likely benefit patients and cure their disease."
Tanja Dowe, CEO of the Debiopharm Innovation Fund
More than 90% of drugs tested in animals fail to pass human clinical trials, resulting in delayed development and high costs. VeriSIM's BIOiSIM platform, driven by AI and machine learning (ML), de-risks R&D decisions by providing meaningful insights much earlier in the drug development process with unprecedented accuracy and scalability. VeriSIM's platform solves this decade-old translatability problem within the drug development phase and ensures clinical success of drugs intended for highly unmet needs. With its first-in-class platform, VeriSIM is transforming the way pharmaceutical and biotech companies address the most challenging diseases impacting humankind.
About VeriSIM Life
VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to significantly improve drug discovery and development by greatly reducing the time and money it takes to bring a drug to market. BIOiSIM is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program not only reduces the time and cost of drug discovery and development, it also greatly reduces the need for animal testing that, in the vast majority of cases, does not translate to humans.
Debiopharm's commitment to patients
Debiopharm develops, manufactures and invests in innovative therapies and technologies that respond to high unmet medical needs in oncology and bacterial infections. We aim to provide strategic funding and guidance for companies with Smart Data & Digital Health solutions with the ambition to change the way drugs are developed and the way patients are treated. Our growing portfolio company achievements includes 18 FDA clearances or CE marks and 2 IPOs. Since 2018 Debiopharm has invested over USD 120 million, typically leading the investment rounds of its 16 portfolio companies.
Zynex | January 04, 2022
Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system.
"I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable. This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events."
said Thomas Sandgaard, CEO
"We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance," said Donald Gregg, Vice President, Zynex Monitoring Solutions. "The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market."
The Zynex Fluid Monitoring System is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume.
About Zynex, Inc.
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems.
Arrowhead Pharmaceuticals | December 21, 2021
Arrowhead Pharmaceuticals, Inc. announced that it has completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. The Company expects that the new facilities will result in the creation of approximately 250 new jobs in the local area. Construction is scheduled to begin in the first quarter of 2022. Arrowhead will continue to operate additional research and development facilities in Madison, WI, and San Diego, CA.
“For more than a decade, Arrowhead has been a dedicated member of the biotech community in the greater Madison, Wisconsin, area. We have built strong local relationships and are pleased to continue our growth with the new Arrowhead campus that will include a new GMP manufacturing facility and associated lab and office facility. This investment reaffirms our commitment to the Wisconsin biotech ecosystem, and we would like to thank the local agencies, who have been a pleasure to work with. Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM™-enabled drug candidates. We view this as a strong competitive advantage as we approach potential commercialization of our rapidly progressing clinical candidates.”
Christopher Anzalone, Ph.D., Arrowhead’s president and CEO
Major project team members include Eppstein Uhen Architects, DPS Group, D’Onofrio Kottke & Associates, Smocke & Associates, Cresa Madison, and Vogel Brothers Building Company.
John Chapman, Vice President and Design Principal at EUA, said, “We are privileged to be collaborating again with Arrowhead on an inventive building design which will enable their employees to treat some of the most challenging diseases.”
Completion of the lab and office space is anticipated in the first quarter of 2023 and completion of the manufacturing facility is expected in the fourth quarter of 2023.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.