PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology
IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models.

I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.”

 Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals

TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration.

“We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.”

About TALLC, Inc.
TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002  and TA-A003  in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. 

About IACTA Pharmaceuticals, Inc.
IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease. 

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PHARMACY MARKET

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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RESEARCH

DEBIOPHARM INVESTS IN VERISIM LIFE'S $15M SERIES A ROUND TO ADVANCE AI-ENABLED DRUG RESEARCH

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.

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BUSINESS INSIGHTS

Pack4U acquires leading pharmacy technology company Catalyst Healthcare

Pack4U | January 07, 2022

Pack4U, a connected health services company, acquires long-time technology partner Catalyst Healthcare whose patented AdhereNet® platform links pharmacists, patients, and care teams to effectively manage drug complexity and improve medication adherence. "We are dedicated to improving patient outcomes at scale. Bringing this domain knowledge in-house is vital for Pack4U. Catalyst's CEO Shane Bishop is a pharmacy thought leader and we are excited about building the next phase of Pack4U with the Catalyst team on board. Catalyst's proprietary and patented platform strengthens our ability to meet the needs of patients, providers and health plans by offering a full, end-to-end, connected care solution seamlessly integrated with our vast clinical team across all states." Pack4U President, Rahul Chopra Pack4U provides in-home and virtual services that connect patients with pharmacists for oversight, medication delivery, remote monitoring, and care coordination. Our complete suite of connected health IP fortifies Pack4U's ability to personalize care, improve health outcomes, and lower total cost of care across North America. "I am extremely excited to see these organizations come together and to join the team that is transforming in-home healthcare," said Shane Bishop. "Pack4U's extensive and diverse team of pharmacists combined with Catalyst's adherence solutions, create opportunity for a new patient monitoring paradigm. With central fills for scale and community pharmacy adoption, we will reach more people to change more lives." "This collaboration follows our aggressive growth in 2021. It expands our vision of in-home care via a full suite of managed services featuring patient specific, in-home medicine dispensing, always-on patient engagement, electronic medicine administration record and supply chain software for centralized filling," said Rahul Chopra. About Pack4U Pack4U Inc is a tech-enabled health services company. We connect people with community pharmacists to manage drug complexity and maximize health benefits through personalized medication delivery, virtual monitoring, and proactive care. Our fully automated, high-volume central fill pharmacy hubs, proprietary health platform and medication adherence network power a robust, scalable solution to chronic condition management that leads to better patient outcomes and total cost of care reduction.

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BUSINESS INSIGHTS

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to CordenPharma

Vifor Pharma Group | December 17, 2021

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio. “In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency. With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders.” Abbas Hussain, CEO of Vifor Pharma Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: “The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers.” Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg, and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement. CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them. This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer. Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group, is a full-service partner in the Contract Development & Manufacturing of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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The foreign corrupt practices act (FCPA) and the Physician Payment Sunshine act( sunshine Act) create an enormous compliance burden and expose pharmaceutical companies to financial risk.

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