CPD AND LEARNING

Applied BioMath, LLC Announces Partnership with Antengene for Systems Pharmacology Modeling in Oncology

Applied BioMath | December 09, 2020

Applied BioMath, the business chief in applying frameworks pharmacology and unthinking demonstrating, reproduction, and examination to de-hazard drug innovative work, today reported a joint effort with Antengene Corporation for the advancement of a frameworks pharmacology displaying in immuno-oncology. Applied BioMath will build up a frameworks pharmacology model for a PDL1/41BB bispecific immunizer, ATG-101, in immuno-oncology signs. The model will be utilized to anticipate clinical beginning and useful portions for first-in-quite a while. "Antengene Corporation is devoted to growing first-in-class as well as top tier treatments in oncology," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "We chose to work together with Applied BioMath with an end goal to give ourselves the most noteworthy probability conceivable of anticipating exact beginning and effectual dosages which is a basic piece of our first-in-quite a while."

Applied BioMath utilizes a thorough fit-for-reason model advancement measure which quantitatively coordinates information about therapeutics with a comprehension of its component of activity with regards to human sickness systems. Their methodology utilizes exclusive calculations and programming that were planned explicitly for frameworks pharmacology model turn of events, reenactment, and examination. "Foreseeing beginning and effectual portions for first-in-quite a while is non-paltry for complex therapeutics, for example, Antengene's bispecific restorative," said Dr. John Burke, Ph.D., Co-Founder, President, and CEO of Applied BioMath. "We have created calculations and devices explicitly for this reason that have a demonstrated history of foreseeing such portions. We anticipate working together with Antengene to help them in this venture."

About Applied BioMath

Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic. For more information about Applied BioMath and its services, visit www.appliedbiomath.com.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a biopharmaceutical company with an integrated drug discovery and clinical development approach, anchored in Asia Pacific with a global footprint. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since official operation in April 2017, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets, obtained 10 IND approvals and has 9 ongoing cross-regional clinical trials in Asia Pacific. At Antengene, we focus on developing drug candidates with novel MoAs and first-in-class/best-in-class potential to address significant unmet medical needs. The vision of Antengene is to "Treat Patients Beyond Borders" through discovery, development and commercialization of first-in-class/best-in-class therapeutics.

Spotlight

New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades.

Spotlight

New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades.

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BUSINESS INSIGHTS

Karo Pharma acquires OTC brand portfolio from Teva Pharmaceuticals

Karo Pharma, Teva Pharmaceuticals | February 04, 2021

Karo Pharma Aktiebolag ("Karo") today reports the securing of an OTC brand portfolio containing Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva Pharmaceuticals (Teva) for an absolute thought of EUR 84m. The exchange moves responsibility for brand portfolio, included Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva to Karo. The brands created deals barely shy of EUR 35m in 2020 on a worldwide premise. The greater part is created in the Nordic business sectors, including Scandinavia, where the brands as of now are dispersed and showcased by Karo under a 7-year permit arrangement that was endorsed in the spring of 2019. The exchange adds around EUR 4m in net deals from new business sectors outside of Scandinavia of which approx. 80% is in Finland. The exchange disentangles the business set-up and gives Karo control of the resources, in this way preparing for long haul advancement of the brands and the worth chain. As far as monetary effect Karo will acknowledge direct investment funds in year 1 of simply under EUR 5m as expenses to Teva are disposed of. Karo as of now popularizes the items in Scandinavia and has dynamic associations with the agreement manufacturers that supply the brands. Subsequently, restricted added expenses and faculty are needed as an immediate aftereffect of the exchange. "The transaction is in full alignment with our strategy of owning and commercializing strong OTC brands within everyday healthcare. It gives us full global control of a very exciting brand portfolio that we will develop and optimize over the next years. It strengthens our position in the Nordic markets and notably it expands our business in Finland where we did not previously control these brands. Over the next years we shall expand life cycle management opportunities, drive activation across more channels and explore geographical market expansion", says Christoffer Lorenzen, CEO of Karo Pharma. The obtaining is an unadulterated resource bargain. No staff or assembling locales are incorporated, which limits business just as the innovation move chances. The exchange, which is financed with existing money and requires no extra credit facilities, is relied upon to close on April 1. About Karo Pharma Karo Pharma delivers smart choices for everyday healthcare. We own and commercialize branded, original over-the-counter products and prescription medicines. Our products are available in more than 60 countries, with Europe and the Nordic region as our core markets. Karo Pharma is headquartered in Stockholm, Sweden and listed on Nasdaq Stockholm Mid Cap.

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PHARMA TECH

TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

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BUSINESS INSIGHTS

EyePoint Pharmaceuticals announced a debt refinancing with Silicon Valley Bank for $45 million in credit facilities

EyePoint Pharmaceuticals, Inc. | March 10, 2022

A pharmaceutical company, EyePoint Pharmaceuticals, Inc.dedicated to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that it has entered into a loan agreement with Silicon Valley Bank to replace its existing credit facility with CRG Servicing LLC for senior secured credit facilities for $45 million (CRG). A $30 million term loan facility and an asset-based revolving credit facility of up to $15 million will be used to replace the existing approximately $40.5 million in liabilities under the previous CRG credit facility, according to the provisions of the new deal. The new facility represents a considerable improvement in economics, lowering the loan interest rate from 12.5 percent to a blended rate of around 5%, saving an estimated $2.8 million in annualized interest. The Silicon Valley Bank agreement stipulates the following: • A $30 million term loan facility with an interest rate equal to the higher of I the Wall Street Journal prime rate plus 2.25 percent or (ii) 5.50 percent. For the first two years of the term loan facility, just interest payments will be required; and • A $15 million asset-based revolving credit facility pays interest at the Wall Street Journal prime rate. The revolving credit facility's availability will be constrained by a borrowing base value of the Company's accounts receivable. “We are very pleased to enter into the new loan agreement with Silicon Valley Bank and replace our existing credit facility with improved economic terms. After strong execution in 2021, we ended the year with over $210 million of cash and investments, positioning EyePoint for these new credit facilities and further improving our balance sheet. We are grateful for the support of our partners at CRG, and we look forward to continued execution of our plan to meet near-term milestones and drive shareholder value.” George O. Elston, Chief Financial Officer of EyePoint Pharmaceuticals "We are delighted to support EyePoint in their pursuit of helping patients with serious eye disorders facing significant unmet need,” said Lauren Cole, Head of East Coast Biotech Credit Solutions at Silicon Valley Bank. “Their pipeline candidate, EYP-1901, a potential six-month intravitreal treatment targeting wet age-related macular degeneration, is a great example of what their proprietary Durasert® technology may accomplish." The terms of the new credit facility with Silicon Valley Bank will be disclosed in the Company's Annual Report on Form 10-K, which is scheduled to be filed with the Securities and Exchange Commission on or before March 11, 2022. The Company has $211.6 million in cash and investments as of December 31, 2021, including over $230 million from two successful follow-on equity offerings in 2021.

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