Pharma Tech

Innovation Zed Announce 2022 Launch of InsulCheck DOSE Add-on Technology for Insulin Pens

Zed | November 15, 2021

Innovation Zed, developer of novel diabetes management technologies headquartered at NovaUCD, at University College Dublin, Ireland are delighted to announce today the arrival of the much anticipated InsulCheck DOSE technology that will be coming to market in 2022.

"It is with great excitement that we announce the arrival of our InsulCheck DOSE by Innovation Zed. As the third generation product of the InsulCheck family, this technology has been a dream of our company from its very inception and this product is the culmination of over a decade of work to support multiple daily injection (MDI) pen users. We understood the difficult challenges presented by various injection pens and in particular the difficulties in working on a technology to reliably and accurately support low-cost disposable pens. This is the reason we at Innovation Zed took an incremental approach to developing the InsulCheck DOSE product.We have taken a unique approach in developing this technology by working closely with users, caregivers, software developers, medical device specialists and previous generations of InsulCheck products to design and develop a product that bolsters and supports the needs of all stakeholders.''


 Dr Dean Minnock, CEO at Innovation Zed

Innovation Zed has collaborated with SHL Medical in the development of InsulCheck DOSE. SHL Medical is a world-leading provider of drug delivery solutions and also offers design-to-build and contract manufacturing services for various medical products through its subsidiary, SHL Technologies.

What is InsulCheck DOSE?
InsulCheck DOSE is a single unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp, temperature and mounting/unmounting events. Through Bluetooth® Low Energy (BLE) technology, InsulCheck DOSE transmits these data points to a paired companion software platform in real time for inclusion in diabetes management therapy.

"InsulCheck DOSE technology supports MDI users by enhancing their traditional injection pen and transforming it into a smart pen that can optimise their treatment and reduce the stresses caused by MDI therapy. Through this technology we are enabling every MDI user to make their existing injection pen a smart pen without having to compromise or change from their existing HMO or health service provider" - said Dr Minnock.


InsulCheck DOSE Features
The technology utilises a multi-sensor approach to accurately detect and register the actual dosage dialled and provide an injection event time stamp to log the event. The incorporated temperature sensors constantly monitor the ambient temperature of the area surrounding the injection pen, providing safety notifications to the user if the surrounding temperature may affect the drug housed inside the pen. Using an OLED display, InsulCheck DOSE provides visual information and feedback to the user, helping improve best practice procedures. A rechargeable lithium battery powers the DOSE device and is capable of operating well over 1 week at a time between charges. As a BLE enabled product, all data captured by InsulCheck DOSE is transferred in real time to a paired mobile application. If the user does not wish or is unable to remain connected with a companion software platform, InsulCheck DOSE has built-in memory to store over 40 days' worth of injection history at a time. Through modification of the sleeve component and firmware refinement, InsulCheck DOSE can become applicable to all injection pens for various drug treatments. At launch, it will support a range of reusable and disposable injection pens on the insulin market from Novo Nordisk, Lilly and Sanofi.

"Our ability to learn, adapt and improve our technology is one of the key aspects of InsulCheck DOSE and one that separates us greatly from our competitors. The future-proof design of InsulCheck DOSE means that it can be adapted to support the various pen mechanisms in use today, whilst maintaining accuracy and reliability for the patient. Among the numerous unique features of this product is the built in Firmware Over The Air (FOTA) capability which allows continuous optimisation of the device's firmware even when deployed in the field. That future-proofing allows InsulCheck DOSE to adapt to physical injection pen variations from the pen manufacturers and improve on device performance 'on the go' from real world user behaviours" - said Dr Minnock.  

Value Proposition
The InsulCheck DOSE device helps patients, automatically track their daily injection and monitor treatment adherence. The intended use of InsulCheck DOSE is as a supporting component in a management ecosystem for therapy optimisation, remote monitoring and enhanced connected care. Dr Minnock explained, "InsulCheck DOSE is a disruptive technology that will revolutionise an entire market and change the lives of millions of MDI users worldwide. Innovation Zed have entered into discussions with market leaders in the diabetes management sector with the intention of finding a strategic global partner in taking this InsulCheck DOSE technology to the market. InsulCheck DOSE is an attractive offering to any organisation working in this space as it can significantly enhance their existing offering to become more competitive and command new growth and additional market share."

Conclusion
InsulCheck DOSE enters production at the end of Q2 2022 and will be available as an FDA registered and CE marked product. Manufacturing of InsulCheck DOSE will be handled by Innovation Zed's existing manufacturing partner SHL Technologies, a subsidiary of SHL Medical. If you wish to understand InsulCheck DOSE or any of our technology offerings in greater detail, please feel free to visit our website or reach out to us directly.

Spotlight

Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

Spotlight

Learn about the industry’s first pharmaceutical supply chain solution that is reducing the cost of care and ensuring access to critical medications for hospitals and health systems.

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Pharma Tech

PharmaKinnex and Data360 Team Up to Extend Client Reach and Improve Patient Access

PRNewswire | July 24, 2023

PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes. From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions. "The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector." Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage. "We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients." Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria. Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment. About PharmaKinnex PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems. About Data360 With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.

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Pharmacy Market

Vincerx Pharma Announces FDA Clearance of IND for VIP943

Globenewswire | August 23, 2023

Vincerx Pharma, Inc. a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943. Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023. "The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs. It combines an internalizing antibody binding to CD123, a novel KSPi payload, a selective and stable linker, and exclusive CellTrapper™ technology. We believe VIP943 has the potential to become a much needed treatment option for patients with acute myeloid leukemia (AML). We're eager to start the clinical program and unlock the potential therapeutic benefits of this compound." Dr. Hamdy concluded by saying, “2023 is shaping up to be a very positive year for Vincerx. Within the last eight months, we successfully filed two INDs (VIP236 and VIP943) and swiftly garnered clearance from the FDA within 30 days. We believe these accomplishments highlight the strength of our development, drug manufacturing, and regulatory expertise. Looking ahead, in addition to beginning our Phase 1 trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024. Collectively, these milestones support the potential for our strategy to develop small molecule and antibody-based conjugate therapies to improve the care of patients with cancer.” About VIP943 VIP943 is a novel ADC developed using Vincerx’s next-generation ADC technology designed to enhance intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to higher efficacy, while limiting unwanted side effects. VIP943 binds to CD123, a validated target in myeloid malignancies. Once inside of the cell, it releases its KSPi payload. Vincerx’s CellTrapper™ technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells. VIP943 has demonstrated increased survival and reduced tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models. In addition, Vincerx presented preclinical data on VIP943 at ASH 2022 demonstrating superiority against Mylotarg™, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release and demonstrated favorable safety in monkeys with an optimal drug, metabolism and pharmacokinetics profile. The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome (MDS). About Vincerx Pharma, Inc. Vincerx Pharma, Inc. (Vincerx) is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. The company’s diverse pipeline consists of the next-generation antibody conjugate, VIP943, on track to begin a Phase 1 study in early Q4 2023; small molecule drug-conjugate, VIP236, in Phase 1; preclinical antibody drug conjugate, VIP924; CDK9 inhibitor, enitociclib, currently in an NIH-sponsored Phase 1; and its next-generation modular bioconjugation platform.

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PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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