Acadias Nuplazid flops schizophrenia trial on the heels of DOJ marketing probe

Fiercepharma | July 23, 2019

Acadias controversial antipsychotic med Nuplazid has faced its share of scrutiny after a safety controversy drew federal eyeballs in March. Now, the drug has to contend with a trial setback in its pursuit of a first-ever add-on approval in schizophrenia. In a phase 3 trial testing Nuplazid as an add-on to antipsychotic treatment, the drug fell short of both its goals, Acadia said Monday. Collected after six weeks of treatment, the data did show a “consistent trend” in improving psychotic symptoms over placebo in adults who did not respond to previous treatment, Acadia said. It also improved patients’ Clinical Global Severity Score, the trial’s secondary endpoint, the company said. But in both cases, the numbers fell short of statistical significance. The trial was meant to support a new indication as the first schizophrenia med approved as an add-on to patients’ current antipsychotic therapy. The slip-up puts a damper on hopes for Nuplazid, which has been churning up sales growth despite a black box warning that drew media scrutiny after the drug’s approval in 2016.

Spotlight

Drug development is a highly complex regulated process that spans many years. Scientists must test thousands of potential drug candidates for every one drug that becomes available.

Spotlight

Drug development is a highly complex regulated process that spans many years. Scientists must test thousands of potential drug candidates for every one drug that becomes available.

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BUSINESS INSIGHTS

TriMas Announces Two New Acquisitions

TriMas | December 14, 2021

TriMas announced that it has recently signed agreements to acquire Omega Plastics to be added to TriMas Packaging, and TFI Aerospace to be added to TriMas Aerospace. Omega, located in Clinton Township, Michigan, specializes in manufacturing custom components and devices for drug delivery, diagnostic and orthopedic medical applications, as well as components for industrial applications. Omega leverages its advanced in-house tool making capabilities, ISO13485-certified injection molding facility and ISO Class 8 clean room to provide its customers a faster product development cycle, from prototype development, testing and validation, to short and medium run production and assembly. Omega is an approved vendor to several leading medical device companies, with a long track record of unparalleled service and quality. Omega currently operates as a private, family-owned company, and is expected to generate approximately $18 million in revenue in fiscal year 2021. “We are excited to announce the agreement between TriMas and Omega. We look forward to expanding Omega’s production capacity to benefit its customers’ longer-term needs, while also leveraging Omega’s advanced tool making capabilities to add rapid prototyping to enhance TriMas Packaging’s speed-to-market advantage on innovation and new product designs. The addition of Omega further expands our Pharmaceutical & Nutraceutical product offerings into additional medical applications, which we believe is an attractive market for long-term growth.” Thomas Amato, President and Chief Executive Officer of TriMas Located near Toronto, Canada, TFI is a leading manufacturer and supplier of specialty fasteners used in a variety of applications, predominantly for the aerospace end market. TFI currently operates as a private, family-owned company, and is expected to generate approximately $6 million in revenue in fiscal year 2021. “In addition to expanding TriMas Packaging through the acquisition of Omega, we are also pleased to announce the acquisition of TFI,” Amato continued. “This acquisition will further expand TriMas Aerospace’s fastener product lines with the addition of complimentary niche products that have an exciting growth trajectory resulting from TFI’s new program wins and the overall aerospace market recovery. We anticipate TFI’s customers will benefit from the added innovation and manufacturing depth offered by TriMas Aerospace, while TriMas Aerospace’s customers will enjoy additional product offerings.” Amato continued, “We continue to execute on our core strategy of augmenting our growth through bolt-on acquisitions by leveraging our strong cash generation. After closing these two acquisitions, we expect our net leverage ratio to remain below 2.0x, providing ample capacity to execute on additional bolt-on acquisitions while also returning capital to shareholders through dividends and share buybacks.” TriMas expects to close on Omega by the end of the year, and closed on TFI simultaneously with signing. “We look forward to welcoming both Omega and TFI to the TriMas family of businesses,” concluded Amato. About TriMas TriMas is a global manufacturer and provider of products for customers primarily in the consumer products, aerospace and industrial markets, with approximately 3,300 dedicated employees in 11 countries. We provide customers with a wide range of innovative and quality product solutions through our market-leading businesses. Our TriMas family of businesses has strong brand names in the markets served, and operates under a common set of values and strategic priorities under the TriMas Business Model. TriMas is publicly traded on the NASDAQ under the ticker symbol “TRS,” and is headquartered in Bloomfield Hills, Michigan.

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PHARMA TECH

Vivera Receives 3rd U.S. Patent Allowance for ZICOH Drug Delivery Device

Vivera Pharmaceuticals, Inc. | May 26, 2022

Vivera is pleased to announce the allowance of its third U.S. patent for ZICOH™, the Company's high-tech, electronic dose-controlled portfolio of drug delivery devices. The patent allowance from the U.S. Patent and Trademark Office secures ZICOH's rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules, and tablets. ZICOH is an electronic dose-controlled delivery device and technology designed to enable real-time communication through the drug supply chain, from drug manufacturers, distributors, and wholesalers to pharmacists, providers, physicians, caregivers, and patients. The device can be programmed to dispense the medication dosage type, amount, and frequency according to the health care provider's orders to ensure compliance with dispensed prescriptions while also implementing controls to help prevent medication misuse and abuse. Later versions of the device will also implement user authentication features, such as fingerprint authorization and facial recognition, to help prevent prescription drugs from being diverted. Medication reminders are another core feature of ZICOH. These reminders can be programmed into the device by the pharmacist per the physician's orders to alert the patient when it's time to take their medication. This feature can be particularly beneficial for patients who forget to take medications on time or for patients and caregivers who manage multiple medications. "ZICOH is a major innovation in the medical device and technology sectors. This device is going to make it easier than ever for patients to comply with their medication regimens, regardless of how complex they are." Mehdi Hatamian, Ph.D., Chief Scientific Advisor for Vivera This third patent differs from the device's two previously issued patents in that it specifically pertains to the dispensing of tablets, capsules, and pills. The device has already secured its patent rights as a secure, smart liquid and inhaler delivery device with automated dose delivery, measurement, and management. "We are proud of the progress we have made on the development of ZICOH's multiplatform uses and technology," said Paul Edalat, CEO and Chairman of Vivera. "The way that Tesla revolutionized the automotive industry, and the way Apple created a category for smart devices, is what Vivera is doing to the prescription dispensing industry. ZICOH will forever change the way that medications are prescribed and dispensed, and Vivera is reaching the milestones to get there in a fraction of the time projected." Vivera is looking forward to bringing ZICOH to market. The Company has already initiated the device's design and is looking forward to having a working prototype by late summer 2022. About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH™, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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PHARMACY MARKET

Sensyne Health and Phesi Form a Joint Commercial Development Partnership with a Leading Pharmaceutical Company

Sensyne Health, Phesi | May 24, 2021

Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc. Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client. This collaboration's financial terms have not been disclosed. About Sensyne – Phesi Strategic Alliance Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients. About Sensyne Health Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines. About Phesi Inc. Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.

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