Phase 1 Clinical Trial for Coronavirus Vaccine Begins in Seattle

PharmaNewsIntelligence | March 17, 2020

Phase 1 clinical trials for a coronavirus vaccine have begun at Kaiser Permanente Washington Health Research Institute (KPWHR) has begun, according to a statement from the National Institutes of Health. The investigational vaccination, funded in part by the National Institute of Allergy and Infectious Disease, began today by administering the first immunization to a healthy adult between ages 18 and 55 years old. In total, the phase 1 clinical trial will enroll 45 adults who fit this criteria and investigate outcomes over a six-week test period.

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BUSINESS INSIGHTS, PHARMA TECH

Kindeva and Meridian Combine: Create Leading Drug-Device Combination Product CDMO

Kindeva and | December 13, 2022

Kindeva Drug Delivery and Meridian Medical Technologies announced the completion of the transaction to combine the two companies. The combination has created a leading global contract development and manufacturing organization focused on drug-device combination products. The combination will operate under the Kindeva name, with Meridian operating as, “Meridian Medical Technologies, a Kindeva Company”. The new Kindeva will have a broader range of drug delivery capabilities, with expertise and technology spanning the parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, formerly the CEO of Meridian, has been named CEO of the newly combined company. “The combination of Kindeva and Meridian creates a clear market leader in the drug-device CDMO sector. Customers will benefit from our enhanced scale and broader array of drug delivery solutions,” Boyer Kindeva, formerly known as 3M Drug Delivery Systems, was acquired by Altaris, LLC in 2020 from 3M Company. Kindeva is a global leader in drug-device combination products with a focus on inhalation, transdermal, and intradermal drug delivery. The company has a long track record of innovation, having invented the first metered dose inhaler in the 1950s. Meridian was acquired by Altaris in December 2021 from Pfizer Inc. Meridian is a leading manufacturer of emergency autoinjectors, having pioneered the emergency autoinjector technology in the 1950s. Meridian owns over 300 patents related to autoinjector drug-device combination products. ArentFox Schiff LLP and Kirkland & Ellis LLP acted as legal counsel. JPMorgan Chase Bank, N.A., Truist Securities, Inc. and KeyBanc Capital Markets Inc. acted as joint lead arrangers for the transaction. About Kindeva Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including autoinjectors, inhalers, transdermal patches, and microneedles. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. About Altaris, LLC Altaris is a healthcare investment firm with an exclusive focus on building companies that deliver value to the healthcare system through innovation and efficiency. Since inception in 2003, Altaris has invested in 49 healthcare companies which have generated significant value appreciation for its investors. Altaris is headquartered in New York City and manages approximately $5 billion of equity capital.

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PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

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RESEARCH, PHARMA TECH

OM1 Releases Analytic Reports, Uncovering Medication Discontinuation in Patients

OM1 | February 06, 2023

OM1, a leading real-world data, results, and technology firm focused on chronic diseases, recently announced the release of its Reasons for Discontinuation (RfD) Analytic Reports. Utilizing the OM1 Real-World Data CloudTM, Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports provide difficult-to-obtain, extremely valuable discontinuation trends for cDMARDs, bDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions. Each year, millions of Americans cease their prescriptions prematurely, costing the pharmaceutical industry in the United States an estimated $250 billion in lost income and can affect the health of these patients. Therefore, it is crucial for pharmaceutical businesses to comprehend patient discontinuation patterns so they may act on information regarding tolerability, costs, and emerging contraindications to enhance the patient experience. Prior to this point, it was extremely difficult to extract these insights due to the fact that crucial information was not reflected in claims or any other sort of structured data but was only available in clinical notes. OM1 is elevating the clinical narrative into actionable insights that pharmaceutical companies can rely on to comprehend patient adherence and clinician prescribing behavior, thanks to its data cloud built on billions of data points from over 300 million patients and unique AI and modeling capabilities. The analyses, which are conducted across multiple strata, such as demographic groups, patient characteristics, medical histories, comorbidities and care pathways, extract insights from the extensive clinical data sets available to OM1 and notes from prescribing clinicians dating back to 2013. Currently, accessible RfD reports include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and atopic dermatitis, with more to come, including schizophrenia, depression, and bipolar illness. About OM1 Founded in 2015, OM1 is a renowned health outcomes, and registries firm focused on treatment outcome measurement, comparison, and prediction. OM1 created the first intelligent data cloud for healthcare, leveraging big data, standardized outcomes measurement, and artificial intelligence technologies to provide more precise information and improve decision-making for stakeholders across the healthcare ecosystem. The company is reimagining real-world data and evidence in immunology, cardiometabolic, mental health and neurosciences, respiratory and ENT specialty areas by establishing vast electronically connected networks of clinicians and health data.

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