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

This pharma messaging guidebook features 20 proven cognitive science techniques that can be used to optimize pharmaceutical claims and messages. 

Spotlight

This pharma messaging guidebook features 20 proven cognitive science techniques that can be used to optimize pharmaceutical claims and messages. 

Related News

BUSINESS INSIGHTS, PHARMACY MARKET

Caris Life Sciences and Xencor Expand Target Discovery Collaboration

Caris Life Sciences and Xencor | January 06, 2023

Caris Life Sciences®, a molecular science and technology company, and Xencor, Inc., a clinical-stage biopharmaceutical company, have announced that they will work more closely together to research, develop, and sell new bispecific and multispecific XmAb® antibodies. This expanded relationship will boost the number of targets and cancer types that Caris will investigate with Caris Discovery, a proprietary multi-omics discovery engine platform. The foundation for drug candidate development on Xencor's XmAb platform will be novel targets and their accompanying validation packages. Under the terms of the new contract, Xencor will receive worldwide commercial rights to study, develop, and market products aimed at up to three targets discovered through collaboration. In addition, Caris will get an upfront payment and may receive up to $187 million in commercial milestone payments and development. The company will also be eligible for royalties on the net sales of products commercialized as a result of the agreement, as well as future rights for molecular profiling and companion diagnostics. Caris Discovery leverages the collective force of its unmatched platform by combining the data generated from the primary patient tissues' molecular interrogation using ADAPT™, which integrates the company's extensive catalog of molecular and clinical data. About Caris Life Sciences Caris Life Sciences® is a Texas-based molecular science firm revolutionizing healthcare. Its market-leading molecular profiling products analyze DNA, RNA, and proteins to produce a molecular blueprint. This plan shows how patients, doctors, and researchers can use the information to improve outcomes and save lives. The company also uses cutting-edge algorithms for artificial intelligence (AI) and machine learning (ML) to improve precision medicine. About Xencor Xencor develops modified antibodies and cytokines for cancer and autoimmune illnesses. More than 20 XmAb® candidates are in clinical development while three are sold by partners. The company’s XmAb technology modifies protein structures to create new therapeutic pathways.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Avita Acquires Q Care Plus, Renames It Avita Care Solutions

Avita Care Solutions | January 10, 2023

PMQ Investors, LLC, the parent company of Avita, has acquired Q Care Plus, Inc. This community-focused care management solution offers stigma-free access to care via telehealth, focusing on telePrEP services. Meanwhile, the terms and conditions of the deal are yet to be revealed. "Bringing Avita and Q Care Plus together comes at a time when reducing health inequities among underserved populations is more critical than ever," said Avita Chief Executive Officer Michael Yount. He further added, "A multiyear pandemic, partisanship-based politics that limit health care rights, and long-standing stigma, fear, and discrimination against marginalized populations like the LGBTQ+ community have exacerbated existing obstacles to health care and created a host of new ones." (Source: PR Newswire) Avita can now broaden its commitment to a community care management strategy that eliminates obstacles for patients and covered entities throughout the care continuum due to its acquisition of Q Care Plus. The company promotes patients' and covered entity partners' capacity to acquire culturally competent LGBTQ+, HIV, PrEP, and sexual wellness care by providing comprehensive access to pharmacy services, 340B program administration, clinical care delivery, and digital health choices. Avita is transitioning to Avita Care Solutions in light of its recent growth. This brand will encompass Avita Pharmaceutical, the company's pharmacy services section, and AvitaCare Atlanta, its new Atlanta medical and primary care center and pharmacy previously owned by AbsoluteCare. There are no plans to rebrand Q Care Plus' digital health platforms. In 2023, Avita will start selling Q Care Plus under the Avita family of brands. About Avita Care Solutions Avita Care Solutions is committed to improving health equity by giving underserved communities comprehensive, caring, and all-inclusive health care and pharmacy services. Its strategy for managing care in the community makes it possible for patients and covered entities to eliminate barriers across the care continuum. Over 145,000 patients and 320+ covered organizations at 65+ locations benefit from Avita's community care management strategy, which includes pharmacy services, program administration, digital health, and clinical care delivery.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Curia Collaborates with Corning to Advance Biopharmaceutical Continuous-Flow Development and Manufacturing Programs

Globenewswire | March 24, 2023

Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API). Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products. “Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.” The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards. “Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.” “Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza. Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives. About Curia Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.

Read More