Pfizer announces positive dermatitis therapy phase III results

pharmatimes | May 16, 2018

Pfizer has announced that its investigational oral Janus kinase 1 (JAK1) inhibitor abrocitinib (PF-04965842) has met all co-primary and secondary endpoints in a pivotal Phase III study evaluating safety and efficacy in patients aged 12 and older with moderate to severe atopic dermatitis. The positive top-line results came from a randomised, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses - 100mg and 200mg once daily - of abrocitinib monotherapy over 12 weeks. By week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo, demonstrating response to treatment for a statistically significant number of patients during the first two to four weeks following first dose.

Spotlight

The information contained in this document is the proprietary and exclusive property of the National Council for Prescription Drug Programs, Inc. (NCPDP) except as otherwise indicated. No part of this document, in whole or in part, may be reproduced, stored, transmitted, or used for design purposes without the prior written permission of NCPDP.

Spotlight

The information contained in this document is the proprietary and exclusive property of the National Council for Prescription Drug Programs, Inc. (NCPDP) except as otherwise indicated. No part of this document, in whole or in part, may be reproduced, stored, transmitted, or used for design purposes without the prior written permission of NCPDP.

Related News

Preparation products of Yiling Pharma approved by FDA for launch in the US market

Yiling Pharmaceutical Co | September 19, 2020

Yiling Pharmaceutical Co., Ltd. announced on Friday that it had received the approvals of the Abbreviated New Drug Applications (ANDA) about Lisinopril Tablets and Acyclovir Capsules, from United States Food and Drug Administration (hereinafter referred to as the "FDA"), which were submitted by Yiling Wanzhou International Pharmaceutical Co., Ltd., one of the wholly-owned subsidiaries of Yiling Pharmaceutical Co., Ltd., meaning that these products are approved to be produced and sold in the U.S. market. The announcement showed that Lisinopril Tablets are mainly used for the treatment of essential hypertension (EH) and renal vascular hypertension (RVH) and were originally researched and developed by Astrazeneca and approved for launch in the United States in 1988. Currently its licensed producer is Alvogen Malta Operations Ltd., and the major manufacturers of its generic drugs are Casi, Ascent, and etc. in the United States. In addition to the originally researched and developed drugs, there are 11 producers for the generic drugs in China, among which, only one has passed the consistency evaluation. According to the IMS database, the saleroom of Lisinopril Tablets was about USD 131.39 million in the U.S. market in 2019.

Read More

PHARMACY MARKET

Insilico Medicine Announced Strategic Collaboration with EQRx

Insilico Medicine | March 25, 2022

A clinical-stage end-to-end artificial intelligence driven drug discovery firm, Insilico Medicine announced the formation of a strategic partnership with EQRx, a company dedicated to creating and delivering novel medications to patients at much-reduced costs. The cooperation will use Insilico's Pharma.AI technology to accelerate the design and creation of de novo small molecules and EQRx's clinical development and commercialization experience. In addition, EQRx and Insilico will form a co-development partnership in which each party will get a profit share according to its investment level. The collaborative agreement identifies and selects up to three therapeutic targets using Insilico's AI-powered platform, Pharma. AI. From small molecule hit identification through lead optimization and preclinical candidate nomination, Insilico will guide the drug discovery process. EQRx will be in charge of clinical development, regulatory affairs, and commercialization. In addition, Insilico may invest in the product candidate(s) at different phases of clinical outcome in exchange for enhanced commercialization income. "Both EQRx and Insilico Medicine strive to accelerate the discovery and development of new medicines and make effective therapeutics more accessible and affordable. This partnership will combine our end-to-end AI-powered drug discovery capabilities with EQRx's innovative partnership model and expertise in clinical development and patient access to accelerate innovative therapies' discovery and development, " Alex Zhavoronkov, Ph.D., founder and founder CEO of Insilico Medicine "We are pleased to partner with Insilico Medicine, a leader in AI-based drug discovery," said Carlos Garcia-Echeverria, Ph.D., chief of Rx Creation at EQRx. "This collaboration will further expand our early-stage R&D efforts to fuel potential pipeline growth as we continue to apply the best of today's innovation in biomedical sciences and digital solutions to discover high-quality, innovative, and more affordable medicines."

Read More

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.

Read More