Amgen, maker of Enbrel, to pick up Celgenes Otezla for 13.4B Dollars. Will FTC hit back?

FiercePharma | August 26, 2019

Looks like Amgen might not be buying Alexion Pharmaceuticals after all. Instead, its beefing up in psoriasis, where it already sells blockbuster TNF inhibitor Enbrel. Amgen Monday said it will take in Celgenes Otezla for 13.4 billion dollars in cash, a purchase that could help Bristol-Myers Squibb move along with its planned acquisition of Celgene for 74 billion dollars, per an agreement with U.S. antitrust authorities. The dollar amount easily dwarfs some recent biopharma deals for entire companies, showing enthusiasm over the immunology and inflammatory markets, led by the world’s best-selling drug and Enbrel rival, Humira. And it’s significantly above the price tag analysts have previously estimated for Otezla, suggesting an intense bidding process for the fast-growing psoriasis drug whose second-quarter sales increased by 31% year over year, to $493 million. “Otezla represents an exciting opportunity to strengthen Amgen's presence in inflammation and continue Amgen's geographic expansion,” Amgen CEO Robert Bradway said in a statement. Otezla is an attractive product that, while still in the early stages of its life cycle, is already raking in blockbuster sales. But Bristol was forced to sell Otezla to win the U.S. Federal Trade Commission's (FTC's) clearance simply because it overlaps with BMS’ own investigational TYK-2 inhibitor, BMS-986165. How will the anti-competition watchdog allow two marketed blockbuster drugs in the same indications to be housed under the same roof?

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Pharma Tech

Ozette Technologies Announces New Collaboration with Umoja Biopharma to Accelerate Biomarker Discovery in Preclinical Studies

Businesswire | June 28, 2023

Ozette Technologies, Inc., a technology-driven life sciences company, announced its collaboration with Umoja Biopharma, Inc., a transformative immuno-oncology company creating off-the-shelf treatments for solid and hematologic cancers. Umoja will use Ozette’s AI-powered single-cell technology for their preclinical studies. As part of this work, the Ozette Platform™ will be used to provide research and development (R&D) support and evaluate biomarker endpoints from preclinical tumor-bearing, humanized mouse models. Humanized mouse models are often deployed in preclinical studies as a tool for modeling human immune responses in the evaluation of potential therapeutics and treatment effects before first-in-human studies. The goal of this collaboration is to help derive insights that have the potential to catalyze Umoja’s therapeutic program development. “Our mission is to unlock the power of the immune system using computation and machine learning. As a result, we can quickly understand how the immune system is evolving and what that means for a therapy and a patient at the single-cell level,” said Dr. Ali Ansary, CEO and Co-founder of Ozette. “This collaboration with Umoja is an important opportunity to continue showcasing Ozette’s technology and innovative impact on the vast variety of therapeutic indications, including cutting-edge T-cell treatments.” Umoja and Ozette share a common mission to increase the efficiency of drug development and expand access to transformative immunotherapies through technology innovation. The partnership will leverage Ozette Endpoints™ and Ozette Discovery™ to enable both companies' multidisciplinary scientific and bioinformatic teams to collaborate and expand the benefits of CAR T-cell immunotherapy to patients in need. “Our collaboration with Ozette is the next step in expanding the value of our preclinical data by leveraging their advanced single-cell technology,” said Ryan Larson, Ph.D., Senior Vice President of Translational Science at Umoja. “The Ozette Platform will allow us to efficiently distill complex biology, that traditionally relies on manual analysis, into actionable insights rapidly. Together, we’re able to gather a deeper and wider set of preclinical insights from our data which, in turn, allows us to increase the efficiency of developing our transformative therapeutics. We’re excited to expand our R&D efforts with Ozette on broader applications at Umoja.” About Ozette Ozette Technologies, Inc. is engineering a transformative leap in measuring and understanding the immune system. The Seattle-based life sciences company is building a groundbreaking high-resolution, single-cell immune monitoring platform and corpus of high-resolution data leveraging its differentiated novel ML technologies. Ozette’s Assay-to-Insights product launch combines three technologies developed by the company: world-class data generation at the Ozette Laboratory under Good Clinical Laboratory Practices (GCLP) guidelines, rapid computational monitoring of pre-defined biomarker endpoints using Ozette Endpoints™, and unbiased discovery and annotation of single-cell data through Ozette Discovery™. Insights generated from Ozette Endpoints™ and Ozette Discovery™ are made available through the Ozette Platform™, a cloud-based system that leverages automation enabling scientific teams to interact and explore their data. Founded in late 2020, Ozette was spun-out of the Fred Hutchinson Cancer Center and incubated at the Allen Institute for AI. Ozette has since published their technology in a number of journals including Nature, Science, and Cell. Ozette’s interdisciplinary team is made up of a deep bench of scientists, statisticians, engineers, and designers with a wide range of experience spanning Genentech, Google, Microsoft, Amazon, Airbnb, and more. Ozette’s team also includes leaders and pioneers in the field of medical research and single-cell analysis, including founders: physician Ali Ansary, and scientists Greg Finak, Evan Greene, and Raphael Gottardo. Ozette believes that mapping and studying the complexity of the immune system unlocks insights that accelerate research and ultimately derive better immunotherapies; we believe in better data. About Umoja Biopharma Umoja Biopharma, Inc. is an early clinical-stage company advancing an entirely new approach to immunotherapy. The Company is a transformative multi-platform immuno-oncology company founded with the goal of creating curative treatments for solid and hematological malignancies. Founded based on pioneering work performed at Seattle Children’s Research Institute and Purdue University, Umoja’s novel approach is powered by integrated cellular immunotherapy technologies including the VivoVec™ off-the-shelf in vivo delivery platform, the RACR™/CAR in vivo cell expansion/control platform, and the TumorTag™ targeting platform. Designed from the ground up to work together, these platforms are being developed to create and harness a powerful immune response in the body to directly, safely, and controllably attack cancer. Umoja believes that its approach can provide broader access to the most advanced immunotherapies and enable more patients to live better, fuller lives.

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Pharmacy Market

Evolution Health Announces Revolutionary Technology Platform to Transform Stakeholder Engagement and Actively Measure Their Impact for Pharmaceutical

prnewswire | September 01, 2023

Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities. This state-of-the-art platform is geared towards three core functionalities Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business. Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement. Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises. "The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group. The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand. This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences. About Evolution Health Group Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.

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Research

Cipher Partner, Moberg Pharma Announces Approval for MOB-015 in the European Union

Newswire | July 05, 2023

Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate. MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023. Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having over 90% market share. Craig Mull, Interim CEO of Cipher commented, "This is a fantastic achievement whereby the European Union has recognised MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible." Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023. About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticalsis a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. About Moberg Pharma Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023.

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