In a crowded psoriasis field, who could nab Celgene’s Otezla-and at what price?

Bristol-Myers Squibb | July 02, 2019

Antitrust regulators recently surprised industry watchers with the stipulation that Bristol-Myers Squibb sell Celgene's Otezla to win U.S. clearance for its $74 billion merger. But since then, as there’s no way around it, analysts have pulled out their calculators trying to put a dollar figure on the drug. Otezla could get Bristol about $5.4 billion, Bernstein analyst Ronny Gal said in a Monday note to clients. But his peers at Credit Suisse, Jefferies, RBC Capital and Wolfe Pharma are modeling around $8 billion to $10 billion. As Gal put it: “This is primarily a question of IP. Most of the patents around Otezla expire in September 2023, Gal noted. There is one patent covering its use in psoriatic arthritis that expires in 2034, which Gal said could be bypassed because it’s a small carveout covered by what’s known as a section VIII statement under Hatch-Waxman, where a generic drugmaker can seek approval by carving out a protected indication.

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Meet students from the Tomodachi J&J Disaster Nursing Training Program in this video—and learn why, after the disaster, they decided to become nurses.

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Meet students from the Tomodachi J&J Disaster Nursing Training Program in this video—and learn why, after the disaster, they decided to become nurses.

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GenScript Receives FDA Emergency Use Authorization for World's First SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript | November 09, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2.

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PHARMA TECH

assisTek Announces New Partnership with Medical Device Technology Creator, Strados Labs

assisTek Inc | June 21, 2022

assisTek, based in Doylestown, PA, has announced its latest partnership with Philadelphia based Strados Labs. Strados Labs is known for their creation of cutting-edge smart technology medical devices for respiratory illnesses. assisTek, has been a longtime leader in the eSource industry across various therapeutic areas, over 900+ Global clinical Trials and offers an array of services for the electronic collection of clinical data. Their technology offerings include eCOA, ePRO, eConsent, BYOD modules and an extensive reputation for their custom solutions to support clinical trial teams worldwide. "We are very excited to announce this partnership and are looking forward to working together with Strados to provide another way for clinicians and patients to gather novel information during their trials. By making the integration seamless into our current eDiary offerings, this paired technology will allow for better patient engagement and more efficient information gathering, with the ultimate goal of improved data for cures and treatment of these conditions," explains Richard Gastineau, CEO of assisTek. Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. "We are grateful and proud to solidify our partnership with assisTek. They have been a leader in integrating technology and data collection in clinical trials for over 20 years," said Strados Labs Director of Business Development, Shane Krauss. "We look forward to working with their experienced and knowledgeable team in clinical trials by helping them scale their digital therapeutics using our clinically validated measures for wheeze, cough, and other adventitious breath sounds, or CABS—which is something no other cleared device can measure." The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados recently received FDA Class II 510(k) clearance for home use of its first product, RESP®, its second FDA clearance in less than 18 months. RESP® was also granted a CE Mark late last year. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, and more)—with plans to add heart failure and pediatrics later this year. The Company is based in Philadelphia and is a privately held company.

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PHARMA TECH

Confo Therapeutics Enters Collaborative Agreement with Regeneron

Confo Therapeutics | December 01, 2021

Confo Therapeutics announced that it has entered into a collaborative agreement with Regeneron Pharmaceuticals, Inc. whereby Confo’s technology platform, which uses conformationally selective VHH antibodies – ConfoBodies® – to stabilize GPCRs in disease-relevant conformations, will be applied with the goal of enabling the discovery of novel therapeutic antibody drug candidates. The agreement will leverage Confo’s expertise in addressing two GPCR targets for which functional antibodies are needed. Confo will be entitled to an upfront payment, research funding, and potential clinical, regulatory, and commercial payments. Further details regarding the agreement have not been disclosed. Confo’s ConfoBody-based technology platform aims to overcome the limitations of drug discovery on GPCRs, the largest and most diverse group of membrane receptors targeted by approximately 30% of all commercialized drugs. “With ten medicines approved by regulatory authorities, Regeneron is regarded in our industry as one of the most effective antibody discovery and development companies, with a successful track record of translating scientific insight into effective and innovative treatments. Working with them underscores the significant potential of our technology platform, in particular our new application to generate antibody drug candidates, and its promise to unveil GPCR drug targets and overcome a range of limitations of current approaches,” Cedric Ververken, Chief Executive Officer of Confo Therapeutics Christel Menet, Chief Scientific Officer of Confo Therapeutics added: “We value this opportunity to showcase the strength of this new addition to our technology suite and participate in what we hope will be the development of successful new antibody-based therapies. Parallel to this, we continue on our own drug development path, and drive innovative small molecule and biological therapeutics into our own pipeline.” About Confo Therapeutics Confo Therapeutics’ unparalleled technology stabilizes functional conformations of GPCRs to uncover a wide range of previously inaccessible drug targets. This platform combined with the pharmacologic and biologic insight it provides, allows Confo to build a multi-indication pipeline of drug candidates with the vision of transforming therapeutic outcomes for patients with severe illnesses lacking disease-modifying treatments. Confo Therapeutics was spun out of Vrije Universiteit Brussel and VIB in 2015. Supported by international life-science focused investors and led by an experienced team of entrepreneurial professionals and scientists from successful biopharmaceutical companies, Confo Therapeutics benefits from the rich scientific and innovative ecosystem in Belgium.

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