Alexion bets $1.4B on Portola and its laggard bleeding drug Andexxa

Fiercepharma | May 05, 2020

Alexion bets $1.4B on Portola and its laggard bleeding drug Andexxa
Alexion has made no secret of its plan to diversify beyond its blockbuster rare disease franchise. Now, the company has taken a flier out on a disappointing drug that targets severe bleeding—and it's hoping to parlay its hospital contacts into a sales boost that'll appease unruly investors. Alexion agreed to buy Portola Pharmaceuticals and its sole approved medicine, anticoagulant reversal agent Andexxa, in a deal valued at around $1.4 billion, the drugmakers said Monday. That's $18 per share in cash—a 131% premium on Portola's Monday closing price of $7.76 per share. The Portola buyout will take Alexion beyond a rare-disease portfolio dominated by blockbuster C5-inhibitor Soliris and follow-up drug Ultomiris. The centerpiece of the deal is a bleeding reversal agent, Andexxa, designed for patients using two common anticoagulant drugs, Xarelto and Eliquis. So far, Andexxa has delivered disappointing sales, but Alexion still sees promise—even if it'll take a while for that promise to pay off.

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If you have ever worked with Orphan Drugs, you know finding appropriate patients is a major commercial challenge. Pharmaceutical sponsors of Orphan Drugs often lack the infrastructure and capabilities necessary to identify physicians who diagnose, treat, and manage these rare patients. TrialCard developed a proven model for making this critical match and has helped many patients gain access to the therapy they so desperately need.

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PHARMA TECH

TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

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Novartis research shows technology talent increasingly drawn to pharma industry since COVID-19

Novartis | June 26, 2020

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Coronavirus tracker: Gilead's remdesivir; White House's vaccine project; Pfizer, BioNTech's vaccine progress; AstraZeneca's pipeline

Fiercepharma | April 29, 2020

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Spotlight

If you have ever worked with Orphan Drugs, you know finding appropriate patients is a major commercial challenge. Pharmaceutical sponsors of Orphan Drugs often lack the infrastructure and capabilities necessary to identify physicians who diagnose, treat, and manage these rare patients. TrialCard developed a proven model for making this critical match and has helped many patients gain access to the therapy they so desperately need.