Could FTC scrutiny of the Roche-Spark merger scuttle future pharma deals? Analysts are fretting

FiercePharma | August 02, 2019

When Roche delayed its planned 4.8 billion dollars purchase of gene therapy developer Spark Therapeutics for the fifth time earlier this week, citing the Federal Trade Commissions FTCs review of the deal, one burning question emerged among pharma watchers- What the heck is the FTCs problem? Shortly thereafter, another troubling question bubbled up- If the FTC is going to be this nitpicky about one giant pharma company’s effort to buy a relatively small player, could that end up scuttling future deals? Bloomberg surveyed nine firms that specialize in mergers and acquisitions, and six of them said they're worried the FTC has changed its approach to reviewing deals. A similar majority said the change—which has yet to be fully understood—could give future dealmakers second thoughts. “You have to start wondering if this scrutiny will slow down or prohibit these kinds of deals, which would be a huge deal for the sector,” said Brad Loncar, CEO of Loncar Investments, in an interviewwith Bloomberg.

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Somalia's first pharmaceutical factory since the start of the country's civil war has opened its doors in Mogadishu. The Horn of Africa nation has not had such a firm operating there since the breakout of violence in the country three decades ago.

Spotlight

Somalia's first pharmaceutical factory since the start of the country's civil war has opened its doors in Mogadishu. The Horn of Africa nation has not had such a firm operating there since the breakout of violence in the country three decades ago.

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RESEARCH, BUSINESS INSIGHTS

Allucent Extends Medidata Clinical Cloud Usage to Expedite New Drug Development

Medidata Solutions | March 13, 2023

Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering. This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology. Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders. Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization. Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals." (Source – Business Wire) About Medidata Solutions Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.

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BUSINESS INSIGHTS, PHARMACY MARKET

Cytel and GSK Advance Clinical Trial Design with Solara

Cytel | February 09, 2023

On February 7, 2023, Cytel Inc., a provider of statistical software and advanced analytics in the life sciences industry, announced that GSK, one of the world's top biopharmaceutical firms, signed a three-year strategic agreement to increase GSK’s deployment of the clinical strategy platform Solara (R). This agreement will contribute significantly to the future development of the Solara platform. The platform can help GSK effectively align on trial goals, traverse trial uncertainties, and create pressure-tested clinical trial designs that reduce costs and expedite speed up to the market. GSK began using Solara in early 2022 and has already profited from the platform in a variety of study design projects. Over 300 users have adopted Solara at the top 20 biopharma firms worldwide since its initial debut in 2021. It is also the recipient of the 2022 Fierce Life Sciences Award for Technology Innovation. Solara blends Cytel's proprietary algorithms evolved over three decades with enormous cloud computational capacity to overcome limits in clinical trial planning and design. Clinical development teams use Solara to quickly generate thousands of trial models representing thousands of design variants. These are used to pressure-test dozens of trial uncertainties, including treatment effect and enrollment rate. The platform's high-speed processing capabilities simulate tens of millions of modeled events that might occur during trial execution in minutes. In addition, Solara's visualizations make it simple to review results and quantify scientific and business trade-offs. The user-friendly interface and dynamic visualization of Solara provide a common language and workspace to facilitate a more data-driven and collaborative trial design process across clinical development functions. About Cytel Founded in 1987, Cytel is the leading provider of statistical tools and advanced analytics for the design and execution of clinical trials. It helps life sciences decision-makers to realize the full potential of their products. Its 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical firms transform insight into confident decisions, from navigating uncertainty to establishing value. The company has an unwavering dedication to scientific rigor and operational excellence, which is directed via its offices in the United Kingdom, North America, Europe, and Asia.

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PHARMACY MARKET, PHARMA TECH

Capsida Biotherapeutics and AbbVie Announce Expansion of Collaboration

Capsida Biotherapeutics | February 27, 2023

Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration. The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021. As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales. Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development. Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases." (Source- PR Newswire) About Capsida Biotherapeutics Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.

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