Mallinckrodt postpones split-up plan as opioid lawsuits cloud spinoffs future

FiercePharma | August 06, 2019

Mallinckrodt postpones split-up plan as opioid lawsuits cloud spinoffs future
Mallinckrodt thought it had a plan to rehabilitate its image, rid itself of low-performing products and banish at least some of its legal problems. But now its put that plan on hold. The Irish drugmaker said Tuesday it had postponed plans to spin off its specialty generics business as potential settlements in numerous opioid lawsuits against the company have created uncertainty about the to-be-independent units future cash flow. Mallinckrodts spinoff plan, announced in December, would create a new company under the Mallinckrodt name consisting of its specialty generics products, including oxycodone; active pharmaceutical ingredients; and the constipation drug Amitiza. What's left over—the company's specialty brands, including H.P. Acthar Gel—would operate under a new, as-yet-undetermined name and without the burden of potentially hefty opioid liabilities. The idea isn't dead, but now isn't the time, the company said Tuesday. “Mallinckrodt continues to actively consider a range of options intended to lead to the ultimate separation of the Specialty Generics business, consistent with its previously stated strategy,” the drugmaker said in a second-quarter earnings release Tuesday. Mallinckrodt is one a group of opioid makers that have been targeted in hundreds of lawsuits for their aggressive marketing as the nation’s addiction epidemic raged. In April 2018, the drugmaker was subpoenaed by a U.S. Attorney’s Office in Florida; it already faced civil investigative demands from officials in Missouri, Washington and Kentucky and subpoenas from New Hampshire, Kentucky and Alaska.

Spotlight

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. To achieve that goal, Congress created a program that requires pharmaceutical manufacturers to provide discounts on outpatient prescription drugs to entities that serve high numbers of uninsured indigent patients. This program, as originated, provided discounts to outpatient facilities for the purpose of sustaining certain services to this population. 340B is important today and going forward for the many patients who are dependent on this program. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

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BUSINESS INSIGHTS

Azzur Group Announces Executive Leadership Changes

Azzur Group, LLC | January 13, 2022

To support rapid company growth and best meet the demands of the business, Azzur Group announces new executive leadership appointments. Originally founded in Philadelphia in 2010, Azzur is a market-leading provider of GxP services for the pharmaceutical, biotechnology, medical device, and healthcare industries with offices and on-demand cleanrooms locations throughout the United States. Today, the organization provides comprehensive GxP solutions through its on-demand cleanrooms, consulting and advisory services, microbiology labs, and aseptic and GxP training. Ryan Ott has been promoted to Chief Operating Officer of Azzur Group. A long-time partner at Azzur, Ryan most recently served as Chief Administrative Officer. During his tenure, he has been instrumental in the overall strategic development of Azzur Group, initially in the Greater Philadelphia Region, while taking on additional responsibility with ongoing national expansion. In his new role, he collaborates with corporate and service-line leaders throughout the organization to execute on Azzur Group's strategic business plan. This includes Shaleen Parekh, who has been appointed to Sr. Vice President of Professional Services, with continuing oversight for Azzur Consulting, Azzur Labs, and Azzur Training Center; and Molly McGlaughlin, who has been appointed Sr. Vice President of Facilities Services, with continuing oversight for Azzur Cleanrooms on Demand™ as its Chief Operating Officer. Appointed to the new role of Chief Innovation Officer is Ravi Samavedam. In this role, he will focus on bringing forward new business concepts and service areas for Azzur's continued expansion. Ravi's extensive life sciences industry experience and dynamic leadership of Azzur Cleanrooms on Demand™ from its creation in 2018 through its national expansion, ideally position him to proactively identify novel service offerings for the enterprise. Most recently, Ravi served as President and COO of Azzur Cleanrooms on Demand™. He has been a member of Azzur Group since 2014. Ilya Vasserman has been promoted to Chief Information Officer (CIO) of Azzur Group and is responsible for overseeing the management and scale-out of Azzur's corporate information technology infrastructure while forming and leading a new corporate-wide procurement group. Ilya will also continue to spearhead technology adoption and internal tool development, furthering our business insights capabilities. Ilya most recently served as Senior Director of Financial Services and has been a member of Azzur Group since 2016. After nearly two years with Azzur Group, David Frank has been promoted to Vice President of Client Development, furthering the growth and maturation of Azzur's business development and marketing capabilities. As part of his expanded responsibilities, David will work closely with the executive leadership team to develop client-centric strategies across the organization to meet customer needs. Since joining Azzur Group in 2020, David has served as the Senior Director, Sales and Marketing. "I'm incredibly thrilled to announce the changes to the Azzur Group executive leadership team. Not only have these individuals proven to be excellent strategic partners for our enterprise, but each embodies Azzur Group's core values in their daily leadership. I offer my sincerest congratulations to Ryan, Ravi, Shaleen, Molly, Ilya, and David, and wish them much success in their new roles." Michael Khavinson, Azzur's Chief Executive Officer About Azzur Group Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

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Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug

Greenmarketreport | April 22, 2020

Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa. “Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.

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PHARMACY MARKET

Rx-360 Launches New auditsPlus®

Rx-360 | June 10, 2021

Rx-360, a global pharmaceutical consortium committed to supply chain integrity and patient safety, is happy to announce the extension of our Audit Program. The release of the new Rx-360 auditsPlus database is the key driver of this growth. This interactive, user-friendly database will not only raise awareness of the Rx-360 Joint Audit Program®. Still, it will also provide Rx-360 program users with new and improved tools to minimize their audit burden. Rx-360's CEO, Jim Fries, stated, "Maintaining quality in pharmaceutical materials is an ever-increasing problem for the pharmaceutical sector. To maintain our commitment to patient safety, this new tool will provide users of our software with better insight into Rx-360 audits. It's another benefit we can provide the industry and our members." Jaye Greene, Rx-360's Head of Audit Operations and Quality, stated, "We are extremely excited to introduce the market to our new auditsPlus platform. The user experience has been greatly improved, and all of the Rx-360 Audit Programs are now easily accessible." About Rx-360 Rx-360, an international pharmaceutical supply chain consortium, was founded in 2009 to support an industry-wide commitment to maintaining patient safety via improved quality and authenticity across the supply chain. The organization's objective is to ensure patient safety by exchanging information and developing processes related to the integrity of the healthcare supply chain and the quality of products used in the supply chain. Rx-360 contains work streams relating to audit and sharing review reports, supply chain security, monitoring and reporting, Asia-focused activities, supplier-focused initiatives, and external relations, communications, and membership to fulfill this mission.

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Spotlight

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. To achieve that goal, Congress created a program that requires pharmaceutical manufacturers to provide discounts on outpatient prescription drugs to entities that serve high numbers of uninsured indigent patients. This program, as originated, provided discounts to outpatient facilities for the purpose of sustaining certain services to this population. 340B is important today and going forward for the many patients who are dependent on this program. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.