Heritage Pharma sues over container of refrigerated drugs knocked into river

Heritage Pharma | April 01, 2019

Heritage Pharma sues over container of refrigerated drugs knocked into river
A refrigerated container of drugs was rolling on the river last year when a supply chain mishap resulted in eight shipping containers falling like dominoes from a ship into the Elizabeth River in Virginia. Now Heritage Pharmaceuticals wants reimbursement. The Eatontown, New Jersey-based drugmaker has filed a federal lawsuit in the Eastern District of Virginia seeking $220,000. The lawsuit names logistics Agility Logistics, Hapag-Lloyd America and Virginia International Terminals. The drugmaker says it was moving 562 packages of pharmaceuticals in a refrigerated container, including diabetes meds Glipizide and Metformin. They were in a container on a ship that arrived in the Norfolk port from India in July 2018. The Virginian-Pilot reported last year that the incident occurred when a spreader bar from the crane hit several containers and then eight containers toppled "like dominoes" into the water. The suit says the drugs were a complete loss. Heritage itself figures prominently in an investigation by states and the Justice Department into alleged pricing fixing of generic drug prices. In 2017, Heritage Pharma’s former CEO Jeffrey Glazer and former president Jason Malek reached settlements to pay $25,000 and cooperate with the ongoing investigation, which has roped in some of the biggest names in the generics business.

Spotlight

The global medical devices market offers tremendous opportunity for U.S. manufacturers, as well as significant challenges, for government policymakers seeking to support U.S. export competitiveness in overseas markets. Creating new and sustained export opportunities for U.S. companies will require a concerted effort to remove or diminish market access barriers, helping U.S. firms to capture a larger share of the world import market. Encouraging and fostering U.S.-based healthcare industries is critical to the future of the U.S. economy, which is why medical technology is a National Export Initiative priority.


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BUSINESS INSIGHTS

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to CordenPharma

Vifor Pharma Group | December 17, 2021

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio. “In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency. With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders.” Abbas Hussain, CEO of Vifor Pharma Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: “The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers.” Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg, and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement. CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them. This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer. Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group, is a full-service partner in the Contract Development & Manufacturing of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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PHARMACY MARKET

The McQuade Center for Strategic Research and Development and Mindset Pharma Collaborate to Develop Psychedelic Medicines

McQuade | January 06, 2022

The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs. “Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.” Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products. In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated. “It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.” Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.” About Mindset Pharma Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset, About the McQuade Center for Strategic Research and Development (MSRD) Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products. Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

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PHARMA TECH

CSL Limited announces tender offer to acquire Vifor Pharma Ltd

Vifor Pharma Group | December 15, 2021

Global biotechnology leader CSL Limited and Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in iron deficiency, nephrology & cardio-renal therapies, announced that they have entered into a definitive agreement for CSL to acquire Vifor Pharma for an aggregate equity value for Vifor Pharma of US$ 11.7 / CHF 10.9 billion. CSL has offered to acquire Vifor Pharma in an all-cash tender offer of US$179.25 per share, payable in U.S. dollars.1 The offer assumes a dividend of CHF 2 expected to be declared at the AGM of 26 April, consistent with past practice. The tender offer represents an implied premium of approximately 61% to the unaffected closing price of Vifor Pharma on 1 December 2021 and a 47% premium to Vifor Pharma’s unaffected 1-month VWAP as of 1 December 2021.2 Patinex AG, Vifor Pharma’s largest shareholder holding 23.2% has agreed to tender its shares into the offer. The Transaction remains subject to the conditions and further terms including: Minimum acceptance rate of 80% of all Vifor Pharma shares on a fully diluted basis; and further customary offer conditions, including regulatory approvals. The tender is currently expected to commence around 18 January 2022 and the transaction is expected to complete around mid-2022. The Board of Directors of Vifor Pharma considers that the proposed transaction respects the interests of all stakeholders and is unanimously recommending the offer to shareholders. There is committed financing for the deal and a strong commitment to pursue regulatory clearances. “Vifor Pharma's strategy has been to focus towards continuing being a market leader in iron deficiency, nephrology and cardio-renal therapies. The offer provides an excellent strategic opportunity for Vifor Pharma to optimize future market opportunities from a position of strength and to create substantial value for all stakeholders.” Jacques Theurillat, Chairman of the Board of Directors Vifor Pharma Group The transaction will enable Vifor Pharma to leverage CSL’s global reach, balance sheet and capabilities to bring more products to patients within its key categories. The transaction also enables Vifor Pharma to accelerate growth in cardiovascular-metabolic, renal and transplant. Centerview Partners UK LLP is acting as exclusive financial advisor to Vifor Pharma on the transaction. IFBC have been retained as Fairness Opinion providers by the Vifor Pharma Board of Directors. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

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Intent Data in the Age of Data Regulation

DECK 7 | March 23, 2020

Since the implementation of Data Protection Act in 2018, the approach behind the use of data has changed dramatically. Our clients and customers don’t just want a great experience, they also want to make sure they can trust us. Tweet This! And it makes perfect sense in the present time and space. But as data is considered a key factor in positive customer experience, the U.S. brands and agencies have found it to be increasingly complicated to earn customer trust while remaining compliant. In an article by John Snyder, CEO at Grapeshot, for Adexchanger, he says that the GDPR will remove 75% of third-party data and what’s left will be more expensive. This has caused the power dynamic between brands and agencies to evolve over time.

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Spotlight

The global medical devices market offers tremendous opportunity for U.S. manufacturers, as well as significant challenges, for government policymakers seeking to support U.S. export competitiveness in overseas markets. Creating new and sustained export opportunities for U.S. companies will require a concerted effort to remove or diminish market access barriers, helping U.S. firms to capture a larger share of the world import market. Encouraging and fostering U.S.-based healthcare industries is critical to the future of the U.S. economy, which is why medical technology is a National Export Initiative priority.

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