The Side-Effects to A Common Blood Cancer Drug

LabRoots | November 13, 2019

A popular cancer drug, known as ruxolitnib, was found to cause an increased weight gain as well as an increase in liver enzymes and systolic blood pressure. “Weight gain with ruxolitinib has previously been reported in clinical trials, but our study provides real-world experience regarding the extent of that weight gain,” said Emily J. Gallagher, MD, PhD, the study’s lead author and Assistant Professor of Medicine (Endocrinology, Diabetes and Bone Disease) at the Icahn School of Medicine at Mount Sinai, specializing in onco-endocrinology, the treatment of endocrine complications of oncology treatments. “We recommend that patients who go on this medication and do have an increase in weight get a full metabolic evaluation.”  Researchers from Icahn School of Medicine at Mount Sinai reported in their study that the FDA-approved ruxolitinib, which was the first and most widely prescribed in treating blood cancers, holds strong metabolic effects. Ruxolitinib treats the particular blood cancer group known as myeloproliferative neoplasms (MPNs), which includes myelofibrosis and polycythemia vera. The drug blocks the enzyme Janus kinases (JAK) ½ resulting in the inhibition of blood cell production. Although previous studies have noted the side-effects, researchers are now beginning to understand the long-term consequences of cancer therapeutics on metabolic 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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PHARMACY MARKET

Medison Pharma Announces Extension of Multi-territorial Agreement with Immunocore and Expansion into Australia and New Zealand

Medison Pharma | May 30, 2022

Medison Pharma a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced the addition of new markets to its multi-territorial agreement with Immunocore Holdings plc a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. The multi-territorial agreement to help seek regulatory authorization and commercialize Immunocore's KIMMTRAK® for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma that affects the eye, which covers Canada, twenty markets across Central Eastern Europe and Israel, will now extend to Australia and New Zealand. KIMMTRAK has been approved by both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where it is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma. "We are delighted to deepen our partnership with Immunocore and proud to further grow the reach of their breakthrough treatment, as part of our mission that knows no borders. We believe that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies. By adding new countries and continents, we are continuing in our efforts to turn our mission into a reality." Meir Jakobsohn, Founder and CEO of Medison "It can be challenging for biotechs to commercialise in a large number of countries, often resulting in delayed access to highly innovative therapies in many areas of the world. Medison's global platform is designed to address this challenge," said Gil Gurfinkel, VP Corporate Development at Medison. "Immunocore's novel therapy for unresectable or metastatic uveal melanoma and our ability to treat patients suffering from this rare and aggressive form of cancer in additional countries is a win-win outcome of our partnership." Medison's expansion of its commercial presence to Australia and New Zealand is the latest addition to its geographic growth, enabling Medison to capitalize on growing market opportunities for its commercial partners. Medison is further enlarging its footprint in Europe with a new office location for its international headquarters in Zug, Switzerland, and operations in Greece and Cyprus, which enlarge its European offering of Central Eastern Europe, the Baltic states, and Balkans. In Canada, the team is also growing and recently moved into larger office space in downtown Toronto. With this latest growth, Medison increases its commercial presence across 25 locations around the world. Medison is hiring across all locations and in key functions. About Medison Pharma Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. About KIMMTRAK® KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. KIMMTRAK is currently approved in 31 countries, including the United States and European Union.

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BUSINESS INSIGHTS

Adalvo Partners With SK Pharma to Create Arphio, a New Business Entity Dedicated Solely to Orphan and Rare Disease Medicines

Adalvo | March 01, 2022

Adalvo, the leading global B2B pharmaceutical company, is thrilled to announce the recent establishment of a new entity ArphioTM a venture initiated in close collaboration with SK Pharma. Together with our new partner, we are developing a powerhouse, solely dedicated to orphan drugs with the intention of improving accessibility of vital treatments, to patients suffering from rare diseases and unmet medical needs. ArphioTM will operate as an independent entity, focusing on rare disease detection, market access and supply of orphan drugs, targeting the EU and ROW regions. ArphioTM has a unique understanding on orphan products and their epidemiology data and unique characteristics. The aim of this venture is to expand access to vital treatments and continue to develop technological capabilities and expertise, while maintaining a patient-centric approach with the possibility of relying on state-of-the art novel technology including worldwide data, artificial intelligence, and machine learning. Arphio is founded by pharmaceutical professionals with expertise covering all major therapeutic areas and pharmaceutical forms in various parts of the globe. The company is focused on rare disease detection, market access and the supply of orphan drugs internationally. Arphio is powered by DrugsIntel (DI), a data science powerhouse focusing on the aggregation, unleashing, processing, unification and deployment of pharmaceutical data covering over 75 countries, and over 6,000 sources. This intelligence tools ensure the successful launch of orphan drugs in the market of operation, based on DI’s unique methodology of these Six factors and Pillars. This stand-alone market player will cover all services and functions ranging from medical, market access, regulatory, direct sales, and marketing activities. ArphioTM proudly boasts of strictly following ethics, compliance, accessibility, and corporate governance. There are over 300 million people living with one or more of over 7,000 identified rare diseases around the world, each supported by family, friends, and caregivers. Currently, only about 5% of orphan disorders can be managed with an approved treatment. It is estimated that it takes about seven years and visits to 10 different doctors for a patient to receive a proper diagnostic of an orphan condition. At ArphioTM, fueled by our passion to improve people’s lives, we will apply innovative technologies to provide effective treatments for people with orphan diseases. Anil Okay, General Manager at Adalvo comments: “We are thrilled to be partnering with SK Pharma on this exciting new journey. We welcome this opportunity to work in the domain of Orphan drugs, and we are eager to make a valuable contribution to patients across the globe who are living with Rare diseases”. “I’m captivated to have Adalvo as our partner with the important endeavor of helping neglected orphan patients and their caregivers with their unmet medical needs. I’m bullish on the synergistical power that could outcome from this collaboration for the benefit of rare disease patients". Dr. Shlomo Sadoun, CEO at SK Pharma About Adalvo Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 70 countries and for over 90 commercial partners globally. The company’s declared purpose is to make a difference for patients all over the world, driven by our smart collaboration network and commitment to delivering highest quality differentiated products and services to our partners. With headquarters in Malta, the company has additional offices in more than 15 countries such as Switzerland, UK, Netherlands, Spain, Iceland, Austria, Romania, Hungary, Bulgaria, Portugal, Czech Republic, and India. At Adalvo, we know that our partners like to be bigger, better, and smarter in the dynamic pharmaceutical sector. That’s why our approach is unique, customized to our partners, and is designed to challenge the status quo: together, this helps our partners achieve their business goals. We take pride in our ability to help its partners reach their goals – be those increasing revenues or pushing into new markets. While partners are a high priority, Adalvo is also committed to its purpose and mission to accelerate the growth and development of employees and local communities. Adalvo tirelessly strives for excellence in all of its endeavors, driven by a deep-rooted passion to making a difference for partners. The company’s purpose driven culture is committed to improving the lives of patients around the world. Our dynamic leadership team brings significant experience and industry know-how to Adalvo, which has helped to establish the company as a reliable global partner. About SK Pharma SK-Pharma is a global pharmaceutical company focusing on making drugs accessible to patients in needs. The vison of the company lay in utilizing cutting edge technologies to support smart business decisions that will lead to better healthcare solutions. Taking patient centric approach, the company holistically follow the patient’s journey and understand better their unmet needs. Mimicking the patient journey allow us to come with viable solutions that change the patient treatment paradigm and make it more suitable to their lifestyle and their unique needs. The group is divided to three divisions: First to launch and the introduction of complex hybrid generic products. The second division is focusing on providing technological solutions to enhance smart business decisions. The third division is specialized in orphan drugs market access and distribution worldwide.

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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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