AbbVie's massive Humira discounts are stifling Netherlands biosimilars: report

AbbVie | April 02, 2019

Could a drug's price ever be too low? That’s what some market-watchers are asking in the Netherlands, where AbbVie is discounting Humira as much as 89%. The De Groene Amsterdammer dug into the procurement process for Humira biosimilars after they launched in Europe last year and turned up aggressive discounts that have effectively held off biosimilar rivals. And some of those would-be competitors have pulled back from the market because of those discounts, the newspaper reports. At least 70% of Dutch patients remain on Humira, according to the publication. And no wonder: AbbVie struck a discount of up to 89% in one case to retain business for its original biologic Those discounts could be a red flag for Humira's sales outside the U.S. this year, Bernstein analyst Ronny Gal figures. His team had expected ex-U.S. Humira sales to fall 35% this year, “but if that report is indicative of the broader environment, cuts may be much deeper," he wrote in a note Monday.

Spotlight

Strategic transformation is at the core of life science companies as they build new business models for the future. To accelerate change, focus will be on developing innovative and relationship-driven partnerships and creating real value for patients. Data is now the currency of life sciences, and mobilizing data throughout the enterprise, transforming work, and using technology symbiotically will be fundamental to advancing digital transformation.

Spotlight

Strategic transformation is at the core of life science companies as they build new business models for the future. To accelerate change, focus will be on developing innovative and relationship-driven partnerships and creating real value for patients. Data is now the currency of life sciences, and mobilizing data throughout the enterprise, transforming work, and using technology symbiotically will be fundamental to advancing digital transformation.

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RESEARCH

Rhythm Pharmaceuticals Receives FDA Approval for obesity med targeting genetic defects

Rhythm | December 01, 2020

Stoutness is a significant issue around the world, in any case, for a small amount of patients, hereditary changes instead of propensities are driving the sickness. With its new FDA endorsement for Imcivree, Rhythm Pharmaceuticals is venturing out treating those cases. For a subset of heftiness patients, hereditary transformations leave them with an "voracious appetite," Rhythm CEO David Meeker, M.D., said in a meeting. Beginning stage hereditary illnesses can leave patients incapable to control corpulence with diet and exercise, and, presently, Rhythm has scored the main FDA endorsement for a focused on medication pointed toward treating them. Imcivree, once known as setmelanotide, scored a FDA gesture to treat patients who have varieties of the POMC, PCSK1 or LEPR qualities. The medication focuses on the MC4R pathway answerable for directing yearning, and the three qualities remembered for the underlying endorsement are only an initial step, Meeker said. The organization built up a test that takes a gander at around 100 hereditary transformations, and it's trying the medication in other hereditary changes with eyes on expected endorsements down the line. With obesity, “you can see the forest,” Meeker said, because the problem is everywhere. The challenge is finding patients who could have an underlying genetic mutations causing excessive hunger, he said, noting that “testing becomes key.” Most people, and most doctors, still think of obesity as a “calories in, calories out,” problem, said Michael Dedekian, medical director of pediatric specialty care at Barbara Bush Children’s Hospital in Maine. Very quickly, though, the medical community’s understanding of obesity is deepening, he said. And, as that’s happening, it’s becoming clear that genetic defects can “wildly disregulate” patients’ hunger. With the approval and new knowledge about genetic defects, Dedekian believes the medical community is entering a “whole new era of obesity treatment." Over time, he has no doubt awareness of the genetic mutations driving some cases will increase. When abnormal hunger presents itself in young children, doctors should strongly consider a genetic test, Dedekian said. Rhythm isn’t planning to deploy a sales force for its initial genetic mutations and will instead focus on “intensive efforts” around disease education and making its test more available, Meeker said. When doctors are confronted with a patient with abnormal hunger, they should be “thinking deep” about the cause, he added.

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PRACTICE MANAGEMENT

Azurity Pharmaceuticals to Acquire and Merge with Arbor Pharmaceuticals

Azurity Pharmaceuticals, Inc. | August 24, 2021

Azurity Pharmaceuticals, Inc. and Arbor Pharmaceuticals, Inc. today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from existing investors including JW Asset Management and KKR. Following the completion of the transaction, which is subject to regulatory approvals, Azurity and Arbor will merge, creating a leading company offering innovative, high-value products to meet the unique needs of patients with underserved conditions. Financial details of the transaction were not disclosed. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” “Arbor is excited to be joining forces with Azurity to further our goal of bringing innovative products to the market that improve patients’ lives,” commented Ed Schutter, CEO of Arbor. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” The combined company, operating as Azurity, will have a portfolio of products serving the unmet needs of patients in the cardiovascular, central nervous system, endocrinological, gastrointestinal, and institutional markets. Azurity will build upon each company’s legacy of success through a distinctive portfolio of 10 exclusively promoted, FDA-approved, branded product families, more than 30 total commercialized products, and a robust pipeline of mid and late-stage products under development. Azurity will continue to develop and commercialize its portfolio of products and deliver them at the right time, in the right way, to the right patients, through a spectrum of healthcare professionals. “We are proud to continue our partnership with Azurity,” said Jeff Edwards, Partner at NovaQuest Private Equity, the majority owner of Azurity. “This combination accelerates our shared vision of building the leading patient-centric company that differentiates itself by bringing distinctive, high-value products that meet the unique needs of our patients, through state-of-the-art innovation and commercialization capabilities.” “Today is a tremendous milestone for both Arbor and Azurity, and a strong validation of the products that they provide to patients in need,” said Jason Wild, Chairman of Arbor and Chief Investment Officer of JW Asset Management. “We are proud to have supported Arbor and its management team and are excited for the company’s next phase of growth in partnership with Azurity,” added Ali Satvat, Co-Head of Americas Health Care Private Equity and Global Head of Health Care Strategic Growth at KKR. JPMorgan Chase Bank, N.A. and Truist Securities, Inc. are financing sources for the transaction for Azurity. Smith Anderson served as legal advisor to Azurity. MTS Health Partners, L.P. served as exclusive sell-side financial advisor and King & Spalding served as legal advisor to Arbor. Simpson Thacher & Bartlett LLP served as legal advisor to KKR. Pending regulatory approvals, the companies anticipate closing the transaction in September. About Azurity Pharmaceuticals: Azurity Pharmaceuticals is a privately-held, specialty pharmaceutical company focusing on the needs of patients requiring customized, user-friendly drug formulations and dosage forms. Azurity’s patient centric products span the cardiovascular, neurology, gastro-intestinal and institutional markets. Azurity’s products have benefited millions of patients for which conventional oral dosage forms are not ideal and whose needs are not served by other commercially available therapies. About Arbor Pharmaceuticals: Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company marketing FDA-approved prescription products in the neuroscience, cardiovascular, and institutional markets. In addition to an extensive pipeline, the company actively pursues growth through acquisition and licensing of late-stage development products. About NovaQuest Private Equity: NovaQuest Private Equity is a leading investor in technology and services companies in the life sciences and healthcare sectors. NovaQuest was formed in 2000 with the vision of building an investment platform to provide strategic capital and operational leverage in partnership with strong management teams. The investment team consists of highly seasoned operational and investment professionals with significant investment experience and deep life science and healthcare expertise. Furthermore, NovaQuest benefits from an extensive network of industry experts and relationships that assist in identifying, analyzing and growing NovaQuest portfolio companies and investments. About JW Asset Management: JW Asset Management is a New York based fund manager with combined assets under management in excess of $1.5 billion. Jason Wild, the firm’s founder and Chief Investment Officer, is a registered pharmacist and Chairman of Arbor Pharmaceuticals and TerrAscend Corp. JW Asset Management has a history of finding attractive investment opportunities and actively invests in both public and private markets. About KKR: KKR is a leading global investment firm that offers alternative asset management and capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of The Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries.

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PHARMACY MARKET

Treosulfan, a First-In-Class Conditioning Agent, is Licensed in Canada by Medexus Pharmaceuticals and Medac GmbH

Medexus Pharmaceuticals | July 13, 2021

Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada. Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it. Medexus has been distributing treosulfan in Canada through the Special Access Program, and Health Canada recently approved Trecondyv for the treatment of adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes who are at increased risk for standard conditioning therapies, as well as pediatric patients older than one year with AML or MDS. About medac GmbH medac GmbH is a privately owned global pharmaceutical firm that is expanding its pharmaceutical and diagnostics businesses. Since its inception in Germany in 1970, medac has specialized in treating diseases related to oncology, hematology, urology, and auto-immune disorders. medac is dedicated to improving current therapeutic products and creating new ones to enhance patients' quality of life. In addition, medac has earned a reputation for developing novel medicines in less common indications. This dedication has resulted in a diverse range of pharmaceutical goods that positively impact the lives of patients. medac is constantly investing in product development and manufacturing and logistical capacities to fulfill the requirements of both patients and healthcare professionals. About Medexus Medexus is a market leader in novel rare disease treatment solutions, with a solid commercial platform in North America. We are building a highly distinctive business with a portfolio of innovative and high-value orphan and rare disease medicines that will support our growth for the next decade, based on a foundation of proven best-in-class medications. Through our key principles of Quality, Innovation, Customer Service, and Teamwork, the Company's goal is to offer the finest healthcare products to healthcare professionals and patients. Medexus Pharmaceuticals specializes in the treatment of auto-immune illness, hematological, and allergies. Rasuvo and Metoject, a unique methotrexate formulation (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor

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