Vifor Pharma and Cara Therapeutics, Inc. | October 20, 2020
Vifor Pharma and Cara Therapeutics, Inc. today announced that both companies have signed a license agreement for commercialization of Korsuva (difelikefalin) Injection (“IV Korsuva”) for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in the US dialysis market for non-Fresenius Medical Care clinics under a Cara 60%, Vifor Pharma 40% profit-sharing arrangement. “With an established fully dedicated nephrology sales force in the US, Vifor Pharma is an ideal commercialization partner to bring IV Korsuva to dialysis patients across the country,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “In addition, we believe Vifor Pharma’s existing relationships with US dialysis providers will provide significant momentum for the launch and adoption of IV Korsuva, if approved. As a result of this agreement, we expect to focus Cara’s internal resources on our clinical programs for Oral Korsuva in atopic dermatitis, pre-dialysis CKD and additional pruritic conditions.”
Ascentage Pharma | January 05, 2021
Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignancies, persistent hepatitis B (CHB), and age-related sicknesses, today reported that the US Food and Drug Administration (FDA) has allowed an Orphan Drug Designation (ODD) to the organization's novel Bcl-2 inhibitor, APG-2575, for the therapy of patients with intense myeloid leukemia (AML). This is the fourth ODD allowed to APG-2575 by the US FDA, following the past ODDs for the therapy of Waldenström macroglobulinemia (WM), ongoing lymphocytic leukemia (CLL), and numerous myeloma (MM). Until this point, four of Ascentage Pharma's investigational drug up-and-comers have been allowed an aggregate of nine ODDs by the US FDA, a record number for any Chinese biopharmaceutical organization.
AML is an exceptionally heterogenous hematologic threat that is more normal in the old populace with a middle age at analysis of 68 years1. The latest information from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) assessed 19,940 new instances of AML and 11,180 passings from this infection in the United States in 2020. Notwithstanding the critical advances in therapeutics as of late, the 5-year endurance pace of AML stays at 25%–30%, which actually speaks to a huge neglected clinical requirement for treatments with more solid viability and a superior wellbeing profile.
The expression "vagrant medications" alludes to drug items produced for the counteraction, finding, and treatment of uncommon illnesses or conditions. In the United States, a vagrant sign is characterized as a sickness or condition with a pervasiveness of under 200,000 patients in the nation. Since the Orphan Drug Act was passed in 1983, the US government has given motivators and strategy backing to support advancement of vagrant medications. Treatments conceded ODDs by the FDA are equipped for different advancement motivators, including a tax break on consumptions brought about in clinical examinations, a waiver of the New Drug Application (NDA) charge, conceivable exploration award granted by the FDA, and above all, 7 years of US market restrictiveness upon endorsement.
Mallax | July 05, 2021
Mallax Pharmaceuticals AB has acquired Sana Pharma Medical AS, forming a new Nordic pharmaceutical platform.
SPM, founded in Norway in 2014, is a rapidly growing OTC company with complete pharmaceutical infrastructure and Nordic distribution coverage. With the well-established brands such as Lunixen and Sedix and additional products based on the chemical melatonin, the Company has a leading position in the fast-growing sleep and anxiety sector. SPM is a well-resourced platform with about 15 FTEs that provides extensive in-house pharmaceutical expertise and experience to serve as an appealing basis for Mallax. Furthermore, the Company has a sizable and steadily growing pipeline of new products that will be released in the future years.
Mallax was founded in 2020 by Impilo, a Nordic healthcare-focused investment firm, and Anders Larnholt, a seasoned pharma, and healthcare executive, with the long-term goal of creating a large and diverse platform with established pharmaceuticals and OTC products for customers and patients across Europe.
Dr. Peter Sjöstrand, the former deputy CEO and CFO of Astra and the former Chairman of the Boards of Gambro and Meda, is named Chairman of the Board of Mallax as part of the transaction.
Mallax was founded in 2020 by Impilo and Anders Larnholt with the ambition of building a leading pharma company and investing significant capital and resources behind the right acquisition opportunities across Europe, with a wide size range for any individual deal ranging from EUR 10 million to EUR 300 million. Mallax's strategy is based on three pillars: sustainability, medical need, and profitable growth. Mallax currently has operations in all Nordic markets due to the acquisition of Sana Pharma Medical.
Impilo is a Nordic investment firm that makes long-term investments in healthcare companies involved in pharmaceuticals, medical technology, healthcare services, and other health-related sectors. Impilo seeks to enhance the value of its assets via long-term active ownership and generate consistent returns for its stakeholders. Impilo has a well-diversified investment portfolio and has raised over SEK 9 billion in capital from leading Nordic and international investors since its inception in 2017.