Aop Orphan Pharmaceuticals GmbH

PALM BEACH GARDENS, Fla., Dec. 20, 2022 /PRNewswire/ -- American Orthopedic Partners (AOP) today announced a new partnership with Premier Orthopaedic Associates (Premier), a full-service orthopedic practice spanning five counties in southern New Jersey. With deep roots in New Jersey and beyond, Premier will serve as the platform for AOP's growing presence in the tri-state area. AOP is a physician-owned, physician-led national orthopedic practice achieving transformational change by offering surgeons an exclusive opportunity to maintain the best of private practice while leveraging the benefits of scale. AOP's partner physicians continue local governance while collaborating on national initiatives and accessing resources to grow their practices. This physician-owned partnership model fuels value creation, clinical innovation, and orthopedic excellence. Jay Bronner, M.D., is CEO and founder of AOP. "With the right structure and with the right culture, physicians with an aligned vision of excellence deliver outstanding clinical value to the patients they serve," said Bronner. "Premier Orthopaedic Associates is joining forces with orthopedic surgeons from across the country dedicated to clinical excellence and sustainable growth." Premier Orthopaedic Associates of Southern New Jersey was founded in 1998 by President and CEO Thomas A. Dwyer, M.D., and serves patients at 10 locations across five counties in South Jersey. Premier is a full-service orthopedic practice and its 33 providers, including physicians, physician assistants, physical and occupational therapists, care for patients of all ages and activity levels. "Premier Orthopaedic Associates is driven by two fundamental goals. The first is to deliver academic quality specialized orthopedic care. The second is to provide all orthopedic care in a convenient one-stop-shop model," said Dwyer. "AOP offers the right partnership model for Premier Orthopaedic Associates and the physician leadership, with its focus on local autonomy, is a clear differentiator. With AOP's partnership and support, Premier will continue to work untiringly to serve the communities in which we live, work and play. We look forward to continuing to nurture our valued local relationships, including our long-standing partnership with Inspira Health." AOP entered the New Jersey market in late 2021 through its partnerships with The Center for the Functional Restoration of the Spine and Atlantic Pediatric Orthopedics, both serving patients in Central New Jersey. The addition of Premier Orthopaedic Associates as a partner and platform will significantly expands AOP's New Jersey footprint and positions AOP for continued growth in the tri-state area and beyond. About American Orthopedic Partners AOP is a national orthopedic practice led by physicians and empowered by scale that drives clinical value through improved outcomes and lower costs. With a belief that health care must remain local, AOP provides operational expertise, recruiting support, business development and growth opportunities, revenue cycle optimization, and quality initiatives to improve care delivery. Learn more about AOP's physician-led partnerships at aorthopartners.com. About Premier Orthopaedic Associates Founded in 1998, Premier Orthopaedic Associates is a full-service orthopedic practice specializing in sports medicine, arthroscopic reconstruction, joint reconstruction, neck and spine care, pain management, hand and wrist surgery, foot and ankle injuries, trauma and fracture treatment, general orthopedics, and physical and occupational therapy. Learn more at poasnj.com. Media Contact: Kristy Lucero Lovell Communications [email protected] SOURCE American Orthopedic Partners; Premier Orthopaedic Associates

VIENNA--(BUSINESS WIRE)-- AOP Health announced its latest updates on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV) from AOP Health´s CONTINUATION-PV study (Reference Kiladjian et al. ASH 2022) and the LOW-PV trial, which is an independent investigator-initiated trial supported by AOP Health (Reference Barbui et al. ASH 2022) presented at ASH 2022 Annual Meeting, New Orleans, USA. This press release features multimedia. View the full release here: Prof. Tiziano Barbui Photocredit: AOP Health/Filippo Capaccioli (Photo: Business Wire) AOP Health has been conducting a pivotal clinical development program in Europe since 2010, including the studies PEGINVERA, PROUD-PV, PEN-PV, CONTINUATION-PV and (post-approval) PASS-PV. With this development program AOP Health obtained the first marketing authorization ever of BESREMi® for the treatment of Polycythaemia Vera by the European Commission (2019), followed by Switzerland, Liechtenstein and Israel. AOP Health's clinical development program was also the basis for marketing authorization in Taiwan, Korea and most recently in the USA in November 2021. “The by now global marketing authorizations of BESREMi®, all based on AOP Health´s clinical development program conducted in Europe, are proof of the integrated drug development and commercialization expertise at AOP Health. Our success and know-how allow us to further pursue our goal of making drugs for rare and special diseases available to patients worldwide.” commented Dr. Rudolf Widman, Founder and Member of the Board of the AOP Health Group. Benefits of treatment confirmed During the ASH 2022 Annual Meeting Prof. Jean-Jacques Kiladjian (Paris) presented results on final data of AOP Health´s CONTINUATION-PV, an open-label, multicenter, phase IIIb study assessing the long-term (up-to 7,3 years) efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT). This new analysis focused on efficacy and safety on either high-risk or low-risk PV patients. The benefits of treatment with Ropeginterferon alfa-2b over BAT, were confirmed in both groups. The results further suggested that low-risk patients may benefit more, thus supporting early treatment start. (Reference Kiladjian et al. ASH 2022) The latter was also a main conclusion from the final results of the Low-PV trial, presented by Prof. Tiziano Barbui (Bergamo): In an early, low-risk PV patient population treatment with Ropeginterferon alfa-2b proved superior in maintaining haematocrit targets, as compared to management by phlebotomy only. (Reference Barbui et al. ASH 2022) Prof. Barbui said, “Since its first approval in Europe in 2019, Ropeginterferon alfa-2b has become the first line therapy of choice for many PV patients and has already led to a change of treatment paradigm for patients with P. vera as reflected by the updated ELN treatment guidelines.” (Reference to Marchetti et al. 2022)” About BESREMi® BESREMi® is the first and currently only interferon approved for polycythaemia vera, a myelo­proliferative neoplasm (MPN), indicated in the European Union as monotherapy in adults for treatment of polycythaemia vera without symptomatic enlarged spleen. Its overall safety and efficacy were demonstrated in multiple clinical studies. BESREMi® (ropeginterferon alfa-2b) is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to every 4 weeks after stabilization of blood values. BESREMi® is designed to be self-administered subcutaneously with a pre-filled pen. For the EMA Summary of Product Characteristics please visit: BESREMi® Link BESREMi® Summary of Product Characteristics: About AOP Health The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also the healthcare professionals treating them. View source version on businesswire.com: Contacts Mag. Nina Roth Nina.Roth@aop-health.com +43-676-3131509 Source: AOP Health Smart Multimedia Gallery Photo Prof. Tiziano Barbui Photocredit: AOP Health/Filippo Capaccioli (Photo: Business Wire) Photo Dr. Rudolf Widmann Photocredit: Studio Koekart: Natascha Unkart & Isabelle Köhler (Photo: Business Wire) Logo View this news release and multimedia online at:

Four new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended four medicines for approval at its November 2022 meeting. The CHMP recommended authorising the COVID-19 vaccine VidPrevtynBeta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below. The committee adopted a positive opinion for a biosimilar medicine , Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break. A generic medicine , Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. The CHMP adopted a positive opinion for a generic medicine , Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant. Recommendations on extensions of therapeutic indication for 11 medicines The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin , Comirnaty , DuoPlavin , Dupixent , Enhertu , Eylea , Imfinzi , Iscover , Lynparza , Plavix and Xofluza . Withdrawals of applications Two applications for marketing authorisation were withdrawn: Orepaxam * for the treatment of pulmonary arterial hypertension, and Febseltiq * for the treatment of cholangiocarcinoma (cancer of the bile ducts). Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes. Question-and-answer documents on the withdrawals are available in the grid below. COVID-19 update The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. Safety update The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee ( PRAC ) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case ofquality, safety or efficacy issues. A public health communication on this referral is available in the grid below. Agenda and minutes The agenda of the November 2022 CHMP meeting is published on EMA's website. Minutes of the October 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the November 2022 CHMP meeting are represented in the graphic below. *This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendation on new medicines Name of medicine VidPrevtyn Beta International non-proprietary name (INN) COVID-19 vaccine (recombinant, adjuvanted) Marketing-authorisation applicant Sanofi Pasteur Therapeutic indication VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral vector COVID-19 vaccine More information VidPrevtyn Beta: Pending EC decision News announcement: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine Positive recommendation on new biosimilar medicine Name of medicine Kauliv INN teriparatide Marketing-authorisation applicant Strides Pharma Cyprus Therapeutic indication Treatment of osteoporosis More information Kauliv: Pending EC decision Positive recommendations on new generic medicines Name of medicine Pirfenidone Viatris INN pirfenidone Marketing-authorisation applicant Viatris Limited Therapeutic indication Treatment of idiopathic pulmonary fibrosis More information Pirfenidone Viatris: Pending EC decision Name of medicine Sugammadex Amomed INN sugammadex Marketing-authorisation applicant AOP Orphan Pharmaceuticals GmbH Therapeutic indication Reversal of neuromuscular blockade induced by rocuronium or vecuronium More information Sugammadex Amomed: Pending EC decision Positive recommendations on extensions of indications Name of medicine Ceprotin INN human protein C Marketing-authorisation holder Takeda Manufacturing Austria AG More information Ceprotin: Pending EC decision Name of medicine Comirnaty INN tozinameran Marketing-authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: Pending EC decision Name of medicine DuoPlavin INN clopidogrel / acetylsalicylic acid Marketing-authorisationholder Sanofi-aventis groupe More information DuoPlavin: Pending EC decision Name of medicine Dupixent INN dupilumab Marketing-authorisation holder Sanofi-aventis groupe More information Dupixent: Pending EC decision Name of medicine Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: Pending EC decision Name of medicine Eylea INN aflibercept Marketing-authorisation holder Bayer AG More information Eylea: Pending EC decision Name of medicine Imfinzi INN durvalumab Marketing-authorisation holder AstraZeneca AB More information Imfinzi: Pending EC decision Name of medicine Iscover INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Iscover: Pending EC decision Name of medicine Lynparza INN olaparib Marketing-authorisationholder AstraZeneca AB More information Lynparza: Pending EC decision Name of medicine Plavix INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Plavix: Pending EC decision Name of medicine Xofluza INN baloxavir marboxil Marketing-authorisationholder Roche Registration GmbH More information Xofluza: Pending EC decision Withdrawal of initial marketing authorisation application Name of medicine Febseltiq INN infigratinib Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Limited More information Febseltiq: Withdrawn application Name of medicine Orepaxam INN treprostinil diolamine Marketing-authorisationapplicant Ferrer Internacional S.A. More information Orepaxam: Withdrawn application Withdrawals of post-authorisation marketing authorisation applications Name of medicine Gavreto INN pralsetinib More information Gavreto: Withdrawn application Name of medicine Ilaris INN canakinumab More information Ilaris: Withdrawn application Conclusion of referral Name of medicine Janus kinase (JAK) inhibitors More information Janus Kinase inhibitors (JAKi) Other updates List item Scientific advice and protocol assistance adopted during the CHMP meeting 7-10 November 2022 (PDF/246.92 KB) (new) Adopted First published: 11/11/2022 EMA/CHMP/SAWP/872304/2022 List item Start of Union reviews adopted during the CHMP meeting of 7-10 November 2022 (PDF/106.5 KB) (new) Adopted First published: 11/11/2022 EMA/846051/2022