Amryt Pharmaceuticals DAC

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Amryt Pharmaceuticals’ Filsuvez (birch bark extract) for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa (EB). Affecting around 500,000 people worldwide, EB is a rare inherited skin disorder that causes the skin to become fragile, causing blisters, tears and the loss of skin segments. NICE’s decision marks the first time the institute has recommended an EB treatment, with around 670 patients in England expected to benefit from Filsuvez. Helen Knight, director of health technology assessment at NICE, said: "There are substantial treatment requirements to manage [EB] symptoms. These include daily cleaning of wounds and dressing changes that can often total 37 hours a week and which themselves can cause substantial pain." The recommendation follows positive results from the phase 3 birch bark extract clinical trial, EASE, which found that the treatment led to quicker wound healing in patients with dystrophic and junctional EB and had potential to reduce the amount of skin affected. The EASE trial was the largest phase 3 randomised control trial to examine the efficacy and safety of Amryt’s Filsuvez gel/Oleogel-S10 in comparison to the control gel for EB. Patients with EB from the EASE double-blind phase who received the treatment experienced a reduction in overall wound burdens, a reduced frequency of dressing changes, and were well tolerated, with a similar safety profile to control gel. Dr Joe Wiley, chief executive of Amryt Pharma, commented on the EASE trial results, stating that they represented an "important advancement for patients and families living with this rare and distressing disorder". Knight added: "[Filsuvez] has the potential to improve the quality of life for people with EB and their carers and help free up time for other activities" after receiving "valuable insight" from patients' experiences with EB from organisations including DEBRA and Genetic Alliance UK. In June 2022, the European Commission approved Filsuvez in the EU for patients aged six months and older for partial-thickness wounds associated with dystrophic and junctional EB.

Entering the second half of 2022, biopharma and life sciences companies from across the globe strengthen their leadership teams with new additions to the c-suite, including legal counsel, presidents, chief medical officers and more. Check out these BioSpace Movers & Shakers. Evommune, Inc. – Gregory S. Moss was named chief corporate strategy and legal officer of the California-based company. Moss most recently served as executive vice president, general counsel & corporate secretary, and chief compliance officer at Kadmon Holdings, Inc., which is now a Sanofi Company. Prior to joining Kadmon in 2012, Moss served as a solicitor in the corporate risk department of a large Australian law firm. Maravai Life Sciences – Peter Leddy joined San Diego-based Maravai as executive vice president and chief administrative officer, a newly-created role. Prior to joining the company full-time, Leddy served as a consultant to Maravai. Before that, he was chief human resources officer at Berkeley Lights and held the same role at Life Technologies and Invitrogen. He held similar positions outside of the life sciences at Dell and PepsiCo. Aptose Biosciences – Fletcher Payne was named senior vice president, chief financial officer of Aptose. Payne most recently served as CFO of Syapse. He served in a CFO capacity and senior financial positions at CytomX Therapeutics, Plexxikon Inc., Rinat Neuroscience Corporation, Dynavax Technologies Corporation, and Cell Genesys, among others. Zentalis Pharmaceuticals – Zentalis Pharmaceuticals named Andrea Paul as general counsel and corporate secretary. Before Zentalis, Paul served as general counsel and corporate secretary at LogicBio Therapeutics, Inc. Previously, she held increasing responsibility at Akebia Therapeutics, Inc., culminating in the role of vice president of legal. Before Akebia, she served as senior corporate counsel at Momenta Pharmaceuticals, Inc. Bright Minds Biosciences – Vancouver-based Bright Minds announced that Alan Kozikowski will no longer serve in the role of chief scientific officer. The company did not specify the reason for Kozikowski’s departure. A search for a new CSO is underway. Jan Torleif Pedersen, a member of the board of directors and former executive at Lundbeck, will serve as the interim CSO until the position is filled. TCR² Therapeutics – Industry and finance veteran Eric Sullivan was named CFO. Prior to TCR², Sullivan served as president, CFO and chief operating officer of Triplet Therapeutics. Before that, he led finance as SVP at Gemini Therapeutics and Oncorus. Earlier in his career, Sullivan held senior financial management positions at bluebird bio and Merrimack Pharmaceuticals. Dunad Therapeutics – Pearl Huang was named chief executive officer of England’s Dunad Therapeutics. Prior to Dunad, she was president and CEO of Cygnal Therapeutics, founded by Flagship Pioneering, where she was also a venture partner. Earlier, she held leadership roles at Roche as SVP of therapeutic modalities. At GlaxoSmithKline, she was vice president, and global head of discovery partnerships with academic. At Merck, Huang was vice president, oncology franchise integrator. She was also a founder and acting CSO of Beigene. Huang serves on the board of directors for KSQ Therapeutics, Waters Corporation and BB Biotech. DTx Pharma, Inc. – Peter Condon was named chief business officer. Condon has held positions as the vice president and head of business development at Gossamer Bio, and senior roles in business development and commercial planning at Calico Life Sciences, Alexion Pharmaceuticals, and Genentech. NeuBase Therapeutics – William Mann was appointed president and will continue to serve as COO. Prior to joining NeuBase, Mann served as the president, CEO, and board member of Helsinn Therapeutics U.S. Before that, he was vice president of corporate development at Sapphire Therapeutics. Mann began his professional career at Novartis, where he led a multidisciplinary drug discovery program and later served as director of business development. Amolyt Pharma – France-based Amolyt named Mark Sumeray as CMO. Sumeray joins Amolyt from Amryt Pharmaceuticals, where he has served as CMO since September 2016. Prior to Amryt, Sumeray served as chief medical officer at Aegerion Pharmaceuticals. Earlier in his career, he led the U.S. cardiovascular and metabolic medical affairs team at Bristol-Myers Squibb. GV20 Therapeutics – GV20 bolstered its leadership team with several appointments. Shirley Liu, a company co-founder, was named CEO. Liu was previously a Biostatistics and Computational Biology professor at Dana-Farber Cancer Institute and Harvard T.H. Chan School of Public Health. Steven Landau, a former executive at Shape Pharmaceuticals and Tensha Therapeutics, was named CMO. Genentech veteran Ying Gong was named CBO. Kures Therapeutics – Chad Beyer was named CEO of Kures, an atai Life Sciences company. Outgoing Kures CEO Srinivas Rao will continue to support and advise Kures’ programs from his role at atai Life Sciences. MediWound Ltd. – Israel’s MediWound named Tzvi Palash as COO. He joins MediWound from Enlivex, where he leads the design and construction of the new cGMP manufacturing facility. Before that, he served as COO at Gamida Cell and was a general manager at ColBar LifeScience. Earlier in his career, Palash held operational roles at Teva Pharmaceutical Industries and Interpham Laboratories. NGM Biopharmaceuticals – Siobhan Nolan Mangini, the company’s CFO, has also been named president of the company. Prior to joining NGM Bio, Nolan Mangini served as president and CFO of Castlight Health, a San Francisco-based healthcare technology company. Before that, she worked as a management consultant at Bain & Company, specializing in health care and private equity practices. Chicago ARC – J&J executive Kate Merton has been named the executive director of Chicago ARC, a new venture collaborative focused on accelerating innovative health equity solutions. Prior to the ARC, Merton ran Anthem’s digital incubator and at J&J, Merton was the Head of Johnson & Johnson Innovation, JLABS New York City, Boston and Philadelphia. Fate Therapeutics – Celgene veteran Brian T. Powl was named chief commercial officer. At Celgene, Powl served as the global commercial CAR-T lead. Most recently, Powl was head of commercial development and marketing at MEI Pharma, Inc. Prior to Celgene, Powl held sales and marketing positions at Novartis Oncology and Centocor, Inc.