Advanz Pharma, a pharmaceutical company with a strategic focus on specialty pharmaceuticals, specialty and hospital generics in Europe, is welcoming Steffen Wagner as its new CEO.
Wagner joins from Stada, where he was a member of the Global Executive Committee and responsible for European markets. A medical doctor by training, he has previously held senior roles at Biogen and within the Novartis Group, and worked as a consultant at McKinsey and Bain.
In addition, Wagner brings extensive international pharma experience that will be highly valuable in driving Advanz Pharma’s continued journey to be the partner of choice for commercializing specialty pharmaceuticals, specialty and hospital generics in Europe, the company said.
Wanger was appointed together with several other recent senior leadership hires as Advanz Pharma now enters into the next phase of its growth journey. These appointments include new CFO Andreas Stickler, who joined from Merck KGaA, and Susanna El-Armale, who joined as chief corporate development officer from Theramex.
“This is a hugely exciting time to be joining Advanz Pharma. It is a great platform on which we can build to achieve our vision to be a partner of choice in specialty pharmaceuticals in Europe,” Wagner said. “We will further expand the commercial footprint and accelerate growth via mergers and acquisitions, business development and licensing, and product launches. I am looking forward to working with my Advanz Pharma colleagues and helping to improve patients’ lives by providing the critical medicines they depend on.”
Lundbeck names CFO, head of corporate functions
Lundbeck is welcoming a new executive. Joerg Hornstein is joining as chief financial officer and member of Lundbeck’s executive management. He will assume the role no later than Sept. 1, 2022, and he will be registered with the Danish Business Authority.
Lundbeck described Hornstein as an action-oriented, change-driven leader, with a strong track record in integrating, restructuring, scaling up and improving business performance and productivity in pharmaceutical, biotech and fast-moving consumer goods industries. He has proven experience in executive management roles and as a principal financial advisor on boards of directors.
Hornstein is joining Lundbeck from AC Immune, a clinical-stage biopharmaceutical company specialized in precision medicine to diagnose, treat and prevent neurodegenerative diseases, headquartered in Lausanne, Switzerland, where he currently serves as executive vice president and chief financial officer.
“Following a thorough internal and external search, we are delighted to welcome Joerg to Lundbeck. He brings extensive experience in delivering results and creating value across increasingly complex financial roles in Merck KGaA, Unternehmensgruppe Theo Mueller and, most recently, as CFO of AC Immune,” said Deborah Dunsire, CEO of Lundbeck.
“Joerg has a strong mix of understanding of neuroscience and pharma, exceptional operational experience across multiple functions and countries, and demonstrated ability to lead through business transformations. The insights he has gained by leading across cultures and through periods of significant change will be valuable in ensuring Lundbeck continues to be well positioned for sustainable, long-term value creation in the years ahead,” Dunsire said.
Hornstein has been with AC Immune since 2017, where he oversaw finance and various corporate functions. Over the years, he led a financial transformation of the company’s operations, leading to a strengthened financial and investor position. He also implemented state of the art systems and processes across all corporate functions, as well as a new portfolio investment approach.
Prior to AC Immune, he served as senior vice president and head of group controlling at Unternehmensgruppe Theo Mueller, a consumer products company with operations across the entire value chain and an annual revenue of approximately 7 billion euros. In this role, Hornstein transformed the financial profile of the business during periods of major acquisitions and significant organic growth.
He began his career at Merck KGaA, where he spent 12 years in financial roles of increasing responsibility across different businesses, including roles at the headquarters in Germany, as well as in Indonesia, China and the United States. Hornstein has lived in six countries and is a German national.
Breckenridge has received the Food and Drug Administration’s tentative approval for dabigatran etexilate capsules.
The medication is the generic of Boehringer Ingelheim's Pradaxa.
Pradaxa is used to reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem; treat blood clots in the veins of legs (deep vein thrombosis) and lungs (pulmonary embolism) after treatment with an injectable medicine to treat blood clots for five to 10 days; and reduce the risk of blood clots from happening again in the veins of legs and lungs after a patient has received treatment for blood clots.
Breckenridge said that the product development was a collaboration between Towa Pharmaceutical Europe, S.L. coupled with an external contract manufacturing organization.
Breckenridge has the three strengths consistent with the brand — 75 mg, 110 mg and 150 mg.
Pradaxa had a market value of $455 million during the 12 months ending February 2022, according to industry data, the company said.
The Association for Accessible Medicines is welcoming a new member.
Meitheal Pharmaceuticals, a fully integrated generic injectables company based in Chicago, has joined the organization.
“We are proud to partner with AAM in support of our mission to bridge important gaps in health care with an affordable and diversified range of generic injectables,” said Tom Shea, CEO of Meitheal Pharmaceuticals. “We look forward to working together to achieve our shared goal of getting safe, effective and more-affordable medicines out of the lab and into the hands of the people who need them.”
The company primarily specializes in the development, manufacture, procurement and sale of generic injectable pharmaceuticals, with 36 FDA-approved products covering indications for anti-infective, oncolytic and intensive care.
“Meitheal’s active engagement in AAM makes our voice even stronger and more effective as we advocate on behalf of the generic industry and its mission to ensure that our quality, safe, effective and affordable medicines are accessible to America’s patients,” said Dan Leonard, CEO of AAM. “We are pleased to welcome Tom Shea’s participation on our board of directors alongside his industry peers.”
Furthermore, Meitheal has an expanding product portfolio and robust pipeline, including single and multidose vials, ready-to-use prefilled syringes and premixed bags. As of the end of March 2022, Meitheal had 49 products in the research and development phase, 24 products were under review by the Food and Drug Administration, and 16 products were planned to be launched in 2022, the company said.
Teva settles patent dispute with Lupin on generic Austedo
Teva Branded Pharmaceutical Products R&D and Auspex Pharmaceuticals, U.S., affiliates of Teva, have reached an agreement with Lupin to resolve the dispute over Lupin’s ANDA for a generic deutetrabenazine product. Teva and Lupin have been involved in a patent infringement litigation in which Teva asserted a number of patents against Lupin that cover Teva’s Austedo (deutetrabenazine) product.
Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.
Austedo is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease.
Teva said that it believes that today’s settlement with Lupin is a further reflection of the strength of its intellectual property covering its Austedo product.
On March 9, 2022, the U.S. Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex. Teva said that it will continue to litigate the ongoing patent infringement suit it brought against Aurobindo regarding Aurobindo’s ANDA for a generic deutetrabenazine product.