Menotropins

Ferring Pharma's CSO says the company's commitment to reproductive and maternal health products is unchanged even as R&D priorities shift. After more than 25 years, Ferring Pharmaceuticals suddenly shuttered a San Diego research institute in March just months after finishing a major renovation. It's all part of the plan, says Chief Scientific Officer Armin Metzger, Ph.D. The research executive, now in his seventh year with Ferring, said that the company is making a concerted pivot toward external innovation to make the best use of capital following two FDA approvals at the end of 2022. It's a shift that Metzger describes as a "fundamental" change. "We will still have internal discovery, but [be] much, much more external focused, giving more flexibility of allocating funds," he said in an interview with Fierce Biotech. The clear-eyed assessment of the company’s priorities set the record straight as to why the Ferring Research Institute, one of the company’s three main R&D hubs, closed after 27 years. The move resulted in nearly 90 staffers being laid off and came after Ferring finished renovations on the institute just last year.  “[T]he turning point was that we got two FDA approvals of two first-in-class assets in one year,” said Metzger. “And this leads to the adaptation, again of the strategy—how we deliver innovation to the patients—and it is not an easy decision-making process.”  In November 2022, Ferring nabbed FDA approval for the first fecal microbiota product, Rebyota, for adults with C. difficile following antibiotic treatment or recurrent infection. Just a few weeks later, gene therapy Adstiladrin was approved for bladder cancer.  The new strategy is not a complete departure from Ferring’s existing work, as those now-approved assets originated from deals. Ferring acquired Rebiotix in April 2018, tacking on the C. difficile treatments, and then a month later, the Swiss pharma signed a commercialization agreement with FKD Therapies for the bladder cancer treatment. “I think a company of our size, with the investment needed now on the later stage, we can't entertain technology platforms in-house,” said Metzger, who added that Ferring will instead rely on "partnerships across the globe.” Ferring’s main therapeutic areas are remaining unchanged, however, including maternal and reproductive health, which Metzger called “the core” of the company. One of the priorities is bringing the infertility treatment Rekovelle to the U.S. after it nabbed approval in Europe and Switzerland. He expects feedback from the FDA in the second half of the year.  In addition to Rekovelle, infertility treatments LutrePulse and Menopur are under development, along with Pabal, a med for postpartum hemorrhage.  But the clinical-stage work is in limbo. A phase 2 trial for a treatment to address inadequate milk production, merotocin, was shuttered earlier this year due to low enrollment and a phase 2 infertility treatment is now absent from the company’s pipeline. A spokesperson for Ferring did not immediately respond to a request for comment on the missing program.  Regardless, Metzger says that in the next year, the company hopes to bolster its portfolio, including potentially boosting the indications for merotocin. This could also mean combination opportunities and female and male infertility assets from Ferring's reproductive medicine pipeline.

SAINT-PREX, Switzerland--( BUSINESS WIRE )--Ferring has today published its 2022 Annual Report. The company reported revenues of €2.3 billion, an increase of +5% on the previous year at actual exchange rates, but a slight decrease of -1% at constant exchange rates. The main highlights of the year were the approvals by the US Food and Drug Administration (FDA) for two pioneering new medicines, Rebyota™ (fecal microbiota, live – jslm), a new microbiome treatment, and Adstiladrin ® (nadofaragene firadenovec-vncg), a novel gene-based therapy for bladder cancer. These were approved in November and December 2022 respectively. This means Ferring was responsible for two out of the eight biological medicine products approved by the US FDA’s Center for Biologics Evaluation and Research in 2022. 1 The ground-breaking approvals of Rebyota™ and Adstiladrin ® will provide new options for patients and important mid- to long-term growth and diversification opportunities for Ferring, reflecting our strategy to progress late-stage opportunities and demonstrating our ongoing commitment to scientific innovation. We also continue to demonstrate leadership in reproductive medicine and maternal health. Carbetocin Ferring (carbetocin, room temperature-stable formulation) became our first-ever product to gain prequalification status from the World Health Organization. This will make it easier for more women in low- and lower middle-income countries to access treatment for the prevention of PPH. For the year, revenues showed a slight decrease of -1% at constant exchange rates, after a strong first three quarters of the year. However, in the fourth quarter, Ferring faced challenges when we were made aware of changes in the manufacturing process of the drug substance for Menopur ® (menotropins for injection), one of our leading products used for ovarian stimulation in women undergoing assisted reproductive technologies. Whilst Ferring’s data reviewed to date indicates that the safety and efficacy of the product remain unaltered, this has resulted in supply constraints as we work with health authorities to resolve the situation. Thus, for the year, the reproductive medicine and maternal health portfolio decreased by -2% at constant exchange rates but was largely offset by the solid growth in the rest of the portfolio. The appreciation of several currencies against the euro resulted in revenues achieving growth of +5% at actual exchange rates. In 2022, expenditure increased as business activity returned to normal following the COVID-19 pandemic. We also invested in the field of microbiome in anticipation of the Rebyota™ launch, alongside increased research and development costs as the pipeline evolved and clinical studies were conducted. Despite inflation, we were able to partly mitigate the increase in operating expenses through disciplined cost management. Nevertheless, operating profit decreased to reach €231 million for the year. “ In 2022, we continued to demonstrate the qualities that make Ferring such an enduring force in the world of healthcare: the inspiration and passion to develop pioneering medicines, a consistent focus on the unmet needs of patients, and the resilience to overcome challenges as they arise,” said Per Falk, President of Ferring Pharmaceuticals. “ Our newly approved products provide important avenues for exploration and growth, built upon our established strength in reproductive medicine and maternal health, where we have a long-standing reputation for innovation and remain committed to building families of every shape and size.” About Ferring Pharmaceuticals Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. Learn more at www.ferring.com , or connect with us on Twitter , Facebook , Instagram , LinkedIn and YouTube . References: 1 U.S. Food and Drug Administration. 2022 Biological License Application Approvals. Available at https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2022-biological-license-application-approvals . Last accessed 24 February 2023. 2 Trends in Maternal Mortality 2000 to 2017: Estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division. World Health Organization 2019. Available at: https://www.unfpa.org/sites/default/files/pub-pdf/Maternal_mortality_report.pdf Last accessed 24 February 2023. # # #