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41 FDF Dossiers, 6 Europe, 35 Listed Dossiers

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Substipharm is a full service pharmaceutical generics development company, with a global pharmaceutical portfolio of more than 30 marketed products in 40 countries. We invest in our own developments, providing the generic industry with a complete range of dossiers and finished dosage forms through our full service contracts. We offer our clients a trusted, credible supplier and have a successful portfolio of medicines and do...

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INTERVIEW #SpeakPharma

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“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient

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FDA’s landmark approvals of BMS’ schizo med, Madrigal’s MASH drug, US$ 16.5 bn Catalent buyout make it to top 10 news of 2024

The year 2024 was marked by some landmark drug approvals in the areas of schizophrenia, metabolic dysfunction-associated steatohepatitis (MASH), chronic obstructive pulmonary disease (COPD) and Alzheimer’s disease. The incoming Trump administration, monkeypox outbreak and drug price negotiations in the US also created big news. Here is PharmaCompass’ compilation of the top 10 news from Phispers of 2024. I. BMS’ US$ 14 bn Karuna bet pays off with landmark FDA approval for schizophrenia med Cobenfy The US Food and Drug Administration’s groundbreaking approval of Bristol Myers Squibb’s Cobenfy to treat schizophrenia has made it to our number one spot. BMS had acquired Cobenfy through its US$ 14 billion purchase of Karuna Therapeutics, announced in December 2023. Cobenfy is the first-ever antipsychotic that targets cholinergic receptors. Cobenfy’s new approach has experts excited. Its peak sales are expected to come in at US$ 7.5 billion a year. While BMS’ Karuna buyout paid off, AbbVie’s US$ 8.7 billion acquisition of Cerevel Therapeutics was dampened when their lead candidate and schizophrenia drug emraclidine failed to meet phase 2 endpoints in two pivotal trials. II. 2024’s biggest deal, US$ 16.5 bn Catalent buyout by Novo’s parent, cleared after intense scrutiny On number two spot is Novo Nordisk Foundation’s acquistion of Catalent via its investment arm Novo Holdings for US$ 16.5 billion, announced in February 2024. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Easily the biggest biopharma acquisition of last year, the deal faced criticism from lawmakers and consumer groups for its potential anti-competitive effects, particularly in the glucagon-like peptide-1 (GLP-1) drug market. Its main competitor Eli Lilly called for scrutiny by competition regulators. However, in December, both the EU regulator and the US Federal Trade Commission gave it the greenlight. III. Madrigal’s Rezdiffra becomes first FDA-approved drug for liver disease MASH For quite some time, the drug development field for the liver condition MASH had been a graveyard for failed programs. In 2024, the field celebrated a hurrah moment when Madrigal’s oral drug Rezdiffra became the first treatment in the US for adults with this common fatty liver disease. The approval has opened a multi-billion dollar opportunity for Madrigal with the American Liver Foundation CEO Lorraine Stiehl calling it a “game-changing” moment. IV. COPD patients get two new treatments — Verona’s Ohtuvayre and Sanofi-Regeneron’s Dupixent The COPD landscape saw remarkable advances in 2024. FDA approved Verona Pharma’s Ohtuvayre, which brings the first new mechanism of action in over two decades for the treatment of COPD. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management. Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Over 390 million people are living with COPD worldwide. V. Novartis inks 20 deals in 2024, promises over US$ 25 billion in biobucks, lays bets on radiopharmas Novartis has been investing in early-stage science, buying out companies in the sub-US$ 5 billion range. The Swiss drugmaker Novartis inked over 20 deals in 2024, paying over US$ 5.5 billion upfront and promising over US$ 25 billion in biobucks. The company has particularly focused on radiopharmaceuticals and molecular glue degraders. It acquired Mariana Oncology to strengthen its radioligand therapy (RLT) pipeline, and also inked RLT deals with PeptiDream and Ratio Therapeutics. VI. Despite political pressure, FDA rejects first MDMA-assisted therapy to treat PTSD; Lykos faces expanded probe In August, FDA declined to approve an MDMA-assisted therapy from Lykos Therapeutics to treat post-traumatic stress disorder (PTSD). In the lead-up to the FDA decision, 80 members of Congress from both sides of the aisle had urged US President Joe Biden and the FDA to consider further studies on the therapy. Not satisfied with just declining Lykos’ MDMA-assisted therapy for PTSD, FDA had expanded its investigation into the clinical trials that tested it. Lykos CEO Amy Emerson stepped down after reducing its workforce by 75 percent. Additionally, its founder Rick Doblin exited its board. VII. Alzheimer’s gets two new treatments as FDA approves Lilly’s Kisunla, Alpha Cognition’s Zunveyl FDA finally approved Eli Lilly’s Alzheimer’s drug Kisunla in July, after delaying action on it in March. This approval, along with that of Biogen and Eisai’s Leqembi in 2023, mark successes in treating the mind-wasting disease after three decades of failed efforts. FDA also approved Alpha Cognition’s Zunveyl to treat mild-to-moderate Alzheimer’s disease. Zunveyl is a prodrug of Alzheimer’s medication galantamine, and is to be taken orally twice a day. Alpha said Zunveyl is designed to address the tolerability issues with galantamine. VIII. IRA price talks conclude; Stelara, Enbrel, Eliquis to bring 51.4% of Medicare savings After filing futile lawsuits questioning the constitutional validity of the Medicare drug price negotiations under the Inflation Reduction Act (IRA), all drug companies came to the bargaining table. In August, the Biden-Harris Administration announced it had reached agreements for lower prices for all 10 drugs selected for negotiations under the IRA. The new prices come into effect from January 1, 2026. A Brookings Institution report said that just three drugs will account for over half of the expected US$ 6 billion savings in 2026. J&J’s Stelara (US$ 1.4 billion), Amgen’s Enbrel (US$ 1.1 billion), and BMS’ Eliquis (US$ 856 million) are expected to account for US$ 3.28 billion or 51.4 percent of Medicare savings. IX. Trump’s picks for new administration send shockwaves across markets, stocks of vaccine makers tumble Donald Trump’s picks for his new administration not only created big news, but also impacted the stock markets. His selection of Robert F. Kennedy Jr., an anti-vaccine activist, to lead the Department of Health and Human Services (HHS), sent shares of several vaccine manufacturers plummeting. In the US, stocks of Pfizer, Moderna, and Novavax dipped. In Europe, stocks of BioNTech, GSK, and Bavarian Nordic tumbled. Trump has nominated Mehmet Oz, a celebrity TV host, to run the Centers for Medicare and Medicaid Services (CMS), which oversees health insurance. X. New mpox outbreak in Africa sparks global response; FDA approves Emergent’s vaccine to treat mpox In August, a new mpox virus clade put Africa in the throes of an mpox outbreak. The WHO declared it a public health emergency of international concern. Emergent BioSolutions said it will donate 50,000 doses of its smallpox vaccine ACAM2000. Multiple countries responded with donations of Bavarian Nordic’s Jynneos, the only widely-approved mpox vaccine at the time. In early September, the FDA approved Emergent’s ACAM2000 as the second mpox vaccine.