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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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About

Cerbios is a privately held company located in Lugano, Switzerland. Cerbios is the ideal CDMO partner from clinical to commercial supply of ADCs, HPAPIs, Proteins and Antibodies. Services offered include Process & Analytical Development, Scale-up and Clinical Supply, Industrial Validation, Commercial Supply and Full CMC Regulatory Support. Cerbios supplies also generic APIs primarily used in Oncology, Respiratory and Dermatology. Cerbios has additionally a 40 years’ experience in the probiotics field: the portfolio includes a FDF based on proprietary strain SF68® for treatment of diarrhea & dysbiosis, ACNE & Seborrheic dermatitis.

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14-17 October, 2024

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15-17 October, 2024

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“We have built considerable expertise in GLP-1 drug development through our oral peptide programs”

This week, Speak Pharma interviews Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, a drug development and manufacturing accelerator that offers a range of integrated programs and tailored services to over 550 customers. Lewis discusses the latest developments in the delivery of oral peptides and how Quotient Sciences is helping customers overcome drug development challenges in this exciting space. 🔑HIGHLIGHTS// latest developments in the delivery of oral peptides Why have glucagon-like peptide-1 (GLP-1) therapies become essential for treating type 2 diabetes and obesity? What makes the oral delivery of peptides such as GLP-1 challenging? GLP-1 and gastric inhibitory polypeptide (GIP) are essential incretin hormones involved in regulating glucose metabolism. Both are produced in the gastrointestinal (GI) tract in response to food intake, specifically glucose and fats. GLP-1 enhances insulin secretion from the pancreas, but only in response to elevated blood glucose levels. GIP has overlapping effects that are slightly contradictory – it promotes the production of glucagon, which can counteract its glucose-lowering effects. In people with type 2 diabetes, the body’s response to incretin hormones is impaired. However, the GLP-1 pathway remains relatively intact, allowing it to still stimulate insulin production. There is a more significant impairment for GIP, making it not as effective. This makes GLP-1 a more attractive target for treatment, leading to the development of several GLP-1 receptor agonists for managing type 2 diabetes, obesity, and potentially other conditions. Incretin analogs, like GLP-1 agonists, have traditionally been challenging to deliver orally. As a result, these medications are most often given by injection. But we know that patients generally prefer taking a tablet or capsule treatment rather than an injection. Peptides such as GLP-1 analogs go through a challenging journey before being absorbed. This is because the gastrointestinal tract functions to digest these into either small amino acids or very short pieces of polypeptides. Even if they get to the epithelium, they tend to have poor permeability, usually resulting in less than 1 percent bioavailability (the proportion of a drug that enters the circulatory system when introduced into the body, thereby having an active effect). Various technologies have been developed to overcome bioavailability issues, with permeation enhancers being the most advanced and validated. For example, SNAC is the permeation enhancer used in Novo Nordisk’s oral pill Rybelsus to promote semaglutide absorption. Mycapssa (octreotide capsules), marketed by Chiesi, employs the Transient Permeation Enhancer (TPE) technology, which utilizes the medium-chain fatty acid (MCFA) sodium caprylate (C8) to augment the absorption of the somatostatin analog octreotide. At Quotient Sciences, over the last decade, we’ve worked on over 14 oral peptide programs and tested about a dozen different permeation enhancer combinations with them. Permeation enhancers tend to be required in large amounts in formulations, and many of them are usually waxy materials with poor flow, so the tablet formulation and manufacturing process require extra attention and careful design. From an analytics perspective, a lot of the standard quality control tests for tablets have been designed for small-molecule drugs and are yet to be optimized for use with peptides. 🔑HIGHLIGHTS// permeation enhancers as the most advanced and validated technology to overcome bioavailability issues/ worked on over 14 oral peptide programs/ tested about a dozen different permeation enhancer combinations How does Quotient Sciences handle the transition from pre-clinical to clinical development? We’ve pioneered an integrated approach through our Translational Pharmaceutics platform for drug development. This platform combines drug product manufacturing with clinical testing in healthy volunteers, allowing us to be incredibly adaptive in our phase I trial design. Through a tight integration of services, we can manufacture a drug, dose it in healthy volunteers, perform bioanalysis and pharmacokinetic analysis, and use data in real time to inform our next steps. In oral peptide programs, we’ve performed numerous studies where we’ve used this capability to optimize the formulation in response to the clinical data. Typical variables we’ve evaluated are the dose of the peptide and the levels of a permeation enhancer, allowing us to identify the relationship between them to maximize human bioavailability. Through our ability to see the full spectrum of data – from preclinical to clinical – for 11 different peptides and 10 different permeation enhancers, we have built up considerable expertise in the development of oral peptide drug products. This allows us to provide a more streamlined drug development process for our clients, as common challenges across programs can be readily overcome. 🔑HIGHLIGHTS// Translational Pharmaceutics platform for drug development/ combine drug product manufacturing with clinical testing in healthy volunteers/ use data in real time to inform next steps/ 11 different peptides and 10 different permeation enhancers What innovations do you see ahead for oral peptide delivery? I see a real convergence in advances in peptide drug discovery and engineering, together with advances in drug delivery that are really pushing the field forward. Technologies such as phage display mean that vast libraries of peptides can be screened for properties of interest. These are being applied to design peptides specifically for oral delivery. From a drug delivery perspective, approaches such as ingestible devices, ionic liquids and various technologies to exploit active uptake mechanisms are showing real promise. One challenge with oral peptide delivery technologies is that their effectiveness can be significantly impacted by food intake. However, I expect that in the coming years, new methods will be developed to mitigate these food-related effects. I also expect artificial intelligence (AI) to greatly benefit oral peptide delivery. In 2021, the US Food and Drug Administration reported it saw more than 100 drug and biologic application submissions containing elements of AI or machine learning (ML) used in the development process. So three to four years later, that number has likely only increased. All these developments promise to make oral peptide therapies more effective and convenient for patients in the years to come. 🔑HIGHLIGHTS// phage display to screen vast libraries of peptides for properties of interest/ ingestible devices, ionic liquids and various technologies to exploit active uptake mechanisms/ AI will greatly benefit oral peptide delivery To learn more about this topic, watch Quotient Sciences’ latest webinar featuring Dr. Andrew Lewis and Dr. Stuart Mair, Chief Medical Officer at Quotient Sciences. Watch it here.

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.