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DATA COMPILATION #PharmaFlow

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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.   

Impressions: 2491

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

STOCK RECAP #PipelineProspector

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Pipeline Prospector March 2023: Silicon Valley Bank collapse hits biotech indices; Pfizer buys out Seagen
Biotech indices have witnessed a lot of volatility throughout 2022 and 2023. Just when they were beginning to look up, the collapse of Silicon Valley Bank (SVB) in mid-March dragged them down once again. The bank's fall left many biotech firms uncertain about their future, as life sciences and healthcare accounted for 12 percent of SVB’s deposits of US$ 173 billion.The indices regained some ground by the end of the month — the Nasdaq Biotechnology Index (NBI) increased by 0.6 percent to US$ 4,125, but the S&P Biotechnology Select Industry Index (SPSIBI) and the SPDR S&P Biotech ETF (XBI) both registered declines, falling by 8.3 percent to US$ 5,898 and 8.2 percent to US$ 76.21, respectively. In February, the NBI had fallen by 6 percent, while the SPSIBI and XBI had both experienced declines of 7 percent and 8 percent, respectively.Several mega and large cap companies, such as Sanofi, Eli Lilly, Novartis, AstraZeneca, Novo Nordisk, GSK and Moderna, posted gains in March.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)Sanofi’s Dupixent succeeds in COPD trial, buys Provention Bio for its diabetes drug The biggest mega cap gainer on the bourses was Sanofi (its stock rose 17 percent in March). Its blockbuster anti-inflammatory drug Dupixent, developed along with Regeneron, succeeded in a late-stage clinical trial for chronic obstructive pulmonary disease (COPD), a disease that causes a progressive decline in lung function. If approved, Dupixent would become the first biologic treatment for COPD. Analysts estimate the label expansion to add US$ 3.5 billion in peak sales for Dupixent. In a further boost, the European Commission approved Dupixent for children aged six months to five years with severe atopic dermatitis. Regeneron’s stock was up 6 percent.In mid-March, Sanofi said it will purchase US-based Provention Bio (up 167 percent) for US$ 2.9 billion. The deal builds on an existing co-promotion agreement between the two companies, with Sanofi gaining full ownership of Provention Bio’s type 1 diabetes therapy Tzield. Also, Sanofi and partner Sobi’s treatment for severe hemophilia A (a hereditary bleeding disorder) in previously treated patients under 12 years, efanesoctocog alfa, met its primary endpoint in a phase 3 pivotal study.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Novartis’ Kisqali proves effective in breast cancer trial; Astra’s Enhertu posts gainsNovartis (10 percent) and AstraZeneca (8 percent) were the other mega cap gainers in March. Novartis’ breast cancer drug Kisqali plus endocrine therapy following surgery proved to be effective in a phase 3 trial in treating patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer who are at risk of recurrence. The Swiss pharma also shared positive long-term data for its gene therapy, Zolgensma, as a treatment for spinal muscular atrophy, a genetic disease that affects muscle movement. Its subsidiary Sandoz received FDA approval for Hyrimoz, a biosimilar of adalimumab.AstraZeneca and partner Daiichi Sankyo (up 15 percent) announced positive results from a mid-stage trial of their blockbuster cancer drug Enhertu in multiple HER2-expressing advanced solid tumors. Astra and Merck’s Lynparza received authorization in the UK as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC).Similarly, AbbVie’s blockbuster drug Skyrizi achieved a win in a late-stage trial for adults with moderate-to-severe active ulcerative colitis, a type of bowel disease that affects the large intestine. The drug also showed positive results in a late-stage trial in adults with moderate-to-severe plaque psoriasis who still experience symptoms after six months of treatment with Novartis’ Cosentyx (secukinumab) and Lilly’s Taltz (ixekizumab).But AbbVie also faced a setback — FDA denied approval to AbbVie’s Parkinson’s therapy ABBV-951 and requested for more information on the device used to administer the medication. Overall, AbbVie’s stock rose 3 percent last month.In good news for Roche, a panel of external advisers to the FDA voted 11-2 in favor of expanding the use of its med Polivy in combination with other drugs for adults with diffuse large B-cell lymphoma. Roche also joined forces with Lilly to develop a blood test that can detect early signs of Alzheimer’s disease.Meanwhile, a combination of Roche’s immunotherapy Tecentriq and Exelixis’ cancer drug Cabometyx failed a late-stage trial in advanced renal cell carcinoma. Roche’s stock remained unchanged in March. Similarly, Merck’s anti-TIGIT therapy vibostolimab, in combination with Keytruda, failed to improve progression-free survival in patients with metastatic non-small cell lung cancer in a phase 2 trial. In a separate phase 2/3 study, Keytruda and chemotherapy significantly improved overall survival in patients with unresectable malignant pleural mesothelioma, a rapidly progressing cancer that develops in the lining of the lungs. Merck’s stock fell 1 percent. FDA brought out a draft guidance for accelerated approvals to improve clinical trials of cancer drugs.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) GSK, Pfizer’s RSV jabs get FDA panel’s backing; Pfizer buys out Seagen for US$ 43 bnA panel of external experts to the FDA backed both GSK (6 percent) and Pfizer’s respiratory syncytial virus (RSV) experimental vaccines, setting the stage for a race between the two rivals to bring out the first shot in the US against the disease. The final results of a trial published in the New England Journal of Medicine showed that Pfizer’s experimental maternal RSV vaccine was 82 percent effective in preventing serious illnesses in children when given to pregnant mothers.Though Pfizer announced its biggest buyout in recent times, its stock saw no change in March. It is acquiring cancer treatment specialist Seagen (up 12 percent) for US$ 43 billion as part of its move to mitigate a hit in revenues from declining sales of its Covid-19 products and patent expirations of some top drugs in the coming years. FDA approved Pfizer’s Zavzpret nasal spray for the treatment of acute migraine. It, however, recalled 4.2 million units of its Nurtec ODT prescription migraine drug because it failed to meet child-resistant packaging requirements.In March, Moderna (11 percent) and partner Merck said they will present phase 2 data of their investigational personalized cancer vaccine, mRNA-4157, at an oncology conference in April. The experimental drug, in combination with Keytruda, received FDA’s breakthrough therapy designation in February. Meanwhile, the vaccine maker said it will open offices in South San Francisco and Seattle as part of its plan to rapidly advance its pipeline of messenger RNA medicines amid declining Covid-19 vaccine sales.BioNTech said it expected the sale of its Covid-19 vaccine to fall from €17.3 billion (US$ 18.7 billion) in 2022 to €5 billion (US$ 5.4 billion) this year. The German mRNA company will allocate up to €2.6 billion (US$ 2.8 billion) towards R&D this year. Its stock fell 5 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Insulin makers cut prices by up to 75 percent; Vertex posts gains in cell therapy for diabetes March saw a lot of activity in the field of diabetes. FDA accepted Lilly’s application for Jardiance as a treatment for children 10 years and older who are suffering from type 2 diabetes. Last month, Lilly (9 percent) decided to slash the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent in the US. Rival Novo Nordisk (11 percent) also said it would cut the US prices of its insulin therapies by up to 75 percent.Large cap biopharma Vertex Pharmaceuticals’ cell therapy candidate VX-264 received investigational new drug application clearance from the FDA as a potential treatment for type 1 diabetes. Vertex’s stock went up 8 percent. And small cap firm Biomea Fusion posted positive topline data from a phase 1/2 study evaluating its lead pipeline candidate — BMF-219 — in patients with type 2 diabetes. Biomea’s stock skyrocketed 129 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Our viewDespite showing some signs of a revival in January, the first quarter of 2023 has been lackluster for biotech indices. In terms of M&As, the industry witnessed the Pfizer-Seagen deal and the Sanofi-Provention Bio deal. But we are expecting a lot more from 2023.In April, FDA is likely to take some important drug approval decisions — such as the one on the expanded use of Pfizer’s pneumococcal vaccine Prevnar 20 for use in infants and children, approval of Emergent BioSolutions’ anthrax vaccine and Daiichi Sankyo’s cancer drug quizartinib, which is under priority review, among many others. These decisions are bound to have an impact on the bourses. We are looking forward to an eventful month.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) 

Impressions: 2369

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-march-2023-silicon-valley-bank-collapse-hits-biotech-indices-pfizer-buys-out-seagen

#PharmaFlow by PHARMACOMPASS
06 Apr 2023

NEWS #PharmaBuzz

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https://www.fiercepharma.com/pharma/exelixis-stock-rises-key-drug-cabometyx-withstands-patent-challenges

FIERCE PHARMA
16 Oct 2024

https://www.fiercepharma.com/pharma/despite-survival-miss-exelixis-presses-fda-prostate-cancer-filing-ipsen-scraps-eu-plan

FIERCE PHARMA
17 Sep 2024

https://www.globenewswire.com/news-release/2024/09/16/2946663/0/en/Final-results-from-CABINET-Phase-III-trial-reinforce-efficacy-benefits-of-Cabometyx-in-advanced-neuroendocrine-tumors.html

GLOBENEWSWIRE
16 Sep 2024

https://www.businesswire.com/news/home/20240913607414/en

BUSINESSWIRE
16 Sep 2024

https://www.globenewswire.com/news-release/2024/09/15/2946293/0/en/Ipsen-provides-update-on-CONTACT-02-Phase-III-trial-in-metastatic-castration-resistant-prostate-cancer-following-final-overall-survival-analysis.html

GLOBENEWSWIRE
15 Sep 2024

https://www.businesswire.com/news/home/20240913609179/en

BUSINESSWIRE
15 Sep 2024