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CPhI Milan - we had a great show

24 Oct 2024

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Gx Inbeneo® autoinjector wins the Red Dot Award

22 Oct 2024

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Roofing Ceremony for new office building at Midas Pharma

17 Oct 2024

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DATA COMPILATION
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DIGITAL CONTENT

8 CORPORATE CONTENT #SupplierSpotlight, 2 DATA COMPILATION #PharmaFlow, 32 NEWS #PharmaBuzz

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8 CORPORATE CONTENT #SupplierSpotlight
2 DATA COMPILATION #PharmaFlow
32 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

21 All APIs, 7 USDMF, 10 CEP/COS, 18 Listed APIs

21 All APIs
7 USDMF
10 CEP/COS
18 Listed APIs

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

KEY PRODUCTS

Aminolevulinic Acid HCl, Crotamiton, Doxapram Hydrochloride, Doxazosin Mesylate, Enzalutamide, Meglumine, Nintedanib Esylate, Pipamperone, Trospium Chloride

Aminolevulinic Acid HCl
Crotamiton
Doxapram Hydrochloride
Doxazosin Mesylate
Enzalutamide
Meglumine
Nintedanib Esylate
Pipamperone
Trospium Chloride

INSPECTIONS & REGISTRATIONS

2 EDQM

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

About

Midas Pharma is a pharmaceutical company that excels in providing extensive expertise while fostering connections between companies, individuals, and knowledge. The core competence of Midas Pharma lies in project management related to pharmaceutical supply chains. The company is actively involved in sourcing, supplying, and developing Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF) manufactured by its contract manufacturing partners. For each project or product, Midas Pharma selects the most suitable match from its network of manufacturing partners.

DCAT WeekDCAT Week

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17-20 March, 2025

New York, USA
IMCAS World CongressIMCAS World Congress

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30 January-01 February, 2025

Palais des Congrès de Paris
Medizin 2025Medizin 2025

Industry Trade Show

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31 January-02 February, 2025

Stuttgart, Germany

CONTACT DETAILS

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Germany

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Rheinstr. 49, 55218 Ingelheim

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+49 61329900

api@midas-pharma.com

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https://www.midas-pharma.com/

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http://www.youtube.com/@midaspharma8178

Digital content

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CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

GMP Certificate 2023

GDP Certificate Human

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GDP Certificate Veterinary

DQS Certificate

Gx Inbeneo

Reference Products Sourcing

DATA COMPILATION #PharmaFlow

FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding.

Impressions: 1097

US, Europe turn to advanced manufacturing, stockpiling to strengthen drug supply chains

Over the last few decades, the United States and Europe have saved trillions of dollars by importing drugs from countries like China and India. Their journey wasn’t easy, with regulatory non-compliance and drug patent scams raising their ugly heads every now and then. The Covid-19 pandemic and the accompanying lockdowns were a wake-up call for these countries to take a long, hard look at their sourcing strategies.Over the last few years, both the US and Europe have embarked on policy changes and ambitious programs to strengthen their drug supply chains. PharmaCompass takes you through US and Europe’s journeys towards more robust pharmaceutical supply chains.Biden’s executive order, CARES Act, state-backed investments strengthen US supply chainDuring the early days of the pandemic, the US government (under former President Donald Trump) had enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to address the economic fallout of the pandemic through a US$ 2.2 trillion stimulus. Through this act, the FDA had taken several drug shortage mitigation efforts. The new administration under President Joe Biden undertook more measures. Notable amongst them was Executive Order 14017 on America’s supply chains. It mandated a comprehensive 100-day review to identify vulnerabilities in key sectors, including pharmaceuticals and active pharmaceutical ingredients (APIs). The review noted that 87 percent of generic API facilities are located overseas, leaving the US healthcare system vulnerable to shortages of essential medicines.Through a Presidential Determination, Biden had also broadened US Department of Health and Human Services’ (HHS) authorities under the Defense Production Act (DPA) of 1950. HHS can now enable investment in domestic manufacturing of essential medicines and medical countermeasures under the DPA. The HHS has invested US$ 17 billion in domestic manufacturing for the medical supply chain, including US$ 500 million to support API manufacturing.Under this effort, Merck has been awarded a €121 million (US$ 132 million) government contract to set up a lateral flow membrane production facility at Sheboygan, Wisconsin. Similarly, California has launched an initiative (known as CalRx) and is working with CIVICA to make US$ 30 insulin available to all who need it.Europe encourages reshoring; EDQM develops monographs for unlicensed alternativesIn recent years, Europe has faced shortages of insulin, antibiotics, oncology drugs, corticosteroids and even paracetamol. To overcome these shortages, the European Medicines Agency (EMA) is encouraging drugmakers to enhance manufacturing capacity and diversify suppliers.There is change visible on the ground. Companies like Midas Pharma, EUROAPI, Seqens are setting up API plants in Europe. Seqens has taken steps to reshore paracetamol production in France and is constructing a new € 100 million (US$ 109 million) production unit in Roussillon. Sanofi is investing €1.3 billion (US$ 1.4 billion) in a new insulin production facility at its existing site in Frankfurt. Similarly, Sandoz has set up a new antibiotic production plant in Austria and a new biosimilar development center in Germany.That said, we know that manufacturing capacities take time to build and are often financially unviable in the developed world. Ergo, a particularly innovative initiative has come from the European Directorate for the Quality of Medicines & HealthCare (EDQM). Their project aims to develop monographs detailing the preparation and testing of unlicensed drugs that can fill the gap left when licensed medicinal products are unavailable. To facilitate this initiative, the European Pharmacopoeia Commission is recruiting experts to verify proposed production methods and analytical procedures.The other means of guarding against supply and demand fluctuations is stockpiling. The EMA has advised the European Commission (EC) and marketing authorization holders (MAH) to stockpile medicines. The regulator has also asked MAHs to establish a shortage prevention plan for critical medicines. Europe’s Health Emergency Response Authority (HERA) is taking a systematic approach to stockpile management.Despite these measures, costs and market structures pose serious challenges. Medicines for Europe, representing the generic and biosimilar medicines industry, has raised concerns about the current market structures. They argue that government purchasing practices, which prioritize obtaining the lowest prices for off-patent medicines, are jeopardizing the European manufacturing footprint and discouraging investments in supply chain resilience.FDA, EMA promote continuous manufacturing; US relies on digital stockpilesDuring the pandemic, there were acute shortages of oncology, cardiovascular, anesthesia, anti-infective, neurological and anti-allergic drugs in the US. A 2022 study undertaken by the Washington University points out that there is excess manufacturing capacity in the US that can be considered for reshoring critical and essential drugs. In fact, 49 percent of generic drug manufacturing capacity in the US is lying idle, and many others are working at less than 50 percent capacity. These capacities can be repurposed. Various advanced manufacturing technologies, such as “continuous flow and on-demand manufacturing capabilities in idled manufacturing sites offer the ability to reduce production cost,” says this report.FDA has been promoting “advanced manufacturing” technologies, such as continuous manufacturing, which are now a part of America’s overall strategy to strengthen and secure the pharmaceutical supply chain. The EMA has also released guidelines on continuous manufacturing of drug substances and drug products. Advanced manufacturing is a collective term for new or innovative medical product manufacturing technologies. Unlike batch manufacturing, which involves sequential processing and testing of material across multiple discrete stages (and often discrete facilities), continuous manufacturing combines the full manufacturing stream into a single, fully integrated flow. While continuous manufacturing may not be suitable for every drug manufacturing process, but where applicable, it tends to eliminate built-in production gaps and shortens the time taken to manufacture a drug from months to days.In the US, the Strategic National Stockpile (SNS) plays a critical role in ensuring the availability of essential medical supplies during emergencies. It now also involves a digital stockpile that does not store physical goods and products. Instead, it stores electronic plans, instructions, and methods to make and test medical products. Digital stockpiles rely on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines.Our viewThe global pharmaceutical supply chain is a complex web spanning multiple countries and continents. While advanced manufacturing and stockpiling may work to an extent, a large chunk of generic drugs and APIs will continue to come from countries like China and India.In order to reduce reliance on China, the US has been proactively expanding its collaboration with India. But this time, there is increased emphasis on quality control. While FDA is increasing the number of inspections at Indian drug plants, the Indian government, on its part, has revised rules for drug manufacturing, with higher GMP standards.Taken together, a multi-pronged approach to addressing supply chain vulnerabilities should secure drug supplies to the US and Europe in the years to come.

Impressions: 4236