EUROAPI DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Olivier Falut appointed EUROAPI’s Chief Financial Officer

16 Oct 2024

// PRESS RELEASE

EUROAPI closes the financing of its FOCUS-27 plan

15 Oct 2024

// PRESS RELEASE

EUROAPI completes financing of FOCUS-27 plan and moves forward

11 Oct 2024

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 14 CORPORATE CONTENT #SupplierSpotlight, 3 COMPANY BIO #AboutSupplier, 4 DATA COMPILATION #PharmaFlow, 186 NEWS #PharmaBuzz

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1 INTERVIEW #SpeakPharma
14 CORPORATE CONTENT #SupplierSpotlight
3 COMPANY BIO #AboutSupplier
4 DATA COMPILATION #PharmaFlow
186 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

131 All APIs, 43 USDMF, 53 CEP/COS, 45 JDMF, 49 KDMF, 59 NDC API, 5 VMF, 110 Listed APIs

131 All APIs
43 USDMF
53 CEP/COS
45 JDMF
49 KDMF
59 NDC API
5 VMF
110 Listed APIs

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 31 Europe

31 FDF Dossiers
31 Europe

INTERMEDIATES

1 All Intermediates

1 All Intermediates

KEY PRODUCTS

Apomorphine Hydrochloride, Dexamethasone, Dexamethasone Sodium Phosphate, Fluticasone Furoate, Fluticasone Propionate, Furosemide, Hydrocortisone, Hydrocortisone (Cortisol), Hydrocortisone Acetate, Hydrocortisone Butyrate, Hydrocortisone Sodium Succinate, Hydrocortisone Valerate, Rifampicin, Spironolactone

Apomorphine Hydrochloride
Dexamethasone
Dexamethasone Sodium Phosphate
Fluticasone Furoate
Fluticasone Propionate
Furosemide
Hydrocortisone
Hydrocortisone (Cortisol)
Hydrocortisone Acetate
Hydrocortisone Butyrate
Hydrocortisone Sodium Succinate
Hydrocortisone Valerate
Rifampicin
Spironolactone

SERVICES

API Manufacturing, API & Drug Product Development

pharmaServices
API Manufacturing
API & Drug Product Development
- 1 Preformulation & Material Science
- 11 API Development

KEY SERVICES

Microbial Fermentation (Yeast & Bacteria), Oligosaccharides Manufacturing, Microbial Fermentation, Therapeutic Protein Extraction & Isolation, Synthesis of Organometallic Compounds, Oligosaccharide API Development, Microbial Fermentation for Small Molecules, Fermentation Biotech CDMO, API Microbial Fermentation, Microbial Fermentation Contract Manufacturing, CDMO for Industrial Fermentation Services, Azide Chemistry, Oligosaccharide API Manufacturing, Oligonucleotides DNA/RNA or Peptide, Oligonucleotides Double Stranded RNA, Phosphorodiamidate Morpholino Oligomer, Oligonucleotides microRNA, Steroid API Development, Purification of Therapeutic Proteins, Oligosaccharide API Development CDMO, Contract Manufacturer for Fermentation, Small Molecule API Manufacturing, Hazardous Raw Material Synthesis

INSPECTIONS & REGISTRATIONS

29 FDA, 48 EDQM, 5 GDUFA

inspections
29 FDA
48 EDQM
5 GDUFA

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

About

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.

CPhI India 2024CPhI India 2024

Industry Trade Show

Not Confirmed

26-28 November, 2024

India Expo Centre, Greater Noida
DDL ConferenceDDL Conference

Industry Trade Show

Attending

11-13 December, 2024

Edinburgh, Scotland
American Pharma SummitAmerican Pharma Summit

Industry Trade Show

Not Confirmed

18-19 November, 2024

The Westin Copley Place - Boston, MA

CONTACT DETAILS

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Country

France

Address

15 rue Traversière , 75012 Paris

Telephone

+33 189206200

contact@euroapi.com

Website

https://www.euroapi.com/en

https://www.linkedin.com/company/euroapi/

YouTube

http://www.youtube.com/@euroapi3005

Digital content

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INTERVIEW #SpeakPharma

“Euroapi is a growth story based on fast-growing CDMO activity and greater focus on existing portfolio”

More than two years ago, Sanofi had announced the creation of a standalone company that will combine its commercial and development activities in active pharmaceutical ingredients (API) with six of its European production sites in France, Italy, Germany, UK and Hungary. Christened Euroapi and listed on the Euronext Paris stock exchange since May 6, the company seeks to address some of the increasing shortages of medicines in recent times. Euroapi develops, produces and markets APIs and ensures additional capacities for European and non-European countries. This way, the company seeks to help balance the pharmaceutical industry's heavy reliance on APIs sourced from China and India. This week, SpeakPharma interviews Karl Rotthier, Euroapi's Chief Executive Officer, to understand the compelling reasons behind the creation of this company, its strategy and growth plans. Euroapi is a new actor in the API world. How would you describe the company? Euroapi is the leading small molecules API company and the second largest API producer in the world. We already have around 200 APIs in our portfolio that are used in everything — from anti-inflammatory drugs to treatments for Parkinson's disease — and two activities: a wide portfolio of APIs (API Solutions) and custom innovative projects for clients (CDMO). We have six development and manufacturing sites situated in five countries – France, Germany, UK, Italy, and Hungary. Headquartered in Paris (France), Euroapi has a large client base spread over 80 countries worldwide. We have around 3,350 skilled employees on our rolls, including 330 scientists. What were the reasons that led to the creation of the company? There were four compelling reasons behind the creation of Euroapi. First, the sale of APIs in a business to business environment is a much different business model as opposed to the standard large pharma discovery and direct to customer sales model. Since we wanted to focus on APIs, it was logical to create a different company specifically designed for this commercial model. The second reason was to concentrate on growth, both in API Solutions and in CDMO services, as this gives access to attract the large pharma and biotechnology companies previously not accessible because they were competing with Sanofi. Third, we wanted to focus on further developing our industry leading technology toolbox. Fourth, we wanted to expand our commitment to provide supply chain security; Euroapi is backward integrated in more than 85% of its products and does not have a long tail supply chain from China or India. Where do you stand in terms of technologies? We have a broad range of technologies and each of our production sites specializes in different ones. For instance, the Haverhill (UK) facility specializes in flow chemistry and spray drying. The two facilities in France have their own technological focus — Elbeuf specializes in fermentation and vitamin B12, while Vertolaye specializes in corticosteroids and solid chemistry. Our site in Germany located in Frankfurt focuses mainly on oligonucleotides and peptides. In Hungary, our facility in Budapest specializes in prostaglandins while our facility in Brindisi (Italy) is dedicated to anti-infectives. Can you talk about the size of the market you operate in, and the growth drivers? We are operating in a large, over Euro 70 billion (US$ 79billion) market, which has growth rate of approximately six to seven percent year over year (excluding COVID years where it was approximately 2%). The growth is supported by consistent and sustainable outsourcing trends, favorable demographics due to an aging population, and an increased access to medicine globally. The number of small molecule drug approvals continues to rise, and there is a long pipeline of small molecule drugs in various stages of clinical trials. The production capacities we have in peptides and oligonucleotides also give us an edge in the biologics space. Our CDMO business seeks to partner with these pre-clinical and clinical phase companies and this new growth lever is now unlocked for us going forward. While you have mentioned several growth drivers, we also know that it’s not easy to enter the API business. What are the barriers to entry? We are in a heavy capital and knowledge investment industry. For instance, highly specialized technological expertise and technical know-how is required to get into this field. Along with expertise, you also require important, up-front investment in infrastructure to establish scale in order to win large contracts. In addition to the high infrastructure costs, there is also a long regulatory timeline to bring the validated and approved plants on line. And last, but not the least, the quality of APIs and reliability of supply is critical. Together, these factors make market entry by new or established entrants quite difficult. Can you tell us the key points of your strategy? We have a compelling strategy focused on clear business and operational levers, combining topline growth, performance improvement initiatives and flexibility. For topline growth, we are increasing our focus on sales to clients other than Sanofi, for our API Solutions business. We are also committing more R&D resources and capacity to innovation and CDMO clients. Moreover, we are expanding our technological platforms and our presence in highly differentiating complex APIs, including a special focus on peptides and oligonucleotides and Highly Potent APIs. To bring about cash efficiencies, we are focusing on our industrial performance, on procurement processes, inventory management and on optimizing our capital expenditures. The API market is highly fragmented, and we are always evaluating actionable opportunities; however, for the near term, our primary focus is on flawless execution of our organic strategy. To sum up, I would say that our strategy is a growth story based on an acceleration of topline growth through fast-growing CDMO activity and greater focus on existing API Solutions portfolio with other clients. Could Euroapi play a role in the repatriation of essential activities for the healthcare sector? Absolutely. Euroapi is well positioned to play a role in the repatriation of essential services for the healthcare sector due to its strengths. We have a critical APIs and intermediate molecules portfolio. Moreover, we boast of a wide range of technologies and know-how, along with large production capacities and industrial footprint across Europe. In addition, we have the determination to innovate in our industrial processes in order to ensure sustainable production, which is competitive and comes with reduced environmental impact.

Impressions: 2937

CORPORATE CONTENT #SupplierSpotlight

Product List 2024

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Corporate Presentation

GMP Certificate 2022

Acquisition of BianoGMP to Strengthen Oligonucleotide Market

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Restart of Prostaglandin Production at Budapest Site

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Peptide & Oligonucleotide Capacity to reach 500 kg/year by 2025

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EUROAPI to invest €40 million for Vitamin B12 production

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Listing on Euronext Paris

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EUROAPI meets all conditions for its listing on Euronext Paris

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French AMF Approval for Euronext Paris Listing

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CDMO Activities at Budapest

Industrial Decarbonization

Oligonucleotides & Peptides

EUROAPI Manifesto

DATA COMPILATION #PharmaFlow

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: 3929

BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally. Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go. It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer. View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.

Impressions: 2223

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 2828

FDA approves four oligonucleotide therapies in 2023; Novartis, GSK, Novo bet big

In the intricate world of molecular biology, oligonucleotides stand out as versatile, powerful molecules. Oligonucleotides are essentially short, single strands of DNA or RNA that modulate gene expression. There are various oligonucleotide therapy (ONT) agents (such as antisense, deoxyribozymes, siRNA and CRISPR/Cas) that offer promising therapeutic tools.A variation of gene therapy, oligonucleotide gene therapies (OGTs) are manufactured using synthetic oligonucleotides. These therapies are designed to enter cells. ONTs act like tools that can fine-tune the behavior of certain genetic instructions, and are therefore often designed to treat rare and genetic diseases and cancers. Sometimes, they may be delivered into cells through lipid nanoparticles or adeno-associated viruses (AAV), halting the translation of a specific protein. Oligonucleotides have also revolutionized vaccine development through the creation of nucleic acid vaccines, such as mRNA vaccines.The first oligonucleotide drug, known as fomivirsen, was approved by the US Food and Drug Administration (FDA) back in 1998. It was developed by Ionis Pharmaceuticals (then known as Isis Pharmaceuticals), and was approved to treat a rare eye disease. However, ONT approvals have picked up since 2016. Currently, there are 20 oligonucleotide drugs approved by the FDA and the European Medicines Agency (EMA) and a majority of them treat orphan and rare diseases.In 2023, FDA approved four ONTs — AstraZeneca-Ionis’ Wainua (eplontersen), Novo Nordisk owned Dicerna Pharmaceuticals’ Rivfloza (nedosiran), Biogen-Ionis’ Qalsody (tofersen) and Iveric Bio’s Izervay (avacincaptad pegol).In 2021, the global ONT market size was estimated to be US$ 18.2 billion. It is expected to increase to US$ 51.4 billion by 2029, growing at a compounded annual rate (CAGR) of 13.85 percent. Similarly, the market for oligonucleotides synthesis (or the process of producing oligonucleotides) was estimated at US$ 7.7 billion globally in 2022 and is expected to grow 11.8 percent CAGR to reach US$ 16.4 billion by 2030. Some of the bigger players in oligonucleotides synthesis are Danaher Corporation, Thermo Fisher Scientific, Merck KGaA, Eurofins, Agilent, Bio-Synthesis, EUROAPI, Eurogentec, STA Pharma, and Bachem.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available)ONTs address neuro disorders; four ONTs bring in US$ 1.24 bn for AlnylamONTs are widely applied to treat neurodegenerative diseases, such as Duchenne muscular dystrophy (DMD). Multiple ONTs have been approved in Europe and the US for DMD, such as Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), and Amondys 45 (casimersen) from Sarepta and NS Pharma’s Viltepso (viltolarsen). Last year, Ionis bagged two approvals in the space. FDA approved its Biogen-partnered therapy Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS). The agency also approved AstraZeneca and Ionis’ drug Wainua (eplontersen), rendering it as the first self-administered treatment for a rare nerve damage disease, known as hereditary transthyretin amyloidosis (ATTR-PN). Analysts estimate global peak sales for Wainua to come in at US$ 750 million for ATTR-PN alone. The drug is also being tested for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a rare heart muscle disorder.Alnylam Pharmaceuticals has also successfully brought four ONTs to market in recent years — Onpattro (patisiran) and Amvuttra (vutrisiran) for rare nerve diseases, and Givlaari (givosiran) and Oxlumo (lumasiran). Givlaari has been approved to treat acute hepatic porphyria (a liver enzyme deficiency) while Oxlumo treats primary hyperoxaluria (a disorder characterized by increased urinary oxalate excretion). The four ONTs brought in US$ 1.24 billion for Alnylam in 2023.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Novartis buys rights to siRNA therapy, GSK bets big on ONT pipeline through dealsAfter Alnylam discovered inclisiran (Leqvio), Novartis acquired global rights to the therapy in a US$ 9.7 billion deal. Leqvio was the first FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction. It brought in US$ 355 million for Novartis in 2023.GSK has increasingly been investing in its ONT pipeline. The British pharma has promised over US$ 5 billion in upfront and milestone payments in multiple deals. In February, GSK exercised its option to license Elsie Biotechnologies’ discovery platform to find and develop novel ONTs. GSK has also entered a discovery collaboration with Wave Life Sciences.Last July, Japanese drugmaker Astellas Pharma completed its approximately US$ 5.9 billion buyout of New Jersey-headquartered Iveric Bio. Iveric focuses on retinal diseases and the deal gives Astellas drug candidates to treat about 160 million people with eye ailments. Subsequently, in August, Iveric’s Izervay (avacincaptad pegol) was approved by the FDA as a new treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).After Novo Nordisk acquired RNAi technology company Dicerna Pharmaceuticals for US$ 3.3 billion in 2021, the latter’s once-monthly RNAi therapy Rivfloza (nedosiran) saw FDA approval last October. Rivfloza was okayed for children nine years and older to treat a rare genetic condition that affects the kidneys, known as primary hyperoxaluria type 1 (PH1).View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Ionis tees up NDAs for rare disease treatments after two late-stage trial winsThe industry is looking for cures to a wide spectrum of diseases like cancer (such as melanoma, pancreatic, liver, glioblastoma, breast and ovarian cancer), cystic fibrosis, Alzheimer’s disease, Parkinson’s disease, hepatitis B, asthma, Rett syndrome, non-alcoholic steatohepatitis, and IgA nephropathy through its research on ONTs.In January, Ionis announced late-stage results wherein its RNA-targeted hereditary angioedema (HAE) candidate, donidalorsen, significantly reduced the rate of HAE attacks in patients treated every four weeks and patients treated every eight weeks. The California-based biotech is readying a new drug application (NDA) to submit to the FDA. HAE is a rare and life-threatening genetic disease that causes unpredictable and frequent severe swelling of the skin, gastrointestinal (GI) tract, upper respiratory system, face and throat. This year, Ionis’ olezarsen was granted fast track designation by the FDA for the rare genetic disease familial chylomicronemia syndrome (FCS). Last September, olezarsen had met its primary endpoint of reducing abnormally high levels of triglycerides in a late-stage trial in patients with the metabolic disorder. Currently, there are no FDA-approved treatments for this condition. If okayed, olezarsen is likely to bring in US $849 million in sales for Ionis by 2032.In March, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in certain adult patients with myelodysplastic syndromes. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024, for Geron’s NDA for imetelstat. It is among the most anticipated drug launches this year.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Our viewDeveloping ONTs is a field fraught with challenges, such as toxicity and drug delivery. There are safety concerns as well as concerns around delivering the therapy. However, technological breakthroughs and collaborations between pharma firms and contract research organizations that focus on drug delivery are continuously working towards addressing these challenges. All in all, we foresee exciting times ahead for ONTs.

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Overview of small molecule drug development & contract manufacturing & more on EUROAPI's CDMO services for complex & small molecules on PharmaCompass.

Overview of small molecule drug development & contract manufacturing & more on EUROAPI's CDMO services for complex & small molecules on PharmaCompass. Q1. What are small molecule APIs? Small-molecule APIs are defined as compounds with low molecular weight that are capable of modulating biochemical processes to diagnose, treat or prevent diseases. Small molecules are composed of two or more atoms with a molecular weight of less than 900 Dalton. Active pharmaceutical ingredients (APIs) fall into two main categories - small molecule API and large molecule API. The quality of the active pharmaceutical ingredients depends on the kind of process adopted for manufacture, quality of the starting raw materials, process parameters, solvents used for the extraction, etc. Manufacturing active pharmaceutical ingredients (APIs) is far more complex than manufacturing drug products. However, the quality system that is followed in API manufacturing units is less stringent compared to that of drug product manufacturing. Specialized expertise is needed to achieve success for the production of small molecule APIs, from small-scale clinical development to cGMP commercial manufacturing. The small-molecule API synthesis is a complicated and multi-step process which involves operations with a range of raw materials having different physical and chemical properties. While biologic products are gradually making their presence felt, small molecule API continues to be the cornerstone of pharmaceutical drug development. Rise in demand for effective treatment of chronic diseases has led to an increase in the demand for small molecule APIs. Small-molecule pharmaceuticals accounted for a large number of new drug applications (NDA) and new molecular entities. Further, they represent two-thirds of the drug development pipeline. While the number of large-molecule therapeutics is increasing, small-molecule drugs remain an important and highly effective component of the pharmaceutical portfolio. Large molecules are in much demand for treating cancer and other autoimmune disorders. However, many of the most important drugs introduced in recent years, including kinase inhibitors and anti-retroviral products, are small molecules. There are a lot of challenges associated with the development and manufacturing of small molecule APIs. The manufacturing of small molecule active pharmaceutical ingredients (APIs) can be outsourced to various CDMOs (contract development & manufacturing organizations) and contract manufacturing organizations (CMOs). They can offer various services for small molecule synthesis and manufacturing, drug substance development with pharmaceutical and biotechnology applications for complex, niche and small molecule programs from the preclinical phase to phase 3 clinical development and commercial manufacturing. Q2. What are the advantages of small molecule APIs and what are the steps involved in the development and manufacturing of small molecule APIs? Small molecule drugs have been the mainstay of the pharmaceutical industry for around a century. Rapid advancement of biopharmaceutical research has opened up the possibility for new and innovative approaches to developing small molecule active pharmaceutical ingredients. Small-molecule therapeutics have participated fully in the rapid expansion of drug development activity over the past few years. They have some considerable advantages over large molecules which are noted below: Defined as any organic compound with low molecular weight, small molecule drugs have some distinct advantages as therapeutics as they can be administered orally, which offer better compliance and a lower cost of administration than injectables. Small molecules can pass through cell membranes to reach intracellular targets, and hence are beneficial for targeted drug delivery. Small molecule drugs can be engineered to deliver a strong therapeutic effect even with a small dose, often below 10 mgs and sometimes in micrograms. The smaller amount of active pharmaceutical ingredient (API) translates into a lower cost for finished products in comparison to large-molecule therapeutics. Small molecule APIs can also be designed to engage biological targets through various modes of action and their distribution can further be tailored. There is a vast amount of formulation expertise and experience with small-molecule drugs, enabling the production of highly controlled formulations that can be delivered to specific sites and released over specific time periods. Small molecules require less cost for construction and maintenance as compared to large molecules. Small-molecule active pharmaceutical ingredient (API) production depends on synthetic chemistry aspects, raw material sourcing and process controls. Clinical trials involving small-molecule therapeutics are often simpler and less expensive than those involving large-molecule drugs. There are various contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) which offer customized API development and manufacturing services. They can provide integrated development and manufacturing services for small molecule drug substances and their intermediates for clinical supplies and commercial manufacturing, depending on the requirement of the customers. Regardless of the breadth of CDMO services offered, CDMOs and contract manufacturing organizations (CMOs) today are seeing a rise in demand for API development and manufacturing services, including solid form selection and particle engineering. Steps involved in small molecule API development and manufacturing are noted below: Route scouting Process development and validation Clinical batch manufacturing Technology transfer and process development Scale-up of established processes Process validation Commercial small molecule API manufacturing Supply chain management Q3. How do CDMOs and CMOs help in the production of small molecule APIs? The demand for small molecule drugs remains high and the highly potent small molecule active pharmaceutical ingredients (HPAPIs) segment is growing quickly. However, there are various challenges involved in the development and manufacturing of small molecule APIs. Working with the right contract development and manufacturing organization (CDMO) partners can help address these challenges so that pharmaceutical companies can continue to benefit from small molecule APIs for clinical supplies and commercial manufacturing. In many cases, a contract development and manufacturing organization (CDMO) plays a critical role in facilitating successful drug development of innovator small molecule candidates. Along with small molecule synthesis and manufacturing, a CDMO can also offer drug substance development services. One-third of small molecule API facilities offer containment capabilities, while less than one-tenth offer controlled substance capabilities. Specialist small-molecule active pharmaceutical ingredient (API) capabilities such as containment capabilities and controlled substance capabilities are driving large contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) to acquire facilities for small molecule clinical development and commercial manufacturing. All the top small molecule API CMOs have increased the number of containment facilities for small molecule API manufacturing. A growing number of small and mid-sized pharmaceutical companies developing innovative small-molecule therapeutics are driving the demand for more contract chemical process development and scale-up capacity. These companies often lack in-house laboratory infrastructure and expertise for small molecule drug substance development services. A right CDMO partner can provide small molecule API development services along with process optimization, scale-up and cGMP manufacturing. They can smoothen the transition from laboratory scale small-molecule API synthesis to commercial manufacturing, streamline the process and reduce the complexity. The rise of oncology drugs is a significant growth driver too, as cancer treatments account for a majority of these new approvals. Small molecule HPAPIs offer great therapeutic benefits to patients at low doses, but they require specialized containment procedures. These features are strongly associated with larger contract manufacturing organizations (CMOs), which can afford to develop or acquire these specialist capabilities. High-potency APIs (HPAPIs) are toxic even in small doses. They pose a risk to human health or risk cross-contamination with other drugs in a regular manufacturing environment. Dedicated contract manufacturing organizations (CMOs) are investing heavily in specialist capabilities to meet the growing demand and fulfill the needs for highly potent small molecule development and production. Q4. Which small molecule development and manufacturing services does EUROAPI offer? From over-the-counter (OTC) analgesics to life-saving treatments for cardiovascular (CVS) diseases, small molecule synthesis is critical to the development and effectiveness of a wide range of pharmaceutical therapies. EUROAPI's current synthesis portfolio has about 60 small molecule API references spanning a highly diverse range of therapeutic uses for both humans and animals. Small molecules synthesis and manufacturing EUROAPI is a global leader in small molecules APIs, and its innovation and R&D capabilities enable it to accelerate its contract development and manufacturing organization (CDMO) activities in complex molecule and small-molecule active pharmaceutical ingredient (API) segments. EUROAPI can leverage its illustrious history in API development and small molecule organic synthesis by merging the collective chemical know-how of Hoechst-Aventis, Roussel-Uclaf, Chinoin, Genzyme and Sanofi. One of the biggest API manufacturers in Europe, EUROAPI can offer a full CMC service for any drug substance to support clinical supplies, up to registration and commercial supply. A team of more than 250 scientists work at its six commercial facilities, which can provide 2,000 m³ cGMP for custom organic synthesis and another 6,000 m³ for microbial fermentation for small molecule manufacturing. It has excellent regulatory and quality track records with international health agencies to support registration and commercial production. Around 150 scientists support all aspects of clinical development at its small molecules process development center of excellence located in Ujpest, Budapest. This center is supported by an R&D team located in Frankfurt that focuses on process engineering and flow chemistry, as well as by process industrialization teams in Vertolaye and Frankfurt.

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