The nomination reflects the founders’ shared vision of expanding patient access to medicines in markets where healthcare systems, infrastructure and commercial pathways can often limit availability. FarmaMondo has focused on helping pharmaceutical and biotechnology companies extend access to therapies beyond their existing footprint, acting as an extension of their business in markets where they lack direct presence.

“Yaron Spigel, Guy Jacoel and Luciano Deportu combine many years of international experience with entrepreneurial courage and complementary strengths. With FarmaMondo, they are building bridges between innovative therapies and patients in markets that have often not been well served.”
EY Entrepreneur Of The Year judges

This recognition reflects FarmaMondo’s ability to combine access expertise, patient identification, reimbursement and access capabilities and cross-functional execution within a single model. Together, these capabilities help pharmaceutical and biotechnology companies navigate complex healthcare environments and expand access to life-changing treatments to underserved patients globally.

Why it matters

Regulatory complexity, reimbursement hurdles, operational risk, and limited in-market infrastructure can all slow access to life-changing treatments. As a result, many pharmaceutical and biotechnology companies struggle to reach patients beyond their established footprint. FarmaMondo was established to address these challenges.
Today, FarmaMondo works with partners to identify patients and deliver structured access and commercialisation models in markets where they are not directly present. Stakeholders describe FarmaMondo as a trusted extension of their own teams, combining the agility of a specialist global organisation with the local capabilities and insights needed to navigate complex healthcare environments.

Looking ahead

The nomination recognises not only FarmaMondo’s growth journey, but also its commitment to ensuring that geography does not determine whether patients can access innovation.
FarmaMondo remains focused on helping innovative therapies reach the patients who need them most while supporting sustainable growth for its pharmaceutical and biotechnology partners.

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About FarmaMondo Group:

FarmaMondo is a specialised international access and commercialisation partner working to unlock opportunities for patients and biotech and pharmaceutical alike. Providing tailored access based on local understanding and expertise, established networks, local funding knowledge, and trusted in-market execution to help bring therapies to patients and realize value in untapped markets.

Source references

EY World Entrepreneur Of The Year programme:
https://www.ey.com/en_ch/newsroom/2026/08/ey-entrepreneur-of-the-year-2026-the-finalists-have-been-confirmed-french-speaking-switzerland-ticino-and-central-switzerland-heavily-represented

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This partnership reflects a shared commitment to addressing unmet medical needs and ensuring that patients, regardless of location, can access innovative therapies through structured, compliant access pathways.

Zemcelpro^® is a groundbreaking stem cell therapy indicated for adult patients with blood cancers, including acute leukemias and myelodysplasias, who require a donor stem cell transplant but for whom no suitable matched donor cells is available. For these patients, Zemcelpro^® may be the only viable option to undergo a potentially curative stem cell transplant.

Cell therapies demand a higher level of operational excellence and precision across medical, regulatory, quality, supply chain, and local market functions. FarmaMondo’s agility, learning capacity and cross-functional capabilities will play a meaningful role in this journey, helping patients with life-threatening conditions reach a treatment that could genuinely change their outlook.

Supporting access to therapies in complex markets

As healthcare systems become increasingly fragmented and access pathways more complex, partnerships that combine global integration with local execution are essential. Through this agreement, FarmaMondo will provide:

• A centralised access model covering regulatory, compliance and supply
• Local expertise to navigate market-specific access and reimbursement environments
• A structured framework ensuring safe, ethical and compliant delivery to patients

This approach helps mitigate the operational and regulatory challenges often associated with delivering therapies across diverse and evolving healthcare systems, creating the conditions for successful launch execution, broader and faster patient access, and meaningful health outcomes for local populations with significant unmet medical needs.

Looking ahead

This partnership represents an important step in broadening access to Zemcelpro^® and reinforces the importance of collaborative models that prioritise patient need while maintaining strong governance and compliance.

As demand for innovative therapies continues to grow beyond core markets, such partnerships will play a critical role in ensuring that medical advances reach the patients who need them most.

About Zemcelpro^®

Zemcelpro^® (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product developed by Cordex, containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro^® has recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro^®. Additional regulatory filings are planned for Zemcelpro^® with other health authorities, including in the US, Canada, the UK, and Switzerland.

Zemcelpro^® has been evaluated in over 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro^® has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro^® has been tested in Phase 2 trials in patients with high- and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro^® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

For more information, visit www.zemcelpro.com.

Zemcelpro^® is a registered trademark of Cordex or its related companies.

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About FarmaMondo

FarmaMondo is an international commercialisation partner specialising in enabling access to innovative and complex therapies in emerging and underserved markets. By combining global coordination with local execution, FarmaMondo supports pharmaceutical and biotechnology companies in delivering treatments through structured and compliant pathways while actively managing the regulatory, pricing, market access, medical affairs and operational risks associated with expansion, offering their partners peace of mind. FarmaMondo plays a critical role in ensuring that patients with high unmet need can access life changing therapies safely and efficiently.

For more information, visit www.farmamondo.com.

About ExCellThera and UM171 Technology

ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera’s proprietary EnhanceTM platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (HSCs) from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the EnhanceTM platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs.
For additional information, visit excellthera.com, and follow us on LinkedIn.

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After a career in leadership at J&J, Douglas built IDIS, an international specialty pharmaceutical organization headquartered in Princeton, NJ. Douglas transformed IDIS into the leading global provider of managed access programs, delivering over 200 global access programs on behalf of 40 pharmaceutical and biotech companies for serious and rare conditions. The company was subsequently acquired by Clinigen Group, validating the transformative commercial value of Douglas’s model. Under her visionary leadership, IDIS proved that expanded access could be delivered systematically, ethically, and at scale so that patients all over the world had access to life-saving medicines.

“Natalie Douglas is one of the most significant figures in global patient access, credited with developing the industry standard for managed access programs and connecting pharma companies to healthcare facilities in hard-to-reach places around the world,” said Yaron Spigel, FarmaMondo CEO. “Natalie’s appointment to our board is pivotal as FarmaMondo expands its partnership base with U.S.-based pharmaceutical and biotech companies seeking to comprehensively serve patients around the globe.”

FarmaMondo is at an inflection point in its growth trajectory as it rapidly expands its footprint in the U.S. market. It has 14 regional affiliates and an oncology, specialty and rare disease portfolio that represents more than 50 therapies across 50 countries. Critically, FarmaMondo delivers commercial patient access with a novel model unmatched in the industry. Douglas’ historic leadership positions her as an ideal board member for the company’s expanded presence in the U.S. market.
“It’s a privilege to lend my global access expertise to FarmaMondo and help them expand their U.S. market presence,” said Natalie Douglas, FarmaMondo Board Director. “I am impressed with what Yaron and his team have built to drive the future model of international market access; FarmaMondo’s work with their pharma partners aligns with my passion to help patients in dire need of life-changing medicines that live outside the traditional geography of major markets.”

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About FarmaMondo Group

FarmaMondo Group is a pharmaceutical organization that delivers pharmaceutical companies with a turnkey, integrated market presence across 50+ emerging markets, from early access through commercialization, bringing vital medicines to patients in need. With 14 regional affiliates, a proven track record across 50+ assets and a portfolio spanning oncology, hematology, endocrinology, neurology and metabolic diseases, FarmaMondo is committed to ensuring that life-changing therapies reach patients in every corner of the world.

Media Contact

Ivy Cohen
Ivy Cohen Corporate Communications
+1 (212) 399-0026
ivy@ivycohen.com

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This expansion represents a significant milestone in the company’s ongoing commitment to bringing innovative, life-changing medicines to patients in emerging markets.

With the India regional office now fully operational, FarmaMondo commences an exciting new chapter to enhance direct access to innovative, specialty, and rare disease therapies for patients and their healthcare professionals across India and South Asia.

Says Mr. Sudheendra Kulkarni, Regional Managing Director, India & South Asia:

“Establishing our India hub is a game-changer for FarmaMondo’s presence across the region, enabling expanded and faster access to innovative medicines where unmet needs are greatest, bringing market specific access solutions is our purpose.”

Says Dr. Alok Dev, Medical Access Director, India and South Asia: “India faces profound challenges in rare diseases, with over 70 million people potentially affected, yet the majority remain undiagnosed or untreated. Our mission at FarmaMondo is to drive awareness, support diagnoses, and expand access to truly life changing specialty medicines.”

Yaron Spigel, CEO, FarmaMondo Group adds: “This expansion underscores FarmaMondo’s unwavering commitment to supporting underserved patients, wherever they are and further deepens our partnerships with global biotech and pharma innovators to unlock access to emerging markets and the patients within.

I am delighted to welcome Sudheendra and the entire team to the FarmaMondo Group, bringing deep expertise in specialty pharmaceuticals, market access, and commercial execution, positioning FarmaMondo India to build on our already strong international presence.”

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About FarmaMondo Group:

Founded in 1915, FarmaMondo is a Swiss-headquartered pharmaceutical group with 13 international affiliates. The company’s full-service commercialization model enables biopharma innovators to bring innovative and specialty medicines to underserved patients in emerging markets. With a proven track record of commercializing more than 50 assets across 40+ countries, FarmaMondo is dedicated to delivering life-changing therapies to patients worldwide—without compromise.

For more information about FarmaMondo, please visit: www.farmamondo.com

FarmaMondo general and partner inquiries:

For general inquiries please contact: info@farmamondo.com

For India related inquiries please contact: info.india@farmamondo.com

For Business Development inquiries please contact: partnering@farmamondo.com

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The agreement combines FarmaMondo’s expertise in market access and commercial distribution across emerging and complex markets with Kedrion’s long-standing leadership in developing and supplying plasma-derived therapies for rare diseases, including hemophilia and immunodeficiencies, as well as for ultra-rare conditions.

Coagadex® is the first and only treatment specifically indicated for hereditary factor X deficiency, an ultra-rare and potentially life-threatening bleeding disorder. By expanding access in the Baltics, this partnership will bring this therapy to patients who historically have had limited treatment options.

“This agreement reflects FarmaMondo’s mission to ensure patients with rare diseases gain timely access to innovative therapies,” said Yaron Spigel, Group CEO of FarmaMondo. “Together with Kedrion, we are proud to make this product available in the Baltics, filling a critical treatment gap for patients and their families.”

“At Kedrion, our focus has always been to deliver plasma-derived therapies that transform lives,” said Ferdinando Borgese VP, Commercial Director Intercontinental, Toll Fractionation & ICM Director, Kedrion. “Partnering with FarmaMondo allows us to make the treatment available to more patients in the Baltics who will benefit from this therapy for hereditary factor X deficiency.”

The collaboration underscores the commitment of both companies to advancing treatment options in rare diseases, strengthening their global partnership, and driving positive outcomes for patients and healthcare providers in the Baltics.

About Farma Mondo Group

FarmaMondo is a Swiss-based global commercialization partner specializing in rare, specialty, and orphan therapies. With 14 affiliates across Latin America, Asia Pacific, India & South Asia, MENA & Turkey, Russia & CIS, and select European countries, FarmaMondo accelerates patient access and creates new revenue opportunities in emerging markets. Trusted by leading biopharma companies, FarmaMondo combines centralized Swiss governance with deep local expertise to deliver life-changing medicines to more patients, faster.

For more details, please visit https://farmamondo.com/  

About Kedrion Biopharma

Kedrion Biopharma collects and fractionates blood plasma to produce and distribute plasma-derived therapies for rare, ultra-rare, and debilitating conditions like coagulation and neurological disorders, immunodeficiencies, and Rh sensitization. We employ approximately 5,200 people worldwide and operate 68 plasma collection centers in the US and 8 in the Czech Republic. With a portfolio of 38 products distributed in over 100 countries, we are the world’s fifth largest player in plasma-derived products. We are committed to creating a world where science and care know no bounds, partnering with the medical-scientific community, institutions, patient advocacy groups, and research bodies to foster innovation and improve care. Every connection we make impacts someone, somewhere.

For more details, please visit kedrion.com

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CHIASSO, Switzerland and London – July 24th, 2025 – Farma Mondo Group announced today the signing of an exclusive distribution agreement with Recordati Rare Diseases to distribute Enjaymo (sutimlimab-jone). The agreement covers various emerging markets across LATAM, APAC, and Russia-CIS.

Farma Mondo is a Swiss-based pharmaceutical group acting as a commercial partner for innovative and specialty medicines in emerging and complex markets. Recordati Rare Diseases is a dedicated business unit focused on rare diseases within the Recordati Group, and since 2007 has had a mission to ‘Focus on the Few’ and reduce the impact of rare and devastating diseases by providing urgently needed medicines.

Yaron Spigel, Group Chief Executive Officer of Farma Mondo, commented: We are excited to be partnering once again with Recordati for their newly acquired cutting edge therapy and working together towards bringing hope for patients where no else does. This collaboration reinforces FarmaMondo’s capabilities to enhance and expand the reach of innovative therapies while complementing our partners existing global commercial strategies.

About Enjaymo

Enjaymo (Sultimlimab-jome) is the first and only FDA/EMA approved treatment for people with cold agglutinin disease (CAD)

ENJAYMO is a prescription medicine used to treat hemolysis in adults living with CAD.

About Farma Mondo Group

Farma Mondo is a fast-growing Swiss group committed to providing healthcare professionals and the patients they care for with commercial access to innovative medicines. Farma Mondo offers biopharmaceutical innovators a high-value, end-to-end commercialization partnership in emerging markets, based on our unique expertise and geographic footprint, and aimed at providing patients with access to innovative specialty medicines. FarmaMondo serves as a one-stop commercial partner, providing access to key emerging markets through a single Swiss-based relationship and 14 operational locations.

About Recordati

Recordati is an international pharmaceutical, uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,580 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest.

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Vilnius, Lithuania and Willowbrook (IL), US  – July 8th, 2025 – Farma Mondo UAB, a subsidiary in Baltics of the FarmaMondo Group, a Swiss-based pharmaceutical group focused on providing market access and speciality distribution services through a unique infrastructure and geographical footprint across emerging and emerged markets, and Pharmazz Inc. (“Pharmazz”) an innovative biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutics that target critical care medicine, announce the signing of an exclusive partnership for the distribution of Tycamzzi in Baltics.

Yaron Spigel, Group Chief Executive Officer of Farma Mondo, commented: We are excited to partner with Pharmazz for its innovative therapy and bringing advanced care to patients in Baltic countries. I thank Pharmazz leadership and Dr. Anil Gulati for their trust in FarmaMondo Group.

Anil Gulati, CEO of Pharmazz, said, “Tycamzzi represents a groundbreaking approach to stroke treatment by preventing neuronal cell death and stimulating dormant regenerative cells to repair damaged brain tissue. Clinical studies have demonstrated statistically significant improvements in neurological outcomes, underscoring its therapeutic potential. We look forward to leveraging Farma Mondo’s strong presence in the Baltics to help bring this innovative therapy to stroke patients.”

About Tycamzzi

Tycamzzi (Sovateltide), a highly selective endothelin-B receptor agonist and synthetic analog of endothelin-1, is a neural progenitor cell therapeutic agent for the treatment of acute cerebral ischemic stroke (ACIS), hypoxic-ischemic encephalopathy (HIE), spinal cord injuries, and Alzheimer’s disease. In May 2023, sovateltide was approved in India for the treatment of cerebral ischemic stroke within 24 h of stroke onset.

About Farma Mondo Group

Farma Mondo is a fast-growing Swiss group committed to providing healthcare professionals and the patients they care for with commercial access to innovative medicines.

Farma Mondo offers biopharmaceutical innovators a high-value, end-to-end commercialization partnership in emerging markets, based on our unique expertise and geographic footprint, and aimed at providing patients with access to innovative specialty medicines.

FarmaMondo serves as a one-stop commercial partner, providing access to key emerging markets through a single Swiss-based relationship and 14 operational locations.

For more details, please visit https://farmamondo.com/

About Pharmazz, Inc.

Pharmazz, Inc. is an innovative biopharmaceutical company with an approved product, a promising drug pipeline, and a seasoned management team. It is a Delaware Corporation based in Willowbrook, Illinois, USA, focused on discovering, acquiring, developing, and commercializing therapeutics that target critical care medicine.

For more details, please visit www.pharmazz.com.

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May 20th, 2025
CHIASSO, Switzerland and San Diego, US –May 20th, 2025 – Farma Mondo Group, a Swiss-based pharmaceutical group focused on providing market access and speciality distribution services through a unique infrastructure and geographical footprint across emerging and emerged markets, and Acadia Pharmaceuticals Inc. a biopharmaceutical company dedicated to developing and commercializing therapies that address unmet medical needs in central nervous system (CNS) disorders and rare diseases, have entered into an Exclusive Distribution Agreement to globally manage Named Patient Supply of DAYBUE® (trofinetide) in specific countries, primarily in Asia-Pacific (APAC-ex-Japan), South Asia, Latin Amecia (LATAM), the Middle East and North Africa (MENA), South Africa, Russia and the Commonwealth of Independent States (CIS). DAYBUE is the first and only FDA-approved treatment for Rett syndrome in adults and children 2 years of age and older.
All requests will be managed through the dedicated email trofinetide@farmamondo.com.

Yaron Spigel, Group Chief Executive Officer of Farma Mondo, commented: We are honored to partner with Acadia Pharmaceuticals to help make DAYBUE available to patients and families around the world who are living with Rett Syndrome. I want to thank the Acadia Team for their trust and collaboration in this important initiative. This agreement significantly expands access to this first and only approved therapy in an area where there is significant unmet need. We look forward to leveraging our infrastructure on behalf to bring Acadia’s innovation to patients. Together, we win.

About FarmaMondo Group
FarmaMondo is a fast-growing, Swiss-based group serving as a commercial partner of biotechnology companies in emerging markets.
The Group offers high value market access and specialty distribution services, through a unique infrastructure and geographical footprint, targeted to enable patient access to Specialty Medicines in key Emerging Markets. Utilizing a phased approach tailored to emerging markets, we optimize regulatory and reimbursement pathways to unlock the full potential of products in line with our biopharma partner’s strategy.

About Acadia
Acadia is advancing breakthroughs in neuroscience to elevate life. The company has been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases.
For more details, please visit https://www.acadia.com

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Carbaglu (Carglumic Acid) is indicated in treatment of hyperammonaemia due to N-acetylglutamate synthase (NAGS) primary deficiency, hyperammonaemia due to methymalonic acidaemia (MMA), hyperammonaemia due to propionic acidaemia (PA).

The reimbursement achieved will grant access to all patients in HK to this essential medicine.

Yaron Spigel, Group Chief Executive Officer of Farma Mondo, commented:

“We are proud to strengthen our partnership with Recordati Rare Diseases for the benefit of children and adults with hyperammonemia due to NAGS primary deficiency and due to MMA and PA in Hong Kong. To give access to these patients is a new success for our local team and strengthen our relationship with Recordati Rare disease. It demonstrates FarmaMondo’s continued commitment to widening access to essential lifesaving medicines in emerging and established markets”

About Farma Mondo Group

Farma Mondo is a fast-growing Swiss group dedicated to providing Biopharma, healthcare professionals and their patients around the world with greater access to medicines, and in the process increasing the value of a pharmaceutical product by extending and expanding its lifecycle. The Group offers high value market access and specialty distribution services, through a unique infrastructure and geographical footprint, targeted to enable patient access to Specialty Medicines in key Emerging Markets through a combined approach of Named Patient access and full commercialization.

For more details, please visit https://farmamondo.com/

About Recordati Rare Diseases

Recordati Rare Diseases forms part of the Recordati Group. Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,450 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest.

For more information, visit https://recordatirarediseases.com

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