Milan, 24th June 2021 – The Group’s new results have been announced by Olon, global leader of APIs production, upon the closure of the 2020 financial statements: the company confirms its trend of organic growth, the success of the integration process of the industrial and research and development activities of the numerous sites acquired in recent years, achieving its absolute historical record in terms of revenues, technical and R&D investments.
Olon closed its books with numbers that reflect a gradual and constant growth over the last five years: 65 million in strategic investments over 2021, focusing to boost most advanced technology platforms and expanding production capacity as well. The forward-looking strategy of the Italian Group focuses on production of highly potent active principles.
In the context of this exceptional international growth, the Rodano (Milan) site has been subject to major investments which have allowed the plant to significantly increase its production capacity and to raise its process quality standards, along with its environmental sustainability and the safety of its workers. The plant has extensive experience and capabilities in the development and manufacturing of highly potent APIs from clinical to commercial scale. In 2021 alone, the Rodano site received investments of 13 million to bolster it on several fronts.
Olon is pleased to announce the completion of a new highly potent API large scale production line, already available for customers. A new, highly automated production line, multi-purpose, and high-containment, suitable for the synthesis of highly active ingredients.
Rodano site, that relies on one of the most extensive expertise in handling highly potent pharmaceuticalprinciples at global level, has raised the level of containment up to the actual standards and very large scale putting in place a set of primary and secondary containment designed to avoid the active substances diffusion in the working environment.
The line significantly strengthens the synthesis, finishing and drying section, to manage acid-based reactions and it can produce batches up to the significant quantity of 250 kg, with a necessary containment band of OEB5, for either highly active or highly toxic products (OEL 0,1-1 micrograms/m3).
“Our new production line in Milan is part of a development capacity expansion to address the strong market demand and furtherly reinforce our historical expertise in handling highly potent pharmaceutical ingredients. This additional capacity benefits customers by expediting the onboarding of new projects”comments Paolo Tubertini, Group Chief Executive Officer
Finally, the group, in line with its vision, has invested major resources into workplace safety, protection of individuals and protection of the environment. “Our aim is to continue to grow. We play a leading role as an Italian company but also as representatives of an industry that is crucial to public health and to the drug supply chain. We hope to pave the way to bring back to Europe the production of active ingredients, which represent the heart of the drug” concludes Roberta Pizzocaro, President of Olon Group.
Olon tracks its roots to 1907, but it was 10 years ago that the company was integrated as Olon Spa. Could you share the latest developments?
When I joined Olon at the beginning of the 2000s, Olon’s primary vision was to become a leader in the production of APIs and intermediates. Once we began to see this vision realized, we started looking at the bigger picture – our role in society and the company’s long-term future. This introspection led to a re-established mission for the company, redefining our role around two pillars: challenging and innovating the way we deliver science, and improving the lives of people. Today, we are one of the largest European suppliers of APIs for both the generic and CDMO markets. We are very active in high potency drugs such as cytotoxic substances, as well as antineoplastic compounds, immunosuppressive agents, hormones, antibiotics, and controlled substances. We have 11 manufacturing plants, eight of which are in Italy, one in Spain, one in the US, and one in India.
Olon made a couple of acquisitions in recent years, expanding its footprint in the US and India as well as in biotech technologies. Could you share the strategy behind these acquisitions?
Over the last few years, we have been investing heavily in both organic and inorganic growth. We acquired Infa Group back in 2016, doubling our generics line. Later in 2017, we acquired the Olon Ricerca Biosciences, a centre fully dedicated to R&D that is based in Ohio. It offers world-class contract research and manufacturing services and a broad array of capabilities with an integrated approach to chemical development. In 2018, Olon acquired Italy-based Capua BioServices, a CDMO company highly specialised in microbial manufacturing. Capua BioServices, based in Italy, expanded our capabilities in this technology and allowed us to take our offer to the food industry. Finally, we made a strategic acquisition in India to expand our integrated portfolio, services and technology platforms.
How does Olon leverage the dual model of API and CDMO supplier?
Traditionally, the pharma industry used to separate the API and CDMO businesses, but I believe there is a case for innovating around an integrated model and leveraging on the synergies created. For instance, we can translate our generics expertise in regulatory matters into the CDMO business. With 350 compounds sold worldwide, Olon has a deep knowledge of global regulations, which we want to inoculate across the structure of the organization, adding value to the CDMO business.
Reversely, we found an opportunity to borrow from the strengths of the CDMO business when it comes to equipment usage. CDMOs are strictly engaged with order agreements from a single customer, which often leads to the under-utilization of an asset. At Olon, we fill the remaining capacity with generic compounds, based on stock levels. In this way, we optimize asset use without compromising service availability to customers. Finally, Olon not only take the partner through the entire journey but is also able to share the responsibility of a product’s performance as part of a contract with transparency. In conclusion, we have the capability to play a crucial role in reaching the final success of the development process.
What do you think is Italy’s competitive advantage as an outsourcing destination for CMDO?
Italy is a leading producer in Europe and the pharma sector accounts for around €33 billion per year, a commensurate figure for a country of our size. Italy offers a rich ecosystem of universities, services, machinery producers, research technicians, analytical labs, all in proximity.
How has Olon contributed to the fight against the pandemic?
We are working as part of five different programs for the development of antiviral drugs. Since the pandemic, we have prioritized imminent health needs and we were able to coordinate with our partners to boost production for some product lines at the detriment of others: When one partner interested in an innovative antiviral API drugs, for instance, asked us to ramp up production at our Rodano site, our other customers showed tremendous understanding and supported us, knowing they can trust us for recouping the volumes when the emergency had passed. Meanwhile, they relied on stock supplies. The industry’s synchronic mobilization is an example of global collaboration and solidarity.
What is Olon’s current innovation focus?
At Olon, we first look at innovation in terms of innovating the way we make things – our production processes, technologies and market strategies. Within this wider program of innovation, we also see innovation as investing in new technologies, such as flow chemistry, enzymatic production and high potency drugs – a landmark space for Olon, where we have been present for 50 years. Personalized and precision medicine will require smaller drugs and therefore, smaller reactors, which will inadvertently increase prices, so we keep abreast of these developments. In 2021, we foresee a total capital investment of €65 million, which is roughly 12% of our sales.
Olon set out to reduce CO2, GHG, and water consumption by 50% between 2015 and 2025. Could you finalize with a few words on the company’s understanding of sustainable growth?
Because we set these targets early on, we are on track to meet them in the next few years. I believe it is important to let our stakeholders know of our commitments to the community and climate. We are constantly committed to reduce the impact on the environment where we operate and to promote a more sustainable API manufacturing approach. We have very aspiring targets to reduce consumption of water and energy, to decrease wastes and carbon dioxide emissions.
The Knighthood of the Republic is thehighest honour established by the President of Republic to recognise the value of those Italian enterprises that have produced significative results in terms of work, social commitment, innovation, internationalization.
About the appointment as Cavaliere del Lavoro, Francesco Pizzocaro commented: “I am sincerely honored of having received this recognition that, as Italian citizen, I have always looked at one of the most coveted honours for professional life. I sincerely thank the President of Republic, those Italian Institution who awarded me with this prestigious title, all the collaborators with whom I have worked along my professional life. It is also thanks to them that today I can experience this beautiful and important event”.
Today ItalyPost Think Tank and Corriere Della Sera Economia promote a roundtable between Presidents of Italian Companies that are driving our economic and social growth, giving a key contribution to employment and development. As major player and global leader of API industry, we will be part of the discussion to share our vision and experience. Our President Roberta Pizzocaro will join the discussion on “Sustainability as a new Competitive Factor”, sharing actions, ideas, and models by which OLON is pursuing sustainability. OLON is constantly committed to reduce the impact on the environment and to promote a more sustainable API manufacturing approach. We have also very challenging targets to reduce consumption of water and energy, to decrease wastes and carbon dioxide emission. Roberta Pizzocaro will share OLON vision on sustainability overall.
Olon Group has been awarded for the performance achieved in 2020, with a prestigious prize received by The British Chamber of Commerce during the latest BCCI Business Excellence Awards. Olon has been awarded for the international growth and the company global development.
Paolo Tubertini, Managing Director, and Alfio Mason, CFO, received the recognition during the award ceremony. Together with Olon Group, a few companies have been awarded by BCCI as business excellence, a pool of leading companies from other industries with globally trusted brands.
“We are very proud of this Award” stated Paolo Tubertini, Olon Managing Director “Our successful entrepreneurial history let us turn into a worldwide leader, with an Italian headquarter and a global footprint. We will keep on investing and growing”.
“I give thanks to Tom Noad, President of British Chamber of Commerce, and to Jill Morris CMG, HM Ambassador. A special thanks to all the colleagues who gave contribution to this significant result” said Alfio Mason, Olon CFO.
Today we celebrate #WorldHealthDay. Olon contributes to fight against global pandemics. We play a key role for the access to therapies, providing active principles that treat major global diseases such as tuberculosis, sickle cell disease, leprosy. This is key for global issues and it is a focus for Olon. Our mission is to challenge and innovate the way to deliver science, to improve the health of all human beings. For #WorldHealthDay we remind how relevant it is to believe in science as a solution to promote health and to improve the quality of #life. We are committed, as key player of the pharmaceutical supply chain, to be innovative every day, #researching and #developing.
OLON has been awarded by the Prize Industria Felix 2021 to be one the best companies for its international vocation, performance of management and financial reliability.
IndustriaFelix is one of the most influencing events about economy and finance among Italian press. The Prize is a full recognition creativity, fervour and determination to those who demonstrate the capacity to build an enterprise producing significative results in terms of social wealth and economic progress.
The companies have been selected by a skilled Scientific Committee, after a journalist survey that analysed 142 thousand financial reports. Among these, the Commission has awarded the 43 most competitive corporations, based in Lombardia, considering management performance, financial reliability, sustainability. These corporations, including Olon, have received The Financial Management Honour of the Prize Industria Felix.
The mission of Industria Felix is promoting a network between valuable companies to promote the image of Italian competitiveness.
“We are proud to be awarded by this prestigious Prize that proves our key role, not only in the chemistry industry but also in the social and economic fabric of Lombardia Region” has commented Drssa Roberta Pizzocaro, President of Olon “Olon contributes to the competitiveness of Lombardia Region considering that our performance let us double our size over the last few years”.
Government is already working to accelerate inclusion of the medicine and associated laboratory testing in the National Health Insurance Scheme
Novartis has already delivered more than 20 000 treatments1 and is committed to implementing two clinical trials with novel biologic treatment for sickle cell disease
Partnership includes establishing national treatment guidelines, newborn screening, and centers of excellence for treatment of sickle cell disease; making accessible treatment options available in line with the global standards of care; and using digital technologies to monitor and evaluate patient registration, report real-time data, and help ensure safe large scale roll-out of medicine
15 000 babies are born with sickle cell disease every year in Ghana2
Accra, Ghana, November 6, 2019 – Today, the Government of Ghana announced the availability of hydroxyurea for the treatment of people with sickle cell disease (SCD), marking the official launch of a first of its kind public-private partnership to improve the diagnosis and accelerate treatment for people with SCD.
The launch follows the signature of a Memorandum of Understanding in January among the Ministry of Health of Ghana, Ghana Health Service, the Sickle Cell Foundation of Ghana and global medicines company Novartis to create a holistic approach to help manage the disease. Ghana is the first African country to commit to offering the global standard of care for their people with SCD. “I am proud of this bold partnership, and it is my hope that, through this collaboration, we will help ease the pain and improve the lives of people living with sickle cell disease in our country. We are committed to put SCD among the priorities on our national health agenda and to take the necessary steps to make treatment broadly available through our National Health Insurance Scheme, bringing much-needed relief to families struggling to cover the cost of care for their loved ones,” said H.E. Alhaji Dr. Mahamudu Bawumia, Vice President of the Republic of Ghana. “Our collective goal is to reimagine what the future could look like for people with sickle cell disease: where children do not need to miss out on school or be singled out; where young adults can have equal opportunity for employment; and where families can flourish and continue to be the bedrock of our civil society—in a nutshell, we will make every effort to ‘normalize’ sickle cell disease within the Ghanaian society.”
To date, Novartis has delivered more than 20 000 treatments of hydroxyurea. Initially, the therapy will be made available through 11 trained treatment centers, as well as through private distribution channels, and is expected to cover the needs of patients for up to 12 months. The partners aim to open more treatment centers by the end of the year, and Novartis is committed to delivering a total of 60 000 treatments. Discussions are aleady underway for inclusion of the medicine and associated laboratory testing in the National Health Insurance Scheme, as well as prioritizing SCD as a national program.
Hydroxyurea is a commonly used medicine for patients with SCD in developed countries, and is approved for use in both adults and children. In October 2018, the Ghana FDA granted marketing authorization to Novartis hydroxyurea, making it the first time that hydroxyurea will be available for this indication in Ghana. A recent study, published in the New England Journal of Medicine3 indicates that hydroxyurea treatment is effective and safe in children with SCD in sub-Saharan Africa and reduces the incidence of pain events (vaso-occlusive crises), malaria, blood transfusions, and death.
“All the traditional names by which SCD is known allude to the episodes of severe pain experienced by people with the disease,” said Prof. Kwaku Ohene-Frempong, MD, President of the Sickle Cell Foundation of Ghana and Program Coordinator for the National Newborn Screening Program for Sickle Cell Disease. “Hydroxyurea is a drug with proven efficacy in reducing pain episodes and other complications of the disease. Currently, the highest standard of care for people with SCD starts with early diagnosis through newborn screening followed by penicillin prophylaxis to prevent early death from infection, and hydroxyurea therapy to ease the pain, prevent other complications and improve quality of life.”
At the same time, Novartis has committed to develop a child-friendly formulation of hydroxyurea and has announced plans to conduct two clinical trials in Ghana and Kenya for its next-generation treatment for SCD, crizanlizumab. Crizanlizumab is a novel targeted biologic therapy that is expected to help reduce pain crises in people with SCD. The trials are expected to start in 2020; this will be the first time that a biologic therapy, which is not a vaccine, enters multicenter clinical trials in sub-Saharan Africa (excluding South Africa)4.
“Novartis is deeply committed to reimagining medicine for patients in Ghana and across Africa,” said Vas Narasimhan, MD, CEO of Novartis. “Building on our long heritage of addressing malaria and leprosy in Africa, we’re excited to help improve the diagnosis and treatment of people with sickle cell disease here in Ghana. Novartis is proud to join this pioneering partnership, which could accelerate efforts to forge a healthier future for children across the continent.”
Sickle cell disease is recognized by the World Health Organization as a public health priority and a neglected health problem in sub-Saharan Africa. Approximately 80% of individuals with
SCD globally are born in sub-Saharan Africa, and there is evidence to suggest that more than half of affected individuals may die before the age of five due to preventable complications. In Ghana, it is estimated that 15 000 babies are born with sickle cell disease every year2.
The five-year partnership aims to improve and extend the lives of people with SCD through a comprehensive approach to screening and diagnosis; treatment and disease management; training and education; and elevating basic and clinical research capabilities. Specifically, the partners aim to collaborate on field testing and implementation of SCD treatment guidelines, the establishment of centers of excellence across regions and the implementation of newborn screening at these centers. In addition, partners plan to employ digital technologies to monitor and evaluate patient registration, report real-time data and help ensure safe large scale roll-out of medicine.
In parallel, Novartis is working with Zipline, a California-based automated logistics company, to make sickle cell treatments widely available, especially in rural areas. Zipline is already operating two distribution centers in Ghana, in Omenako and Asante Mampong, with plans to open two more in the near future.
In addition, in order to help further ensure a sustainable supply of high quality hydroxyurea, Novartis has entered a strategic collaboration with Olon, a manufacturer based in Italy that supplies the active ingredient for the drug. “We are proud to collaborate with Novartis and its partners to help make hydroxyurea more broadly available and in a sustainable way,” said Paolo Tubertini, CEO of Olon. “As a demonstration of our commitment to patients with sickle cell disease and this program, we will also contribute, without cost, the active ingredient to cover approximately 12 000 thousand treatments. Our hope is to continue to meet the needs and challenges of those living with sickle cell disease and their families to improve access to quality health care.”
About Sickle Cell Disease Sickle cell disease is a deblitating, inherited blood disorder. It causes affected red blood cells to become sickle-shaped, stiff and fragile – easily breaking apart. Blood vessels and blood cells become sticky due to damage caused by sickle cells and ongoing chronic inflammation5,6. That leads to blood cells sticking to each other and to the blood vessels and causing blockages – called vaso-occlusion – which can lead to the acute episodes of pain (known as sickle cell pain crises or vaso-occlusive crises), stroke and other life-threatening complications5,7. It is a lifelong illness that can put an emotional, physical, and financial burden on patients and their families8,9.
SCD is a global health problem, with the highest burden of disease concentrated in sub-Saharan Africa. In countries in West, Central and East Africa, the prevalence of the sickle cell gene is between 10 to 30 percent, while in some areas it is as high as 45%10. It is estimated that approximately 1 000 children in Africa are born with SCD every day and more than half die before they reach five years of age11. This is due primarily to lack of early diagnosis through newborn screening, penicillin prophylaxis, parental education, and comprehensive care. In resource-poor countries, more than 90 percent of children with SCD do not survive to adulthood12. Despite the adoption by the WHO of an SCD strategy for Africa in 2010, the disease is largely absent from the global or national health agenda.
One treatment equals one month’s supply for an adult patient above 33kg of weight
Odame I. Perspective: We need a global solution. Nature. 2014 Nov;515(7526):S10
Scott D. Grosse, Isaac Odame, Hani K. Atrash, et al. Sickle Cell Disease in Africa: A Neglected Cause of Early Childhood Mortality. American Journal of Preventive Medicine 41, no. S4 (December 2011): S398-405.
Bernadette Modell and Matthew Darlison. Global epidemiology of haemoglobin disorders and derived service indicators. Bulletin of the World Health Organization 86, no. 6 (June 2008): 480-487.
Corporate QualityControl, R&D, Regulatory Affairs and M&S, OLON has developed a comprehensive Corporate Quality Policy to support at the best our Customers’ related needs in the changing regulatory scenario that involves the current Nitrosamine situation.OLON already started the confirmatory tests execution in line with the Agencies expectation thanks to the analytical Know-How gained, new OrbitrapSpectrometer and fluent support from certificated partners labs.