We are excited to join forces with Recipharm to expand the reach of our pipeline and bring our innovative CNS focused products to new partners and patients across global markets.

This partnership exemplifies our ability to combine cutting-edge development platforms like Flexitab™ with Recipharm’s strong manufacturing expertise and regulatory history. Recipharm’s proven track record in executing FDA and EU-approved manufacturing transfers, coupled with our reliable supply chain, makes us the ideal partner to bring these novel CNS therapies to market. By joining forces with Spektus Pharma, we aim to deliver treatments that make a real difference to patients and meet growing global demand for innovative, safe, solutions in CNS care.

This grant represents a significant milestone in our commitment to advancing RNA manufacturing technologies that meet FDA standards. We are proud to lead this transformative effort, expanding access to RNA-based solutions for underserved regions.

Our previously-announced collaboration with MIT has underscored the potential of continuous manufacturing for RNA therapeutics. This grant will help to strengthen our role as a pioneer in innovation and support our mission to make lifesaving technologies more accessible. 

We are dedicated to delivering innovative, end-to-end solutions that help our customers bring high-quality drug products to market efficiently. Our advanced capabilities in oral dose formulations, coupled with our state-of-the-art API development services, allow us to support every stage of the product lifecycle. With the current investments in our oral product development capabilities in Germany and India and the addition of our ReciPredict platform, we are able to accelerate timelines, improve cost efficiency and enhance process reliability during product development, Tech Transfers and life cycle management. This comprehensive approach ensures that we can manage even the most complex projects, helping our customers achieve the best outcomes for their patients. Our existing high potency manufacturing suite enables Recipharm to collaborate with pharmaceutical companies on manufacturing advanced treatments, including oncology drugs and other highly potent medicines, while adhering to the highest safety and compliance standards.

We are excited about this strategic alliance with Exela, which significantly enhances our manufacturing footprint in the US. This partnership aligns with our commitment to provide high-quality manufacturing solutions and expand our capabilities in the production of sterile products, such as GLP1, peptides, biologics, ADCs and other critical pharmaceuticals.

Recipharm is a highly respected CDMO with world-wide reach. We are honoured and excited to be Recipharm’s exclusive US partner. This collaboration offers a unique and efficient CDMO platform for biopharma customers that seek to participate in both US and EU markets and are looking for scale, speed and versatility with experience in delivering complex projects.

With these advancements, we can now offer late-stage product development, clinical supply and commercial manufacturing from a single site. This integration makes it more efficient and cost-effective for our customers, providing them with access to top experts, while ensuring efficiencies in material consumption, including APIs. With our investment in ReciPredict as well as the GMP pilot scale for dry granulation and now the pilot scale for dry technologies, we have the tools and equipment at hand to support our customers with a faster clinic-to-market timeline for new drugs and de-risking manufacturing, ensuring greater certainty in meeting customer needs.

ReciPredict accelerates the journey of new drugs to the clinical stage by 3-6 months, substantially expediting the drug development process. It also offers significant cost savings by reducing API consumption by 30% to 70%. Another crucial advantage is that applying ReciPredict de-risks tech transfers by identifying the right parameters for best process robustness, consequently achieving consistent and high-quality results. This is a win-win for our customers and for patients, as it helps bring new drugs to market faster.

Today's announcement marks a significant step forward in our sustainability journey. We take pride in the validation of our GHG emission reduction targets by the SBTi and the evident improvement in our CDP ratings. These accomplishments underscore our unwavering dedication to reducing our environmental impact and actively contributing to a more sustainable future. Furthermore, they attest to our transparency regarding our environmental progress, as we willingly open ourselves to scrutiny by internationally-recognised third parties.

We are delighted to be working with GeneVentiv, an ambitious and innovative biotech who wanted to leverage not just our equipment and space, but our extensive knowledge and expertise too.

Gene therapies pose unique development and manufacturing challenges, so it was essential we chose the right partner to collaborate with, to minimise manufacturing risks and ensure we meet our key development milestones. ReciBioPharm quickly demonstrated that their team is the perfect development and manufacturing partner for our asset, enabling us to access their extensive experience and impressive capabilities. Our collaboration with them provides us with GLP and GMP product to meet both our IND and Phase I/II milestones.

Extending this agreement involves combining our cutting-edge nasal technology with Resyca’s product development capabilities. This collaboration with Resyca will enable us to bring innovative solutions to the market that will redefine the landscape of nasal drug delivery.

We are thrilled to enter into this extended strategic partnership with Medspray. This move aligns perfectly with our mission to pioneer advancements in aerosol drug delivery systems. The exclusive licence from Medspray will significantly strengthen our position in the market, allowing us to bring innovative and effective soft mist nasal delivery devices to patients worldwide together with our pharma customers.

We are proud to be associated with Medspray and Resyca in this landmark licensing agreement. As a CDMO committed to driving innovation, we look forward to supporting both companies in bringing their pioneering soft mist nasal delivery devices to the market to improve patient experience and expand what is possible via the nasal delivery route.

Harmonizing quality processes and GxP documentation across Recipharm sites will make our quality operations more efficient and scalable. With Veeva Vault Quality, Recipharm is setting a new global standard for quality management, site collaboration, and compliance. The system will enable us to provide our customers with a standard approach to quality. It forms a key part of our focus on continuous improvement, to unleash excellence in quality across our services.

Unifying quality processes, content, and training on Veeva Vault Quality will help Recipharm keep contract development and manufacturing on track as it continues to scale. We’re excited to partner with Recipharm in evolving its quality operations.

This collaboration has enabled a number of Acuitas partners to rapidly progress from concept to clinic thanks to Acuitas’ deep process and analytical experience and our flexible development capability and strong CGMP execution. We look forward to continuing our work together and, with Acuitas’ licensed customer base, to bringing new mRNA-based therapeutics to patients.

At Acuitas, we have a commitment to excellence and a high standard for quality control for our proprietary delivery technology and the ReciBioPharm team has the same dedication to the manufacturing and transfer of our LNP. We are proud to call them our partners and look forward to the continuation of this positive business relationship.

Oz-UK has an excellent reputation for innovation in methods and processes for accelerating the early stages of product formulation. This relationship will enable us to bring greener pMDIs to the patients who rely on them to treat chronic illnesses such as asthma and COPD more quickly than ever before. With the manufacturing expertise and development capabilities to support a choice of propellant, and a team of experts on hand at both Recipharm and Oz-UK to support our customers, we are well placed to become the partner of choice for companies developing sustainable pMDIs for respiratory care.

Recipharm’s agility in adapting to the challenges of the new greener propellants is impressive, and a big part of what attracted us to work with them. We’ve requested specific valve builds and have been able to put them on products and test them in our lab within a week. This is the speed that is needed for success in the transition to low-GWP propellants, and we are excited to see our clients’ programmes accelerate as a result of this collaboration.

Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform. Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases. This agreement represents a key milestone and the beginning of an exciting journey. Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project.

There are more than 7,000 rare diseases that need a cure. We are proud to be partnering with Ahead Therapeutics and look forward to providing a GLP environment to scale up production for a vital treatment to tackle what is currently an unmet patient need. Together with our partner, we are determined to help them turn hope into reality for people living with myasthenia gravis. We have the expertise to help Ahead Therapeutics bring drugs to market faster, so they can continue to deliver on their promise to change patients’ lives.

I am delighted that both Richard and Jeremy have chosen to join Recipharm at this exciting time as we build our capabilities and capacity to serve our customers in their transition to low-GWP propellant pMDIs. Combined with our collaboration with Honeywell, and our expertise in valves and actuators under our Bespak® brand, we aim to be the partner of choice for companies developing their pMDI portfolios to embrace more sustainable respiratory care.

Honeywell is making great strides to offer patients who rely on pMDIs a lower greenhouse gas solution to meet their medical needs, Through our collaboration with Recipharm, the increased use of near-zero GWP propellant used in pMDIs will help reduce the environmental impact of the life-saving medical treatments patients need, without sacrificing performance.

As the first CDMO to partner with Honeywell for use of Solstice Air, this collaboration significantly accelerates and simplifies our customers’ pathway to develop the next generation of low greenhouse gas pMDIs, Our collaboration is supported by Recipharm’s investment in manufacturing with HFO-1234ze(E) cGMP at our Holmes Chapel, United Kingdom site, and the further development of the Bespak® valve range to ensure the required product performance.

Arranta Bio is pleased with the settlement and has known from the outset that it was on firm legal ground. We will continue with our delivery of plasmid products for our customers and, ultimately, the patients that we serve. With the litigation resolved, Arranta Bio is well positioned and excited about our growth prospects and the future.

FDA’s approval is a major development in the biologics market. It will help shift the perception of microbiome medicines and open the door for new opportunities for patients around the world. I would like to thank colleagues, past and present, who have been involved in the VOWST project. Their hard work and perseverance over almost ten years have enabled this major milestone which has the potential to improve patients’ health and save lives. I can’t think of a better example to illustrate our mission, to be the bridge between innovators and patients.

We are proud to be working with MIT on this ground-breaking FDA initiative to be forward thinkers and push the boundaries of biologics manufacturing. Our work can enable new vaccines and therapies to be deployed quickly and be economically viable for patients in need. This project is yet another step towards our vision to be the CDMO of choice, for the benefit of patients.

This project leverages advances made at MIT in the continuous pharmaceutical manufacturing made over the last 10+ years, as well as more recent advances in the modular manufacturing of vaccines and other biotherapeutics. MIT is pleased to collaborate with Arranta Bio and researchers at Rensselaer Polytechnic Institute and Pennsylvania State University to advance technologies for continuous mRNA manufacturing.

I am delighted to welcome Joaquim to the Recipharm team as we continue to drive our business forward. Joaquim’s impressive credentials and expertise will be a real asset to the senior leadership team and to the business.

Recipharm’s reputation and service offering in the industry is second to none. I am thrilled to be working for a leading top five CDMO on the quest for continuous growth.

By leveraging Stevanato Group's integrated capabilities, from plastic injection molding and assembly capabilities to comprehensive scientific and analytical support services, we will be able to offer a turnkey solution, and accelerate and de-risk our pharmaceutical customers’ development programs. This is particularly true for novel inhaled biological products.

Biopharma companies are advancing patient care with new, innovative treatments, particularly in biologics and mRNA therapies. These products require specialized, high-performance drug containment systems, like our Alba® syringe platform, together with patient-centric drug delivery devices like the PFSI™. Thanks to our integrated end-to-end capabilities we are able to support our customers at scale with a comprehensive system solution.

Creating a network of strategic collaboration partners is an important element of our long-term strategy to match customers’ needs and address self-administration trends in patient care with user-friendly drug delivery devices that provide variable and accurate dosing. This agreement marks another key step in broadening our high-value solutions and integrated capabilities as we continue to diversify and enhance our presence in the drug delivery market of pen injectors, auto-injectors, inhalers, and wearable pods.

The opening of our additional development laboratory space for RNA technologies at Watertown means we are well positioned to help our clients quickly and effectively scale up processes for successful GMP manufacturing. Arranta’s ability to support best-in-class process development prior to GMP is critically important in achieving the objective of reducing the amount of time to get into the clinic and successfully advancing life-changing medicine to patients.

We’ve been working closely with RedHill since 2015 to develop and manufacture Talicia, so extending our collaboration until 2026 marks an important moment in our partnership and is testament to the hard work of both teams. Not only this, but the Recipharm and RedHill teams have also proven their expertise in delivering breakthrough solutions to the patients through formulation and commercial manufacturing expertise.

Talicia® has been growing strongly since its launch, and now occupies a leading position amongst branded therapies for its indicated use. This is a position set to further solidify with a growing prescriber base and increased payor coverage, with physicians recognizing the therapeutic value it brings.

Our customers and therefore patients can benefit from Recipharm’s superior product, and we are proud to be creating a benchmark for ‘real world nasal drug delivery performance’. Our ability to offer drug formulation specific tailoring provides a competitive advantage.

By investing in new BFS technologies like Lab+, we are able to fully support our customers through both Phase I and II clinical projects. This new machinery means we can make small batches and removes the need to dedicate a whole filling line to one project. We can offer a system that is new, and rare on the market, allowing our customers to design and test their products, to see how they will look and react in a BFS system. The new Lab+ technology supports proof-of-concept, feasibility batches (cGMP & non-cGMP) and clinical I and II batches. Recipharm is proud to make such an investment and become one of the first CDMOs in the world to use this type of technology. We look forward to supporting our customers with their packaging compatibility requirements and expanding our BFS offering.

The investment at our Wasserburg facility demonstrates Recipharm’s commitment to meet ongoing customer demand for sterile filling capabilities. The demand for pre-filled syringes is rapidly growing, with the projected market value by 2030 expecting to reach USD 6.5 billion. We are proud to be able to offer such a comprehensive service to our customers spanning device design, development and manufacturing to drug product fill & finish, and look forward to continuing to simplify the journey to market for our customers and of course helping patients access vital medicines.

We are continuing our relentless pursuit of improving access to important, life-saving inhaled therapies, while methodically building capabilities for new inhaled therapies which will help address areas of significant unmet medical need. With TRB-3 and TRB-4 we are demonstrating our ability to rapidly progress our pipeline in an effort to meet patient needs as quickly as possible. We are very excited to again be working with Recipharm to advance these important medicines.

TRB-3 and TRB-4 are exciting developments for the treatment of two increasingly common chronic respiratory conditions. Recipharm is delighted to collaborate with Transpire Bio again and we will continue to share our extensive experience and expertise in developing and commercializing inhalation products to help bring these new inhaled medicines to market.

Our mission is to improve access to important, life-saving inhaled therapies, and to introduce new inhaled therapies to help address areas of significant unmet medical need. TRB-1 and TRB-2 are our first offerings in development which will help improve access for potentially millions of patients. We are very excited to be working with Recipharm to advance these important medicines.

Recipharm is very pleased to be leveraging its broad experience and expertise in developing and commercializing inhalation technologies and products in support of the development and advancement of Transpire Bio’s TRB-1 and TRB-2 respiratory products. We look forward to the collaboration.

We are committed to decarbonisation and helping our customers meet their sustainability objectives by transitioning their pMDI products to the new propellants and helping reduce the Green House Gas (GHG) emissions from their products. Recipharm is working hard to help customers identify and reduce GHG emissions related to both product manufacturing and usage with the common aim of meeting the requirements of the Paris Agreement of limiting global warming to 1.5 degrees Celsius. Not only that, but as other industries are also asked by regulators to phase-out propellants with higher GWP, it’s likely that the existing propellants will become less available and more costly. It is therefore important that we prepare to work with new propellants to safeguard the supply of pMDIs to patients. 2022 is an exciting year for Recipharm and our investment in these new manufacturing lines will support us in introducing more sustainable propellants to our pMDI production.

We are excited about the next phase of working with Recipharm. We’re really looking forward to addressing the challenges of reformulation for low-GWP inhalation products with the Recipharm team.

This acquisition is an important step in growing our Biologics business and developing our US presence. We will be building on the pioneering excellence which lies at the heart of these companies and providing drug developers in the Biologics market with scientifically differentiated CDMO services and expertise for ATMPs. These deals, together with our recent acquisition of GenIbet, a specialist in the manufacture of biological clinical material, mean that we will be well placed to develop new capabilities in innovative technologies across gene therapy, viral vectors, mRNA/ plasmids, oncolytic virus and microbiome. I would also like to take this opportunity to congratulate Mark on his achievements in building the Arranta Bio operation so successfully. I am looking forward to working with both David as he takes over the leadership at Arranta Bio and with Tom Hochuli at Vibalogics as we move into the next exciting phase of our combined growth. We are thrilled to be closing both acquisitions and look forward to welcoming the Arranta Bio and Vibalogics teams into the Recipharm organisation.

Given the unprovoked invasion of Ukraine and the tragic humanitarian crisis which is now unfolding, we believe it is important to offer our help wherever it can be most effective. We at Recipharm are working with NGO partners to provide urgent aid and other humanitarian assistance to refugees. Our employees are keen to engage with this issue and to lend their support where they can, so we are setting up a matched funding arrangement to facilitate the donation process, working in conjunction with UNICEF, our chosen partner.

The Monts facility demonstrates our commitment as a business to meet not just present customer demand for aseptic filling, but future customer requirements, and we are investing significant sums in updating the facility and expanding its capacity. While we are bolstering our biologics capabilities, we also continue to offer strong small molecule expertise, providing a single partner to the industry for all their commercial scale aseptic filling needs. The current experience with the Monts project suggest opportunities for further breakthroughs in productivity and line flexibility.