Business Insights, PHARMACY MARKET

Hovione and Laxxon Medical Establish an Agreement for the cGMP Production of 3D Screen Printed Pharmaceutical Applications

Hovione and Laxxon Medical

Hovione and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. Under the terms of the agreement, Hovione will establish the Laxxon Medical 3D screen printing technology at Hovione's cGMP production sites first in Portugal and later in the USA.

The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines.

"Laxxon is thrilled to establish a long-term partnership with Hovione." said Klaus Kuehne, COO of Laxxon Medical. "This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry thus accelerating our ability to serve our customers." "Hovione has a global reputation for their pharmaceutical innovation services, expertise and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts." said Helmut Kerschbaumer, Laxxon's CEO. "We are looking forward to collaborating with Hovione to promote innovation through 3D screen printing."

"We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics but it also has the potential to reduce the time and cost of drug development" says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds "Hovione has a track record of turning emerging pharmaceutical production technologies into reliable and scalable offerings at both developmental and commercial scales. We are excited at the prospect of supporting Laxxon in industrializing its 3D printing technology and make it accessible to a greater number of pharmaceutical and medical device companies."

With this partnership the platform will be available from early development phases to routine commercial manufacturing.

About Hovione

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) Hovione has a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Spotlight

Spotlight

Related News

RESEARCH

ISOMORPHIC LABS ANNOUNCES STRATEGIC MULTI-TARGET RESEARCH COLLABORATION WITH LILLY

PR Newswire | January 08, 2024

Isomorphic Labs, a digital biology company with a mission to redefine drug discovery using the power of artificial intelligence, today announced that it has entered into a strategic research collaboration with Eli Lilly and Company. This marks Isomorphic Labs' first pharmaceutical partnership. Under the terms of the agreement, Isomorphic Labs will partner with Lilly to discover small molecule therapeutics against multiple targets and will receive an upfront cash payment of $45 million. Isomorphic Labs is eligible to receive up to $1.7 billion in performance-based milestone payments, excluding the upfront payment and any subsequent tiered royalties of up to low double digits on net sales. "We're thrilled to embark on this partnership and apply our proprietary technology platform, the next generation of AlphaFold, and access to massive computing power to Lilly's development programs," said Demis Hassabis, CEO and founder of Isomorphic Labs. "The focus we share on advancing groundbreaking drug design approaches and appreciation of state-of-the-art science makes this partnership particularly compelling." Isomorphic Labs operates autonomously within Alphabet, with its own dedicated resources and exclusive focus on the application of AI to drug discovery. The company is reimagining the entire drug discovery process from first principles with an AI-first approach, working to build powerful new predictive and generative models of biological phenomena to anticipate how drugs will perform and design novel molecules. Building on the success of AlphaFold and working in collaboration with Google DeepMind, Isomorphic Labs has made remarkable progress in developing the Next Generation of AlphaFold. This new iteration of AlphaFold expands beyond proteins to include small molecules and nucleic acids. Through deep integration of this next generation AlphaFold with other breakthrough AI models developed at Isomorphic Labs, the company is able to better understand the underlying biological mechanisms of drug targets, and rationally design novel therapeutics. ABOUT ISOMORPHIC LABS Isomorphic Labs is an autonomous subsidiary of Alphabet that was launched from Alphabet's DeepMind in 2021 to build on the success of AlphaFold, the company's groundbreaking work in protein folding. That work was heralded as the 'Breakthrough of the Year' by Science and 'Method of the Year' by Nature in 2021. Based in London and now with a second location in Lausanne, Switzerland, Isomorphic Labs was founded and is led by AI pioneer Demis Hassabis, who also co-founded and leads Google DeepMind. As pioneers in digital biology, the company's mission is to use AI to accelerate drug discovery and ultimately find cures for some of humanity's most devastating diseases. Using its AI-first approach to drug discovery and biology, the company's ambition is to advance a new era of medical breakthroughs.

Read More

PHARMA TECH

Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine

PR Newswire | January 09, 2024

Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine. Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies. Key Highlights of the Collaboration: Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies. Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry. "This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care." "This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market." About Flagship Pioneering: Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. About Samsung C&T: Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.

Read More

PHARMA TECH

Medison Pharma Announces Agreement with Regeneron Pharmaceuticals to Commercialize Libtayo (cemiplimab) in Multiple Countries

PR Newswire | January 08, 2024

Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today their exclusive multi-national agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases, to commercialize Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in select European markets and additional markets around the world. Libtayo was invented in laboratories at Regeneron, which acquired exclusive worldwide development, commercialization, and manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work together with all stakeholders and regulatory authorities to facilitate a seamless transition of commercialization activities to Medison during the first half of 2024. Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is currently approved by regulatory authorities in more than two dozen countries, including by the European Medicines Agency (EMA). In select markets, it is approved as monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), as monotherapy treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC), as both monotherapy or in combination with chemotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) and/or as monotherapy treatment for certain patients with recurrent or metastatic cervical cancer. Libtayo is a leading and first-in-class PD-1 inhibitor approved for the treatment of two non-melanoma skin cancers and is considered standard of care in these indications. "Our multi-regional commercial platform is a great fit for Regeneron's go-to-market plan and another great opportunity for Medison to facilitate access to highly innovative therapies for people suffering from rare and severe diseases," said Meir Jakobsohn, Founder and Executive Chairman of Medison. "Regeneron's selection of Medison is yet another testimony of the unique value that our multi-regional solution can generate for innovative biotech companies wishing to focus on selected markets." "We are proud to partner with Regeneron," said Gil Gurfinkel, CEO of Medison. "Our one-of-a-kind centralized, unified commercial platform, with single alliance management across multiple markets and regions, is of great value to more and more leading biotech companies. Our platform enables biotech companies to transform numerous complex and fragmented markets and regions into a unified territory." About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced BCC, advanced CSCC and advanced NSCLC, as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron. Outside of the U.S., the generic name for Libtayo is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. About Medison Pharma Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.

Read More