Prnewswire | September 21, 2020
In drug discovery, as with many of the life sciences, data is key. The size of a dataset and the quality of the analyses has a powerful influence on the success of a given drug development programme. There is great potential for the cloud to aid drug discovery, as it offers companies the ability to dynamically scale their research and analyse more data than they would with their on-premise infrastructure. OMass Therapeutics saw an opportunity to accelerate their virtual screening capabilities by utilising Harvard University's REAL database and YellowDog's multi-cloud workload management solution. With access to an on-demand supercomputer, OMass were able to dock 500 times more virtual compounds, and significantly enrich the top 10% of compounds screened. This top-level analysis enabled OMass to focus their attention on the most likely active molecules for their specific drug target.
AM-Pharma | September 08, 2021
AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, and Kyowa Kirin Co., Ltd, a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, today announced that they have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. Ilofotase alfa is currently being evaluated in the global pivotal REVIVAL Phase III clinical study as the potential first disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI). In July of this year, AM-Pharma announced the enrollment of the first patient in Japan as part of the ongoing REVIVAL trial.
“This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.”
“Kyowa Kirin is a leading Japanese specialty pharmaceutical company deeply rooted in science that shares our commitment to addressing high unmet medical needs. Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan,” stated Erik van den Berg, Chief Executive Officer at AM-Pharma. “This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.”
Under the terms of the agreement, AM-Pharma will receive EUR 20 million upfront payment, and EUR 30 million related to milestones prior to regulatory submission, and up to EUR 195 million upon submission, NHI price listing and sales milestone payments bringing the overall deal value to EUR 245 million. In addition, AM-Pharma is entitled to tiered double-digit royalties on sales and a drug supply fee. Kyowa Kirin will gain the exclusive right to develop and commercialize ilofotase alfa in Japan. AM-Pharma is responsible for the completion of the REVIVAL pivotal Phase III study, as well as a Phase I pharmacokinetics, safety and tolerability study in Japan and drug supply, whereas Kyowa Kirin will be responsible for the regulatory approval process and commercialization of ilofotase alfa in Japan.
The REVIVAL trial is a Phase III pivotal study evaluating AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. The primary endpoint of the study is all-cause mortality 28 days post-treatment start with ilofotase alfa at a dose of 1.6 mg/kg. In the Phase II study of ilofotase alfa, the patient group treated with this dose experienced a statistically significant 46% relative reduction in mortality compared to the group treated with placebo (p= 0.022). REVIVAL was initiated in November 2020 and is enrolling up to 1,600 patients in North America, Europe and Japan. As per the study protocol, four interim analyses for futility and/or efficacy will be conducted when enrollment hits certain levels and the first futility analysis will occur when 400 patients have been treated. Up to about 120 clinical sites worldwide, including as many as 11 sites in Japan, will enroll patients into the single global pivotal Phase III REVIVAL trial in SA-AKI patients. The U.S. Food and Drug Administration, European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency have all approved the REVIVAL protocol. In addition to the REVIVAL study, the PMDA has approved enrollment into a Phase I pharmacokinetics (PK), safety and tolerability study in healthy Japanese subjects, which is being conducted in parallel to REVIVAL in Japan.
About ilofotase alfa
AM-Pharma’s therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (AP) constructed from two naturally occurring human isoforms of the AP enzyme. The Company’s compound is highly stable and active and has a dual mechanism of action. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as, ATP, ADP, lipopolysaccharide (LPS) and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway (A2aR). AM-Pharma has shown that treatment of patients with ilofotase alfa not only reduces local and systemic inflammation but also protects the kidney, and possibly other organs, against further damage.
About AKI and Sepsis
Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 3 million patients in the US, Europe, and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in 40-60% of critical care admissions. Depending on the severity and cause of renal injury, mortality occurs in up to 60% of the cases. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem. Sepsis is a condition that is responsible for 1 out of 3 deaths in hospitals and is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The kidney is the most commonly affected organ, resulting in SA-AKI and significantly increasing the risk for mortality and morbidity in sepsis. No singular effective therapy to alter the progression of these devastating conditions has been approved.4
AM-Pharma's purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.
Hovione | February 23, 2022
Hovione, the leader in spray drying and particle engineering, announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome®, Zerion´s proprietary solubility enhancement technology platform.
Zerion´s innovative Dispersome® technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome® technology with Hovione's unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility.
"We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome® to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients. Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome®".
Jean-Luc Herbeaux, Hovione´s Chief Operating Officer
Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome® platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg.
The announcement of this partnership follows Hovione's communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company's commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing.
Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with 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 solution across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API, formulation development and devices. Hovione is a company with a culture 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.
About Zerion Pharma ApS
Zerion has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic outcomes for the patients. The Dispersome® technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin, a sustainable and biodegradable by-product from cheese production. Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems.