Hemogenyx Pharmaceuticals plc signed Biological Investigation and Material Supply Agreement with Eli Lilly

Hemogenyx Pharmaceuticals | July 14, 2020

On 26 June 2020 the Company announced a Development Agreement with a global pharmaceutical company ("GlobalCo"). GlobalCo has now consented to the use of its name in the announcement, an updated version of which is shown below.

Hemogenyx Pharmaceuticals plc is pleased to announce that it has signed a Biological Investigation and Material Supply Agreement ("Agreement") with Eli Lilly and Company ("Lilly"), a leading global pharmaceutical company engaged in the research, development, manufacture and marketing of human pharmaceutical and veterinary products.

Under the Agreement, Lilly will supply the Company with certain biological materials and related confidential information in order for Company to perform research and development activities aimed at the discovery and validation of novel materials ("Materials") to be used for the treatment of systemic lupus erythematosus ("Lupus") and possibly other autoimmune diseases.

Spotlight

While the co-rotating, intermeshing TSE is more commonly used in pharmaceutical R&D and production, the counter-rotating, intermeshing TSE is a viable tool to successfully process these formulations. Energy input must be strategically balanced to perform mixing functions without degradation of API. Changes of screw rpm, temperature, residence time, residence time distribution, and feed rate all played roles in both degradation and solubility.

Spotlight

While the co-rotating, intermeshing TSE is more commonly used in pharmaceutical R&D and production, the counter-rotating, intermeshing TSE is a viable tool to successfully process these formulations. Energy input must be strategically balanced to perform mixing functions without degradation of API. Changes of screw rpm, temperature, residence time, residence time distribution, and feed rate all played roles in both degradation and solubility.

Related News

BUSINESS INSIGHTS

Element Further Expands Its Life Sciences Testing Business With Additional Pharmaceutical and Biotech Testing Capabilities in North America and Europe

Element Materials Technology | January 15, 2022

Element Materials Technology (Element) completed its sixth life sciences-focused acquisition of 2021, with the formal completion of the acquisition of JMI Laboratories. Element has now built out its expertise and capability for pharmaceutical and biopharmaceutical customers, expanding to a team of more than 1,000 experts in 23 facilities across North America and Europe. This significant step change in pharmaceutical and medical testing capabilities from Element forms part of its broader strategic shift to increase its global presence in Life Sciences and Connected Technologies. “Our expansion into life sciences and connected technologies over the last two years has seen us gain a leadership position in these strategically important end-markets. As we celebrate 10 years of being a standalone Element business, we see more and more opportunities to work closely with our customers throughout their product and testing lifecycles.” Jo Wetz, Element CEO Cherie Gudz, Vice President, Life Sciences Americas, said: “In a world still dealing with a pandemic, the life sciences sector has never been more vital. The six acquisitions this past year alone cements Element’s commitment to continue to build a scale business in this vital sector, which now forms our largest global end-market. We are thrilled to have JMI’s team and expertise join the Element family”. Based in North Liberty, Iowa, JMI is a market leader in antimicrobial resistance monitoring studies utilized for US-FDA regulatory and new drug application submissions, through their proprietary SENTRY Antimicrobial Surveillance Program. It offers microbiology and molecular testing services to assist in the development of new antimicrobials and clinical trial support. The Company is CLIA accredited and able to test under GLP conditions. The business is notable for its team of highly scientific and well-published industry recognized experts in the field, including 10 MD/PhDs with extensive knowledge of microbiology and antimicrobials, and can consult on a broad range of scientific topics covering epidemiology, mechanisms of resistance in bacterial and fungal organisms, microbiology diagnostics and susceptibility testing methods.

Read More

PHARMACY MARKET

M-Pharma and Kyowa Kirin Sign Exclusive License Agreement for Commercialization of Ilofotase Alfa in Japan

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. About REVIVAL 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 About AM-Pharma 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.

Read More

PHARMA TECH

Angelini Pharma Selects AiDEA’s Artificial Intelligence to Boost Its Growth

Angelini Pharma | March 11, 2021

Trueblue, a main supplier of AI answers for Operational and Analytical CRM in the Life Science industry reports that Angelini Pharma, as a feature of a significant global computerized change measure, has picked AiDEA, the principal AI-Digital Cloud Pharma CRM arrangement dependent on Microsoft Dynamics 365. Angelini Pharma is a main pharmaceutical organization focused on aiding patients in the remedial zones of Central Nervous System (CNS) and Mental Health (including Pain), Rare Diseases and Consumer Healthcare. Angelini's new computerized vision is to reposition and lift its Customer Engagement abilities utilizing Artificial Intelligence by actualizing a creative AI-Driven CRM system. This layouts a make way towards Digital, yet in addition the eagerness to go worldwide through accepted procedures that empower connections with key customers while supporting the organization's global development, along these lines advancing its business and operational abilities. Angelini Pharma will execute the AiDEA CRM suite in excess of 24 subsidiaries around the world, offering its workers a wide scope of Artificial Intelligence applications. The main Pharma Company will accordingly exploit noteworthy bits of knowledge and omni-channel optimization algorithms intended to augment the utilization of assets, optimize Customer Engagement Activities on all channels and better address the issues of every stakeholder. After an intensive assessment interaction of the ideal accomplice and because of a previous fruitful Data Warehouse and Corporate Business Intelligence project, Angelini Pharma picked Trueblue's, which exhibited the abilities, advancement, adaptability and business benefit of its foundation dependent on Microsoft technologies. “We decided to boost the deployment of our Multichannel strategy to better support our ongoing transformation, and while advancing significantly, we realized the need to further accelerate also expanding to solutions based on the use of Artificial Intelligence," says Pierluigi Antonelli, Angelini Pharma’s CEO. "Trueblue's AiDEA Suite enables us to leverage our existing investments while accelerating our AI transformation to ensure our subsidiaries can better serve their customers". On a global level, organizations that are deliberately scaling artificial intelligence report a profit from investment almost multiple times more noteworthy than those that are merely experimenting. "We are excited about this relationship that has been lasting for several years and that makes Angelini Pharma the main player of a new paradigm, in this particularly important historical moment for the pharmaceutical context," says Marco Bonesini - CEO & Co-founder of Trueblue. "Our goal is to contribute to the growth of Angelini Pharma at international level with the strength of AiDEA and all the potential of an omni-channel AI-Driven solution based on Microsoft Dynamics 365, which is truly ready to change the CRM market in the pharmaceutical sector".

Read More