13 March 2012
AM-Pharma Announces Appointment of Industry Expert Guido Magni as Board Member.
Bunnik, The Netherlands, 16 March 2012. AM‐Pharma B.V., a biopharmaceutical company focused on the preclinical and clinical development of recombinant human Alkaline Phosphatase (AP) for treatment of Acute Kidney Injury and inflammatory bowel diseases, has appointed Dr Guido Magni as a member of its Supervisory Board.
Dr Magni MD PhD was trained as an MD with a specialization in neuropharmacology. He was previously the global head of the medical science department of Roche Pharmaceuticals, Basel, Switzerland, a post he held for 12 years. During this time he was responsible for the development and the approval of a large number of New Molecular/Biological Entities including Cellcept, Pegasys, Xeloda, Herceptin, Tamiflu, Tarceva and Mabthera. In his position as global head he defined and ensured the implementation of the overall strategies, goals and objectives of the department, with responsibility for drug development from first in human trials right through to registration and post‐marketing approval. Dr Magni also is venture partner of Versant, with oversight of Versant’s European activities. Furthermore, Dr Magni serves as a board member of Biotie and was a board member of Adolor Corporation, recently sold to Cubist, and Anabasis, recently sold to Dompe. Dr Magni is the author of more than 100 papers published in internationally peer reviewed journals.
David Brister, who has been a supervisory board member of AM‐Pharma for 3 years, will step down from the board.
Erik van der Berg, CEO of AM‐Pharma, said:
“Guido has a wealth of experience in pharmaceutical drug development combined with a global network in both the research and pharmaceutical community as well as in the venture capital community. We are delighted to have attracted someone with his experience to our board. I also thank David for his valuable contribution over the last 3 years.”
Dr Magni, commenting on his appointment, said:
“AM‐Pharma has embarked on a robust development plan for its recombinant human Alkaline Phosphatase for the treatment of Acute Kidney Injury, and has shown very promising data in this large unmet medical need. The board members and management team have an outstanding reputation and I
am very pleased to join this excellent team.”
Notes for Editors
About AM‐Pharma www.am‐pharma.com
AM‐Pharma is a biopharmaceutical company focused on the preclinical and clinical development of Alkaline Phosphatase as protective treatment of acute kidney injury and inflammatory bowel diseases. AM‐Pharma is based in Bunnik, The Netherlands.
Based on the strong results of the Phase II trials with bovine Alkaline Phosphatase in Acute Kidney Injury and a Phase II trial in Ulcerative Colitis – a form of inflammatory bowel disease ‐, AM‐Pharma is developing an innovative recombinant form of human Alkaline Phosphatase. This recombinant Alkaline Phosphatase will be used in future trials and for commercialization. AM‐Pharma raised €29.2M in Q4 2011, enabling AM‐Pharma to finalize the GMP production and the development through phase II in patients.
About Acute Kidney Injury
Acute Kidney Injury (AKI) involves an inflammatory process in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 2 million patients. It occurs in as many as 4% of hospital admissions and 40% of critical care admissions. Depending on the severity and cause of renal injury, mortality ranges from 10% to as high as 70%. Annually, the deaths of around 700,000 patients in Europe, US and Japan are
related to AKI. In the US alone, around USD10 billion is spent each year on managing this big medical problem. The most important causes of AKI are sepsis, cardiovascular surgery, exposure to nephrotoxic drugs and trauma. AKI patients that need dialysis have the worst prognosis. Currently the only treatment option is dialysis and supportive care. No drugs are approved to treat this condition. Typically these patients are treated in Intensive Care, often with support of nephrologists. The incidence is increasing because of an aging population, an increasing exposure to nephrotoxic drugs in hospitals, increasing number of surgical interventions and an increasing incidence of hospital infections. An effective drug to treat AKI could be commercially very important. Because of the large number of patients suffering from AKI, the high medical need and the lack of competitors, worldwide annual sales of over USD2 billion could be achieved with an effective drug treatment.
About Inflammatory Bowel Diseases
Inflammatory Bowel Disease (IBD) is a group of disorders that cause inflammation, most commonly in the small and large intestine (colon). The two major types of this disorder include Crohn’s disease, which is unique to the small intestine and Ulcerative Colitis, which occurs in the colon and is characterized by ulcers (open, painful wounds). One of the main symptoms of Ulcerative Colitis is a gradual onset of severe diarrhea mixed with blood, cramps, high fever and peritonitis. Approximately 25‐40% of patients undergo surgery.
The incidence of Ulcerative Colitis in the Western market is around one million patients, of which 60% have a moderate to severe form of the disease. However, only around 650,000 of these patients receive medical treatment for the disease.
Currently, Infliximab (marketed under the name Remicade) is the only biologic that has been approved for the treatment of Ulcerative Colitis. As an oral therapy, AM‐Pharma’s alkaline phosphatase has compelling advantages, including the potential for lower side effects.
AM‐Pharma conducted an open‐label trial on 21 moderate‐to‐severe Ulcerative Colitis patients who were unresponsive to treatment with steroids and immune suppressants. The results of the trial indicated that each one of the patients benefited significantly from treatment with Alkaline Phosphatase. Within the limitations of the study size, it was also concluded that oral alkaline phosphatase therapy has a comparable efficacy potential to the market leader Infliximab in inducing clinical response and remission.
About Alkaline Phosphatase
Alkaline Phosphatase (AP) is an enzyme that is naturally present in humans on epithelial cells of the gastrointestinal tract, kidney, liver and lungs. An important role of AP is the dephosphorylation of proinflammatory substances like lipopolysacharides (LPS) and extra‐cellular ATP. AM‐Pharma has shown that treatment with exogenous AP can reduce local inflammation and protect the kidney against further damage.