Bunnik, Netherlands
Bunnik, Netherlands
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BUNNIK, Netherlands--(BUSINESS WIRE)--AM-Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases, announced completion of recruitment in the adaptive Phase II trial to treat sepsis patients with Acute Kidney Injury (AKI). The trial, titled A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (STOP-AKI), completed recruitment with 301 patients, which makes it the largest interventional clinical study in AKI to date. The STOP-AKI adaptive Phase II trial is being conducted in two parts. First, data from 131 patients were evaluated to select the most effective dose of recAP. Second, an additional 170 patients were recruited into two arms, receiving either the optimal dose of recAP identified initially, or placebo. The study was conducted in more than 50 intensive care units (ICU) in Western Europe and North America. Erik van den Berg, CEO of AM-Pharma said: “We are pleased to announce that we have enrolled the last patient in the STOP-AKI trial. I would like to express my appreciation to all staff in the investigating ICUs for their dedication and diligence in supporting the trial. We will now enter a new and exciting phase of patient follow-up, data analysis and discussions with our scientific advisors. We anticipate publishing and presenting results from the trial in early 2018.” In May 2015, Pfizer Inc. (NYSE:PFE) acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon completion of the STOP-AKI trial. In April 2016, AM-Pharma received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP in the treatment of AKI. The fast track designation facilitates the development and expedites the review process of drugs designed to treat severe conditions with unmet medical need.1 This status also enables a continuous dialogue with the FDA around the clinical and regulatory development of recAP. AM-Pharma is a biopharmaceutical company focused on the preclinical and clinical development of recAP (recombinant Human Alkaline Phosphatase) as a treatment of Acute Kidney Injury (AKI), Ulcerative Colitis (UC), and Hypophosphatasia (HPP). Based on strong results from Phase II trials with bovine Alkaline Phosphatase in AKI and UC, AM-Pharma developed an innovative recombinant form of human Alkaline Phosphatase (recAP), and has completed recruitment of 301 patients in the STOP-AKI adaptive Phase II trial for sepsis-associated AKI. In May 2015, AM-Pharma entered an agreement with Pfizer. Under the terms of the agreement, Pfizer made an upfront payment of $87.5 million for a minority equity interest, and obtained an exclusive option to acquire the Company, with additional potential payments of up to $512.5 million upon option exercise and potential launch of any product that may result from the agreement. 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 Europe, the US and Japan, and is associated with mortality in roughly 700,000 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%. In the US alone, hospitals spend around $10 billion each year on managing this major 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 Units, often with support of nephrologists.2,3,4 AM-Pharma’s therapeutic candidate, recAP (recombinant Alkaline Phosphatase), is a proprietary recombinant human AP constructed from two naturally occurring human isoforms of the AP enzyme, which is highly stable and active. It is in Phase II development for the potential treatment of AKI, with the potential to be developed for HPP. An oral formulation has been developed for the treatment of UC. The enzyme is produced by cGMP manufacture for preclinical and clinical trial supply and commercialization. 1 U.S. Food and Drug Administration; available at http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm


The invention relates to the field of medicine and in particular to means and methods for preserving renal function after a treatment with a risk of reducing renal function. The present invention also relates to means and methods for shortening the duration of renal replacement therapy, increasing the creatinine clearance and decreasing the adverse effects of medicaments.


The global market for Scleroderma Diagnostics and Therapeutics features a fragmented marketplace owing to the presence of several pharmaceutical companies market with different drugs for the multiple complex symptoms experienced by a scleroderma patient, observes Transparency Market Research (TMR) in a recent report. Some of the leading international pharmaceutical companies have products in clinical trial phases for treatment of systemic sclerosis symptoms. The relatively lower number of these companies has made competitive rivalry in the niche scleroderma diagnostics and therapeutics market low to moderate. The need for expertise in the field of rare diseases has made the scleroderma diagnostics and therapeutics difficult for new players to enter. Strategic collaborations and attempts to expand business across key regional markets are some of the most popular strategies undertaken by these players. Pfizer, Inc., for instance, has entered into multiple agreements in 2015 such as the acquisition of AM Pharma, Baxter portfolio of marketed vaccines, collaborations with OPKO Health, Merck KGaA, and various investments in ViiV Healthcare Limited and Hisun Pharmaceuticals. In terms of drug category, the segment of immunosuppressive agents is expected to retain dominance over the forecast period. In terms of geography, developed regions such as North America and Europe take the lead. TMR estimates that the global scleroderma diagnostics and therapeutics market will expand at a CAGR of 9.7% from 2016 to 2024 and rise from US$1,633.5 mn in 2015 to US$3,663.7 mn by 2024. The scleroderma therapeutics market is driven by factors such as rise in clinical trials for systemic sclerosis, high acceptance of new therapies by patients, and new drug approvals for conditions such as pulmonary arterial hypertension, a significant symptom for certain systemic scleroderma patients. The high unmet medical needs owing to the nonexistence of adequate therapies for scleroderma is also a highly favorable opportunity that can be encashed by developing innovative treatment methods and drug classes for the condition. Rising focus on undertaking awareness-raising initiatives is also expected to augment growth of the market in emerging economies such as Asia Pacific and Latin America, the relatively underdeveloped nature and the vast unmet needs across which present vast growth opportunities for market players to strengthen their foothold. A recent instance is the observance of an education/information day in June 2016 by Scleroderma Singapore and Scleroderma Australia as well as by certain Indian hospitals and support groups to promote better awareness regarding the disease. High Cost of Treatment and Drugs to Impede Growth Orphan drugs are usually premium-priced and the high cost of certain new launches is likely to remain one of the most impactful obstacles for the growth of the scleroderma diagnostics market in price-sensitive regions such as Asia Pacific and Africa. It is estimated that the per year treatment cost of a single systemic sclerosis patient suffering from pulmonary hypertension falls in the bracket of hundreds of thousands of dollars. Along with high disposable incomes, the favorable reimbursement structure in developed regions make these treatment costs for patients in regions such as Europe and North America more affordable than in developing regions such as Asia Pacific and Africa. This review of the market is based on a recent market research report by Transparency Market Research, titled "Scleroderma Diagnostics and Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2016 - 2024." For the study, the global scleroderma diagnostics and therapeutics market is segmented as follows: Transparency Market Research (TMR) is a U.S. based provider of syndicated research, customized research, and consulting services. TMR's global and regional market intelligence coverage includes industries such as pharmaceutical, chemicals and materials, technology and media, food and beverages, and consumer goods, among others. Each TMR research report provides clients with a 360-degree view of the market with statistical forecasts, competitive landscape, detailed segmentation, key trends, and strategic recommendations.


The invention relates to the field of medicine and in particular to means and methods for preserving renal function after a treatment with a risk of reducing renal function. The present invention also relates to means and methods for shortening the duration of renal replacement therapy, increasing the creatinine clearance and decreasing the adverse effects of medicaments.


Patent
AM Pharma | Date: 2016-01-28

The invention relates to the field of medicine and in particular to means and methods for preserving renal function after a treatment with a risk of reducing renal function. The present invention also relates to means and methods for shortening the duration of renal replacement therapy, increasing the creatinine clearance and decreasing the adverse effects of medicaments.


Patent
AM Pharma | Date: 2015-01-26

The invention relates to improved alkaline phosphatases, pharmaceutical compositions comprising improved alkaline phosphatases and the use of improved alkaline phosphatases for preventing, treating or curing diseases.


Patent
AM Pharma | Date: 2015-01-26

The invention relates to the field of downstream processing (DSP) of an alkaline phosphatase (AP). More specifically, it relates to a method for reducing host cell protein content in a composition comprising AP. The invention further relates to a composition comprising an AP and a reduced content of a host cell protein.


Patent
AM Pharma | Date: 2015-03-23

The invention relates to phosphatases and more in specific to (genetically) modified phosphatases, pharmaceutical compositions comprising (genetically) modified phosphatases and the use of (genetically) modified phosphatases for treating or curing for example sepsis, inflammatory bowel disease or other inflammatory diseases, or renal failure. The invention further relates to a method for producing phosphatases.


Patent
AM Pharma | Date: 2013-09-06

The invention relates to phosphatases and more in specific to (genetically) modified phosphatases, pharmaceutical compositions comprising (genetically) modified phosphatases and the use of (genetically) modified phosphatases for treating or curing for example sepsis, inflammatory bowel disease or other inflammatory diseases, or renal failure. The invention further relates to a method for producing phosphatases.


Patent
AM Pharma | Date: 2013-11-27

The invention relates to phosphatases and more in specific to (genetically) modified phosphatases, pharmaceutical compositions comprising (genetically) modified phosphatases and the use of (genetically) modified phosphatases for treating or curing for example sepsis, inflammatory bowel disease or other inflammatory diseases, or renal failure. The invention further relates to a method for producing phosphatases.

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