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New Zoledronic Acid Formulation beats Novartis’ Aclasta/Reclast
Renascence Pharmaceutical's Zoledronic Acid formulation RP001 beats Novartis' $2 Billion drug in a proof of concept clinical trial. Novartis' Aclasta/Reclast goes off patent in 2012, and RP001, available for licensing, has full patent life.
By: Ketan Desai MD PhD
Easton, Pennsylvania, June 12, 2010
Renascence Pharmaceuticals today announced the results of the proof of concept clinical study on its lead compound, RP001. A new formulation of Zoledronic Acid, RP001 was compared in a head to head study against Novartis’ Reclast/Aclasta. Designed to overcome the side effect profile of Reclast/Aclasta, especially post-dose symptoms but also osteonecrosis of the jaw (ONJ), the study was conducted in eight subjects over a period of six months. Based on the label, it was expected that approximately 50% of subjects treated with Reclast/Aclasta would suffer from post-dose symptoms. This phenomenon is unique to Zoledronic Acid as other bisphosphonates do not have the same profile. In contrast, ONJ has been reported with all bisphosphonates including Alendronate, Risedronate (Actonel, Sanofi-Aventis)
Subjects were randomized to receive RP001 or Reclast/Aclasta in a one to one ratio. Of the four subjects who received Reclast/Aclasta, three had arthralgia, two had myalgia, one had headaches, and one had fever post infusion. The incidence was higher than expected at 100%. In contrast not a single subject treated with RP001 had any post dose symptoms including headaches, fever, myalgia or arthralgia. While the study was initially meant to treat 10 subjects in each group, the large difference between the two drugs lead to a premature cessation of the study. The study sample was not large enough to detect a difference in the incidence of ONJ.
Novartis’ Zoledronic Acid is the most potent bisphosphonate in the market with sales of about $2 billion. As Reclast/Aclasta, it is used for the treatment of osteoporosis and Paget’s disease. As Zometa, it is used in the treatment of tumor metastasis and hypercalcemia of malignancy. The patent of Reclast/Aclasta is scheduled to expire in 2012, and many companies are planning or have generic versions of Zoledronic Acid. RP001 should be superior to these generics and a patent was filed in April 2010. Given the recent approval for Amgen’s Prolia, it is expected that generic Zoledronic Acid will come under pressure. Thus, RP001 is an attractive option of an improved version of a well known and effective drug. It is available for out-licensing. For further information, contact CEO Ketan Desai MD PhD at 610-252-8240. Renascence Pharmaceuticals is a fully owned subsidiary of International Medical Consultants (http://www.intmedc.com).
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Renascence Pharmaceuticals is a fully owned subsidiary of IMC. IMC is a full service consulting company in the pharmaceutical, radiology, and medical field with offices in US and India. Renascence Pharmaceuticals develops drugs for Oncology, Osteoporosis, CNS (Alzheimers Disease, Traumatic Brain Injury and ALS) and Rheumatology. It has three compounds, all in the clinical stage, with RP001 being the most advanced and available for licensing. The other two compounds are in phase I studies and will be taken forward for CNS and Oncology/Rheumatology.