Products

Biologics

We are developing recombinant protein products like erythropoietin (Anew-Epo) for treating anemia. Leveraging extensive safety and efficacy data from our partner and supplier,  Anew finishes development (Phase III studies) and applies for approval to market and sell in North America, Europe, Japan and Asia-Pacific, Latin American, Israel, and Emerging Market countries in 2017 and 2018. How can we differentiate ourselves from 3 other manufacturers of EPO – contact us for a description of “A New Epo Paradigm” and how this new paradigm will change the way dialysis patients receive EPO and drastically reduce the cardiovascular side effects from over-dosing of EPO.

Mabs

Mabs” are highly specific monoclonal antibodies made by recombinant DNA technology. We have exclusive rights to data and manufacturing expertise to develop and commercialize Mabs that are highly similar to Genentech/Roche’s rituximab (brand name Rituxan/MabThera), trastuzumab (branded Herceptin), bevacizumab (brand names Avastin or Lucentis), and an anti-epidermal growth factor receptor chimeric antibody developed by Imclone/Lilly called cetuximab (brand name Erbitux). The Mabs generate over $12 Million per year in revenue and the indications and use continue to expand.

Some of the Mabs have cancer and non-cancer indications e.g. rituximab and bevacizumab, while two of the antibodies are internalized after binding to the membrane receptor, e.g. trastuzumab and cetuximab. Data from Phase III studies of Anew’s rituximab show highly similar efficacy and safety in patients with B-cell cancers (NHL) and Anew is also pursuing several Orphan Drug indications. Bevacizumab is being pursued for use in solid tumors and for use in macular edema and neovascular diseases of the eye. Herceptin and Erbitux are internalized inside the tumor cell, so they are being developed as anti-body-drug conjugates (ADCs) carrying cytotoxic drugs and toxins inside the cell and providing high specificity of killing the tumor cells and not the surrounding normal cells. The ADCs will be developed either by Anew or by a partnership with a company with patents and expertise in making ADCs, or this program can be completed internally because of 30 years of ADC experience in the management team of Anew.

Other Mab and recombinant biologic drug programs that are patentable and proprietary are being considered by the Company as follow-on products to expand the pipeline of biologic agents. The Company has a manufacturing and supply agreement with it’s strategic partner to provide a GMP-quality product for Phase III and commercial supply, with the added option of utilizing contract manufacturing organizations (CMOs) to make product as well.