Nektar Therapeutics's PEGylation Technology Enables Peptide Mimetic, Highlighted by Data Presented at 45th ERA-EDTA Congress
SAN CARLOS, Calif., May 12 /PRNewswire-FirstCall/ -- Nektar Therapeutics highlighted today that its proprietary PEGylation technology is used in the novel therapeutic, Hematide(TM), a synthetic, peptide-based erythropoiesis-stimulating agent that is under development by Takeda Global Research & Development Center, Inc. and Affymax. Data were presented for Hematide(TM) today at the 45th ERA-EDTA Congress in Stockholm, Sweden, which showed that Hematide(TM) administered once every four weeks was well-tolerated and maintained mean hemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12-month period.(1)
"The data on Hematide(TM) demonstrate how Nektar's advanced PEGylation chemistry can be used in peptide mimetics to enable a once-monthly dosing schedule while maintaining efficacy," said Tim Riley, Vice President of PEGylation Research at Nektar. "This represents another example of the unique value and broad applicability of Nektar's PEGylation technology and its ability to enable new therapeutics that otherwise might not be possible."
Under the terms of an exclusive agreement between Nektar and Affymax, Nektar is entitled to receive royalties on the global sales of Hematide(TM) for all indications, as well as manufacturing revenues.
With the use of Nektar's advanced PEGylation technology, the properties of therapeutic agents, such as Hematide(TM), can be enhanced by increasing drug circulation time in the bloodstream, decreasing immunogenicity, and reducing dosing frequency. Nektar proprietary technology uses advanced conjugation chemistry and techniques to attach polyethylene glycol polymers to therapeutic agents.
Hematide(TM), a novel, synthetic, peptide-based erythropoiesis-stimulating agent (ESA), is a product candidate that has demonstrated the ability to stimulate the production of red blood cells. If proven safe and effective in clinical trials, it may offer physicians and patients an alternative therapy to recombinant erythropoietin, a hormone that stimulates red blood cell formation.
Affymax and Takeda are collaborating on the development of Hematide(TM). The product will be commercialized in the European Union by Takeda. Affymax is conducting Phase 3 clinical trials for Hematide(TM) to treat anemia in chronic renal failure indications. Takeda is also focusing on a recently initiated Phase 1 clinical trial to evaluate Hematide(TM) to treat chemotherapy-induced anemia in prostate, breast and non-small cell lung cancer patients. Hematide(TM) is a trademark of Affymax.
Nektar Therapeutics is a biopharmaceutical company that develops and enables differentiated therapeutics with its industry-leading PEGylation and pulmonary drug development technology platforms. Nektar also develops its own products by applying its PEGylation and pulmonary technology platforms to existing medicines with the objective to enhance performance, such as improving efficacy, safety and compliance.
This press release contains forward-looking statements regarding the potential of Hematide(TM), the potential of Nektar's PEGylation Technology, and the overall prospects for Nektar's business. These forward-looking statements involve important risks and uncertainties, including but not limited to: (i) because Hematide(TM) is still in clinical development, the risk of failure is high and can occur at any stage due to many factors including but not limited to safety and efficacy considerations; (ii) Takeda and Affymax may fail to obtain regulatory approval for Hematide(TM) in one or more indications; (iii) if Hematide(TM) does receive regulatory approval, Nektar's actual manufacturing revenues and royalties from Hematide(TM) will depend on the level of sales by Takeda and Affymax; (iv) Nektar's efforts to develop product candidates based on its PEGylation Technology is subject to numerous scientific, clinical and regulatory risks and the risk of failure is high and can occur at any stage of development; and (v) Nektar's patent applications may fail to issue; patents that have issued may not be enforceable; or unanticipated intellectual property licenses from third parties may be required in the future. Other important risks and uncertainties are detailed in the Nektar's filings with the Securities and Exchange Commission including its most recent Quarterly Report on Form 10-Q filed on May 9, 2008. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward- looking statements, whether as a result of new information, future events, or otherwise.
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