SANTA CLARA, Calif. & TOKYO--(BUSINESS WIRE)--April 27, 2006--Ilypsa, Inc. ("Ilypsa"; headquarters: Santa Clara, California; President and CEO: Jay P. Shepard) and Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) announced today that they have entered into a license agreement that gives Astellas exclusive rights to develop and market ILY101 in Japan, a drug to treat hyperphosphatemia which was discovered by and is under development by Ilypsa.
Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentration triggers various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease.
ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.
"We are delighted to enter into partnership with Ilypsa on ILY101," said Toichi Takenaka, Ph.D., President and CEO of Astellas. "ILY101, with its unique profile, is an important addition to our product portfolio in the ethical pharmaceutical business in Japan. I believe ILY101 will contribute to physicians and patients by offering a new option for the treatment of hyperphosphatemia."
"We are excited to have attracted a leading partner such as Astellas for the development and commercialization of ILY101 in Japan. Astellas has the proven pharmaceutical experience to enable an accelerated path for bringing this innovative compound to patients in Japan where there is significant medical need," said Jay P. Shepard, President and CEO, Ilypsa, Inc.
Under this agreement, Astellas will pay Ilypsa a total of US$ 92 million, including an upfront payment of US$ 22 million, as well as royalties in the mid-teen range on future sales of the drug in Japan. A Phase 1 clinical trial for Japan will be started during fiscal year 2006. Ilypsa has recently completed its Phase 1 clinical trial of ILY101 in the US and intends to initiate a Phase 2 study in chronic kidney disease patients with hyperphosphatemia within the next few months.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at www.astellas.com.
Ilypsa, Inc. is a privately held biopharmaceutical company discovering and developing a pipeline of next-generation renal care pharmaceutical products. Pioneering the use of a proprietary high throughput discovery and development platform created and validated at Symyx Technologies, Inc. (Nasdaq:SMMX - News), Ilypsa has rapidly created non-absorbed polymeric phosphate and potassium binder compounds to treat chronic kidney and metabolic diseases. To date, Ilypsa has raised $46 million in a Series A and a Series B round of financing. Investors include NLV Partners, 5AM Ventures, US Venture Partners, Johnson & Johnson Development Corporation and Delphi Ventures. For more information, please visit www.ilypsa.com.
Gerrit Klaerner, Ph.D., 408-215-2826
(VP, Business and Corporate Development)
Astellas Pharma Inc.
Akihiro Tanaka, Ph.D., +81-3-3244-3201
(VP, Corporate Communications)
Source: Ilypsa, Inc.