PipelineReview.com - Biotech News & Online Store - Abraxis BioScience Receives Milestone Payment from Taiho Pharmaceutical Co. for the Initiation of the First Clinical Trial for ABRAXANE in Japan

Abraxis BioScience Receives Milestone Payment from Taiho Pharmaceutical Co. for the Initiation of the First Clinical Trial for ABRAXANE in Japan

13 Jul 2006

LOS ANGELES, CA, USA | Jul 13, 2006 | Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical

company, today announced that it has received a $3 million milestone payment from Taiho Pharmaceutical Co., Ltd., (Taiho), for initiation of a Phase 1 clinical trial for ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound).

On May 27, 2005, the company entered into a license agreement with Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Pharmaceutical Ltd., under which Abraxis BioScience granted to Taiho the exclusive rights to market and sell ABRAXANE in Japan. A joint committee was also established to oversee the development of ABRAXANE in Japan for the treatment of breast, lung and gastric cancer and other solid tumors. The Japanese market for chemotherapy agents currently accounts for approximately $2.6 billion.

"We are very pleased that our partner, Taiho, has moved ABRAXANE into Phase 1 development in Japan," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "This milestone is an important step in our collaboration with Taiho and represents our continued commitment toward global expansion of approvals for ABRAXANE."

At the signing of the licensing agreement, Taiho paid the company an upfront payment of $20 million. Abraxis is entitled to additional payments of $35.5 million, which excludes the milestone payment just received, upon the achievement of various clinical, regulatory and sales milestones. Abraxis will also receive royalties from Taiho based on net sales of ABRAXANE in Japan. Abraxis will supply Taiho with ABRAXANE for the Japanese market at an undisclosed transfer price.

ABRAXANE received approval by the U.S. Food and Drug Administration (FDA) in January 2005 for the treatment of metastatic breast cancer after failure of prior chemotherapy. In June 2006, ABRAXANE was approved in Canada for the treatment of metastatic breast cancer. Canada is the first major commercial market to grant an approval for ABRAXANE that includes first-line treatment of metastatic breast cancer. ABRAXANE is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast and non-small cell lung, adjuvant breast, neo-adjuvant breast, malignant melanoma, ovarian, prostate, pancreatic, gastric, and head and neck.

About ABRAXANE(R)

The U.S. Food and Drug Administration approved ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE(R), please visit www.abraxane.com.

About Abraxis BioScience, Inc.

Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANE(R), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.

About Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with its headquarters in Tokyo, Japan. Taiho is one of the leading companies focused on oncology. For more information about Taiho, please visit the company's Web site at www.taiho.co.jp/english/index.html.

FORWARD-LOOKING STATEMENT

The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the expected cost benefits and the acceleration of the market penetration for ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the successful development and subsequent market adoption of ABRAXANE in Japan, the continued market adoption and demand of ABRAXANE in North America and its potential market penetration outside of the U.S., the costs associated with the ongoing launch of ABRAXANE, the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing any other products, including those in the pipeline, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission.

CONTACT: Abraxis BioScience, Inc.
Christine Cassiano, 310-826-5102

SOURCE: Abraxis BioScience, Inc

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