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Tuesday, January 25, 2011

中化提供原料藥予Ariad 與 Merck合作開發肉瘤(Leiomyosarcoma & Liposarcoma & Osteosarcoma & Soft Tissue Sarcoma & Metastatic Sarcoma) 新藥 ridaforolimus (deforolimus; AP23573; MK-8669; an mTOR Inhibitor)

Ariad Gains Most in 18 Months on Cancer Drug Results

Jan 19, 2011 Ariad Pharmaceuticals Inc., a biotechnology company with no approved products, gained the most in 18 months after its experimental cancer therapy slowed tumor growth in an advanced human study. Ariad increased $1.79, or 34 percent, to $7.04 at 4 p.m. New York time in Nasdaq Stock Market composite trading for the biggest increase since July 2009. The shares have almost tripled in the last 12 months. The pill, ridaforolimus, reduced the risk of progression in sarcomas by 28 percent, Cambridge, Massachusetts-based Ariad said today in a statement. Patients also lived about three weeks longer without their cancer worsening. If approved, the pill may generate $365 million by 2015 for Ariad and its partner, Merck & Co., said Phil Nadeau, an analyst with Cowen & Co. "Metastatic sarcoma is a fatal disease for which there are very few active therapies available today, and thus the unmet medical need is high," Nadeau said today in a report. "The data are solid, and likely to get ridaforolimus on the market." Merck, of Whitehouse Station, New Jersey, gained rights to develop and sell ridaforolimus for multiple cancer types in May under a restructured partnership with Ariad. The biotech is eligible for milestone and royalty payments under the accord. Merck plans to seek U.S. clearance for the drug this year, Ariad Chief Executive Officer Harvey Berger said today on a conference call with analysts and investors. "Overall we're certainly enthusiastic about it," he said. Sarcomas are tumors that develop in connective tissues. About 12,000 U.S. patients are diagnosed each year, Nadeau said. The most common side effects with Ariad's drug were dry mouth sores, fatigue, diarrhea and platelet disorders.

Merck takes control of Ariad cancer program in $583M deal

May 5, 2010 —Merck has opted to move into the driver's seat to steer the development of Ariad's late-stage cancer therapy ridaforolimus. The pharma company (ARIA) is taking direct control over the clinical development of the drug, paying Cambridge, MA-based Ariad $50 million upfront along with $19 million to reimburse the biotech for its R&D expenses to date and a reconfigured $514 million in regulatory and sales milestones. Ridaforolimus is an mTOR inhibitor now in Phase III for advanced sarcomas. And the deal appears to mark a significant change for Ariad's business plan, which had included building a sales force around the launch of its first cancer drug. In a press conference this morning, Ariad CEO Harvey J. Berger, M.D. noted that the biotech company is retaining an option to handle 25 percent of the marketing work in the U.S., which allows the developer to get involved in commercialization work at a lower cost than it had expected earlier. Merck has already paid Ariad more than $125 million for its work developing the therapy. Ariad's milestone package includes $25 million for acceptance of the new drug application by the FDA, $25 million for U.S. marketing approval, $10 million for European marketing approval, $5 million for Japanese marketing approval and $200 million in milestones based on achievement of "significant sales thresholds." Ariad also stands to gain tiered double-digit royalties from sales. For Ariad, the shift in control gives the developer a chance to pivot to other prospects. "This will allow us to focus our resources on commencing the pivotal trial for our next promising product candidate - AP24534 - our investigational pan BCR-ABL inhibitor and on advancing development of AP26113 - our investigational ALK inhibitor," said Berger.

中化生 新藥上市帶動業績

2011-01-26 工商時報    中化生(1762)拜美國客戶Ariad,獲美國FDA118通過完成Rapamycin衍生物Ridaforolimus在肉骨癌的臨床三期研究所賜,在Ariad最近股價大漲下,激勵近日股價走勢耀眼。 去年中化生獲利雖不如預期,但今年與中化、美國上市藥廠合作研發的免疫製劑,將開始在市場上銷售,將推波業績成長。

 

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