Healthcare Industry News:  synthetic anthracycline 

Biopharmaceuticals Oncology Regulatory

 News Release - April 11, 2008

Amrubicin is Designated as an Orphan Medicinal Product by the European Commission for the Treatment of Small Cell Lung Cancer

BOUDRY, Switzerland--(HSMN NewsFeed)--Celgene International Sarl (NASDAQ: CELG ) today announced that amrubicin hydrochloride has been designated as an orphan medicinal product by the European Commission (EC) for the treatment of small cell lung cancer following the favorable opinion of the European Medicines Agency’s (EMEA) Committee for Orphan Medicinal Products (COMP).

Criteria for designation of orphan medicinal product require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than 5 in 10,000 persons in the EU. In the European Union, small cell lung cancer affects more than 57,000 people and approximately 34,000 new cases of the disease will be diagnosed this year.

Orphan medicinal product designation is granted by the EC to provide special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Orphan designation will provide amrubicin with 10 years of marketing exclusivity following marketing approval for the treatment of small cell lung cancer.

“The decision by the European Commission to designate amrubicin hydrochloride an orphan medicinal product continues our efforts to deliver innovative therapies worldwide to patients in areas of great unmet medical need such as solid tumor cancers,” said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation.

In March 2008, the Company also announced that the U.S. Food and Drug Administration has granted orphan drug designation for amrubicin in the treatment of small cell lung cancer.

About Amrubicin

Amrubicin is a third-generation, synthetic anthracycline analogue with potent anti-tumor activity against various human tumor xenografts and is a strong topoisomerase II inhibitor. Amrubicin is being studied as a single agent and in combination with anti-cancer therapies for small cell lung cancer.

Amrubicin is currently approved and marketed in Japan for the treatment of both small cell lung cancer and non-small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo Pharma, the original developer of the therapy. Dainippon Sumitomo also licensed the North American and European marketing rights for amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in March 2008.

About Small Cell Lung Cancer

Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and nearly all cases are attributable to cigarette smoking, with the remaining cases thought to be caused by environmental or genetic factors. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non-small cell lung cancer. An estimated 66,000 patients are diagnosed with SCLC each year in the US and EU (approximately 32,000 in the US and 34,000 in the EU). Approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease.

About Celgene International Sárl

Celgene International Sárl, located in Boudry, Switzerland, is a wholly owned subsidiary and the international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at

This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.

Source: Celgene International Sarl

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