Celgene Corporation Announces POMALYST® Granted Breakthrough Therapy Designation from FDA for HIV-Positive and Negative Kaposi Sarcoma

Celgene plans to submit sNDA by end of 2019

Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa

SUMMIT, NJ, USA I May 13, 2019 I Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma.

Kaposi sarcoma is a multicentric tumor caused by Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8. Patients suffer multiple lesions on the skin and oral mucosa, and at times other organs such as the lungs or gastrointestinal mucosa. Kaposi sarcoma most commonly arises in persons infected with HIV. There is a substantial need for new treatments because there are no approved therapies for HIV-positive patients who are refractory to or intolerant of systemic chemotherapy. Although the use of combination anti-retroviral treatments (cART or HAART) has reduced the incidence of advanced Kaposi sarcoma in the United States, there are still nearly 2000 new cases each year. The disease is more highly prevalent in areas of the world where HIV treatments are less available, such as sub-Saharan Africa, and in some countries is the most common tumor in men overall.

“The encouraging news of the FDA Breakthrough Therapy designation for POMALYST in Kaposi sarcoma reflects the urgency in accelerating the development of therapies to address diseases of this type,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We will continue to work closely with the agency to move this program forward for patients with this rare and serious cancer.”

The Breakthrough Therapy designation was granted by the FDA on the basis of the results of a clinical study performed under a Cooperative Research and Development Agreement (CRADA) by a team led by Dr. Robert Yarchoan, of the HIV and AIDS Malignancy Branch within the Center for Cancer Research of the National Cancer Institutes (NCI). The results of that study, published in the Journal of Clinical Oncology (MN Polizzotto et al, JCO, 2016, 34, 4125-31), evaluated POMALYST in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy.

According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases.

Celgene plans to submit a supplemental New Drug Application for POMALYST in this disease area by the end of 2019.

Celgene also has two additional studies planned in this disease. In partnership with the AIDS Malignancy Consortium (AMC), a U.S. multicenter study will be performed to confirm and extend the results of the NCI study. The AMC is also sponsoring a second study in sub-Saharan Africa, where Kaposi sarcoma continues to be a serious problem. This program is a part of the Celgene Global Health effort to discover and develop new drugs for diseases that affect patients in the lower- and middle-income countries where health systems and medical resources are less advanced.

POMALYST is not approved for Kaposi sarcoma in any country.

About POMALYST

POMALYST is one of Celgene’s IMiD® agents - proprietary small molecule, orally-available compounds for the treatment of some blood cancers. IMiD agents are hypothesized to have multiple mechanisms of action and have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds in different settings and diseases.

U.S. Safety Information

Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

About Celgene Global Health

Celgene Global Health (CGH) is a dedicated R&D unit of Celgene committed to discovering, developing and delivering novel drugs for Diseases of the Developing World (DDWs). Collaborating with non-profit and academic institutions around the globe, CGH has utilized the company’s library of more than 400,000 compounds to evaluate candidates for drug development for DDWs. More than ten discovery and development programs are ongoing in several disease areas such as malaria and tuberculosis. For more information, visit https://www.celgene.com/responsibility/global-health/

About Celgene

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 www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

SOURCE: Celgene

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