Minneapolis (November 15, 2000) – MGI PHARMA, INC. (Nasdaq: MOGN) today announced that it has entered into an asset purchase agreement with a subsidiary of MedImmune, Inc. (Nasdaq: MEDI) for Hexalen® (altretamine), an orally administered chemotherapeutic agent approved in the United States for treatment of ovarian cancer in patients with persistent or recurrent disease following first-line therapy with cisplatin and/or alkylating agent-based combination chemotherapy. Hexalen is approved for the treatment of ovarian cancer in over 20 countries in addition to the United States.
“We are excited about the opportunity to further develop the market for Hexalen and to enhance our sales and marketing organization's experience within the field of oncology,” stated Lonnie Moulder, executive vice president of MGI PHARMA. “Hexalen is an important product which has induced complete responses in patients refractory to first-line therapy and provides the convenience of oral dosing administration. It is an example of our continuing efforts to build a balanced portfolio of oncology products. We intend to announce further expansion of our oncology pipeline by the end of the first quarter of 2001.”
Under the terms of the purchase agreement, MGI PHARMA will pay $7.2 million plus royalties on sales of Hexalen for ten years. The $7.2 million will be paid over 18 months and will be initially capitalized and amortized over the estimated commercial life of Hexalen. After closing this acquisition, MGI PHARMA intends to assume full product responsibilities early in 2001.
"We are pleased to enter into this agreement for Hexalen with MGI PHARMA," said Michael Richman, MedImmune's vice president, business development. "We believe that MGI PHARMA's commercial organization can provide the required attention to reestablish Hexalen as a second-line therapy against advanced, refractory ovarian cancer. Given other priorities, our sales force has not actively promoted this medically important product since late 1998, when it produced approximately $3 million in annual net sales."
The results of a Southwest Oncology Group (SWOG) trial of Hexalen for consolidation of clinical complete response in patients with stage III epithelial ovarian cancer were reported at the annual meeting of the American Society of Clinical Oncology in May 2000. The objective of this trial was to determine whether six months of therapy with Hexalen can result in a two-year overall survival rate of greater than 65 percent in women who are in clinical complete remission following first-line chemotherapy. In this multicenter trial of Hexalen, the two-year overall survival rate for the 97 evaluable patients was 75 percent. Side effects of Hexalen were comparable to those seen with other approved chemotherapies and include mild to moderate myelosuppression, neurotoxicity, nausea and vomiting. “Hexalen is an important drug in the management of recurrent ovarian cancer and may affect the long term maintenance of clinically complete remission in patients after first-line chemotherapy,” stated Dr. David S. Alberts, professor of medicine, pharmacology and public health and associate dean for research, College of Medicine and Arizona Cancer Center, University of Arizona.
Ovarian cancer is the leading cause of gynecological cancer-related deaths among American women. The American Cancer Society estimates that approximately 23,100 new cases of ovarian cancer will be diagnosed and 14,000 women will die of ovarian cancer in the United States during 2000. Worldwide, 166,000 new cases of ovarian cancer and 101,000 deaths are estimated to occur annually. Taxol® and Paraplatin® are the two most commonly prescribed drugs as first-line treatment of ovarian cancer.
MGI PHARMA, INC. is an oncology focused pharmaceutical company. It acquires, develops and commercializes differentiated pharmaceutical products that meet patient needs. MGI PHARMA focuses its sales efforts solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its products in international markets.
MedImmune, Inc. is a fully integrated biotechnology company focused on developing and marketing products that address medical needs in areas such as infectious disease, immune regulation and cancer. Headquartered in Gaithersburg, Maryland, MedImmune has manufacturing facilities in Frederick, Maryland and Nijmegen, the Netherlands, and an oncology subsidiary in West Conshohocken, Pennsylvania.
This news release contains forward-looking statements that may include statements regarding intent, belief or current expectations of the company and its management. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that may cause the company's actual results to differ materially from the results discussed in these statements. Factors that might affect MGI PHARMA's results include, but are not limited to continued sales of Hexalen® or MGI PHARMA's other marketed products, the ability of irofulven, or MGI PHARMA's other product candidates, to be proven safe and effective in humans and to ultimately compete successfully with other therapies, development or acquisition of additional products, reliance on contract manufacturing, changes in strategic alliances, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission. MGI PHARMA does not intend to update any of the forward-looking statements after the date of this news release to conform them to actual results.