MGI PHARMA Announces Exclusive
License and Distribution Agreement With Barr Laboratories
for Anti-Cancer Agent, Mylocel(TM) Tablets
Future Collaborations Are Possible for Proprietary Oncology Products Requiring Physician Promotion
MINNEAPOLIS, Jan. 25 /PRNewswire/ -- MGI PHARMA, INC., (Nasdaq: MOGN - news) today announced that it has signed an exclusive agreement with Barr Laboratories, Inc., (NYSE: BRL - news) for the U.S. marketing and distribution rights for MYLOCEL(TM) Tablets, a recently FDA-approved oral tablet formulation of hydroxyurea manufactured by Barr Laboratories. MGI PHARMA will market and distribute the proprietary product under the MYLOCEL brand name in the United States, beginning late in the first quarter of fiscal 2001, using its experienced 50-person sales organization. Barr will receive royalty payments based upon product contributions derived from MGI PHARMA's sale of products under the agreement.
MYLOCEL Tablets (hydroxyurea) are an antineoplastic agent indicated for the treatment of melanoma, resistant chronic myelocytic leukemia (CML), and recurrent, metastatic, or inoperable carcinoma of the ovary. It is also indicated for use in combination with radiation therapy for certain head and neck cancers. The U.S. market for all forms of hydroxyurea totals approximately $20 million annually.
``MGI PHARMA is very pleased to be selected by Barr Laboratories to be the exclusive marketer of this innovative therapy,'' commented Lonnie Moulder, executive vice president of MGI PHARMA. ``MYLOCEL Tablets is yet another solid addition to our expanding portfolio of approved oncology products, and will provide great synergy for our sales and marketing efforts with our existing and future oncology product offerings. Our recently announced acquisition of Hexalen® capsules for the treatment of ovarian cancer patients was another example, and we intend to announce further expansion of our oncology pipeline by the end of the first quarter of 2001.''
Moulder added, ``MGI continues to demonstrate the successful focus of our business development strategy on the development and marketing of novel products to the oncology market. This exciting new relationship with Barr Laboratories also offers the potential to discuss future proprietary oncology product opportunities that require promotion to oncologists.''
``The launch of Barr Laboratories' innovative therapy, MYLOCEL Tablets, by MGI PHARMA's established oncology sales force represents a major milestone for our proprietary drug program,'' said Bruce L. Downey, Barr's chairman and CEO. ``MGI PHARMA's sales force will educate physicians about how our product can simplify drug therapy and enhance patient compliance.''
About MYLOCEL Tablets
MYLOCEL Tablets are available as a 1000 mg. triple-scored tablet, which allows for tight patient titration in 250 mg. increments as well as the convenience of once daily dosing with a single tablet MYLOCEL Tablets are designed to simplify drug therapy and enhance patient compliance by eliminating the larger number of doses patients would be required to ingest because the highest dosage strength previously available was 500 mg. A patent for the product is currently pending.
Physicians who will prescribe the product primarily include oncologists and hematologists. MYLOCEL Tablets will be competitively priced to offer affordable simplicity and convenience for both the physician and the patient.
MGI PHARMA, INC., is an oncology-focused pharmaceutical company that 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. For more information about MGI PHARMA, please visit the Company's web site at www.mgipharma.com.
Barr Laboratories, Inc., based in Pomona, New York, is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary pharmaceuticals. 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 the successful launch of MYLOCEL(TM) Tablets, continued sales of MGI PHARMA's other marketed products, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans and to ultimately compete successfully with other therapies, 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.
SOURCE: MGI PHARMA, INC. |
