MGI PHARMA and HELSINN Expand Aloxi Agreement
Monday November 17, 7:31 am ET
MINNEAPOLIS & LUGANO, Switzerland--(BUSINESS WIRE)--Nov. 17, 2003--MGI PHARMA, INC. (Nasdaq:MOGN - News), an oncology-focused biopharmaceutical company, and HELSINN HEALTHCARE SA, a privately-owned Swiss pharmaceutical group, today announced an expansion of their exclusive United States and Canada license and distribution agreement for Aloxi(TM) (palonosetron hydrochloride) injection to include rights for the post operative nausea and vomiting (PONV) application of Aloxi and an oral formulation of Aloxi. MGI PHARMA currently markets Aloxi injection in the United States for prevention of chemotherapy induced nausea and vomiting (CINV).
PONV is a common consequence of anesthetic and surgical procedures. Patients undergoing abdominal, gynecological, and ear, nose and throat surgery are at the highest risk for PONV. In the United States, more than 40 million surgical procedures are performed annually, and the incidence of PONV is estimated at 25% to 30%. If not prevented, PONV can cause hospital re-admissions and increase healthcare costs for patients who undergo surgery. If approved for the prevention of PONV, Aloxi would compete in an approximately $400 million PONV market in the United States.
"Given the joint success that HELSINN and MGI are achieving with Aloxi, we decided to expand and strengthen our Aloxi franchise," said Enrico Braglia, managing director of HELSINN. "We intend to begin the pivotal trials for PONV and the CINV oral formulation in early 2004 in order to bring the products to the U.S. market as soon as possible."
"With the recent approval of Aloxi and success in the initial launch phase, we are now pleased to expand the Aloxi franchise and our relationship with HELSINN," commented Lonnie Moulder, president and chief executive officer of MGI PHARMA. "We look forward to leveraging the unique features of Aloxi in order to maximize the overall market opportunity. We believe PONV and oral Aloxi products could add over $100 million of annual sales potential for the Aloxi products."
Under the terms of the expanded agreement, MGI will make initial payments to HELSINN totaling $22.5 million. MGI PHARMA expects to make additional payments totaling $25 million over the course of the next several years upon achievement of certain development milestones leading up to the approvals of Aloxi for PONV and an oral Aloxi formulation in the United States. MGI PHARMA will also pay royalties and product supply fees based upon net sales. HELSINN will continue to fund and conduct all development of Aloxi, and will supply finished product for commercialization.
Webcast of Conference Call
MGI will broadcast its conference call regarding Aloxi with investors live over the Internet on Monday, November 17, 2003 at 1:00 p.m. Eastern Time. Lonnie Moulder, president and CEO of MGI PHARMA, and members of the Company's executive management team will review the expanded Aloxi rights and development plans, answer questions from analysts, and provide commentary on MGI's business. All interested parties are welcome to listen to this audio webcast. |
