Wednesday, January 12, 2005

MGI PHARMA EXPECTS LOWER EARNINGS FOR 2005

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MGI Pharma Inc.'s shares fell 11 percent on Tuesday following the company's announcement of a weaker-than-expected forecast for 2005.

MGI said it expects earnings before interest and taxes to be $62 million in 2005. According to Reuters, the healthcare brand name drug development company had previously estimated this number to be $75 million.

Analysts told Reuters the shortfall is attributed to expenses connected with the launch of MGI's Dacogen (decitabine), an experimental drug under review by the Food and Drug Administration for the treatment of blood disorders.

MGI said it expects sales of the biotechnology brand name injection drug Aloxi (palonosetron hydrochloride), used to treat nausea associated with chemotherapy, to be between $155 million and $160 million. This estimate is up slightly from an October forecast of $150 million to $155 million, Reuters reported.

For the year ending December 2005, MGI expects total revenue to increase more than 40 percent to approximately $285 million, with approximately $260 million coming from Aloxi sales.

MGI shares closed at $23.95, down $2.96 in heavy trading on the Nasdaq.

Thursday, March 18, 2004

SALES OF HELSINN HEALTHCARE, MGI PHARMA'S ALOXI EXPECTED TO EXCEED PREVIOUS

Q1, FY GUIDANCE

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Sales of Helsinn Healthcare SA and MGI Pharma Inc.'s Aloxi (palonosetron hydrochloride) injectable nausea therapy are expected to exceed previously released first-quarter and full-year guidance, according to an MGI Pharma press release.

MGI Pharma now anticipates sales of Aloxi, the biotechnology brand name injection drug, will be in the range of $15 million to $17 million in the first quarter, up from its previously disclosed estimate of $12 million. Furthermore, the company said recent trends suggest that overall healthcare brand name drug Aloxi sales for the year could exceed its prior guidance of between $100 million and $110 million.

"More than 125,000 patient treatments with Aloxi injection have occurred since its launch in September 2003," said Lonnie Moulder, MGI Pharma's chief executive officer. "We are very pleased that the launch of Aloxi is off to a great start and believe that this sales performance positions us well to continue executing on our business development initiatives."

Aloxi, the biotechnology brand name drug, received Food and Drug Administration approval in July to prevent acute nausea and vomiting associated with initial and follow-up courses of cancer chemotherapy that are moderately or highly emetogenic, or vomit-inducing. It was also approved to prevent delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.

MGI markets the biotechnology brand name drug Aloxi in the United States in accordance with an April 2001 distribution and marketing agreement with Helsinn.

Shares of MGI closed at $56.68, up $3.23, or 6 percent, in heavy trading on the Nasdaq.

Tuesday, July 29, 2003

FDA APPROVES TWO INDICATIONS FOR HELSINN HEALTHCARE'S ALOXI THERAPY

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Helsinn Healthcare SA's biotechnology brand name drug Aloxi (palonosetron) was granted approval by the Food and Drug Administration for two indications, the company said.

The biotechnology brand name drug Aloxi received approval to prevent acute nausea and vomiting associated with initial and follow-up courses of moderately and highly emetogenic cancer chemotherapy. It was also approved to prevent delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.

The therapy will be marketed in the United States by MGI Pharma Inc., an oncology-focused biopharmaceutical company, in accordance with an April 2001 distribution and marketing agreement between Helsinn and MGI Pharma.

In recent Phase III studies, the biotechnology brand name injection drug Aloxi, a selective 5-HT3 receptor antagonist, showed efficacy in preventing nausea and vomiting caused by chemotherapy when compared with 5-HT3 receptor antagonists that are currently available for use.

Data from the trials were presented in Chicago at the American Society of Clinical Oncology Annual Meeting and in Berlin at the Multinational Association of Supportive Care in Cancer conference, both held in June.

MGI shares closed at $34.65, up $2.68, or 8.4 percent, in heavy trading on the Nasdaq.