Zeltia Says Yondelis Sales to Exceed 1 Billion Euros

25 Sep 2008 • by Natalie Aster

Zeltia SA Chairman Jose Maria Fernandez Sousa-Faro said global sales from the Yondelis cancer treatment will exceed 1 billion euros ($1.5 billion) as the drug wins approval for use against a second form of the disease.

Yondelis is already sold as a therapy for soft-tissue sarcoma, a type of cancer that begins in tissues such as muscle and fat. The Spanish developer of tumor-fighting drugs made from sea creatures expects to seek approval for use in ovarian cancer in the fourth quarter of this year, Fernandez Sousa-Faro said.

PharmaMar, Zeltia's cancer research unit, last year started marketing its first product after two decades of investigation, validating Fernandez Sousa-Faro's bet of looking in the sea for treatments for human illnesses. The 63-year-old biochemistry professor expects regulators to grant approval for Yondelis for ovarian cancer by the middle of next year.

"We are at the start of an era that will prove that the sea can be an excellent source of medicines," Fernandez Sousa-Faro said in an interview in Madrid, where the company is based.

Zeltia rose as much as 4.3 percent to 4.65 euros and traded 3.1 percent higher at 4.60 euros as of 10:51 a.m. in Madrid. The stock had lost 27 percent this year before today.

"The potential of Yondelis is very significant," said Javier Rivela, an analyst at ING Wholesale Banking in Madrid. He rates the stock "buy" with a target price of 8.6 euros.

Global Sales

The 1 billion-euro estimate is based on global sales of Yondelis as a treatment for soft-tissue sarcoma and ovarian cancer for relapsed patients. New Brunswick, New Jersey-based Johnson & Johnson owns the marketing rights for Yondelis outside Europe and helps finance the research. Revenue may exceed that figure should Yondelis be used for other tumors or as a first- choice treatment for sarcomas or ovarian cancer, he said.

Yondelis has shown positive results fighting prostate and breast cancer, and there is a late-stage trial to test the compound as the first choice for treating one type of sarcoma, he said. In Europe there are about 15,000 soft-tissue sarcoma cases diagnosed each year and Yondelis could be used for about 4,000 as a second-choice therapy, according to a PharmaMar presentation.

PharmaMar has pledged to generate 30 million euros in sales from Yondelis this year and 100 million euros in 2011, though a delay in the approval process in Italy may cause the company to miss the 2008 forecast, he said.

"As of August we were exceeding the budget by 14 percent, but we have to wait to see what the impact of the Italian delay is," he said. "Whatever happens, we will be very close to the 30 million euros this year."

`Almost Certain'

The company on Sept. 15 presented a late-stage study of Yondelis for ovarian cancer at the European Society for Medical Oncology's meeting in Stockholm. The trials, started in 2005, involved 672 patients in 124 hospitals in 21 countries. Patients using the medicine and Johnson & Johnson's Doxil had better results than those treated only with Doxil.

"Our oncologists, who have taken part in the approval process of many treatments, consider the approval as almost certain after seeing the results," the chairman said. "It's very difficult to estimate Yondelis sales for ovarian cancer, but the market must be at least four times that of soft-tissue sarcomas."

PharmaMar has three other molecules in clinical trials as cancer treatments and it's in talks with companies about licensing agreements for one of the treatments, called Aplidin. The drugmaker will present "very interesting results" for Aplidin as a lymphoma treatment at the American Society of Hematology's meeting in December, he said.

Alzheimer's Disease

While PharmaMar is focused on cancer treatments, Zeltia has another unit devoted to seeking a cure for Alzheimer's disease. The division, Noscira, completed an initial trial of its compound NP12 and will soon announce the next round of testing, he said. Noscira is in talks with six possible partners for a licensing agreement for NP12, Fernandez Sousa-Faro said.

Zeltia may postpone a possible initial public offering of Noscira next year because of market volatility. The company is considering other ways to finance the research of the business, such as possible private placement, he said.

Source: Bloomberg