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Novartis, Basel, Switzerland, has announced that the Japanese health authority has approved Sandostatin LAR (octreotide acetate for injectable suspension) for the treatment of acromegaly and pituitary gigantism which is unresponsive to or unsuitable for surgery or other drug therapies, and for symptoms associated with gastrointestinal hormone secreting tumors (also known as gastroenteropancreatic (GEP) neuroendocrine tumors (NET), including carcinoid tumors, gastrinomas, and VIPomas (Vasoactive Intestinal Peptide- secreting tumors).

The approval from the Japanese Ministry of Health, Labor and Welfare was based on clinical data from studies conducted in Japan and Western countries, including the member states of the European Union and the United States, where Sandostatin LAR is approved already. Sandostatin LAR is approved in more than 70 countries.

"Sandostatin LAR is the standard around the world for these conditions and we're pleased that the health authorities in Japan have approved the drug so patients in Japan can now benefit from it," said David Epstein, president, Novartis Oncology.

Clinical Data

The data from two Japanese trials, one in acromegaly and pituitary gigantism and the other in carcinoid syndrome, were consistent with findings of the previous western Phase III studies that were the basis for approval in the U.S. and E.U. In the western Phase III acromegaly studies, data showed that Sandostatin LAR was effective in reducing GH levels to <2.5ng/mL as the therapeutic goal in 89 out of 128 patients (69.5%). In addition, IGF-1 level was normalized in 85 out of 128 patients (66.4%). The drug markedly reduced clinical symptoms of acromegaly including headache, fatigue, perspiration, arthralgia, parathesias and carpal tunnel syndrome.

In the western Phase III clinical trials for malignant carcinoid syndrome, data from 93 patients, in whom subcutaneous treatment with Sandostatin Injection had adequately controlled clinical symptoms, Sandostatin LAR was shown to be as efficacious as Sandostatin Injection in controlling clinical symptoms.

About Sandostatin LAR

Sandostatin LAR (octreotide acetate for injectable suspension), launched in most major countries in 1998 and in the US in 1999 is a convenient, once-monthly injection with a well-established safety profile for superior control of both GH and normalization of IGF-1. Sandostatin LAR is indicated for long-term maintenance therapy in acromegalic patients for whom medical therapy is appropriate and who have been shown to respond to and can tolerate Sandostatin(r) (octreotide acetate) injection.

In acromegaly, Sandostatin LAR targets the tumor to control in four critical areas: 1) the site of tumor where hypersecretion starts, 2) GH secretion, 3) IGF-1 production, and 4) symptoms including headache, fatigue, perspiration, arthralgia, parathesias and carpal tunnel syndrome. Sandostatin LAR is also indicated to control symptoms, such as severe diarrhea and flushing, of functional GEP tumors (e.g. metastatic carcinoid tumors and vasoactive intestinal peptide-secreting tumors (VIPomas)) in patients who have responded to and tolerated subcutaneous injections of Sandostatin.

Contraindications and adverse events

In clinical studies of acromegaly, some patients experienced diarrhea, abdominal pain, flatulence, constipation, nausea, vomiting, pain at injection site, slow or irregular heart rate, and high or low blood sugar levels. In studies of carcinoid syndrome, some patients experienced nausea, abdominal pain, headache, dizziness, fatigue, flatulence, vomiting, pain at injection site, and low blood sugar levels.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world.

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Publication:Worldwide Biotech
Date:Jun 1, 2004

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