Basel, Switzerland, 23 April 2004 - Novartis announced today 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® (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.
The foregoing release contains forward-looking statements that can be identified by terminology such as "can now benefit" or similar expressions, or by express or implied discussions regarding potential new indications for Sandostatin LAR or regarding potential future sales of Sandostatin LAR. Such forward-looking statements reflect the current views of the company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Sandostatin LAR to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Sandostatin LAR will be approved for any additional indications in any market or will reach any particular sales levels. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding commercialization of Sandostatin LAR could be affected by, among other things, additional analysis of Sandostatin LAR clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated, or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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. For further information please consult http://www.novartis.com.
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Additional information can be found also at www.sandostatin.com and media materials at www.novartisoncologyvpo.com.
