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Globalsandostatinlarjcopromidpressreleasesept3009


Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
MEDIA RELEASE • COMMUNIQUE AUX MEDIAS • MEDIENMITTEILUNG

Newly published Phase III data show Novartis drug Sandostatin® LAR®
reduced risk of disease progression by 66% in advanced NET patients

Study published in Journal of Clinical Oncology demonstrate antitumor benefit of Sandostatin LAR in advanced midgut neuroendocrine tumor (NET) patients Data show Sandostatin LAR more than doubled time without tumor progression for median of 14 months versus six months with placebo National Comprehensive Cancer Network (NCCN) treatment guidelines for advanced NET patients updated based on these data
Basel, October 1, 2009
— Data published in the Journal of Clinical Oncology show that
patients with advanced neuroendocrine tumors (NET) of the midgut who were treated
with Sandostatin® LAR® (octreotide acetate for injectable suspension) experienced a 66%
reduction in risk of disease progression versus placebo1. Sandostatin LAR is indicated to
treat symptoms associated with functional gastroenteropancreatic neuroendocrine
tumors (GEP-NET)2.
These data are from the Phase IIIb study PROMID. In the study, patients receiving
octreotide LAR more than doubled time without tumor progression for a median of 14
months compared with a median of six months for those who received placebo1.
Neuroendocrine tumors are the second most common gastrointestinal malignancy after
colon cancer3. These tumors originate from cells that have roles both in the endocrine
and nervous systems, and they can be either functioning or non-functioning4. Functioning
NET causes the symptoms of carcinoid syndrome, including flushing, diarrhea and
wheezing. The majority of NET are non-functioning, which means they do not cause
symptoms of carcinoid syndrome3. Once a NET has spread from its point of origin to
other parts of the body a patient has few treatment options5.
“PROMID is a placebo-controlled, randomized trial that showed octreotide LAR can
control tumor growth in all patients with NET of the midgut whether or not they
experience symptoms,” said PROMID lead investigator Professor Rudolf Arnold,
Philipps-University, Marburg, Germany. “These are promising data for patients with NET
who face limited treatment options."
The PROMID study showed antitumor benefit in patients with functioning and non-
functioning tumors resulting from treatment with octreotide LAR. In an analysis of
patients with non-functioning tumors, time to tumor progression for patients receiving
octreotide LAR was 28.8 months versus 5.9 months for those on placebo (hazard
ratio=0.25 [95% confidence interval 0.10-0.59]). For patients with functioning tumors,
time to tumor progression for patients receiving octreotide LAR was 14.3 months and 5.5
months for those on placebo (hazard ratio=0.23 [95% confidence interval 0.09 to 0.57])1.
Earlier this year, the NCCN updated its clinical practice guidelines based on the results of
PROMID. The NCCN guidelines now recommend the use of octreotide LAR as a
treatment option for all metastatic, unresectable midgut NET patients, regardless of
symptoms6.
"For more than a decade, octreotide LAR has been a cornerstone of NET treatment for
the symptoms of functional gastroenteropancreatic neuroendocrine tumors," said David
Epstein, President and CEO, Novartis Oncology, Novartis Molecular Diagnostics. "The
findings of the PROMID trial are critical because they show octreotide LAR also has the
potential to control tumor growth and provide the benefit of treatment to even more
patients with an unmet medical need."
About PROMID
PROMID (Placebo-controlled, double-blind, prospective Randomized study on the effect
of Octreotide LAR in the control of tumor growth in patients with metastatic
neuroendocrine MIDgut tumors) is a Phase IIIb study conducted at 18 sites in Germany
to evaluate the antitumor effect of octreotide LAR in patients regardless of symptoms.
The study included 85 patients who were treated with either octreotide LAR or placebo
until tumor progression. All participants were treatment-naïve, had locally inoperable or
metastatic NET with the primary tumor in the midgut and were without curative
therapeutic options. Novartis provided funding for this trial.
The results of the pre-planned interim analysis now published in the Journal of Clinical
Oncology
were first presented at the Gastrointestinal Cancers Symposium of the
American Society of Clinical Oncology (ASCO GI) in January. An updated analysis with
longer patient follow-up was presented earlier this year at the annual meeting of the
American Society of Clinical Oncology (ASCO) in Orlando, Florida. The updated results
confirm that octreotide LAR, when compared to placebo, more than doubled time without
tumor growth (15.6 months vs. 5.9 months) and reduced the risk of disease progression
by 67% (hazard ratio=0.33 with 95% confidence interval 0.19 to 0.55; P=0.000017)7.
The safety profile observed in the PROMID study was consistent with that seen in
previous studies of octreotide LAR. The most frequently observed serious adverse
events affected the gastrointestinal tract (octreotide LAR arm: n=6, placebo arm n=8), the
hematopoetic system (octreotide LAR arm: n=5, placebo arm n=1) and the general
health status (fatigue, fever; octreotide LAR arm: n=8, placebo arm n=2). Serious
adverse events occurred in 11 octreotide LAR-treated patients and 10 placebo recipients.
Discontinuation of treatment due to adverse effects occurred in five of 42 patients in the
octreotide LAR and in none of the 43 patients in the placebo arm.
About neuroendocrine tumors
There are many different types of NET, which can occur throughout the body8. However,
most are found in the digestive system and are collectively called GEP-NET4,9. Carcinoid
tumors and pancreatic NET are types of GEP-NET3. Although it is considered a rare
cancer, the incidence of NET is on the rise and more prevalent than originally reported8.
About Sandostatin LAR
Sandostatin LAR is a long-acting, injectable depot formulation of octreotide acetate that
is indicated for the treatment of acromegaly for patients in whom surgery or radiotherapy
is inappropriate or ineffective; for patients until radiotherapy becomes fully effective; and
for the relief of symptoms associated with functional GEP-NET. Octreotide has been
used to treat the clinical syndromes associated with NET and substantially reduces, and
in many cases can control, growth hormone and/or normalize IGF-1 levels in patients
with acromegaly, a disease caused by a GH-secreting pituitary adenoma1.

Sandostatin LAR
important safety information
Patients who have a known hypersensitivity to octreotide or to any of the excipients
should not take Sandostatin LAR. Dose adjustments of drugs, such as beta-blockers,
calcium channel blockers or agents to control fluid and electrolyte balance may be
necessary. Caution should be used in patients with insulinomas and in patients with
diabetes mellitus. Thyroid function should be monitored in patients receiving prolonged
treatment with octreotide. Patients receiving Sandostatin LAR should receive periodic
examination of the gallbladder; and patients who have a history of vitamin B12
deprivation should have their vitamin B12 levels monitored. Caution should be used in
patients who are pregnant; patients should be advised to use adequate contraception, if
necessary. Patients should not breast-feed during Sandostatin LAR treatment. The use
of Sandostatin LAR may increase the bioavailability of bromocriptine, impair intestinal
absorption of cyclosporin and delay that of cimetidine. Drugs mainly metabolized by
CYP3A4 and drugs with a low therapeutic index should be used with caution1.
The most common (≥ 1/10) adverse drug reactions in clinical studies with Sandostatin
LAR were diarrhea, abdominal pain, nausea, constipation, flatulence, headache,
cholelithiasis, hyperglycemia and injection-site localized pain. Common (≥ 1/100, < 1/10)
adverse drug reactions were dyspepsia, vomiting, abdominal bloating, steatorrhea, loose
stools, discoloration of feces, dizziness, hypothyroidism, thyroid dysfunction (e.g.,
decreased thyroid stimulating hormone, decreased Total T4 and decreased Free T4),
cholecystitis, biliary sludge, hyperbilirubinemia, hypoglycemia, impairment of glucose
tolerance, anorexia, elevated transaminase levels, pruritus, rash, alopecia, dyspnea and
bradycardia1.
Uncommon (≥ 1/1000, <1/100) adverse drug reactions included dehydration and
tachycardia. The following adverse reactions have been reported postmarketing:
anaphylaxis, allergy/hypersensitivity reactions, urticaria, acute pancreatitis, acute
hepatitis without cholestasis, cholestatic hepatitis, cholestasis, jaundice, cholestatic
jaundice, arrhythmia, increased alkaline phosphatase levels and increased gamma
glutamyl transferase levels1.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by
terminology such as “risk,” “promising,” “potential,” or similar expressions, or by express
or implied discussions regarding potential new indications or labeling for Sandostatin
LAR or regarding potential future revenues from Sandostatin LAR. You should not place
undue reliance on these statements. Such forward-looking statements reflect the current
views of management 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
submitted or approved for any additional indications or labeling in any market. Nor can
there be any guarantee that Sandostatin LAR will achieve any particular levels of
revenue in the future. In particular, management’s expectations regarding Sandostatin
LAR could be affected by, among other things, unexpected regulatory actions or delays
or government regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing clinical data;
the company’s ability to obtain or maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general public pricing
pressures; the impact that the foregoing factors could have on the values attributed to the
Novartis Group's assets and liabilities as recorded in the Group's consolidated balance
sheet, and other risks and factors referred to in Novartis AG’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.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and
societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is the only company
with leading positions in each of these areas. In 2008, the Group’s continuing operations
achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately
USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-
equivalent associates and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
References
1.
Journal of Clinical Oncology. online August 24, 2009. http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2009.22.8510. Prescribing information for Sandostatin LAR Modlin IM, et al. “Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008 Sept 7;100(18):1282-1289. Kloppel G, Perren A, Heitz PU The Gastroenteropancreatic Neuroendocrine Cell System and Its Tumors: The WHO Classification. Ann. of the New York Acad of Sci. 2006 Jan 16 2005; 1014:13-27. Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Annals of Onc 19: 1727-1733, 2008. Update.http://www.nccn.org/network/business_insights/flash_updates/2009-05-28.asp. Last accessed July 2009. Arnold R, et al. Placebo-controlled, double-blind, prospective, randomized study of the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: A report from the PROMID study group. Abstract # 4508. American Society of Clinical Oncology 2009 Annual Meeting, Orlando, FL. Yao, J. One Hundred Years After "Carcinoid:" Epidemiology of and Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United States. Journal of Clinical Oncology. June 20 2009; vol. 26, number 18. American Cancer Society. Detailed Guide: Gastrointestinal Carcinoid Tumors. What are the key statistics about gastrointestinal http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_gastrointestinal_carcinoid_tumors_14.asp?rnav=cri . Accessed July 2009
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Source: http://www.novartisoncology.com.au/files/media/newsroom/media-releases/SandostatinLARJCOPROMIDPressReleaseSept3009.pdf

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