PRESS RELEASE: Novartis: Afinitor® And -2-

invasive  fungal  infections  should   not  receive  Afinitor.   Oral 
ulceration is a  common side  effect with  Afinitor. Renal  function, 
blood  glucose,  lipids  and   hematological  parameters  should   be 
evaluated  prior  to   the  start  of   therapy  with  Afinitor   and 
periodically thereafter. Strong or moderate CYP3A4 or  P-glycoprotein 
inhibitors should be avoided. An increase in the dose of Afinitor  is 
recommended when co-administered with  a strong CYP3A4 inducer.  Live 
vaccinations and  close contact  with those  who have  received  live 
vaccines should  be avoided  by  patients taking  Afinitor.  Afinitor 
should not  be  used  in patients  with  severe  hepatic  impairment. 
Afinitor may cause fetal harm in pregnant women. 
 
The  most  common   adverse  reactions   irrespective  of   causality 
(incidence >= 30%)  were stomatitis,  infections, asthenia,  fatigue, 
cough and  diarrhea.  The most  common  grade 3/4  adverse  reactions 
irrespective of causality (incidence >= 3%) were infections, dyspnea, 
fatigue, stomatitis,  dehydration,  pneumonitis, abdominal  pain  and 
asthenia. The most common laboratory abnormalities (incidence >= 50%) 
were     anemia,     hypercholesterolemia,      hypertriglyceridemia, 
hyperglycemia, lymphopenia and increased creatinine. The most  common 
grade  3/4   laboratory   abnormalities  (incidence   >=   3%)   were 
lymphopenia,    hyperglycemia,    anemia,    hypophosphatemia     and 
hypercholesterolemia. Deaths due to acute respiratory failure (0.7%), 
infection (0.7%)  and acute  renal failure  (0.4%) were  observed  in 
patients receiving Afinitor. 
 
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 adenoma. 
 
Sandostatin LAR was  first approved  in France  in June  1995 and  is 
currently  approved  in  85  countries.  For  more  than  a   decade, 
Sandostatin  LAR  has  achieved  a  long-standing  track  record   of 
sustained efficacy with a well-established safety profile. 
 
Not all indications are approved in every country. 
 
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; patients with  diabetes 
mellitus thyroid function should be monitored if 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  with 
pregnancy; 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 that  have a  low therapeutic  index should  be used  with 
caution. 
 
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 bradycardia. 
 
The  uncommon  (>=  1/1000,  <1/100)  adverse  drug  reactions   were 
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 levels. 
 
Disclaimer 
The foregoing release contains forward-looking statements that can be 
identified by terminology such  as "may," "potential," "to  explore," 
"further evaluation  is  ongoing," "committed,"  "will,"  or  similar 
expressions, or by express or implied discussions regarding potential 
future  regulatory  filings  or  marketing  approvals  for  Afinitor, 
potential  new  indications  or  labeling  for  Sandostatin  LAR   or 
regarding potential future revenues from Afinitor and/or  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 
Afinitor and/or 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  Afinitor will  be 
approved for sale  in any  additional market, or  for any  additional 
indication  or  labeling.   Nor  can  there  be  any  guarantee  that 
Sandostatin LAR will  be approved for  any additional indications  or 
labeling in  any market.  Neither  can there  be any  guarantee  that 
Afinitor or Sandostatin  LAR will  achieve any  particular levels  of 
revenue in  the  future.  In  particular,  management's  expectations 
regarding Afinitor and  Sandostatin LAR could  be affected by,  among 
other things, unexpected clinical trial results, including unexpected 
new clinical  data and  unexpected  additional analysis  of  existing 
clinical data; 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;  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 AG 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 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 
98,000 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] Yao,  et al.  Daily  Oral Everolimus  Activity in  Patients  with 
Metastatic  Pancreatic   Neuroendocrine  Tumors   After  Failure   of 
Cytotoxic Chemotherapy:  A Phase  II Trial.  11th World  Congress  on 
Gastrointestinal Cancer, Barcelona, Spain. 
[2] Yao, et al. A Phase II Trial of Daily Oral RAD001 (Everolimus) in 
Patients With Metastatic Pancreatic Neuroendocrine Tumors (NET) After 
Failure of Cytotoxic Chemotherapy. 33rd European Society for  Medical 
Oncology Congress, Stockholm, Sweden. 
[3] Halfdanarson, et  al. Pancreatic  neuroendocrine tumors  (PNETs): 
incidence, prognosis  and  recent  trend  toward  improved  survival. 
Annals of Onc 19: 1727-1733, 2008. 
[4] 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. 
[5] American  Cancer  Society.  What are  the  Key  Statistics  about 
Gastrointestinal      Carcinoid      Tumors?      Available       at: 
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_ 

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June 24, 2009 11:46 ET (15:46 GMT)

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