Pharmaceuticals Novarties

8/8/2019 Pharmaceuticals Novarties

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Pharmaceuticals

Innovating to treat disease more effectively

Our global Pharmaceuticals portfolio includes more than 50 key marketed

products, many of which are innovative leaders in their therapeutic areas. In

2009 we received a total of 25 positive regulatory decisions in the United

States, Europe and Japan.

Key pharmaceutical products marketed by Novartis are listed below by

therapeutic area.

Not all products or indications are available in all countries.

Regulatory requirements in various countries limit the product

information that we can provide. Please consult your physician about

any medical condition or prescription product.

Note that some product links are intended for US residents only.

The Pharmaceuticals Division of Novartis is recognized worldwide for the

innovative medicines we provide to patients, physicians and healthcare

organizations. This growing business develops and markets patent-protected

prescription drugs for important health needs. Our products are

concentrated in major therapeutic areas including:

Cardiovascular and Metabolism


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Novartis is focused on improving the lives of the hundreds

of millions of people with cardiovascular and metabolic diseases and

provides therapies and support programs to treat high blood pressure and

diabetes - both major public health issues.

The portfolio includes the following treatments for high blood pressure:*

y Diovan (valsartan), an angiotensin receptor blocker (ARB)

y Co-Diovan/DiovanHCT(valsartan and hydrochlorothiazide)

y Exforge (amlodipine and valsartan), a single pill combining two high blood

pressure medicines

y Tekturna/Rasilez(aliskiren), a direct renin inhibitor

y Tekturna HCT/RasilezHCT(aliskiren with hydrochlorothiazide)

y Valturna (aliskiren with valsartan), available in the US

The following oral treatments are for the management oftype 2 diabetes:*

y Galvus (vildagliptin), a DPP-4 inhibitor

y Eucreas (vildagliptin and metformin)

Innovating to treat disease more effectively

Our global Pharmaceuticals portfolio includes more than 50 key marketed

products, many of which are innovative leaders in their therapeutic areas. In

2009 we received a total of 25 positive regulatory decisions in the United

States, Europe and Japan.Key pharmaceutical products marketed by Novartis are listed below by

therapeutic area.

Not all products or indications are available in all countries.

Regulatory requirements in various countries limit the product


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information that we can provide. Please consult your physician about

any medical condition or prescription product.

Note that some product links are intended for US residents only

Oncology

Our oncology portfolio provides cancer patients with a broad range of

therapies and practical solutions for the treatment of cancer and

hematology. These include:*

y Afinitor(everolimus) for patients with advanced renal cell carcinoma

(kidney cancer), whose disease has progressed on or after treatment with

VEGF-targeted therapy

y Exjade (deferasirox) for the removal of excess iron due to blood

transfusions

y Femara (letrozole) for early-stage or advanced breast cancer in

postmenopausal women

y Gleevec/Glivec(imatinib mesylate/imatinib) for certain forms of: chronic

myeloid leukemia, acute lymphoblastic leukemia, and gastrointestinal

stromal tumors

y Proleukin (aldesleukin) for metastatic renal cell carcinoma and metastatic

melanoma

y Sandostatin LAR & Sandostatin SC(octreotide acetate for injectable

suspension & octreotide acetate) for acromegaly and symptoms associated

with certain gastroenteropancreatic neuroendocrine tumors (carcinoid and

VIPomas)

y Tasigna (nilotinib) for certain forms of chronic myeloid leukemia in patients

resistant or intolerant to prior treatment including Gleevec/Glivec

y Zometa (zoledronic acid) for prevention of skeletal related events in

patients with bone metastases from solid tumors and multiple myeloma, as

well as the treatment of hypercalcemia of malignancy


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Neuroscience and Opthalmics

The Novartis Neuroscience portfolio includes treatments

for central nervous system disorders as well as ophthalmic conditions.

For central nervous system disorders our products cover the following

disease areas:

y Alzheimer's disease

y Parkinson's disease

y Epilepsy

y Depression

y Attention-deficit hyperactivity disorder (ADHD)

y Schizophrenia

Novartis also has treatments for ophthalmic conditions, most importantly

"wet" age-related macular degeneration (AMD), a leading cause of blindness

in people over age 50.

Neuroscience productsOur neuroscience medicines include:*

y Exelon and Exelon Patch (rivastigmine tartrate) for the treatment of

Alzheimer's disease and dementia associated with Parkinson's disease

y Trileptal(oxcarbazepine) for the treatment of epilepsy

y Stalevo (carbidopa, levodopa and entacapone) for the treatment of

Parkinson's disease

y Extavia, a multiple sclerosis treatment

Ophthalmics productsIn ophthalmics, Lucentis (ranibizumab) is a therapy which improves vision in

patients with "wet" AMD.*

Neuroscience and ophthalmics development compounds

Novartis has a number of compounds in late-stage development, including

therapies for multiple sclerosis, diabetic macular edema and depression.


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Respiratory

Respiratory diseases threaten the quality and longevity of life, and Novartis

is addressing unmet needs in this area. Products include:*

y Xolair(omalizumab), a biological therapy that targets one of the underlying

causes ofsevere allergic asthma

y TOBI(tobramycin), a nebulizer-inhaled antibiotic therapy for the treatment

ofPseudomonas aeruginosa (Pa) infection in people with cystic fibrosis

y OnbrezBreezhaler(indacaterol), an inhaled once-daily bronchodilator for

the treatment of chronic obstructive pulmonary disease (COPD), a group of

diseases including chronic bronchitis and emphysema

In addition, Novartis has a number of compounds in late-stage development

for the treatment of COPD and cystic fibrosis.

Immunology and Infectious Diseases

Novartis has a diverse portfolio of medications to treat disorders that affect

the bodys immune response and occur when the immune system is

overactive and/or begins to fight against itself.

In Immunology and Infectious Diseases, our focus is on the following disease

areas:*

Transplantation

We have a broad portfolio of immunosuppressants which are used to help

prevent organ rejection. These include Neoral(cyclosporine), Simulect

(basiliximab), myfortic(micophenolic acid) and Certican/Zortress

(everolimus).

We are also developing new medications for patients requiring a kidney, liver

or heart transplantation.

Nephrology / Hepatitis

Our portfolio includes Tyzeka/Sebivo(telbivudine), a therapy for chronic

hepatitis B, as well as development projects addressing hepatitis C and

chronic kidney disease.


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Autoinflammatory and autoimmune diseases

Ilaris (canakinumab) is a new biological medicine that treats a rare

autoinflammatory disease with debilitating symptoms called cryopyrin-

associated periodic syndromes (CAPS).

We are also developing new treatments for patients suffering from chronic

autoimmune diseases such as psoriasis, rheumatoid arthritis and gouty

arthritis.

Additional marketed products include Aclasta/Reclast(zoledronic acid 5 mg),

a once-yearly infusion to treat osteoporosis in postmenopausal women and

in men at increased risk of fractures, and Cubicin (daptomicyn), an antibiotic

for severe infections. Development of new treatments for complicated

infections caused by multiresistant microbes and bacteria is ongoing.

Vaccines and Diagnostics

The Novartis Vaccines and Diagnostics Division provides

more than 20 vaccines to prevent viral and bacterial diseases, as well assophisticated instruments, assays and software to protect the blood supply

from the spread of infections.

The division consists of two businesses - Novartis Vaccines and Novartis

Diagnostics, the blood testing business.

Novartis Vaccines

Novartis Vaccines is dedicated to delivering on the promise of preventionthrough the research, development and production of innovative, safe and

effective vaccines. At the heart of everything we do is our commitment to

preventing the spread of life-threatening diseases, protecting vulnerable

populations, and keeping healthy people healthy.


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By focusing on disease prevention, Novartis Vaccines plays a key role in the

company's core mission: keeping people healthy, alleviating suffering and

enhancing quality of life.

The current vaccine portfolio includes vaccines to prevent:

y Influenza

y Meningitis

y Rabies

y Japanese encephalitis

y Tick-borne encephalitis

y Haemophilus Influenzae type B (Hib)

y Polio

y Diphtheria

y Tetanusy Pertussis (whooping cough)

Novartis Diagnostics: the blood testing business

Building on more than a decade of dedication to blood safety, Novartis

Diagnostics is developing a future of innovative solutions for preventive

screening and the prediction of health outcomes.

Novartis Diagnostics products are used to test millions of blood donations

around the world each year for pathogens such as HIV (the AIDS virus),

hepatitis B and hepatitis C, and West Nile virus.

More than 80 percent of the US blood supply is tested on Novartis

Diagnostics systems to ensure safety for transfusion or use in other blood

products.

Sandoz


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Novartis is the only pharmaceutical company with aglobal leadership position in both patented prescription and generic

pharmaceuticals.

Sandoz plays a critical role in the Novartis strategy of offering a range of

treatment options to patients, physicians and healthcare providers

worldwide. This broad portfolio helps to make affordable, high-quality

medicines available to patients around the world and stabilize healthcare

systems.

Two main elements empower the Sandoz business strategy:

y Global reach and reputation: In addition to its unique position within

Novartis, Sandoz benefits from a strong global presence and powerful brand

recognition worldwide.

y Unique epertise: Sandoz distinguishes itself primarily through its ability to

develop and produce differentiated medicines. Sandoz is the pioneer of

biosimilars follow-on versions of biopharmaceuticals following patent

expiry with the first three approved and marketed products in the EU

(human growth hormone Omnitrope, anemia medicine Binocrit / epoetin alfa

Hexal, and oncology medicine Zarzio / Filgrastim Hexal).

Sandoz - adding value all the way up

Sandoz difficult-to-make medicines add value by making life easier for

patients. The portfolio ranges from complex oral solids through injectables,

high-tech patches and state-of-the-art inhalers to biosimilars.

For additional information please roll-over the Sandoz graphic below.

Consumer Health


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The Consumer Health Division creates, develops and manufactures a wide

range of products designed to restore, maintain or improve the health

and well-being of our customers

Novartis to acquire Corthera Inc., gaining worldwide rights to Phase

III project relaxin for treatment of acute decompensated heart

failure

y Phase II results show relaxin has vasodilator (widens blood vessels) effects,

improves breathlessness, reduces cardiovascular morbidity and days in

hospital

y Acute decompensated heart failure (ADHF) remains a major clinical

challenge with a high and increasing incidence and substantial morbidity and

mortality

y Novartis to pay USD 120 million for acquisition; Cortheras current

shareholders eligible for additional payments of up to USD 500 million

contingent upon successful development and commercialization milestones

Basel, December 23, 2009 - Novartis will gain exclusive worldwide rights

to relaxin, a recombinant version of a naturally occurring human peptide,

through the acquisition of the privately held US biopharmaceutical company

Corthera Inc. Relaxin is currently in Phase III clinical trials as a potential

treatment option for patients with acute decompensated heart failure

(ADHF).

Novartis will assume full responsibility for the development and

commercialization of relaxin, with regulatory submissions in the US and

Europe planned for 2013. The US Food and Drug Administration (FDA) has

granted Fast Track designation to relaxin as part of its program to expedite


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the review of new drugs intended to treat serious or life-threatening

conditions that can potentially address unmet medical needs.

Relaxin, which is administered to hospitalized patients via a 48-hour

infusion, has been shown to cause an increase in cardiac output, systemic

and renal vasodilation, which suggests potential benefits for patients with

ADHF. In its natural form, this peptide is responsible for relaxing the female

reproductive tract as well as mediating the cardiovascular and renal changes

during pregnancy, leading to studies showing its potential applications in this

cardiovascular disease.

Despite a range of current treatment options, acute decompensated heartfailure is the leading cause of hospitalization in people over age 65 and

remains a major clinical challenge with a high and increasing incidence and

substantial morbidity and mortality, said Trevor Mundel, MD, Global Head of

Development at Novartis AG. Relaxin will be an important addition to our

expanding pipeline of novel development projects targeting cardiovascular

disease.

Acute decompensated heart failure estimated to affect millions of people inthe US and in Europe is a condition often associated with chronic heart

disease where patients typically suffer from severe shortness of breath

(dyspnea) and the hearts ability to pump blood from the lungs is impaired.

As a result, the lungs become overfilled with fluid, which reduces oxygen

uptake. Diuretics and vasodilators are the current standard of care, but

available agents from these classes have been associated with renal

impairment, low blood pressure (hypotension) and adverse outcomes.

We are extremely pleased to be entering into this transaction with Novartis,

given their world-class capabilities and global leadership position in

cardiovascular disease, said Stan Abel, President and Chief Executive

Officer of Corthera. This transaction highlights relaxins potential as an

important treatment option for patients suffering from acute heart failure.


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Relaxin is expected to further strengthen the position of Novartis and its

extensive range of cardiovascular medicines and development portfolio:

y Diovan (valsartan) an angiotensin receptor blocker (ARB), is the number

one selling hypertension medication worldwide[1], and is indicated in chronic

heart failure (NHYA class II IV). Diovan has been shown to significantly

reduce hospitalizations for heart failure.[2]

y Tekturna/Rasilez (aliskiren) a first-in-class direct renin inhibitor

approved for treatment of hypertension that is also currently in Phase III

studies for use in chronic heart failure.

y LCZ696 a single molecule dual-acting angiotensin receptor blocker /

neprilysin inhibitor (ARNI) that entered Phase III development in late 2009

for systolic heart failure.

y LCI699 a Phase II and first-in-class aldosterone synthase inhibitor (ASI)

being explored as a potential treatment for heart failure.

Relaxin also further complements the Novartis strategy to expand in acute

cardiology care that includes elinogrel, an anti-platelet agent in Phase II

development with potential to reduce the risk of heart attack and stroke.

Novartis has hospital-based specialty sales forces in place to maximize the

commercial potential of this development portfolio.

Corthera successfully completed Phase II clinical trials in early 2009 before

initiating Phase III trials in October. Pre-RELAX-AHF, a 234-patient PhaseIIb, placebo-controlled clinical trial, explored the efficacy, tolerability and

safety of intravenous relaxin in patients with ADHF who had normal to

severe high blood pressure.[3]

Terms ofAgreement


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Under the terms of the transaction, Novartis will acquire all of the

outstanding shares of Cortheras stock for USD 120 million. In addition,

Cortheras current shareholders will be eligible to receive additional

payments of up to USD 500 million that are contingent upon clinical

milestones, regulatory approval of relaxin and the achievement of

commercialization targets. This transaction, which is subject to customary

regulatory approvals, is expected to be completed in the first quarter of

2010.

Corthera Inc. is a private biopharmaceutical company. Cortheras investors

include Domain Associates, Kleiner Perkins Caufield & Byers, Caxton

Advantage Life Science Fund, and Sears Capital Management Inc.

* Novartis will acquire the exclusive worldwide rights for relaxin in all

countries except Australia and Canada

Disclaimer

The foregoing release contains forward-looking statements that can be

identified by terminology such as to acquire, to expand, to pay,

eligible, contingent, will, potential, planned, Fast Track,

potentially, pipeline, or similar expressions, or by express or implied

discussions regarding potential regulatory approval for this proposed

acquisition, the potential future development or marketing of relaxin or of

the other products or new indications for existing products described in this

release, or regarding potential future revenues from such products or

indications. 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 to be materially

different from any future results, performance or achievements expressed or

implied by such statements. In particular, there can be no guarantee that

Novartis will receive the necessary regulatory approvals to proceed with this

acquisition, or that the proposed acquisition will be completed in the

expected form or within the expected time frame or at all. Nor can there be


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any guarantee that relaxin or the other products or new indications for

existing products described in this release will be submitted or approved for

sale in any market, or in accordance with any particular timeline. Neither can

there be any guarantee that relaxin or any of these other products will

achieve any particular levels of revenue in the future. Neither can there be

any guarantee that Novartis will achieve any particular future financial

results or future growth rates or that Novartis will be able to realize any of

the potential strategic benefits or opportunities as a result of the proposed

acquisition. In particular, managements expectations could be affected by,

among other things, unexpected clinical trial results, including unexpected

new clinical data and unexpected additional analysis of existing clinical data;

the companys ability to obtain or maintain patent or other proprietary

intellectual property protection; unexpected regulatory actions or delays or

government regulation generally; 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 AGs 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 adiversified 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 Groups continuing operations

achieved net sales of USD 41.5 billion and net income of USD 8.2 billion.


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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.

Novartis corporate press kit

Novartis is a world leader in the research, development, manufacturing andmarketing of products to protect and improve health and well-being. Our

goal is to discover, develop and successfully market innovative products to

prevent and cure diseases, to ease suffering and to enhance the quality of

life. We also want to provide a shareholder return that reflects outstanding

performance and to adequately reward those who invest ideas and work in

our company.

Company: NOVARTIS, ISTANBUL TURKEYEntry Submitted by: EFFECT PUBLIC RELATIONSCompany Description: Market leader in sales, Novartis Turkey functions in pharmaceutical andconsumer health industries. Offering treatment in diabetes, cardiology, respiratory, oncology,dermatology, rheumatology, CNS and ophthalmology Novartis Turkey has around 2000employees working in production, marketing and clinical research working in 5 productionfactories.Nomination Category: Company & Office CategoriesNomination Sub Category: Best Corporate Social Responsibility Program in the Middle East and

Africa

Nomination Title: NOVARTIS HEALTH WAGON PROJECT, TURKEY

1. Tell the story about what this nominated company achieved in the past year (up to 500words). Focus on specific accomplishments, and relate these accomplishments to pastperformance or industry norms. Be sure to mention obstacles overcome, innovations ordiscoveries made, and outcomes:


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The Health Wagon Project of Novartis Turkey is an extensive training andpublic awareness campaign on chronic diseases where Novartis is offeringtreatment; cardiology, respiratory, oncology, dermatology, rheumatology, CNSand ophthalmology.

The project is conducted in 20 different cities around Turkey on main railwayroutes from November 2005 till August 2006.

?A Train Wagon is redecorated as a health unit with examination rooms and ameeting room for educational purposes.?Two physicians and one nurse worked in this project permanently.?Training sessions were held about diseases - hypertension, diabetes, hyper-lipidemia, asthma, alzheimer, osteoporosis, IBS, cancer, epilepsy, Parkinsonsdisease, acromegaly, depression, fungus, thalassemia- their symptoms,precautions and the maintenance of health. Besides the permanent responsibledoctor of the wagon, training was given by the local KoLs or family

physicians.?In parallel to the trainings, the other activity of the Health Wagon wasmetabolic syndrome screening conducted on the Cardio-Metabolic Risk Factorsin Turkey under the supervision of the Metabolic Syndrome Association. It isthe first report on ethiological factors of coronary artery disease amongadults researching dislipidemia prevelance and relation of dislipidemia withinsulin resistance; postprandial glycemia and kidney functions in Turkey.

Objectives:?To increase public awareness on Novartis?To increase public awareness on chronic diseases.

?Screening?Strengthen reputation of Novartis among stakeholders.?CME need of GPs and Specialists

Promotional Activities:

?An opening ceremony was organized in each city with the participation of thelocal government, NGO and health office representatives, physicians,academicians and the media.?Posters and brochures were distributed around the city before wagon arrivesthe city. Billboards, radio programs, telephone/sms messages, publicannouncements also supported the communication of the Project.?Internet site under Novartis Turkey web site was updated daily to communicatethe activities in the Novartis Health Wagon with photos (www.novartis.com.tr)

Results:

Novartis Health Wagon project was a transformational, highest impact project.?5000 people were trained throughout 9 months.


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?1317 people screened for their metabolic risk factors.?Metabolic Syndrome Association and Ministry of Health approaches Novartis asa partner.?The coverage in local media was considerably high.

10 days after the program, for each city a tele-survey is conducted with theparticipants to evaluate the success of trainings.

?Effectiveness of the trainings is measured by the behavior change at the endof the training 1:o91% found the trainings beneficialo44% visited a doctor later ono25% changed their nourishment style or started dieto85% shared the knowledge with the familyo37% started exercisingo10% quitted smoking

?Awareness of the public about Novartis:Recall of the Novartis Health Wagon Project is 99% among those whoparticipated the training.Novartis is the 5th, with 2.3%, among the first recalled pharma companies,which are providing products for chronic diseases

Critical Success Factors:Project increased the improvement of public awareness on wide range ofdiseases and to make them take action related to their health problems. 5000patients have been given quality and effective education. The project reachedsuccess through full cooperation with important stakeholders. The project

also supported the development of the Report of the Cardio Metabolic RiskFactors in Turkey.

Key learnings:?This is the first and only project implemented in various cities, achievingthe contribution of all the key stakeholders at the same time, namely Ministryof Health and Health Offices of the Ministry in the cities, National SecurityOffices, Governors, Municipalities, Medical Universities, Metabolic SyndromeSociety, local media and field force.?The coverage in local media is considerably high.

2. List hyperlinks to any online news stories, press releases, or other documents that supportthe claims made in the section above. IMPORTANT: Begin each link with http://, and encloseeach link in square brackets; for example, [http://www.youraddress.com]:

More information regarding the project can be found at :http://www.novartis.com.tr/vagon

http://thestevies.com/IBA07Attachments/NovartisHealthWagonProject.doc


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http://thestevies.com/IBA07Attachments/NovartisHealthWagonProject.pdf

3. Provide a brief (up to 100 words) biography about the leader of this nominated company:

Dr. Aylin Grer

Graduated from Hacettepe University, completed her MBA at Bilkent Universityand received her PhD at Istanbul University, Labor Economics and IndustryRelations Department in 2001. Gurer worked at United Nations (Ankara) asInternational Projects Coordinator She joined Novartis in 1997 and she wasappointed as the Corporate Relations and Communications Director in 2005.

Ekin ErimGraduated from Hacettepe University in 1996, Erim worked at Nurus, Bayindir,Yasamkent, Total Lighting and DBR. After working at Saatchi & Saatchi Erimjoined Novartis Turkey as Corporate Communication Associate in 2005. She wasappointed as the Pharma Communication Manager in 2007.

Presentation Transcript

Chronic Constipation: An Unresolved Problem for Many Patients:

Chronic Constipation: An Unresolved Problem for Many Patients Charlene Prather, MD

Division of Gastroenterology and Hepatology Saint Louis University School of Medicine

Presentation Objectives:

Presentation Objectives Definition of chronic constipation Epidemiology and resource

utilization Review of available therapies and limitations Unmet medical need C

Definition: Causes of Chronic Constipation:

Definition: Causes of Chronic Constipation Secondary Drug induced Metabolic factors

Comorbid conditions Primary Impaired colonic transit/motility Altered neuroenteric

function and reflexes Failure of muscular apparatus Ineffective defecation (functional

outlet obstruction) Pelvic dyssynergia and anismus Normal transit constipation C

Constipation Is a Constellation of Symptoms:

Constipation Is a Constellation of Symptoms Most commonly reported symptoms Hard,

lumpy stools Increased straining Infrequent bowel movements Sensation of incomplete


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evacuation Bloating/fullness Chronic constipation More persistent than intermittent or

episodic Several months duration C

Constipation Is More Than Just Infrequent Passage of Stool: Sandler RS, et al. Dig Dis Sci. 1987;32:841-845. n = 1128 Constipation Is More Than

Just Infrequent Passage of Stool 53 Constipation symptoms reported most often

Reduced Stool Frequency Is Not the Most Commonly Reported Symptom in

Constipation:

Reduced Stool Frequency Is Not the Most Commonly Reported Symptom in

Constipation EPOC = Epidemiology of constipation; BM = Bowel movement. 1. Stewart

WF, et al. Am J Gastroenterol. 1999;94:3530-3540. 2. Par P, et al. Am J

Gastroenterol. 2001;96:3130-3137. Stewart (EPOC) 19991 Par 20012 n = 1476 n =1149 Constipation symptoms reported most often C

Rome II Defines Functional Constipation Based on Multiple Symptoms:

Rome II Defines Functional Constipation Based on Multiple Symptoms Rome II

diagnostic criteria for functional constipation At least 12 wk, which need not be

consecutive, over the past 12 months of 2 or more of Straining* Lumpy or hard stools*

Sensation of incomplete evacuation* Sensation of anorectal obstruction/blockage*

Manual maneuvers to facilitate defecation* < 3 defecations/wk Loose stools not presentInsufficient criteria for IBS * > 1/4 of defecations. Drossman DA, et al. In: Rome II: The

Functional Gastrointestinal Disorders. 2000:382-391. C

Prevalence in the General Population:

Prevalence in the General Population 1. Stewart WF, et al. Am J Gastroenterol.

1999;94:3530-3540. 2. Drossman DA, et al. Dig Dis Sci. 1993;38:1569-1580. 3. Harris

Interactive Study, Wave 2. Data on file. 4. Par P, et al. Am J Gastroenterol.

2001;96:3130-3137. 53

Approximately 25% of Sufferers Seek Care:

Approximately 25% of Sufferers Seek Care 1. Stewart WF, et al. Am J Gastroenterol.

1999;94:3530-3540. 2. Drossman DA, et al. Dig Dis Sci. 1993;38:1569-1580. 3. Harris


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Interactive Study, Wave 2. Data on file. 4. Par P, et al. Am J Gastroenterol.

2001;96:3130-3137. 53

Constipation Affects All Age Groups: Constipation Affects All Age Groups 53 Canadian population. Par P, et al. Am J

Gastroenterol. 2001;96:3130-3137. N = 1149 n = 378 n = 367 n = 217 n = 187

Epidemiology:

Epidemiology Chronic constipation is common Slightly more common in women F/M

ratio = range 1.3 to 2.5 Affects all age groups Stewart WF, et al. Am J Gastroenterol.

1999;94:3530-3540. Par P, et al. Am J Gastroenterol. 2001;96:3130-3137. Sandler

RS, et al. Dig Dis Sci. 1987;32:841-845. C

Profile of a Typical Chronic Constipation Patient in My Practice:

Profile of a Typical Chronic Constipation Patient in My Practice Generally female

Symptomatic for > 10 yr Majority have tried lifestyle changes, fiber, and OTC laxatives

prior to seeking care Manages condition with multiple therapies Most often referred by a

primary care physician Copes with condition, but is not completely satisfied C

Constipation Can Have a Negative Impact on Quality of Life: Constipation Can Have a Negative Impact on Quality of Life In Olmstead County,

Minnesota, people with CC reported significant impairment in QoL on SF-36 scale (n =

126)1 In Canada, people with self-reported or Rome II constipation had significantly

worse SF-36 scores than the normal population (n = 472)2 In Australia, people with

constipation had significantly worse SF-12 scores on both mental and physical scales (n

= 227)3 1. OKeefe EA, et al. J Gerontol A Biol Sci Med Sci. 1995;50:M184-M189. 2.

Irvine EJ, et al. Am J Gastroenterol. 2002;97:1986-1993. 3. Koloski NA, et al. Am J

Gastroenterol. 2000;95:67-71. C

Constipation Significantly Impacts Healthcare Utilization:

Constipation Significantly Impacts Healthcare Utilization 5.7 million constipation-related

outpatient visits annually1,2 4.1 million physician office-based visits 991,000 emergency

room visits 587,000 hospital outpatient visits $2752/patient for tertiary care evaluation3

1. National Ambulatory Medical Care Survey, 2001. www.cdc.gov 2. National Hospital


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Physicians Believe Patient Satisfaction With Current Therapies Is Low:

Physicians Believe Patient Satisfaction With Current Therapies Is Low Yes 18% Are

your patients completely satisfied? No 82% Schiller LR, et al. Am Coll Gastroenterol.

2004, abstract submitted. C n = 311 60% of physicians agreed that they do not have

adequate products 90% of physicians wanted better treatment options Physicians cited

frustration with current treatments one of the top 3 reasons patients state for seeking

care *Not mutually exclusive.

Many Constipation Patients Are Not Satisfied With Available Treatments:

Many Constipation Patients Are Not Satisfied With Available Treatments C 1. Schiller

LR, et al. Am Coll of Gastroenterol. 2004, abstract submitted. 2. Irvine EJ, et al. Am J

Gastroenterol. 2002;97:1986-1993. 3. Ferrazzi S, et al. Can J Gastroenterol.

2002;16:159-164. *Not mutually exclusive. Yes 53% Are you completely satisfied? 1 No

47% n = 557

Chronic Constipation: A Condition in Need of a Better Approach:

Chronic Constipation: A Condition in Need of a Better Approach Characterized by a

constellation of symptoms High resource utilization and significant negative impact on

patients lives Current pharmacologic agents have limitations Many patients are not

satisfied with available therapies Better treatment options are needed C


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Novartis

"Sandoz Laboratories" redirects here. For the new Sandoz company founded in 2003, see

Sandoz.

Novartis International AG

Type Public (SIX: NOVN, NYSE: NVS)

Industry Pharmaceutical industry

Founded 1996 (from merger)

Headquarters Basel, Switzerland

KeypeopleDaniel Vasella (Chairman), Joseph

Jimenez[1] (CEO)

Products

Pharmaceuticals, generic drugs,

over-the-counter drugs, vaccines,

diagnostics, contact lenses, animal

health (list...)

Revenue US $44.27 billion (2009)[2]

Operatingincome

US $9.98 billion (2009)[2]

Net income US $8.40 billion (2009)[2]


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Employees 99,830 (FTE, 2009)[2]

Subsidiaries Ciba Vision, Sandoz

Website www.novartis.com

Novartis International AG is a multinational pharmaceutical company based in Basel,

Switzerland, ranking number three in sales among the world-wide industry, which accounted

36.173 billon in 2008.[3] It currently is the sixth largest pharmaceutical company in terms of

revenue ($41.5 billion in 2009) with a profit margin of about 20%, which is the same as its

industry competitors. Their profits were down by 31% from 2007 levels. [4] Novartis

manufactures drugs such as clozapine (Clozaril), diclofenac (Voltaren), carbamazepine(Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec / Glivec), ciclosporin (Neoral /

Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others.

Renamed to Novartis following an acquisition by Ciba-Geigy, it owns Sandoz, a large

manufacturer of generic drugs. The company formerly owned the Gerber Products Company, a

major infant and baby products producer, but sold it to Nestl on 1 September 2007. [5][6][7][8]

Novartis is a full member of the European Federation of Pharmaceutical Industries and

Associations (EFPIA) [9] and of the International Federation of Pharmaceutical Manufacturers

and Associations (IFPMA) [10]

Contents

y 1 Collaborative research

y 2 History

o 2.1 Ciba-Geigy

o 2.2 Sandoz

o 2.3 After the merger

y 3 Basel headquarters campus redesign

y

4 Productso 4.1 Pharmaceuticals

o 4.2 Consumer health (OTC)

o 4.3 Animal health

y 5 Research and development

y 6 Controversies and criticism

o 6.1 Challenge to India's patent laws

o 6.2 Advertising practices


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o 6.3 'No' to free flu vaccines

o 6.4 Sexual discrimination

Collaborative research

In addition to internal research and development activities Novartis is also involved in publicly

funded collaborative research projects, with other industrial and academic partners. One example

in the area of non-clinical safety assessment is the InnoMed PredTox. [11][12] The company is

expanding its activities in joint research projects within the framework of the Innovative

Medicines Initiative of EFPIA and the European Commission.[13] The company's research

operations have their global headquarters in Cambridge, Massachusetts.

History

Novartis headquarters in Basel

Novartis was created in 1996 from the merger ofCiba-Geigy and Sandoz Laboratories, both

Swiss companies with long histories. Ciba-Geigy was formed in 1970 by the merger ofJ. R.

Geigy Ltd (founded in Basel in 1758) and CIBA (founded in Basel in 1859). Combining the

histories of the merger partners, the company's effective history spans 250 years.[15]

Ciba-Geigy

Johann Rudolf Geigy-Gemuseus (17331793) began trading in 1758 in "materials, chemicals,dyes and drugs of all kinds"[16] in Basel, Switzerland. Johann Rudolf Geigy-Merian (18301917)

and Johann Muller-Pack acquired a site in Basel in 1857, where they built a dyewood mill and a

dye extraction plant. Two years later, they began the production of synthetic fuchsine. In 1901,

they formed the public limited company Geigy and the name of the company was changed to J.

R. Geigy Ltd in 1914.


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In 1859 Alexander Clavel (1805 1873) took up the production of fuchsine in his factory for

silk-dyeing works in Basel. In 1864, a new site for the production of synthetic dyes was

constructed, and in 1873, Clavel sold his dye factory to the new company Bindschedler and

Busch. In 1884 Bindschedler and Busch was transformed into a joint-stock company with the

name "Gesellschaft fr Chemische Industrie Basel" (Company for Chemical Industry Basel). Theacronym, CIBA, was adopted as the company's name in 1945.

In 1925 J. R. Geigy Ltd. began producing textile auxiliaries,[clarification needed] an activity which

Ciba took up in 1928.

In 1939, Geigy chemist Paul Hermann Mller discovered that DDT was effective against

malaria-bearing insects. He received the 1948 Nobel Prize in Medicine for this work.

CIBA and Geigy merged in 1971 to form Ciba-Geigy Ltd.. This company merged with Sandoz

in 1996, with the pharmaceutical divisions of both staying together to form Novartis. Other Ciba-

Geigy businesses being spun off as independent companies.

Sandoz

The Chemiefirma Kern und Sandoz ("Kern and Sandoz Chemistry Firm") was founded in 1886

by Alfred Kern (18501893) and Edouard Sandoz (18531928). The first dyes manufactured by

them were alizarine blue and auramine. After Kern's death, the partnership became the

corporation Chemische Fabrik vormals Sandoz in 1895. The company began producing the

fever-reducing drug antipyrin in the same year. In 1899, the company began producing the sugar

substitute, saccharin. Further pharmaceutical research began in 1917 under Arthur Stoll (1887

1971), who is the founder of Sandoz's pharmaceutical department in 1917. In 1918, Arthur Stoll

isolates ergotamine from ergot; the substance is eventually used to treat migraine and headeaches

and is introduced under the trade name Gynergen in 1921.

Between the World Wars, Gynergen (1921) and Calcium-Sandoz (1929) were brought to market.

Sandoz also produced chemicals for textiles, paper, and leather, beginning in 1929. In 1939, the

company began producing agricultural chemicals.

The psychedelic effects of lysergic acid diethylamide (LSD) were discovered at the Sandoz

laboratories in 1943 by Arthur Stoll and Albert Hofmann (patent by Stoll and Hofmann in USA

on Mar. 23, 1948). Sandoz began clinical trials and marketed the substance, from 1947 through

the mid 1960s, under the name Delysidas a psychiatric drug, thought useful for treating a widevariety of mental ailments, ranging from alcoholism to sexual deviancy. Sandoz suggested in its

marketing literature that psychiatrists take LSD themselves,[17] to gain a better subjective

understanding of the schizophrenic experience, and many did exactly that and so did other

scientific researchers. For several years, the psychedelic drugs also were called

"psychotomimetic" because they were thought to mimic psychosis. Later research caused this


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term to be abandoned, as neuroscientists gained a better understanding of psychoses, including

schizophrenia. Research on LSD peaked in the 1950s and early 1960s. Sandoz withdrew the drug

from the market in the mid-1960s. The drug became a cultural novelty of the 1960s after

psychologist Timothy Leary at Harvard University began to promulgate its use for recreational

and spiritual experiences among the general public.Sandoz opened its first foreign offices in 1964.

In 1967, Sandoz merged with Wander AG (known for Ovomaltine and Isostar). Sandoz acquired

the companies Delmark, Wasabrd (a Swedish manufacturer of crisp bread), and Gerber

Products Company (a baby food company).

On 1 November 1986, a fire broke out in a production plant storage room, which led to Sandoz

chemical spill and a large amount of pesticide being released into the upper Rhine river. This

exposure killed many fish and other aquatic life.

In 1995, Sandoz spun off its specialty chemicals business to form Clariant. Subsequently, in

1997, Clariant merged with the specialty chemicals business that was spun off from Hoechst AG

in Germany.

In 2005, Sandoz expanded significantly though the acquisition ofHexal, one of Germany's

leading generic drug companies, and Eon Labs, a fast-growing United States generic

pharmaceutical company.

"Sandoz" continues to be used as a Novartis generic drug brand (see below for details).

After the merger

Suffern, New York: the sole Novartis pharmaceutical production facility in the United States

After the merger, Novartis reorganized its operating units and spun out its chemical activities as

Ciba Specialty Chemicals (now a part of BASF).In 1998 the company made headlines with its biotechnology licensing agreement with the

University of California at Berkeley Department of Plant and Microbial Biology. Critics of the

agreement expressed concern over prospects that the agreement would diminish academic

objectivity, or lead to the commercialization of genetically modified plants. The agreement

expired in 2003.


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Novartis combined its agricultural division with that of AstraZeneca to create, Syngenta, in

November 2000.

In 2003, Novartis created a subsidiary that bundles its generic drug production, reusing the

predecessor brand name of Sandoz.

In 2005, Novartis introduced Certican (Everolimus), an immunosuppressant, and in October2006 began marketing Telbivudine, a new antiviral drug for hepatitis B.

On 20 April 2006, Novartis acquired the California-based Chiron Corporation. Chiron formerly

was divided into three units: Chiron Vaccines, Chiron Blood Testing, and Chiron

BioPharmaceuticals, to be integrated into Novartis Pharmaceuticals. Chiron Vaccines and Chiron

Blood Testing now are combined to form Novartis Vaccines and Diagnostics.

The ongoing Basel Campus Project has the aim to transform the St. Johann site - Novartis

headquarters in Basel - "from an industrial complex to a place of innovation, knowledge, and

encounter".

On 12 October 2009, Novartis has entered into an agreement for exclusive US and Canadian

rights to Fanapt(iloperidone), a new oral medication that is approved by the U.S. Food and Drug

Administration (FDA) for the acute treatment of adults with schizophrenia.

On 6 November 2009, Novartis reached an agreement to acquire an 85% stake in the Chinese

vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. as part of a strategic

initiative to build a vaccines industry leader in this country and expand the Group's limited

presence in this fast-growing market segment. This proposed acquisition will require government

and regulatory approvals in China.

On 4 January 2010, Novartis offered to pay US $39.3 billion to fully acquire Alcon, the worldslargest eye-care company, including a majority stake held by Nestl. Novartis had bought 25% of

Alcon in 2008.

Basel headquarters campus redesign


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Human resources building of the new Basel campus of Novartis - designed by Frank Gehry

An ongoing Basel Campus Project has the aim to transform the Saint Johann siteNovartis

headquarters in Basel"from an industrial complex to a place of innovation, knowledge, and

encounter".The pharmaceutical giant decided to transform the existing Ciba-Geigy office

buildings and chemical factories of its headquarters in 2001.

The buildings gradually were demolished and replaced with works by architects and artists of

international stature. Frank Gehry, Rafael Moneo, and from SANAA, Kazuyo Sejima and Ryue

Nishizawa were among the architects and Jenny Holzer and Richard Serra among the artists.

Marked diversity of forms now dominates the campus. Novel features and technologies were

introduced by Gehry to conform to the building standards of the Swiss government that prohibit

air-conditioning, while still selecting a contemporary style of massive use of glass exteriors. One

adaptation by the architect includes the integration of a building vent, teepee-style, through the

roof, which creates a chimney effect that draws cool air in at the lower levels and vents warmerair.

Products

Pharmaceuticals

y Comtan- $420 M (2007)- Parkinson's disease

y Diovan- $5.0 B sales[24] (2007)- Hypertension

y

Exjade- $357 M (2007) - Iron chelatory Femara- $937 M (2007)- Breast cancer

y Gleevec- $3.1 B- for Chronic myeloid leukemia

y Lescol- $665 M (2007)- hypercholesterolemia

y Lotrel- $748 M (2007)- Hypertension

y Lucentis- $393 M (2007)- Age-related macular degeneration

y Ritalin- $375 M (2007) - AD/HD

y Exelon- $632 M (2007)- Alzheimer's disease

y Sandimmune and Neoral- $944 M (2007)- Organ transplantation

y Sandostatin - $1.0 B (2007) - Acromegaly

y Tegretol- $413 M (2007)- Epilepsy

y Termalgin - (Paracetamol and compounds.) - Treatment of fever and light pain.y Tobramycin- $273 M (2007)- Cystic fibrosis

y Trileptal- $692 M (2007)- Epilepsy

y Voltaren- $747 M (2007)- anti-inflammatory

y Zometa- $1.3 B (2007)- Cancer complications

y Tofranil- - antidepressant


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Consumer health (OTC)

y Benefiber

y Buckley's cold and cough formula

y Bufferin

y Comtrex cold and coughy Denavir/Vectavir

y Desenex

y Doan's pain relief

y Ex-Lax

y Excedrin

y Fenistil

y Gas-X

y Habitrol

y Keri skin care

y

L

amisil foot carey Lipactin Herpes symptomatic treatment

y Maalox

y Nicotinell

y No-doz

y Otrivine

y Prevacid 24HR

y Tavist

y Theraflu

y Triaminic

y Vagistat

y Voltaren

In January 2009 the United States Department of Health and Human Services awarded Novartis

a $486 million contract for construction of the first U.S. plant to produce cell-based influenza

vaccine, to be located in Holly Springs, North Carolina. The stated goal of this program is the

capability of producing 150,000,000 doses of pandemic vaccine within six months of declaring a

flu pandemic.

Animal health

Pet Care

y Interceptor (Milbemycin oxime), oral worm control prouduct

y Sentinel Flavor Tabs (Milbemycin oxime, Lufenuron), oral flea control product

y Deramaxx (Deracoxib), oral treatment for pain and inflammation from osteoarthritis in

dogs

y Capstar (Nitenpyram), oral tablet for flea control


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y Milbemax (Milbemycin oxime, Praziquantel), oral worm treatment

y Program (Lufenuron), oral tablet for flea control

Livestock

y Acatalk Duostar (Fluazuron, Ivermectin), tick control for cattley CLiK (Dicyclanil), blowfly control for sheep

y Denagard (Tiamulin)

y Fasinex (Triclabendazole)

y ViraShield

Bioprotection (insect and rodent control)

y Actara (Thiamenthoxam)

y Atrazine (Atrazine)

y Larvadex (Cyromazine)y Neporex (Cyromazine)

y Oxyfly (Lambda-cyhalothrin))

y Virusnip (Potassium monopersulfate)

Research and development

Major therapeutic areas:

y autoimmunity/transplantation/inflammatory disease

y cardiovascular disease

y

diabetesy gastrointestinal disease

y infectious diseases

y musculoskeletal disease

y neuroscience

y oncology

y ophthalmology

y respiratory disease

Novartis Vaccines was established in April 2006, following the Novartis acquisition of Chiron.

Controversies and criticism

Challenge to India's patent laws

In 2006, Novartis launched a court case against India seeking to prohibit the country from

developing generic drugs based on patented medicines.Novartis had challenged a law that

allows India to refuse to recognize a patent for an existing medicine if there is a modified

formula resulting in a re-patent of the drug.On August 5, 2007 an Indian court in Chennai ruled


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against Novartis saying that, "Novartis legal challenge - mounted to limit competition to its own

patented medicines - was a threat to people suffering from cancer, HIV and AIDS, diabetes and

other diseases who are too poor to pay for them." [28] The high court also claimed to have no

jurisdiction on whether Indian Patent law complied with WTO patent guidelines.

In the months leading up to the hearing, more than half a million people wrote to the CEO ofNovartis expressing their opposition to the suit. Novartis has decided not to appeal the ruling.

Advertising practices

In September 2008 the United States FDA sent a notice to Novartis Pharmaceuticals regarding its

advertising of Focalin XR, an ADHD drug, in which the company overstated its efficacy while

marketing to the public and medical professionals.

'No' to free flu vaccines

In June 2009, Novartis declined to provide free vaccines to the poor in order to counter a current

flu epidemic, saying developing nations or donor nations should cover the costs. Daniel Vasella,

Novartis chief executive, told the Financial Times that he would consider offering discounted

pricing to low-income nations, but unlike GlaxoSmithKline, would not offer vaccines for free.

Sexual discrimination

On May 17, 2010, a jury in the United States District Court for the Southern District of New

York awarded $3,367,250 in compensatory damages against Novartis, finding that the company

had committed sexual discrimination against twelve female sales representatives and entry-level

managers since 2002, in matters of pay, promotion, and treatment after learning that the

employees were pregnant. Two days later (the trial was bifurcated so that the punitive damages

verdict was argued and deliberated separately), the jury awarded punitive damages in the amount

of $250 million, representing about 2 percent of Novartis' gross revenues for 2009. Normally

punitive damages would be reduced to less than a 10-1 ratio, but the trial was for a group of

named plaintiffs in a class action, who were representing a class of 5,600 class members. The

jury was instructed to award compensatory damages just to the named plaintiffs, but to award

punitive damages to the entire class. Once the court makes findings on compensatory damages

for the remaining class members (which are estimated by plaintiffs' counsel at just under $1

billion), the $250 million is expected to satisfy the Supreme Court's single-digit ratio test forproportionality of compensatory to punitive damages


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Metadata

This file contains additional information, probably added from the digital camera or scanner used to

create or digitize it. If the file has been modified from its original state, some details may not fully reflect

the modified file.

Camera manufacturer Canon

Camera model Canon PowerShot S500

Exposure time 1/200 sec (0.005)

F Number f/11

Date and time of data generation23:57, 12 June 2006

Lens focal length 22.21875 mm

Orientation Normal

Horizontal resolution 180 dpi

Vertical resolution 180 dpi

File change date and time 23:57, 12 June 2006

Y and Cpositioning 1

Exif version 2.2

Date and time of digitizing 23:57, 12 June 2006

Image compression mode 3

Shutter speed 7.65625

Aperture 6.90625

Exposure bias 0

Maximum land aperture 4.59375

Metering mode Pattern

Flash Flash did not fire, auto mode


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Color space sRGB

Focal plane X resolution 9,159.0106007067

Focal plane Y resolution 9,169.8113207547

Focal plane resolution unit inches

Sensing method One-chip color area sensor

Custom image processing Normal process

Exposure mode Auto exposure

White balance Auto white balance

Digital zoom ratio 1

Scene capture type Standard

Novartis

Novartis AG

(Novartis Aktiengesellschaft)

(Novartis Anonim irketi)

Kurulu 1996 (birleme)

Yer Basel, svire

nemli ahslar Daniel Vasella


34/37

(Bakan)

Joseph Jimenez[1]

(CEO)

Alan la sektr

rn

Eczaclk

Edeer ila

Tezgahst ila piyasas

A

Tehis bilimi

Kornea lensleri

Veteriner ilalar

Gelir US $44.27 milyar (2009)[2]

letme geliri US $9.98 milyar (2009)[2]

alan says 99,830 (FTE, 2009)[2]

Yan kuruluCiba Vision

Sandoz

Novartis'in Basel'deki merkezi


35/37

y 1 Tarih

o 1.1 Ciba-Geigy

y 2 Novartis'in Trkiye'deki Fabrikas

Tarih

Novartis 1996'da ok uzun gemileri olan Ciba-Geigy ve Sandoz Laboratories'in

birlemesiyle olumu bir irkettir. Bu irketler yllar nceki byk birlemeler ile olutu. J. R.

Geigy (1758'de Basel'de kuruldu.) ve Ciba (1859'da Basel'de kuruldu) ila irketlerinin

birlemesiyle 1970'te Ciba-Geigy adl irket olutu . Bu irketlerin yaklak 250 yllk tarihleri

vardr.[3]

Ciba-Geigy

Johann Rudolf Geigy-Gemuseus (1733 - 1793) svire'nin Basel kentinde 1758'de kimyasallar,

boyalar, ilalar vb. eitler ile ticarete balad. Johann Rudolf Geigy-Merian (1830 - 1917) ve

Johann Mller-Pack 1857'de Basel'e yerleme hakkn elde etti, oraya dyewood ileme ve boya

karma fabrikas kurdular. ki yl geti, onlar sentetik fuchsine retmeye baladlar. 1901'de

Geigy irketin ynetimini, Halka Ak Limited irketine (Public Limited Company, PLC)

evirdi ve 1914'te, irketin ad J.R. Geigy Ltd olarak deitirildi.

Novartis'in Trkiye'deki Fabrikas [deitir]

Novartis Trkiye Kurtky retim Tesisleri, 31 Mays 2005 tarihinde almtr. Bu fabrika 110

bin metrekare ak arazi zerinde 51 bin metrekare kapal alanda kuruludur.

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