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Three- and 4-year-olds are selfish and not likely to share — hardly news to any parent who has presided over a toddler play date. The good news is children do develop altruism and the desire for things to be fair by the time they are 7 or 8, according to a Swiss study.

The study, led by Ernst Fehr at the University of Zurich and published in Nature, is based on research done with 229 Swiss children. The study delves deeply into when children learn to share, at what age equality becomes important to them, whether they are more willing to share with kids they know than with strangers, and how birth order affects a child’s willingness to share.

For the study, children were offered candy and choices in several scenarios.

In a scenario called the sharing treatment, the child was offered two choices. Choice No. 1: one piece of candy for himself or herself and one piece of candy for another child. Choice No. 2: two pieces for himself or herself, and nothing for the other child.

At age 3 and 4, only 8.7% of children in the sharing treatment chose to give another child they knew one of the pieces of candy. By age 7 and 8, 45% of children chose to share one of the candies. In general, older children chose more consistently egalitarian outcomes in all the scenarios, according to researchers. They were more likely to want everything to be fair.

For instance, in a scenario called the envy treatment, when the child could choose one for himself and one for his partner or one for himself and two for his partner, the older child was more likely to decide everyone should get just one candy.

The study also says that as children become more egalitarian, they also become more parochial. In some cases, the children were paired with kids from their schools, while sometimes they were paired with kids they did not know. At all ages, children were more likely to share with children they knew, but that tendency increased with age.

Researchers also sliced and diced their data by birth order. Children who didn’t have siblings were more likely to share than children with siblings. The least likely to share? Youngest children.

The researchers argue that studying the development of egalitarianism and parochialism — and their possible connection — is important to understanding the evolution of humans. “These results indicate that human egalitarianism and parochialism have deep developmental roots, and the simultaneous emergence of altruistic sharing and parochialism during childhood is intriguing in view of recent evolutionary theories which predict that the same evolutionary process jointly drives both human altruism and parochialism,” the researchers write.

Kaiser Permanente is telling 960 mothers that they and their babies may have been exposed to a San Francisco maternity ward worker diagnosed with active tuberculosis.

Kaiser announced it had started notifying patients Tuesday about the worker formerly employed in the postpartum unit of its San Francisco Medical Center.

The part-time employee worked at Kaiser from March 10 to August 10 and no longer works for the organization.

Kaiser learned of the employee’s diagnosis last week and said the medical center followed all appropriate screening procedures when hiring the employee.

“We feel that this is a low-risk exposure, but we want to be aggressive about identifying any potential contacts,” Dr. Stephen Parodi, chief of infectious diseases for Kaiser Permanente in Northern California, told the San Francisco Chronicle.

Dr. Parodi said the infection risk for patients was low and that the worker had a common strain of TB that responds well to antibiotics.


For more information visit the Web site of Kaiser Permanente, or call Kaiser at (800) 464-4000.

Knowledge about cancer facts, including cancer risks from smoking, are lagging in low-income countries, a new survey shows.

The survey comes from the International Union Against Cancer (UICC), a global nonprofit group based in Geneva, Switzerland.

“The survey reveals there are some big, unheard messages” about cancer, David Hill, PhD, president-elect of the UICC, states in a news release. Hill, who directs the Cancer Council Victoria in Melbourne, Australia, calls for cancer education worldwide to correct cancer myths.

The survey, conducted in October 2007, included face-to-face or phone interviews with nearly 30,000 people in 29 countries: Australia, Austria, Bolivia, Canada, China, Czech Republic, Dominican Republic, Georgia, Greece, Guatemala, Indonesia, Israel, Kenya, Lebanon, Mexico, New Zealand, Nigeria, Panama, Peru, Philippines, Romania, Serbia, Spain, Turkey, Ukraine, the U.K., the U.S., Uruguay, and Venezuela.

All participants answered the same questions about cancer. Those answers show an income gap in cancer beliefs, which may have risky consequences.

Seventeen of the countries in the survey are middle-income countries. Ten others, including the U.S., are high-income countries. Only two, Kenya and Nigeria, are low-income countries, according to the UICC.


Beliefs About Cancer Risks

Only 69% of people in low-income countries noted smoking cigarettes as a cancer risk, compared with 90% of people in middle-income countries and 94% of people in high-income countries.

People in wealthier countries were more likely to see cancer risk in not eating fruits, vegetables, and whole grains; in fatty foods, pollution, sun exposure, bacterial and viral infection; but not in alcohol.

Worldwide, most people said they thought eating red meat didn’t raise cancer risk; that belief was particularly common in low-income countries.

How do those beliefs stack up against cancer facts?

Smoking is a known cancer risk. Eating a diet rich in fruits, vegetables, and whole grains is associated with lower cancer risk, but it’s not guaranteed to prevent cancer. Consuming a lot of red meat and alcohol has been tied to increased risk of some cancers, but isn’t proven to cause cancer.

As for infections, some are linked to cancer, such as human papillomavirus (HPV)and cervical cancer. But not all cancers are linked to infection.

Beliefs About a Cancer Cure

The belief that cancer can be cured was most common in high-income countries. Among people in high-income countries, 83% said they thought that cancer could be cured, compared to 61% of those in middle-income countries and 52% of those in low-income countries.

Which view is correct? That depends on what kind of cancer you’re talking about. Many cancers can be treated when caught early, but not all cancers can be cured.

When asked who should make decisions about medical treatments for cancer, 75% of people in low-income countries said the doctor should make such decisions. Only 11% of people in high-income countries agreed; most of them thought medical decisions should be made by the doctor and patient (43%) or by the patient (29%).

The survey has a margin of error of 1.32%.

Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Aug 27, 2008 - Cell Genesys, Inc. (Nasdaq:CEGE) today announced that it has terminated VITAL-2, the second of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere(R) (docetaxel) to Taxotere plus prednisone in patients with advanced-stage prostate cancer. The Company ended the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an imbalance in deaths between the two treatment arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this time, a specific cause for the imbalance in deaths has not been identified and the IDMC reported no new safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to understand the potential cause for the higher rate of deaths observed in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables. In light of the IDMC’s observation with respect to VITAL-2, the Company has requested that the IDMC perform a previously unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.

“Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study,” stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. “Notwithstanding this disappointing outcome, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial.”

Dr. Sherwin continued, “The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our ongoing development program for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we will provide further details regarding this in the near future. As a reminder, the company ended the second quarter of 2008 with $166 million in cash.”

VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in hormone-refractory prostate cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial was an improvement in survival. VITAL-2 was initiated in June 2005 and to date had enrolled 408 patients at 115 clinical trial sites located in North America and the European Union. VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer, is designed to compare GVAX cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier stage HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned interim analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the recommendation to continue the trial.

Conference Call and Webcast

Members of the Cell Genesys management team will host a conference call today, Wednesday, August 27, 2008, at 8:30 a.m. ET to discuss the IDMC’s recommendation. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing (800) 475-6701 from locations in the U.S. and (320) 365-3844 from outside the U.S. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 958709.

About GVAX Immunotherapy for Prostate Cancer

GVAX immunotherapy for prostate cancer is comprised of two prostate tumor cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine that plays a key role in stimulating the body’s immune response, and then irradiated for safety. GVAX immunotherapy for prostate cancer is designed to be administered through intradermal injections on an outpatient basis.

About Cell Genesys

Cell Genesys (Nasdaq: CEGE) is focused on the development and commercialization of novel biological therapies for patients with cancer. The company’s lead product platform is GVAX(R) immunotherapy for cancer, which holds the potential to treat multiple types of cancer including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, California, and has manufacturing operations in Hayward, California. For additional information, please visit the company’s website at www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company’s progress, results, findings, analysis and timing of clinical trials and preclinical programs, the timing of completion of and results from the VITAL-1 futility analysis discussed above and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, regulatory requirements and the regulatory approval process for clinical trials, manufacture and commercialization of the company’s products, competitive technologies and products, the need for and reliance on partnerships with third parties, and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company’s reports on Form 10-Q, 10-K, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Contact

Cell Genesys, Inc.
Susan Ferris, 650-266-3200
Investor Relations

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Tel-Aviv Court Rules in Favor of Sun Pharmaceutical; No Special Tender Offer Necessary in Taro Offer

MUMBAI, India, August 26, 2008 /PRNewswire/ — Sun Pharmaceutical Industries Ltd. today announced it was victorious in all elements of its defense of the litigation brought against it in the Tel-Aviv District Court by Taro Pharmaceutical Industries Ltd. (Taro) and certain of its directors.

The Tel-Aviv Court yesterday rejected Taro’s contention that Sun Pharma should have conducted a “special tender offer” under Israeli Law. As a result, Sun Pharma will be in a position to complete the previously announced Tender Offer by its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida). Following the closing of the Tender Offer, all conditions to Sun Pharma’s Option Agreement to acquire all the shares held by the controlling shareholders of Taro will be satisfied and the controlling shareholders will have to deliver their shares.

In a well reasoned and comprehensive decision, Honorable Judge Dr. Michal Agmon-Gonen J. of the Tel-Aviv District Court ruled that it was “disingenuous” for Taro’s directors to claim now, over a year after they approved the transaction, that a special tender offer was required. The court stated that the directors should have “studied the agreements” prior to their being signed, and should have confirmed then that they were in the company’s best interest. The court stated that the directors cannot claim now that they suddenly decided a special tender offer is necessary.

Dilip Shanghvi, Chairman and Managing Director, Sun Pharma said, “It is clear based on yesterday’s ruling that the lawsuit by Taro’s independent directors was part of a calculated effort by Barry Levitt to avoid living up to his obligations under the Option Agreement. It is time for Dr. Levitt and his family to live up to the contract and do what is required of them under the Option Agreement.”

With respect to those directors who are also shareholders, the court stated that “these shareholders benefited from Sun’s investment, which basically saved Taro from collapse,” and characterized their conduct in challenging Sun Pharma’s exercise of its contractual option as “grave.”

The court also ordered Taro and the other plaintiffs to pay Sun Pharma’s costs related to the litigation.

The complete terms and conditions of the tender offer are set out in the Offer to Purchase, which is filed with the U.S. Securities and Exchange Commission. Taro shareholders may obtain copies of all of the offering documents, including the Offer to Purchase, free of charge at the SEC’s website (www.sec.gov) or by directing a request to MacKenzie Partners, Inc., the Information Agent for the offer, at 105 Madison Avenue, New York, New York 10016, (212) 929-5500 (Call Collect) or Call Toll-Free (800) 322-2885, Email: . tenderoffer@mackenziepartners.com

Greenhill & Co., LLC is acting as the Dealer Manager for the Tender Offer and MacKenzie is acting as the Information Agent for the Tender Offer.

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, U.S. and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.

 Contacts Uday Baldota Tel +91 22 6645 5645, Xtn 605 Tel Direct +91 22 66455605 Mobile +91 98670 10529 E mail uday.baldota@sunpharma.com Brunswick Group for Sun Pharma Nina Devlin / Andrea Shores +1 212 333 3810 Arad Communications for Sun Pharma Gali Dahan +972 3 7693320 Mira Desai Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455606 Mobile +91 98219 23797 Email mira.desai@sunpharma.com MacKenzie Partners Robert Marese +1 212 929 5500 Greenhill Ashish Contractor +1 212 389 1537 

CONTACT: Uday Baldota, +91-22-6645-5645, Xtn 605, Direct, +91-22-66455605,Mobile, +91-98670-10529, , or Mira Desai, +91 226645 5645, Xtn 606, Direct, +91-22-66455606, Mobile, +91-98219-23797,, both of Sun Pharma; Nina Devlin or Andrea Shoresof Brunswick Group, +1-212-333-3810, or Gali Dahan of Arad Communications,+972-3-7693320, all for Sun Pharma; Robert Marese of MacKenzie Partners,+1-212-929-5500; Ashish Contractor of Greenhill, +1-212-389-1537 uday.baldota@sunpharma.com mira.desai@sunpharma.com

Web site: http://www.brunswickgroup.com/http://www.sunpharma.com/

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Gleevec Receives FDA Priority Review as First Therapy to Reduce Recurrence of Gastrointestinal Stromal Tumors After Surgery

- Clinical data showing unprecedented 89% reduction in risk of GIST relapse with use of Gleevec after surgery are basis for FDA, EMEA, Swissmedic filings

EAST HANOVER, N.J., August 27, 2008 /PRNewswire/ — Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1). Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.

* Known as Glivec(R) (imatinib) outside the US, Canada and Israel.

The Gleevec submissions are based on data from a Phase III, double-blind, randomized, multicenter, international study of more than 700 GIST patients who had surgery to remove their tumors. The results showed a dramatic 89% reduction in risk of kit-positive GIST returning after surgery (adjuvant setting) in patients treated with Gleevec versus placebo(2).

In early 2007, the study met its primary efficacy endpoint, showing an advantage for Gleevec in recurrence-free survival. At that time, following the recommendation of the independent study data monitoring committee to stop the trial accrual early, the study investigators made public the interim results and offered Gleevec to patients receiving placebo(3).

Approximately half of all patients with newly diagnosed GIST are considered candidates for surgical resection, or removal of their tumors. Of those who have the surgery, about half will suffer a recurrence(4). If approved for this indication, Gleevec will be the first treatment option available to GIST patients after surgery to reduce the risk of disease recurrence or to possibly prevent the disease from returning.

“The dramatic clinical results from this study of Gleevec in the adjuvant GIST setting are especially encouraging when we consider the incremental benefit we typically see with other adjuvant therapies for solid tumors,” said Rainer Boehm, MD, Executive Vice President, North American Region Head, Novartis Oncology. “The adjuvant use of Gleevec, if approved, would represent an important advance in the ongoing post-surgery management of GIST.”

Gleevec is currently indicated in both the US and EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If approved, the use of Gleevec for the treatment of GIST in the adjuvant setting would add to its eight current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and five other rare diseases. Novartis also has a therapy for the treatment of carcinoid tumors and acromegaly and multiple treatments in the pipeline targeting rare diseases.

Filing data

The study on which the regulatory filing is based compared the recurrence-free survival of GIST patients taking Gleevec 400 mg/day versus placebo for one year immediately following surgery. The results showed that 98% of patients receiving Gleevec remained recurrence free at one year following surgery compared to approximately 82% of those receiving placebo(3). This shows that as a result of adjuvant therapy with Gleevec, there was an 89% reduction in risk of GIST returning(2).

The study, known as ACOSOG Z90001, was conducted at multiple cancer centers throughout the US and Canada, under a Cooperative Research and Development Agreement between Novartis and the National Cancer Institute (NCI). The study was led by the American College of Surgeons Oncology Group (ACOSOG).

The investigators reported that Gleevec therapy was well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Gleevec. These include nausea, diarrhea and swelling (edema)(3).

About gastrointestinal stromal tumors (GIST)

Gastrointestinal stromal tumors (GIST) belong to a group of cancers known as soft tissue sarcomas. They are the most common sarcomas and can be found most often in the stomach and small intestine. The incidence of GIST is estimated to be 4,500 - 6,000 new cases per year in the US (15-20 cases per million population)(5), of which more than 90% are kit-positive(6). Kit — also known as CD117 — is a protein that, when mutated, has been identified as one of the major causes of GIST.

About Gleevec

Gleevec(R) (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. Follow-up is limited to 5 years. Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha (IFN-alpha) therapy; adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL); adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements; adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT mutation or with c-KIT mutational status unknown; adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1- PDGFR alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR alpha fusion kinase-negative or unknown; adult patients with unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans (DFSP); patients with KIT (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Important safety information(7)

Fetal harm can occur when Gleevec is administered to a pregnant woman; therefore, women of childbearing potential should be advised to not become pregnant while taking Gleevec tablets and to avoid breast-feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants. Sexually active female patients taking Gleevec should use adequate contraception. If the patient does become pregnant while taking Gleevec, the patient should be advised of the potential hazard to the fetus.

In adult Ph+ CML patients, severe (NCI Grades 3/4) lab abnormalities — including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (<1%-33%) and hepatotoxicity (approx 5%) — and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion, pulmonary edema, and ascites) and superficial edema (1.3%-11%), hemorrhage (1.8%-19%), and musculoskeletal pain (2%-9%) were reported among patients receiving Gleevec*. Severe fluid retention appears to be dose-related, was more common in the advanced-phase studies (where the dosage was 600 mg/day), and is more common in the elderly.

* Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.

In HES/CEL patients, instances of Grade 3 leukopenia, neutropenia, lymphopenia, and anemia were reported.

For DFSP, severe (NCI Grades 3/4) lab abnormalities included anemia (17%), thrombocytopenia (17%), neutropenia (8%) and increased creatinine (8%).

In GIST, severe (NCI Grades 3/4) lab abnormalities (400 mg/day; 600 mg/day) — including neutropenia (10%; 11%), anemia (3%; 9%), thrombocytopenia (0%; 1%) and hepatotoxicity (6%; 8%) — and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (e.g., pleural effusion or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain (11%; 4%), nausea (6%; 4%), diarrhea (3%; 7%) and musculoskeletal pain (6%; 1%) were reported among patients receiving Gleevec.

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other comorbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.

Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions. Therapy with Gleevec was discontinued for drug-related adverse reactions in 2.4% to 5% of adult patients with Ph+ CML and for adverse reactions in 5% of KIT+ GIST patients. None of the 5 patients in the ASM study discontinued Gleevec due to drug-related events or abnormal laboratory values. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).

A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment.

Some GIST patients (5%) were reported to have severe gastrointestinal (GI) bleeds and/or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds.

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, increased intracranial pressure, papilledema, and GI perforation.

In patients with HES and cardiac involvement, cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures, and temporarily withholding imatinib. MDS/MPD disease and systemic mastocytosis may be associated with high eosinophil levels. Performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD or ASM associated with high eosinophil levels. If either is abnormal, the prophylactic use of systemic steroids (1-2 mg/kg) for 1-2 weeks concomitantly with imatinib should be considered at the initiation of therapy.

Bullous dermatologic reactions (eg, erythema multiforme and Stevens- Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several postmarketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.

Consider potential toxicities-specifically liver, kidney and cardiac toxicity, and immunosuppression from long-term use.

Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6 and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored, in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include ketoconazole, acetaminophen, warfarin, erythromycin and phenytoin. (Please see full Prescribing Information for other potential drug interactions).

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablets to reduce exposure to iron.

Common side effects of Gleevec tablets

The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%- 49%) and rash and related terms (36%-47%).*+

* Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.

+ For more detailed study information, please see full Prescribing Information.

The adverse reactions and safety profile for Ph+ ALL, MDS/MPD, ASM and HES/CEL were generally similar to the safety profile for Ph+ CML.

The most frequently reported drug-related adverse reactions reported in the Ph+ ALL studies were mild nausea, vomiting, diarrhea, myalgia, muscle cramps and rash, which were easily manageable. Superficial edemas were also a common finding in all studies and were described primarily as periorbital or lower-limb edemas. However, these edemas were rarely severe and may be managed with diuretics, other supportive measures, or, in some patients, by reducing the dose of Gleevec.

Frequently reported adverse reactions (all Grades) in the seven MDS/MPD patients assessed were nausea (57%); diarrhea and muscle cramps (43% each); anemia, fatigue, arthralgia and periorbital edema (29% each).

All ASM patients experienced at least one adverse reaction at some time. The most frequently reported adverse reactions were diarrhea, nausea, ascites, muscle cramps, dyspnea, fatigue, peripheral edema, anemia, pruritus, rash and lower respiratory tract infection.

All HES/CEL patients experienced at least one adverse reaction, the most common being gastrointestinal, cutaneous and musculoskeletal disorders. Hematologic abnormalities were also frequent, with instances of Grade 3 leukopenia, neutropenia, lymphopenia and anemia.

Frequently reported adverse reactions (all Grades) in the 12 DFSP patients assessed included nausea and fatigue (42% each); periorbital, peripheral and eye edema (33% each); diarrhea, vomiting, rash, lacrimation increased and anemia (25% each); face edema, pyrexia, exertional dyspnea, rhinitis, and anorexia (17% each).

The majority of patients who received Gleevec in the GIST study experienced adverse reactions at some time. Most adverse reactions were mild to moderate in severity. The most frequently reported adverse reactions (400 mg/day; 600 mg/day) (all Grades) were superficial edema (81%; 77%), nausea (63%; 74%), muscle cramps (47%; 58%), diarrhea (59%; 70%), fatigue (48%; 53%), abdominal pain (40%; 37%), rash and related terms (38%; 53%), vomiting (38%; 35%), musculoskeletal pain (37%; 30%) and hemorrhage (26%; 34%).*

* For more detailed study information, please see full Prescribing Information.

Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.

Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.

Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “priority review”, “risk”, “commitment”, “potentially”, “will”, “if approved”, “possibly”, “encouraging”, “would”, or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Gleevec or regarding potential future revenues from Gleevec. 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 Gleevec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gleevec will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Gleevec will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Gleevec 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, 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 Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , which provides healthcare solutions that address the evolving needs of patients and societies. Focused on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

For more information

Additional information regarding Gleevec and Novartis Oncology can be found on the websites www.novartisoncologyvpo.com, www.gleevec.com, www.us.tasigna.com and www.novartisoncology.us.

References

1. Fast Track, Priority Review and Accelerated Approval. US Food and Drug Administration - Center for Drug Evaluation and Research. http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm. Accessed 31 July 2008.

2. Internal data.

3. Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571 (Gleevec(R)) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST). http://www.cancer.gov/clinicaltrials/ACOSOG-Z9001. Accessed June 2008.

4. Van den Abbeele A., Benjamin R., Blanke C, et al. Clinical Management of GIST. Recurrence patterns and prognostic factors for survival. 2003;1-24.

5. American Cancer Society. Cancer Reference Information. Detailed Guide for Gastrointestinal Stromal Tumors. Key Statistics. http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statisti cs_About_Gastrointestinal_Stromal_Tumors.asp?rnav=cri. Accessed 22 February 2008.

6. US Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 2. Imatinib for Gastrointestinal Stromal Tumors (GISTs). Available at: http://www.ahrq.gov/clinic/ta/gist/gist1.htm

7. Gleevec(R) (imatinib mesylate) tablets prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Nov 2007.

 Media Contacts Media only: Kim Fox, Novartis Oncology, P: +1 862 778 7692 Dana Kahn Cooper, P: +1 732 817 1800, C: +1 732 239 6664 Investors only: Jill Pozarek, Novartis Corporation, +1-212-830-2445 

CONTACT: Media, Kim Fox, Novartis Oncology, +1-862-778-7692, or P: +1 212830 2445, or Dana Kahn Cooper, +1-732-817-1800, C, +1-732-239-6664; orInvestors, Jill Pozarek of Novartis Corporation, +1-212-830-2445

Web site: http://www.novartis.com/

Ticker Symbol: (NYSE:NVS)

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Ordering traditional Ayurvedic medicines on the Internet may be unsafe.

Approximately one-fifth of Ayurvedic medicines sold online to Americans contain metals, including lead, according to a new study by Boston University researchers. Ayurveda is a traditional medical system used in India and by many South Asians living worldwide.

Since 1978, more than 80 cases of lead poisoning associated with Ayurvedic medicine have been reported, according to the study, published in The Journal of the American Medical Association.

Researchers used five different Internet search engines to locate 25 sites selling Ayurvedic medicines. They identified 673 products and randomly chose 230 to order. These orders were all placed in 2005. After receiving 193 of the 230 products, researchers sent their purchases to the New England Regional EPA for testing.

Results show that 20.7% of the products contained lead, mercury, and/or arsenic. Of the products manufactured in the United States, 21.7 percent contained metals. Of the Indian-manufactured products, 19.5 percent contained metals. Those identified as containing metal contained enough metal to be considered toxic according to one or more acceptable standards for daily intake.

There are two main types of Ayurvedic medicines: herbal-only and rasa shastra, which is the practice of deliberately combining herbs with metals (such as mercury, lead, iron, and zinc), minerals (such as mica) or gems (such as pearls). Rasa shastra experts say these medicines are safe and therapeutic when properly prepared and administered.

Researchers found that the rasa shastra medicines were more than twice as likely as non-rasa shastra medicines to contain detectable metals, and had higher median concentrations of lead and mercury.

Based on their findings, the study’s authors are calling for tougher regulations for dietary supplements. “New FDA regulations and current Indian policies do not specify any maximum acceptable concentrations or daily dose limits for metals in dietary supplements for domestic use,” the study says. “We suggest strictly enforced, government-mandated daily dose limits for toxic metals in all dietary supplements and requirements that all manufacturers demonstrate compliance through independent third-party testing.”

Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for Byetta

SAN DIEGO and INDIANAPOLIS, August 26, 2008 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. and Eli Lilly and Company in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) update to a prior alert for BYETTA(R) (exenatide) injection referencing pancreatitis. The companies were aware of the pancreatitis cases referenced in the alert, as well as others, and previously reported these cases to the FDA. The complete conference call replay will be available through Amylin’s and Lilly’s corporate websites after the call.

Since 2006, the U.S. prescribing information for BYETTA has included information about pancreatitis. A recent study has also shown that patients with type 2 diabetes were at nearly three times the risk of developing pancreatitis than those without diabetes.(1) While a definite causal relationship between BYETTA and pancreatitis has not been proved, to better understand the suspected relationship, Amylin and Lilly continue to pursue a comprehensive drug safety program that includes extensive internal and external review of individual cases, and clinical and epidemiologic studies.

“At Amylin and Lilly, patient safety is our foremost concern. We are committed to continuing to work closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products,” said Orville G. Kolterman, Senior Vice President, Research and Development at Amylin. “It is important to understand that pancreatitis, an inflammatory condition of the pancreas, is a rare event. Further, the characteristics and complications of the pancreatitis cases in patients on BYETTA are consistent with pancreatitis in the general population. We believe BYETTA continues to have a positive benefit-risk profile for patients with type 2 diabetes.”

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. BYETTA was approved in April 2005 and has been used by approximately one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.

About Diabetes

Diabetes affects more than 21 million in the United States and an estimated 246 million adults worldwide.(2,3) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(4)

According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(5) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(6) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(7,8)

Important Safety Information for BYETTA

BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For full prescribing information, visit www.BYETTA.com.

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin’s research and development activities leverage the company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California with over 2,000 employees nationwide. Further information about Amylin Pharmaceuticals is available at www.amylin.com.

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly’s current diabetes products visit, www.lillydiabetes.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin’s and Lilly’s most recently filed SEC including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.

1. Noel R, Braun D, Patterson R, Bloomgren G. Increased risk of acute pancreatitis observed in patients with type 2 diabetes. 24th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. Copenhagen, Denmark. International Society for Pharmacoepidemiology: 2008.

2. The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed June 2, 2008.

3. “All About Diabetes.” American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 6, 2008.

4. “Direct and Indirect Costs of Diabetes in the United States.” American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 6, 2008.

5. Saydah SH, Fradkin J and Cowie CC. “Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes.” JAMA: 291(3), January 21, 2004.

6. Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

7. Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.

8. Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.

CONTACT: Alice Izzo of Amylin, office, +1-858-642-7272, or cell,+1-858-232-9072; or Kindra Strupp of Lilly, office, +1-317-277-5170, orcell, +1-317-554-9577

Web site: http://www.amylin.com/http://www.lilly.com/http://www.BYETTA.com/http://www.lillydiabetes.com/

Ticker Symbol: (NASDAQ-NMS:AMLN),(NYSE:LLY)

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NICE Final Guidance Recommends Lucentis As Cost-Effective Treatment for Wet AMD

NICE Final Guidance Recommends Lucentis As Cost-Effective Treatment for Wet AMD, a Leading Cause of Blindness

Lucentis is only approved therapy to demonstrate improvement in vision and vision-related function in vast majority of wet AMD patients
NICE decision secures access to innovative medication for eligible patients with wet AMD in England and Wales
 

BASEL, Switzerland, August 27, 2008 - The National Institute for Health and Clinical Excellence (NICE) has recommended Lucentis® (ranibizumab) as a cost-effective therapy for all eligible patients with wet age-related macular degeneration (AMD), an eye disease that is the leading cause of blindness in people over the age of 50.

The announcement is an important development for patients because NICE determines access to medicines in England and Wales based on agreed standards of cost-effectiveness. The final guidance comes at the end of a rigorous review which assessed the potential benefits of Lucentis for patients relative to the cost of the medicine.

“The final guidance is excellent news for patients with wet AMD who are in need of access to this highly effective treatment,” said Mr Winfried Amoaku, Associate Professor of Ophthalmology and Hon Consultant Ophthalmologist (Retinal Specialist), University Hospital, Nottingham, and Vice-President of the Royal College of Ophthalmologists, UK. “Wet AMD is a debilitating disease that can rapidly lead to loss of vision and all too often, to loss of independence and quality of life for patients. When fully implemented, the NICE decision will ensure that patients have access to Lucentis for as long as they need to preserve or improve their vision.”
 

Lucentis was developed specifically for use in the eye and is the only approved therapy shown to improve vision and vision-related function in a vast majority of patients with wet AMD. The NICE decision was based on data from clinical trials involving more than 7,000 patients, demonstrating that Lucentis enabled patients to read on average an additional four lines (21 letters) on an eye-chart compared to those receiving no treatment. This benefit was sustained for two years[1],[2],[3].

The review evaluated all medications approved for treating wet AMD in the UK, and heard evidence from health professionals, health economic experts and patient groups.

The final NICE guidance includes a reimbursement scheme under which the first 14 injections in each affected eye will be funded by the UK National Health Service (NHS), while the drug costs for any subsequent Lucentis injections will be reimbursed by Novartis[4].

“We are committed to working in partnership with health authorities to ensure that as many patients as possible with wet AMD can benefit from treatment with Lucentis,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “This reimbursement scheme is an important collaboration that will ensure patients living with wet AMD in England and Wales receive the best possible care.”

Lucentis has been approved in more than 70 countries and has already received positive health economic assessments in a number of other countries including Australia, Belgium, Canada, France, the Netherlands, Scotland, South Korea and Sweden.

AMD is a degenerative eye disease affecting the macula - the central part of the retina at the back of the eye that is responsible for the central vision necessary for everyday activities like reading, driving, telling time or identifying faces. Approximately 25 to 30 million people worldwide are living with the disease, which is a major burden on healthcare systems.

There are two types of AMD: dry and wet. Neovascular or ‘wet’ AMD accounts for about 15% of all AMD cases, but the majority of vision loss. It is associated with the growth of pathological new vessels under the macula that are fragile and leak fluid and blood. If not treated, scar tissue develops and destroys the macula.

Lucentis is an anti-VEGF (vascular endothelial growth factor) therapy that works by binding to and neutralizing all forms of VEGF-A, a protein that is believed to cause abnormal blood vessel growth and leakage beneath the macula.

Lucentis was developed by Genentech and Novartis Pharma AG. Genentech has the commercial rights to Lucentis in the US, while Novartis has exclusive rights in the rest of the world.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential”, “will”, “committed”, “believed”, or similar expressions, or by express or implied discussions regarding potential additional reimbursement approvals or health economic assessments for Lucentis or regarding potential future revenues from Lucentis. 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 Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for reimbursement in any additional markets. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Lucentis 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, 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 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1] Rosenfeld, PJ et al, for the MARINA Study group. Ranibizumab for Neovascular Age-Related Macular Degeneration. N Engl J Med 2006;355(14):1419-31.
[2] Brown, D et al, for the ANCHOR Study group. Ranibizumab versus Verteporfin for Neovascular Age-Related Macular Degeneration. N Engl J Med 2006;355(14):1432-44.
[3] Data on file, Novartis.
[4] NICE Final Guidance. Ranibizumab and pegaptanib for age-related macular degeneration. At www.nice.org.uk.
# # #
Novartis Media Relations
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com Ulrike Engels-Lange
Novartis Pharma Communications
+41 61 324 8790 (direct)
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ulrike.engels_lange@novartis.com

e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944  
Ruth Metzler-Arnold +41 61 324 9980  North America: 
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
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e-mail: investor.relations@novartis.com e-mail: investor.relations@novartis.com
 

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A new TV commercial shows kids eating hot dogs in a school cafeteria and one little boy’s haunting lament: “I was dumbfounded when the doctor told me I have late-stage colon cancer.”

It’s a startling revelation in an ad that vilifies one of America’s most beloved, if maligned, foods, while stoking fears about a dreaded disease.

But the boy doesn’t have cancer. Neither do two other kids in the ad who claim to be afflicted.

The commercial’s pro-vegetarian sponsors say it’s a dramatization that highlights research linking processed meats, including hot dogs, with higher odds of getting colon cancer.

But that connection is based on studies of adults, not children, and the increased risk is slight, even if you ate a hot dog a day. While compelling, it isn’t conclusive.

So what exactly is the truth about hot dogs?

The 33-second ad launched last month in several U.S. cities provides the perfect opportunity to separate fact from fiction about this mysterious yet so familiar meat. It is to run in September in Chicago and Denver.

The bottom line from several nutritionists familiar with the ad is this: Hot dogs aren’t exactly a “health food,” but eating one every now and then probably won’t hurt you.

“My concern about this campaign is it’s giving the indication that the occasional hot dog in the school lunch is going to increase cancer risk,” said Colleen Doyle, the American Cancer Society’s nutrition director. “An occasional hot dog isn’t going to increase that risk.”

Americans as a whole eat hot dogs more than occasionally. According to the National Hot Dog & Sausage Council, U.S. consumers spent more than $4 billion on hot dogs and sausages last year. That includes more than 1.5 billion pounds of hot dogs and sausages bought at retail stores alone.

The health concerns primarily come from their high fat and salt content and sodium nitrate and nitrite, commonly added preservatives and color-enhancers. Nitrate-related substances have been reported to cause cancer in animals, but there’s no proof they do that in people.

Hot dogs typically contain muscle meat trimmings from pork or beef. Contrary to legend, they do not contain animal eyeballs, hooves or genitals, according to the Hot Dog Council’s Janet Riley. But the government does allow them to contain pig snouts and stomachs, cow lips and livers, goat gullets and lamb spleens. If they have these byproducts, the label should spell out which ones, a U.S. Department of Agriculture spokeswoman said.

Some also are made with leaner meats, including turkey, as well as tofu or soy protein.

Check the label of a name-brand hot dog, and chances are fat provides around 80 percent of total calories, more than double what’s often advised. What’s more, saturated fat and trans fat - the fats most strongly linked with artery-clogging - are common ingredients, in some cases providing at least half the fat content.

The hot dog council called the new ad an alarmist scare tactic, but the promoters, a group called The Cancer Project, defend their campaign.

Dr. Neal Barnard, president of the Physicians Committee for Responsible Medicine, called the ad “a way to raise appropriate concern about a deadly concern.” Barnard also heads The Cancer Project, an offshoot of his anti-meat advocacy group.

Hot dogs may be considered as American as apple pie, but Barnard said it’s time to change that tradition.

“Children are born with no traditions whatsoever,” he said. “You or I might think a hot dog, that just goes with baseball … We can always change our traditions to be healthful.”

The new ad is based on an analysis of five studies in adults by scientists working with cancer research groups not affiliated with Barnard’s.

Their report last November said eating 50 grams a day of processed meats for several years increases colorectal cancer risk by 21 percent. That equals about one hot dog a day or two deli slices of bologna or five slices of bacon.

The duration of daily consumption linked with that higher risk is uncertain. Colorectal cancer was diagnosed between three and 19 years after the studies began, but participants could have been eating processed meats for years before that, said dietitian Karen Collins, nutrition adviser with the American Institute for Cancer Research, a group that analyzed the studies.

For a U.S. adult, eating one hot dog daily for several years would increase the average risk of getting colorectal cancer, which is 5.8 percent, to 7 percent. On a population level, it would increase the number of people nationwide who get colorectal cancer each year from 58 per 100,000 people to 70 per 100,000, Collins said.

“It’s not the kind of impact on risk that, say, tobacco smoking has on lung cancer. But on the other hand, colon cancer is one of our most common cancers, so small changes still affect a lot of people,” Collins said.

Eating a hot dog once or twice a month would mean up to about a 1.4 percent increased risk, she said. “The risk we get from things like lack of physical activity, excess body weight, lack of adequate vegetables and fruits, these are much more important to work on than to worry about” a 1.4 percent increased risk.

Scientists who analyzed the studies recommend avoiding processed meat - advice that makes sense, said Lilian Cheung, of the nutrition department at Harvard’s School of Public Health.

Cheung is not connected to Barnard’s group, but called its campaign “a good spark plug” to improve school foods and raise awareness.

The ad is part of a campaign to improve foods in schools and get the government to stop providing processed meats. The government provides some, such as ham and processed turkey. However hot dogs, pepperoni pizza, bacon and other popular processed meats are bought from local vendors, not the federal government, according to the USDA.

Cancer Project promoters want all processed meats off school menus. They recently issued a report analyzing menus from one month last spring at 28 large school districts. Half got failing grades for serving too much processed meat.

Many school districts are working to improve their menus, including Chicago’s, which is among those the Cancer Project “failed.”

However, Chicago schools’ hot dogs are zero-trans-fat turkey dogs, said spokesman Franklin Shuftan.