PRESS RELEASE: New data reinforces strength of -2-

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-2 of 3- 21 May 2013 12:16:00 UTC  PRESS RELEASE: New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations

Novartis International AG / New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

-- BLAZE study showed once-daily QVA149 significantly improved patient self-reported shortness of breath and lung function compared to placebo and tiotropium 18 mcg[1]

-- SPARK results showed that QVA149 significantly reduced rate of all exacerbations compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg[2],[3]

-- Pooled GLOW 1 and 2 data showed once-daily Seebri(R) Breezhaler(R) (glycopyrronium) significantly improved lung function in the first 4 hours following morning administration compared to open-label tiotropium[4]

-- COPD is projected to be the third leading cause of death by 2020[5]

Basel, May 21, 2013 - New data from the Novartis chronic obstructive pulmonary disease (COPD) portfolio were presented today at the American Thoracic Society (ATS) International Conference May 17-22, 2013 in Philadelphia, PA, USA. In total, Novartis presented 34 respiratory abstracts, featuring latest findings from the IGNITE clinical trial program including BLAZE[1] and SPARK[2],[3],[6],[7] studies, plus data from pooled GLOW1 and 2 studies[4],[8],[9],[10].

The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) when compared to placebo and blinded tiotropium 18 mcg[1]. The SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg[2],[3].

"The expanding Novartis COPD portfolio brings us another step closer to meeting the unmet needs of millions of patients worldwide," said Tim Wright, Head of Development, Novartis Pharmaceuticals. "These important results for both QVA149 and Seebri(R) Breezhaler(R) add further weight to our COPD portfolio, providing the right treatment for the right patient at the right time."

COPD affects an estimated 210 million people worldwide[11] and is projected to be the third leading cause of death by 2020[5]. New treatments which effectively manage COPD are very important to patients and physicians, as COPD can impose a significant burden on patients and reduce quality of life[12],[13].

The BLAZE study showed that after six weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus both placebo (p<0.001) and tiotropium 18 mcg (p=0.021)[1]. BLAZE was the first study to evaluate direct electronic patient self-reported shortness of breath and showed that QVA149 significantly improved lung function versus placebo and tiotropium 18 mcg (as demonstrated by mean FEV(1) )at all time points (45 minutes pre-dose to four hours post-dose) after six weeks of treatment (p<0.001)[1].

The SPARK study, recently published in Lancet Respiratory Medicine[14], demonstrated that QVA149 significantly reduced the rate of all COPD exacerbations (mild, moderate and severe) by 15% versus glycopyrronium 50 mcg (p=0.0012) and 14% versus OL tiotropium 18 mcg (p=0.0017)[2],[3]. The primary endpoint of the study was also met since QVA149 demonstrated a significantly reduced rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038)[2],[3]. The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg[2],[3]. SPARK also showed that patients receiving QVA149 had substantially improved lung function (measured by trough FEV(1) )compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg (both p<0.0001)[2],[6]. In addition, QVA149 showed significant differences in health-related quality of life as demonstrated by St George's Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium 50 mcg (p<0.01) and OL tiotropium 18 mcg (p<0.05)[2],[6].

All treatments in the BLAZE and SPARK studies had an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse or serious adverse events[1],[2],[7].

In a pooled analysis of GLOW1 and GLOW2 data, once-daily glycopyrronium 50 mcg (Seebri(R) Breezhaler(R) ) demonstrated significant improvements in lung function during first 4 hours following morning administration (measured by FEV(1) AUC(0-4h) ) versus placebo and OL tiotropium 18 mcg, at Day 1, 12 weeks and 26 weeks[4]. Once-daily glycopyrronium 50 mcg also demonstrated sustained improvements in lung function (measured by trough FEV(1) ) versus placebo over the long term[4]. Glycopyrronium 50 mcg was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium 18 mcg[9].

About the study designs

BLAZE was a 6-week, multicenter, blinded, double-dummy, placebo-controlled, 3-period crossover study[1]. Patients with moderate to severe COPD (N=247) were randomized to once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg), tiotropium 18 mcg or placebo to assess the effect of QVA149 on patient self-reported shortness of breath[1].

SPARK was a 64-week, multicenter, double-blind, parallel-group, active controlled study assessing QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50 mcg and OL tiotropium 18 mcg on the rate of moderate to severe COPD exacerbations in 2,224 patients, >=40 years with severe to very severe COPD[14].

GLOW1 and GLOW2 were multicenter, randomized, double-blind, placebo-controlled, parallel group studies in patients with moderate to severe COPD[15],[16]. GLOW1 was a 26 week study with 822 patients randomized to receive once-daily glycopyrronium 50 mcg (Seebri(R) Breezhaler(R) ) or placebo[15]. GLOW2 was a 52 week study with 1,066 patients randomized to receive once-daily glycopyrronium 50 mcg or placebo, and included an exploratory arm to compare the effects of once-daily OL tiotropium 18 mcg versus placebo and glycopyrronium 50 mcg[16].

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices.

Onbrez(R) Breezhaler(R) (indacaterol maleate) is a long-acting beta(2) -agonist (LABA) that offers clinically relevant 24-hour bronchodilation combined with a rapid onset of action within five minutes at first dose, as demonstrated in the INERGIZE Phase III trial program[17]-[31]. Onbrez Breezhaler 150 mcg once-daily provided greater clinical benefit in terms of reduced shortness of breath, lower use of rescue medication and improved health status, compared with blinded tiotropium bromide 18 mcg[28]. Onbrez Breezhaleris approved in more than 100 countries around the world for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD[32]. It was first launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals in markets worldwide including Japan (Onbrez(R) Inhalation Capsules 150 mcg once-daily) and US (Arcapta(TM) Neohaler(TM) 75 mcg once-daily).

Once-daily Seebri(R) Breezhaler(R) (glycopyrronium bromide) is a novel inhaled long-acting muscarinic antagonist (LAMA; also referred to as a long-acting anticholinergic) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[33] Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium bromide 50 mcg delivered rapid and significant sustained improvements in lung function (measured by mean FEV(1) ) post-morning dose on Day 1 compared with placebo and sustained this for 24 hours over 52 weeks, and significantly improved exercise endurance versus placebo[15],[16],[34]. There are eleven approvals for once-daily Seebri Breezhaler (glycopyrronium bromide) including Japan, the European Union, Canada, and Australia. Worldwide submissions and reviews of once-daily Seebri Breezhaler (glycopyrronium bromide) are ongoing.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN) with more than 7,000* patients across 42 countries[14],[32],[35]-[45]. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE**, ARISE, BEACON**) have already completed in 2012. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life.

*Total refers to all 10 IGNITE studies.

**BLAZE & BEACON were not included within the Q4 2012 filings to the EU and Japan.

Novartis continues development of respiratory products for delivery via a platform called the Breezhaler(R) device. This is a single-dose dry powder inhaler (SDDPI)[33], which has low air flow resistance, making it suitable for patients with airflow limitation[46]. The Breezhaler(R) device allows patients to hear, feel and see that they have taken the full dose correctly[33].

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients' function and quality of life[5],[47]. It affects an estimated 210 (MORE TO FOLLOW) Dow Jones Newswires

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-3 of 3- 21 May 2013 12:16:00 UTC  PRESS RELEASE: New data reinforces strength of -2-
million people worldwide[11] and is projected to be the third leading cause of death by 2020[5]. COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation[12].

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "projected," "investigational," "committed," "ongoing," "continues" or similar expressions, or by express or implied discussions regarding potential approvals, or new indications or labeling for QVA149, Seebri Breezhaler and Onbrez Breezhaler, or regarding potential future revenues from such products. 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. There can be no guarantee that QVA149 will be submitted or approved for sale in any market, or that Seebri Breezhaler or Onbrez Breezhaler will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that such products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding these products could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

et al

et al

et al

et al

http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-managem ent.html et al

et al

et al

et al.

et al.

http://www.who.int/gard/publications/GARD%20Book%202007.pdf .

et al

. BMC Public Health

11 et al.

Int J Chron Obstruct Pulmon Dis

7 10.2147/COPD.S29280 http://dx.crossref.org/10.2147%2FCOPD.S29280 et al

Lancet Respir Med

http://www.thelancet.com/journals/lanres/onlinefirst et al

Respiratory Research

et al

Eur Resp J.

et al

Respir Res

et al

Int J Chron Obstruct Pulmon Dis

et al

Pulm Pharmacol Ther

et al

Eur Respir J

http://www.novctrd.com/ctrdWebApp/clinicaltrialrepository/displayFile.do ?trialResult=2737 et al

Respir Med

et al

Respir Med

et al

BMC Pulm Med

et al

Pulm Pharmacol Ther

et al

Am J Respir Crit Care Med

et al

Eur Respir J

et al

Thorax

et al

Eur Respir J

et al

(2) Chest

et al

Respir Med

et al

Thorax

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici nes/001114/human_med_001219.jsp&mid=WC0b01ac058001d124 .

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info rmation/human/002430/WC500133769.pdf et al

Int J Chron Obstruct Pulmon Dis

et al

et al

Lancet Respiratory Medicine

et al

et al

QVA149 A2322 (BLAZE).

QVA149 A1301 (ARISE).

www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6 www.clinicaltrials.gov/ct2/show/NCT01709903?id=01709903&rank=1 Spiriva Medical Review Part 2.

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cf m Advair Medical Review.

www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKU S.pdf et al.

CMRO

et al

Obstructive, occupational and environmental diseases

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