Novartis extends leadership in clinical trial data transparency, reinforcing its support of clinical research and innovation

Wed Feb 26, 2014 1:16am EST

* Reuters is not responsible for the content in this press release.

Novartis International AG / Novartis extends leadership in clinical trial data transparency, reinforcing its support of clinical research and innovation . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

  • Novartis announces that researchers can now request access to patient level data on newly approved innovative medicines in the United States and EU in 2014 through the Idea Point portal, and is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language and additional interpretation of data as of the end of 2014
  • Novartis has voluntarily disclosed publicly summaries of Clinical Study Reports (CSR) of its innovative medicines on its website (http://www.novctrd.com) and was the first pharma company to publish summaries within one year of the study completion
  • Novartis to continue its industry leading practice of publishing detailed summary reports of clinical trial results of innovative medicines, both positive and negative, including trial design and key efficacy and safety data

             
Basel, February 26, 2014 - Novartis announced today additional steps to extend its leadership in clinical trial data transparency. Since 2005, and before requirements were in place, Novartis has been voluntarily disclosing summaries of Clinical Study Reports of its innovative medicines on its own website (http://www.novctrd.com). In addition, the company is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language summaries and additional interpretation of data as of the end of 2014.

Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion further enabling clinical research while protecting patient privacy.

To date, Novartis has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the same site as well as 1,777 clinical study summaries (known as "redacted clinical study reports"). Researchers can also now request access to patient level data on newly approved innovative medicines in 2014 through the same Idea Point portal as other pharmaceutical companies.

"Novartis has taken action to extend our leadership regarding clinical data transparency and access to data by researchers. This is designed to further advance science and innovation which can benefit patients," stated Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We also believe that patient rights and privacy remains paramount, and recognize that such data should not be released without the express consent of the patient".

Novartis is consistently rated as having one of the industry's most respected development pipelines, with over 200 projects in clinical development, including 144 in the Pharmaceuticals Division. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for potentially best-in-class or first-in-class medicines that could significantly advance treatment standards for patients worldwide. The company is committed to science-based innovation that makes a meaningful and measurable difference to patients' lives by delivering the right medicine to the right patient at the right time. The company's unique approach to drug development coupled with its vigorous investment in R&D has yielded important results for patients. In 2013 alone, the company received thirteen major approvals from regulatory authorities and obtained three breakthrough therapy designations for investigative medicines from the U.S. Food and Drug Administration - among the highest number for any company.

Disclaimer
This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as "leadership," "support," "can," "committed," "to include," "as of," "to continue," "to extend," "designed," "believe," "should," "potentially," "could," or similar expressions. Such forward-looking statements reflect the current views of the Group 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 expressed or implied by such statements. These expectations could be affected by, among other things, risks and factors referred to in the Risk Factors section of Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update it in the future.

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 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

# # #

Novartis Media Relations

Central media line : +41 61 324 2200  
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com
Anja von Treskow
Novartis Global Media Relations
+41 61 324 8137 (direct)
+41 79 367 4723 (mobile)
anja.vontreskow@novartis.com

Dermot Doherty
Novartis Global Media Relations
+ 41 61 696 8653 (direct)
+ 41 79 536 9755 (mobile)
dermot.doherty@novartis.com

e-mail: media.relations@novartis.com

For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact: journalisthelp@thenewsmarket.com.

Novartis Investor Relations

Central phone: +41 61 324 7944   
Samir Shah +41 61 324 7944 North America:  
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Susan Donofrio +1 862 778 9257
    
e-mail: investor.relations@novartis.com  




This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via Globenewswire

HUG#1764690

--- End of Message ---

Novartis International AG
P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;


Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.