[Ip-health] Press release: Medicines for Malaria Venture announces collaborations with Cipla and Strides

Elizabeth Poll polle at mmv.org
Thu Nov 27 03:05:42 PST 2014


Dear colleagues,

We have some exciting news to share with you: MMV has just signed agreements with Cipla and Strides for the development of rectal artesunate for pre-referral treatment of children with severe malaria. This medicine offers the potential to buy more time to get a child in a critical condition to a healthcare facility where they may receive the full care they need.

Please find the press release and notes for editors copied below.

Best wishes,
Lizzie


PRESS RELEASE

Medicines for Malaria Venture announces collaborations with Cipla and Strides
Collaborations set to advance life-saving pre-referral treatment for severe malaria

Switzerland and India, 27 November 2014. Medicines for Malaria Venture (MMV) signs collaboration agreements with two Indian pharmaceutical companies, Cipla Limited and Strides Arcolab Limited for the development of rectal artesunate for pre-referral treatment of children with severe malaria.

The collaborations, established under the MMV-led "Improving Severe Malaria Outcomes" project funded by UNITAID<http://www.unitaid.eu/en/>[1], aim to develop a rectal artesunate product for submission to WHO prequalification. Cipla and Strides will each develop a product building on the clinical studies led by TDR, the Special Programme for Research and Training in Tropical Diseases hosted by the World Health Organization.

The goal is to achieve WHO-prequalification of a rectal artesunate product by 2016.

"This is a significant milestone in our project to improve severe malaria outcomes," said Dr David Reddy, MMV's CEO.  "We have agreed a clear pathway with these two manufacturers to bring this product to an internationally acceptable quality standard. This will help make the product available to more patients, buying more time and saving more lives. We look forward to working closely with Cipla and Strides and thank UNITAID for supporting these efforts."

Mr Subhanu Saxena, MD & Global CEO, Cipla Limited said: "We are happy to join hands with MMV that shares our ongoing commitment to fight against malaria. Cipla is one of the major suppliers of antimalarial products worldwide and we have designed many innovative medicines for children in developing countries. Through this collaboration, we will endeavour to make rectal artesunate accessible to each and every child with severe malaria in a pre-referral setting in malaria-endemic countries."

"We are excited to be part of this initiative, as it will expand access to quality, affordable medicines for a wider population and save more lives," said Mohan Kumar, CEO, Strides Arcolab Limited.


Notes for editors

About the topic
An estimated 5.6 million cases of severe malaria each year result in around 627,000 deaths, mostly of children under 5.[2]  Severe malaria is the result of inadequately treated uncomplicated malaria and can quickly lead to death.

A WHO-TDR trial conducted in 17,000 patients in Bangladesh, Ghana and Tanzania demonstrated that "if patients with severe malaria cannot be treated orally and access to injections will take several hours, a single inexpensive artesunate suppository at the time of referral substantially reduces the risk of death or permanent disability."[3]

Although the WHO guidelines for the treatment of malaria recommend use of rectal artesunate,[4] there is currently no product with WHO prequalification or marketing authorisation by a stringent regulatory authority. This prevents international donors from funding the procurement of this potentially life-saving treatment.

About Cipla Limited
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For more than 70 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 150 countries.  Cipla's portfolio includes over 1500 products in various therapeutic categories with one quality standard globally. Cipla's turnover in 2013/14 was 1.7 billion USD.

Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla's emphasis on access for patients was recognized globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than one dollar a day and thereby treating many millions of patients since 2001.

Cipla's research and development focuses on developing innovative products and drug delivery systems and has given India and the world many 'firsts' for instance Triomune. In a tightly regulated environment, the company's manufacturing facilities have approvals from all the main regulators including US FDA, UKMHRA, WHO, MCC, ANVISA, and PMDA which means the company provides one universal standard both domestically and internationally.

About Strides Arcolab Limited
Strides Arcolab Limited, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical Company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products.

The Company has 8 manufacturing facilities presence in more than 75 countries in developed and emerging markets.

Additional information is available at the Company's website at www.stridesarco.com<http://www.stridesarco.com>.

About Medicines for Malaria Venture (MMV)
MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs.

Since its foundation in 1999, MMV has developed and brought to registration four new medicines with its partners: Pyramax(r), (pyronaridine-artesunate) co-developed with Shin Poong; Eurartesim(r) (dihydroartemisinin-piperaquine) with Sigma-Tau; Guilin's artesunate injection for the treatment of severe malaria, Artesun(r); and Coartem(r) Dispersible (artemether-lumefantrine), a child-friendly formulation developed with Novartis. Since 2009, over 250 million courses of Coartem Dispersible treatment have been supplied to 50 malaria-endemic countries; and since prequalification in 2010, an estimated 25 million vials of artesunate injection have been delivered, saving 165,000 additional lives.

Managing the largest portfolio of antimalarial R&D projects ever assembled, of over 65 projects, MMV has seven new drugs in clinical development addressing unmet medical needs in malaria, including medicines for children, pregnant women and relapsing malaria, and drugs that could support the elimination/eradication agenda. MMV's success in research and access & product management comes from its extensive partnership network of over 300 pharmaceutical, academic and endemic-country partners in 50 countries.

MMV's vision is a world in which innovative medicines will cure and protect the vulnerable and under-served populations at risk of malaria, and ultimately help to eradicate this terrible disease. For more information, please visit www.mmv.org<http://www.mmv.org>

For more information:

Cipla Limited:
Charlotte Chunawala
Global Head - Corporate Communications
Mobile: +91 750 625 7377
Email: charlotte.chunawala at cipla.com<mailto:charlotte.chunawala at cipla.com>

Strides Arcolab Limited:
Mohan Kumar, CEO, Pharma +91 80 6784 0748
Vikesh Kumar +91 80 6784 0827
Kannan N +91 98450 54745

Medicines for Malaria Venture:
Jaya Banerji
Director Communications and Advocacy
Mobile: +41 79 707 71 81
Email: banerjij at mmv.org<mailto:banerjij at mmv.org>

MMV Disclaimer
This document contains certain forward-looking statements that may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions, or by discussion of, among other things, vision, strategy, goals, plans, or intentions. It contains hypothetical future product target profiles, development timelines and approval/launch dates, positioning statements, claims and actions for which the relevant data may still have to be established. Stated or implied strategies and action items may be implemented only upon receipt of approvals including, but not limited to, local institutional review board approvals, local regulatory approvals, and following local laws and regulations. Thus, actual results, performances or events may differ from those expressed or implied by such statements.
We ask you not rely unduly on these statements. Such forward-looking statements reflect the current views of Medicines for Malaria Venture (MMV) and its partner(s) regarding future events, and involve known and unknown risks and uncertainties.
MMV accepts no liability for the information presented here, nor for the consequences of any actions taken on the basis of this information. Furthermore, MMV accepts no liability for the decisions made by its pharmaceutical partner(s), the impact of any of their decisions, their earnings and their financial status.
1 UNITAID invests to increase availability to better and more affordable products to prevent, test and treat HIV/AIDS, tuberculosis and malaria in developing countries.  It was launched in 2006 by Brazil, Chile, France, Norway and the United Kingdom. UNITAID is hosted by the World Health Organization and is currently supported by 17 contributing members.

2 World Health Organization. World Malaria Report 2013: www.who.int/malaria/publications/world_malaria_report_2013/en/

3 Gomes MF et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet. 373(9663):557-66 (2009).

4 World Health Organization. Guidelines for the treatment of malaria. Second edition
March 2010: http://www.who.int/malaria/publications/atoz/9789241547925/en/

Elizabeth Poll | Medicines for Malaria Venture
Editor and Publications Officer
T: +41 22 555 03 17 | M: +41 79 907 59 92
Email: polle at mmv.org<mailto:polle at mmv.org>

Defeating Malaria Together | www.mmv.org<http://www.mmv.org>




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[1] UNITAID invests to increase availability to better and more affordable products to prevent, test and treat HIV/AIDS, tuberculosis and malaria in developing countries.  It was launched in 2006 by Brazil, Chile, France, Norway and the United Kingdom. UNITAID is hosted by the World Health Organization and is currently supported by 17 contributing members.



[2] World Health Organization. World Malaria Report 2013: www.who.int/malaria/publications/world_malaria_report_2013/en/

[3] Gomes MF et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet. 373(9663):557-66 (2009).

[4] World Health Organization. Guidelines for the treatment of malaria. Second edition

March 2010: http://www.who.int/malaria/publications/atoz/9789241547925/en/

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