PR85214

MUMBAI, India, August 21 /PRNewswire=KYODO JBN/ --

- First approved allogeneic cell therapy product globally for the treatment of CLI

- Developed by Stempeutics over a period of twelve years, breakthrough

treatment designed to address root cause of the disease at an affordable cost

- Cipla to market and distribute the drug in India to provide patient access

    Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today

announced that its partner Stempeutics Research Pvt. Ltd has received

regulatory approval by the Drug Controller General of India (DCGI) for the

launch of Stempeucel(R) in India. The product is indicated for the treatment of

CLI due to Buerger's Disease and Atherosclerotic Peripheral Arterial Disease.

It is the first allogeneic cell therapy product to be approved for commercial

use in India and the first stem cell product to be approved globally for CLI

treatment.

    The product has been developed by Stempeutics over a period of twelve

years. The company's proprietary pooling approach provides for an efficient

manufacturing process thereby enabling the product to be made accessible to

patients at an affordable cost. More than one million doses can be produced

from a single set of master cell banks, which is unique in regenerative

medicine, thus providing consistent product to patients. The proprietary

technology also helps Stempeucel(R) extend the therapeutic potential of the drug

across multiple disease categories. Under the agreement signed between the two

companies, Cipla has received exclusive rights to market and distribute the

product in India by leveraging its expansive distribution strengths across the country.

    CLI is a progressive form of peripheral arterial disease that is caused by

severe blockage in the arteries thereby reducing blood flow. This may result in

the development of sores and wounds in legs and feet with a high risk of limb

amputation. It is estimated that about 5 million patients in India are impacted

by this debilitating disease. With the current contemporary vascular

techniques, it is estimated only 25% of patients can be managed with

satisfactory clinical outcomes.

    Stempeucel(R) is a breakthrough treatment which is designed to enhance the

body's limited capability to restore blood flow in ischemic tissue. It is

derived from allogeneic pooled mesenchymal stromal cells isolated from the bone

marrow of healthy, adult voluntary donors. It directly addresses the root cause

of the disease by reducing inflammation, stimulating growth of collateral blood

vessels and repairing damaged muscle, thereby reducing the pain, healing the

ulcers and salvaging the affected limb. The drug is administered through intramuscular

injections around the calf muscle region and around the site of ulcers.

    Currently, Stempeutics is working on a strategy for other international

markets including US, EU and Japan. The global critical limb ischemia treatment

market expected to generate USD 5,390 million by 2025, at a CAGR of 8.1%

between 2020 and 2025.

    Commenting on the DCGI approval, Mr. Manohar BN, MD & CEO of Stempeutics,

said, "Obtaining DCGI approval for Stempeucel (R) is an important and historic

milestone for Stempeutics. It is a strong recognition for Stempeutics for its

sustained excellence of scientific and clinical work and underscores our global

leadership in allogeneic, pooled MSC technology. We believe that the

Stempeucel® product is a game-changer, offering an advanced therapeutic

treatment for millions of patients suffering from this dreadful disease."

    Mr. Umang Vohra, Managing Director and Global CEO of Cipla, said, "Our

focus on innovation is guided by our strong sense of responsibility to address

unmet patient needs and alleviate suffering. We are pleased to see that our

decade-long partnership with Stempeutics has achieved a significant milestone.

CLI is a serious and painful condition that impacts patients worldwide and we

are happy that we are able to introduce this stem cell therapy in the country

at an affordable cost."

    Dr Pawan Kumar Gupta, Senior VP, Medical & Regulatory Affairs, Stempeutics,

said, "We are excited to receive this marketing approval from DCGI for this

very important indication. In CLI, fatty deposits block arteries in the leg,

leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and

gangrene. Patients with CLI are at an immediate risk for limb amputation and

death. Now Stempeucel (R) provides hope for a new, effective treatment and a

better quality of life for such CLI patients. Also, Stempeutics is committed to

advancing its peripheral artery disease programs in CLI to other parts of the World."

    About Stempeutics:

    Stempeutics is an advanced clinical-stage Biotech Company based out of

Bangalore. It was founded by Manipal Education and Medical Group (MEMG) in 2006

and later entered strategic alliances with Cipla in 2009 and with Kemwell in

2019. Stempeutics's strength lies in developing innovative stem cell products

by nurturing cutting edge research and clinical applications through dedicated

efforts of its highly qualified team. Its goal is to develop novel cell therapy

drugs addressing major unmet medical needs with India first global next approach.

    About Cipla:

    Established in 1935, Cipla is a global pharmaceutical company focused on

agile and sustainable growth, complex generics, and deepening portfolio in our

home markets of India, South Africa, North America, and key regulated and

emerging markets. Our strengths in the respiratory, anti-retroviral, urology,

cardiology, anti-infective and CNS segments are well-known. Our 46

manufacturing sites around the world produce 50+ dosage forms and 1,500+

products using cutting-edge technology platforms to cater to our 80+ markets.

Cipla is ranked 3rd largest in pharma in India (IQVIA MAT June'20), 3rd largest

in the pharma private market in South Africa (IQVIA MAT June'20), and is among

the most dispensed generic players in the U.S. For over eight decades, making a

difference to patients has inspired every aspect of Cipla's work. Our

paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less

than a dollar a day in Africa in 2001 is widely acknowledged as having

contributed to bringing inclusiveness, accessibility and affordability to the

centre of the HIV movement. A responsible corporate citizen, Cipla's

humanitarian approach to healthcare in pursuit of its purpose of 'Caring for

Life' and deep-rooted community links wherever it is present make it a partner

of choice to global health bodies, peers and all stakeholders. For more, please

visit www.cipla.com, or click on Twitter [https://twitter.com/Cipla_Global ],

Facebook [https://www.facebook.com/Cipla ]/, LinkedIn

[https://www.linkedin.com/company/cipla ].

For queries, please contact:

Cipla Corporate Communications

Heena Kanal

E-Mail: CorpComm@cipla.com

Cipla Investor Relations

Naveen Bansal

E-Mail: Investor.Relations@cipla.com

Stempeutics Corporate Relations

Dr. Raviraja N S

Mobile No.: +91 9900239214

E-Mail: raviraja.ns@stempeutics.com

Logo: https://mma.prnewswire.com/media/947146/Cipla_Logo.jpg

Source: Cipla