Cipla and Stempeutics collaborate for launch of Stempeucel®, first 'Made in India' Cell Therapy to treat Critical Limb Ischemia (CLI)

• 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® 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® 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® 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® 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® 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, Facebook, LinkedIn.

For queries, please contact:
Cipla Corporate Communications			Cipla Investor Relations
Heena Kanal			Naveen Bansal
E-Mail: CorpComm@cipla.com			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

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India based Stem Cell Research Firm to Test its Stem Cell Product for Acute Respiratory Disease Syndrome (ARDS) COVID-19

• Stempeutics will test its stem cell product Stempeucel® for Acute Respiratory Disease Syndrome (ARDS) caused by COVID-19 Pneumonia.


• Consortium consists of 12 entities from 8 countries (USA, UK, Germany, Israel, Italy, etc.). Consortium is led by Dr. Miomir Knezevic, CEO & Founder of Educell Ltd, cell therapy service, Trzin, Slovenia.


• Stempeutics is the only company from Asia in this consortium. Stempeutics will export its Stempeucel® product (clinical grade MSCs- mesenchymal stromal/stem cells) manufactured in its GMP (Good Manufacturing Practice) facility using its patented pooling technology (subject to regulatory approvals).


• The consortium has submitted a project entitled the Fight Against Corona! (FAC!) for Euro 8.3 million funding to the European Commission (EU funding programme H2020)


• Stempeutics is also working closely with agencies in India for making these solutions available in India

 

Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!). Under this partnership, Stempeutics will export its stem cell product Stempeucel® (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell Ltd, Slovenia.

Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 infection. Mortality in COVID-19 infected patients with the inflammatory lung condition ARDS (Acute Respiratory Distress Syndrome)is reported to approach 50%, and is associated with older age, co-morbidities such as diabetes, cardiovascular disease, COPD (chronic obstructive pulmonary disease), higher disease severity, and elevated markers of inflammation. Current therapeutic  interventions (with the exception of ventilators/respirators which are in very short supply) do not appear to be improving in-hospital survival. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 infected patients, especially in severe cases. A promising new therapy for the ARDS, the terminal stage of COVID-19, using MSCs can quickly (2-4 days) reduce inflammation of the lung tissue, and allow patients to more quickly come off of the ventilatory support and hopefully fully recover with less significant lung damage.

Stempeucel® is an allogeneic, off the shelf, pooled mesenchymal stromal cells having anti- inflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel® product exhibits a wide range of potent therapeutic properties. The product exhibits potent immunomodulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the body’s immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel® will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS.

Commenting on this initiative, Dr. Miomir Knezevic, Leader of the Global Consortium and Founder of Educell said, “We are happy to partner with Stempeutics since its product Stempeucel® is already designated as an ATMP1 in Europe and also Stempeucel® technology has been patented in many countries in Europe. Stempeutics manufacturing process is scalable and the product is affordable – which are key to meet the demands of COVID-19 patients"

Mr. BN Manohar, CEO of Stempeutics said, “From the clinical data using Stempeucel® in different clinical trials in other indications it may be postulated that Stempeucel® has the potential capability for treating COVID-19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel® by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID-19 infection".

Dr. Stephen Minger, Scientific Advisor for the Global Consortium and ex Global Director of R&D, Cell Technologies GE Healthcare added “The most severely affected CV-2 infected patients will often go on to develop ARDS which necessitates assisted ventilation to preserve breathing and lung function. Moreover, many ARDS patients will also experience an acute but severe life-threatening inflammatory response (cytokine storm) which can result in long-term damage to lung tissue and lung function. Treating ARDS patients with allogeneic expanded bone marrow derived MSCs could alleviate and ameliorate lung inflammation and compromised lung function and significantly reduce the time required for patients to be ventilated”.

Dr. Raviraja N S, Sr. Director Business Development and Innovation, Stempeutics, said, “Given the severe shortage of ventilators in the world, and the high mortality rate of patients who develop ARDS (approx. 50%), the clinical use of MSCs in COVID-19 ADRS patients could drastically impact on the healthcare burden currently occurring due to very large patient numbers, limited equipment and overworked medical personnel".

Mr. B N Manohar - MD & CEO, Stempeutics Research


Manohar is the MD & CEO of Stempeutics Research – a leading stem cell research and product development company in India. He earned his B.E. degree in Electronics & Communication from REC Trichy in 1977. Post that he did M.E. in Computer Science from College of Engineering, Guindy. Manohar has transformed Stempeutics – a life science start-up from R&D to Commercialization stage with Global recognition. Stempeutics has developed an innovative drug called "Stempeucel" for addressing major unmet medical needs in India and Globally.

This drug developed by an Indian company has received many Global Recognitions. Fourteen countries including US & Japan has granted patent for the novelty and inventiveness of the drug. Europe has recognized this drug by granting Advanced Therapy Medicinal Product classification and Orphan Drug Designation. Recently it became the FIRST stem cell product to be approved by DCGI for conditional marketing for treating patients suffering from life threatening disease call Buerger's Disease. Stempeutics has put India on the "World map of Regenerative Medicine". Under Manohar's leadership Stempeutics has been recognized as India's hottest start-ups by Business Today in 2008 and Karnataka Government bestowed "Emerging Company of the Year award" in 2011 and 2013. In 2017 Manohar was awarded "Biotechnologist of the Year" award by Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing business alliance with major pharma company Cipla. Recently Stempeutics has tied up with Alkem Labs for Osteoarthritis indication. Prior to Joining Manipal Group, Manohar has had 12 years successful stints at Wipro GE Medical Systems. At GE Medical he has handled multiple senior assignments including Vice President – Customer Service where he received GE Asia Service Award for highest revenue growth in 1998. Currently Manohar serves in the Boards of Stempeutics and MentisSoft.