Cipla Gets Approval to Introduce Zemdri® (Plazomicin) Injection in India, for Treatment of cUTR

Cipla Limited (BSE: 500087; NSE: CIPLA EQ) received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic plazomicin in India.

Plazomicin is a new intravenous (IV) aminoglycoside indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis. UTIs are a global health problem affecting approximately 150 million patients each year. The emergence of drug resistant uropathogens has posed a big challenge in management of UTIs. A pivotal clinical trial and in-vitro studies demonstrated efficacious and safe results in comparison to meropenem. It also highlighted plazomicin’s ability to retain in-vitro activity against strains resistant to older aminoglycosides. Plazomicin's introduction in India underscores Cipla's proactive response to the urgent global challenge of antimicrobial resistance (AMR).

Cipla USA Inc., a subsidiary of Cipla, holds the patent for plazomicin sulfate, an intravenous aminoglycoside administered once daily. The company possesses global rights for this molecule, excluding Greater China, and is the innovator of the brand called ZEMDRI®. Cipla USA Inc. currently markets the product in the USA, where it received approval from the US FDA in 2018. ZEMDRI®, for an appropriate time, held the designation of a new technology add-on payment (NTAP) status granted by the US Medicare and Medicaid Services (CMS) - specifically for hospital administration.

Commenting on the approval, Mr. Umang Vohra, Managing Director, and Global CEO, Cipla, said, “The introduction of plazomicin in India is an important step forward in bringing solutions that address the evolving healthcare challenges of our time. Cipla remains steadfast in building capabilities and driving stewardship activities to counter the global threat of AMR. Our focus remains on developing a robust antimicrobial portfolio, forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life.”

As a part of Cipla’s extensive efforts to address antimicrobial resistance (AMR), the company is also implementing EHS management programs, strengthening wastewater and solid waste management, adhering to local environmental regulations, and providing vital training towards its sustainability initiatives.

Cipla and CSIR-CDRI to Jointly Develop a Novel Ophthalmic Formulation for Fungal Keratitis

Cipla Limited announced, on Thursday, that the company has entered into a collaborative research agreement with CSIR-Central Drug Research Institute (CSIR-CDRI), a constituent laboratory of the Council of Scientific and Industrial Research (CSIR) , Government of India, to jointly develop a novel ophthalmic formulation for fungal keratitis. The collaboration aims to leverage the combined expertise and resources of both organizations to develop a safe and efficacious drug for fungal keratitis.

Globally, approximately 1.2 million cases of fungal keratitis are reported every year with tropical countries recording a higher incidence. Fungal keratitis often occurs following ocular trauma and exposure to fungal pathogens from organic matter, thus putting agricultural workers at greater risk. Other risk factors include the use of local steroid eye drops, injury, poor personal hygiene, and regular contact lens wear. Left untreated, the condition can result in corneal destruction, leading to a profound loss of vision. Existing therapies have limitations, such as the need for prolonged and frequent use of drugs, and emerging drug resistance.

CSIR-CDRI has developed a prototype formulation for an antifungal drug to optimize its delivery in the eye. In preclinical studies, this formulation supports faster resolution of the infection. Cipla will scale up the product, conduct the required studies and seek regulatory approvals for commercialization, ensuring accessibility for those in need.

Commenting on this association Mr. Umang Vohra, Managing Director, and Global CEO, Cipla, said, “At Cipla, our growth is centered on our commitment to patients, extending care to communities through patient-centric innovation. This collaboration with CSIR-CDRI is a testament to our commitment to providing innovative and top-quality healthcare solutions to all those in need, encompassing drugs, devices, and diagnostics. With this, we are sustaining our antimicrobial resistance stewardship by investing in anti-infectives and leading industry voice in the fight against AMR.”

Welcoming this partnership, Dr Radha Rangarajan, Director CSIR-CDRI said, “Our research focuses on finding innovative, cost-effective solutions for India’s unmet clinical needs. CDRI scientists have developed a unique ophthalmic formulation of the antifungal drug. This in turn, is expected to accelerate cure and lead to better outcomes. Our collaboration with Cipla will enable the translation of the research into a drug product, with the potential to reduce the burden of disease.”

This research and development endeavor unites both Cipla and CSIR-CDRI in their commitment to affordable healthcare. The two partners have an ongoing collaboration for the development of Levormeloxifene for contraception.

Cipla Makes Additional Investment in GoApptiv to Hold 22.99% Stake in the Health/Pharma Tech Company

Strengthens investment in channels of the future to expand patient reach

Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") announced today that it has agreed to further invest INR 42 crore (approx.) in digital tech company GoApptiv Private Limited (hereafter referred to as “GoApptiv”).

Founded in 2016, GoApptiv aims to revolutionize the healthcare and pharmaceutical space in India with its unique 'phygital' model that provides quality healthcare access to extra-urban and rural India.

In line with Cipla’s ambition to strengthen investments in channels of the future, this additional investment will further expand Cipla’s presence across the healthcare continuum, especially to the underserved population by enabling greater access to lifesaving treatments.

With the completion of this deal, Cipla’s total stake in GoApptiv will increase to 22.99% on a fully diluted basis. This is Cipla’s third investment in GoApptiv, which will be made in a combination of equity shares and compulsorily convertible preference shares. GoApptiv has experienced significant expansion in underpenetrated areas and product lines following prior investments by Cipla in 2022 and 2020.

Commenting on the development, Umang Vohra, MD Global CEO, Cipla Limited, said, “Our long-standing partnership with GoApptiv has helped us increase penetration in underserved rural areas of India and address critical healthcare gaps where pharmaceutical coverage is limited. As we advance in the era of technology-driven healthcare, this expanded investment will not only enhance our collective abilities to deliver patient-centric solutions, but also furthers our digitisation agenda to drive Cipla’s next phase of growth.”

GoApptiv’s use of technology to provide quality and affordable healthcare aligns with Cipla's commitment to making a positive impact on communities through innovative solutions. Cipla plans to continue supporting GoApptiv through further investment rounds, solidifying their partnership in addressing healthcare disparities in underserved regions of India.

This year in July, GoApptiv incorporated a wholly-owned subsidiary company — ‘Pactiv Healthcare’— with an objective to handle the manufacturing, development, production, purchase, and sale of pharmaceutical, healthcare and wellness products to significantly benefit the Rural markets platform aims to drive agile market access, optimise patient experiences, deliver organisational growth and empower every stakeholder in the healthcare ecosystem. With its combination of proprietary technology and on-ground field force, GoApptiv claims to have been able to reach: 27 States, 200,000+ villages, 3,424 markets, 3,100 Tehsils, 618 districts.

The company explains – "The Indian Healthcare Industry is at the cusp of a "digital revolution". However, while physicians and patients are individually adapting to 'digital', healthcare companies have been slow to embrace innovation. Traditional pharma companies tend to implement digital solutions in silos, and even these limited efforts are focussed solely on urban markets. The reason for this is that, extra-urban and rural markets are extremely fragmented and highly unstructured, therefore setting these companies back with significant costs (major entry barrier). GoApptiv has taken a lead in developing "smart-shared platforms" that address this gap. The company's end-to-end solutions provide the digital infrastructure required to enable pharma companies to expand their footprint with cost efficiency and speed to market by leveraging economies of scale."

Cipla and Skye Air Mobility Launches Drone-based Medical and Pharma Delivery Services in Himachal Pradesh

Commenced operations in flood-affected Himachal Pradesh.

Indian multinational pharmaceutical conglomerate, Cipla Limited (BSE: 500087; NSE: CIPLA EQ), has announced the launch of drone-powered deliveries for its critical medicines (cardiac, respiratory and other essential chronic therapies) for hospitals and pharmacies in Himachal Pradesh, India, in partnership with Skye Air Mobility, a Gurugram-based drone delivery tech company focused primarily on healthcare, e-commerce and food logistics.

The use of drones will support on-time delivery of Cipla’s medicines to chemists and clinics in remote areas, while minimizing risks such as delays, temperature excursions affecting cold chain products, and roadside accidents. Cipla is the first among large Indian pharma companies to adopt drone- based deliveries to facilitate expedited supply to stockists in remote areas.

In its inaugural phase, the company has successfully completed several drone deliveries in Himachal Pradesh covering approximately 50 kilometres distance in under 25 minutes. This has been vital amidst adverse and prevailing weather conditions that have impacted conventional transportation routes in the state.

Commenting on the milestone, Cipla’s Global Supply Chain Head, Swapn Malpani said, “Driven by our purpose of ‘Caring for Life’, we are leveraging technology to make healthcare more accessible and extend our circle of care to all our key stakeholders. As we accelerate our digital agenda across all functions, implementing drone-powered distribution enhances our supply chain resilience, strengthens connects with channel partners, helps us stay future ready and maintain reliable, prompt delivery of our trusted high-quality drugs to stockists and patients in the region."

In future, Cipla aims to scale the service through distribution to hospitals and expand market coverage to inaccessible and hilly terrains such as Uttarakhand and Northeast in India.

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

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