Piramal Pharma Solutions Supports George Medicines in Developing its New Drug for Hypertension, WIDAPLIK™ (telmisartan, amlodipine and indapamide)

(PRNewsfoto/Piramal Pharma Solutions)

Peter DeYoung, CEO, Piramal Global Pharma, Piramal Pharma Ltd

Mark Mallon, CEO, George Medicines.

George Medicines Logo

• Piramal Pharma Solutions extended its robust CDMO capabilities to George Medicines to develop WIDAPLIK.
• WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
• WIDAPLIK contains three medicines that are clinically proven to reduce blood pressure: telmisartan, amlodipine, and indapamide.

MUMBAI, India, Aug. 28, 2025 /CNW/ -- George Medicines, a leading late-stage biopharma company, in partnership with Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635) developed WIDAPLIK, a new drug for treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. The U.S. Food and Drug Administration (FDA) approved WIDAPLIK on June 6, 2025.

WIDAPLIK is a single pill combination of three medicines, telmisartan, amlodipine, and indapamide, for the treatment of hypertension, developed in three doses (10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg strengths), including two doses that are lower than those currently available in single pill combinations. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the established safety profile of its three component antihypertensive medications.

WIDAPLIK carries a Boxed Warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. Please see full Prescribing Information and Important Safety Information, including Boxed Warning for WIDAPLIK here.

George Medicines and Piramal Pharma Solutions began their collaboration on WIDAPLIK in December 2018, when the formulation was developed at Piramal's Pharmaceutical Development site in Ahmedabad, India. In June 2020, the project was transferred to Piramal's drug product facility in Pithampur, India for validation and manufacturing. Leveraging Piramal's vast technical expertise and extensive experience advancing innovations, George Medicines achieved FDA approval for WIDAPLIK this year.

The success of this endeavor underscores the advantages of Piramal's integrated approach to drug development. By leveraging the expertise and specialized capabilities of each facility involved in the project, Piramal Pharma Solutions and George Medicines developed WIDAPLIK with remarkable efficiency. This accomplishment will help enable patients worldwide to access this new treatment, furthering Piramal Pharma Solutions' mission to reduce the global burden of disease.

"This achievement highlights the value that Piramal Pharma Solutions delivers to its clients and the patients they serve," said Peter DeYoung, CEO, Piramal Global Pharma. "We are excited to deepen our collaboration with George Medicines, expanding access to transformative treatment options like WIDAPLIK to support our mission and enhance patient outcomes on a global scale."

"Our strategic partnership with Piramal Pharma Solutions has been an important part of the success to date of WIDAPLIK," added Mark Mallon, CEO, George Medicines. "Globally, more than one billion adults have hypertension, and it remains a major cause of premature death worldwide. With its triple combination efficacy, multiple dosing options, including two doses that are lower than those currently available in single pill combinations, and its established safety profile, WIDAPLIK has the potential to change the hypertension treatment paradigm. Piramal Pharma Solutions is an excellent development and manufacturing partner on this program who brings capacity, know-how, and shares our commitment to affordability, access, and quality, and we look forward to the continuation of our strong partnership."

Piramal Pharma Solutions is immensely proud to have contributed to George Medicines' milestone achievement and looks forward to continued success with its partners, aiming to deliver more treatment to patients in need worldwide.

IMPORTANT SAFETY INFORMATION

WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.

• Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
• Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
• Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
• Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
• Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
• WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
• If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
• If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
• People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
• In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium

The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.

For further information, please see accompanying complete Prescribing Information for WIDAPLIK.

To report SUSPECTED ADVERSE REACTIONS contact either:

• George Medicines at: [email protected] or call 1-888-508-2083; or
• FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088

About Piramal Pharma Solutions

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.

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About Piramal Pharma Limited

Piramal Pharma Limited (PPL, NSE: PPLPHARMA I BSE: 543635), offers a portfolio of differentiated products and services through its 17* global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and the Piramal Consumer Healthcare business, selling over-the-counter consumer and wellness products. In addition, one of PPL's associate companies, Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, has emerged as one of the market leaders in the ophthalmology therapy area in the Indian pharma market. Further, PPL has a strategic minority investment in Yapan Bio Private Limited, that operates in the biologics / bio-therapeutics and vaccine segments.

For more information, visit: Piramal Pharma | LinkedIn

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About George Medicines

George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.

George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world's leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia's leading life sciences venture capital firm.

For more information, please visit www.george-medicines.com.

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