ZYDUSLIFE

By Rishika Sadam

HYDERABAD, India, April 3 (Reuters) - Soon-to-be brides and grooms seeking shortcuts to shed pounds before the big day have become the latest consumer target for weight-loss drugs in India.

New Delhi wellness clinic Klarity Skin Clinic touts a "Mounjaro bride" package, while other clinics have woven weight-loss injections into "pre-wedding" transformation packages typically focused on skin treatments and hairstyle makeovers.

In a social media video, Klarity offers "guided nutrition, Mounjaro and smart workouts" to prepare brides to walk down the aisle. The clinic did not respond to a request for comment.

Eight doctors interviewed by Reuters said they have been fielding inquiries from brides, and some grooms, about taking weight-loss drugs before taking their vows. Many asked for Eli Lilly's LLY.N Mounjaro, the first GLP-1 medication to enter India's market for both diabetes and weight loss. It has become more sought after than Novo Nordisk's NOVOb.CO rival Wegovy, the doctors said.

"Over the last few months, over 20% of the queries we've received for obesity injections are from to-be brides, who also openly give us a timeline on how soon they are getting married," said Rajat Goel, a bariatric surgeon at Hindivine Healthcare in New Delhi.

He said he prescribed the drugs only if patients were medically eligible, not for cosmetic use.

TRADITION AND SOCIETAL PRESSURE

Weddings in India are grand affairs for families that can afford them, with culture and tradition exerting a strong influence. Many marriages continue to be arranged by families, often bringing expectations around physical appearance and financial status.

Aditi, a 26-year-old finance worker from Mumbai, consulted a doctor in November for a weight-loss prescription after exercise and diet failed to get the desired results.

"When I see the result, I feel happy,” Aditi said about losing 10 kilograms (22 pounds) on Mounjaro before her February wedding. "If I am not happy, I don't feel confident. I did not want to feel that way at the time of the wedding."

She is one of the half a dozen brides, and one groom, who spoke to Reuters about pre-wedding use of weight-loss drugs, but asked not to use their family names due to social stigmas. They cited societal pressure to look a "certain way" at their wedding and most had discontinued the injections soon after.

Novo and Lilly launched their obesity drugs in India last year. The market is forecast to reach 80 billion rupees ($851.79 million) by 2030. Mounjaro sales doubled in the months after launch, making it the highest-selling drug in the world's most populous nation.

Indian drugmakers began selling cheaper versions of Novo's medicine last month after the patent on semaglutide, its active ingredient, expired, widening access.

The drugs are intended for adults classified as obese, or for those considered overweight with a weight-related medical condition such as diabetes, hypertension or sleep apnea.

"Mounjaro has been approved by regulators for specific medical indications and is intended to be used only under the supervision of a qualified healthcare professional," Lilly said in a statement.

The lowest Mounjaro injection pen dose sells for 13,125 rupees ($139.50) per month in India, while the highest dose costs 25,781 rupees.

Novo, which this week cut prices of Ozempic and Wegovy for the second time, is selling the lowest Wegovy dose for 5,660 rupees ($60.90) and the highest for 16,400 rupees a month.

Novo said it discourages any form of self-medication of semaglutide or deviation from the indicated use on label.

CHEAPER DRUGS, MISUSE CONCERNS

India could have more than 440 million overweight or obese people by 2050, one of the world's highest totals, according to The Lancet.

Akshitha, who got married in Hyderabad last year, said the drugs helped her shed 15 kg (33 pounds), taking her weight to 76 kg before the wedding. A family doctor had suggested she try the injections when she worried about her weight, she said.

"There's so much chaos before the wedding, with all the planning and preparation. I knew I would not get time to go to the gym and be on a diet. That's when these drugs looked like a better option," she said, adding she might consider using them again after a future pregnancy.

With local drugmakers flooding the market with cheaper weight-loss medicines, India's drugs regulator has raised concerns about misuse and intensified scrutiny of unauthorized sales and promotion.

"We understand the curiosity, but this cannot be a quick fix," said Dr. Swati Pradhan, founder of obesity and metabolic wellness clinic Live Light.

Pradhan said she prescribed the injections to only a few soon-to-be brides if they were medically eligible and showed signs of other medical issues, while insisting on lifestyle changes for sustainable results.

For 27-year-old Priya, a tech worker from Bengaluru, weight-loss drugs became a way to counter body-shaming from prospective grooms' families.

"I've had men and their families reject my proposal because of my weight. I was told I was fat," Priya told Reuters.

She initially used Novo's oral semaglutide, approved in India for diabetes, as an off-label treatment and lost more than 12 kg before switching to injectable Mounjaro.

Her search for a groom continues.

($1 = 94.0850 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad; Editing by Bill Berkrot)

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April 1 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES DEMAND ORDER FOR FY2019-20 TO FY2023-24

• GETS TAX DEMAND ORDER WORTH 14.2 MILLION RUPEES

Source text: ID:nNSE86Nt5q

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Adds details, background, comments

By Rishika Sadam

March 31 (Reuters) - Novo Nordisk NOVOb.CO has again cut the prices of its blockbuster diabetes and weight-loss drugs Ozempic and Wegovy by up to 36% and 48% in India, to fend off competition from cheaper generics made by local drugmakers.

India's market for diabetes and weight-loss drugs is set for a shake-up after the Danish drugmaker's patent on semaglutide, the active component in Ozempic and Wegovy, expired on March 20.

At least half a dozen Indian drugmakers, including Dr Reddy's REDY.NS, Zydus ZYDU.NS and Sun Pharma SUN.NS, launched multiple brands of the blockbuster diabetes and weight-loss drugs, up to 70% cheaper than Novo's drugs in some cases.

Ozempic's and Wegovy's lowest doses of 0.25 mg in India will now be priced at 1,415 rupees ($15.04) for a weekly shot from 2,200 rupees and 2,712 rupees earlier, respectively, Novo Nordisk India said in a statement on Tuesday.

The average price reduction across doses is 23.8% for Ozempic and 27% for Wegovy, it said.

"We've heard from patients and doctors, and we're acting on that feedback," said Vikrant Shrotriya, managing director at Novo Nordisk India, adding that the drugs also offer cardiovascular benefits.

The entry of generics will also challenge Novo and U.S. rival Eli Lilly LLY.N, which launched its blockbuster diabetes and obesity drugs in India last year, as they seek to cement their position in the country.

Lilly's Mounjaro became India's top-selling drug by value within months of its launch, according to data from Pharmarack, a research firm.

Novo's Ozempic is available in three dose strengths of 0.25 mg, 0.5 mg and 1 mg in India, while Wegovy has five dose strengths.

Ozempic's and Wegovy's 1 mg weekly shot is now priced at 2,275 rupees ($24.18) after price cuts of 18.5% and 34.2%, respectively. The company slashed Wegovy's 0.5 mg dose price by 41.5% to 2,025 rupees.

"..this price reduction reflects how innovation can become more accessible when market dynamics evolve," Venu Gopal Pareek, a bariatric surgeon said, adding that patients might choose Novo's drugs over generics given that it is an original molecule, and if the price difference is not beyond 15%.

Last year, Novo slashed Wegovy's price for the first time by up to 37% from its launch price, anticipating stiff competition from local drugmakers.

($1 = 93.9890 Indian rupees)

(Reporting by Rishika Sadam and Yagnoseni Das in Bengaluru; Editing by Devika Syamnath and Janane Venkatraman)

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March 25 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES TAX DEMAND PENALTY OF 32.8 MILLION RUPEES

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Adds background, details from statement

March 24 (Reuters) - India's drug regulator has tightened surveillance against the unauthorised sale and promotion of weight-loss drugs, the health ministry said on Tuesday, after local drugmakers launched cheaper generic versions of Ozempic and Wegovy over the weekend.

At least half a dozen Indian drugmakers, including Dr Reddy's REDY.NS, Zydus ZYDU.NS and Sun Pharma SUN.NS, launched multiple brands of the blockbuster diabetes and weight-loss drugs, up to 70% cheaper than Novo Nordisk's drugs in some cases, after the patent for semaglutide expired last week.

Semaglutide is the active component in Ozempic and Wegovy.

The patent expiry had triggered concerns about misuse and confusion among prescribers as costs fall sharply.

The Central Drugs Standard Control Organization (CDSCO) conducted inspections at 49 entities across the country, including drug wholesalers, retailers, and slimming clinics, the statement said.

It focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing, the statement said, adding that notices were sent to defaulting entities.

"These drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks," the statement said, adding that there have been concerns regarding their on-demand availability across various platforms.

Earlier this month, the CDSCO also warned pharmaceutical companies against direct or indirect advertising of weight-loss medicines, including obesity awareness campaigns that could act as surrogate promotions.

Analysts had expected more than 40 Indian drugmakers to launch over 50 brands after patent expiry, as they race to grab a share of the market that could grow to 80 billion rupees ($852.62 million) by 2030 from about 15 billion rupees today, according to research firm Pharmarack.

($1 = 93.8280 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad and Urvi Dugar in Bengaluru; Editing by Rashmi Aich and Janane Venkatraman)

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March 20 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - LAUNCHES SEMAGLUTIDE INJECTION IN REUSABLE MULTI-DOSE PEN DEVICE IN INDIA

• ZYDUS LIFESCIENCES - HAS EXCLUSIVE RIGHTS TO REUSABLE PEN DEVICE FOR SEMAGLUTIDE

• ZYDUS LIFESCIENCES - SEMAGLUTIDE INJECTION PRICED AT 2,200 RUPEES PER MONTH

• ZYDUS LIFESCIENCES - ZYDUS' SEMAGLUTIDE INJECTION WILL BE AVAILABLE IN 15MG/3ML CARTRIDGE

• ZYDUS LIFESCIENCES - SEMAGLUTIDE LAUNCHED UNDER SEMAGLYN, MASHEMA, AND ALTERME BRANDS

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By Rishika Sadam

HYDERABAD, March 19 (Reuters) - India's market for diabetes and weight-loss drugs is set for a shake-up as Danish drugmaker Novo Nordisk's NOVOb.CO patent on semaglutide expires this week, triggering a wave of cheaper generics from local drugmakers and worries about uneven oversight in an overcrowded market.

More than 40 Indian firms are expected to launch over 50 brands within weeks, analysts and doctors said, widening access in a price-sensitive market, but also raising concerns about misuse and confusion among prescribers as costs fall sharply.

Sun Pharma SUN.NS, Mankind Pharma MNKI.NS, Dr. Reddy's REDY.NS, Zydus ZYDU.NS, Lupin LUPN.NS and Alkem ALKE.NS are among the companies expected to launch generic versions of semaglutide, the active ingredient in Novo's diabetes drug Ozempic and weight-loss treatment Wegovy.

"With high demand, falling prices and multiple brands, you may see direct pharmacy purchases, distributor-level leakages, or cosmetic or lifestyle use especially in urban markets," said Salil Kallianpur, an independent analyst.

"This could lead to misuse, poor titration and unmanaged side effects and eventually regulatory tightening."

India's drug regulator did not respond to a request for comment. Semaglutide is a prescription drug, but enforcement in India has often been uneven, with doctors and pharmacists playing a key gatekeeping role.

The entry of generics will also challenge Novo and U.S. rival Eli Lilly LLY.N, which launched blockbuster diabetes and obesity drugs in India last year, as they seek to cement their position in the country.

Lilly's Mounjaro became India's top-selling drug by value within months of launch, according to data from Pharmarack, a research firm.

India, the world's most populous nation, has the second-highest number of adults with diabetes after China and could have more than 440 million overweight or obese people by 2050, according to The Lancet, a medical journal, and the International Diabetes Federation.

India's obesity drug market could grow to 80 billion rupees ($856.6 million) by 2030 from about 15 billion rupees today, according to Pharmarack estimates.

EYES ON THE PRICE

Indian generic drugmakers, known globally for producing low-cost medicines, are expected to price their generics at discounts of at least 50% to 60%.

Analysts say monthly prices for the lowest dose could fall from about 11,000 rupees to 3,000 to 5,000 rupees as early generics arrive and eventually to around 1,500 to 2,500 rupees, expanding access beyond a niche urban elite.

"I will consult my doctor to check if I can move to using a generic version, as that appears to be lighter on the pocket," said 32-year-old Vishal, a tech worker from Hyderabad, who is considering a switch from Wegovy.

Many other patients in India's out-of-pocket market have also begun enquiring about cheaper options, some of which are expected to launch as soon as Saturday, the day after Novo's patent expires.

"The price range being quoted is broadly 2,500 to 3,500 rupees, which is quite low," said bariatric surgeon Venugopal Pareek. Six of his patients are waiting for generic versions to switch from Novo or Lilly drugs.

Lower prices are expected to expand the patient pool.

"Onboarding of patients from lower economic strata may happen on branded generics," said Sheetal Sapale, commercial vice president at Pharmarack, noting that company profits would depend on pricing discipline.

Novo and Lilly did not immediately respond to Reuters requests for a comment.

DOCTORS' CHOICE

Even as prices fall, analysts say the winner in the market will depend not just on cost, but also on doctor confidence.

India's pharmaceutical market is heavily driven by physician prescriptions and uptake will depend on doctors' familiarity and confidence in individual brands.

An initial glut of products is likely to overwhelm prescribers, analysts said, with uneven experiences and aggressive marketing.

Many generic drugmakers are opting for brand names that incorporate "sema," which could also add to confusion.

Over time, analysts expect doctors' trust to consolidate around a handful of players offering reliable supply, quality delivery devices and consistent outcomes.

"Weaker players with poor quality and no differentiation will likely exit within two to three years," Kallianpur said.

(Reporting by Rishika Sadam; Editing by Dhanya Skariachan and Thomas Derpinghaus)

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March 17 (Reuters) - Indian drugmakers Zydus Lifesciences ZYDU.NS and Lupin LUPN.NS have signed a licensing and supply deal on Tuesday to co‑market semaglutide injections in the country ahead of the ingredient's patent expiry.

Semaglutide is a GLP-1 receptor agonist used to treat Type 2 Diabetes and, increasingly, for weight management by helping regulate blood sugar and appetite.

The upcoming patent expiry for semaglutide has triggered a rush among Indian drugmakers to develop cheaper versions to capture market share in the world's most populous nation, which has the second-highest number of adults with diabetes after China.

Here are some key details:

• Lupin will have semi‑exclusive rights to co‑market Zydus' injection under the brand names Semanext and Lupin's Livarise.

• Lupin will pay Zydus upfront licensing fees and milestone-based payments.

• Zydus will manufacture the product at its Ahmedabad facility in Gujarat, and market the product under the brand names Semaglyntm, Mashematm And Alterme.

• Unlike existing treatments that require multiple single-use pens, Zydus' single-adjustable pen will allow patients select different doses, lowering costs.

• In January, Zydus received approval from India's regulator to make and sell generic versions of the weight-loss drugs.

• Larger peer Dr Reddy's Laboratories REDY.NS is likely to launch its generic semaglutide injection in March under the brand name Obeda, Reuters reported last month.

(Reporting by Urvi Dugar in Bengaluru; Editing by Sherry Jacob-Phillips)

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March 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - SENTYNL THERAPEUTICS ENTERS INTO AGREEMENT WITH PRG S&T

• ZYDUS LIFESCIENCES - AGREEMENT TO LICENSE MOLECULE FOR HUTCHINSONGILFORD PROGERIA SYNDROME

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March 13 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES FINAL APPROVAL FROM USFDA FOR CEVIMELINE HYDROCHLORIDE CAPSULES 30MG

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Feb 27 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - SUCCESSFUL CLINICAL DEVELOPMENT OF PEMBROLIZUMAB BIOSIMILAR FYB206

• ZYDUS LIFESCIENCES - ACHIEVEMENT CLEARS PATHWAY FOR NEAR-TERM BLA FILING WITH USFDA

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Feb 25 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS PLANS TO LAUNCH INNOVATIVE SEMAGLUTIDE INJECTION IN INDIA ON DAY 1 OF PATENT EXPIRY

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Feb 19 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• LAUNCHES BIOSIMILAR AFLIBERCEPT 2 MG ANYRA

• SIGNS AGREEMENT WITH REGENERON AND BAYER

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Feb 18 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - RECEIVES USFDA APPROVAL FOR BOSENTAN TABLETS, 32 MG

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Feb 12 (Reuters) - India's Zydus Lifesciences ZYDU.NS said on Thursday that it and its U.S. unit have agreed to pay $120 million to Astellas Pharma 4503.T as part of a deal to settle a patent dispute over the Japanese drugmaker's bladder disorder drug Mirabegron.

Zydus and its unit will also pay a pre-paid per‑unit licensing fee on sales of its generic Mirabegron in the U.S. from the date of the agreement until September 2027, the company said.

(Reporting by Hritam Mukherjee in Bengaluru; Editing by Sherry Jacob-Phillips)

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Feb 9 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES Q3 CONSOL NET PROFIT 10.42 BILLION RUPEES; IBES EST. 9.32 BILLION RUPEES

• ZYDUS LIFESCIENCES Q3 CONSOL TOTAL REVENUE FROM OPERATIONS 68.65 BILLION RUPEES; IBES EST. 61.76 BILLION RUPEES

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Feb 4 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - ZYDUS RECEIVES TENTATIVE APPROVAL FROM USFDA FOR DAPAGLIFLOZIN TABLETS

• ZYDUS LIFESCIENCES - RECEIVES TENTATIVE APPROVAL FROM USFDA FOR DAPAGLIFLOZIN TABLETS, 5 MG AND 10 MG

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Jan 23 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• USFDA INSPECTION CLOSED AT ZYDUS UNIT-2 PLANT IN ANKLESHWAR

• INSPECTION CONCLUDED WITH 3 OBSERVATIONS

Source text: ID:nBSE42WxM

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Jan 22 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - LAUNCHES BIOSIMILAR OF NIVOLUMAB IN INDIA

• ZYDUS LIFESCIENCES - BIOSIMILAR TISHTHA PRICED AT 28,950 RUPEES FOR 100 MG AND 13,950 RUPEES FOR 40 MG

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Adds background throughout, shares in paragraph 2

Jan 13 (Reuters) - The U.S. Food and Drug Administration approved Fortress Biotech FBIO.O and Indian drugmaker Zydus Lifesciences' ZYDU.NS drug for children with a rare genetic disorder that impairs copper absorption, Fortress said on Tuesday.

Shares of Fortress Bio rose more than 13% in premarket trading.

The drug, branded as Zycubo, is approved to treat Menkes disease, where patients are born without the ability to absorb copper from their diet. It is caused by mutations in a particular gene that is responsible for the transport of copper throughout the body.

The approval makes it the first drug on the market to treat this disease in the United States.

Symptoms of this condition include sparse and de-pigmented hair, seizures and developmental delays. If left untreated, many patients die between the ages of two and three years.

The disease primarily affects male infants. According to the companies, recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births.

Fortress is eligible to receive tiered royalties on net sales of Zycubo and up to $129 million in aggregate development and sales milestones from Zydus.

The drug, chemically known as CUTX-101, is an under-the-skin injectable formulation of copper histidinate, a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract.

It helps increase copper levels in the blood, to improve body and brain function.

The approval was based on data showing Zycubo improved overall survival in patients who received early treatment, with a nearly 80% reduction in the risk of death compared with those who were untreated.

Current treatments include daily copper injections.

(Reporting by Padmanabhan Ananthan and Sneha S K in Bengaluru; Editing by Devika Syamnath)

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Jan 9 (Reuters) - FDA:

• FDA APPROVES FIRST GENERIC ROBENACOXIB TABLET FOR POSTOPERATIVE PAIN & INFLAMMATION IN CATS

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Dec 30 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• GETS TAX DEMAND ORDER OF 28 MILLION RUPEES

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Oct 6 (Reuters) - Zydus Lifesciences ZYDU.NS:

• RECEIVES HEALTH CANADA APPROVAL FOR LIOTHYRONINE TABLETS

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Oct 1 (Reuters) - The U.S Food and Drug Administration on Wednesday declined to approve Fortress Biotech FBIO.O and Indian drugmaker Zydus Lifesciences' ZYDU.NS drug for a type of rare genetic disease in children, Fortress said.

(Reporting by Padmanabhan Ananthan and Sneha S K in Bengaluru; Editing by Vijay Kishore)

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** Zydus Lifesciences ZYDU.NS rises 2% to 1,032 rupees

** Stock set to rise for six straight day, if gains hold

** Drugmaker and Netherlands-based Synthon BV enters exclusive licensing, supply agreement for Ozanimod Capsules, generic version of Bristol Myers Squibb's ZEPOSIA, targeting U.S. market

** Stock rated "hold" on avg; median PT is 1,018.5 rupees, per data compiled by LSEG

** ZYDU gains 6.2%

(Reporting by Rudra Pratap Singh in Bengaluru)

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Sept 4 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS AND SYNTHON ENTERED INTO EXCLUSIVE LICENSING AND SUPPLY AGREEMENT

• AGREEMENT FOR OZANIMOD CAPSULES FOR THE U.S. MARKET

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July 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• USFDA CLOSES REMOTE REGULATORY ASSESSMENT AT MATODA FACILITY

• NO OBSERVATIONS NOTED; SITE RECOMMENDED FOR APPROVAL

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June 18 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• CLOSURE OF USFDA INSPECTION AT ZYDUS’ ONCOLOGY INJECTABLE PLANT AT AHMEDABAD

• INSPECTION IS CLOSED WITH 2 OBSERVATIONS

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