SUNPHARMA

Updates March 20 story with Novo Nordisk comment on Wegovy launch timing in paragraph 11

By Rishika Sadam

HYDERABAD, March 21 (Reuters) - Eli Lilly launched its blockbuster diabetes and weight-loss drug Mounjaro in India on Thursday, beating rival Novo Nordisk for a much-awaited entry into the world's most populous country grappling with increasing rates of obesity and diabetes.

U.S.-based Lilly LLY.N and Danish Novo Nordisk NOVOb.CO have seen skyrocketing global demand for their innovative weight-loss drugs, with investor interest also boosting the drugmakers' valuations.

Mounjaro, a once-weekly injection approved by India's drug regulator, is priced at 4,375 rupees ($50.67) for a 5 mg vial and 3,500 rupees ($40.54) for a 2.5 mg vial, its lowest doses, the company told Reuters exclusively. Its highest dose is 15 mg.

A patient in India may have to spend about $200 a month when taking a weekly dose of 5 mg, subject to doctor's prescription.

Mounjaro carries a list price of $1,086.37 for each monthly fill in the U.S., but the amount patients pay largely depends on their insurance plan. Lilly also offers 5 mg, 7.5 mg and 10 mg vials of Zepbound, with prices around $499 for a month's supply if customers pay directly in cash without any third-party entities.

Chemically known as tirzepatide, Mounjaro is currently sold in the UK and Europe under the same brand name for both diabetes and weight loss. It is sold as Zepbound for obesity in the U.S.

Lilly, however, said that the pricing in different geographies cannot be compared given significant variation in healthcare systems, economies and reimbursement policies in each country.

"(Mounjaro) launch is ahead of Novo Nordisk and the first mover advantage should help ... but pricing seems high (for the Indian market). At the highest dose, a patient will have to spend close to 700,000 rupees (around $8,100) per annum," Vishal Manchanda, analyst at Systematix Institutional Equities said.

Novo's weight-loss drug, Wegovy, can cost non-insured U.S. patients more than $1,000 a month.

Novo's India team has been pushing the global leadership to launch Wegovy as early as 2025 in the country as opposed to the company's target of a 2026 launch.

The drugmaker told Reuters that Wegovy has already been approved in India, but said it did not have a confirmed date for the medicine's launch there.

The company's shares were down 0.6% at 1145 GMT, underperforming the broader European market .STOXX. Shares of U.S.-based Lilly rose as much as 2.07% to $854.39 on Thursday.

Novo's stock has fallen over 12% so far this year, while Lilly's has jumped 8%.

Novo is not the only competition Lilly will have to confront in India. Local drugmakers such as Sun Pharma SUN.NS, Cipla CIPL.NS, Dr. Reddy's REDY.NS and Lupin LUPN.NS have been racing to make generic versions of these drugs to grab a share of the global market estimated to be worth $150 billion in the next decade.

The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.

"The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India," said President and General Manager Winselow Tucker at Lilly India.

Obesity and diabetes rates in India, a country of more than 1.4 billion people, have been steadily climbing. The number of adults with diabetes is set to increase to over 124 million by 2045 from 74.2 million in 2021, according to International Diabetes Federation.

Meanwhile, a government survey conducted between 2019 and 2021 showed that 24% of women and nearly 23% of men between the ages of 15 and 49 were either overweight or obese, up from 20.6% of women and 19% of men in 2015-2016.

Wegovy and Novo's diabetes drug, Ozempic — which has the same main ingredient — and Mounjaro, belong to a class of therapies known as GLP-1 receptor agonists that help control blood sugar and slow digestion, making people feel fuller for longer.

($1 = 86.3425 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad, Maggie Fick in London and Bhanvi Satija in Bengaluru; Additional reporting by Manvi Pant in Bengaluru; Editing by Janane Venkatraman, Alan Barona and Tomasz Janowski)

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March 20 (Reuters) - Eli Lilly LLY.N on Thursday launched in India its diabetes and weight-loss drug, Mounjaro, which has already clocked in over $20 billion in global sales since its initial U.S. launch in 2022.

India, the world's most populous country, has high obesity rates and the second-highest number of people with type 2 diabetes. Around 11% of Indian adults are expected to become obese by 2035, according to the World Obesity Federation Atlas.

Here are the local and international drugmakers also eyeing the Indian market and looking to introduce rivals to Lilly's drug:

NOVO NORDISK

The Danish drugmaker NOVOb.CO had said it aims to launch its blockbuster weight-loss drug, Wegovy, in India by 2026.

The active ingredient in Wegovy is semaglutide, which is likely to go off-patent in 2026 in India.

Wegovy and Lilly's Mounjaro belong to the same class of treatments called GLP-1 agonists, which soared into popularity globally triggering a shortage of supply. GLP-1 drugs mimic a gut hormone that helps control blood sugar levels and slow digestion, making people feel fuller for longer.

SUN PHARMA

Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own GLP-1 treatment, utreglutide, for weight loss and type 2 diabetes.

The drugmaker said earlier this month it expects to launch the drug in the next four to five years.

BIOCON

Indian drugmaker Biocon BION.NS is developing its own version of Novo's Wegovy, as the drug is set to lose exclusivity next year in emerging markets such as India, Brazil, Mexico, and Saudi Arabia.

ZYDUS LIFESCIENCES

India's Zydus Lifesciences ZYDU.NS is developing the generic version of Semaglutide and plans on launching the drug after its patent expires in India.

CIPLA

Cipla CIPL.NS, India's third-largest drugmaker by sales, is among the Indian drugmakers making cheaper versions of Novo's Wegovy.

Cipla has also said it is open to partnering with Lilly to market Mounjaro in India.

DR. REDDY'S

India's Dr. Reddy's REDY.NS has said it plans to launch generic versions of Semaglutide in all the markets as Novo's patent expires.

LUPIN

India's Lupin LUPN.NS is another generic drugmaker looking to grab a share of the burgeoning obesity treatment market with its own version of Novo's Wegovy.

NATCO, MANKIND PHARMA, AUROBINDO PHARMA

Media reports say India's Natco Pharma NATP.NS, Mankind Pharma MNKI.NS, Aurobindo Pharma ARBN.NS are also developing cheaper versions of Novo's Wegovy.

Reuters was not able to independently verify the reports.

(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)

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March 10 (Reuters) - India's Sun Pharmaceutical Industries SUN.NS said on Monday that it will acquire Checkpoint Therapeutics CKPT.O, a U.S.-based immunotherapy and targeted oncology company, in a deal valued at up to $355 million.

(Reporting by Aleef Jahan in Bengaluru; Editing by Sherry Jacob-Phillips)

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Repeats March 1 story with no change to text

By Rishika Sadam

MUMBAI, March 1 (Reuters) - India's largest drugmaker by revenue Sun Pharmaceutical SUN.NS is aiming to launch its experimental anti-obesity and type 2 diabetes drug in the next four to five years, Managing Director Dilip Shanghvi said on Friday.

The company is among many Indian drugmakers looking to grab a slice of the growing weight-loss drug market, which is expected to reach $150 billion globally by the end of the decade.

Sun Pharma's push into this category comes after companies such as Novo Nordisk NOVOb.CO and Eli Lilly LLY.N saw skyrocketing demand for their weight-loss drugs Wegovy and Zepbound, which boosted the drugmakers' valuations.

Sun Pharma's novel investigational drug, also known as Utreglutide (GL0034), belongs to a drug class called GLP-1 receptor agonists, which suppress appetite by mimicking gut hormones and have also been found to have medical benefits for conditions beyond type 2 diabetes and weight loss.

The active ingredients in Wegovy and Zepbound also belong to the same class of drugs.

Sun Pharma, which expects to conduct mid-stage trials for the drug this year, earlier said it demonstrated clinically meaningful weight loss and significant metabolic improvements in the first phase of trials.

"The findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers," it said last year.

The company will focus on launching it in India as well as global markets, a source with knowledge of the matter said on Friday.

Sun Pharma said in August it would consider a partnership or licensing the product in large markets such as the U.S. and Europe for commercialization.

Generic drugmakers such as Dr Reddy's REDY.NS, Cipla CIPL.NS and Lupin LUPN.NS are also developing their own generic versions of these drugs, the launch of which is subject to patent expiry of active ingredients in original drugs.

(Reporting by Rishika Sadam in Mumbai; Editing by Shounak Dasgupta)

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By Rishika Sadam

MUMBAI, March 1 (Reuters) - India's largest drugmaker by revenue Sun Pharmaceutical SUN.NS is aiming to launch its experimental anti-obesity and type 2 diabetes drug in the next four to five years, Managing Director Dilip Shanghvi said on Friday.

The company is among many Indian drugmakers looking to grab a slice of the growing weight-loss drug market, which is expected to reach $150 billion globally by the end of the decade.

Sun Pharma's push into this category comes after companies such as Novo Nordisk NOVOb.CO and Eli Lilly LLY.N saw skyrocketing demand for their weight-loss drugs Wegovy and Zepbound, which boosted the drugmakers' valuations.

Sun Pharma's novel investigational drug, also known as Utreglutide (GL0034), belongs to a drug class called GLP-1 receptor agonists, which suppress appetite by mimicking gut hormones and have also been found to have medical benefits for conditions beyond type 2 diabetes and weight loss.

The active ingredients in Wegovy and Zepbound also belong to the same class of drugs.

Sun Pharma, which expects to conduct mid-stage trials for the drug this year, earlier said it demonstrated clinically meaningful weight loss and significant metabolic improvements in the first phase of trials.

"The findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers," it said last year.

The company will focus on launching it in India as well as global markets, a source with knowledge of the matter said on Friday.

Sun Pharma said in August it would consider a partnership or licensing the product in large markets such as the U.S. and Europe for commercialization.

Generic drugmakers such as Dr Reddy's REDY.NS, Cipla CIPL.NS and Lupin LUPN.NS are also developing their own generic versions of these drugs, the launch of which is subject to patent expiry of active ingredients in original drugs.

(Reporting by Rishika Sadam in Mumbai; Editing by Shounak Dasgupta)

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By Rishika Sadam

HYDERABAD, India, Feb 21 (Reuters) - Indian pharmaceutical companies will be able to retain their dominant market share in the U.S. in selling generic drugs even if President Donald Trump imposes high tariffs because they are "highly competitive", a government-backed trade body said.

The U.S. accounts for nearly a third of India's pharmaceutical exports, mainly cheaper versions of popular drugs, with sales jumping 16% to about $9 billion last fiscal year.

Trump has said he could impose tariffs of 25% or more on pharmaceutical imports and an announcement could be made by next month. India's drug industry has said it hopes bilateral talks will earn them an exception, though Trump has ruled out any such concession so far.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil), set up by the trade ministry, said it believed that the Trump warning was mostly directed at costly imports of patented and other such products from other countries.

"India pharma will not selectively be imposed high duties and its exports are highly competitive, so it can still compete in the newer environment (with import duties if at all imposed) without losing its share," Pharmexcil Director General Raja Bhanu told Reuters.

"The government will certainly have discussions about the changing situations and try to bring the best possible solution."

India imposes about 10% tax on pharma imports from the U.S. while paying nearly no tariff for its exports to the country, according to industry experts.

India sells about 65% of all generic drugs in the U.S, according to Citi Research. According to the Indian government, generic drugs are 50% to 90% cheaper than branded ones.

Higher tariffs will further pressure thin margins of up to 15% of core earnings for most Indian generic drugs unless costs are passed onto consumers, analysts said.

"Tariffs (if not passed through) may result in a large part of the Indian generic drug supply to the U.S. turning unviable," Citi Research said in a note.

"Companies may be forced to rationalize portfolios or (make) exits that may result in massive shortages in the U.S. and resultant drug price increases. If Indian players start exiting from the generics, drug shortages in the U.S. may escalate beyond control."

According to research firm IQVIA, overall cheaper generic drugs saved the U.S. healthcare system about $408 billion in 2022.

Sun Pharma SUN.NS, India's largest drugmaker that made 32%of its total revenue through U.S. sales last fiscal year, has already said it will pass on any costs to consumers.

Other big Indian players include Dr Reddy's REDY.NS, Cipla CIPL.NS and Zydus Lifesciences ZYDU.NS.

The tariff uncertainty could dominate discussions at the BioAsia conference in India's Telangana state next week, expected to be attended by executives from pharma giants including Eli Lilly LLY.N, Novo Nordisk NOVOb.CO.

(Reporting by Rishika Sadam in Hyderabad; Kashish Tanon and Bhanvi Satija in Bengaluru; editing by David Evans)

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Feb 20 (Reuters) - Duopharma Biotech DUOP.KL:

• WRIT OF SUMMONS SERVED ON UNIT BY SUN PHARMACEUTICAL INDUSTRIES

Further company coverage: DUOP.KL

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Adds analyst comments in paragraphs 7 and 10, Sun Pharma MD comments in paragraph 11, updates levels

By Kashish Tandon

Feb 19 (Reuters) - An index of Indian pharmaceutical company shares .NIPHARM slid 2% to its lowest level in seven months on Wednesday after U.S. President Donald Trump said he intends to impose tariffs of about 25% or higher on pharma imports.

Twelve of the 20 stocks on the sub-index traded lower. Sun Pharma SUN.NS, India's top drugmaker by revenue, fell 2%, and Dr Reddy's REDY.NS slipped 4% to its lowest level since June.

Aurobindo Pharma ARBN.NS tumbled 6% to its lowest level in nearly a year, and Cipla CIPL.NS, India's no. 3 drugmaker, shed 2.2%.

The sub-index pared some losses and was trading 0.7% lower as of 10:44 a.m. IST.

Indian drugmakers earn a significant share of revenue from the U.S., the largest importer of Indian pharma products.

India's pharma exports to the country stood at $8.73 billion in fiscal 2024 - a nearly 16% increase from previous year - accounting for about 31% of the industry's overall exports, as per data from government-backed trade body Pharmaceuticals Export Promotion Council of India (Pharmexcil).

Trump's tariff plans are making investors jittery at the moment, as most of these companies rely on the U.S. for most of their revenue, said Shrikant Akolkar, a pharma analyst with Nuvama Institutional Equities.

The U.S. President on Tuesday told reporters that sectoral tariffs on pharmaceuticals and semiconductor chips would begin at "25% or higher", rising substantially over the course of a year, but did not provide a date for the announcement of the duties.

Trump added that he wanted to provide some time for drug and chip makers to set up U.S. factories so they could avoid tariffs.

"Even if these companies start setting up manufacturing within U.S. borders, it is a long way to go as they would need fresh approvals and also labour which is costlier in the U.S. compared to India," Akolkar said.

Earlier this week, Sun Pharma MD Dilip Shanghvi told ET Now that tariffs, if imposed, will be passed on to consumers.

Pharma stocks have lost about 12% so far this year, while the benchmark Nifty 50 .NSEI declined 4%.

(Reporting by Kashish Tandon in Bengaluru; Editing by Savio D'Souza and Janane Venkatraman)

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Feb 17 (Reuters) - Sun Pharma MD To ET NOW:

• NO MAJOR IMPACT OF POSSIBLE US TARIFFS ON INDIAN PHARMA INDUSTRY

• ANY IMPACT FROM US TARIFFS WILL BE MINIMAL

• MOST OF THE US TARIFFS, IF IMPOSED, WILL BE PASSED ON TO CONSUMERS

Further company coverage: SUN.NS

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Feb 4 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMA - PHILOGEN COMPLETES PATIENT ENROLLMENT OF THE PHASE III FIBROSARC TRIAL IN SOFT TISSUE SARCOMA

Source text: [ID:]

Further company coverage: SUN.NS

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Adds analyst comment in paragraph 5

By Kashish Tandon and Rishika Sadam

HYDERABAD/BENGALURU Jan 31 (Reuters) - Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, reported a bigger-than-expected quarterly profit on Friday, aided by strong sales in the domestic market.

The Mumbai-based firm's consolidated net profit rose 15% to 29.03 billion rupees ($335.3 million) in the third quarter, beating analysts' average estimate of 28.81 billion rupees, according to data compiled by LSEG.

Sales in India, Sun Pharma's largest revenue-generating region, rose 14% to 43 billion rupees, or about 31% of total sales. That was bigger than the 11% increase in the previous quarter.

Its high-margin global specialty pharmaceutical segment, which includes medicines for conditions such as alopecia and psoriasis, reported a 17.5% jump in sales to $370 million, or 21% of total sales.

"Increasing contribution from global specialty drugs is a key positive for Sun Pharma and will continue to boost margins in near term, said Shrikant Akolkar, an analyst at Nuvama Institutional Equities.

Overall, the company's revenue rose 10.5% to 136.75 billion rupees, surpassing analysts' estimates of 134.22 billion rupees.

That was despite U.S. sales increasing just 0.7%.

Most of India's generic drugmakers derive a significant share of revenue from the United States, where lower drug prices due to stiff competition have been weighing on profit margins.

Among its rivals, Dr Reddy's REDY.NS missed profit estimates for the quarter, while Cipla CIPL.NS beat expectations. However, both the generic drugmakers saw muted growth in their key North American market.

($1 = 86.5860 Indian rupees)

(Reporting by Rishika Sadam and Kashish Tandon; Editing by Savio D'Souza)

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Jan 16 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMACEUTICAL INDUSTRIES LTD - TO ACQUIRE 100% STAKE IN ANTIBE THERAPEUTICS

Source text: ID:nBSE8B4gmx

Further company coverage: SUN.NS

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Dec 31 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMACEUTICAL INDUSTRIES LTD - PHARMA TO SELL 100% SHARES IN JAPAN SUBSIDIARY

Source text: ID:nBSE6q35rt

Further company coverage: SUN.NS

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Dec 13 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMACEUTICAL INDUSTRIES LTD - RECEIVES ORDER FROM STATUTORY AUTHORITY

• SUN PHARMACEUTICAL INDUSTRIES LTD - ORDER FOR REDEMPTION FINE OF 4 MILLION RUPEES

Source text: ID:nBSE9HGyFK

Further company coverage: SUN.NS

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By Leroy Leo and Rishika Sadam

BENGALURU/HYDERABAD, Dec 3 (Reuters) - Novo Nordisk's NOVOb.CO team in India has been pushing the Danish drugmaker's global leadership for an earlier launch of its popular weight-loss drug Wegovy over fears of falling behind rival Eli Lilly LLY.N in the potentially huge market, two sources familiar with the plans told Reuters.

Officials at the Danish drugmaker have said Wegovy might be introduced in India in 2026 once regulatory approvals are in hand and there is sufficient supply. More recently, Novo's India team proposed moving the launch to next year, around the same time Lilly is expected to introduce its weight-loss drug Mounjaro.

In a closed-door meeting at Novo's Denmark headquarters about two months ago, the India team raised concerns that the company could lag behind Lilly in the domestic market if Wegovy was not launched early, said one of the sources, who spoke on condition of anonymity as they were not authorized to speak to the media.

Novo declined to comment on internal discussions and Reuters could not determine what response the India-based executives received.

Wegovy and Novo's diabetes drug Ozempic, which has the same main ingredient, and Mounjaro, belong to a class of therapies known as GLP-1 receptor agonists that help control blood sugar and slow digestion, making people feel fuller for longer.

The companies have been struggling to meet soaring demand in the U.S. and the few other countries where the drugs have been launched so far. Novo and Lilly are both scaling up production as they vie for a dominant share of a weight-loss market that some analysts forecast could reach $150 billion a year in the next decade.

Novo received regulatory approval in India for injectable semaglutide - the active ingredient in Wegovy and Ozempic - in late 2022, according to one of the sources.

"We are working to make Wegovy (semaglutide injection 2.4 milligrams) available as soon as possible. We do not yet have a confirmed date for launch," Novo India said in a statement to Reuters.

Lilly, in response to a Reuters request, said its 2025 Mounjaro launch is also subject to the supply situation.

Last month, Novo launched Wegovy in China, the world's second-largest pharmaceuticals market, pricing a month's supply of the starter dose at 1,400 yuan ($193.27), far lower than its U.S. list price of more than $1,300, although most people don't pay that much.

India's generic drugmakers, including Cipla CIPL.NS and Dr Reddy's REDY.NS, are making cheaper copies of Wegovy, with the timing of any launch subject to patent expiry. Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, is developing its own experimental GLP weight-loss drug.

India, a country of more than 1.4 billion people, has seen an increase in the prevalence of obesity. A government survey conducted between 2019 and 2021 showed that 24% of women and nearly 23% of men between the ages of 15 and 49 were either overweight or obese, up from 20.6% of women and 19% of men in 2015-2016.

Dr. Rishma Pai, a consultant gynaecologist at three hospitals in Mumbai who participated in a Novo survey about attitudes towards obesity, said the company has been reaching out to many types of doctors for a few years to spread awareness about obesity medications and better understand how to promote their acceptance in India.

Acceptance no longer appears to be an issue.

"Every patient is asking about these weight-loss injections," Pai said.

(Reporting by Rishika Sadam in Hyderabad and Leroy Leo in Bengaluru; Editing by Michele Gershberg and Bill Berkrot)

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Nov 26 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMACEUTICAL INDUSTRIES LTD - RECEIVES ORDER FROM CUSTOMS AUTHORITY

• SUN PHARMACEUTICAL INDUSTRIES - FINED 2.7 MILLION RUPEES, PENALTY 12.6 MILLION RUPEES

• SUN PHARMA - SUN PHARMA LABORATORIES FINED 90 MILLION RUPEES, PENALTY 478.9 MILLION RUPEES

Source text: ID:nBSE924qv0

Further company coverage: SUN.NS

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Nov 5 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• COMMISSIONER OF CUSTOMS PASSED ORDER IMPOSING PENALTY OF 53.6 MILLION RUPEES

Source text: ID:nNSE1m00Fj

Further company coverage: SUN.NS

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HYDERABAD/BENGALURU, Oct 28 (Reuters) - Sun Pharmaceuticals SUN.NS, India's largest drugmaker by revenue, reported second-quarter profit above analysts' estimates on Monday, aided by strong sales of its specialty drugs that are used to treat uncommon medical conditions.

The Mumbai-based firm's net profit rose 28% to 30.40 billion rupees (nearly $362 million) in the three months ended Sept. 30, beating analysts' average estimate of 28.87 billion rupees, according to LSEG data.

($1 = 84.0510 Indian rupees)

(Reporting by Rishika Sadam and Kashish Tandon; Editing by Sumana Nandy and Rashmi Aich)

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Adds comment from Novo Holdings in paragraph 13

By Ludwig Burger

FRANKFURT, Oct 23 (Reuters) - The CEO of pharmaceuticals giant Roche ROG.S said authorities should block the takeover of contract drug manufacturer Catalent CTLT.N by Novo Nordisk's controlling shareholder, as it could hit competition in the booming weight-loss drug industry.

Though it stressed on Wednesday it was not itself affected, Roche is among the first drugmakers to voice opposition to the transaction with potentially wide-ranging repercussions for weight-loss drugs based on the gut hormone GLP-1.

"Limiting the competition in this space is not a good idea," Roche's CEO Thomas Schinecker said in a media call. "From an industry perspective, it would be a wrong decision by authorities."

"It could be a problem for other smaller players, if there is a restriction in how many (contract manufacturers) are available," he told journalists, speaking after the release of quarterly sales on Wednesday.

The company said it would not comment further on any interactions with competition authorities.

"In general, if companies start buying up CMOs (contract manufacturing organisations), that will limit the amount of competition that there can be," Schinecker added in a later analyst call.

Last week, an alliance of U.S. consumer, patient and workers advocacy groups petitioned the U.S. Federal Trade Commission to block Novo Holdings, which controls Novo Nordisk NOVOb.CO, from acquiring Catalent, saying the deal threatened competition in weight loss drugs and gene therapies.

Executives at Eli Lilly LLY.N, Novo's main rival in the obesity and diabetes drug market, have repeatedly voiced concerns over the transaction, which will also see Novo Nordisk take direct ownership of three Catalent sites where injection pens are filled in Italy, Belgium and the United States.

The advocacy groups said at the time that the deal could constrain competitors such as Amgen AMGN.O, Pfizer PFE.N, Roche and AstraZeneca AZN.L, which are reportedly developing their own obesity drugs, some of which are based on difficult-to-make peptides.

Viking Therapeutics VKTX.O, Structure Therapeutics GPCR.O and Sun Pharma SUN.NS could also be affected, the advocacy groups said.

A Novo Nordisk spokesperson, commenting on the Roche CEO's remarks, said: "If the acquisition is approved, Novo Nordisk will purchase three manufacturing sites from Novo Holdings. Catalent will still operate close to 50 sites independently and separate from Novo Nordisk."

The Novo Nordisk spokesperson said that a "large number" of other contract drugmakers compete with Catalent and said that, if the acquisition is approved, pharma and biotech companies "will continue to have access to ample choice for contract manufacturing, including Catalent." The spokesperson reiterated the company's expectation that the transaction will close towards the end of this year.

Novo Holdings said Catalent would continue to operate independently as a leading contract drug manufacturer.

Catalent said: "We are confident that the transaction is pro-competitive, and we are unaware of any competitive GLP-1 products being manufactured for commercial sale at the three sites that Novo Nordisk is planning to acquire."

It added it would continue to work closely with European and U.S. regulators and that it still expected the transaction to close towards the end of 2024.

Novo would not be the first pharma major to run contract manufacturing operations serving rivals, as Pfizer PFE.N and Boehringer Ingelheim, for example, also own such divisions.

The head of Roche's pharmaceutical division, Teresa Graham, underscored on Wednesday that Roche itself was not impacted: "We are quite confident in the capacity we have. We have reserved capacity with other CMOs."

When asked last week to comment on scrutiny of the Catalent deal, Roche said it would use both in-house and external manufacturing for future commercial production of its obesity drugs.

(Additional reporting by Maggie Fick in London, Editing by Rachel More, Tomasz Janowski, Mark Potter and David Evans)

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Adds Novo Holdings comment in paragraph 7

By Jody Godoy and Maggie Fick

NEW YORK, Oct 18 (Reuters) - U.S. consumer groups and two large labor unions urged the U.S. Federal Trade Commission on Thursday to block Novo Holdings, the controlling shareholder of Novo Nordisk NOVOb.CO, from acquiring contract drug manufacturer Catalent CTLT.N, saying the deal threatens competition in weight loss drugs and cutting-edge gene therapies.

U.S. Public Interest Research Group, Service Employees International Union (SEIU) and others expressed concerns in a letter to the FTC about the $16.5 billion deal, which Novo Holdings has said would boost supply of Wegovy, Novo's blockbuster GLP-1 injectable weight-loss drug.

Last week, U.S. Senator Elizabeth Warren, a Democrat, called on the FTC to look closely at the deal over similar concerns.

The deal could constrain options for competitors such as Amgen AMGN.O, Pfizer PFE.N, Roche ROG.S, and AstraZeneca AZN.L, who are reportedly developing their own GLP-1 drugs, the groups said.

"Because of the proposed acquisition, there is a real question of whether these future rivals to Novo will be able to secure the expertise to bring the product to market and have available and qualified capacity to manufacture these products when they commercially launch," the groups said.

Viking Therapeutics VKTX.O, Structure Therapeutics GPCR.O and Sun Pharma SUN.NS also have GLP-1 drugs in development and could be affected, the groups said.

Novo Holdings, in a statement to Reuters on Friday in response to the consumer groups' letter, said: "We remain confident in the pro-competitive rationale for this transaction and are committed to realizing the benefits it will bring to customers, and patients, and the local communities which Catalent now serves."

A Catalent spokesperson reiterated the company's position on the deal in a statement on Friday to Reuters in response to the letter: "Novo Holdings’ pending acquisition of Catalent will further strengthen Catalent’s ability to deliver better outcomes for our customers and the patients they serve."

A Viking spokesperson declined to comment. A Roche spokesperson declined to comment on the letter, but said that the drugmaker has secured near-term supplies for its clinical trials of the GLP-1 drugs it is developing. Roche plans to manage the scaling up of commercial production "by using a mix of in-house and external manufacturing", the spokesperson said.

The other companies did not immediately respond to requests for comment on Thursday.

According to the terms of the deal, Novo Holdings would sell three of Catalent's factories, where injection pens are filled in sterile conditions, in Italy, Belgium and the United States, on to Novo Nordisk for $11 billion.

Novo Nordisk has said it is committed to honoring existing contracts at the plants, and that it is not aware of any competitive GLP-1 products being manufactured for commercial sale at the three sites.

"We have and will continue to work closely with the FTC and EU regulators as intended under the law. We still expect the transaction to close toward the end of the calendar year," Novo Nordisk said in its response to the consumer groups' letter.

The groups, which included Consumer Action, diabetes group Beta Cell Action, Doctors for America and the American Federation of State, County and Municipal Employees (AFSCME) union, also expressed concern that Novo Holding's ownership could affect Catalent's capacity to manufacture gene therapies.

AFSCME represents around 1.6 million public sector workers, and SEIU has around 2 million members who work in healthcare, the public sector and property services.

Ten consumer groups had signed on to the letter on Thursday afternoon.

"The competitive concerns here go far beyond existing drugs. We believe the commission should look at the impact on future therapies including gene therapy," said David Balto, the antitrust lawyer who represents the groups and drafted the letter.

The letter mentioned Catalent's contracts with Sarepta Therapeutics SRPT.O, to produce its gene therapy Elevidys, and with Novartis NOVN.S, to produce its gene therapy Zolgensma. The Catalent facilities involved are separate from the three factories that Novo Holdings plans to sell on to Novo Nordisk.

Sarepta does not anticipate any impact from the Catalent acquisition, spokesperson Tracy Sorrentino said on Thursday. Sarepta's contract with Catalent runs through 2028.

A Novartis spokesperson said on Thursday that Zolgensma is no longer manufactured at any Catalent facility.

(Reporting by Jody Godoy in New York and Maggie Fick in London; Editing by Tomasz Janowski, Louise Heavens and Mark Potter)

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By Jody Godoy, Maggie Fick

NEW YORK, Oct 17 (Reuters) - Five U.S. consumer groups and two large labor unions urged the U.S. Federal Trade Commission on Thursday to block Novo Nordisk's NOVOb.CO controlling shareholder from acquiring contract drug manufacturer Catalent CTLT.N, saying the deal threatens competition in weight loss drugs and cutting-edge gene therapies.

U.S. Public Interest Research Group, Service Employees International Union (SEIU) and others expressed concerns in a letter to the FTC about the $16.5 billion deal, which Novo Holdings has said would boost supply of Wegovy, Novo's blockbuster GLP-1 injectable weight loss drug.

Last week, U.S. Senator Elizabeth Warren, a Democrat, called on the FTC to look closely at the deal over similar concerns.

The deal could constrain options for competitors such as Amgen AMGN.O, Pfizer PFE.N, Roche ROG.S, and AstraZeneca AZN.L, who are reportedly developing their own GLP-1 drugs, the groups said.

""Because of the proposed acquisition, there is a real question of whether these future rivals to Novo will be able to secure the expertise to bring the product to market and have available and qualified capacity to manufacture these products when they commercially launch," the groups said.

Viking Therapeutics VKTX.O, Structure Therapeutics GPCR.O and Sun Pharma SUN.NS also have GLP-1 drugs in development and could be affected, the groups said.

According to the terms of the deal, Novo Holdings would sell three of Catalent's factories, where injection pens are filled in sterile conditions, in Italy, Belgium and the United States, on to Novo Nordisk for $11 billion.

Novo Nordisk has said it is committed to honoring existing contracts at the plants, and that it is not aware of any competitive GLP-1 products being manufactured for commercial sale at the three sites.

The groups, which included Consumer Action, Doctors for America and the American Federation of State, County and Municipal Employees (AFSCME) union, also expressed concern that Novo Holding's ownership could affect Catalent's capacity to manufacture gene therapies.

AFSCME represents around 1.6 million public sector workers, and SEIU has around 2 million members who work in healthcare, the public sector and property services.

"The competitive concerns here go far beyond existing drugs. We believe the commission should look at the impact on future therapies including gene therapy," said David Balto, the antitrust lawyer who represents the groups and drafted the letter.

The letter mentioned Catalent's contracts with Sarepta Therapeutics SRPT.O, to produce its gene therapy Elevidys, and with Novartis NOVN.S, to produce its gene therapy Zolgensma. The Catalent facilities producing these therapies are separate from the three factories that Novo Holdings plans to sell on to Novo Nordisk.

(Reporting by Jody Godoy in New York and Maggie Fick in London; Editing by Nick Zieminski)

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Sept 30 (Reuters) - Philogen SpA PHIL.MI:

• PHILOGEN SPA - ANNOUNCED THAT THEY HAVE ENTERED INTO A GLOBAL LICENSING AGREEMENT FOR COMMERCIALIZING PHILOGEN'S SPECIALTY PRODUCT, FIBROMUN

• PHILOGEN SPA - SUN PHARMA WILL HAVE EXCLUSIVE WORLDWIDE RIGHTS TO COMMERCIALISE FIBROMUN

• PHILOGEN SPA - OTHER FINANCIAL TERMS WERE NOT DISCLOSED

Source text for Eikon: ID:nINF57kRzF

Further company coverage: PHIL.MI

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By Rishika Sadam

BENGALURU, Sept 26 (Reuters) - India's drug regulator has found more than 50 drugs, including some batches of widely used antacids and paracetamol, to be substandard or fake, according to government documents.

The regulator, Central Drugs Standard Control Organisation, releases a monthly list of substandard or fake medicines sold in the country after routine tests across the country by multiple agencies.

The regulator found some drugs as "not of standard quality", including a batch each of Alkem Laboratories' ALKE.NS popular antacid Pan-D, Hetero's anti-infective Cepodem and Shelcal, a vitamin and calcium tablet brand made by privately-owned Pure & Cure Healthcare, and several antibiotics, according to the lists for August.

Sun Pharmaceutical Industries SUN.NS separately informed the regulator of a fake batch of Pantocid, a popular Indian brand of an antacid called pantoprazole. The agency said it is investigating the matter.

Fake, or "spurious", batches of Sun's drug Pulmosil, used to treat high blood pressure in the lungs, and Glenmark Pharmaceuticals' GLEN.NS anti-hypertension drug Telma H, among others, were also notified by the companies to the regulator and were being investigated.

"When a medicine is found to be below quality standards, the drug regulator sends a notice to the manufacturer to check and recall that batch of product. Companies too conduct their own tests on leftover samples to check for the possibility of counterfeit," said Rajiv Singhal, general secretary of drug retailer body All India Organisation of Chemists and Druggists.

The companies did not immediately respond to Reuters' request for comment.

Gastrointestinal, anti-diabetic, vitamins and nutraceutical drug sales were one of the top contributors to the domestic pharma market growth in August, according to research firm Pharmarack.

India, one of the world's largest drug producers and exporters, is working to restore confidence after Indian-made cough syrups were linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.

(Reporting by Rishika Sadam; Editing by Leroy Leo)

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Sept 17 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMA - GOT TAX ORDER IMPOSING PENALTY OF 3.5 MILLION RUPEES

Further company coverage: SUN.NS

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Sept 4 (Reuters) - The U.S. Drug Enforcement Administration (DEA) has increased the production limit for Takeda Pharmaceutical's 4502.T ADHD drug Vyvanse and its generic versions by about 24% to address the medicine's ongoing shortage in the United States.

The raised production limit follows the Food and Drug Administration's request in July, the DEA said in a notice on Tuesday.

Attention deficit hyperactivity disorder (ADHD) drugs have been in short supply for years. The FDA warned of a shortage of Israel-based drugmaker Teva Pharmaceutical Industries' TEVA.TA Adderall in October 2022, troubled by manufacturing delays.

That led to a spike in demand and subsequent shortage of Takeda's Vyvanse.

Vyvanse, also known as lisdexamfetamine, is classified by the DEA as a schedule II controlled substance, which is applied to drugs considered to have a high likelihood of being abused, and additional prescribing safeguards are put in place.

The production limit for lisdexamfetamine was increased by 6,236 kilograms (kg), which includes 1,558 kg to address increased domestic demand and 4,678 kg for increased foreign demand for finished dosage medications, according to the DEA.

"These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally," DEA said.

US FDA approved generic versions of Vyvanse from 11 drugmakers, including U.S.-based drugmakers Mallinckrodt and Viatris VTRS.O, UK-based Hikma Pharmaceuticals HIK.L, and Indian drugmaker Sun Pharmaceutical Industries SUN.NS, last year after Takeda lost exclusivity over the drug.

Bloomberg News first reported about the increased limits on Tuesday.

(Reporting by Mariam Sunny in Bengaluru; Editing by Vijay Kishore)

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Sept 2 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMA - GETS ORDER WITH TAX INTEREST OF 8.3 MILLION RUPEES, PENALTY 1.1 MILLION RUPEES

Source text for Eikon: ID:nBSE3V3wZl

Further company coverage: SUN.NS

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Aug 23 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMA INTRODUCES TREATMENT, STARIZO IN INDIA

• INTRODUCES STARIZO IN INDIA FOR ACUTE BACTERIAL SKIN, SKIN STRUCTURE INFECTIONS

Source text for Eikon: [ID:]

Further company coverage: SUN.NS

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Aug 14 (Reuters) - Sun Pharmaceutical Industries Ltd SUN.NS:

• SUN PHARMA- TO INVEST UPTO $15 MN INVESTMENT IN PHARMAZZ INC

• SUN PHARMA - INVESTMENT RESULTING IN MORE THAN 5% HOLDING IN PHARMAZZ INC

Source text for Eikon: ID:nBSEc1HKr6

Further company coverage: SUN.NS

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Adds details, analyst comment

By Rishika Sadam and Kashish Tandon

HYDERABAD/BENGALURU, Aug 1 (Reuters) - Sun Pharmaceutical SUN.NS, India's largest drugmaker by revenue, reported first-quarter profit above analysts' estimates on Thursday, helped by strong domestic sales.

The Mumbai-based company's net profit rose 40% to 28.36 billion rupees ($339 million) in the three months ended June 30, beating analysts' average estimate of 24.78 billion rupees, according to LSEG data.

Revenue, however, missed analysts' estimates as generic drugmakers continue to take the hit of lower pricing of drugs in the competitive U.S. market.

"PAT (profit after tax) beat consensus led by higher gross margin and lower R&D spends. Strong India and steady emerging markets partly compensated for weak U.S. and ROW (rest of the world) markets," Shrikant Akolkar, an analyst at Nuvama Institutional Equities said.

Total revenue rose 6% to 126.53 billion rupees but below the estimate of 128.58 billion rupees, as per LSEG data, while sales in the United States rose just 0.5% to 38.85 billion rupees.

Most of India's generic drugmakers derive a significant share of revenue from the United States, where lower drug prices amid stiff competition have been weighing on companies' margins.

Global Specialty sales, which includes the popular medication Ilumya for treating the chronic skin condition Plaque Psoriasis, rose 14.7% to 266 million rupees. The segment contributed to 18% of total sales in fiscal 2024.

Sales in India, their largest segment by region, rose 16.4% to 41.45 billion rupees.

Rivals Cipla CIPL.NS and Reddy's REDY.NS first-quarter profit also beat Street view.

Shares of Sun Pharma turned volatile after results and ended flat.

($1 = 83.7040 Indian rupees)

(Reporting by Rishika Sadam and Kashish Tandon; Editing by Savio D'Souza and Eileen Soreng)

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Recasts paragraph 1, adds lawsuit details in paragraphs 5-7, comment in paragraph 8, background on IMVEXXY in paragraph 9

July 25 (Reuters) - Mayne Pharma MYX.AX has filed a lawsuit against India's Sun Pharma SUN.NS over infringements of patents related to a certain product used for menopause-related vaginal pain, the Australian drugmaker said on Thursday.

In the lawsuit filed at the United States District Court for New Jersey, Mayne Pharma accused its rival of violating all 20 Orange Book-listed patents linked to IMVEXXY - a vaginal insert aimed at reducing pain during sexual intercourse after menopause.

Orange Book-listed patents are those approved by the U.S. Food and Drug Administration (FDA) and deemed safe to use.

The Australian drugmaker said it filed the lawsuit after a notification indicated Sun Pharma's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of IMVEXXY.

The ANDA is a request filed to the health regulator for approval of an already licensed drug to manufacture the medication in the United States. These application processes do not warrant the applicant to go through a clinical trial.

Sun Pharma did not immediately respond to a Reuters' request for comment.

Mayne Pharma's complaint also indicated that Sun Pharma filed a Paragraph IV certification, suggesting the latter challenged the patent's (IMVEXXY) listing in the Orange Book as invalid or inapplicable.

This "formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Sun Pharma's ANDA," Mayne Pharma said in a statement.

IMVEXXY is distributed by TherapeuticsMD TXMD.O and had sealed the FDA's approval in 2018.

(Reporting by Rajasik Mukherjee; Editing by Sherry Jacob-Phillips)

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