Zydus Lifesciences announced the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq Extended-Release Tablets). Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.
Source: Business-standard

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The Directorate General of Foreign Trade (DGFT) has officially announced the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA).
The decision, communicated through Trade Notice dated April 18, 2024, marks the culmination of a period during which country-wise quantitative restrictions (QR) were imposed on the import of IPA, as per DGFT Notification No. 64/2015-20 dated March 31, 2023, and Public Notice No. 04/2015-20 dated April 11, 2023. These measures were originally implemented for a one-year period from April 1, 2023, to March 31, 2024.
Following inquiries from various stakeholders, including the trade and industry community, regarding the official termination of these safeguard measures, the government has clarified its stance. According to the notification, country-wise QR measures on the import of IPA under HS code 29051220 have been discontinued effective April 1, 2024.
This move signifies that the import of IPA is now “Free” without any policy conditions, providing a significant boost to businesses involved in the import and distribution of isopropyl alcohol. IPA is a key ingredient in various industries, including pharmaceuticals, cosmetics, and sanitization products, and the removal of restrictions is expected to streamline trade operations and support industry growth.
The decision to lift safeguard measures on IPA imports reflects the government’s commitment to promoting a conducive environment for trade and commerce while ensuring the availability of essential raw materials for various sectors. It also underscores India’s commitment to aligning its trade policies with global standards and fostering a competitive business environment.
For any further queries or clarifications, stakeholders have been urged to reach out to the DGFT.
This announcement is anticipated to have a positive impact on the import and manufacturing landscape in India, facilitating smoother trade operations and contributing to economic growth and development in the country. The lifting of safeguard measures on IPA imports signifies a progressive step towards enhancing trade facilitation and promoting a conducive business environment in India.
Source: Pharmabiz

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Dr. Reddy’s Laboratories has introduced a condition-management programme for Irritable Bowel Syndrome (IBS).
DailyBloom IBS is based on research and enabled by a mobile application developed in-house. It focuses on a comprehensive care plan, including diet management, psychological and physical wellness support for patients, the drugmaker said.
IBS is a functional gastrointestinal disorder characterised by abdominal pain, bloating and altered bowel habits. Studies show IBS leads to significant morbidity, work absenteeism, loss of productivity, economic burden to the society and impacts the quality of life of patients, Dr. Reddy’s said.
A chronic condition, it can be managed more effectively by using an integrated care approach involving education, lifestyle changes, personalised nutrition and wellness, along with standard of care medical management. DailyBloom IBS is a 14-week care plan that comes with a personalised approach to ensure that each patient’s experience is tailored to their specific needs, the company said about the programme that will be made available at a cost.
“Our initiative is India’s first integrated care plan for IBS. We have drawn on our three-decade old market leadership in the gastrointestinal (GI) segment consisting of trusted and established oral drug brands such as Omez, Razo, Econorm, and Redotil, said M.V. Ramana, CEO-Branded Markets (India and Emerging Markets).
Dr. Reddy’s said the IBS programme was built with a team of multi-disciplinary experts, patients and gastroenterologists through research over a period of 12 months. The entry into condition management with DailyBloom IBS is its latest offering in digital therapeutics and follows the launch of Nerivio, a drug-free non-invasive migraine management wearable device in India, Germany and South Africa.
Source: Thehindu

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Pharma major Cipla Ltd will acquire the cosmetics and personal care distribution and marketing business of Ivia Beaute Pvt Ltd, including the latter’s brands Astaberry, Ikin and Bhimsaini, on a worldwide basis for Rs 130 crore, according to a regulatory filing by the company. Cipla Health Ltd (CHL), a wholly owned subsidiary and consumer healthcare arm, has signed a Business Transfer Agreement (BTA) for purchase of the distribution and marketing business undertaking of the cosmetics and personal care business of Ivia Beaute Pvt Ltd, Cipla said.
This strategic move is aligned with Cipla’s focus on enhancing its consumer healthcare and wellness portfolio, it added.
The acquisition will include Ivia Beaute’s brands namely Astaberry, Ikin and Bhimsaini on a worldwide basis, the company said.
On the cost of acquisition, Cipla said it will be “Rs 130 crore on the closing date and Rs 110 crore contingent upon achievement of certain financial parameters (milestones) for next 3 years as mentioned in the BTA”.
“The transaction is expected to be completed within 60 days from the signing of BTA or such other date mutually agreed between the parties in writing and shall be subject to successful completion/waiver of the conditions precedent and closing conditions as mentioned in such BTA,” it added.
Commenting on the acquisition, CHL CEO and Whole Time Director Shivam Puri said, “This move not only solidifies our presence in the expansive and dynamic beauty and personal care sector but also builds on our well-established footprint in Tier 2-6 cities.”
He further said, “Integrating Astaberry, Ikin and Bhimsaini into our portfolio seamlessly complements our existing offerings across key OTC/consumer healthcare categories, empowering us to deliver comprehensive solutions that cater effectively to the diverse everyday needs of our consumers.”
With a brand legacy of over 16 years, Astaberry caters to consumers through a wide range of unique products to help them address their skincare needs, the company said.
Source: Indiatimes

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Laurus Labs, once a leading manufacturer of antiretroviral (ARV) drugs, is undergoing yet another transformation under Satyanarayana Chava, its Founder & CEO. Until 2011, ARVs—a group of medication used to manage and treat human immunodeficiency virus (HIV) infection—accounted for a substantial portion of the company’s revenue. Then it made a strategic shift towards becoming an active pharmaceutical ingredient (API)-focussed company.
Subsequently, the company forayed into the formulations business in 2014, which helped it become an integrated pharma company by 2020. As a result of that shift, the ARV API contributes only 25% of revenues now, while the contract development and manufacturing organisation (CDMO) segment has seen significant growth.
The success of these shifts is evident in the numbers. Over the past five years, Laurus Labs, which was founded in 2005, has seen a significant growth in revenues, rising from Rs 2,292 crore in FY19 to Rs 6,041 crore in FY23, an increase of 164% over the period. However, there has been a slight dip in revenues in the first nine months of FY24, settling at Rs 3,601 crore.
Further, Laurus Labs’s biotechnology business represents a strategic diversification into a high-growth sector with significant potential for development. The biotech business is relatively new, launched in 2021 through the acquisition of Richcore Life Sciences, a pioneer in microbial fermentation technology.
By leveraging its expertise in fermentation technology and focussing on sustainable and innovative products, Laurus Bio (what Richcore is called after acquisition) aims to capture a significant share of the growing biomanufacturing market—which is valued at $216.7 billion in 2023, according to business consulting firm Grand View Research, and is projected to grow to $420.7 billion by 2030, with a CAGR of 9.5%. Rising demand for sustainable solutions, bio-based products, and advances in biotechnology are driving this growth. India, which is emerging as a significant player in this space, also has a thriving biomanufacturing market estimated at $58 billion in 2023, per the national investment promotion agency Invest India, and is anticipated to double every two to three years, and could reach $300 billion by 2030.
“Our investment in [the] bio [space] in 2021 helped Laurus offer a combination of biology and chemistry for sustainable products. Laurus’s recent investment in ImmunoACT, launching the country’s first indigenously developed CAR-T [cell therapy] for cancer treatment, is another area of interest. These investments were augmented by licensing patents from IIT Kanpur on certain rare disease molecules,” says Chava.
Chava, winner in the pharma & healthcare category of the BT-PwC India’s Best CEOs ranking this year, is now targeting investments in emerging areas such as precision fermentation, viral vector manufacturing, and cell and gene therapy, with the CDMO segment expected to lead near-term growth. Chava, who has a master’s degree and a PhD in chemistry from Andhra University, an Executive MBA from the Indian School of Business, and a postgraduate diploma in quality management from the World Quality Council, brings over three decades of pharmaceutical experience.
Pharmaceutical analysts are upbeat about the company as the CDMO segment’s project pipeline is expanding, and the animal health unit is expected to contribute gradually from Q4FY24. The biotech segment is witnessing momentum, with plans for capacity expansion.
Gross profitability has improved, with potential margin improvements as sales volumes increase, analysts say. Significant investments in capex have been made, with expectations for future demand. Commercialisation of CAR-T therapy has commenced, with profitability expected in Q4FY24. “Laurus Labs would incur a cumulative capex of Rs 2,800 crore over FY22-24, across CDMO, non-ARV formulation, and non-ARV API segments. Further, it is undergoing a validation phase for products in the animal health segment, and capex for the crop science segment. It is [also] building a product pipeline in the non-ARV formulation segment,” says Tushar Manudhane, Research Analyst at brokerage firm Motilal Oswal Financial Services.
But there has been a dip in revenue and profits in FY24. Speaking about this, he says, the anticipated increase in sales from CDMO and non-ARV segments has been delayed. The company experienced adverse effects on its performance, especially in the third quarter of FY24, adds Manudhane.
A report from research firm K.R. Choksey Research indicated that despite underperforming on profitability in Q3FY24, Laurus Labs could see improvement in its margins. “Regulatory compliance remains robust, with significant investments in R&D and capacity expansion in high-growth segments like CDMO and bio,” said the research firm’s report.
With the pieces falling into place, it’s no wonder that the analysts are upbeat about Laurus Labs.
Source: Businesstoday

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Dr Reddy’s Laboratories, a pharmaceutical company, launched Nerivio, its migraine management device in India last year. The company has now launched the device in Europe.
Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Migraine is a global health challenge, affecting around 30% of adults on 15 or more days per month, impacting 1.7% to 4% of the population.
The current best estimate of global migraine prevalence is 14–15%, and, in terms of burden, migraine accounts for 4.9% of global ill health, quantified as years lived with disability. Around 8 to 10 million people in Germany are affected, 14.8% of women and 6.0% of men.
Nerivio, a prescription-based, non-invasive solution, is designed to address both acute and preventive treatment of migraines. Worn on the upper arm, each Nerivio device offers 18 sessions lasting 45 minutes each. For acute migraine treatment, it’s recommended to use within 60 minutes of headache onset, while for preventive measures, it can be used every other day.
The company asserts that Nerivio operates through Remote Electrical Neuromodulation (REN), targeting nerve endings to trigger conditioned pain modulation. This stimulation initiates a natural process of pain relief in the brainstem, resulting in widespread pain inhibition that targets the root cause of migraine discomfort in the head.
The Nerivio migraine treatment device is accompanied by the Nerivio app, accessible on both Android and iOS platforms. This app allows users to adjust the device’s intensity levels and includes an interactive migraine diary for symptom logging, response tracking, and sharing valuable analytics.
Source: Indiatimes

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Bayer launched the patented drug vericiguat under the brand name Verquvo in India. VERQUVO (vericiguat) is the first soluble guanylate cyclase stimulator, a new class of drugs, which works on a pathway not currently targeted by existing heart failure treatments and was studied in a population with a higher risk of cardiovascular death or heart failure hospitalization.
3 out of every 5 Indian heart failure patients may succumb within 5 years of their diagnosis.
Under this new partnership, Dr. Reddy’s will market the drug under a second brand name Gantra® in India, expanding the reach of vericiguat to meet the needs of patients with Chronic Heart Failure with reduced ejection fraction (less than 45%).
Dr. Reddy’s Laboratories Ltd. and Bayer announced that both companies have entered into a partnership to market and distribute a second brand of Vericiguat in India. Under the terms of this agreement, Bayer has granted non-exclusive rights to Dr. Reddy’s under the brand name Gantra®. Vericiguat, a soluble guanylate cyclase (sGC) stimulator, in India, is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45%), following a recent event of worsening heart failure which required hospitalization or outpatient intravenous (IV) diuretics. Vericiguat works on a pathway not currently targeted by existing heart failure treatments and can reduce the combined risk of cardiovascular death and heart failure hospitalization in such patient. India has between 8-10 million people with heart failure, making it one of the largest populations with this condition.
Shweta Rai, Managing Director, Bayer Zydus Pharma and Country Division Head (CDH) for Bayer’s Pharmaceuticals Business in South Asia said, “Despite therapy, chronic heart failure patients can experience disease progression that disrupts their lives and leads to worsening heart failure events. Vericiguat can help slow down disease progression, reduce hospital admissions and improve their chances of survival. The introduction of a second brand of vericiguat in India, through our partnership with Dr. Reddy’s is a reaffirmation of our commitment to making innovative healthcare solutions accessible to as many patients as possible. We are excited about the possibilities this partnership with Dr. Reddy’s presents in improving health outcomes for patients with chronic HF, following a recent event of worsening heart failure.”
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s said: “Strengthening our chronic therapy portfolio in India continues to be a focus area for us. Vericiguat is a first-in-class sGC stimulator indicated for adults with symptomatic, chronic HF and ejection fraction less than 45% following worsening heart failure. The addition of Vericiguat bolsters our heart failure management portfolio that includes Cidmus®, Daplo® and beta blockers. The partnership with Bayer is part of Dr. Reddy’s continuous efforts to make innovative medicines available to patients in India through strategic collaborations. We will use our strengths in marketing and distribution to widen access to this novel treatment in metros and beyond into tier-I and tier-II towns in India.”
Heart failure is a major public health issue affecting more than 8-10 million people in India. The average age of an Indian heart failure patient is a decade younger than their Western counterparts being 55 – 60 yrs. Despite the substantially younger age of patients with HF in India, the 5-year mortality rate is 60%. In patients with chronic heart failure, with reduced ejection fraction (less than 45%) an event of worsening heart failure can happen at any stage. 90% of patients who suffer from worsening heart failure are not in the advanced stage of chronic heart failure. HF remains the commonest cardiac cause of hospitalization in India with worsening heart failure events being one of the most important causes of death in heart failure patients.
Source: Pharmacytimes

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Merck, Germany-based science and technology company, announced the appointment of Dhananjay Singh as the managing director of Merck Life Science in India, in addition to his current position as head of Science & Lab Solutions Commercial, India. Effective April 1, 2024.
Dhananjay Singh has taken over from Sreenath NS, who is retiring after 36 years of service with Merck in India.
“Dhananjay’s expertise in market dynamics and multi-stakeholder relationship management will further strengthen Merck Life Science’s position in the Indian market,” said Pratima Reddy, country speaker, Merck India.
“Together with the India country leadership team, I look forward to his continued leadership to spearhead initiatives aimed at shaping India’s narrative towards people-centric performance and progress.” added Reddy.
In his role as MD, Dhananjay Singh will be responsible for driving the life science strategy in India, ensuring governance and compliance alongside other leaders from Merck’s businesses in India.
Dhananjay Singh joined SigmaAldrich in 1997. Over the years he took on several leadership roles in Commercial Organisation before his appointment as head of Science & Lab Solutions Commercial for India, a position he held since 2022.
Source: Economictimes

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Biocon Ltd. is pivoting to anti-obesity therapies as patents for the blockbuster medications start to expire, unleashing a wave of generic supply for the market that’s expected to touch $100 billion by 2030.
The Bengaluru-based firm has scored an early win among its peers with the UK approval for the first generic version of liraglutide injectible, which is losing patent protection in November. The weight loss drug, sold under the brand name Saxenda by patent holder Novo Nordisk A/S, is among the first of the groundbreaking medications in this category to lose patent protection.
While Saxenda is far less effective for weight loss than later iterations like Wegovy and Ozempic, its generic version is just the beginning of a jackpot that drugmakers like Biocon are awaiting. “My leadership team and organization is ensuring that we do not give up the lead position we have now,” Chief Executive Officer Siddharth Mittal said in an interview.
Another 15 peptide formulations are under development, of which one or two drugs will seek regulatory approval this year, he said. Biocon has also filed applications before the US and European regulators for liraglutide.
The company, helmed by Kiran Mazumdar Shaw, is leading the charge among Indian drugmakers — the world’s largest supplier of generic medicines — as they race to grab a slice of the obesity drugs market. The global frenzy around these medicines has already lured sector giants Sun Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd., and Cipla Ltd., who are also developing their anti-obesity drugs.
Weight loss drugs have already produced record profit for innovative pharmaceutical companies from Novo Nordisk to Eli Lilly & Co. The gold rush is set to spread to generic makers like India’s biggest players when patents expire in the coming years on Ozempic and Wegovy, allowing cheaper copies of the medication to flood the market and plug supply gaps.
Novo Nordisk’s Ozempic and Wegovy are made with the same active ingredient, semaglutide, while Eli Lilly’s tirzepatide drug is sold as Zepbound. These, along with liraglutide, are part of a class of medications called glucagon-like peptide 1, or GLP-1, agonists.
Biocon is building capability “to take advantage of what could be a very, very strategic peptide opportunity with GLPs at the center,” Group Chief Executive Officer Peter Bains told analysts in November.
‘Very Complementary’
The loss of exclusivity for GLPs will create a multibillion dollar market over the next 10 years and this opportunity was “very complementary” to Biocon’s current biologics business, according to Bains.
In the UK, Mittal said the company will wait for the publicly-funded, National Health Services, to float a tender to launch its liraglutide injectible. Biocon’s UK application was filed through its European partner, Zentiva SA. The total addressable UK market opportunity for GLP-1 in diabetes and weight loss is $425 million, according to a March 27 statement by Biocon.
Despite the weight-loss segment being a rage globally, these drugs are yet to make an widescale appearance in India whose 1.4 billion-plus population is rapidly getting more affluent and obese.
Novo Nordisk, which only sells its semaglutide-based pill Rybelsus in India, is planning to introduce injectibles Wegovy and Ozempic in 2026, Reuters reported in February. Eli Lilly is conducting clinical trials in India for weight-loss pill, orforglipron.
Biocon has not yet filed for liraglutide approval in India and it is working with the local drug regulators to see if the requirement of a clinical trials can be waived, Mittal said. The company is also looking for a partner to market its obesity drugs in India after it sold its branded formulations business to Eris Lifesciences Ltd. last month.
Over the next 20 years, “this is a very attractive space”, Mittal said. The UK approval shows that Biocon can confidently “capture the opportunity in the coming years.”
Source: ETPharma

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