Page 3 - Lupin

Lupin inks pact to acquire two inhalation brands from Sunovion for $75 mn

Drug maker Lupin on Thursday said it will acquire two inhalation brands from Sunovion Pharmaceuticals Inc for USD 75 million (around Rs 622 crore). The drug firm has inked a pact with US-based Sunovion to acquire Brovana (arformoterol tartrate) inhalation solution and Xopenex HFA (levalbuterol tartrate) inhalation aerosol. The Mumbai-based firm expects the transaction to be accretive to earnings in the first year. The acquisition of these two brands will expand the company's inhalation product portfolio in the US and strengthen its presence in the respiratory therapy area while continuing to provide patients access to these important medicines, Lupin said in a statement. Brovana is indicated for long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Xopenex HFA is a short-acting beta2-adrenergic agonist (SABA), indicated for the treatment or prevention of bronchospasm in adults, ...

Lupin ties up with global agencies to support tuberculosis treatment

Drug firm Lupin on Friday said it has tied up with Unitaid, The Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis prevention treatment initiative to be rolled out to 138 countries. As per the agreement, the Mumbai-based firm will introduce two new formulations, a fixed-dose combination of Rifapentine + Isoniazid and Rifapentine 300 mg standalone tablets, at an affordable price in various regions, including many low-and middle-income countries with a large burden of tuberculosis (TB). "We are committed to enhancing the global access to affordable and high-quality drugs and APIs for the treatment of tuberculosis... "Through this, we will further reinforce our long legacy to provide shorter, more patient-friendly treatment options to prevent TB," Lupin Managing Director Nilesh Gupta said in a statement. Lupin is a leading player in the cardiovascular, anti-diabetic, and respiratory segments.

Lupin gets USFDA nod to market generic HIV drug Darunavir tablets

Drug firm Lupin on Tuesday said it has received an approval from the US health regulator to market Darunavir Tablets, used to treat Human Immunodeficiency Virus (HIV) infection, in the American market. The Mumbai-based company said it is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. Lupin will also potentially have shared 180-day exclusivity on the 600 mg tablets, it added. The company has received the approval from the US Food and Drug Administration (USFDA) for the medication in strengths of 600 mg and 800 mg, Lupin said. The drug firm's product is a generic equivalent of Janssen Products' Prezista Tablets. As per MAT June 2022 data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US. Lupin shares were trading 2.17 per cent up at Rs 738.30 apiece on the BSE.

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Lupin gets warning letter from USFDA for Tarapur API plant in Maharashtra

Drug firm Lupin on Thursday said it has received a warning letter from the US health regulator for its Tarapur-based manufacturing facility in Maharashtra. The US Food and Drug Administration (USFDA) inspected the site from March 22, 2022 to April 4, 2022. The company manufactures both fermentation-based and synthetic APIs (active pharmaceutical ingredients) at the plant. "The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," the Mumbai-based company said in a regulatory filing. The drug firm is committed to addressing the concerns raised by the USFDA and will work with the agency to resolve the issues at the earliest, it added. Lupin did not share details about the issues flagged by the US health regulator. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The letter identifies the violation, such as

Lupin receives approval from US FDA for Sildenafil for Oral Suspension

The company has launched the tablets in strengths of 5 mg, 20 mg and 40 mg after having received an approval from the United States Food and Drug Administration earlier, Lupin Ltd said in a statement

Lupin dips 3% as US FDA issues warning letter for Tarapur facility

Lupin said it does not believe the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility

Nifty Pharma index sees biggest jump in four months, shows data

The Nifty Pharma index finished at 12,750, up 3.1 per cent - most since May 20 and third biggest single-day gain of the year

Lupin gets nod for arthritis drug 'Rymti' from Canadian health authority

Drug maker Lupin on Tuesday said its biosimilar product Rymti, indicated for the treatment of arthritis, has received approval from the Canadian health authority. The company's product is the biosimilar of reference drug Enbrel (Etanercept). The product is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis , plaque psoriasis and paediatric plaque psoriasis. "The approval for Rymti in Canada is a key milestone in our endeavours to improve access to medicines," Lupin Biotech President Cyrus Karkaria said in a statement. It underscores the scientific success of the company's biosimilar programmes and commitment to advancing healthcare through innovation, he added.

Lupin receives US FDA approval for kit used in colonoscopy preparation

Pharmaceuticals firm Lupin Ltd on Friday said it has launched the generic sodium sulfate, potassium sulfate and magnesium sulfate oral solution, used for cleansing colon as a preparation for colonoscopy, in the US market following approval from the country's health regulator. The approval by the US Food and Drug Administration (USFDA) is for sodium sulfate, potassium sulfate and magnesium sulfate oral solution of strength 17.5 g/3.13 g/1.6 g per 6 ounces, Lupin Ltd said in a regulatory filing. The approved oral solution is a generic equivalent of Suprep Bowel Prep Kit Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, of Braintree Laboratories Inc, it added. The solution had an estimated annual sales of USD 202 million in the US, the company said citing IQVIA MAT July 2022 data.

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The technical analyst from HDFC Securities recommends buying Lupin 700 Call and simultaneously selling 720 Call for the August series.

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Lupin gets USFDA approval to market generic cancer treatment drug

Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America. The company in partnership with Pharmascience Inc. has received approval from the US Food and Drug Administration (FDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, it said in a statement. The Mumbai-based drug maker's product is a generic version of Bristol-Myers Squibb Company's Sprycel tablets. As per IQVIA MAT data, Dasatinib tablets had an estimated annual sale of USD 1,569 million in the US. Shares of Lupin settled at Rs 662.50 apiece, up 1.49 per cent on the BSE.

Lupin pharmaceutical inks licensing pact with Japan-based I'rom Group

Drug maker Lupin on Thursday said it has inked a licensing pact with Japan-based I'rom Group Co for a product used in the treatment of postmenopausal women with osteoporosis, among others. Under the terms of the agreement, I'rom along with the Mumbai-based drugmaker will conduct clinical trials, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis. Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture and prevention of skeletal-related events in patients with bone metastases from solid tumours, among other indications. Following the completion of the clinical trial and receipt of marketing authorisation in Japan, I'rom will commercialise the product in the island nation, Lupin said in a statement. As part of the agreement, the drug maker will receive multiple milestone payments, it added. Currently, Denosumab is available under two brands, Pralia and Ranmark, with market size of about USD 500 mill

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Lupin gets USFDA approval for Formoterol Fumarate Inhalation Solution

Lupin on Wednesday said it has received approval from the USFDA for Formoterol Fumarate Inhalation Solution, used in treating symptoms of chronic obstructive pulmonary disease. The company has received approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Mylan Specialty's Perforomist Inhalation Solution, the Mumbai-based drug maker said in a statement. As per IQVIA MAT June 2022 data, the medication had annual sales of around USD 282 million in the US market. Shares of Lupin ended 2.55 per cent down at Rs 677.65 apiece on the BSE on Wednesday.

Lupin receives USFDA nod for rufinamide tablets to treat seizures

Pharmaceuticals firm Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic rufinamide tablets used in the treatment seizures. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of rufinamide tablets of strengths 100 mg, 200 mg, and 400 mg, Lupin said in a statement. These are the generic equivalent of banzel tablets of same strengths of Eisai Inc, it added. The product will be manufactured at Lupin's facility in Goa, the company said. Rufinamide tablets had estimated annual sales of USD 164 million in the US, Lupin said citing IQVIA MAT June 2022 data.

Lupin revising product portfolio in US to overcome price erosion impact

Homegrown pharmaceutical firm Lupin Ltd is rationalising its product portfolio in the US, transitioning from simple oral solid medicines to more complex generics to overcome the impact of price erosion witnessed in the market, according to the company's CEO Vinita Gupta. With its planned product pipeline for complex generic medicines in the next two years, she said in the years to come the company hopes to have up to 40 per cent of its revenue coming from such medicines in the US market. "...Oral solids (are) still the bread and butter (for the company), but the kind of price erosion one has witnessed on the oral solid side, we decided that it made sense to rationalise the portfolio that does not make sense," she told analysts. Gupta further said, "Whether it's negative margin or low margin, it makes sense to really take the overhead out of our P&L (profit and loss) to improve profitability. We are taking those steps." She was responding to a query on Lupin's strategy to counter ..

Lupin reports Q1 net loss at Rs 89 cr on lower US sales; revenue falls 12%

'Our numbers are muted this quarter, but we expect a strong bounce back from Q2 onwards,' says Lupin MD

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