Lupin Pharma developing new products to treat cancer, other diseases

Lupin Pharma developing new products to treat cancer, other diseases

Drug maker Lupin is in the process of developing a pipeline of products under its new drug discovery programme to treat various diseases like cancer and metabolic disorders, a top company official said.

The company, which last month inked a partnership with global pharma company AbbVie for the development and commercialisation of its novel oncology drug to treat hematological cancers, is focussing on first-to-market kind of opportunities with its new products.

“The Novel Drug Discovery and Development (NDDD) is focused and committed on developing a pipeline of highly differentiated and innovative new chemical entities in various therapeutic areas like oncology, immunology and metabolic disorders,” Lupin President NDDD Raj Kamboj told PTI.

When asked about company’s ambitions from the programme over the next twothree years, he said, “Lupin will focus NDDD activities to advance pipeline programs where there are first-to-market and/or best-in-class opportunities. Emphasis will be stressed on designing compounds that are differentiated in their respective class. This in turn will create attractive partnering opportunities.”

Sharing details, Kamboj said the Mumbaibased company is currently working on developing various products, including two major ones to treat chronic kidney diseases and lung cancer. Lupin currently utilises its Pune-based research and development centre for NDDD programme. Last month, AbbVie licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein1) inhibitor programme. Through this partnership, AbbVie gains exclusive global rights to develop and commercialise MALT1 inhibitors. Under the terms of the agreement with AbbVie, Lupin is entitled for an upfront payment of USD 30 million. Upon successful completion of regulatory, development and commercial milestones, the company is eligible to receive total milestone payments of up to USD 947 million.

Additionally, Lupin will be entitled to receive a double-digit royalty on the sales of the product and will retain commercial rights to the programme in India, the company added. “The deal with AbbVie is a tribute to the outstanding scientific and technical progress that NDDD has been able to achieve,” Kamboj said.

[Courtesy: https://www.business-standard.com/article/health/lupin-pharma-developing-new-products-to-treat-cancer-other-diseases-119011300093_1.html, Business Standard, PTI]

Lupin receives FDA approval for Lurasidone Hydrochloride Tablets

Pharma major Lupin announced that it has received approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. It is indicated for:

• Treatment of adult patients with schizophrenia.
• Monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).
• Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).

Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg had annual sales of approximately USD 3217.3 million in the US (IQVIA MAT September 2018).

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials and the issue was identified upon standard visual inspection prior to patient administration. If injected, this product (containing rubber particulate matter from the stopper) could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses. Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs Ceftriaxone for Injection, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. To date, the Company has not received any reports of adverse events related to the recalled lots. Ceftriaxone for Injection, USP, is packaged in a glass vial, in pack of 10, containing 10 vials in a carton, with NDC