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Gennova Bio launches biogeneric pegfilgrastim (Pegex) in India

Wednesday, April 14, 2010, 19:33 This news item was posted in Biotech category and has 0 Comments so far.

Gennova Biopharmaceuticals has launched the bio similar pegfilgrastim Pegex for the treatment of cancer patients in India.

Pegex (pegfilgrastim) is indicated to reduce the duration of Neutropenia and also the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for treatment of cancer.

Gennova’s Pegex will compete with similar peg-filgrastim biogenerics including Intas Biopharmaceuticals Ltd’s brand Neupeg.

“Cytotoxic chemotherapy induced neutropenia is often identified in 10 – 57% of patients and with certain chemotherapy regimens the risk of febrile neutropenia is more than 20%.  Old age and other co-morbid conditions can also increase the risk of febrile Neutropenia,” stated Arun Khanna, COO of Emcure Pharmaceuticals said announcing the launch.

Currently filgrastim, the conventional growth factor is used in a majority as a daily injection for 5-10 days per chemotherapy cycle.  Sometimes, due to logistic reasons the patient cannot take the recommended daily filgrastim injections leading to chemotherapy dose delays and dose reductions thus probably affecting the outcome.

Pegex (pegfilgrastim) offers the convenience of one injection per chemotherapy cycle with similar safety and efficacy profile as filgrastim, he added.

Neutropenia is a condition of reduced number of neutrophils in the blood.  Neutrophils are part of WBC’s (White Blood Cells) which plays an important role in fighting infection and maintaining immunity.

During cytotoxic chemotherapy sometimes the patient’s neutrophil count can come down drastically exposing the patient at increased risk of infection which could lead to prolonged admission and also use of certain high end antibiotics.

Neutropenia can sometimes be catastrophic.  Presence of neutropenia can force the physician to reduce the intended chemotherapy dose or postpone the regimen until the neutrophil count comes to an acceptable level.

Grannulocyte – Colony stimulating growth factors (G-CSF) like filgrastim and pegfilgrastim are used to increase the neutrophil count in chemotherapy induced neutropenia.

The cost of Pegex (pegfilgrastim) is Rs.17,900 to the patient which is the most economical brand as compared to other pegfilgrastim brands which are currently priced above Rs. 27,000, Gennova said in a press release.

Gennova Biopharmaceuticals has also developed Elaxim, the biosimilar version of tenectaplase. This drug is used in the management of myocardial infarction with S/T segment elevation.

Elaxim has been used in 11,000 patients in India, and data from 2100 such patients are published in peer-reviewed journals.

Gennova Biopharmaceuticals Ltd (GBL) is a biotech company located in Pune, India. Gennova is a subsidiary of Emcure Pharmaceuticals Ltd.

Gennova already manufactures and markets its own brands of TNK-tPA (tissue-plasminogen activator), GM-CSF (granulocyte-macrophage colony stimulating Factor) and EPO (recombinant human erythropoietin) and boasts of a robust pipeline.

Gennova has recombinant protein expression and characterization platforms using E. coli, yeast, and mammalian (CHO cells) systems.

Headquartered in Pune, India, Emcure is a vertically integrated pharmaceutical company with world class research and manufacturing facilities spread across API, formulations and biotechnology.

Emcure is a preferred outsourcing partner for some of the MNCs both in the Indian and global markets.

Emcure also researches, manufactures and markets formulations under its own brands in the domestic market and exports formulations to USA, Europe, Asia, Africa, CIS, Europe, Latin America and the Middle East.

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