Wednesday, November 14, 2012

Biocon cancer portfolio gaining strength - Everolimus and Nab-paclitaxel

Over the last few months, new regulatory approvals and clinical data from new trials have transformed the market potential of two marketed cancer drugs - Novartis' Afintior (Everolimus) and Celgene's Abraxane (nab-paclitaxel).  Innovators obviously would be the one's most happy about this, but the other company which is also going to gain out of this is India based Biocon.   

Biocon has both these cancer drugs in its portfolio and should be able to provide Indian patients with affordable access to these new treatments, which can significantly extend patients life
 :
1) Evertor (Everolimus) - The first and only branded generic version of Novartis renal cell carcinoma drug  Afinitor in India
2)  Abraxane ( Nab-paclitaxel )- Licensed from innovator Abraxis Life Science ( later acquired by Celgene) 

Recently approved additional Indications for Afinitor and Abraxane
When  Biocon launched Evertor in January 2011, it was just approved for Renal cell carcinoma  and a few other rare types of cancer. In July this year, the USFDA granted approval to Afinitor for for treatment of  post menopausal women with  Hormone receptor positive and HER2-ve breast cancer who have failed prior treatment with aromatase inhibitors.  The approval was based on path breaking benefit demonstrated by Afinitor in global Phase 3 trials.   Novartis at its recent R&D investor day highlighted that they are expecting $ 2billion in incremental sales from Afinitor in breast cancer alone.  Unfortunately in India as well breast cancer is one of the most commonly occuring cancer. Biocon should be able provide affordable access of this path breaking drug to Indian women patients.

Abraxane which is already approved for second line treatment of breast cancer was recently approved by USFDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.  

Abraxane approval was based on results of a large randomized clinical trial (1,038 patients) that showed a significantly higher response rate in patients with NSCLC treated with Abraxane plus carboplatin (33%) compared with patients who received conventional paclitaxel and carboplatin (25%).  Abraxane + carboplatin regimen demonstrated superior response rates in patients who had squamous-cell tumors (41% versus 24%) and those with large-cell carcinoma (33% versus 15%).

Abraxane is also all set for gaining approval in Pancreatic cancer and Metastatic Melanoma as well
Over the last month, Abraxane reported Phase 3 data in these indications. In pancreatic cancer in the Phase 3 study, 861 treatment-naive pancreatic cancer patients were randomized to treatment with Abraxane plus the chemotherapy gemcitabine or gemcitabine alone. The combination of Abraxane/gemcitabine demonstrated a statistically significant improvement in overall survival, the study's primary endpoint. Analsyts are projecting peak sales in excess of $1billion for Abraxane in pancreatic cancer. Post the announcement of data, Celgene stock was up approximately 12 percent.

Also recently Celgene / Abraxis reported top-line results of a Phase III study of Abraxane in 529 chemotherapy-naive patients with metastatic melanoma which demonstrated statistically significant improvement in progression-free survival (PFS) compared to patients receiving dacarbazine chemotherapy.

About Everolimus / Afinitor / Evertor
Everolimus is marketed under the brand name Evertor and is is the first and only generic brand of Everolimus in India. Novartis is the innovator of Everolimus and sells it under the brand Afinitor.

About Abraxane  / nab-paclitaxel
Biocon sells nab-paclitaxel under the brand name Abraxane under license from the innovator (Abraxis Bioscience - acquired by Celgene). n August 2007, Abraxis established a licensing agreement with Biocon for the commercialization of ABRAXANE in India. Under the terms of the agreement, Biocon has the right to market ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Subsequently, Abraxis received approval in October 2007 from Indias Drug Control General to market ABRAXANE in India.

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