Weekly Movers: Lupin, Natco Pharma, Keryx, Puma Biotech
pharmafile | April 4, 2016 | Feature | Research and Development, Sales and Marketing |
Another week of big gains and some major losses has come to pass. While the Indian pharma sector continues to grapple with compliance issues with international regulators, drug trial results were also major drivers for stock movements in the past week. Here’s a quick recap:
Shares in one of India’s largest generic firm Lupin dropped over 14% following news the US Food and Drug Administration (FDA) has made observations over one of its key manufacturing plants.
The company came out to reassure investors the observations for its Mandideep facility were minor in nature, which helped pare some losses. Lupin also said it didn’t see any supply disruption at the facility.
Lupin said there were a total of three observations made by the US FDA following the inspection of its Mandideep manufacturing facility in Madhya Pradesh between 2 February and 19 February 2016.
Natco Pharma, another Indian generics maker saw its shares fall almost 15% following news the US regulators have issued 483 observations for two of the company’s manufacturing plants.
The US FDA has made eight observations for the company’s Kothur facility, Natco’s only drug formulations manufacturing plant. The drug maker said the US regulators visited its active pharmaceutical ingredients facility in Manali and its pharmaceutical formulations plant at Kothur, between February and March.
Shares in Keryx Pharma jumped over 13% following news its trial drug to treat anaemia met the primary endpoint in late-stage trails.
If approved by the FDA, it will be the only such iron treatment in tablet form available to these patients. It is estimated that 1.6 million people in the US suffer with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anaemia.
Puma Biotechnology (NYSE: PBYI) saw its shares plunge 27.5% following the announcement the company will delay US regulatory the submission for its breast cancer drug to mid-2016.
The biotechnology firm had initially planned a New Drug Application for its trial drug neratinib in the first quarter of the year.
Anjali Shukla
