Pharma cos bag 28% of total US FDA approvals in CY12

UR Associates has come out with its report pharma sector. According to the research firm, Indian pharma companies including its foreign subsidiaries have received 171 ANDA approvals.

The US FDA has granted 620 generic product final approvals during 2012. The approvals have been highest during the July-September 2012 period with 193 product approvals. The product approvals in the four quarters were:  
 
• Jan March 2012: 144 
• April June 2012: 148 
• July September 2012: 193 
• October December 2012: 135 
 
An analysis of the US FDA generic drug approvals during this period reveals some interesting facts: 

• Mylan Pharma and its subsidiaries with 43 approvals is the company with the highest number of ANDA approvals during the period 
• It is followed by Canadian based Apotex Pharma with 32 ANDA approvals during the period 
• India's Aurobindo Pharma  has received the third highest number of generic approvals with 31 ANDA approvals. 
• Teva Pharmaceuticals with 28 product approvals is the fourth highest during the period 

Indian pharma companies including its foreign subsidiaries have received 171 ANDA approvals. This is equivalent to 28% of the total approvals given during the period. Aurobindo Pharma with 31 generic product approvals stands first among Indian companies followed by Dr. Reddy's and Strides Arcolab  which received 19 product approvals. Sun Pharma with 18 approvals and Wockhardt with 16 approvals stand fourth and fifth respectively. 
 
Pharma company fear new EU quality rule: First, the tender-based system in certain key European markets eroded margins of key Indian pharmaceutical firms. Now more trouble from Europe seems to be on the way in the form of a directive of the Falsified Medicines Act. Come July 2013, the European Union (EU) will insist that each and every pharma export consignment be accompanied by a letter from a competent authority in the country concerned certifying that the products were manufactured to meet European quality standards. "The letter (requirement) was to come into force from April 2013. Now we are told it would happen from July 2013. We are awaiting further clarity on the issue," said a senior employee of a generic pharma major. Implications abound for active pharma ingredients (APIs). "There are indications that the Drugs Controller General of India (DCGI) would be the competent authority. We are hopeful of handling it appropriately," an official source said. According to sources, India has an option of getting recognised as an equivalent country to the EU which would obviate the need for the certificate. But the industry is not pleased. For, the process of obtaining a letter for every export consignment would be time consuming. 

Crofelemer approval a boost for Glenmark Pharma: The US FDA has approved Crofelemer, a new drug, to treat diarrhoea in HIV-afflicted patients undergoing antiretroviral therapy. Glenmark has the exclusive rights to sell this drug in India and 140 developing markets, not including China. It had estimated at the time of announcing the tie-up that the drug could earn up to $80 million (around Rs.4,350 million today) in revenue for Glenmark for this treatment. Glenmark will also supply the basic input for making this formulation to Salix Pharmaceuticals Inc., which holds the rights to sell this drug in developed markets, and had filed for US FDA approval for the drug. Salix was facing some delay in getting approvals, though this drug had been earmarked for fast-track clearance by FDA. More uncertainty had developed over Glenmark's Crofelemer opportunity as Napo Pharmaceuticals Inc. moved to terminate its licensing agreements. But the matter went into arbitration, which went in Glenmark's favour. The arbitrators also affirmed the company's right to supply Crofelemer to relief agencies for territories it has rights to. The development marks the successful culmination of a key new drug opportunity for Glenmark, albeit a co-developed product. That should be seen as a positive, but the actual benefits will take some time to reflect in its performance. Glenmark is expected to launch its first formulation only in 2014-15. That is a long way away for investors, and till then revenue will be limited to the supplies to Salix.  
 
Dr Reddys starts mining $136 million drug exclusivity: Dr Reddy's Laboratories has embarked on yet another 180-day exclusivity opportunity with the launch of its Finasteride tablets in the US market. Finasteride, which is marketed by a Merck subsidiary under Propecia brand, had an estimated $136 million sales for 12 months ended October 2012. Dr Reddy's would market the 1 mg tablets in the bottle counts of 30 and 90. Under the exclusivity, Dr Reddy's would be the only company other than the innovator to market the drug for six months in the US. However, analysts are wary of the price erosion on introduction of the generic drug. Finasteride is indicated for the treatment of benign prostatic hyperplasia and male pattern baldness.