Glenmark wins case against Napo Pharma

UR Associates has come out with his report on pharma sector. According to research firm, Indian pharma companies received 29% of total US FDA generic drug approvals during the April-August period.

Glenmark wins case against US' Napo Pharma: 

Pharma company Glenmark has won a legal battle against Napo Pharma over rights to sell HIV-associated diarrhoea drug Crofelemer in 140 countries. In its verdict, international arbitrator, the International Centre for Dispute Resolution (ICDR), ruled in favour of Glenmark. According to the verdict, Glenmark has exclusive rights to commercialise and distribute Crofelemer, through relief agencies, in the 140 countries that comprise the Glenmark territory. The potential peak sales of the drug are pegged at $80 million (around Rs 4.4 billion) for the 140 markets. Glenmark had sought arbitration in the US last December after its partner — Napo Pharma — terminated an agreement under which Glenmark held the exclusive rights to distribute Crofelemer in 140 countries including India. In a three-party agreement, Napo Pharmaceuticals which discovered the molecule had licensed it to Salix Pharmaceuticals and Glenmark for developing and marketing the drug in certain territories. Napo terminated the agreement in last November citing breach of agreement. Salix was to sell the drug in regulated markets such as North America, Japan and Europe. 

Zydus Cadila concludes deal to re-launch Urokinase drug:  

Cadila Healthcare Ltd, a group company of Zydus Cadila, has informed that it has concluded the agreement to re-launch KINLYTIC (Urokinase) in North America with Microbix Biosystems. Both companies are now working towards regulatory approval expected by late 2014. In January, Cadila had signed a Letter of Intent (LOI) to market the drug in North American market with the Canadian biotech company Microbix Biosystems Inc. KINLYTIC (urokinase) is expected to reach $400 million in the US market, as per Microbix statement. KINLYTIC (urokinase) injection is used to dissolve blood clots that have formed in the lungs (pulmonary embolism). Urokinase is an enzyme produced by the kidney. Tissue cultures of human kidney cells are used to produce the drug. The product was first approved in 1978 and up till now has been administered to over four million patients worldwide. The drug was unavailable since 2009 due to lack of an approved manufacturing facility, said Microbix statement. In 2008, Microbix acquired all rights to KINLYTIC and has been working to re-introduce the drug since then. The drug was originally developed by Abbott Laboratories.
 
Pfizer ends supply deal with Claris Lifesciences : 

Pfizer Inc has terminated its three-year old supply deal with Claris Lifesciences, immediately after a ban on the Ahmedabad company's US sales was lifted. "Pfizer has terminated its supply agreement and has no current plans to source any products from Claris," a Pfizer spokesperson said in response to an email query. Pfizer lost two crucial years when the ban was in force and did not see any major business coming from generic injectables made by Claris. Claris entered into an agreement with Pfizer in 2009 to gain access to markets in North America, Europe and Australia. The deal allowed the world's top pharma company by revenues to sell 15 off-patent parenteral products made by Claris in the Western markets under its own brand name and add more products to its global generic basket worth $10 billion.

The US FDA has in total given 289 generic product approvals and tentative approvals (excluding labeling revisions, modified indications and manufacturing changes) during the period April-August 23rd. An analysis of the US FDA generic drug approvals during this period reveals some interesting facts:

• Mylan Pharma and its subsidiaries with 23 approvals is the company with the highest number of ANDA approvals during the period. 
• It is closely followed by Canadian based Apotex Pharma with 22 ANDA approvals during the period 
• Teva Pharmaceuticals with 19 product approvals is the 3rd highest during the period. 
• Indian pharma companies including its foreign subsidiaries have received 82 ANDA approvals. This is equivalent to 29% of the total approvals given during the period. 
• Aurobindo Pharma with fourteen approvals is the Indian drug company that received the highest number of approvals during the period. 
• It is followed by Dr Reddy’s with 10 approvals and Sun Pharma and its subsidiaries with 9 approvals. 
• These companies are followed by Strides Arcolab (8 approvals), Wockhardt (7 approvals), Hetero Labs (7 approvals), Torrent Pharma (6 approvals), Cipla (5 approvals), Glenmark (4 approvals), Lupin (4 approvals), Ranbaxy, Alembic Pharma and Orchid Healthcare (2 approvals) and Suven Lifesciences, Wockhardt and Zydus Pharma (1 approval).
• Wockhardt has witnessed a flurry of approvals during the last one month with six of its seven approvals coming in August 2012.
• Some of the major drugs that became generic during the period are Plavix (market size of USD6.7 bn), Zyprexa (USD3.3 bn), Actos (USD 2.7bn), Lyrica (USD 1.8 bn), Valtrex (USD1.3 bn) and Boniva (USD510 mn).  

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