Sun Pharmaceuticals is expected to become the sole supplier of key cancer drug Doxil in the US market, with innovator firm Johnson & Johnson (J&J) hitting a production snag with its manufacturing partner Boehringer. The injectable drug, which has annual sales of about $500 million, is used to treat ovarian cancer and multiple myeloma.
Shares of Sun Pharmaceuticals hit a 52-week high of R587 in intra-day trade on Thursday, after J&J said it expects supply shortage from next month and advised patients to “contact Sun Pharma for availability of this product”. The stock closed 2.23% up at R581.30 on the Bombay Stock Exchange. Sun Pharma already holds 50% of the Doxil market share in the US.
“Based on current usage rates, we expect to encounter outages in mid-to-late October 2013. We currently cannot estimate when Doxil will be available again,” said a statement from Janssen Pharmaceuticals, a unit of J&J.
Analysts are of the opinion that Sun could repeat last year’s success with Doxil generic. Sun sold $120 million worth of Doxil in calender year 2012 and $63 million year-to-date in calender year 2013.
“Sun highlighted that doxycycline pricing (and hence sales) had picked up significantly due to a shortage in the market but additional competition could enter any time,” wrote Prashant Nair and Anshuman Gupta in a Citi Research report dated September 23. The generic is made by Sun Pharma's US subsidiary, Sun Pharma Global FZE.
Sun Pharma began supplying the drug on special USFDA importation last year owing to shortages in the US and finally received approval in February 2013 becoming the only other player besides the innovator in the space.
Doxil production hit a snag in 2011 when a Boehringer manufacturing plant in Ohio was forced to halt after regulators questioned the quality of the products being made at the facility.
J&J said publicly at the time that it planned to hire another company to make the medicine.
Boehringer's unit signed a consent decree with the USFDA in January this year over manufacturing and sterility quality problems. The decree bans the plant from making some drugs until the agency is satisfied that problems at the plant--more than 100 basic preventative maintenance activities hadn't been taken care of for at least a month — are cleared up. Earlier this month, J&J also sued Boehringer saying the company breached its 2009 agreement to make Doxil. The action seeks to force Boehringer into arbitration.