Two weeks after getting a closeout letter from the FDA withdrawing a ban on its injectable drugs made at plants in India and New Jersey, Claris Lifesciences says it will go it alone in the U.S. market. With the sterile injectables market prime, in part because of Claris' two-year absence, it is a strategy that may pay off nicely.
Pfizer ($PFE) last week acknowledged that it had severed its three-year supply deal with Claris after the company ran afoul of the FDA in 2010. Now Claris says that in addition to Pfizer, it will no longer sell through West-Ward Pharmaceutical or Sagent Pharmaceuticals ($SGNT).
Pitting itself against its former partner, West-Ward, should make for an interesting development since West-Ward's parent, Hikma Pharmaceuticals, just announced that its sterile injectables business was the bright spot in its earnings last quarter. It reported nearly doubling sales in that division to $225 million, which hiked the company's total revenue nearly 35% to $532.3 million. Citing stats from the FDA on growing drug shortages, a West-Ward executive last year said the company saw big opportunities in picking up that slack. The improvement in that part of Hikma's business, however, was offset by production problems at a solid dose generics plant in Eatontown, NJ, that is the subject of an FDA warning letter.
The FDA imposed an import alert on Claris' Ahmedabad, India, plant in June 2010, after reports that some of the company's products were contaminated with fungus. Pfizer was forced to recall some antibiotics and an anti-nausea product contracted out to Claris that were tied to the contamination issues. The FDA said Sagent discovered that some of Claris' sterile products "were contaminated with a swirling mass," which the complainant identified as the fungus Cladosporium. The FDA said Claris failed to get to the "root cause" of the problem.
Earlier this month, however, the FDA told Claris that its plant in Ahmedabad, and one in North Brunswick, NJ, that also was included in the warning letter, had now been cleared.
- read the release (PDF)
Claris closeout letter ends product ban tied to contamination
Pfizer severs supply deal with India's Claris
FDA blocks Claris imports on plant troubles
West-Ward plant problems undermine Hikma earnings
West-Ward sees shortages as 'major opportunity