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Wednesday, September 15, 2010

Savient Pharmaceuticals, Inc. SVNT FDA Approval Gout Drug

Savient Pharmaceuticals, Inc. (SVNT) received FDA Approval last night and the stock is on fire this morning. Savient Pharmaceuticals, Inc. hit $19.10 in pre market but recently slipped into the high $17's. CNBC just announced that Savient Pharmaceuticals is the stock of the day which caused SVNT to jump back to $18.25. This stock will be very active at the open and can be played from both the long and short side.

However, with the latest FDA news below, Savient Pharmaceuticals now becomes a viable takeover candidate. This would have me trading SVNT from the long side versus the short side.

FDA Approves KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy

Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA(TM) (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease." Full Press Release Here

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