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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Merck MRK buys Schering-Plough SGP 3/9/09

The Dow Jones Futures are taking a bit of a nose dive as Dow component Merck ( MRK ) buys Schering-Plough ( SGP ) for 41.1 Billion today, 3/9/09.

• COMBINED COMPANY POSITIONED FOR SUSTAINABLE GROWTH THROUGH SCIENTIFIC INNOVATION AND A STRONGER, MORE DIVERSIFIED PRODUCT PORTFOLIO
  
• Powerful Joint R&D Pipeline with Strong Candidates in All Development Phases Doubles the Number of Late-Stage Compounds to 18
  
• Broader Product Portfolio in Critical Therapeutic Areas
  
• Expanded Global Presence Including High-Growth Emerging Markets
  
• Expected to be Significantly Accretive, Increase Efficiencies and Result in Cost Savings of Approximately $3.5 Billion Annually
  
• Merck Committed to Maintain Current Dividend

March 9, 2009 - Merck & Co., Inc. (NYSE: MRK) and Schering-Plough Corporation (NYSE: SGP) today announced that their Boards of Directors have unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine, under the name Merck, in a stock and cash transaction. Under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 shares and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Merck Chairman, President and Chief Executive Officer Richard T. Clark will lead the combined company.

Based on the closing price of Merck stock on March 6, 2009, the consideration to be received by Schering-Plough shareholders is valued at $23.61 per share, or $41.1 billion in the aggregate. This price represents a premium to Schering-Plough shareholders of approximately 34 percent based on the closing price of Schering-Plough stock on March 6, 2009. The consideration also represents a premium of approximately 44 percent based on the average closing price of the two stocks over the last 30 trading days

Full Article

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ELAN - ELN - Tysabri Drug goes wrong!

Tonight Elan ( ELN ) is down another 35% as the company released an SEC filing stating that two patients taking Tysabri were infected with the rare PML brain disorder.

These two incidents happened today and yesterday....both patients are in Europe....one still hospitalized, the other is at home and clinically stable.

Elan was $32 just days ago and now has fallen to $11.50 afterhours tonight.

ELN has strong support in the $7 range so if it got there it might be interesting. This is fresh news so tomorrow I will look to see how the market takes this news.

Watching my level 2 trading....i'm seeing big blocks coming in for sale: 500,000 share blocks coming in hitting the bidders. Not a good sign!!

ELN could trade between 80-120 million shares tomorrow I would guess. Who knows maybe more! Keep this stock on your watchlists.

Please note: Biogen Idec ( BIIB ) is also a partner for this drug

http://www.sec.gov/Archives/edgar/data/737572/000095016208000315/elan6k_073108.htm

EPCT - Epicept up 200% Pre Market Drug Approval

Today ECPT - Epicept is up over 200% on approval of Ceplene, one of their drugs.

Ceplene(R) Receives Positive European Opinion for Approval From CHMP

Marketing Authorization Normally Anticipated within 67 Days in the EU
Conference Call to be Held July 28 at 9:00 a.m. Eastern Time

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion regarding the marketing authorization for Ceplene® (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU