Savient Pharmaceuticals ( SVNT) Drug/indication: Krystexxa for gout Approval decision date: Sept. 14, 2010 Recent stock performance:At around $14, the stock is up about 30% since early June. The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.
Alkermes ( ALKS) Drug/indication:Vivitrol for opioid addiction FDA advisory panel: Sept. 16, 2010 Approval decision date: Oct. 12, 2010 Recent stock performance:At just under $14, the stock is up about 45% for the year. If approved, Vivitrol will be the first long-acting, non-narcotic treatment for patients addicted to opioids. Alkermes currently sells a version of Vivitrol for alcholol dependence.
Roche Drug/indication: Avastin for metastatic breast cancer Approval decision date: Sept. 17, 2010 FDA will decide whether or not to revoke Avastin's approval in breast cancer based on phase III data that failed to demonstrate a survival benefit for patients. Roche has argued that Avastin does benefit breast cancer patients despite the lack of prolonged survival, although a recent FDA advisory panel disagreed.
Novartis ( NVS) Drug/indication: Gilenia for multiple sclerosis Approval decision date: Sept. 21, 2010 Recent stock performance:Shares are down about 5% for the year. An FDA advisory panel said Gilenia was safe and effective as a treatment for multiple sclerosis, at a meeting on June 10. If approved, Gilenia would be the first multiple sclerosis drug administered as a pill, and as such, the drug could have an impact on already approved, injectable MS drugs from Biogen Idec ( BIIB), Teva ( TEVA) and Merck-Serono.
Hospira ( HSP) Drug/indication: Dyloject for acute moderate-to-severe pain in adults Approval decision date: Oct. 3, 2010 Recent stock performance: At $51, shares are down 15% since hitting a year-high in mid-July. If approved, Dyloject will be the first IV nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID. Dyloject was developed by Javelin Pharmaceuticals, which Hospira acquired in July.
Alexza Pharmaceuticals ( ALXA) Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder Approval decision date: Oct. 11, 2010 Recent stock performance: At around $3, stock is still far from the 52-week high of nearly $4 reached in May. AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail ( BVF) will market AZ-004 in the U.S. and Canada, if approved.
Jazz Pharmaceuticals ( JAZZ) Drug/indication: JZP-6 for fibromyalgia Approval decision date: Oct. 11, 2010 Recent stock performance: Shares tumbled to around $8.50 from more than $10 after the negative FDA advisory panel vote. On July 20, an FDA advisory panel voted against approval of JZP-6 due to unacceptable risks of the drug being misused and potentially abused. JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
Vivus ( VVUS - Get Report) Drug/indication: Qnexa for obesity Approval decision date: October 28, 2010 Recent stock performance: At $5.61, Vivus' value was cut in half by the negative FDA advisory panel vote. The odds in favor of Qnexa's approval took a big hit in July when an FDA advisory panel voted against the drug's approval due to a lack of long-term safety data. Vivus is expected to announce results from a two-year safety study of Qnexa in the third quarter.
Biodel ( BIOD) Drug/indication: VIAject for diabetes Approval decision date: Oct. 29, 2010 Recent stock performance: Closed Friday at $3.88. The stock has traded as low as $3.22 and as high as $6.25 this year. VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream faster than currently marketed rapid-acting insulins.
Cadence Pharmaceuticals ( CADX) Drug/indication: Ofirmev for pain/fever Approval decision date: Nov. 4, 2010 Recent stock performance: At $8.21, stock is down 21% from its April high. This is the second review cycle for Ofirmev following an FDA complete response letter issued in February.
Amgen ( AMGN - Get Report) Drug/indication:Prolia for bone complications in cancer patients Approval decision date: Nov. 18, 2010 Recent stock performance: Amgen is down 8% for the year. Prolia was previously approved as a treatment for osteoporosis. Amgen is seeking additional approvals for Prolia in various cancer indications.
Orexigen Therapeutics ( OREX) Drug/indication: Contrave for obesity FDA advisory panel: Dec. 7, 2010 Approval decision date: Jan. 31, 2011 Recent stock performance: At 4.73, the stock is starting to lift off its July low of $3.81. Orexigen is the third company, after Vivus and Arena, to bring its obesity drug in front an FDA advisory panel.
Human Genome Sciences Drug/indication: Benlysta for lupus Approval decision date: Dec. 9, 2010 If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline will co-market Benlysta.
Mannkind ( MNKD) Drug/indication: Afrezza for diabetes Approval decision date: Dec. 29, 2010 Recent stock performance: At $5.87, stock has lost almost half its value since March. This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.
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