本帖最后由 何鸿燊 于 2010-12-18 17:15 编辑
Biotech Calendar: FDA Drug Approvals in 2011
Adam Feuerstein
12/13/10 - 07:19 AM EST
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological order based on the drug approval decision date. I've also included information on pending FDA advisory panels. At the end of the calendar is a list of companies with potential regulatory milestones in 2011 based on expected but not yet completed drug approval filings.
In all, this calendar contains drug approval and regulatory milestone information on 34 drug and biotech stocks for 2011.
Mannkind(MNKD)
Drug/indication: Afrezza for diabetes
Approval decision date: Dec. 29, 2010
This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.
Alimera Sciences(ALIM) and pSivida(PSDV)
Drug/indication: Iluvien for diabetic macular edema
Approval decision date: Dec. 30, 2010
AztraZeneca(AZN)
Drug/indication: Zictifa for medullary thyroid cancer
Approval decision date: Jan. 7, 2011
An FDA advisory panel on Dec. 2 gave conditional support to the approval of Zictifa, also recommending that a post-approval study be conducted to determine if a lower dose could reduce side effects while maintaining efficacy.
Clinical Data(CLDA)
Drug/indication: Vilazodone for major depressive disorder
Approval decision date: Jan. 22, 2011
Orexigen Therapeutics(OREX)
Drug/indication: Contrave for obesity
Approval decision date: Jan. 31, 2011
An FDA advisory panel held Dec. 7 voted 13-7 to recommend Contrave's approval.
Bristol-Myers Squibb(BMY)
Drug/indication: Yervoy (ipilimumab) for melanoma
FDA advisory panel meeting: Feb. 9, 2011
Approval decision date: March 26, 2011
Both the FDA advisory panel meeting and the FDA's approval decision date for Yervoy were pushed back from December after Bristol submitted additional clinical data. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.
Pfizer(PFE) and Protalix Biotherapeutics(PLX)
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011
Salix Pharmaceuticals(SLXP)
Drug/indication: Xiafaxan for irritable bowel syndrome
Approval decision date: March 7, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy.
Human Genome Sciences(HGSI)
Drug/indication: Benlysta for lupus
Approval decision date: March 10, 2011
If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline(GSK) will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.
Dendreon(DNDN)
Drug/indication: Provenge for prostate cancer (manufacturing expansion)
Approval decision date: March 2011
Dendreon is seeking FDA approval to expand Provenge manufacturing capacity at its New Jersey facility. Two additional Provenge plants are under construction outside Atlanta and in Orange Country, Calif. that are expected to come on line in the middle of the year.
InterMune(ITMN)
Drug/indication: Esbriet for idiopathic pulmonary fibrosis
Approval decision date: First quarter 2011 (estimated)
Intermune is seeking European approval for Esbriet after the FDA rejected the drug in 2010.
Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: First quarter 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.
Forest Laboratories(FRX)
Drug/indication: Daxas for chronic obstructive pulmonary disorder
Approval decision date: First quarter 2011
This is the second FDA review cycle for Daxas.
Xenoport(XNPT) and GlaxoSmithKline
Drug/indication: Horizant for restless leg syndrome
Approval decision date: April 6, 2011
This is the second FDA review cycle for Horizant. The original new drug application was filed to FDA in January 2009.
Spectrum Pharmaceuticals(SPPI)
Drug/indication: Fusilev for colon cancer
Approval decision date: April 29, 2011
This is the second review for Fusilev in colon cancer. The drug is already approved as a treatment for a form of bone cancer.
Adventrx Pharmaceuticals(ANX)
Drug/indication: ANX-530 for non-small cell lung cancer
Approval decision date: May 3, 2011 (estimated, based on Adventrx's Nov. 3, 2010 filing and assuming a six-month FDA review.)
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issue a refuse-to-file letter for ANX-530 in 2010.
Vertex Pharmaceuticals(VRTX)
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011 (estimated, based on Vertex's filing for approval on Nov. 23, 2010 and assuming six-month FDA review.)
Delcath Systems(DCTH)
Drug/indication: Hepatic ChemoSat Delivery System for liver metastases in melanoma patients
Approval decision date: June 2011 (estimated, based on expected 2010 year-end filing and a six-month FDA review.)
Seattle Genetics(SGEN)
Drug/indication: brentuximab vedotin for Hodgkin's lymphoma
Approval decision date: Third quarter 2011 (estimated, based on the company's forecast for a first-quarter 2011 approval filing.)
MELA Sciences(MELA)
Device/indication: MELAFind for diagnosis of melanoma
Approval decision date: Unknown
FDA rejected MELAFind in March 2010 but an FDA advisory panel in November narrowly recommended the device's approval over the FDA's objection. The FDA has not said when it will issue another approval decision for MELAFind.
Additional drugs with potential regulatory milestones in 2011:
Osiris Therapeutics(OSIR)
Drug/indication: Prochymal for graft-versus-host disease
Status: Prochymal phase III studies failed but Osiris says it plans to meet with FDA "early next year" to determine if Prochymal can still be filed for approval.
Transcept Pharmaceuticals(TSPT)
Drug/indication: Intermezzo for insomnia
Status: Transcept intends to resubmit Intermezzo to FDA in first quarter 2011 following a complete response letter in October 2009.
Genzyme(GENZ) and Isis Pharmaceuticals(ISIS)
Drug/indication: mipomersen for severe hypercholesterolemia
Status: Genzyme is expected to file for mipomersen approval in the first half 2011.
MAP Pharmaceuticals(MAPP)
Drug/indication: Levadex for migraines
Status: MAP intends to file for Levadex approval in the first half of 2011.
Arena Pharmaceuticals(ARNA)
Drug/indication: lorcaserin for obesity
Status: FDA rejected lorcaserin in October. Arena has not yet disclosed a timetable for resubmitting lorcaserin to FDA.
Vivus(VVUS)
Drug/indication: Qnexa for obesity
Status: FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to FDA before the end of 2010.
Amylin Pharmaceuticals(AMLN), Alkermes(ALKS) and Eli Lilly(LLY)
Drug/indication: Bydureon for diabetes
Status: Additional clinical work required by FDA after October rejection is ongoing. Resubmission expected by end of 2011.
Alexza Pharmaceuticals(ALXA)
Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder
Status: FDA rejected Alexza in October; Alexza still determining a resubmission strategy.
Sources: BioMedTracker, company reports, TheStreet research.
--Written by Adam Feuerstein in Boston. |
发表于 2010-12-18 18:12
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