Agent & Drews Bio Plays - Page 26
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.
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.
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.
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.
I like SLXP - I think they stand a good chance of positive results in March.
Here is a recent article with some more info:
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company’s two pivotal Phase 3 efficacy and safety studies of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS. The studies showed XIFAXAN 550 mg tablets demonstrated a statistically significant improvement for the adequate relief of global IBS symptoms, IBS-related bloating, abdominal pain and stool consistency following completion of a 14-day course of therapy. IBS, one of the most common chronic medical conditions, is characterized by altered bowel habits with bloating, abdominal pain and discomfort. The FDA is currently reviewing Salix’s supplemental New Drug Application (sNDA) for XIFAXAN 550 mg tablets for the proposed indication of the treatment of Non-C IBS. The Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the application is March 7, 2011.
TARGET 1 and TARGET 2 – two identically-designed 600-plus patient, double-blind, placebo-controlled trials – demonstrated that a 14-day course of XIFAXAN 550 mg, taken 3 times daily, achieved adequate relief of global IBS symptoms (primary endpoint) and adequate relief of IBS-related bloating (key secondary endpoint) in a significantly greater proportion of patients, compared with placebo, during the primary evaluation period (first 4 weeks following treatment) as well as during the entire study period (10 weeks following treatment). The statistically significant weekly findings in the primary endpoint and key secondary endpoint noted above were supported by daily findings in the secondary endpoints of global IBS symptoms, bloating, stool consistency and abdominal pain and discomfort. Additionally, the NEJM publication includes results of an analysis of a composite endpoint of abdominal pain or discomfort and loose or watery stools as outlined in the March 2010 draft FDA Guidance for Industry relating to the clinical evaluation of products for treatment of IBS.
“An alteration in gut flora has been proposed as an important contributor to the pathophysiology of IBS that might underlie some of the gastrointestinal symptoms associated with this condition,” said Mark Pimentel, M.D., Gastrointestinal Motility Program Director at Cedars–Sinai Medical Center and Principal Investigator of the clinical trials. "These findings conclusively show that a targeted, gut-selective antibiotic such as rifaximin can provide long-lasting results."
“These findings show the potential of rifaximin to treat multiple symptoms of IBS and affect gut flora, an underlying cause of IBS, with a side effect profile comparable to placebo,” said Bill Forbes, PharmD., Executive Vice President of Research and Development and Chief Development Officer at Salix Pharmaceuticals. “Rifaximin’s utility to treat the underlying causes of IBS symptoms is a significant scientific development for patients suffering from symptoms associated with IBS without constipation, including bloating, abdominal pain and diarrhea.”
Here I am... A newbie trying to figure out the ins and outs of bio stocks... and you throw this at me... nice :) ( i need to figure out how to make the smiley face)
btw... a few post back you listed a buttload of bio stocks and their FDA decision date. It is a great list,but I do have a question ... where / how did you compile it? I'm looking to learn how to do the DD and ain't afraid or to proud to ask.
keep up the good work... i am a learning... slow but surely.
Huntin - Found the lists from other sources online. As far as DD - I like to check SEC filings, yahoo stock info, as many stock message boards as possible. Depending on what the product is sometimes you can get user reviews as well. I like to check for insider buys/sells prior to FDA dates too.
As for OREX - what a beast!