CRIS FDA Approval. CTIC withdraws NDA + ISTA DRRX ZIOP ALTH VICL ARRY news

Jan 30, 2012 No Comments by

Roche Holding AG (ROG.VX, RHHBY) and Curis Inc. (CRIS)  – The FDA announced today that it approved vismodegib  for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. This was in advance of the original PDUFA date of 8 March, 2012.

Cell Therapeutics, Inc.  (Nasdaq and MTA: CTIC) announced today that it has withdrawn its New Drug Application (NDA) for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL) in patients who failed two or more lines of prior therapy. The company cited insufficient time to prepare for the  Oncologic Drugs Advisory Committee scheduled for February 9, 2012. As a result, both the Committee meeting and PDUFA date have been removed from the calendar. It plans to resubmit the NDA later in 2012.

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) announced that it has withdrawn its unsolicited proposal to acquire ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA). ISTA also announced it has completed enrolment of its Phase 2 trial of BEPOSONE nasal spray combining bepotastine besilate with a steroid for the treatment of symptoms associated with seasonal allergic rhinitis. Data are due in 1H 2012.

DURECT Corporation(Nasdaq: DRRX) today reported that Takeda  has given notice that it is returning its development and commercialization rights to POSIDUR in Europe and their other licensed territories. This follows Phase 3 data earlier this year that showed it did not meet its co-primary endpoints. Despite this, the company intends to have a pre-NDA meeting with the FDA in mid-2012.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced today that the Independent Data Monitoring Committee (IDMC) recommended continuation of the Phase 3 trial (PICASSO 3) for palifosfamide  in front-line metastatic soft tissue sarcoma. It maintained previous guidance that completion of enrollment for PICASSO 3 is expected by the end of the first quarter of 2012. The outcome in progression-free survival, the study’s primary endpoint for accelerated approval, is anticipated in the second half of 2012.

Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in January by the Committee For Medicinal Products for Human Use (CHMP) for conditional approval of FOLOTYN for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. A final opinion on the re-examination could be issued by the EMA within four to five months.

Vical Incorporated (Nasdaq:VICL) reiterated previous guidance that it expects to release topline data from its Phase 3 trial of Allovectin for melanoma in mid-2012.

Array BioPharma Inc. (NASDAQ: ARRY) gave a pipeline update today noting that over the next year it expects to

Over the next 12 months, the company expects results to be reported from seven clinical trials.

  • Phase 2 final combination results for selumetinib plus docetaxel in patients with non-small cell lung cancer (top-line results were reported in September 2011)
  • Phase 2 combination data for selumetinib plus DTIC in patients with melanoma
  • Phase 2 data for MEK162 in patients with melanoma
  • Phase 2 top-line data for ARRY-797 in patients with osteoarthritis pain
  • Phase 2 combination data for ARRY-520 plus dexamethasone in patients with multiple myeloma (MM)
  • Phase 1b combination data for ARRY-520 plus Velcade® (bortezomib) in patients with MM
  • Phase 1 dose escalation data (interim) for the new formulation of ARRY-614 in patients with myelodysplastic syndromes
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Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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