Replies to post #125710 on Biotech Values

[acgood]

FDA approves Xalkori(crizotinib)

This is a moderately important lift for SNTA which has the most advanced HSP90 inhibitor ganetespib. Everyone is clamoring for use of this drug in crizotinib failure patients, either alone or in combo with retreatment for ALK population in NSCLC. This has been discussed repeatedly on calls/webcasts since ASCO 2011.

Having criz approved simplifies the trial planning, and I think something will be underway within months, as soon as either 1) some coop group ays for it, 2) SNTA inks an asian partnership with large upfront cash, or (if they just cut to the chase) 3) PFE buys SNTA

[DewDiligence]

Xalkori (crizotinib) is priced at $320/day (~$115K for a year if patients stay on drug that long), according to today’s WSJ:

http://online.wsj.com/article/SB10001424053111904009304576532892704206326.html

[genisi]

Given the increasing number of molecular diagnostic and cytogenetic studies and the availability of superior (to standard chemotherapy) and targeted drugs, pathologists will need to use the minimum amount of tissue required for diagnosis while preserving as much tumor tissue as possible for molecular tests to guide therapy. I assume the most common mutations in EGFR and KRAS genes will be screened first and if negative, and the remaining material is suf?cient, then EML4-ALK translocation will be screened for.

[DewDiligence]

Xalkori (crizotinib) has a new warning in the FDA label:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome has occurred. Monitor monthly and as clinically indicated with more frequent testing in patients with Grade 2-4 elevations. Temporarily suspend, dose reduce, or permanently discontinue XALKORI as indicated.

This language was not in the original Xalkori label when the drug was approved by the FDA in Aug 2011.

[DewDiligence]

ABT licenses prostate-cancer biomarkers from Stanford University:

http://finance.yahoo.com/news/abbott-licenses-biomarkers-differentiating-aggressive-130000797.html

Abbott announced today it has acquired an exclusive license for several novel biomarkers from Stanford University for use in developing a molecular diagnostic test that could satisfy a longstanding unmet medical need: differentiating aggressive from nonaggressive prostate cancer.

Abbott will develop a molecular assay based on its proprietary FISH (fluorescence in situ hybridization) technology to detect rearrangements of the ERG and ETV1 genes and measure loss of the PTEN gene. A study published in the British Journal of Cancer evaluated 308 men diagnosed with prostate cancer who were treated conservatively. Those who did not show ERG/ETV1 genetic aberrations with no PTEN gene loss had excellent prognosis, evidenced by an 85 percent survival rate after 11 years. Men who showed PTEN gene loss in the absence of the gene rearrangements had a poor survival rate of 13.7 percent. The study showed the promise of the new biomarkers to identify patients who would benefit most from intensive therapies.

[DewDiligence]

ABT inks deal with JNJ/PCYC for ibrutinib companion diagnostic:

http://finance.yahoo.com/news/abbott-collaborate-janssen-pharmacyclics-development-140000515.html

The financial terms were not disclosed. ABT inked a similar deal with PFE for the companion diagnostic to Xalkori (#msg-66584680).