Replies to post #192456 on Biotech Values

[DewDiligence]

Right. ABBV does, however, have a face-saving incentive to not unduly undermine Imbruvica sales even with sales of 100%-owned regimens: justifying to investors the huge price paid for PCYC.

p.s. With Imbruvica, ABBV's bottom-line economics are essentially the same for sales in the US vs ex-US; the only difference is who books the sales.

[DewDiligence]

ABBV/Roche—Registrational phase-2 Venetoclax* trial succeeds in CLL:

http://finance.yahoo.com/news/phase-2-study-venetoclax-patients-123000896.html

AbbVie…today announced that a Phase 2 trial of its investigational medicine venetoclax met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion, according to an independent review analysis.

…Data from this study will be presented at an upcoming medical conference and will serve as the pivotal registration data for applications to the FDA, EMA and other health authorities. The safety profile was similar to previous studies and no unexpected safety signals were reported for venetoclax.

*f/k/a ABT-199.

[DewDiligence]

ABBV/Roche present phase-2 Venetoclax* data in second-line CLL with 17p deletion; NDA/MAA submitted:

http://finance.yahoo.com/news/abbvie-reports-phase-2-results-160500524.html

The data show venetoclax monotherapy achieved its primary endpoint with a 79.4 percent (n=85/107) overall response rate (ORR), with 84.7 percent having sustained duration of response (12 month estimate, overall median duration of response was not reached)…. Partial response (PR) was reported in 69.2 percent (n=74) of patients.

Treatment-emergent adverse events (AEs) (all grades) in ≥20 percent of patients were neutropenia (43%), diarrhea (29%), nausea (29%), anemia (27%) and fatigue (22%). Grade 3/4 AEs in ≥10 percent of patients were neutropenia (40%), anemia (18%) and thrombocytopenia (15%).

The sponsors have submitted the data from this Phase 2 study…to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively…

The success of this pivotal trial was announced in August (#msg-116144008), but the details were unveiled today at ASH.

* f/k/a ABT-199.