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first JAK inhibitor for myelofibrosis could bring in 500m, second JAK could be a blockbuster (at 20% royalties, 200m), sheddase inhibitor could bring in about 300m. Think of all the re-evals, INCY represents the best value, though possibly up to 6b cap?

Myelofibrosis med: Ruxolitinib

- partnered with Novartis
- Pfizer, Sanofi, AstraZeneca are about 18-24 months behind for Myelofibrosis
- also in P1/2 for ALL, AML, MDS, pediatric hematologic CA … NHL trials to start in second half 2011, awaiting P3 results for Polycythemia vera, and enrollment behind schedule.
- submitted to europe & FDA for myelofibrosis

Phase 3 results:
->50% of patients had a marked reduction (25% or more) in palpable spleen size for >1 year, confirmed by MRI
- 48% of patients had at least a 35% reduction in spleen volume
- After one month, fatigue, night sweats, & itchiness were improved by >50%

The market:
- 30,000 patients in the US with myeloproliferative disease
- 71,000 with polycythemia vera in the US.
- (however, an INCY presentation says 16k & 90K respectively)
- pricing will be 40-60k, on par with biological meds (ie, Avastin, Humira).
- The myeloproliferative disease market is expected to heavily utilize this med as there are no other alternatives.
- 20-25% of the the Polycythemia vera market is intolerant of current standard of care (hydroxyurea), so possibly ? 20% ? of the the PV group to use the INCY med. In discussions with missash, he was hesitant of PV patients using this as he said they usually did ok with repeat blood draws, without any treatment.

- INCY has US rights, Novartis has outside US less tiered double-digit royalties to INCY

- 10,000 MPD pts X 50K = 500m in sales, +/- any other lymphoma indications


INCY's second JAK inhibitor is in P2b for RA (3 month, double blind, placebo controlled trial to be done in early 2012)

-RA market for biologicals is current 16b, INCY's med is oral rather than injected, and appears as efficacious as monotherapy.

-comparable to PFE's JAK inhibitor, though PFE is further ahead by ~ 2 years.
- PFE P3 results as monotherapy:
ACR20: 66%
ACR50: 37%
ACR70: 20%

(better than remicade (IV)- 5.8b... enbrel is injected, 3.5b, humira is injected, 5.4b) with projected late 2012 launch.

INCY 2a trial:
ACR20: 72%
ACR50: 44%
ACR70: 30%

- LLY has worldwide rights, INCY gets 20-30% royalties. Seeking collaboration for topical format for psoriasis


sheddase inhibitor

oral med for breast CA, currently in P2 in combo with Herceptin (results pending) … 11% vs 23% in p52HER2+ ORR in P1.

ORR was 41% versus 12% based on an intent-to-treat analysis (ITT) and the median PFS was 178 days versus 94 days for the p95HER2-positive and p95HER2-negative patients, respectively. This contrasts with the results of prior published studies conducted in the absence of INCB7839 where the ORR was lower and the PFS was shorter in p95HER2-positive patients.

Estimates show 20-40% of HER2+ are p95HER2+ (approx 30% of breast CA HER2+, so... ~6% of breast CA?) ~200-250,000 breast CA patients a year = ~12,000 x ?25k = 300m / yr

INCB28060 – in P1 for solid tumors, partnered with novartis

INCB2436 – in P1 for solid tumors, expect results in first half 2012, followed by initiation of P2
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