Data Data Data...

We can thank the Tufts Center for the Study of Drug Development for officially estimating the cost to bring a biotech product to market, that is $1.2B with average preclinical costs of $615M and clinical costs of $626M, and requires just over eight years to bring to market. Note:

• Average out-of-pocket cost per approved biopharmaceutical for the preclinical period totaled $198 million. When capitalized, this estimate is $615 million per biopharmaceutical.
• Average out-of-pocket clinical period cost per approved biopharmaceutical was $361 million. When capitalized, this estimate is $626 million.

Also on the data front…Array Biopharma, Inc. (NASDAQ: ARRY) reported preliminary results of their MEK enzyme inhibitor (ARRY-142886) showing inhibition of MEK1/2 - an enzyme that plays an important role in the Ras/Raf/MEK/ERK cell signaling pathway, which regulates cell proliferation.

Results demonstrated 39 of 57 patients completed at least one cycle of treatment with ARRY-142886. After completion of the second cycle, 19 (49%) had stable disease, and nine of these patients (six melanoma, one each of breast cancer, non-small cell lung cancer and medullary thyroid cancer) remained stable for five or more months (range, 5-14+ months; median, 6 months). Two patients, one with thyroid cancer and the other with melanoma, continue to receive treatment with ARRY-142886 after one year. Sixteen of the 20 patients with melanoma completed at least one cycle of treatment. Twelve had stable disease after completion of cycle two, with stable disease persisting for at least five months in six patients (range, 5 - 13+ months; median, 6.5 months).

Encouraging results indeed as Phase II studies are initiated.

(Image courtesy of www.plala.or.jp)