Array Pharma advances p38 lead to clinic

Array just completed an IND for ARRY-797, and expects to launch safety trials as a precursor to RA application trials.

TAK1 - key activator of AMPK signaling?

One target first put forth by a Scottish academic a year ago is TAK1, though the academic mentioned it in respect to inflammatory response. A recent paper from the Baylor College of Medicine describes suggests TAK1 might be an interesting target for diabetes, as it appears that this is what metformin affects.

VEGFR for non-cancer vascular applications?

VEGF receptor promotes optical clarity
Researchers from the Medical College of Georgia and colleagues published in Nature that soluble VEGF receptor 1 promoted avascularity and optical clarity in the cornea of mice by serving as a "trap" for VEGF-A, a stimulator of angiogenesis. They believe soluble VEGF receptor 1 (also known as soluble FLT1) can be used to prevent or treat neovascularization, and they said it may serve as a target for inducing angiogenesis for pre-eclampsia, wound healing, stroke and heart disease.

Gleevec wins expanded approval

dermatofibrosarcoma protuberans,
relapsed/refractory Ph+ ALL,
certain forms of myelodysplastic/myeloproliferative diseases,
hypereosinophilic syndrome/chronic eosinophilic leukemia, and
aggressive systemic mastocytosis.

Average clinical trial costs

Phase I: $15,700/patient
Phase II: $19,300/patient
Phase III: $26,000/patient

Another big TK inhibitor deal

Bayer & Regeneron.
$75M upfront.
$245M in potential downstream payments. ($40M for phase 3 initiation, $70M for marketing approval, $135M in sales milestones beginning at $200M in annual sales.)
Shared development expenses.
Shared ex-US profits.
For ex-US rights to a phase II compound targeting an indication that there's already one approved remedy (Macugen) and another pending (Lucentis.)

Met TK linked to autism

treatment for EGFR skin rashes

Interesting apporach to treating EGFR inhibitor caused skin rashes. While the EGFR inhibitor is prescribed for an internal solid tumor, this company seeks to treat the skin rashes by topically applying a phosphatse to initiate more EGFR signaling on the skin.

Leonard Saltz on targeted therapies

Article mainly focused on cost of these cancer drugs.

CGI-Genentech

$25M upfront (mix of license and equity)
>$500M in downstream potential
This deal addresses a SINGLE target with multiple indications!

Roche-Plexxikon B-Raf deal

$40M upfront
$6M in annual R & D funding
$660M in downstream potential
Compound not yet in the clinic

PIramed-Genentech

Aggregate value of $230M; undisclosed upfront

2010: kinases $58B annually (Pharmaprojects)

According to a new report, the kinase-targeted drug market is set to grow from $12.7 bn (€10bn) in 2005 to $58.6bn in 2010. Cancer (mainly solid tumours) is expected to remain the dominant application throughout the forecast period.

EGFR market....

...is $3B. (2005):
In 2005, the four major marketed drugs targeting the EGFr pathway, trastuzumab (Herceptin; Genentech), cetuximab (Erbitux; ImClone Systems); erlotinib (Tarceva; OSI Pharmaceuticals), and the now withdrawn gefitinib (Iressa; AstraZeneca), generated worldwide sales of more than $3 billion. The recent entry of panitumumab (Vectibix; Amgen) into the USA market and the possible approval of Tykerb, create new challenges in clinical use and marketing of these agents.

Oncology Drug Development Update - Targeting the Epidermal Growth Factor Receptor (EGFr) Signal Transduction Pathway: "In 2005, the four major marketed drugs targeting the EGFr pathway, trastuzumab (Herceptin; Genentech), cetuximab (Erbitux; ImClone Systems); erlotinib (Tarceva; OSI Pharmaceuticals), and the now withdrawn gefitinib (Iressa; AstraZeneca), generated worldwide sales of more than $3 billion. The recent entry of panitumumab (Vectibix; Amgen) into the USA market and the possible approval of Tykerb, create new challenges in clinical use and marketing of these agents."

Dual Drug Approach Gives Reason to Cheer

NVS researcher uses p38 inhibitor to "manage" the degeneration of heart muscle.

Dual Drug Approach Gives Reason to Cheer