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Re: asmarterwookie post# 246185

Saturday, 12/19/2015 5:50:45 PM

Saturday, December 19, 2015 5:50:45 PM

Post# of 347009
From a Forbes article on drug development costs:

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

It would appear that AZN has a lot invested in Durvalumab

Johnson & Johnson, which had the most new drugs approved and spent $5.2 billion per drug. “That is a whole biotech company and it is also part of our R&D budgets.”

From last week's news on Durvalmab:

http://www.fiercebiotech.com/story/astrazeneca-hit-another-setback-durvalumab-disappoints-lung-cancer/2015-12-18

Anyone harboring any last shred of hope in seeing AstraZeneca ($AZN) gain an accelerated approval on its marquee drug program for durvalumab should be prepared to be disappointed. The pharma giant says its latest read on a single-arm study of durvalumab, a PD-L1 checkpoint inhibitor, indicates that investigators won't come out with the data needed to win over regulators--virtually ruling out any move to gain a fast approval to use it as a solo therapy to fight lung cancer as the leaders in the field continue to consolidate their positions.

Here is AZN's oncology pipeline, as it relates to Duurvalmab:

Durvalumab
Clinical Trial Development Program

Durvalumab (MEDI4736) is being evaluated for its potential effects on non–small-cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and other tumor types.13 Select clinical trials are listed in table below

Durvalumab (MEDI4736; anti-PD-L1 mAb)
PHASE I
NSCLC


SCCHN


Solid Tumors
A Phase I study of MEDI4736 in Advanced Solid Tumors NCT01938612

Other
A Phase I study of MEDI4736 in MDS NCT02117219

NSCLC
A Phase Ib study of MEDI4736 with Tremelimumab in Advanced NSCLC NCT02000947
A Phase I study of MEDI4736 with Gefitinib in Locally Advanced or Metastatic NSCLC NCT02088112


SCCHN



Solid Tumors
A Phase I Study of MEDI4736 with Tremelimumab in Advanced Solid Tumors NCT02261220

Melanoma


Others
A Phase I Study of MEDI0680 with MEDI4736 in Advanced Malignancies NCT02118337

PHASE II
In Monotherapy
A Phase II Study of Sequential Switching to MEDI4736 in Locally Advanced or Metastatic NSCLC NCT02179671
A Phase II Study of MEDI4736 in Locally Advanced or Metastatic NSCLC (ATLANTIC) NCT02087423

A Phase II Study of MEDI4736 in Recurrent or Metastatic SCCHN NCT02207530



In Combination

A Phase II Study of MEDI4736 and Tremelimumab Alone and in Combination in SCCHN NCT02319044
A Phase lb/II Study to Assess Combination of MEDI4736 With Either AZD9150 or AZD5069 in Metastatic SCCHN NCT02499328

A Phase lb/ll Safety and Tolerability of MEDI6469 in Solid Tumors and Aggressive B-cell Lymphomas NCT02205333

A Phase I/II Study of MEDI4736 with Dabrafenib and Trametinib or Trametinib Alone in Metastatic or Unresectable Melanoma NCT02027961

A Phase lb/ll Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma NCT02340975

PHASE III
A Phase II/III Study of S1400 Biomarker-Targeted 2nd-Line Therapy in Locally Advanced or Metastatic Squamous NSCLC NCT02154490
A Phase III Study of MEDI4736 Following Concurrent Chemoradiation in Locally Advanced, Unresectable NSCLC (PACIFIC) NCT02125461

A Global Study of MEDI4736 vs Standard of Care in Patients With Locally Advanced or Metastatic NSCLC (ARCTIC) NCT02352948
A Phase III Study of MEDI4736 With or Without Tremelimumab Versus SOC in NSCLC (MYSTIC) NCT02453282
A Double-Blind Placebo-Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC NCT02273375

A Study of MEDI4736 Monotherapy and in Combination With Tremelimumab vs Standard of Care Therapy in SCCHN NCT02369874

So, throw this in with the cancellation of of trials (over safety concerns) for other apps last October, and Durvalumab starts looking a little tarnished. I would think that AZN is looking for a way to brighten the prospects for it's cornerstone oncology candidate. If you had spent over 5 billion and alot of time and effort developing your cornerstone oncology drug, and building your oncology pipeline around it, how much would you pay to brighten the prospects for that drug, and have access to an entire platfrom that may have positive effects on many illnesses? AZN might have more to gain than the others.







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