Replies to post #124803 on Biotech Values

[turtlepower]

ARRY

Here's the link to the OA trial

http://clinicaltrials.gov/ct2/show/NCT01366014

There's also a trial for a compound called 382 that doesn't ring a bell. Anyone remember what that is?
http://clinicaltrials.gov/ct2/show/NCT01316822

[rkrw]

Yes, interesting the pain IND was filed just prior to the June guidance.

P38 for pain is going to be a tough one, they aren't the first one to try. And asthma is a high bar indication as well.

[jq1234]

IND in June for pain? 797 finished phase 2 in acute pain setting in 2008.

[mcbio]

ARRY - 4Q11 CC notes

1. ARRY-380 - ARRY previously noted that the drug would only move forward with a partner. ARRY has also disclosed before that they have been in partnering discussions for the drug, though there has never been a lot of buzz. They disclosed during this call that they hope to culminate a deal in the coming quarters.

2. Regarding the Genentech deal for the ChK-1 program, ARRY will be entitled to potential milestones and royalties on both drugs in the partnership, not just ARRY's own ChK-1 candidate but Genentech's as well.

3. ARRY-614 - MDS may be the 6th or 7th most prevalent cancer. About 65% of MDS patients fall into the "Low/Int-1" population where Vidaza, Dacogen, and Revlimid are apparently not beneficial. ARRY is targeting this patient population, as well as HMA and/or Revlimid failures where there is no SOC. ARRY also plans to develop 614 in combo with other agents.

4. No buzz on own development of MEK162 going forward so I do assume that ARRY will not co-develop the drug going forward and will just allow NVS to bear all expenses going forward in exchange for double-digit royalties.

5. ARRY-502 (asthma) - ARRY wants to seek a big pharma partner after the 28-day Phase 2 study it expects to commence next Spring.

6. ARRY hopes to land partnership deals for its early stage GPR-119 diabetes program and TrkA pain program in the next few years.

7. ARRY expects to burn $15M/quarter for fiscal 2012 before milestones and they are projecting $20M in milestones for fiscal 2012, which would equate to net $40M burn for fiscal 2012.

[ghmm]

Anyone else thinking that at some point Roche/Genentech reaquires them?

I may get a few shares again with that being the "safety net". I am slowly to act and a bit greedy so it'll probably pop next week before I buy and all the Array longs can thank me...or it'll drop a bit and I'll buy then it'll really drop and all the longs can yell at me :-).

Thanks for the ReadMe was helpful and nice for looking up some of the royalties would be helpful if you had rates for us lazy people :-).

[mcbio]

ARRY - 1Q12 results

[Detailed results behind the recently reported top-line Phase 2 selumetinib combo NSCLC data is to be reported in calendar 2012 so, at a minimum, we're at least two months away from this detailed data. CC is tomorrow and I'll post any tidbits above and beyond what's in this PR, including whether or not ARRY gives any inkling as to whether they believe AZN will proceed into Phase 3 trials with selumetinib. Given their tone in the PR, notwithstanding the risk of ARRY just talking book, I assume ARRY expects AZN to take selumetinib into Phase 3 trials.]

http://finance.yahoo.com/news/Array-BioPharma-Reports-bw-3756337475.html?x=0&.v=1

Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2012

BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) today reported financial results for the first quarter of fiscal 2012.

Array reported revenue of $22.1 million for the first quarter of fiscal 2012, compared to revenue of $18.5 million for the same period in fiscal 2011. During the first quarter of fiscal 2012, Array earned $2.5 million in revenue for achieving a milestone from its collaboration with Genentech. Array reported a significantly reduced net loss of $3.6 million, or ($0.06) per share, for the first quarter, compared to a net loss of $10.6 million, or ($0.20) per share, for the first quarter in fiscal 2011. Array spent $12.6 million in proprietary research and development for the quarter to advance its proprietary pipeline, compared to $13.9 million spent for the same period last year. Cash flow from operations was $13.6 million for the first quarter of fiscal 2012. Array ended the first quarter of fiscal 2012 with $78 million in cash, cash equivalents and marketable securities.

There are currently eight Array-invented drugs in Phase 2 clinical development, six of which are partner-funded. During fiscal 2012, the company expects results to be reported on six clinical trials, the first of which was announced in September 2011: Top-line results of selumetinib in combination with docetaxel versus docetaxel alone in patients with second-line KRAS-mutant non-small cell lung cancer (NSCLC). Complete results from this Phase 2 trial are expected to be released in calendar 2012. Additional data releases planned during fiscal 2012 include:

• Phase 2 combination data on selumetinib in patients with melanoma
• Phase 2 data on ARRY-520 in patients with multiple myeloma (MM)
• Phase 2 data on ARRY-797 in patients with osteoarthritis (OA) pain
• Phase 1 data on ARRY-614 in patients with myelodysplastic syndromes (MDS)
• Phase 1 data on ARRY-502 in healthy volunteers

“The recently announced top-line Phase 2 results for selumetinib in KRAS mutant NSCLC, we believe, are the most promising results to date in this patient population,” said Robert E. Conway, Chief Executive Officer. “Selumetinib in combination with docetaxel showed statistical significance in the key secondary end-points of progression free survival, objective response rate, and alive and progression free at six months, as well as a numerical increase in the primary endpoint of overall survival versus docetaxel alone, demonstrating the therapeutic potential of this drug. There is a significant opportunity to help the more than 160,000 patients with KRAS mutant NSCLC who currently have a poor prognosis with limited treatment options.”

SUMMARY OF RECENT AND EXPECTED KEY EVENTS
Top-line Results Announced for Selumetinib and ARRY-502

Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer: Array announced results from a randomized Phase 2 placebo-controlled study conducted by AstraZeneca comparing the efficacy of selumetinib in combination with docetaxel versus docetaxel alone in the second-line treatment of 87 patients prospectively selected with KRAS-mutant, locally advanced or metastatic NSCLC. This was the first completed randomized combination trial with a MEK inhibitor. Selumetinib was licensed from Array to AstraZeneca. The study’s primary endpoint of overall survival demonstrated a numerically greater increase in survival in favor of selumetinib in combination with docetaxel versus docetaxel alone, but did not reach statistical significance.

The key secondary endpoints of progression-free survival, objective response rate, and alive and progression-free at six months were all demonstrated with statistical significance, showing improvement in favor of selumetinib in combination with docetaxel versus docetaxel alone. Further data and analyses will be presented by the study’s academic investigators at a forthcoming scientific conference.

AstraZeneca is also completing a Phase 2 trial with selumetinib in combination with dacarbazine versus dacarbazine alone as first-line treatment of patients with melanoma whose tumors harbor BRAF mutations. This trial completed enrollment of 91 patients in March 2010 with the primary endpoint of overall survival.

ARRY-502 – CRTh2 antagonist for asthma: Array completed a 14-day Phase 1, randomized, double-blind, multiple ascending dose trial with ARRY-502 in healthy volunteers. Preliminary results indicated that ARRY-502 was well tolerated at all doses evaluated with all treatment-related adverse events being mild. There were proportional increases in ARRY-502 exposure with increasing dose. ARRY-502 provided robust and sustained pharmacodynamic activity. Phase 1 clinical data, along with other assessments, indicate the potential for once a day dosing of ARRY-502 in asthma. Array plans to initiate a Phase 2 trial in persistent asthma during the first half of 2012.

Proprietary Development Programs
ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array will present Phase 1 data and top-line results of a Phase 2 trial with ARRY-520 in patients with relapsed or refractory MM at the American Society of Hematology (ASH) annual meeting in December 2011. Array is expanding this study with a combination of ARRY-520 and dexamethasone in patients with MM refractory to both Velcade® (bortezomib) and Revlimid® (lenalidomide) (dual-refractory MM). Array continues to enroll a Phase 1b combination study with ARRY-520 and Velcade in patients with relapsed or refractory MM. By year-end, M.D. Anderson Cancer Center plans to initiate an investigator-sponsored Phase 1b study with ARRY-520 and carfilzomib in patients with relapsed or refractory MM in collaboration with Array and Onyx Therapeutics, Inc.

ARRY-614: A dual p38/Tie2 inhibitor for Myelodysplastic Syndromes (MDS): Array will present top-line results at the 2011 ASH Annual Meeting from a Phase 1 dose escalation/expansion trial with ARRY-614 in patients with Low/Intermediate-1 risk MDS. Array has tested a new formulation with enhanced drug exposure and lower variability which has the potential to be the commercial formulation and will be used in future studies expected to start this quarter.

ARRY-797 – p38 inhibitor for Pain: Array continued a 28-day Phase 2, randomized, double-blind study comparing ARRY-797 with OxyContin® and placebo in approximately 150 patients with moderate to severe pain from osteoarthritis of the knee despite continuing NSAID use. Array anticipates reporting top-line results during the first half of calendar 2012.

Select Partnered Programs and New Partnering Agreements
AMG 151 (ARRY-403) (Amgen) – Glucokinase Activator for Type 2 diabetes: In October 2011, Amgen initiated a Phase 2a, 28-day trial of AMG 151 in combination with metformin in approximately 224 patients with Type 2 diabetes. The primary endpoint is change in fasting plasma glucose levels from baseline from day one to end of treatment.

MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer: Novartis is continuing a Phase 2 open-label trial with MEK162 in patients with metastatic malignant cutaneous melanoma and three Phase 1b combination trials in selected patients with advanced solid tumors.

ARRY-575 (Genentech) – Chk-1 inhibitor for cancer:
Array and Genentech, a member of the Roche Group, announced an oncology agreement for the development of each company’s small-molecule Checkpoint kinase 1 (Chk-1) program. The programs include Genentech’s compound GDC-0425 (RG7602), currently in Phase 1, and Array’s compound ARRY-575, which is being prepared for an investigational new drug application to initiate a Phase 1 trial in cancer patients. Under the terms of the agreement, Genentech is responsible for all clinical development and commercialization activities. Array received an upfront payment of $28 million in September 2011 and is eligible to receive clinical and commercial milestone payments up to $685 million and up to double-digit royalties on sales of any resulting drugs.

ARRY-543 (ASLAN Pharmaceuticals) - HER2 / EGFR inhibitor for gastric cancer: ASLAN Pharmaceuticals Pte Ltd and Array entered into a license agreement in July 2011 to develop Array's HER2 / EGFR inhibitor, ARRY-543, currently entering Phase 2 development for solid tumors. Under the agreement, ASLAN will fund and globally develop ARRY-543 through proof of concept, initially targeting patients with gastric cancer through a development program conducted in Asia. Upon achievement of proof of concept, ASLAN will identify a global partner for Phase 3 development and commercialization. Array and ASLAN will share the proceeds of such partnering transaction.

Strengthening Leadership
Hired Karsten Witt, M.D.: Array hired Karsten Witt, M.D., as Vice President of Clinical Sciences. Dr. Witt has been involved in filing six investigational new drug applications and five new drug applications across the U.S., Europe and Japan, including the registration of Tarceva® (erlotinib). Prior to joining Array, Dr. Witt served as Sr. Vice President Pharmaceutical Operations at OSI Pharmaceuticals, where he was intimately involved in the development of small-molecule targeted oncology therapies, including the EGFR inhibitor Tarceva®.

Array Analyst Day on December 16, 2011

Array will hold an Analyst Day meeting in New York City on Friday, December 16, 2011, at 8:30 am eastern time. Further details will be announced in the near future.

Array will hold a conference call on Tuesday, November 1, 2011, at 9:00 a.m. Eastern Time to discuss these results. Robert E. Conway, Chief Executive Officer, and Michael Carruthers, Chief Financial Officer, will lead the call.

Conference Call Information

Date:

Tuesday, November 1, 2011

Time:

9:00 a.m. Eastern Time

Toll-Free:

800-260-8140

Toll:

617-614-3672

Pass Code:

85947414

Webcast & Conference Call Slides:

http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome

A replay of the call will be available as a webcast on www.arraybiopharma.com

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. For more information on Array, please go to www.arraybiopharma.com.