Replies to post #108465 on Biotech Values

[mcbio]

ARRY - notes on 1Q11 CC

1. Selumetinib (fka AZD6244), the 1st gen MEK inhibitor partnered with AZN for cancer, is the most advanced MEK inhibitor in the clinic. ARRY is potentially due double-digit royalties depending on sales levels. There are two ongoing Phase 2 trials, one testing selumetinib plus DTIC vs. DTIC alone in 1st line melanoma patients with BRAF mutation and another testing selumetinib + Taxotere vs. Taxotere alone in 2nd line NSCLC patients with KRAS mutation, that will report data in 2011. This data is "potentially a big value-creating event for ARRY." This data could drive confidence not only in selumetinib but also in ARRY-162, the 2nd gen MEK inhibitor that was recently partnered with NVS.

2. ARRY-520, the KSP inhibitor for multiple myeloma - ARRY will report Phase 1 data for the single agent trial with 520 in MM patients in the first week in December (apparently some patients have been on 520 for 12 - 14 months). ARRY has seen "startling data" pre-clinically when combining 520 with Velcade in MM patients. ARRY is now initiating a Phase 1b combo trial of 520 and Velcade in MM patients.

3. A caller asked during Q&A how a KSP inhibitor such as 520 works to enhance Velcade. Kevin Koch said ARRY has done extensive work looking at survival factors and which tumors depend on which survival factors. It is believed that MCL1 is important in MM patients. Proteasome inhibitors (like Velcade) regulate the half-life of certain survival factors. 520 is highly dependent on the ratio of MCL1 and other proteins that stabilize its activity and existence. Since Velcade controls the half-life of some survival proteins, the combo of 520 and Velcade is highly productive (at least in the pre-clinic so far).

4. Clinical strategy for 520: An increasing number of patients are failing Velcade and Revlimid. The numbers are "kind of piling up" according to Kevin Koch. ARRY intends to look at Velcade-refractory patients first and look to go after this patient population with a controlled trial.

5. Of its proprietary drugs, ARRY considers 520 as more of a key focus compared to its other drugs because it has the potential for significant near-term value creation with potential PoC data. (ARRY is in discussions with potential partners for the other drugs in the pipeline while also advancing some alone; I'm guessing 380 is the subject of partnering discussions given the potential but the large amount of resources that will be needed to advance the drug.)

[mcbio]

ARRY - achieves $10M CELG milestone

http://finance.yahoo.com/news/Array-BioPharma-Achieves-bw-4214696567.html?x=0&.v=1

Array BioPharma Achieves Clinical Milestone in Celgene Collaboration

BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) announced today that a $10 million clinical research milestone was achieved in its collaboration with Celgene Corporation (NASDAQ:CELG - News). Celgene and Array entered into this research collaboration in September 2007. Array anticipates initiating a Phase 1 dose escalation trial in cancer patients with ARRY-382, a small molecule cFMS inhibitor, during the first quarter of 2011. Array is responsible for the continued development of ARRY-382 through Phase 1, and Celgene has an option to obtain exclusive rights to ARRY-382. If Celgene exercises this option, Celgene would be responsible for additional development and commercialization of this drug, and Array would be entitled to receive additional milestones, as well as royalties on sales of the drug.

“Our partnership with Array reflects the important role the cFMS pathway plays in cancer,” said Tom Daniel, M.D., President of Research and Early Development for Celgene Corporation. “Array has expeditiously delivered this promising new agent to IND and we look forward to evaluating its activity in cancer patients as we continue our ongoing collaboration on additional targets.”

In addition, Array continues to work on advancing two preclinical collaboration targets: TYK2 inhibitors for the treatment of inflammatory disease and PDGFR inhibitors for the treatment of fibrosis. Under the terms of the collaboration, Celgene has the option to select a total of two programs.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company's Web site at www.celgene.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.

[mcbio]

ARRY - 2Q11 results

http://finance.yahoo.com/news/Array-BioPharma-Reports-bw-2465582393.html?x=0&.v=1

Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2011

BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) today reported financial results for the second quarter of fiscal 2011.

Array reported revenue of $16.5 million for the second quarter of fiscal 2011, compared to revenue of $9.6 million for the same period in fiscal 2010. The Company spent $14.5 million in proprietary research and development for the quarter to advance its fully owned clinical development and discovery programs. This compares to $19.1 million spent on proprietary research and development during the second quarter of fiscal 2010. Array reported a net loss of $12.4 million, or ($0.23) per share, for the second quarter, compared to a net loss of $21.8 million, or ($0.44) per share, for the second quarter in fiscal 2010. Cash used in operating activities was $11.0 million during the quarter. Array ended the second quarter of fiscal 2011 with $98.9 million in cash, cash equivalents and marketable securities.

The Company reported revenue of $35.0 million for the six-month period ended December 31, 2010, compared to revenue of $17.5 million for the same period in fiscal 2010. Net loss for the six months ended December 31, 2010, was $23.1 million, or ($0.42) per share, compared to a net loss of $46.6 million, or ($0.96) per share, reported in the same six-month period in fiscal 2010.

“With the completion of two Phase 2 trials expected for our MEK inhibitor, selumetinib, by our partner AstraZeneca, along with the potential for AstraZeneca’s initiation of Phase 3 trials for selumetinib, calendar 2011 looks to be a significant year for Array,” said Robert E. Conway, Chief Executive Officer. “Given the advancement of our proprietary and partnered programs anticipated for the year along with our solid cash position and reduced burn rate, we believe we are positioned to deliver value from Array’s research and development engine to partners and shareholders.”

SUMMARY OF KEY DEVELOPMENT PROGRAMS

Selumetinib (AZD6244) (AstraZeneca) – MEK inhibitor for cancer:

AstraZeneca completed enrollment in two Phase 2 trials with selumetinib, which are the first two randomized Phase 2 combination trials with a MEK inhibitor:

•Selumetinib plus DTIC compared with DTIC in first line melanoma patients with BRAF- mutation. The trial completed enrollment of 91 patients in March 2010 with the primary end-point of overall survival.
•Selumetinib plus Taxotere compared with Taxotere in second line non small lung cancer patients with KRAS-mutation. The trial completed enrollment of approximately 80 patients in July 2010 with the primary end-point of overall survival.

In addition, AstraZeneca has multiple on-going Phase 2 combination trials:

•Selumetinib compared with Temodar® (temozolomide) in patients with metastatic melanoma of the eye. Approximately 160 patients are anticipated to enroll in this trial.
•Selumetinib with Tarceva® (erlotinib) in patients with KRAS wild type NSCLC (selumetinib plus Tarceva vs. Tarceva) and in patients with KRAS mutant NSCLC (selumetinib plus Tarceva vs. selumetinib). Approximately 100 patients are anticipated to enroll in this trial.
•Selumetinib with Camptosar® (irinotecan) in patients with KRAS or BRAF mutant 2nd line colorectal cancer. Approximately 60 patients are anticipated to enroll in this trial.
•Selumetinib with Nexavar® (sorafenib) in patients with advanced hepatocellular carcinoma. Approximately 100 patients are anticipated to enroll in this trial.

In total, AstraZeneca has 40 on-going or completed Phase 1 or 2 clinical trials with selumetinib.

MEK162 (ARRY-162) (Novartis) – MEK inhibitor for cancer:

Pursuant to an agreement signed in April 2010, Array and Novartis are engaged in the joint development of MEK162 in oncology indications. Array has completed or is enrolling patients with solid tumors in an ongoing multi-arm Phase 1 MEK162 dose escalation and expansion trial. Pending the results of these multiple arms, we intend to conduct additional trials with MEK162 in combination with other agents, as well as in single agent trials. The current status of this study is:

•The dose escalation trial completed enrollment of 19 patients in January 2010.
•The first expansion arm in patients with biliary tract cancer completed enrollment of 28 patients in September 2010.
•Approximately 25 patients with KRAS-mutant colorectal cancer and 15 patients with BRAF-mutant colorectal cancer are anticipated to enroll in additional expansion arms of this trial.

ARRY-520 – KSP inhibitor for Multiple Myeloma (MM): Array presented data on a Phase 1 trial with ARRY-520, a novel KSP inhibitor, in patients with MM at the December 2010 Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.

This Phase 1, open-label, multicenter, dose-escalation study was designed to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-520. The study enrolled patients with relapsed or refractory MM with at least two prior lines of therapy (including both a bortezomib and an IMiD-based regimen) with a median of five prior therapies. ARRY-520 has shown promising preliminary clinical activity. Of 30 evaluable patients, confirmed partial responses have been observed in two patients, one of whom had eight prior lines of treatment and has continued on study for more than 18 months. In addition, confirmed minimal responses have been reported in two patients. As of December 4, 2011 [clearly should be "2010"], twelve patients remained on study, including all responders, and eight patients had been treated for longer than six months.

Array has two other on-going clinical trials of ARRY-520:

•Phase 2 trial in patients with relapsed or refractory multiple myeloma.
•Phase 1b combination study with ARRY-520 and Velcade® (bortezomib) in patients with relapsed or refractory multiple myeloma.

AMG 151 / ARRY-403 (Amgen) – Glucokinase activator for type 2 diabetes: Array completed a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes with AMG 151 / ARRY-403, a small-molecule glucokinase activator that Array partnered with Amgen Inc. in December 2009. Amgen is responsible for all future development under the collaboration agreement. Array also continued a research program, which is being funded by Amgen to identify and advance second-generation glucokinase activators.

OTHER RECENT EVENTS

ARRY-380 – HER2 oral, selective inhibitor for cancer: Array announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer at the December 2010 San Antonio Breast Cancer Symposium.

Interim results were presented on 19 patients with HER2 positive cancer treated with ARRY-380 at doses greater than or equal to 200 mg (twice daily). All of the HER2 positive metastatic breast cancer patients had been previously treated with Herceptin® (trastuzumab), and 81 percent were previously treated with Tykerb® (lapatinib). Thirty two percent of the 19 patients had a partial response or stable disease for six months or longer. Fifteen of the 19 patients had measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST); of these patients, seven had regressions in target lesions. Of the four patients with no measurable disease, three had regressions of non-target chest wall lesions.

ARRY-380 was well-tolerated; the predominant treatment-related adverse events have been Grade 1. Because ARRY-380 is selective for HER2 and does not inhibit EGFR, there was, as expected, a low incidence and severity of diarrhea, rash and fatigue. Additionally, there were no Grade 4 events or adverse cardiac events reported. The maximum tolerated dose of ARRY-380 established in this Phase 1 trial is 600 mg (twice daily). An expansion cohort in patients with HER2 positive metastatic breast cancer is ongoing to confirm safety and explore efficacy and pharmacodynamic markers.

ARRY-382 (Celgene) cFMS inhibitor for cancer: In December 2010, Array announced that it received a $10 million clinical research milestone payment in its collaboration with Celgene Corporation (NASDAQ:CELG - News), entered into in September 2007. Array anticipates initiating a Phase 1 dose escalation trial in cancer patients with ARRY-382 during the first quarter of calendar 2011. Array is responsible for the continued development of ARRY-382 through Phase 1, and Celgene has an option to obtain exclusive rights to ARRY-382. If Celgene exercises this option, Celgene would be responsible for additional development and commercialization of this drug, and Array would be entitled to receive additional milestones as well as royalties on sales of the drug.

Array will hold a conference call on Tuesday, February 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, February 1, 2011
Time: 9:00 a.m. eastern time
Toll-Free: 800-482-9816
Toll: 719-325-2114
Pass Code: 4527581

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 and by phone for one week by dialing toll-free [phone] or [phone]. The access code is 4527581.

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.