On February 5, 2015 Dendreon reported that it has entered into an amended agreement with Valeant Pharmaceuticals International in connection with the previously announced court-supervised sales process (Press release Dendreon, FEB 5, 2015, View Source [SID:1234501485]). Under the terms of the amended agreement, subject to bankruptcy court approval, Valeant would acquire the world-wide rights of PROVENGE (sipuleucel-T) and certain other Dendreon assets for $400 million, subject to higher and better bids.

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As previously announced, the bid deadline for interested parties to submit qualified bids to participate in an auction for the Company’s assets is scheduled for February 10, 2015 at 5:00 p.m. Eastern Time. Assuming additional qualified bids are submitted, an auction would be held on February 12, 2015. Under the terms of the amended agreement, Valeant will serve as the "stalking horse" bidder in conjunction with the court-supervised auction.

The Company is operating in the ordinary course and continues to produce and deliver PROVENGE without interruption.

On February 5, 2015 Synta Pharmaceuticals reported an outlined a new corporate strategy aimed at focusing the Company’s resources on achieving key value creating milestones in 2015 and 2016, and transforming the organization into a leading oncology biopharmaceuticals company (Press release Synta Pharmaceuticals, FEB 5, 2015, View Source;p=RssLanding&cat=news&id=2014219 [SID:1234501488]).

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Synta’s core strengths in oncology research and development are exemplified by the discovery and rapid development of ganetespib, its Phase 3, novel, potent, small molecule inhibitor of Heat Shock Protein 90 (Hsp90), and its Hsp90 Drug Conjugate (HDC) platform, which includes a broad library of potential product candidates. As part of its new strategy, the Company will align its talent and resources around these core strengths, focusing on several key areas:

Maximizing the value of ganetespib for patients and shareholders

Synta will focus its clinical development activities on ganetespib. Ganetespib is in development for the treatment of a broad range of cancers, with its lead program in non-small cell lung cancer (NSCLC) in the company sponsored pivotal Phase 3 GALAXY-2 clinical trial. Interim analysis from this study is expected in the second half of 2015 and final analysis is expected in the first half of 2016. In addition, ganetespib is also in a Phase 3 clinical trial for acute myeloid leukemia (AML), and Phase 2 clinical trials for ovarian and breast cancer, each sponsored through cooperative groups. As part of its development plan for ganetespib, Synta is exploring certain biomarkers, which it expects may guide future development of the product, pending confirmation of their prognostic and predictive potential via results of ongoing studies.

Advancing candidates from our Hsp90 Drug Conjugate (HDC) platform into the clinic

Synta has initiated IND-enabling studies for its lead HDC drug candidate, STA-12-8666, with an expectation to file an Investigational New Drug (IND) application by the first quarter of 2016. STA-12-8666 is a conjugate of an Hsp90 inhibitor bound to SN-38, the active metabolite of irinotecan. STA-12-8666 has demonstrated significant activity in patient derived xenograft (PDX) models of pancreatic cancer and small cell lung cancer. STA-12-8666 also showed improved tolerability compared to irinotecan in preclinical models. In addition to STA-12-8666, Synta expects to identify one additional HDC drug candidate to nominate for preclinical development by the end of 2015. Synta intends to continue pursuing partnerships and business development activities to advance other candidates within its HDC platform.

Optimizing our pipeline and research agenda

Synta performed a comprehensive review of the Company’s drug candidate portfolio, development programs and research agenda in order to optimize the allocation of its limited resources. This review has led to a rationalization of the Company’s portfolio and research activities, demonstrated by the divestiture of Synta’s IL-12/23 inhibitor program and its CRAC ion channel inhibitor program in 2014. As part of this effort, the company reduced its headcount in 2014 by a total of 20 people and reallocated resources to increase support of the ongoing ganetespib development program and HDC platform. Going forward, Synta intends to build its pipeline through a focused, internal research agenda, complemented by external partnerships and business development activities. To support the future pipeline development and research agenda, Synta has named Dr. Neil Spector, Sandra P. Coates Chair Breast Cancer Research, Duke University Medical Center, Scientific Advisor to the Company. Dr. Spector will retain his full-time faculty appointment and research/clinical responsibilities at Duke, while dedicating a percentage of his consulting time to Synta activities.

Adapting our structures to achieve our goals and strengthen our balance sheet

Synta is adapting its operating model to better suit its future strategy needs. Rather than focusing primarily on building internal capabilities across discovery, development and commercialization, this new model will reflect a leaner, more agile organization that leverages internal strategic capabilities with the expertise of external capabilities, as-needed.

As part of this change in Synta’s operating model, the company announced today a reduction in force of approximately 20%. Synta expects to realize cost savings from this downsizing in 2015. On a cumulative basis, headcount has been reduced from 133 at the beginning of 2014 to 90 today. The company will continue to seek productivity improvements and increased operating efficiencies as the new operating model for the organization is put in place. This will include a consolidation of Synta’s office and laboratory facilities in 2016.

Upcoming Milestones

The company plans to achieve the following key milestones by the end of 2016:

Completion of interim analysis of GALAXY-2 in 2H 2015 with final analysis in 1H 2016
Pending a successful outcome of GALAXY-2, filing of a New Drug Application (NDA) for ganetespib in NSCLC in 2016
Submission of an IND for STA-12-8666 by Q1 2016
Initiating IND enabling studies for an additional HDC drug candidate in 2016

Anne Whitaker, President and Chief Executive Officer of Synta, commented, "Our ambition is to bring to market novel cancer medicines to treat patients battling cancer by leveraging our internal strengths in oncology research, development and commercialization, as well as external relationships with academia, investigators, and partners. The next several quarters hold tremendous potential for bearing out the value of our pipeline. The structural changes we are making within our organization, while difficult decisions, are necessary to help us realize this potential. We are extremely grateful for the contributions of those who will be leaving the Company, and we all wish them much success in their future endeavors."

Biogen Idec has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing 10-K , Biogen Idec, FEB 4, 2015, View Source [SID1234501473]).

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Immunomedics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Immunomedics, FEB 4, 2015, View Source [SID1234501476]).

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On February 4, 2015 OncoMed Pharmaceuticals reported that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line advanced-stage non-small cell lung cancer (NSCLC) (Press release OncoMed, FEB 4, 2015, View Source [SID:1234501460]).

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"Based on anti-tumor activity and the safety profile observed in our Phase 1b study of demcizumab plus standard-of-care in non-small cell lung cancer, we believe demcizumab has the potential to achieve meaningful clinical benefits for patients with this difficult cancer. We look forward to assessing, with the study investigators, demcizumab’s activity and safety in a randomized setting," said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer.

The Phase 2 "DENALI" trial is expected to enroll approximately 200 patients with first-line metastatic Stage IV non-squamous NSCLC whose tumors do not have an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation. Patients will be randomized into one of three study arms to compare the efficacy and safety of demcizumab combined with carboplatin and pemetrexed versus carboplatin and pemetrexed alone. In all three arms, patients will receive carboplatin and pemetrexed for four cycles, followed by pemetrexed maintenance. In addition, patients in Arm 1 will receive the chemotherapy plus placebo, patients in Arm 2 will receive chemotherapy with one truncated course of demcizumab every three weeks for four doses and patients in Arm 3 will receive chemotherapy with two truncated courses of demcizumab with the second truncated course starting at Day 168. The primary endpoint is progression-free survival. Secondary endpoints include response rate, duration of response, overall survival, safety, immunogenicity and pharmacokinetics. The DENALI study will also explore pharmacodynamics and several potential predictive biomarkers. DENALI will be conducted at approximately 60 sites in Europe, the United States and Australia.

"This is a major milestone for us, as it is the first of two randomized Phase 2 trials being conducted for demcizumab in our collaboration with Celgene, and the first anti-DLL4 antibody to enter this phase of development. Patient dosing for the second demcizumab randomized Phase 2 trial in pancreatic cancer should also begin shortly. Two additional Phase 2 trials are already underway for tarextumab, our anti-Notch2/3 antibody. Depending on each study’s rate of enrollment and other factors, we expect these four randomized Phase 2 studies to produce results in the 2016-2017 timeframe," said Paul J. Hastings, OncoMed’s Chairman and Chief Executive Officer.

In OncoMed’s Phase 1b clinical study of demcizumab in NSCLC, the combination of demcizumab with pemetrexed and carboplatin was generally well tolerated. No moderate to severe cardiopulmonary adverse events occurred with truncated demcizumab administration. Of 33 patients evaluable for efficacy, one (3%) had a complete response, 15 (45%) had a partial response and 13 (39%) had stable disease per RECIST criteria for an overall clinical benefit rate of 88 percent. Among the 14 evaluable patients who received demcizumab on a truncated dosing schedule, one had a complete response, seven had a partial response, five achieved stable disease and one had progressive disease resulting in an overall clinical benefit rate in this subset of patients of 93 percent. Eight patients treated with demcizumab at or above the Phase 2 dose schedule had progression-free survival for greater than 300 days. Final clinical data from this Phase 1b trial are anticipated to be presented at a medical meeting in 2015.