Horizon Pharma plc to Release Fourth-Quarter and Full-Year 2018 Financial Results and Host Webcast on Feb. 27, 2019

On January 29, 2019 Horizon Pharma plc (Nasdaq: HZNP) reported that its fourth-quarter and full-year 2018 financial results will be released on Wednesday, Feb. 27, 2019 (Press release, Horizon Pharma, JAN 29, 2019, View Source [SID1234532932]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes before the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Array BioPharma to Report Financial Results for the Second Quarter of Fiscal 2019 on February 5, 2019

On January 29, 2019 Array BioPharma Inc. (Nasdaq: ARRY) reported that it will report financial results for the second quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, February 5, 2019 (Press release, Array BioPharma, JAN 29, 2019, View Source [SID1234532950]). Ron Squarer, Chief Executive Officer, will lead the call.

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Date:

Tuesday, February 5, 2019

Time:

9:00 a.m. Eastern Time

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

9778144

Webcast, including Replay and Conference Call Slides:
View Source

FACIT and Triphase Accelerator Announce New Partnership with Celgene for First-in-class WDR5 Leukemia Therapy

On January 29, 2019 Triphase Accelerator, together with its majority shareholder FACIT, reported a new strategic collaboration with Celgene for a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers including leukemia (Press release, Celgene, JAN 29, 2019, View Source [SID1234536469]). Triphase is a drug development company advancing novel compounds through Phase 2 proof-of-concept, including the WDR5 program.

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Under the terms of the agreement, Celgene has the option to acquire TRPH-395 from Triphase Accelerator. Celgene will pay an upfront of US$40M and upon exercise of the option, Celgene will pay up to US$940M in contingent development, regulatory and sales milestones. Additional payments for sales-based royalties are also possible.

"As with our previously announced spin outs, the Drug Discovery team at Ontario Institute for Cancer Research (OICR), led by Dr. Rima Al Awar, has yet again produced a world-class asset for patients with cancer," remarked Dr. David O’Neill, President of FACIT. FACIT seed financed Propellon Therapeutics to commercialize the preclinical asset and ran a competitive global business development process to identify strategic partners. Multiple formal offers were received from the US, Europe and Japan, reflecting the high quality of science in the program.

Dr. O’Neill continued "The quality of the team and commitment by Triphase Accelerator to engage Ontario researchers and clinical sites in its high content studies, combined with its long-standing relationship with Celgene made this partnership the most compelling path to impact patients and the local economy." While additional payments to the program are largely contingent on clinical success, the significant financial commitment will enable re-investable returns by FACIT in the Ontario innovation economy.

The WDR5 protein is critical for the formation and activities of certain protein complexes that are associated with DNA and indirectly modify genes. These processes represent an exciting new therapeutic field, referred to as epigenetics. Blood cancers like leukemia can result when WDR5-associated protein complexes are not appropriately regulated in the body. Drug compounds that can disrupt these cancer-causing cellular activities represent a novel therapeutic approach, which may also improve clinical outcomes in patients with solid tumours.

"This transaction represents a significant milestone for Triphase Accelerator as it brings together our long-standing collaboration with Celgene and a first-in-class asset from Ontario" said Dr. Ilse Treurnicht, Executive Chairperson at Triphase Accelerator. "We are excited that this transaction is another step forward to realizing the vision of the founding partners – OICR, MaRS Innovation and MaRS – and will allow Triphase to apply its unique science based, rapid, and cost-effective approach to advancing this Ontario based program toward clinical proof of concept."

"Our investment in Propellon’s technology reflects our commitment to developing first-in-class epigenetic therapies for patients with hematological cancers," remarked Dr. Jorge DiMartino, Vice President of Translational Development at Celgene. "The teams at OICR Drug Discovery, FACIT and Triphase Accelerator have together created an optimal pathway for oncology innovation and help make Ontario a strong collaborator and destination for our investment."

"This is a great day for cancer research in Ontario. Congratulations to FACIT, OICR and Triphase Accelerator," said Todd Smith, Minister of Economic Development, Job Creation and Trade. "This discovery and investment will benefit Ontario cancer patients and support industry jobs in the province. Ontario is open for business, and we welcome more innovative cancer research and trials."

"This is an exciting development for cancer research and innovation in Ontario, and I congratulate FACIT, OICR and Triphase Accelerator on their important collaboration," said Christine Elliott, Deputy Premier and Minister of Health and Long-Term Care. "It’s partnerships like these that keep Ontario open for business and are invaluable as we work toward developing a long-term transformational health care strategy guided by innovation, integration and the better use of technology."

Perrigo To Receive Milestone Payment Of $250 Million From RPI Finance Trust

On January 29, 2019 Perrigo Company plc (NYSE: PRGO; TASE), a leading global provider of "Quality, Affordable Self-care Products", reported that the company expects to receive a milestone payment of $250 million from RPI Finance Trust, an affiliate of Royalty Pharma ("RPI") (Press release, Perrigo Company, JAN 29, 2019, View Source [SID1234532951]). This expected payment is the result of RPI’s contingent payments for Tysabri exceeding $333 million in calendar 2018.

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Perrigo’s President and CEO Murray S. Kessler stated, "Receipt of this milestone payment will enhance our financial flexibility to drive growth organically and through bolt-on acquisitions. We look forward to sharing more details about the company’s transformation plans including our capital allocation strategy during our upcoming Analyst Event, planned for this spring."

Under Perrigo’s agreement with RPI, Perrigo has the right to receive an additional $400 million milestone payment if RPI’s contingent payments for Tysabri sales in 2020 exceed $351 million.

IMV Announces Clinical Update for DPX-Survivac Program in Ovarian Cancer Following Positive Feedback from U.S. FDA

On January 29, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported updates on its clinical program for its lead investigational treatment, DPX-Survivac, as a potential monotherapy in advanced recurrent ovarian cancer (Press release, IMV, JAN 29, 2019, View Source [SID1234534098]). In December 2018, IMV met with the U.S. Food and Drug Administration (FDA) in a Type B meeting to discuss the results-to-date of its DECIDE1 clinical trial and ongoing development plan, as well as to obtain agency guidance on a potential accelerated regulatory pathway for DPX-Survivac as a T cell immunotherapy for the treatment of advanced ovarian cancer in patients with progressing disease.

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"This FDA meeting was an important milestone for the DPX-Survivac program, and we are very pleased to be aligned with the agency on key aspects of our clinical development plan," said Frederic Ors, Chief Executive Officer at IMV. "We believe that, with no currently approved immunotherapy options available, ovarian cancer remains a serious unmet medical need. We look forward to advancing our ongoing phase 2 DECIDE study in order to potentially expedite DPX-Survivac development as a possible first-in-class T cell immunotherapy treatment for patients with advanced ovarian cancer."

FDA Meeting Highlights

The purpose of IMV’s Type B meeting with the FDA was to request feedback on the design of the clinical program for DPX-Survivac. This program includes the ongoing DECIDE phase 2 clinical study and a potential future registration trial for accelerated approval in a subset of ovarian cancer patients.

The FDA reviewed the Company’s proposed clinical development plan and acknowledged the potential for accelerated approvals in advanced ovarian cancer based on objective response rate (ORR) according to RECIST 1.1 criteria with reported median duration of response (DOR). In addition, the FDA provided important guidance on clinical design considerations for different lines of therapy and platinum-sensitive and -resistant patient populations.

In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial, and further discussed those details with the FDA during the Type B meeting. The phase 2 primary endpoint, based on objective response rate (ORR) per RECIST 1.1 criteria, is intended to confirm the high response rate and duration of clinical benefits observed in previously announced results in a patient population defined by a clinical biomarker based on baseline tumor burden (BTB).

Multiple clinical sites are now open for enrollment in the DECIDE phase 2 trial. Subject to phase 2 results, IMV plans to schedule a follow-up meeting with FDA to finalize the design of a potential pivotal trial based on ORR and DOR.

About the DECIDE Phase 2 Trial Cohort

The DECIDE (DPX-Survivac with low dose intermittent cyclophosphamide) phase 2 study is an open label safety and efficacy study for individuals with advanced platinum-sensitive and -resistant ovarian cancer with sum of base line target lesions per RECIST criteria less than 5 cm. Primary and secondary endpoints include:

Safety profile,

ORR and DOR using RECIST 1.1 criteria,

Induction of systemic survivin-specific T cells in the blood, and

Induction of T cell infiltration into tumors.