3 Things In Biotech You Should Learn Today: February 5, 2017

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Includes: AMGN, BMY, EYEG, FMI, MRK
by: Zach Hartman
Summary

Bristol-Myers checks in big time in lung cancer.

Amgen stumbles in bone care study.

EyeGate comes crashing down after trial failure.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Bristol-Myers checks in big time in lung cancer

Company: Bristol-Myers Squibb (NYSE:BMY)

Therapy: Nivolumab and ipilimumab

Disease: Non-small cell lung cancer (NSCLC)

News: BMY announced findings from the CheckMate-227 study, which is assessing (in part) the combination of nivolumab and ipilimumab compared with chemotherapy in previously untreated NSCLC. The study has met one of its primary endpoints, progression-free survival, in patients with so-called high tumor mutational burden, assessed using a Foundation Medicine (NASDAQ:FMI) assay. The study will continue to follow patients to assess overall survival.

Looking forward: You'd better go ahead and start getting used to hearing "tumor mutational burden" when it comes to immunotherapies, because it's quickly emerged as one of the most promising biomarkers of response to the immune checkpoint inhibitors. Likely, this is also BMY's first salvo to finally getting nivolumab approved in first-line lung, although the toxicity is still a potential issue here.

Overall, this is great news for BMY, and it puts Merck (NYSE:MRK) in its sights.

Amgen stumbles in bone care study

Company: Amgen (NASDAQ:AMGN)

Therapy: Denosumab

Disease: Bone complications relating to breast cancer

News: AMGN's partner announced top line findings from the D-CARE study, which assessed the RANKL inhibitor denosumab compared with placebo as adjuvant therapy for early-stage breast cancer at a high risk of recurrence. Unfortunately, the study did not meet its primary endpoint of bone metastasis-free survival. The findings will be presented in full at a later date.

Looking forward: This is definitely a setback for the continued growth of the denosumab franchise, which currently brings in billions in revenue for AMGN. So certainly, this news isn't catastrophic for AMGN, but now it's at a greater risk for erosion of sales as biosimilars are explored.

As patent expirations loom in the coming years, AMGN is going to need to look for innovation in other areas.

EyeGate comes crashing down after trial failure

Company: EyeGate (NASDAQ:EYEG)

Therapy: EGP-437

Disease: Post-cataract surgery inflammation and pain

News: EYEG announced top line findings from its phase 2b study involving EGP-437 in patients who have undergone cataract surgery. Although there were trends towards improvements in the study endpoints, the co-primary endpoints were not significantly improved. The company explained that the vehicle control appeared to perform better than anticipated, making its as-expected efficacy end up in trial failure.

Looking forward: Unfortunately, this is the reality of clinical trials when you're operating on relatively fine lines of improvement for patients. The drug performed as expected, but it cannot be determined that it had a genuine effect because of better-than-expected performance of the control.

If EYEG can't get a response squared away quickly, then it's likely its time is up. I would be hyper-cautious about investing in the stock at this time.

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