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TTPH Implodes On IGNITE3, EC Approves 2nd Herceptin Biosimilar, PTIE At It Again

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Today's Daily Dose brings you news about Tetraphase's disappointing IGNITE3 results; Pain Therapeutics' resubmission of REMOXY NDA; management changes at Arbutus; approval of the second Herceptin biosimilar in Europe; scrapping of yet another potential Alzheimer's drug, and the potential of Exelixis' Cabozantinib in first line treatment for differentiated thyroid cancer.

Read on…

Arbutus Biopharma Corp.'s (ABUS) Executive Vice President and Chief Financial Officer, Bruce Cousins, is leaving the Company but will remain available on a consulting basis.

Koert VandenEnden, Arbutus' Vice President of Finance, will serve as Interim Chief Financial Officer until a permanent successor to the outgoing Executive Vice President and CFO, Bruce Cousins, is appointed.

To know more about ABUS, please visit our Company Spotlight column.

ABUS closed Tuesday's trading at $5.65, up 6.60%.

Celltrion Inc.'s Herzuma, a biosimilar version of Roche's (RHHBY) Herceptin, has been approved by the European Commission, becoming the second Herceptin biosimilar to be greenlighted in Europe.

Herzuma is approved for early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

The first Herceptin biosimilar to be approved in Europe is Samsung Bioepis' Ontruzant. It was approved by the European Commission on Nov.19, 2017. In the U.S., Mylan and Biocon's Ogivri is the first biosimilar version of Herceptin to be approved. It was approved by the FDA on Dec.1, 2017.

Herceptin brought home sales of 7.01 billion Swiss francs for Roche in 2017, compared to 6.78 billion Swiss francs in 2016.

Exelixis Inc.'s (EXEL) phase II investigator-sponsored trial of Cabozantinib for the first-line treatment of metastatic radioiodine (RAI)-refractory differentiated thyroid carcinoma has demonstrated an objective response rate of 54% among 35 evaluable patients while stable disease was observed in 43%.

The results from the study will be presented during an oral session on February 16 starting at 1:30 p.m. MT at the 2018 Multidisciplinary Head and Neck Cancers Symposium, which is being held in Scottsdale, Arizona, February 15-17, 2018.

The Company plans to initiate a pivotal phase III trial of Cabozantinib later this year.

EXEL closed Tuesday's trading at $28.80, down 0.86%.

Merck (MRK) has decided to discontinue its phase III study evaluating Verubecestat in people with prodromal Alzheimer's disease based on the recommendation of an external Data Monitoring Committee.

The eDMC concluded that it was unlikely that positive benefit/risk could be established if the trial continued.

Verubecestat is the second Alzheimer's disease drug candidate to be abandoned this month.

Last week, Boehringer Ingelheim announced that it is halting the development of BI 409306 in Alzheimer's disease after the compound failed to meet the endpoints in a phase II study.

Related Reading

Race For A New Alzheimer's Drug

MRK closed Tuesday's trading at $54.90, down 0.96%.

Quidel Corp. (QDEL) has received FDA clearance for its CLIA Waived QuickVue Influenza A+B assay for the rapid, differential detection of influenza types A and B.

The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.

QDEL closed Tuesday's trading at $44.31, down 0.09%.

Pain Therapeutics Inc. (PTIE) has resubmitted its New Drug Application for REMOXY to the FDA.

REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

REMOXY ER was issued a Complete Response Letter by the FDA in September 2016.

PTIE closed Tuesday's trading at $6.19, up 4.03%.

Shares of Tetraphase Pharmaceuticals Inc. (TTPH) were down over 55% in extended trading on Tuesday, following the failure of its IGNITE3 clinical trial to meet the co-primary efficacy endpoints.

IGNITE3 was a phase III clinical trial evaluating the efficacy and safety of investigational once-daily IV Eravacycline against FDA-approved injectable ertapenem (1g every 24 hours) for the treatment of complicated urinary tract infections.

According to the Company, the study failed to meet the co-primary efficacy endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat (micro-ITT) population at the end-of-IV (EOI) treatment visit and at the test-of-cure (TOC) visit, which were evaluated using a 10% non-inferiority margin.

Eravacycline is also being explored in the treatment of complicated intra-abdominal infections, and a New Drug Application for the compound in this indication was submitted to the FDA last month. Eravacycline is also under review by the European Medicines Agency for the treatment of complicated intra-abdominal infections.

TTPH closed Tuesday's trading at $5.43, down 0.55%. In after-hours, the stock fell 55.06% to $2.44.

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