BPC February 17 update

Biotech Week in Review - February 17; Upcoming 1Q Biotech Catalysts; IPO tracker added to BioPharmCatalyst

Weekly watchlist

Before we review the last trading week, a notice in regard to tools soon to appear on BioPharmCatalyst that was announced to readers of the daily edition.

Over the next few weeks 3-4 additional tools, or refinements of existing tools will be released on BioPharmCatalyst. The first of which is featured on the IPO Calendar. Readers can now track 40 of the most recent IPOs from the Healthcare sector and access the following data:

- IPO listing price and date.

- Price after first trading day. 

- Current return. 

Next to review the week that was together with upcoming 1Q catalysts.

In the large cap space, AstraZeneca plc (ADR) (NYSE:AZN) announced on Friday that it met its primary endpoint in its Phase 3 OLYMPIAD trial of Lynparza (olaparib) compared with standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. The data, which were the first positive Phase 3 batch for a PARP inhibitor, puts the company in a battle with TESARO Inc (NASDAQ:TSRO) which also has a PARP inhibitor in its pipeline. Its drug Niraparib is awaiting review from the FDA for the treatment of ovarian cancer with a PDUFA date of June 30 under priority review. Data from Tesaro’s breast cancer trial are due in 2H 2017.

Merck (NYSE: MRK) suffered the fate of many others developing treatments for Alzheimer’s disease (AD) when on Tuesday it announced it will be stopping its Phase 2/3 EPOCH (trial 017) trial of verubecestat following notice from the Data Monitoring Committee that there was virtually no chance of finding a positive clinical effect.

In legal news, Editas Medicine Inc (NASDAQ:EDIT) spiked up in trading mid-week to close the week up 38% to $26.02 from Wednesday’s open following news that the US Patent and Trademark Office ruled that patents awarded to the Broad Institute CRISPR-Cas9 technology will remain. This news came as a relief to Broad and Editas, which had been at risk of losing its intellectual property.

On the small cap front, the week got off to a positive start for Zosano Pharma Corporation (NASDAQ:ZSAN), when it announcement that it achieved both co-primary endpoints in its Phase 3 trial of M207 for the treatment of migraine. Shares closed the week up 160% to $3.12.

However, later that day Aviragen Therapeutics (NASDAQ:AVIR) suffered back-to-back trial failures when it announced that its Phase 2b SPIRITUS trial, in moderate to severe asthmatics with a rhinovirus (RV) infection, did not meet the primary endpoint, sending shares down 35% at the close of the week.

The week ended on a sour noted for ArQule, Inc. (Nasdaq: ARQL) when it announced on Friday that its Phase 3 trial of tivantinib in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival, adding to a long list of failed late-stage trials for the company. Shares of the company dropped 18% to $1.20.

Upcoming 1Q Catalysts:

Drug Stage Catalyst

Naloxone Intranasal
Opioid overdose

CRL CRL announced February 21, 2017.

mGluR mutation positive ADHD

Phase 2/3 Phase 2/3 data released March 20, 2017 - primary endpoint not met. Subset of data released April 20, 2017 - to be presented April 21, 2017.

Selinexor - STORM
Quadruple Refractory Multiple Myeloma

Phase 2b Phase 2b STORM Study Expansion data due April 2018.

Telotristat etiprate (XERMELO)
Carcinoid Syndrome

Approved Approved February 28, 2017.

ND0612H (Trial 006)
Severe Parkinson's Disease

Phase 2 Phase 2 trial met key primary and secondary endpoints - March 1, 2017.

Lower back pain

Phase 3 Phase 3 data released March 20, 2017 - endpoints met.

Roche (RHHBY) - Perjeta + Herceptin (APHINITY)
Adjuvant HER2+ breast cancer

Phase 3 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. Primary endpoint was met March 2, 2017. Data released June 5, 2017 - HR 0.81. Disease-free-survival +0.9% over Herceptin.

Cystic fibrosis

Phase 2 Phase 2 28-day data due 4Q 2017.

Chronic pain

CRL CRL issued September 26, 2016. NDA to be resubmitted in 1Q 2018 following additional trials to be completed by the end of 2017.

Lactose intolerance

Phase 2/3 Phase 2/3 top-line data released March 28, 2017. Primary endpoint met. End of Phase 2 meeting with FDA planned by the end of 2017 with Phase 3 trial to potentially commence 1H 2018.

Oliceridine (TRV130)
Moderate to severe acute pain

Phase 3 Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met but commercial doubts raised. Noted July 20, 2017 that NDA filing due September or October 2017.