Webinar Outlines 2018 Biotech Outlook

This week, STAT held a webinar entitled “What to Expect in Biotech in 2018.” The broadcast was hosted by Adam Feurstein, a senior biotech reporter, and Damian Garde, a national biotech reporter. The goal of the webinar was to provide a framework of the themes that are likely to shape the biotech sector in the coming year, as well to provide a look at biotech stocks in 2018.

Garde highlighted the strides that both FDA Commissioner Scott Gottlieb, MD, and the FDA itself made in 2017 to expedite drug approvals and provide a more efficient, streamlined drug development process. Garde noted that it will be important to watch certain drugs after they’ve received expedited approval to make sure that drug efficacy or safety is still maintained through this quicker process.

Feurstein discussed potential upcoming FDA drug approvals throughout the year that could affect the biotech market, including:

• Vertex Pharma’s tezacaftor for the treatment of cystic fibrosis
• Novartis’ tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant
• Acorda Therapeutics’ CVT-201 (Inbrija) for the treatment of Parkinson disease
• Gilead Sciences’ bictegravir for the treatment of HIV/AIDS

According to a J.P. Morgan poll, 60% of investor respondents expect the biotech sector to outperform the broader market in 2018, and 84% expect an increase in mergers and acquisitions.

Presenters briefly mentioned biosimilars in the broadcast, stating that they’re here to stay, and companies that are making reference products will have to become innovative to keep up with the expected cost-savings from biosimilars, once more come to market.

As far as how the new tax reform bill could affect biotech companies, STAT believes that the increase in cash savings could result in either more mergers and acquisitions, or stock share buybacks later this year. According to the webcast, Amgen, Gilead Sciences, and Merck all hold more than $20 billion overseas.

The presentation closed with some drug launches and clinical trials to watch this year:

Drug launches:

• Gilead Sciences is launching axicabtagene ciloleucel (Yescarta) in the fourth quarter.
• Novartis is launching tisagenlecleucel (Kymriah) in the fourth quarter.
• Amgen is launching evolocumab (Repatha) in the second quarter.
• Regeneron—Sanofi are launching alirocumab (Praluent) in the second quarter.

Clinical Trials:

• Aimmune's AR101 for a peanut allergy indication in a phase 3 trial
• Celldex’s glembatumumab vedotin for the treatment of triple-negative breast cancer in a phase 2 trial
• Incyte—Merck’s epacadostat plus pembrolizumab (Keytruda) for the treatment of melanoma in a phase 2 trial
• AstraZeneca’s durvalumab (Imfinzi) plus tremelimumab for the treatment of lung, head and neck cancer in a phase 3 trial
• Esperion’s ETC-1002 (bempedoic acid) for the treatment of diabetes and elevated lipids in a phase 2 trial