Biotech Trends 2018: Immuno-oncology Disappoints

Biotech Investing

2018 marked another critical year of growth for the biotech market. Learn about key biotech trends before the new year begins.

2018 marked another critical year of growth for the biotech market, which was influenced by multiple trends.

In 2017, it was predicted that the immuno-oncology (I/O) market’s ambitious clinical trials would finally come to fruition. However, many trials had lackluster results, casting a shadow on the field.

I/O disappointments weren’t the only news for biotech trends, with biosimilars and approvals from the US Food and Drug Administration being other biotech trends the market focused on. 

To close out the year, the Investing News Network (INN) spoke to industry experts and companies to share with investors the biggest biotech trends of 2018. Read on to learn more.

Biotech trends 2018: I/O trials disappoint

David Nierengarten, managing director at Wedbush Pac Grow Healthcare, told INN in a telephone interview that a surprise for the biotech market was the “repeated lack of really head-turning data, especially with the combo trials with chemotherapies.”

This was one of the main things that weighed down the sector in the second half of the year, Nierengarten emphasized. However, he said, after a big biotech rally in the beginning of the year, it’s natural for there to be a pullback in the second half of the year — he doesn’t believe this is tied to anything more fundamental.

In one I/O trial, Syndax Pharmaceuticals (NASDAQ:SNDX) said that E2112, its NCI-sponsored, ECOG-ACRIN-led pivotal trial of entinostat plus exemestane in HR+, HER2- breast cancer, failed to show a statistically significant PFS improvement.

The company’s share price dropped 25 percent based on this news, and GlobalData (LSE:DATA) says that experts had been expressing caution over the study results “due to the evolved treatment landscape.”

In another I/O clinical trial, Incyte (NASDAQ:INCY) and Merck’s (NYSE:MRK) Phase 3 clinical trial for epacadostat, an IDO inhibitor, failed to prove efficacy. After that, other companies working on IDO inhibitors halted or scaled back their own trials.

However, oncology research and development still dominates the biotech industry, William Looney, executive editor for In Vivo at Informa Pharma Intelligence, told INN. This raises questions about how long expectations of “rich compound valuations can continue as therapeutic class competition grows.”

Bonnie Bain, global head and executive vice president of healthcare operations and strategy at GlobalData, and Kelly Lambrinos, senior editorial analyst at GlobalData, told INN that in 2018 multiple companies had positive oncology data.

A few companies mentioned by GlobalData include Adaptimmune (NASDAQ:ADAP), Aduro Biotech (NASDAQ:ADRO), Aeglea Biotherapeutics (NASDAQ:AGLE), Zymeworks (NYSE:ZYME,TSX:ZYME), Nektar Therapeutics (NASDAQ:NKTR) and Infinity Pharmaceuticals (NASDAQ:INFI).

Biotech trends 2018: FDA approves even more drugs

Every year, the FDA seemingly approves drugs at a record rate and at a higher amount. Back in 2016, just 22 novel drugs were approved, and at of the end of 2017, 46 novel drugs had been approved. 

Thus far in 2018, 56 novel drugs have been approved, representing a 21-percent increase from 2017. This was a biotech trend many industry experts believe influenced the market this year.

Progenics Pharmaceuticals (NASDAQ:PGNX) represents a notable FDA approval. Its drug received approval for a rare tumor treatment with Azedra in late July. This was the first approved therapy for unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma that require systemic anticancer therapy.

Secondly, Paratek Pharmaceuticals (NASDAQ:PRTK) received FDA approval for its drug Nuzyra for the treatment of community-acquired bacterial pneumonia. The drug is set to launch in Q1 2019. Investors can look forward to the company’s Q2 financial report next year to give an idea of the drug’s revenue.

GlobalData told INN that 2018 also had a substantial amount of orphan drug approvals and a rise in orphan drug designation requests. There are no signs of the rare disease field slowing down, they said.

According to GlobalData, investors were closely watching Achillion Pharmaceuticals’ (NASDAQ:ACHN) update for its C3 glomerulopathy (C3G) and paroxysmal nocturnal hemoglobinuria (PNH) studies. ACH-4471 is Achillion’s investigational drug in trials for both indications.

In mid-December, the company presented positive interim data for the drug in Phase 2 trials. The proof of concept was validated for PNH as a monotherapy and when combined with a C5 inhibitor. As for C3G, the mechanism was also validated, and an end of Phase 2 meeting is targeted for Q4 2019.

Other orphan drug results involve Duchenne muscular dystrophy, Pompe disease and cystic fibrosis.

In addition to these approvals, Looney added that there’s been an uptick in successful launches for the “first round of complex gene-based therapies, with several hundred compounds in various clinical trial stages.” These drugs may “offer the hope of multiple cures against a broad range of chronic and rare diseases in the early years of the next decade,” he said.

Biotech trends 2018: Biosimilars make headway

Biosimilars may not be a new trend — they were highlighted in the FDA’s 2017 New Drug Therapy Approvals — but 2018 brought even more opportunities and downfalls to the space. GlobalData said that multiple federal policies were announced that attempt to “lay the foundation for a cost-effective and sustainable biosimilars market.”

In November, the Centers for Medicare and Medicaid Services (CMS) published its final changes for Phase B reimbursements, outlining a system where biosimilars will each get separate billing codes. GlobalData says this is unlikely to drive down drug prices in the near term, but it’s a positive move toward market competition.

The CMS also gave new rules to Medicare Advantage plans in August. The organization said it plans to offer the option of applying step therapy for physician-administered and other Part B drugs for a more cost-effective option.

August also had big news for the biosimilar development of Johnson & Johnson (NYSE:JNJ) and Pfizer’s (NYSE:PFE) landmark case. Johnson & Johnson released a motion to dismiss Pfizer’s allegation of an antitrust injury. The court handling the motion denied Johnson & Johnson’s motion, allowing competition to continue for the biosimilar drugs each company is marketing respectively.

“Tactics sway[ed] the sale of the former’s Remicade through exclusive contracts and bundle rebates over Pfizer’s biosimilar Inflectra,” GlobalData said. The court decision denied this civil action.

Some biosimilar drugs approved this year from the FDA include Pfizer’s drug Retacrit, Coherus Biosciences’ (NASDAQ:CHRS) drug Udenyca and Teva (NYSE:TEVA) and Celltrion’s (KRX:068270) drug Herzuma.

Biotech trends 2018: Investor takeaway

Closing out the year, investors may want to keep an eye on these evolving biotech trends moving into 2019. Developing clinical trials and FDA approvals are also an opportunity for investors to watch for trial results and drug launches.

Investors interested in more biotech trends can take a look at INN’s top biotech news stories to see what grabbed our investor audience’s attention.

Don’t forget to follow@INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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