It's going to be an action-packed second half for a handful of big pharmaceutical companies, and perhaps the most interesting six-month stretch in Novartis (NYSE: NVS) history. Newly launched therapies from the Swiss pharmaceutical and Pfizer (NYSE: PFE) will be closely monitored for various reasons.
AbbVie (NYSE: ABBV) and Novartis expect key decisions by the Food and Drug Administration (FDA) and clinical trial readings from Bristol-Myers Squibb (NYSE: BMY) ] and Merck (NYSE: MRK) can help their cancer immunotherapy stars shine even brighter. Self GlaxoSmithKline (NYSE: GSK) has a few experimental tests that could provide great gains for the company and its shareholders.
Large Oncological Readings Forward
Bristol-Myers Squibb gets its last chance to treat patients with newly diagnosed non-small cell lung cancer (NSCLC) with its immunotherapy combination of Opdivo and Yervoy. Last year, the company tried to submit an application to the FDA based on preliminary results from the CheckMate-227 study that showed patients with high tumor mutation load, a measurement that Bristol concocted, responded well to Opdivo plus Yervoy.
FDA was not I am not interested in an application based on an endpoint that was not a specific target at the beginning of the study, especially when the data was not particularly convincing. At the same time, oncologists are accustomed to using standard chemotherapy plus Merck's Keytruda to treat NSCLC in the first line, thanks to outcome data showing that patients' risk of death is half compared to standard care.
Merck probably has the first line NSCLC indication stitched with Keytruda, but it still struggles with Tecentriq plus chemotherapy from Roche (NASDAQOTH: RHHBY) for two major first-time indications: Recently diagnosed small cell lung cancer and triple-negative breast cancer. These are both difficult to treat and patients need a new alternative. Before the end of 2019, we should see data from studies with Keytruda and chemotherapy for both indications.
GlaxoSmithKline tries to resume the oncology map with a chimeric antigen receptor modified T cell (CAR-T) therapy that trains the patient's own immune cells to find and destroy BCMA surface cancer cell cells. Glaxo therapy is one of several BCMA-directed treatments in late stage development right now, so the stars are a must.
] Other readings on the way
Before the turn of the year we also get the chance to see if Glaxo's new HIV treatment, Dovato, has what it takes to beat the new market leader from Gilead Sciences  (NASDAQ : GILD) called Biktarvy. Dovato obtained approval in April, and so far it doesn't just fly from the shelves.
In the third quarter, GlaxoSmithKline presents 96 weeks of data from the central studies that supported Dovato's approval. If the security profile doesn't hold up to Biktarvy, Dovato will be very difficult to market.
First-quarter sales of Novartis heart failure, Entresto, jumped 85% over last year to an annual $ 1.4 billion, thanks to evidence that the patient gives the drug at the hospital significantly reduced rehabilitation risk. It can get another boost this year if the Paragon study shows that it reduces the risk of heart disease for less severe cases than Entresto is currently used to treat.
Annual sales of AbbVie's flagship rheumatoid arthritis treatment, Humira, peaked in 2018, only shy of $ 20 billion. Investors will see the company's next generation rheumatoid arthritis treatment, upadacitinib, earn approval with as few restrictions as possible, and avoid repeating the disaster Eli Lilly (NYSE: LLY) went in with a substance of the same class, Olumiant. Due to a potentially increased risk of dangerous blood clots recorded during clinical trials supporting Olumiant's application, the FDA approved only one dose that was considered too low to be effective.
Age-related macular degeneration (AMD) is expected to affect 1.5 million Americans by 2020, making it the main cause of visual impairment among older adults. Global Sale of Regeneron s (NASDAQ: RAIN) The AMD fabric, Eylea, reached an annual $ 7 billion over the first three months of 2019, which may be a high water mark. . Novartis barreling against this lucrative space with a candidate called brolucizumab.
Novartis used a prioritization voucher to ensure a brief review of brolucizumab's application. Depending on the FDA's decision, Novartis can fill its Eylea competitor before the end of the year.
There is no room for error with brolucizumab because the clock is ticking. Similar biosimilar versions of Regenerons Eylea should appear in the EU in 2025.
New drug launches
More often than not, drugs spied as future blockbusters fail to meet their expectations. Two ongoing commercial launches that investors will keep an eye on in the second half come from Pfizer, and you guessed it, Novartis.
Pfizer's long-awaited oral transthyretin (TTR) stabilizer, Vyndamax, obtained approval to treat patients with heart problems caused by TTR which continue to break down into amyloid fragments. Vyndamax does not work as effectively as Onpattro, an infusion from Alnylam (NASDAQ: ALNY) by knocking down the TTR, but it is much more convenient. If Pfizer can skip Alnylam in the TTR room, it can get money to develop RNAs like Alnylam is much more difficult.
Another RNA substance against an existential crisis is Biogen s NASDAQ: BIIB) Spinraza, a blockbuster treatment for a severe muscle spreading disease called spinal muscle atrophy (SMA). Biogen's leading growth driver can be in trouble because a thought price for drug prices has rated Spinraza approx. four times more expensive than a newly approved gene therapy from Novartis, Zolgensma.
Novartis wants to sell Zolgensma with 2.1 million list prices steadily over a five-year period, which is about the same as the total Spinraza maintenance treatment over time. While a one-time therapy seems like a much better deal than multiple injections of Spinraza every year for life, insurance companies are wondering about Zolgensma's $ 2.1 million price tag because it puts them in a difficult position.
Novarti's plan is popular with health plan sponsors, who ultimately pay for these drugs. Unfortunately, it is much less popular among America's unique collection of middlemen serving in the gaps between drug users and plan sponsors, and none of them are coming in the past. The White House recently moved away from a plan to reduce the inter-median impact of prescription drug supply chains.
If a giant like Novartis fails to commercialize Zolgensma, its smoother pour much less money into the development of gene therapy regardless of how these treatment agents distribute the patients who need them. All of these events are important, but if you only have time to see one to see where the biopharmaceutical industry is heading, make Zolgensma's commercial launch.