It will be an action packed second half for a handful of big pharmaceutical companies and perhaps the most interesting six month range in Novartis & # 39; (NYSE: NVS) story. Recently introduced therapies by the Swiss pharmaceutical giant and Pfizer (NYSE: PFE) are closely monitored for various reasons.
AbbVie (NYSE: ABBV) and Novartis await key decisions by the Food and Drug Administration (FDA) and clinical trial results from Bristol-Myers Squibb (NYSE: BMY) and Merck . (NYSE: MRK) could help make the stars of their cancer immunotherapy shine brighter. Even GlaxoSmithKline (NYSE: GSK) has some late-stage trials that could bring great benefits to the company and its shareholders.
Merck has probably sutured the first-line NSCLC indication with Keytruda, but with Tecentriq plus chemotherapy of Roche (NASDAQOTH: RHHBY) for two more important indications: newly diagnosed small cell lung cancer and triple lung cancer – negative breast cancer. Both are difficult to treat and patients need a new option. Before the end of 2019, data from studies with Keytruda and chemotherapy should be available for both indications.
GlaxoSmithKline tries to re-position itself on the oncological map with a chimeric antigen receptor modified T-cell (CAR-T) therapy that trains patients' own immune cells to find and destroy cancer cells with BCMA on their surface , Glaxo therapy is one of several BCMA-guided late-stage treatments, so excellent results are a must.
Before the end of the year, we'll see if Glaxo's new HIV drug Dovato has what it calls the new leader of Gilead Sciences [zuschlagen19659017] (NASDAQ: GILD) Biktarvy. The approval for Dovato was granted in April, and it does not fly off the shelves so far.
In the third quarter, GlaxoSmithKline will provide data for 96 weeks from the pivotal studies confirming approval for Dovato. If his safety profile does not stand up to Biktarvy, it will be terribly difficult for Dovato to market it.
Novartis & # 39; s drug for heart failure, Entresto, increased 85% year-on-year to $ 1.4 billion in the first quarter. This is because administering the drug in the hospital significantly reduces the risk of re-hospitalization. This could be further boosted this year if the Paragon study shows that the risk of cardiac events is significantly reduced in less severe cases than is currently the case with Entresto.
The annual sales of AbbVie's flagship treatment for rheumatoid arthritis, Humira, reached a peak of just under $ 20 billion in 2018. Investors want the next generation of the company, the treatment of rheumatoid arthritis, Upadacitinib, to be approved with as few restrictions as possible and that the disaster will not be repeated. Eli Lilly (NYSE: LLY) was infected with a drug of the same class, Olumiant. Due to a potential increased risk of developing dangerous blood clots found in clinical trials that support the use of Olumiant, the FDA only approved a dosage considered too low to be effective in 2020, making it the leading cause of vision loss in older adults. Regeneron (NASDAQ: REGN) AMD drug Eylea reached an annualized $ 7 billion in the first three months of 2019, which could be a high-water mark. Novartis is embarking on a lucrative market with a candidate called brolucizumab.
Novartis used a priority review coupon to ensure a shortened review of the use of brolucizumab. Depending on the FDA's decision, Novartis could use its Eylea competitor before year-end.
Brolucizumab is safe because the clock is ticking. Low-cost biosimilar versions of Regeneron's Eylea should emerge in the EU in 2025.
New drugs are coming onto the market.
Mostly medications advertised as future blockbusters do not meet their expectations. Two ongoing launches that investors want to keep track of in the second half are from Pfizer and, you guessed, from Novartis.
Pfizer's long-awaited oral transthyretin stabilizer (TTR), Vyndamax, has been approved for the treatment of patients with heart problems caused by TTR who continue to degrade into amyloid fragments. Vyndamax does not seem to be as effective as Onpattro, an infusion of Alnylam (NASDAQ: ALNY) to knock down TTR, but it is much more practical. If Pfizer can skip Alnylam in TTR space, it could be a lot harder to raise money for the development of RNA drugs like Alnylam.
Another RNA drug in an existential crisis is Biogen (NASDAQ: BIIB) Spinraza, a blockbuster treatment for severe muscle wasting disease called Spinal Muscular Atrophy (SMA) referred to as. Biogen's main growth driver could be in trouble because a drug-pricing think tank considers Spinraza four times more expensive than a Novartis-approved gene therapy called Zolgensma.
Novartis plans to sell Zolgensmas at a list price of $ 2.1 million evenly above the list price A five-year period that roughly equals the total cost of spinraza maintenance therapy over the same period. While one-time gene therapy seems to be a much better deal than injecting Spinraza into Lifetime injections per year, insurers are worried about Zolgensma's $ 2.1 million price tag for putting them in an awkward position.
Novartis' plan is popular among health plan sponsors who ultimately pay for these medicines. Unfortunately, it is far less popular among America's unique collection of middlemen earning a living in the sphere between drug makers and plan sponsors than lately. The White House has recently adopted a plan to reduce the influence of intermediaries in the supply chain for prescription drugs.
If a giant like Novartis can not successfully commercialize Zolgensma, his colleagues will spend far less money developing gene therapies on how these treatments will benefit the patients who need them. All these events are important, but if you only have time to look at one, see where the biopharmaceutical industry leads, then make it Zolgensma's commercial start.