Source: Clovis Oncology.
According to industry trade group Phrma, there were 771 cancer drugs and vaccines in clinical trials last year. The vast majority of them aren't likely to pan out -- more than 90% of cancer drugs fall short in clinical trials -- but here are three that have caught my eye and that could move shares in the companies developing them higher or lower next year.
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No. 1: Celldex Therapeutics
In August, Celldex Therapeutics delivered bad news to investors when it announced that it would need to complete phase 3 trials of its brain cancer drug Rintega before filing an application for approval with the FDA. The admission disappointed investors hoping that the combination of a significant unmet need and solid early-stage trial results could clear the way for an accelerated approval.
Clearly, the delay pushes back the timing of any potential revenue, but if Rintega succeeds in its phase 3 trials, it could become a top seller. In phase 2 studies, Rintega delayed tumor growth in glioblastoma patients and reduced the risk of death in these patients by 43% when used alongside Avastin and a control agent, compared with Avastin and a control agent alone.
Investors could get insight into Rintega's phase 3 studies later this year or in early 2016, when monitors will conduct an interim look at the data. If the monitors decide to continue the trial to completion, then full trial results should be available in Q4 of 2016. Either way, next year will be an important one for Celldex.
No. 2: Medivation Medivation already has one billion-dollar blockbuster cancer drug on the market in Xtandi, which is used to treat prostate cancer, and it could have a second cancer drug on the market as early as 2017.
Last month, Medivation paid $410 million in upfront cash to BioMarin to get BMN-673, or talazoparib, a PARP inhibitor, in phase 3 trials as a treatment for a subset of breast cancer patients. Specifically, talazoparib is being studied as a therapy for metastatic breast cancer patients who have already tried no more than two prior therapies and who have BRCA gene mutations that make them more amenable to the benefits of PARP inhibitors, which interrupt cell repair.
Talazoparib's study is expected to conclude in the middle of next year, and if talazoparib is effective, then a filing for approval could come shortly thereafter.
A similar PARP inhibitor made by AstraZeneca won approval earlier this year in ovarian cancer, and it reached the market with a six-figure annualized price tag. Because 10% of all breast cancer patients possess BRCA mutations and 12% of women may suffer from breast cancer in their lifetime, talazoparib could generate hundreds of millions of dollars in sales for Medivation, making it a company to keep tabs on in 2016.
No. 3: Clovis Oncology In September, Clovis Oncology presented data showing that 60% of lung cancer patients with a T790 mutation that makes them resistant to other therapies responded to its drug rociletinib.
Those results could mean that the FDA will greenlight rociletinib in when it makes its approval decision next March, and if so, this could become an important drug. According to the National Cancer Institute, more than 400,000 Americans are living with lung cancer, and NSCLC accounts for the vast majority of these cases. Additionally, there are over 220,000 new cases of lung cancer diagnosed in the U.S. every year, and many of these patients will relapse because of developing a T790 mutation.
Rociletinib's potential impact on Clovis Oncology next year is one reason to be watching the company's shares, but it's not the only reason. Clovis Oncology is also developing its own PARP inhibitor, rucaparib, for use in ovarian cancer. In phase 2 trials, 65% of patients responded to rucaparib and if phase 3 trials are similarly strong Clovis plans to file for FDA approval by the middle of 2016. Based on that timeline, if everything goes Clovis' way, the companycould have two cancer drugs on the market in 2017.
Looking aheadBiopharmaceutical companies are elbows deep in researching next-generation cancer treatments, and while these new treatments won't cure cancer, they could make significant improvements in patient survival.
However, investors still need to remember that the vast majority of cancer drugs fail in their clinical trials, and Celldex, Medivation, and Clovis Oncology aren't immune to that risk. Having said that, I think these three companies have a shot at getting their therapies across the finish line, and that's why I'll be paying close attention to each of them in 2016.
The article 3 Cancer Companies to Watch Closely in 2016 originally appeared on Fool.com.
Todd Campbell owns shares of Celldex Therapeutics. Todd owns E.B. Capital Markets, LLC. E.B.Capital's clients may have positions in the companies mentioned. The Motley Fool recommends BioMarin Pharmaceutical and Celldex Therapeutics. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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