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5 Biotechs With $45 Billion Worth of Not-Yet Approved Drugs in the Pipeline



7/24/2017 6:31:26 AM

5 Biotechs With $45 Billion Worth of Not-Yet Approved Drugs in the Pipeline July 24, 2017
By Mark Terry, BioSpace.com Breaking News Staff

EvalutePharma, a market research firm, recently published a report on the biopharmaceutical industry. Part of the analysis involved the net present value—the current value of possible future sales—of the pipeline drugs at some of the largest pharmaceutical companies. Keith Speights, writing for The Motley Fool, takes a look at the top five.


1. Biogen’s aducanumab.

A few years ago Biogen (BIIB) pivoted from its dominant multiple sclerosis (MS) franchise to push into Alzheimer’s work. The company’s aducanumab for Alzheimer’s is in Phase III trials. The drug, a monoclonal antibody, is designed to clear amyloid-beta. In March 2015, the company released top-line results from a Phase I trial of aducanumab in AD. It used two dosages, 3-mg and 10-mg, and both led to improved cognitive function. The 10-mg dose had better results, but also had more adverse effects, notably dangerous brain swelling. So the company launched a 6-mg trail, but this dose seemed to be less effective and had a worse safety profile than the 10-mg dose.

In December 2016, Biogen released positive data from the Phase Ib trial indicating the drug slowed progression of the disease. It’s a long way from final results, expected sometime in 2020, and late-stage trials are notorious for Alzheimer’s drug failures. EvaluatePharma, however, notes that if approved, aducanumab could bring in $10.2 billion.

2. Johnson & Johnson’s apalutamide.

This drug (ARN-509) is in multiple Phase III trials for prostate cancer, including a combo trial with J&J’s Zytiga. Johnson & Johnson (JNJ) plans to submit its first regulatory application in the next year, with another three by the end of 2021. EvaluatePharma projects the drug’s current net value of $9.8 billion.

The drug is in the SPARTAN trial, a Phase III trial for non-metastatic, castration-resistant prostate cancer. It is in the ATLAS trial for high-risk localized and locally advanced prostate cancer, in combination with radiation therapy, and NCT-02257736, in men with chemotherapy-naïve, metastatic, castration-resistant prostate cancer in combination with abiraterone acetate and prednisone. The Spartan and NCT trial data is expected by the end of 2018.

3. Eli Lilly and Co’s abemaciclib.

This drug is being studied in Phase III trials for non-small cell lung cancer and breast cancer. It is also being studied in Phase II trials in pancreatic cancer and squamous non-small cell lung cancer.
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EvaluatePharma’s projected net present value for the drug is more than $8.8 billion.

Speights writes, “The FDA recently granted priority review for Lilly’s new drug application for abemaciclib in treating breast cancer. An approval decision is expected in the first quarter of 2018. Lilly also plans to file for regulatory approval of the drug in Europe and Japan in the second half of 2017.”

4. AbbVie’s Rova-T.

Rova-T is in a Phase III trial as a first-line treatment for non-small cell lung cancer, and in a Phase II trial as a third-line treatment for the same disease. Its net present value is calculated as $8.5 billion. It’s also been projected to make $1.5 billion in 2022 alone, if approved. It joins AbbVie (ABBV)’s other top drug picks, elagolix, for endometriosis and uterine fibroids, and ABT-494 (upadacitinib) for several autoimmune disorders.

AbbVie acquired the drug when it bought Stemcentrx. The company also plans to evaluate the drug in immuno-oncology combination therapies.

5. Celgene's ozanimod.

This drug is being studied in two Phase III trials, one for relapsing multiple sclerosis and the other for ulcerative colitis. It is also being investigated in a Phase II trial for Crohn’s disease.

The drug has a net present value of almost $8.2 billion.

Speights writes, “Like AbbVie and Johnson & Johnson, Celgene added ozanimod to its pipeline as a result of an acquisition—in this case, the 2015 buyout of Receptos (RCPT). Celgene has a tremendously promising pipeline, but ozanimod looks to be one of its brightest stars. If it’s approved for all three indications, the biotech thinks the drug could generate peak annual sales between $4 billion and $6 billion.”


Read at BioSpace.com


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