This has been an outstanding year for biotech stocks, and 2020 could be even better thanks to a slate of bonafide life-savers that hit pharmacy shelves months ahead of schedule.
The FDA approved dozens of drugs in 2019, but the agency rushed to greenlight these new cancer therapies much sooner than expected. Here's why they could be the industry's most successful product launches in 2020.
|New Drug (Generic Name)||Indication||Company (Symbol)|
|Enhertu (fam-trastuzumab deruxtecan-nxki)||Breast cancer||AstraZeneca (NASDAQ:AZN)|
Padcev (enfortumab vedotin-ejfv)
|Bladder cancer||Seattle Genetics (NASDAQ:SGEN)|
|Brukinsa (zanubrutinib)||Mantle cell lymphoma||Beigene (NASDAQ:BGNE)|
Some things can't wait
In 2019, it cost $2.6 million to file a drug application with the FDA, and it still takes up to two months to learn whether the agency will begin reviewing that application. Once the review begins, the FDA provides an expected action date exactly 10 months later, or six months later for a shortened priority review.
If the FDA's fees and timing seem ridiculous you should know that before electronic filing was available, new drug applications could fill an office from floor to ceiling. That's why it's always a good idea to pay attention to drugs the agency finds important enough to finish reviewing months ahead of schedule.
Brukinsa from Beigene
In November, the FDA approved a new Bruton's tyrosine kinase (BTK) inhibitor called Brukinsa for patients with mantle cell lymphoma who have relapsed after standard first-line treatment.
During trials leading to its approval, Brukinsa shrank tumors for 84% of lymphoma patients. Another BTK-inhibitor marketed by Johnson & Johnson (NYSE:JNJ) and AbbVie (NYSE:ABBV) called Imbruvica earned approval to treat the same group of patients in 2013 after shrinking tumors just 66% of the time.
During the first nine months of 2019, J&J and AbbVie reported Imbruvica sales that reached a combined $5.9 billion. With an apparent advantage over Imbruvica, Brukinsa could begin adding 10-figure sums to Beigene's top line in a few short years.
Padcev from Seattle Genetics
Antibody-drug conjugates (ADCs) are mini-chemo bombs attached to proteins that recognize specific targets frequently found on cancer cells. Once reaching their target, ADCs deliver a lethal payload to cancerous cells while leaving healthy neighboring cells alone.
ADCs nearly fell out of favor after some high-profile clinical trial failures, but they're making a comeback. In December, the FDA approved a first-in-class Nectin-4-directed antibody called Padcev from Seattle Genetics.
The antibody side of Padcev seeks out a new target, but it's attached to the same chemotherapy used in the first ADC from Seattle Genetics, Adcetris. Padcev's approved to treat bladder cancer patients who have relapsed following treatment with Keytruda or similar therapies.
During the pivotal study that led to its approval, Padcev shrank tumors for 44% of patients. Bladder cancer isn't the most common malignancy, but it claims the lives of around 17,000 Americans annually. With a new treatment option, though, this figure should fall significantly.
Enhertu from AstraZeneca
Two days after greenlighting Padcev, the FDA approved another ADC from AstraZeneca, called Enhertu. The antibody in Enhertu is also the active ingredient in Herceptin, a targeted cancer drug approved in 1998 to treat breast cancer patients with HER2 positive tumors.
During a pivotal trial leading to its approval, Enhertu shrank tumors for a surprising 60.3% of patients who had relapsed after at least two lines of therapy. Enhertu isn't for everyone, but it is aimed at a large patient group. In 2019, around 50,000 breast cancer patients will be diagnosed with HER2-positive tumors.
A clear favorite
If you're thinking about buying shares of any drugmakers, you could do a lot worse than Beigene, AstraZeneca, or Seattle Genetics. If I were to pick just one, though, it would probably be Beigene.
You may remember that in 2017, Celgene acquired rights to Beigene's PD-1 inhibitor, tislelizumab and Beigene began marketing Celgene's cancer drugs in China. During the first nine months of 2019, sales of Celgene's products in Beigene's territory rose soared 78% from the previous-year period to $166 million.
Earlier this year, Bristol-Myers Squibb acquired Celgene and returned tislelizumab to Beigene. Not long after that, Amgen agreed to purchase around $2.7 billion of Beigene shares in return for a hand in developing 20 new cancer drug candidates. Beigene will also market three Amgen products in China -- Xgeva, Kyprolis, and Blincyto.
At recent prices, Beigene stock is trading at 23.6 times trailing sales, which is awfully high. With Brukinsa's U.S. launch under way, growing sales in China of products from Celgene and Amgen, and tislelizumab under review at the FDA, it's probably worth the risk.