Fortune favors the brave, but when the brave catches a cold, they may not fare too well. With flu season in full swing, a cacophony of coughs and sneezes can be heard from a mile away, and over-the-counter solutions just are just snot enough anymore. Though U.S. health officials haven’t reported many flu cases this season, it may be too soon to know if this year’s bugs will be as severe as years past.
New Drugs On The Block
In preparation of a gnarly flu virus this year, biotech companies have been working tirelessly to create a drug strong enough to tackle this year’s flu. On Wednesday, the Food and Drug Administration (FDA) approved the first new antiviral flu medicine in twenty years. The drug, created by Japanese pharmaceutical company subsidiary, Genentech, is called Xofluza (or baloxavir marboxil).
“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option.”
–FDA Commissioner Scott Gottlieb, M.D.
Xofluza, for which I am unclear how to pronounce phonetically, stands out from previous flu drugs because it attacks the virus immediately through a single oral dose. According to the official FDA press release, if treatment is started within 48 hours of becoming sick with the flu, Xofluza alleviates the associated symptoms in a short amount of time. The new option for flu sufferers is already gaining respect in the medical field. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, told CBS News that he applauds Xofluza because of its unique ability to “inhibit replication of the flu virus in the first place, at a step much earlier than the current medications available.” Dr. Glatter raved about simplicity surrounding the regimen for treatment with Xofluza. The drug is “simpler to take — just one tablet, compared with other options, one of which requires twice-daily dosing for 5 days.”
FDA Is Poppin’ Pill Approvals
The FDA’s approval of Xofluza not only represents a huge advancement for flu drug development as well as increased accessibility of options for consumer treatment but even more so, Xofluza’s green light follows 46 other drugs approved by the agency just this year. The FDA claims that their reasons for approving so many novel medicines have to do with a drive to innovate and create “new drugs and therapeutic biological products.”
The agency, through their Center for Drug Evaluation and Research (CDER), is determined to increase the “availability of new drugs, biological products, and treatment options for patients” to further the advancement of health care for the American public. As the FDA approves the distribution and regulation of new drugs, pharmaceutical and biotechnology companies are reaping the financial benefits alongside the medical benefits enjoyed by their patients.
Biotech Stocks Respond Nicely To FDA-Approved Treatment
Joining the ride for the FDA’s approval-happy tour is pharmaceutical giant and critically-acclaimed creator of Viagra, Pfizer Inc. (PFE). Last week, on Oct. 17, the FDA approved Pfizer’s (PFE) new drug, Talzenna, which treats patients with a “germline BRCA-mutated, HER2-negative breast cancer.
“Patients with germline BRCA-positive breast cancer are typically diagnosed at a younger age than those with non-hereditary breast cancer, and there are no therapies specifically approved for them outside of the current standard of care.”
–Jennifer Litton, lead investigator, and associate professor, University of Texas MD Anderson Cancer Center
Earlier this year, Pfizer (PFE) along with Eli Lilly and Company (LLY) announced that both were working on treatment options for osteoarthritis (OA) pain felt in the knee or hip. Recent data findings indicate that “more than half of the patients treated” with Tanezumab (drug both are working on) reported a “50% or greater reduction in osteoarthritis pain of the knee or hip.” For those not aware of the collaborate efforts of Pfizer (PFE) and Eli Lilly, the two pharmaceutical companies entered into a $1.23 billion agreement in 2013 to jointly develop the drug.
Capitalizing on these impressive gains, Pfizer (PFE) announced this week that has plans in the works for a new biopharmaceutical company called Cerevel Therapeutics, LLC, in partnership with Bain Capital, LP. Pfizer (PFE) hopes that this new joint venture will create new treatment options for patients suffering from the central nervous system (CNS) disorders including, but not limited to, Parkinson’s and Alzheimer’s disease, epilepsy, schizophrenia, and addiction.
Pfizer will retain a 25% stake in this partnership agreement. Cerevel Therapeutics’ headquarter will be reportedly be housed somewhere in the Greater Boston Area.
As the world’s population continues to grow older in developed markets, the demand for drugs and medical services will increase. This growing need presents a lucrative opportunity for pharmaceutical companies and investors involved in the industry. It’s interesting that as medical advancements continue, more diseases are coming out of the woodwork. People are getting sicker, obesity in the U.S. is at an all-time high, and people, the world over, need affordable and effective treatment. The FDA’s approving of nearly 50 drugs in one year is representative of this very real epidemic.
My hope is that as more drugs become available, we see a decline in the need for treatment because of the effectiveness of new medicines, and ultimately, a healthier population.