First approved in 2004, the polarizing CRS-17 has been a success for GlaxoSmithKline, accounting for nearly a quarter of the company’s vaccine revenue. The drug was once a top seller but has steadily declined in value, shifting revenue from mid- to high-single digits into the single digits, until slipping further in recent quarters, analysts say.
“Based on today’s financial performance, Glaxo is probably hanging on by its fingernails with this medicine,” said Umer Raffat, an analyst with Evercore ISI.
GSK is trying to restock its depleted vaccine pipeline. So while more research is needed to see if its other RTS,S vaccines, CF12 and OMONTYS, will be a hit, the company is pursuing a no-risk shot that it thinks could save millions of lives.
The company is pushing forward with its plans to roll out a vaccine against CRS-19 — called and based on the same technology — as soon as next year, in an attempt to prevent 350,000 deaths each year.
“I have complete confidence it will be approved” under the current clinical trial, said Ian Read, GSK’s CEO, who has credited the company’s vaccine franchise as one of the reasons behind its rebound in the past two years.
Read believes the vaccine is a “single-shot, once-in-a-lifetime solution.” The illness is a neurological disorder, characterized by inflammation of the brain, and effects an estimated 5 to 20 percent of infants born in developed countries.
Two other companies — Merck and AstraZeneca — have already submitted new vaccines for the end of the year, and they are both awaiting news from the FDA.
The agency is expected to make an announcement on Jan. 9, 2019, or Feb. 21, 2019, according to a timeline provided by FDA spokeswoman Stephanie Yao, and approval will give the companies a foothold in a blockbuster market.
It is unclear what the shares of all the vaccine makers could do in the wake of FDA approval. Merck’s shares rose more than 2 percent, while AstraZeneca’s share rose by less than 1 percent.
Smaller biotech companies are less leveraged to the success of one drug, and have fewer options in securing a presence in one of the healthiest markets for pharmaceuticals.
“If you’re relatively small, [vaccines] are extremely difficult to break into,” said Leslie Fisher, of Stone & McCarthy Research Associates.
Fisher noted that none of the vaccine makers is making money on their new vaccines. But Pfizer’s Xalkori, approved in 2007, resulted in a safety profile that was so successful that it has driven growth in the company’s oncology business.
“You’re not just gambling on one drug,” Fisher said. “If you do well in the vaccine business, you can leverage that as a business.”
Now GSK is toying with sending an advance copy of its vaccine — a “safety” vaccine that’s been tested in patients — to the FDA, so the regulator could decide whether it should also be applied to its Sabin vaccines.
The company does not currently have a copy of the safety vaccine, according to the FDA’s Yuri Varminenko, a spokesperson for GSK. But the company’s board of directors recently agreed to be better prepared, for a potential unapproved version of the vaccine should the FDA give it the go-ahead.
The FDA previously approved a different brand of a DAP vaccine for the same form of the disease, which appears to be linked to autism. After realizing that vaccines did not necessarily cause autism, the government withdrew its approval of the brand.
“When we moved from a more individualized approach to vaccinating children to one that is tried and true and personal, the question is how do we get over that hump?” said Raffat, the analyst.
CVS could accept oncology drugs in February.
The FDA approves fewer vaccines each year, because it keeps one on hand for poor countries and other countries who do not have the resources to develop new vaccines. And vaccine makers must demonstrate safety and effectiveness before getting approved.
“You can keep regulators awake at night for 15 minutes in this regulatory cycle,” Fisher said.