Last week’s announcement that a lupus drug developed by Rockville-based Human Genome Sciences, Inc. and GlaxoSmithKline PLC had been approved by the U.S. Food and Drug Administration could mean big things for patients and for the county’s biotechnology sector, medical experts, public officials and business leaders said.
“It’s the first medication that‘s been released to augment the treatment of lupus in the last 55 years,” said Dr. Stephen Hellman, chairman of the nephrology department at Shady Grove Adventist Hospital in Rockville. “So this is a medicine that is long in coming.”
The drug—called Benlysta—is a development that is also a long time in coming for the county’s biotechnology industry, said Sally Sternbach, the executive director of Rockville Economic Development, Inc.
“It is fabulous news for the biotech sector,” Sternbach told the Rockville City Council on Monday. “It has been, for many people’s opinion, a sector that has been a long time in delivering on its promise.”
Montgomery County Executive Isiah Leggett said in a statement that the long and winding regulatory road to approval of a new drug “makes FDA’s approval of Benlysta even more enormous for HGS, its pharmaceutical partner GlaxoSmithKline PLC and, of course, for Montgomery County.
“This impressive accomplishment allows the national and international spotlight to shine even brighter on the climate of success we’ve cultivated over the years in Montgomery County, Maryland, one that enables members of our local biotech community, like HGS, to reach commercial success,” said Leggett (D).
Wednesday’s announcement of the federal approval capped a big week for county biotech companies, particularly in Rockville.
On March 7, Gov. Martin O’Malley visited Novavax, Inc. in Rockville, in recognition of the company securing a federal contract worth up to $170 million for development of an influenza vaccine.
After a quick tour, O’Malley traveled north on Interstate 270 to attend the groundbreaking of the new Bioscience Education Center at Montgomery College-Germantown.
“This has been an outstanding week in Maryland for moving our life sciences industry forward …,” O’Malley (D) said in a statement in which he congratulated HGS. “These advancements will continue to keep Maryland on the cutting edge of science, discovery and innovation.”
Science catching up with medicine
The breakthrough lupus drug was such a long time in coming because “we did not have the basic science available to us,” Hellman said. “Some of lupus is in genetics.”
Lupus is an inflammatory disease in which antibodies in the immune system attack joints, skin, the kidneys, the lungs, the heart and even the brain. It can first appear in people from age 14 to 44.
“As the basic science of genetics has expanded, so has the understanding of antibodies that attack the organs and tissues,” Hellman said.
Benlysta, which is administered as a series of injections over a period of several weeks, blocks antibodies from attacking organs, tissues and joints.
As an internist, Hellman specializes in diseases of the renal system, which includes the kidneys. He also sees patients with some skin and joint issues.
While Benlysta has been effective in treating skin and joint disease—and some believe that it could be effective in treating yet-to-be-determined diseases—it has yet to be proven beneficial to African Americans or in treating kidney disease.
The data on the drug is still new and more studies have to be done in the coming months, Hellman said.
“We hope that it will be shown to be beneficial as time goes on,” he said. “As of today there’s not enough data to show that this new medication, Benlysta, is going to help the kidneys. It’s a little too early in the development.”
Meanwhile, the rollout of the new drug is full-speed ahead, HGS President and CEO H. Thomas Watkins said in a statement.
“We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus,” Watkins said.
Meeting the neighbors
Having a biotech developing a breakthrough drug in the same neighborhood as Shady Grove Adventist Hospital is beneficial to doctors, Hellman said.
“Many of us physicians know the people on a first name basis who have been working with HGS,” he said.
A scientist Hellman knows at HGS was able to tell him “Oh, it’s close, we’re getting closer,” in regard to the development of Benlysta, Hellman said.
Such informal communication between medical professionals is one of the selling points of the so-called Science City of biotechnology firms, educational institutions and research facilities that the county has approved for development in Shady Grove.
Knowing that a new medicine is in the development pipeline can help doctors give hope to patients living with a debilitating disease, such as lupus, Hellman said.
“There are instances when I’m seeing lupus patients in my internal medicine practice and I can say ‘Sit tight, there is help on the way,’” he said.