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Monday, May 29, 2023

Researchers Strike Gold With Zinc Cold Remedy

In 1994, two Los Angeles researchers hit upon an idea while debating studies that showed natural remedies could slow the common cold. Why not turn the remedies into a nose spray? After all, they reasoned, colds are located in the nose. It took another two years for Charles Hensley and R. Steven Davidson to quit their jobs at a biotech company and start their own firm to develop the spray. Earlier this month, their Gel Tech Inc. was propelled into the national spotlight after the release of a study indicating its Zicam product could reduce the average duration of a cold from nearly 10 days to less than two. Stories appeared on television and in USA Today and other publications detailing the study commissioned by Gel Tech, which indicated that the results would soon appear in the American Journal of Infection Control. However, the journal later decided against publishing the results because Gel Tech violated its guidelines by releasing the study to other media before it appeared in the journal. That hasn’t slowed sales of Zicam, which is available nationwide over the counter. Sales have spiked since the media coverage, and the company has had trouble keeping up with demand. Revenue so far this year has already surpassed $10 million, and Davidson is projecting $20 million for the current cold season. “The extent of publicity it got was a surprise,” said Gel Tech Chairman Brown Russell. “We’ve seen a big increase.” The study claims that Zicam, a zinc nose spray, shortened the duration of the common cold when tested on 104 people over two cold seasons. Gel Tech officials said the study underwent a peer-review process and was reviewed by medical experts before being released. An independent study of Zicam is expected to be released in the coming weeks. And even though the scientific community is divided over the effectiveness of zinc in fighting colds, Hensley, Gel Tech’s chief scientist, and Davidson, its chief executive, are confident that their results will be confirmed. The theory driving their work is that zinc reduces cold symptoms because zinc ions are roughly the same size and shape as the molecules that cold viruses must pass through in the nasal cavity. A zinc nasal spray coats that cavity, conceivably stopping any movement of the virus. “To us, it was common sense,” Hensley said. “The cold is in the nose, not the mouth.” In 1996, with lofty ambitions to develop a cure for the common cold, the two quit their jobs at another biotech firm and joined two other friends to finance BioDelivery Technology, their startup in Woodland Hills. Hensley has a scientific background in testing cardiac drugs and Davidson has worked in the field of holistic health. The two began work in a lab, testing various zinc compounds, eventually settling on a gel nose spray that adheres to the nasal cavity. Throughout the first year, they brought in research and cold experts to review their methods and to hold in-house trials. “We spent many, many months doing different combinations before trials,” Hensley said. “We brought in technicians from the field, chemists, biochemists all to confirm what we’d found.” In February 1997, the two began talks with Gum Tech International Inc., a Phoenix-based company that makes gum products. Initially, the two companies partnered for distribution of Zicam at retail stores. But eventually they formed Gel Tech Inc., with Gum Tech owning a 60 percent stake. “(Gum Tech) had experience on the regulatory aspect in terms of the FDA and could also help us get into retail,” Davidson said. “We recognized that we have limitations.” In November 1998, Zicam began hitting retail shelves on a trial basis. (Zicam is not regulated by the FDA and isn’t required to undergo vigorous testing for approval because it is sold as a homeopathic product.) Albertson’s and Eckerd’s began selling the product for prices ranging from $9 to $12. Last month, the product was launched nationwide in such chains as Rite Aid and 7-Eleven. The big jump in sales came after all the publicity earlier this month. While consumers are buying Zicam, Gel Tech has been subjected to some criticism. Time magazine ran a story after the study was pulled from the Journal of Infection Control, suggesting that washing your hands could be as beneficial as taking Zicam. One of Gel Tech’s biggest competitors, Quigley Corp., a Pennsylvania company that makes zinc lozenges marketed as Cold-EEZE, was among the first to raise questions about the early release of the Gel Tech study. Quigley issued a statement cautioning the public and media to wait until the Zicam study is published before “blindly accepting the alleged results.” Even Gel Tech officials believe more trials are needed to prove to the scientific community that Zicam works. “There’s still the question of whether it will play out the same in the real world,” said Fariba Ghobsian, senior vice president and biotech analyst for securities firm Cruttendon Roth. “They have done the clinical experiments, but when you go to the real world, things can change.” Ghobsian was an early advisor to Gel Tech. Meanwhile, Gel Tech’s founders are already talking about the possibility of an initial public offering in another year and more homeopathic products down the line. “There’s a lot of pressure to expand,” Davidson said. “We had a successful launch and we’re growing fast, so there’s a lot of catch-up to do.”

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