Sabinsa supports drugs to supplements status switch for brain health ingredient

27-Oct-2009 - Last updated on 07-Jan-2010 at 16:12 GMT

New Jersey-based botanicals specialist, Sabinsa, has thrown its weight behind a citizen’s petition lodged by Canadian firm, Ovos Natural Health, that seeks to have its brain health ingredient recognized as dietary supplement ingredient after it initially sought drug approval.

Sabinsa said the petition seeks to activate a latent section of the 1994 Dietary Supplements and Health Education Act (DSHEA) that could set a precedent for ingredients seeking to make the drug-supplement switch, if successful.

A Sabinsa spokesperson said the company possessed some ingredients that may wish to make a similar switch, if Ovos’s petition is successful and the precedent is established.

“There are many reasons why in some situations companies may change to the nutraceutical route,” she said.

For Ovos, the desire to switch came about because clinical trials on the amino acid, homotaurine, failed to meet drug requirements and costs were ballooning.

Major support

Ovos president Gary Schmid said the 180-day period the FDA sets itself to deal with such matters expires on December 26.

“We welcome the support of a major player like Sabinsa on this,” Schmid told NutraIngredients-USA.com. Sabinsa’s comments have been formally lodged with the FDA.

The only link between Sabinsa and Ovos is the fact they are both represented by the same legal firm, Ullman, Shapiro & Ullman, which lodged the petition.

The firm’s Marc Ullman said of the petition: “FDA should support companies that invest in science and IP, the way DSHEA intended FDA to.”

Sabinsa chief executive officer, Jeff Lind, said research-backed ingredients should be supported as dietary supplements, even if they have sought to exist as drugs.

“As a company that invests heavily in science to back its products, we strongly believe that FDA needs to implement all parts of DSHEA including those portions of the law that ensure that companies engaging in serious scientific research can get their products onto the market,” he said.

Ovos Natural Health was set up last year by the Canadian drug firm, Bellus Health, to develop nutraceuticals. Ovos has a branded version of homotaurine called Vivimind that recently received approval from the Italian Ministry of Health to be marketed as a dietary supplement there.

Switch to nutra

Ovos withdrew its application for approval of homotaurine as an Investigational New Drug Application (NDI) in May last year after a Phase III trial, that tested the ingredient in 1,052 Alzheimer’s disease patients above the age of 50, failed to meet drug requirements.

“While the results of that trial indicated that homotaurine was safe, issues relating to the ability to achieve statistically significant results acceptable to FDA for the primary efficacy study endpoints led the company to conclude that it was no longer economically feasible to complete drug approval process,” states the petition.

Bellus Health then formed Ovos “specifically for the purposes of commercializing homotaurine as a dietary supplement”.

The firm said its trials on the ingredient have demonstrated that after 18 months it preserved hippocampus volume by 68 percent compared to placebo and improved cognitive performance by 33 percent compared to placebo after one year.

Homotaurine is an amino acid found in certain species of seaweed. Clinical trials on the patented ingredient, which is a ‘nature identical’ compound, have found that it can help support brain health and preserve memory.

The Federal Food Drug and Cosmetic Act (FDCA) seeks to protect the pharmaceutical market by stating that a substance cannot be marketed as a dietary supplement if it has been authorized for investigation as a new drug.