Finally, tech to boost old drugs with hydrogen is here

Finally, tech to boost old drugs with hydrogen is here:

MAGIC DRUG

Drugmakers are breathing new life into old drugs — with hydrogen. Substituting a heavier form of the gaseous element in drugs can slow their breakdown by the body, leaving them in the bloodstream longer. That means a patient can take them less frequently — and that, in theory, might reduce the severity of side effects.

While the technology has been around for 40 years, it’s taken that long to understand it well enough to bring such a treatment before the US Food and Drug Administration. The regulator is reviewing what would be the first medicine made with deuterium, or hea- vy hydrogen: a pill from Teva Pharmaceutical Industries Ltd. to treat a symptom of Huntington’s disease. The Israeli drugmaker plans to submit more data to the FDA by the end of the month, and is confident the drug will reach patients next year.

“This is a new concept, and FDA approval will make it a lot clearer for the field,” said Graham Timmins, an associate professor at the University of New Mexico who has studied the technology, known as deuteration.

Should Teva get regulatory approval, it would open a market in the “many tens of billions of dollars,” said Roger Tung, whose company Concert Pharmaceuticals Inc. is also developing treatments with deuterium. “It would show the breadth of possibilities,” Tung, the chief executive officer of Lexington, Massachusetts-based Concert, said in an interview. “Deuterium provides unique properties that cannot be attained in any other way.”

The approach interferes with one of the ways that the body metabolizes or eliminates drugs, involving enzymes that “nibble away” at the hydrogen in the molecule, Timmins said.

Deuterium is essentially an armored hydrogen, tougher and more difficult for the enzymes to break down, so it sticks around longer in the body. Other than that, the drug works the same as the original.

Companies like Concert and Auspex Pharmaceuticals Inc., acquired by Teva last year for $3.5 billion, have built their businesses by patenting deuterated versions of marketed drugs, then testing them to make sure they’re safe and effective. Concert takes “an opportunistic approach” to partnerships, Tung said. The company collaborates in some cases with the producers of the original drugs, though it doesn’t have a partnership with Vertex Pharmaceuticals Inc. on a deuterated version of Vertex’s Kalydeco treatment for cystic fibrosis. Vertex declined to comment on Concert’s product.

For each of its potential products, Concert has intellectual property rights in the US and believes it has “freedom to operate,” Tung said. Teva said it doesn’t have any licensing or royalty agreements on SD-809, and there is no litigation involving companies that sell tetrabenazine, the drug SD-809 is based on. H. Lundbeck A/S and Valeant Pharmaceuticals International Inc., which market tetrabenazine under the brand name Xenazine, declined to comment.