Biotech Stocks

Why Expensive U.S. Drug Trials are Pushing Pharma Research Overseas

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, May 7, 2019 /PRNewswire/ -- American pharmaceutical and biotech companies who need to conduct clinical trials are looking more and more to conduct them overseas in the European Union, because the EU offers lower cost alternatives to U.S. trials… which not only saves money, buy also can save time to market. Many U.S. based companies have taken notice. A recent article with an industry insider said: "A typical drug is unlikely to reach pharmacy shelves for a decade after scientists first develop it, and getting it through all of the regulatory hurdles can cost billions of dollars. That's a serious challenge for smaller pharmaceutical companies… (companies have) found a shortcut by conducting clinical trials in (the E.U.), where it's been able to move much faster than its ongoing American experiments."  "Like any small biotech company, we have to make the most of limited resources… The big challenge there ultimately comes to time and money, and of course those two are inextricably related. The more time you spend, the more money you're burning; we look for every opportunity to shorten the pathway." Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Esperion Therapeutics, Inc. (NASDAQ: ESPR), Athenex, Inc. (NASDAQ: ATNX), TherapeuticsMD, Inc. (NASDAQ: TXMD).

The insider went on to provide some other reasons, in addition to lower costs, that the E.U. is offering better options. It continued: "In the U.S., there are so many clinical trials happening that… participants… (have) become a hot commodity. Not so (overseas)… It took us nearly a year in the US to fill the first patient cohort," (the insider) said. "We filled the first patient cohort… (overseas) in the first month and a half."  The article also addressed the high degree of efficacy of safety standards in the E.U., saying: "… as far as safety standards and rigor go, the trials are the same… (citing) the Clinical Trial Site Standards Harmonization Action Collaborative, an international agreement that set universal safety standards for clinical research no matter where it occurs… It's fairly common for small biotechs to look for opportunities outside the U.S. that may help accelerate the process…"