Drug Approvals Expected to Rise as Trump Pledges to Speed Up Approval Process: Latest Reports on AEterna Zentaris and Momenta Pharmaceuticals

NEW YORK, NY / ACCESSWIRE / February 1, 2017 / The Biotech Industry has outperformed the broader markets in 2017, despite all the criticism drug makers have been facing. The iShares NASDAQ Biotechnology Index ETF gained 2.84 percent to close at 278.07, up 4.78 percent year-to-date, while the SPDR S&P Biotech ETF spiked 4.14 percent to close at 64.90, up 9.65 percent year-to-date. In comparison, the Dow Jones Industrial Average and the S&P 500 Index have posted gains of 0.51 percent and 1.79 percent, respectively, so far this year. The Biotech Industry received a boost Tuesday after President Trump stated he would loosen drug regulations and push for a faster drug approval process.

“We’re also gonna be streamlining the process so that from your standpoint, when you have a drug, you can actually get it approved if it works instead of waiting for many, many years,” President Trump said. “The U.S. drug companies have produced extraordinary results for our country, but the pricing has been astronomical for our country.”

The U.S. Food and Drug Administration (FDA) approved just 22 new drugs in 2016, less than half of the 45 new drugs approved in 2015, according to Reuters. The number of drugs approved last year was the lowest number of approvals since 2010.

AEterna Zentaris Inc. (NASDAQ: AEZS)

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AEterna Zentaris’ shares spiked 21.15 percent to close at $3.15 a share Tuesday. The stock traded between $2.85 and $3.45 on volume of 3.07 million shares traded. On January 30th, the company announced the completion of the pivotal Phase 3 clinical trial of Zoptrex in women with advanced, recurrent or metastatic endometrial cancer. The Company currently expects to report top-line results in April 2017. Zoptrex is the first targeted oncological therapy using a peptide as the targeting agent and, therefore, it represents potentially a new tool in the treatment of cancer tumors that overexpress the LHRH receptor.

David A. Dodd, President and Chief Executive Officer of the Company stated, “With the completion of the clinical portion of this trial, we will now focus on analyzing the data and, if warranted by the results, submitting a new drug application later this year. There is a significant unmet medical need for a treatment for women with advanced, recurrent or metastatic endometrial cancer and we are hopeful that Zoptrex will provide clinicians and their patients with an effective therapy for treating the disease.”

Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)

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Momenta Pharmaceuticals’ shares jumped 25.17 percent to close at $18.90 a share Tuesday. The stock traded between $15.65 and $19.10 on volume of 3.22 million shares traded. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications. On January 30th, the company announced that the United States District Court for the District of Delaware has found Teva Pharmaceutical’s patents invalid in the COPAXONE litigation trial. The District Court’s decision is appealable to the Federal Circuit.

“We are very pleased with the District Court’s decision to invalidate the four method of use patents litigated by Teva to block Sandoz’s potential launch of our Glatopa 40 mg product,” said Craig Wheeler, President and Chief Executive Officer of Momenta. “Today’s favorable ruling further bolsters our confidence in the potential for us to offer multiple sclerosis patients a more affordable generic version of COPAXONE 40 mg following regulatory approval.”

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