Palm Beach, FL –May 7, 2019 – 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…”
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from its ongoing open label, single arm Phase 1/2 study of Annamycin in Poland. After receiving a single starting dose of 120 mg/m2 in the first cohort of the dose escalation phase of the trial, 2 of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant. The results for all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level of 150 mg/m2. To date in the European trial, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported. No additional patient data have been developed in the Company’s parallel US clinical trial, which is currently recruiting its second cohort to be given a dose level of 120 mg/m2 (the US trial started at a lower initial dose of 100 mg/m2).
“The progress in Europe, specifically Poland, continues to be encouraging,” commented Walter Klemp, Moleculin’s Chairman and CEO. “In just a few months, we have completed the first cohort and we’ve seen a partial response from 2 out of 3 patients sufficient to qualify them for a potentially curative bone marrow transplant. It’s important to remember that these are relapsed or refractory patients for whom the standard of care failed. So, to see this kind of response at the starting dose level in the dose-ranging phase, we believe is quite remarkable. And, although this data is still preliminary and may not be indicative of the ultimate outcome of the trial, the improvement in activity at 120 mg/m2 in Poland as compared with the 100 mg/m2 cohort in the US is consistent with our expectations for Annamycin.”
Mr. Klemp continued: “Recognizing that cardiotoxicity is a significant limitation of existing therapies, we are pleased that we continue to see no evidence of cardiotoxicity in any of the patients treated thus far. Specifically, there was no observed reduction in left ventricle ejection fraction, which is the standard metric for acute cardiotoxicity, nor any change in biomarkers that would indicate the potential for long-term cardiovascular impairment. This is an important step in the ongoing clinical study of Annamycin and toward our goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union.”
Dr. Robert Shepard, Moleculin’s Chief Medical Officer for Annamycin added: “With the Polish trial now progressing to 150 mg/m2, we expect to see even better results. And, although 150 mg/m2 was the maximum tolerable dose established by the prior developer of Annamycin due to the incidence of mucositis in patients above that dose level, now that the cryotherapy protocol is well understood to mitigate the potential for dose-limiting mucositis, there is a good opportunity for dose levels to progress even beyond 150 mg/m2, so the potential to help patients is very exciting.” Read this and more news for MBRX at: https://financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company’s lead development candidate Zygel™ (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome (FXS). FDA’s Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs, and can lead to expedited review by FDA in order to get new important drugs to the patient earlier.
“The FDA’s decision to grant Fast Track Designation for Zygel underscores the significance and severity of the unmet medical need that exists for patients living with Fragile X Syndrome and their caregivers,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We believe that Zygel has the potential to be the first treatment indicated to directly address the core behavioral symptoms of this syndrome, and we look forward to working closely with the FDA to obtain approval to market Zygel as soon as possible.”
Esperion Therapeutics, Inc. (NASDAQ: ESPR) recently announced that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies.
The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid / ezetimibe combination tablet NDA review is set for February 26, 2020. These dates are consistent with our expectations and reflect the standard review period. The FDA has communicated that there is no current plan to hold an advisory committee meeting to discuss the applications.
Athenex, Inc. (NASDAQ: ATNX) a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, recently announced that it has directly entered into an agreement for the sale of its common stock in a private placement with three institutional investors, namely Perceptive Advisors, Avoro Capital Advisors (formerly known as venBio Select Advisor) and OrbiMed. The transaction is expected to result in gross proceeds to Athenex of approximately $100 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities of Oraxol (oral paclitaxel and encequidar (also known as HM30181A)); clinical regulatory activities of KX2-391 ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for Oraxol; manufacturing infrastructure; and working capital and general corporate purposes.
TherapeuticsMD, Inc. (NASDAQ: TXMD) an innovative, leading women’s healthcare company, recently announced the presentation of results from the Men’s Attitude Toward Menopause Survey (MATE), a large study of men’s understanding of and attitudes related to menopause, at the American College of Obstetricians and Gynecologists 2019 Annual Meeting. The data, representing insights collected from 450 men married to and living with women of menopausal age, uncovered men’s perceptions and attitudes towards menopause and their role in their partner’s menopausal transition.
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