Stocosil Proceeds with NDA filing of ST-101 under 505(b)(2) Regulatory Pathway

By: PRLog
Responses from End-of-Phase 2 FDA Meeting Provide Clarity on Next Steps
CITY OF INDUSTRY, Calif. - Dec. 21, 2015 - PRLog -- We are pleased to announce that positive feedback was received from the FDA with respect to our lead drug product- ST-101. Stocosil requested an End of Phase 2 (EOP2) meeting to confirm the adequacy of the nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) data for ST-101 to support a 505(b)(2) NDA submission. On Tuesday, December 15, 2015, we received responses to our EOP2 meeting package. The FDA’s response was very clear and provided the company with a defined 505(b)(2) pathway for the product.

“We are very pleased and encouraged by the FDA’s feedback which clearly defined the regulatory pathway for ST-101 and we are moving quickly forward to submission of the NDA in the United States as well as other regulated countries outside of the US,” said Pyng Soon, CEO of Stocosil.

“Based on the positive feedback obtained from the FDA, we are positively looking forward to working with Stocosil and proceeding with the NDA submission for successful registration and commercialization of Olostar® in the United States,” said Seng Ho Jeon, Executive Director of the Global Business Department at Daewoong.

The regulatory filing strategy necessary for the successful EOP2 meeting was developed and supported by the team from Autotelic Inc. Previously, the team made it possible for any nanoparticle formulation of paclitaxel approvable by demonstration of bioequivalence to Abraxane.

About ST-101

Stocosil has recently obtained the rights to ST-101 from Daewoong for development and marketing in the United States, Canada, Australia, Japan, Taiwan and certain South American countries. ST-101 is an FDC tablet containing the active pharmaceutical ingredients olmesartan medoxomil and rosuvastatin calcium. Olmesartan medoxomil is marketed as BENICAR® tablets by Daiichi-Sankyo, Inc.; and, rosuvastatin calcium is marketed as CRESTOR® tablets by AstraZeneca Pharmaceuticals, L.P. ST-101 is being developed for the treatment of combined hypertension and hyperlipidemia. The dose strengths of ST-101 we intend to market in the United States are 40/20, 20/20, 20/10 and 20/5 (mg of olmesartan medoxomil/mg of rosuvastatin calcium), the same dose strengths of OLOSTAR® commercialized in South Korea.

About Stocosil Inc.

We are a development stage pharmaceutical company focused on the research, development, and commercialization of the next generation of products for the treatment of high blood pressure (hypertension (HTN)) and high cholesterol (dyslipidemia). Our focus is on the use of FDC and/or Therapeutic Drug Monitoring (TDM) for the treatment of difficult to treat hypertension. More information is available at www.stocosil.com.

About Daewoong Pharmaceutical Co. Ltd.

Daewoong is one of the leading pharmaceutical companies in South Korea. Olostar® is the first FDC consisting of Olmesartan and Rosuvastatin, which achieved its technology recognition and got awarded with the “Technology Award” at the 16th Korean New Drug Awards on February 27th, 2015.

About Autotelic Inc.

Autotelic works through our partners to transform how medications are being delivered. The Autotelic Inc. platform is our Therapeutic Drug Monitoring (TDM) device which allows PK guided dosing, reducing the toxicity from overmedication and increasing the efficacy from under-medication. Current dosing schemes result in either too much drug exposure or too little drug exposure because of individual pharmacokinetic variations. Our pipeline includes TDM devices for management of oncology, hypertension and pain. More information is available at www.autotelicinc.com.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as "assumes," "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the combination drugs of olmesartan medoxomil and rosuvastatin calcium; and the clinical development and commercial potential of ST-101. All such forward-looking statements are based on Stocosil’s current beliefs and expectations, and should not be regarded as a representation by Stocosil that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Stocosil’s businesses, including: the company may require substantial additional funding in order to obtain regulatory approval for and commercialize any products; the risk that delays in the regulatory approval or commercial launch of Stocosil will enable competitors to develop and bring new competing products to market before the approval, if any, of ST-101; the scope and validity of patent protection for ST-101 as well as Stocosil’s platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; and additional risks set forth in any of Stocosil’s public announcements. These forward-looking statements represent Stocosil’s judgment as of the date of this release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Stocosil undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Contact
Mr. Pyng Soon, Esq.
Chief Executive Officer
T: 626-964-5788
info@stocosil.com

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