BOTHELL, Wash., Sept. 26 /PRNewswire-FirstCall/ — SCOLR Pharma, Inc. (Amex: DDD - News) announcedtoday that the United States Food and Drug Administration (”FDA”) has accepted for review the Company’s Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on the Company’s patented Controlled Delivery Technology (CDT®) platform. The ANDA was submitted to the FDA on August 5, 2008. This is the first application filed by SCOLR Pharma with the FDA.
Pseudoephedrine is a decongestant that is an active ingredient in Allegra® D, Sudafed® PSE, Claritin® D, Zyrtec® D and other over-the-counter (OTC) and prescription products. The domestic OTC market for pseudoephedrine-containing products is estimated to exceed $1 billion annually.”We are pleased with the FDA’s decision to accept our ANDA for review,” said Tanya M. Raco, the Company’s Associate Vice President of Regulatory Affairs and Quality Assurance. “We believe the timely notification received from the FDA is a testimony to the quality of our filing. If approved by the FDA, our pseudoephedrine formulation could provide important competitive advantages over existing marketed formulations in terms of both tablet size and manufacturing costs. Even more importantly, approval would demonstrate the novel advantages of our proprietary drug delivery technology. Acceptance by the FDA of a filing means that the application has been deemed complete by the FDA and will be reviewed,” Raco said.
About SCOLR Pharma:
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma’s corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/.
This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements related to the timing and success of regulatory applications and potential advantages of new products. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products and we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.
Contacts:
Investor Relations:
Cameron Associates
Kevin McGrath
212.245.4577
Kevin@cameronassoc.com
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Source: SCOLR Pharma, Inc.
Company has relocated its headquarters to new facility in Bothell, Washington
BELLEVUE, Wash., Sept. 24 /PRNewswire-FirstCall/ — SCOLR Pharma, Inc. (Amex: DDD) today announced that it has received the remaining $3.1 million of the total $4.1 million payment, pursuant to the terms of the lease termination agreement with the Company’s former landlord. In addition, the Company has completed the relocation of its headquarters to 19204 North Creek Parkway, Suite 100 Bothell, Washington. The Company’s telephone number will remain (425) 373-0171.
In May 2008, SCOLR entered into a lease termination agreement for its corporate facility providing for the Company to receive a total payment of $4.1 million. Under the terms of the agreement, the Company received an upfront payment of $1 million upon execution of the agreement with the remaining $3.1 million received when the Company vacated its premises on September 23, 2008 and relocated its corporate headquarters to a new more cost effective facility in Bothell, Washington. SCOLR will recognize the total lease termination payment of $4.1 million as a gain in the third quarter of 2008.
SCOLR Pharma’s new corporate headquarters is in the North Creek Business Park, Bothell Washington. The facility includes approximately 20,500 square feet of research and development facilities and administrative offices.
Daniel O. Wilds, SCOLR Pharma’s President and CEO, said, “We are very pleased to have completed this relocation and the fulfillment of our obligations under the lease termination agreement. Our new facility, formerly occupied by a pharmaceutical company, is ideally suited for both our current and anticipated needs.”
About SCOLR Pharma:
Based in Bellevue, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma’s corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/.
Contact:
Investor Relations:
Cameron Associates
Kevin McGrath
212.245.4577
Kevin@cameronassoc.com
