BELLEVUE, Wash.–(BUSINESS WIRE)–SCOLR Pharma, Inc. (AMEX: DDD - News) announced the initiation of the third of three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The Company expects to complete the trial in late 2008. If approved, the Company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the United States. Ibuprofen is an analgesic that is sold in immediate-dose products as Advil® and Motrin®, among others, as well as generically.
The Company expects to enroll approximately 240 patients at a single center in the United States. This randomized, placebo-controlled, double-blind, parallel group study is designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg ER in dental pain following molar extraction. It is anticipated that the data from this trial will be used to support application to the U.S. Food and Drug Administration for product approval in the United States. Additional information about the clinical trial can be found at www.clinicaltrials.gov. As previously reported, the Company will also be required to complete a label comprehension and consumer use study for product approval.
Daniel O. Wilds, the Company’s Chief Executive Officer, commented, “The final protocol for this trial reflects the previously announced special protocol assessment guidance from the FDA and represents a significant milestone for SCOLR in advancing development of its extended-release ibuprofen.”
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. Total global OTC sales of the analgesic market in which the 12-hour ibuprofen product will compete are estimated at more than $8 billion, according to IMS Review Plus data. The Company estimates the annual U.S. sales of immediate-release OTC ibuprofen products exceeds $1 billion.
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/.
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. 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.
Contact:
Investor Relations:
Cameron Associates
Kevin McGrath, 212-245-4577
Kevin@cameronassoc.com
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Source: SCOLR Pharma, Inc.
BELLEVUE, Wash.–(BUSINESS WIRE)–SCOLR Pharma, Inc. (AMEX: DDD - News) today announced the voting results of its Annual Meeting of Stockholders, which was held on June 5, 2008 at The American Stock Exchange in New York, New York.
At the meeting, the shareholders of the Company re-elected Randall L-W. Caudill, D. Phil., Reza Fassihi, Ph.D., Herbert Lucas, Jr., Wayne L. Pines, Bruce S. Morra, Jeffrey B. Reich, Michael N. Taglich, Gregory L. Weaver and Daniel O. Wilds as directors to hold office until the next annual meeting of stockholders. In addition, shareholders of the Company ratified the appointment of Grant Thornton LLP as the Company’s independent registered public accounting firm for fiscal 2008.
No other business came before the meeting.
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
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Source: SCOLR Pharma, Inc.
BELLEVUE, Wash.–(BUSINESS WIRE)–SCOLR Pharma, Inc. (AMEX: DDD - News) today reported financial results for the three months ended March 31, 2008. The Company will host a live conference call today, May 2, 2008, at 11:30 a.m. (Eastern Daylight Time).
Daniel O. Wilds, SCOLR Pharma’s President and CEO, stated, “We are optimistic about the Company’s future as we continue to advance development of our lead product candidates, ibuprofen and pseudoephedrine. During the first quarter, we completed two product performance pivotal trials to evaluate the safety and efficacy of our over-the-counter (OTC) 12-hour CDT-based ibuprofen, continued stability testing, and initiated work to design a label comprehension study in support of our New Drug Application (NDA). We now expect to start a third pivotal trial and a label comprehension study by the end of the second quarter of 2008. Our activities to submit an Abbreviated New Drug Application (ANDA) for a 12-hour CDT-based pseudoephedrine product to the FDA in 2008 are progressing well and we remain confident in the potential for our lead product candidates. In addition, we are managing the Company’s resources carefully as we advance and appropriately pace the development of our pipeline. We expect that the proceeds of the recently announced $4.1 million buyout of the lease of the Company’s corporate facility will provide us with sufficient resources to fund our operations through 2009.”Total revenues of $265,555 were 76% or $854,364 lower for the three months ended March 31, 2008, compared to $1.1 million for the same period in 2007. The higher level of revenues for 2007 was primarily due to $795,000 of research and development fees and licensing revenues from a license agreement that was terminated in the first quarter of 2007.
Royalty income increased 19%, or $43,221 to $265,555 in the first quarter of 2008 compared to the fourth quarter of 2007. This increase reflects the positive trend in sales of SCOLR’s nutritional products from its alliance with Perrigo. Royalty income decreased 18%, or $60,065 to $265,555 for the first quarter of 2008, compared to $325,620 for the same period in 2007. Royalty payments from Perrigo are based solely on Perrigo’s net profits of CDT-based products. SCOLR expects sales to increase during the remainder of 2008 as Perrigo expands sales at a large national retailer.
Net loss increased 5%, or $97,049 to $2.0 million for the three months ended March 31, 2008, compared to $1.9 million for the same period in 2007. The increase in net loss was primarily due to lower revenues offset by lower operating expenses.
Research and development expenses decreased 51%, or $912,662 to $883,212 for the three months ended March 31, 2008, compared to approximately $1.8 million for the same period in 2007. This decrease was primarily due to our previously reported decision to defer development activities on certain projects pending additional funding, as well as the delayed commencement of our third ibuprofen trial while we waited for guidance from the FDA regarding our special protocol assessment.
Marketing and selling expenses decreased 5%, or $12,189 to $237,693 for the three months ended March 31, 2008, compared to $249,882 for the same period in 2007, primarily due to a reduction of $7,371 of non-cash, share-based compensation expense related to stock option grants. Additionally, advertising and tradeshow expense decreased $6,773 due to a reduction in advertising, reduced participation in tradeshows and commission expense decreased $4,363 due to lower royalty income. These expense decreases were offset by an increase in payroll related expenses due to annual increases.
General and administrative expenses increased 5%, or $55,786 to $1.23 million for the three months ended March 31, 2008, compared to $1.18 million for the same period in 2007, primarily due to increases in payroll related expenses and the non-cash, share-based compensation expense related to stock option grants.
As of March 31, 2008, SCOLR had $9.5 million of working capital compared to $14.7 million as of March 31, 2007. With the additional $4.1 million of proceeds from the buyout of the lease of the Company’s corporate facility, the Company expects to have sufficient liquidity to fund its operations through 2009.
SCOLR Conference Call
As previously announced, SCOLR Pharma will host a conference call on May 2, 2008, at 11:30 a.m. (Eastern Daylight Time). Shareholders and other interested parties may participate in the conference call by dialing +1 888 713 4215 (domestic) or +1 617 213 4867 (international) and entering access code 75175619, a few minutes before 11:30 a.m. EDT on May 2, 2008. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.scolr.com.
A replay of the conference call will be accessible two hours after its completion through May 16, 2008, by dialing +1 888 286 8010 (domestic) or +1 617 801 6888 (international) and entering access code 43955907. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com, and www.scolr.com.
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/.
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. 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.
SCOLR Pharma, Inc. CONDENSED BALANCE SHEETS
March 31, 2008(Unaudited)
December 31, 2007
ASSETS
Current Assets
Cash and cash equivalents
$
9,459,276
$
11,825,371
Accounts receivable
264,038
225,900
Interest and other receivables
185
16
Prepaid expenses
382,008
423,213
Total current assets
10,105,507
12,474,500
Property and Equipment — net of accumulated depreciation of $1,048,943 and $964,738, respectively
664,726
748,931
Intangible assets — net of accumulated amortization of $404,668 and $385,452, respectively
507,051
464,023
$
11,277,284
$
13,687,454
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities
Accounts payable
$
214,300
$
757,420
Accrued liabilities
348,437
586,849
Current portion of term loan
81,930
80,047
Total current liabilities
644,667
1,424,316
Long-term portion of term loan
89,917
111,119
Total liabilities
734,584
1,535,435
Commitments and Contingencies
Stockholders’ Equity
Preferred stock, authorized 5,000,000 shares, $.01 par value, none issued or outstanding
—
—
Common stock, authorized 100,000,000 shares, $.001 par value 41,128,359 and 40,991,385 issued and outstanding as of March 31, 2008 and December 31, 2007, respectively
41,128
40,991
Additional paid-in capital
70,327,838
69,945,666
Accumulated deficit
(59,826,266
)
(57,834,638
)
Total stockholders’ equity
10,542,700
12,152,019
$
11,277,284
$
13,687,454
SCOLR Pharma, Inc. CONDENSED STATEMENTS OF OPERATIONS (Unaudited)