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Tobacco company Star Scientific Inc. has six months to get its stock price above $1 per share or face possible delisting from the Nasdaq stock exchange.
The Petersburg-based company said it was notified by Nasdaq officials on Nov. 5 that it was not in compliance with the exchange's minimum-bid rules because its closing per-share bid price was below $1 for 30 consecutive days.
Star said it has until May 4 to regain compliance. To do so, the closing bid price for its stock must be $1 or more for at least 10 consecutive trading days.
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Star Scientific, Inc. (Nasdaq: STSI) reported today that on November 5, 2009 it received a deficiency letter from NASDAQ staff indicating that the company is not in compliance with the NASDAQ minimum bid rule. The letter noted that for the previous thirty consecutive trading days the company's minimum closing bid price per share had been below the $1.00 minimum bid price requirement set forth in NASDAQ Rule 5450(a)(1). In accordance with Marketplace Rule 5810(c)(3)(A), Star has 180 days, or until May 4, 2010, to regain compliance. In its notice NASDAQ indicated that if at any time during this period the minimum closing bid price is $1.00 or more per share for at least ten consecutive trading days, NASDAQ will provide confirmation that the company has regained compliance and the matter will be closed. The deficiency letter has no effect on the current listing or trading of Star Scientific shares.
Star Scientific Inc. plans to introduce a nutraceutical in 2010 that would help adult smokers maintain a nicotine-free metabolism.
The Petersburg-based company announced today that CigRx, developed by its subsidiary Rock Creek Pharmaceuticals, will be marketed and sold in partnership with inVentiv Health, Inc. . . .
The product, a dietary supplement, does not contain nicotine. It would be taken orally like a throat lozenge, dissolved and swallowed, according to Sara Machir, Star's vice president of communications and investor relations. CigRX would be directed at people who are trying to quit or who already are abstaining from smoking, she said.
Star Scientific, Inc. (Nasdaq: STSI) announced today that the company plans to introduce the CigRx(TM) nutraceutical product developed by its subsidiary, Rock Creek Pharmaceuticals, for worldwide marketing and sales in partnership with inVentiv Health, Inc. (Nasdaq: VTIV). inVentiv Health offers a complete range of commercialization solutions for every stage of the product lifecycle, in a range of healthcare categories that includes nutraceutical products. The company has marketing and sales capabilities in 40 countries around the globe. Jonnie R. Williams, Star's CEO, stated, "Cigarette smoking is the leading cause of preventable death in the world. However, the global cigarette business, which now exceeds $300 billion, continues to grow. Our goal is to make CigRx(TM) available to adult smokers worldwide who wish to maintain a nicotine-free metabolism." Rock Creek Pharmaceuticals will be responsible for the manufacturing of CigRx(TM), and the company anticipates that inVentiv Health will be involved in the product marketing and sales, with a focus on product education for physicians and health care professionals, as well as consumers.
Star Scientific, Inc. (NASDAQ:STSI) makers of low-nitrosamine smokeless tobacco products, announced that the company will utilize a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December, 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured curing process: the International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star's products. The company believes that this novel process, as...
Star Scientific Inc., makers of low-nitrosamine smokeless tobacco products, said that the company will use a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process is the subject of a patent application, filed in December 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured curing process, the company claimed. . . .
Late last week, Star submitted comments to the FDA in response to the agency's request for input on the regulatory framework established by the act, which was signed into law by President Obama in June 2009. Click here to view the comments.
The comments focus on the need for tobacco product labeling that lists the levels of the most lethal carcinogens in the products in a way that is clear to adult tobacco users.
Paul L. Perito, Star's chairman and president, said, "Adult tobacco users need to have access to information about the spectrum of harm associated with tobacco use in order to be able make informed choices about the products they purchase." He added that he hopes clear and accurate labeling will be one of the cornerstones of tobacco regulation policy.
Star Scientific Inc. wants to be the first company seeking approval from federal regulators to sell so-called "modified-risk" tobacco products with reduced toxins.
The Petersburg-based company, which makes smokeless tobacco products, said yesterday that it plans to ask the Food and Drug Administration next year for approval to market its products as potentially less risky to consumers' health.
Congress passed legislation this year that for the first time gives the FDA authority to regulate tobacco products. The legislation also lets tobacco companies submit products for scientific review by the FDA and approval to be marketed as "modified-risk."
Star did not provide details about any new products, which it said are still in development. Company spokeswoman Sara Machir said one would be similar to the dissolvable, lozenge-like smokeless tobacco products the company now sells under brand names Stonewall and Ariva.
"What would distinguish it is the even significantly lower nitrosamine levels," she said.
* Co to seek approval for "modified risk" tobacco products
* Says expects FDA submission by early 2010
* Says process will help to achieve lower toxin levels
* Shares jump 22 pct
Sept 22 (Reuters) - Star Scientific Inc (STSI.O) said Tuesday it plans to seek regulatory approval in early 2010 for tobacco products that promise reduced levels of carcinogens, sending its shares up as much as 22 percent.
Star Scientific, Inc. (Nasdaq: STSI) reported that the company's counsel has received a notice of a first office action, or "Non-Final Detailed Action" from the US Patent & Trademark Office (PTO) as part of the patent reexamination process initiated by RJ Reynolds in January, 2009. As the company previously reported, RJR requested that the PTO find invalid Claims 4, 12 and 20 of the "649" process patent the Office granted in March, 2001. RJR also requested that the PTO find invalid Claim 41 of the "401" process patent issued by the PTO in July, 2002. Statistics published by the PTO regarding reexamination show that 92% of reexamination requests are granted. Granted requests must cite a "substantial new question of patentability" that is identified by reviewing the information submitted by the requestor (RJR). It is typical, therefore, as in this case, for the first office action from the PTO to reject patent claims.
However, PTO statistics also show that almost 90% of patents are maintained following "ex parte" reexaminations. Because Reynolds filed its reexamination request on an ex parte basis, it may no longer participate in the reexamination process nor any possible appeals. Star anticipates that its legal team will submit detailed information and input to the patent re-examiners on or before November 11, 2009, which will be its first response to the PTO. The Company looks forward to having the opportunity to respond on the merits to the first office action.
Star Scientific, Inc. (Nasdaq: STSI) filed its second-quarter report on Form 10-Q today with the Securities and Exchange Commission. The company reported net sales of $.2 million for the second quarter, significantly higher when compared with net sales of $.05 million for the same quarter in 2008. Net sales for the first six months of 2009 totaled $.38 million compared with $.2 million for the same period in 2008. Sales volumes rebounded strongly compared with lower volumes for first-quarter 2009, which the company believes was due to the passage of amendments to the Children's Health Insurance Program bill that are financed by increases in the federal excise tax on tobacco products. The company reported a second-quarter net loss of $7.0 million compared with a $6.4 million loss for the same period in 2008. This increase was due primarily to additional costs associated with the May, 2009 jury trial of the company's patent infringement lawsuit against RJ Reynolds Tobacco Company. Total operating costs for second quarter 2009 of $6.4 million increased from $5.8 million for the same period in 2008.
The research and development portion of those expenses included $.1 million in product development work to enhance the company's dissolvable smokeless tobacco products, Ariva(R) and Stonewall(R). As part of that effort, the company recently completed successful focus group testing for several new versions of Ariva(R), including additional blends. The company also is in active discussions with another tobacco company regarding an agreement aimed at expanding distribution and marketing of Ariva(R) and Stonewall(R). If an agreement is achieved, Star anticipates it will be able to achieve both cost reductions and broadened product distribution for its dissolvable tobacco products.
Second quarter R&D expenses also included expenditures of $.4 million by the company's Rock Creek Pharmaceuticals subsidiary. These expenditures related to assessing the applicability of low-TSNA tobacco and certain MAO agents for several applications, including in a non-nicotine nutraceutical product designed to minimize nicotine cravings.
Rock Creek now has completed two preliminary studies to assess the viability and safety of the active components for a non-nicotine nutraceutical (a dietary supplement product).
Star Scientific Inc.'s loss widened in the second quarter, despite higher sales, as the company's legal expenses rose.
The Petersburg-based company also reported yesterday that it is in "active discussions with another tobacco company" to expand the distribution and marketing of its smokeless tobacco products.
Star Scientific reported a loss of $7.02 million, or 7 cents per share, for the second quarter, compared with a loss of $6.38 million, or 7 cents per share, in the same period in 2008.
The company attributed the wider loss mostly to higher expenses, primarily a $2.7 million increase in legal costs resulting from the company's patent-infringement lawsuit against cigarette maker R.J. Reynolds Tobacco Co.
Star said its revenue rose in the second quarter to $238,205, from $52,176 in the same period of 2008.
Petersburg-based Star Scientific Inc. has asked a judge to throw out a June jury verdict that its patents for reducing carcinogens in cigarettes were invalid. . . .
"We believe the verdict was contrary to the evidence presented on both infringement and validity, and that the company will be vindicated at the conclusion of the judicial process," Star's chairman and president, Paul Perito, said in a statement yesterday.
Reynolds spokesman David Howard said the company expected Star's motion for a retrial. "The bottom line is, we stand by the unanimous decision of the 12-member jury in this case, and are confident that decision will be upheld on appeal," he said.
* Star Scientific files motion asking for a new trial
* Star says willing to take case to appeals court
* Star shares close up 2 cents at $1.01
* Reynolds shares close down 24 cents at $38.87 (Adds comment from R.J. Reynolds, byline; updates stock movement)
Star Scientific, Inc. (Nasdaq: STSI) announced that its trial counsel has filed a motion for Judgment as a Matter of Law and In the Alternative, for a New Trial, with the US District Court in Maryland. The motion requests the Court to set aside the June 16th jury verdict that was reached at the conclusion of the trial of Star's patent infringement lawsuit against RJ Reynolds Tobacco Company (RJR), and to grant Star a new trial. The motion will be available on the Star Scientific website, http://www.starscientific.com.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090317/STARSCIENTIFICLOGO )
If the motion is denied, the next step will be for Judge Garbis to enter final judgment, which will effectively close out the case at the District Court level. Star then can immediately file a notice of appeal with the US Court of Appeals for the Federal Circuit. The company has retained Carter G. Phillips, Esquire, managing partner of the Washington, DC office of Sidley Austin, to head up the Federal Circuit appeal.
Star Scientific Inc.’s patents for reducing carcinogens in cigarettes are invalid, a federal jury said, giving a victory to Reynolds American Inc. and causing Star to plunge more than 80 percent in after-hours trading.
The U.S. jury rejected Star’s efforts to seek hundreds of millions of dollars from Reynolds over a process to reduce tobacco-specific nitrosamines that cause lung cancer, finding Reynolds didn’t infringe Star’s patents, and that the two Star patents were invalid. Star pledged to appeal.
Star claimed during the trial that Reynolds was unable on its own to reduce nitrosamines as much as Star could, so opted to use the technology as part of an effort to “neutralize” competition. Reynolds denied the claim, and challenged the validity of the Star patents.