Saturday, January 30, 2016

Oasmia Pharmaceutical AB (Nasdaq: OASM) to Ring the Nasdaq Stock Market Opening Bell on January 11

Source:  Oasmia Pharmaceutical AB


Oasmia Pharmaceutical AB (Nasdaq: OASM), a developer of a new generation of drugs within human and veterinary oncology, today announced that the Company will ring the Nasdaq Opening Bell on Monday, January 11 in honor of its recent listing on the Nasdaq Capital Market. 

“On behalf of the entire Oasmia team, we are honored and appreciative of the opportunity to ring the Nasdaq Opening Bell,” said Julian Aleksov, Executive Chairman of Oasmia. “We believe the human and animal oncology treatments we have brought to market, as well as the next-generation technologies we continue to develop, will have a profound impact on the treatment of various cancers for both patients and physicians. With our recently established US sales and marketing platform, we are confident in the continued adoption of our family of products, making us well-positioned for future growth and recognition among US security-holders.” 

A webcast of the Nasdaq Closing Bell will be available at: https://new.livestream.com/nasdaq/live - The ceremony will begin at approximately 9:20am EST. 

The Company began trading on the Nasdaq Capital Market on October 23, 2015.  

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on Nasdaq Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and Nasdaq Capital Market (OASM.US).

Oasmia Submits Application for Market Approval of its Next Generation Anti-Cancer Drug Doxophos® in Russia


Source:  Oasmia Pharmaceutical AB


Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, announced today that it has submitted an application for marketing approval of Doxophos for Russia and the Commonwealth of the Independent States (CIS). The Company expects market approval of Doxophos by the end of 2016.
  
Doxophos is a hybrid and novel nanoparticle formulation of one of the most commonly used anti-cancer substances in the world – doxorubicin. The product is based on the Company’s patented technology XR-17. Doxorubicin is the active substance in the prominent oncology family of brands Adriamycin®, Caelyx® and Doxil® of which there was reported sales of $600 million USD in 2013, prior to a global shortage that created a tremendous market void. The shortage was due in large part to the permanent closing of a production planned used by Johnson & Johnson’s sole supplier of Doxil. 

“It is a very positive indication for Oasmia that we are able to submit this application for marketing approval in Russia this early,” said Julian Aleksov, Executive Chairman of Oasmia. “We believe the market potential for Doxophos is significant based upon the successful use of doxorubicin on going use in cancer treatments, as well as the market share created by a shortage of the drug.  We are confident that once Doxophos is approved, the product will garner widespread adoption, ultimately generating strong revenues and value for our shareholders.” 

Doxorubicin was named among to the World Health Organization (WHO) Model List of Essential Medicines in April 2015, and is well known for its treatment of a variety of different cancers, such as leukaemia, Hodgkin’s lymphoma, bladder cancer, breast cancer, stomach cancer, lung cancer, ovarian cancer and thyroid cancer. 

According to recent data, Russia is facing a growing incidence of all major cancer types with high mortality rates. In fact, statistics from the Lancet Oncology Commission indicate that the overall risk of dying from cancer in Russia is about 60%, which is higher than the 40% in the United Kingdom and the 33% in the United States.  This, coupled with the existing market for cytostatics in Russia, which amounts to over $2 billion with an annual growth rate of 36%, creates a significant market opportunity for the Company as it expands its product line.  

About Doxophos
Doxophos is a novel nanoparticle formulation of doxorubicin in combination with Oasmia’s patented technology XR-17. Doxorubicin is one of the oldest and most widely used anti-cancer substances in the world and is used to treat a variety of different forms of cancer such as leukaemia, Hodgkin’s lymphoma, bladder cancer, breast cancer, stomach cancer, lung cancer, ovarian cancer, thyroid cancer, soft tissue sarcoma and multiple myeloma.  


About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Capital Markets (OASM.US).

Oasmia Pharmaceutical’s Next Generation Anti-cancer Drug Docecal Approved for Clinical Trials

Source:  Oasmia Pharmaceutical AB


Oasmia Pharmaceutical's nanoparticle and water soluble, docetaxel-based drug Docecal is scheduled to enter clinical pivotal trials and begin patient recruitment in January 2016.

 

Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, announced today that its next anti-cancer drug Docecal, has been approved for clinical clients and patient recruitment will commence in January 2016. 

Docecal is a nanoparticle and water soluble formulation of docetaxel, one of the most commonly used anti-cancer substances in oncology today, in combination with the Company’s patented technology XR-17. Docetaxel is the most active substance in the cytostatic Taxotere, marketed by the global healthcare provider Sanofi-Aventis. Prior to the patent expiration in 2010, Sanofi-Aventis executed $3 billion in Taxotere sales 2009.  Taxotere has continued to perform, generating sales of $350 million in 2014, clearly demonstrating market demand for the product. 

Taxotere is used either as mono therapy or in combination with other anti-cancer medicine in the treatment of prostate cancer, breast cancer, lung cancer, gastric cancer and head & neck cancer. The product is a formulation of docetaxel and Polysorbate 80, a water soluble emulsifier made of polyethoxylated sorbitan and oleic acid. By comparison, Oasmia’s product Docecal is solvent free and requires no pre-treatment, leading the Company to believe its technology represents a significant upgrade over products like Taxotere that are already established within the oncology market. 

“This approval to commence clinical trials is a significant step forward for the Company, as this product is of highest priority to reach the market as soon as possible,” said Julian Aleksov, Executive Chairman of Oasmia. “Docecal possesses tremendous potential within the human oncology market that has already exceeded $100 billion in sales in 2015 and could reach $147 billion by 2018. We believe this market opportunity, when coupled with recent advancements and sales of Paclical, position the Company to capture significant share of the market.” 

“We are excited to conduct the first clinical studies with this very important product, one that I am confident will showcase the results we expect from cancer treatment using Docecal,” said Margareta Eriksson, Head of Clinical Development for Oasmia. “We believe this combination of docetaxel and Oasmia’s patented XR-17 technology has the potential to overcome many difficulties faced by patients treated by Taxotere, thus improving their overall quality of life.” 

Clinical trials with Docecal are scheduled to begin in January 2016.  

About Docecal
Docecal is a water soluble formulation of docetaxel in combination with Oasmia’s patented technology XR-17. Docetaxel is standard treatment for a variety of different kinds of cancers, such as prostate cancer, breast cancer, lung cancer and stomach cancer. 

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Capital Markets (OASM.US).


Oasmia Pharmaceutical's Lead Human Cancer Drug Paclical(r) Generates Strong Interest at the 19th Annual Russian Cancer Congress


Source:  Oasmia Pharmaceutical AB


Data showing the efficacy and benefits of the recently approved cancer drug Paclical, as compared to current paclitaxel treatment, poised for continued growth in Russia and CIS countries.

Oasmia Pharmaceutical AB (OASM), or the "Company," a developer of a new generation of drugs within human and veterinary oncology, recently presented clinical data at the 19th annual Russian Cancer Congress that illustrate the efficacy and benefits of the Company's recently approved cancer drug Paclical. The data, which were presented by Russian lead oncologists Professor Tjulandin and Dr. Chekini, were well received by the many oncologists in attendance at the event, positioning the drug for further growth in the Russian market.

The Company's presentation elaborated on the results from the extensive clinical program indicating that Paclical possesses efficacy which is equal to current standard treatment, albeit with several benefits such as allowing for higher doses, shorter infusion times and no premedication. In addition, a recently published study showed that Paclical is bioequivalent with Abraxane(r), the current market leader within the segment. Abraxane's net sales are expected to be in the range of $1 billion to $1.25 billion in 2015, according to research analyst Zacks.

"We are pleased that Paclical has generated this significant volume of interest among oncologists attending such a high profile conference and the Company's presentation," said Julian Aleksov, Executive Chairman of Oasmia. "It shows that our product has tremendous potential to gain substantial market share in Russia and the CIS, which the magnitude of our initial orders from Russia also indicate. We are very confident that future development coupled with the sales efforts by our distribution partner in the region will be very beneficial for Oasmia, ultimately increasing the Company's revenue and achieving value on behalf of our shareholders."

The 19th annual Russian Cancer Congress took place from November 17-19 in Moscow and is the largest oncologist conference held annually in Russia.

About Paclical
Paclical is a water-soluble formulation of paclitaxel and Oasmia's patented excipient, XR-17. Paclitaxel is one of the most widely used anti-cancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Paclical consists of a freeze dried powder dissolved in conventional solution for infusion. In April 2015, Paclical received a marketing authorization for treatment of ovarian cancer in the Russian Federation.

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company's product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company's product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ USA (OASM.US).

 

Oasmia Pharmaceutical AB Confirms Final Data Indicating Positive Top-line Results for Paclical® From Head-to-Head Comparison Study with Abraxane®

Source:  Oasmia Pharmaceutical AB

- Final analysis of the pharmacokinetic study confirms that water soluble and solvent free Paclical and US-market approved Abraxane have nearly identical concentration curves of both total and unbound paclitaxel following intravenous infusion of 260mg/m2 suggesting the same efficacy of the two drugs

Oasmia Pharmaceutical AB (OASM), confirmed today the previously published findings from a head-to-head comparison study of its lead human cancer product Paclical and Celgene's Abraxane, demonstrated superimposable paclitaxel PK profiles. The study was conducted in women with metastatic breast cancer.
   
"The present cross-over study of Paclical and Abraxane demonstrating virtually identical plasma levels of total and unbound drugs for the two formulations," stated Olof BorgÄ, PhD, pharmacokinetic expert. "Statistical analysis demonstrated the two formulations to be bioequivalent with regard to drug concentrations. The bioequivalence demonstrated for unbound paclitaxel is of particular importance, since it is this concentration that is related to clinical effects. Also, the ratio between unbound and total drug showed bioequivalence."

Oasmia believes that results from this study strengthen its position for rapid growth among competitors within the oncology sector, including Celgene Corporation and Sorrento Therapeutics, Inc. In 2014, Abraxane generated total net sales of $947 million, a 28 percent increase from the prior year. Further, Sorrento Therapeutics expanded its Cynviloq strategy into multiple cancer indications, potentially receiving over $1 billion compensation for rights.

"We are pleased that the final study data reflects the optimism many in the pharmaceutical industry have displayed regarding Paclical's potential and its role as a key branded player in the oncology sector", said Julian Aleksov, Executive Chairman of Oasima Pharmaceutical AB. "Abraxane is the current taxane market leader in the United States, and we have now clearly demonstrated that Paclical is at least an equal but with a more cost effective nanoparticle technology."

About Oasmia Pharmaceutical AB  
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company's product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. Oasmia is listed on NASDAQ Stockholm (OASM.ST), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ USA (OASM.US).

Oasmia Pharmaceutical receives order of $7.5 million in end-user value for the Russian market

Source:  Oasmia Pharmaceutical AB

Interest continues to rise as Oasmia receives a new order for its lead oncology product Paclical® through the company's commercial partner Pharmasyntez

 

Oasmia Pharmaceutical AB (NASDAQ: OASM, FWB: OMAX) - a developer of a new generation of drugs within human and veterinary oncology, announced today that it its distribution partner in Russia and the Commonwealth of Independent States, CIS, Pharmasyntez, has placed its second order for Paclical, Oasmia’s lead cancer product for an end user sale value of $7.5 million. The announcement comes on the heels of the first order to the Russia market for $1.5 million in end-user value, totaling an end-user sales value of over $9 million USD in commercial orders within one week. 

“We are thrilled that Paclical has been so well received in Russia and CIS,” said Julian Aleksov, Executive Chairman of Oasmia. “These positive initial orders are a reflection of the market’s confidence in the product. We are confident in imminent sales growth as the product continues to garner interest for its ability to enable higher doses, shorten infusion time, eliminate the need for pre-medication and improve the safety profile for patients compared to the available standard treatments.” 

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Stockholm (OASM:SE), the Frankfurt Stock Exchange (OMAX:GR, ISIN SE0000722365) and on NASDAQ US (OASM:US). 


About Pharmasyntez
The company was founded in 1997 and is now one of the ten biggest pharmaceutical companies in Russia. Pharmasyntez specializes in drugs against tuberculosis, but also manufactures antibiotics and solutions for infusions. Furthermore, the company cooperates with a number of leading institutes and universities in Russia.  


About Paclical
Paclical is a water-soluble formulation of paclitaxel and Oasmias patented excipient, XR-17. Paclitaxel is one of the most widely used anti-cancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Paclical® consists of a freeze dried powder dissolved in conventional solution for infusion. In April 2015, Paclical received a marketing authorization for treatment of ovarian cancer in the Russian Federation.

 


Tuesday, January 12, 2016

22nd Century Files Modified Risk Tobacco Product Application with the FDA for World’s Lowest Nicotine Tobacco Cigarettes





Source:  22nd Century Group, Inc.

Proprietary “Very Low Nicotine” Cigarettes Drastically Reduce Smokers’ Exposure to Nicotine

22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that on December 31, 2015, the Company’s wholly owned subsidiary, Goodrich Tobacco Company, submitted a Modified Risk Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA) seeking a reduced exposure order so that 22nd Century’s “BRAND A” Very Low Nicotine (VLN) cigarettes may be introduced into commerce in the United States. The application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine. 


The World’s Lowest Nicotine Tobacco Cigarettes
BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®. With more than 200 patents relating to the genes in the tobacco plant responsible for nicotine production, 22nd Century is the only company in the world capable of producing virtually nicotine-free tobacco. Without any artificial extraction or chemical processes, 22nd Century’s BRAND A cigarettes are made with the Company’s proprietary VLN tobacco that is grown on independently-owned farms in the United States. The finished cigarettes have the taste and sensory characteristics of conventional cigarettes, but contain only trace amounts of nicotine so that smokers’ exposure to nicotine is drastically reduced.

Under Section 911 of the federal Food, Drug, and Cosmetic Act, a tobacco product may not be introduced for commerce in the United States if the label or advertising represents that the tobacco product contains a reduced level of a substance or a reduced exposure to a substance unless given specific approval to do so by the FDA.

“The scientific testing conducted in support of our submission to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced exposure to nicotine,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited about the prospect of introducing BRAND A into the U.S. market.”

It has been well established that cigarette smoking is toxic and poses health risks to smokers. Cigarette smoking is a complex behavior that is sustained primarily by the pharmacological properties of nicotine. Accordingly, many public health officials believe it is a critically important health need to provide consumers with a product that reduces exposure to nicotine. This fact echoes former U.S. FDA Commissioner Dr. David Kessler’s recommendation that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate harm reduction strategy.”
 
Unlike so-called “light” or “ultra-light” cigarettes (which terms are now banned by the FDA from labeling and marketing in the United States), 22nd Century’s proprietary BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components. The Company’s application to the FDA provides a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Century’s VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal exposure to the most addictive component of tobacco.

Most recently, in October 2015, The New England Journal of Medicine published a landmark clinical study N Engl J Med 2015; 373:1340-1349 led by the Center for the Evaluation of Nicotine in Cigarettes. The double-blind, parallel, randomized clinical trial by Donny et al involved 840 smokers at ten locations who were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes. The researchers concluded that:

As compared with cigarettes of conventional nicotine content, 22nd Century’s proprietary Very Low Nicotine cigarettes were “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.”
 
“The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy…” explained public health policy reform advocates, Drs. Michael Fiore and Timothy Baker in a companion article (Fiore) in the same issue of The New England Journal of Medicine. “Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.”

The available scientific literature shows that smoking 22nd Century’s VLN cigarettes results in reduced nicotine exposure with minimal compensatory smoking behavior and no greater exposure to harmful or potentially harmful toxicants, particularly when exposure is maintained for longer than one week. Similarly the prolonged use of VLN cigarettes seems to result in a decrease in dependence.
“It is the goal of the U.S. Department of Health and Human Services, as outlined in the program Healthy People 2010, to reduce cigarette smoking in the United States to 12% by the year 2020,” explained Gregg M. Gellman, 22nd Century’s Director of Regulatory Affairs. “Based on the scientific rationale and clinical data referenced in our application to the FDA, we believe 22nd Century’s proprietary Very Low Nicotine cigarettes could be an invaluable tool in helping to drastically reduce smokers’ exposure to nicotine and thereby greatly reducing cravings for, and consumption of, cigarettes.”

With approximately 277 billion cigarettes manufactured in the U.S. in 2014 – representing more than $80 billion in sales – the cigarette market in the United States remains enormous. At present, however, the United States is completely devoid of any “reduced exposure cigarette” option. If 22nd Century’s application to the FDA is successful, the Company’s VLN cigarettes will offer millions of American smokers a distinct reduced exposure product choice.

22nd Century’s Receives USDA Phytosanitary Certificate to Export Proprietary Tobacco Seeds





Source:  22nd Century Group, Inc.

Central American growing program may enable the Company to bring reduced exposure tobacco products to price-conscious smokers around the world.

22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today that the Company is exporting multiple varieties of its proprietary tobacco seeds to Central America for testing and possible expanded agricultural production. The United States Department of Agriculture (USDA) issued a phytosanitary certificate to 22nd Century to facilitate export of the Company’s proprietary Nicotiana tabacum (tobacco) seeds to growers in Central America. 


22nd Century remains committed to utilizing US-grown tobacco for cigarettes manufactured for sale in the United States and other countries. However, in order to satisfy demand for its proprietary tobacco in parts of the world unable to afford premium-priced leaf, 22nd Century is conducting field trials with select growers in Central America.

The first crops grown from the Company’s proprietary tobacco varieties in Central America will come due for harvest in early 2016. 22nd Century anticipates that the field trials will produce tobacco that compares favorably with the Company’s previous contract-grown crops. With growing seasons all year long, plentiful rainfall, and tens of thousands of acres of suitable farmland, Central American farms have the potential to produce large quantities of quality tobacco leaf for 22nd Century – at extremely attractive prices.

“Some of the world’s largest cigarette markets are highly price sensitive,” explained Henry Sicignano, III, President and CEO of 22nd Century. “Our Central American growing program may enable 22nd Century to provide price-conscious smokers in many parts of the world with incredibly important products that no other company can provide, including Very Low Nicotine tobacco cigarettes – with 95% less nicotine than conventional cigarettes – as recently described in The New England Journal of Medicine.

22nd Century Announces New Cannabis Research Collaboration with Anandia Laboratories

Source:  22nd Century Group, Inc.

Initial focus will include cannabinoid-free cannabis for commercial hemp industry and High levels of non-THC cannabinoids, such as CBD, for legal medical marijuana markets.

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today an important new initiative in plant biotechnology: 22nd Century has entered into a new cannabis research collaboration with strategic partner Anandia Laboratories, Inc. (Anandia), based in Vancouver, Canada. As a part of this research collaboration, Anandia will develop and grow cannabis strains that express highly desirable characteristics and will lead to exciting commercialization opportunities. Dr. Paul Rushton, 22nd Century’s new Vice President of Plant Biotechnology, will have responsibility for this partnership with Anandia.

The Company last year announced that Botanical Genetics, LLC (a wholly owned subsidiary of 22nd Century Group) entered into a worldwide license agreement with Anandia that granted exclusive rights to 22nd Century in the United States to four genes required for cannabinoid production in the cannabis plant. The license also granted 22nd Century co-exclusive rights with Anandia to this proprietary technology in all countries outside of the U.S. and Canada. Anandia retained exclusive rights in Canada.

The proprietary technology licensed from Anandia allows for the development of cannabis strains that demonstrate either an increase or decrease in the production and content of all, or certain subsets of, cannabinoids. The long-term goals of the Company’s research activities relating to cannabis are to develop, protect and commercially produce unique cannabis plant varieties that include high levels of non-THC cannabinoids, such as CBD, for the legal medical marijuana markets, as well as virtually cannabinoid-free cannabis for the commercial hemp industry.

Jonathan Page, Ph.D., Co-Founder, CEO and Chief Scientific Officer of Anandia – and the inventor of some of 22nd Century’s powerful transcription factor technology in the tobacco plant – is an internationally-recognized pioneer and leader in cannabis science who co-led the team that first sequenced the cannabis genome and has made fundamental discoveries about cannabinoid biosynthesis. Applying Dr. Page’s expertise and Anandia’s patented technology, the Anandia team will use modern plant breeding approaches and genomics to create next-generation cannabis strains.
Dr. Page stated, “Anandia benefits from an excellent relationship with 22nd Century and we are excited to be expanding our relationship through this research collaboration aimed at creating unique cannabis strains with highly desirable traits that can be commercialized quickly.”

Henry Sicignano, III, President and CEO of 22nd Century explained, “In much the same way that we enjoy a monopoly on the nicotinic biosynthetic pathway of tobacco, our license agreement and research activities with Anandia will facilitate 22nd Century’s control of the cannabinoid biosynthetic pathway in cannabis throughout the U.S. market.” Mr. Sicignano continued, “Though not directly related to our main tobacco businesses, the exclusivity in, and control of, ‘next generation cannabis strains’ could ultimately be worth billions of dollars to 22nd Century.”

22nd Century Announces Hiring of Key Executive; Dr. Paul J. Rushton Will Spearhead Growth and Commercialization of 22nd Century’s Plant Biotechnology Portfolio

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today the appointment of Paul J. Rushton, Ph.D. as the Company’s Vice President of Plant Biotechnology. Dr. Rushton is uniquely qualified to grow and commercialize the Company’s impressive patent portfolio relating to both tobacco and cannabis. He has extensive experience in tobacco biotechnology, including work at the University of Virginia on 22nd Century sponsored research projects, as well as nearly a decade working at the world-renowned Max Planck Institute for Plant Breeding in Germany. 

Dr. Rushton has published over fifty scientific articles in the United States and abroad. He serves on the editorial boards of a number of scientific journals. While at the Max Planck Institute, Dr. Rushton provided the first evidence that WRKY transcription factors play crucial roles in plants’ responses to stress. Dr. Rushton’s research resulted in him personally defining and naming the important WRKY family of plant transcription factors.

While at the University of Virginia, Dr. Rushton designed and published the tobacco transcription factors database (TOBFAC). This database is possibly the largest collection of transcription factor sequences (genes which turn on or off particular plant responses) from a single tobacco species (over 2,500 genes) and is the world’s most extensive database for tobacco genomic research.
http://compsysbio.achs.virginia.edu/tobfac/ Dr. Rushton is also co-inventor of several patents related to nicotine production in tobacco. Dr. Rushton was part of the team of scientists lead by Michael P. Timko, Ph.D, at the University of Virginia who worked on sponsored tobacco research projects for the Company. Thus, Dr. Rushton already has very strong and important experience in working with 22nd Century’s unique tobacco technology.

“Hiring a scientist of Paul Rushton’s caliber – especially given his extensive work in tobacco plant biotechnology – is like finding the proverbial needle in a haystack. He will be invaluable to 22nd Century,” explained Henry Sicignano, III, CEO and President. “Paul’s experience will enable him to contribute immediately to the Company’s Modified Risk Tobacco Products in development and to spearhead our cannabis technology initiatives.”

For more information about Dr. Paul Rushton and his research, visit: https://therushtonlab.wordpress.com/

The New England Journal of Medicine Publishes Landmark Study Using 22nd Century’s Proprietary Very Low Nicotine Cigarettes

Source:  22nd Century Group, Inc.

22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced that The New England Journal of Medicine has published a special article describing a milestone study that used the Company’s proprietary SPECTRUM research cigarettes (N Engl J Med 2015; 373:1340-1349). The Center for the Evaluation of Nicotine in Cigarettes led the double-blind, parallel, randomized clinical trial involving 840 smokers at ten locations. The authors concluded that data from the study suggests, as compared with cigarettes of conventional nicotine content, 22nd Century’s proprietary low nicotine SPECTRUM cigarettes were “associated with reductions in smoking, nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse events.”

he study, which was funded by the National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, included six styles of 22nd Century’s SPECTRUM research cigarettes. The SPECTRUM cigarettes had nicotine contents ranging from 15.8 mg per gram of tobacco (similar to commercial brands) to 0.4 mg per gram (“very low nicotine”). The very low nicotine SPECTRUM cigarettes contain 95% less nicotine than conventional cigarettes. 22nd Century is the only company in the world capable of growing tobacco with such low nicotine content.

Researchers found that during the 6th and final week of the trial, participants who were assigned 22nd Century SPECTRUM cigarettes with 0.4 mg/g nicotine smoked fewer cigarettes per day (14.9) than those assigned to their usual brand (22.2). In fact, very low nicotine cigarettes were found to reduce exposure to, and dependence on, nicotine and to reduce cravings while adverse events were generally mild and similar among groups. Moreover, in the 30 days following the trial, smokers of very low nicotine cigarettes reported they attempted to quit smoking at a rate double that of participants who smoked cigarettes with 15.8 mg/gram nicotine (34.7% vs. 17%).

The study’s lead author, Dr. Eric Donny, explained in an article posted on usatoday.com, "The evidence is getting stronger that reducing nicotine reduces smoking and makes people less addicted to cigarettes and, in doing so, might make them more likely to quit." To further test this theory, 22nd Century’s proprietary SPECTRUM cigarettes are being used in a Phase III clinical study that follows 1,250 smokers for five months (ClinicalTrials.gov NCT02139930).

The results of previous studies using very low nicotine cigarettes have demonstrated a host of desirable outcomes including reduced smoking, reduced nicotine exposure, reduce nicotine dependence, increased abstinence, reduced exposure to toxicants and few adverse events with little evidence of withdrawal-related discomfort or safety concerns. Unlike “light” cigarettes (as previously labeled and marketed by conventional tobacco companies) which reduce machine-smoking nicotine yields by diluting the smoke rather than by reducing the nicotine content of the tobacco itself, very low nicotine cigarettes do not result in compensatory smoking.

In the past 8 years, the prospect of reducing the addictiveness of cigarettes has received renewed attention from numerous health organizations, including the Institute of Medicine, the World Health Organization (WHO) and the Office of the U.S. Surgeon General. The Tobacco Control Act, enacted in 2009, granted the FDA authority to set standards that reduce the nicotine content of all cigarettes sold in the United States.

“The current study by Donny and colleagues adds to a growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy…” explained public health policy reform advocates, Drs. Michael Fiore and Timothy Baker in a companion article in the same issue of the NEJM. “Reducing the nicotine content of combustible tobacco to levels that will not sustain dependence seems to us to be the most promising regulatory policy option for preventing [at least] 20 million premature deaths.”

About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants through genetic engineering and plant breeding. The Company’s mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 185 issued patents and more than 50 pending patent applications around the world. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.