The Mission Report

The MissionIR Report - December 2011

In-depth analysis, timely updates, latest market news

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Market News

Company Updates

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FluoroPharma Medical Granted Additional Patent Protection

FluoroPharma Medical recently announced that composition of matter patents covering AZPET, the company's Alzheimer's Disease agent, have been issued by the U.S. patent office expiring in 2028. FluoroPharma has also been granted patent rights in China for BFPET, its imaging agent for measuring cardiovascular blood flow. The patents will expand the company's intellectual property protection in these important growth markets where diagnostic imaging is playing an increasingly significant role in the early detection of disease.

FluoroPharma is developing breakthrough diagnostic imaging products that utilize positron emission tomography (PET) technology, a molecular imaging platform that is growing rapidly due to its inherently superior sensitivity and specificity compared to other imaging options. The company's imaging products will give clinicians the ability to detect and assess pathology before clinical manifestation of diseases.

"There is an urgent need to encourage fast, early diagnostic intervention and to recognize the advantages that early diagnosis entails for both patients and overall economics of healthcare systems around the globe," stated Dr. David Elmaleh, FluoroPharma's Chairman of the Board of Directors and inventor of the technology. "Improved patient outcomes and more appropriate treatments are possible if better, earlier diagnoses are made. Our agents harness the power of PET/CT to give this utility."

"Strong composition of matter patents in both the U.S. and high growth markets like China are very important to the commercial potential for BFPET and AZPET," commented Thijs Spoor, FluoroPharma's President and Chief Executive Officer. "China represents one of the most significant sources for growth of PET technology and therefore PET imaging agents. This patent grant along with the others in our growing patent estate should add to the value of FluoroPharma's technology and be recognized by potential partners."

In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, and Ireland.

October Home Sales Rise 1.3 Percent

Sales of new homes rose in October and the supply of homes on the market fell to its lowest level since April of last year, showing some healing in the battered housing sector.

The Commerce Department said this week that sales of new single-family homes edged up 1.3 percent to a seasonally adjusted 307,000-unit annual rate, which was the fastest pace in five months yet still below analysts' expectations.

The supply of new homes on the market would last 6.3 months at October's sales pace, down from 6.4 months in September.

The data fueled hopes the housing market could at least be bottoming out.

"This looks like a bottom. The market is stabilizing," said Gregory Miller, an economist at Suntrust Bank in Atlanta.

Financial markets largely dismissed the data, with investors focused on efforts in Europe to quell the region's debt crisis. Prices for U.S. stocks rose sharply on hopes fresh proposals could be emerging.

With euro zone policymakers staring into the abyss as bond investors question their ability bail out weaker members, Germany and France stepped up a drive for a fiscal union.

Europe's troubles are casting a pall over the economic outlook for the United States and the world.

The Organization for Economic Cooperation and Development, a Paris-based research center for governments of industrial economies, slashed its global growth forecast and warned that the euro zone could break up.

It also warned that the impact on the economy could be more grave than widely believed.

So far, the U.S. recovery, which has made strides since the summer thanks to strong factory output and improved consumer spending, seems to be holding its own.

Retail sales soared over the Thanksgiving weekend as shoppers scooped up discounted merchandise.

A survey conducted by the National Retail Federation found sales hit a record $52.4 billion, a 16.4 percent jump over the prior year, raising hopes consumer spending would be strong over the holiday season.

But falling home prices and tighter credit continue to be the bane of the recovery, which has progressed with fits and starts since the 2007-2009 recession.

The Commerce Department's report showed the median sales price dropped 0.5 percent in October to $212,300, the lowest in a year.

Falling prices could hamper the housing market by making buyers see homes as a bad investment. Still, compared to October last year, the median price was up 4.0 percent.

The housing market has been hurt by a glut of unsold properties and an unemployment rate that has been stuck around 9 percent.

The U.S. Federal Reserve has held short-term interest rates at nearly zero since 2008 and has expanded its balance sheet in a bid to get credit to businesses and households. That has helped bring 30-year mortgage rates to record lows. The problem is that even with low rates, many would-be borrowers still cannot get a loan.

A report from the New York Federal Reserve Bank showed U.S. consumers continued to dig out from record debt loads taken on during the housing boom, with total consumer credit dropping 0.6 percent in the third quarter.

VistaGen Therapeutics Expands and Extends Collaboration Agreement

VistaGen Therapeutics, Inc. and the University Health Network (UHN), one of Canada's largest research hospitals, announced the expansion of their existing collaborative pluripotent stem cell research and development program, and extended it through September 2017.

In 2007, VistaGen and Dr. Gordon Keller, head of UHN's McEwen Centre for Regenerative Medicine in Toronto, agreed to combine Dr. Keller's human pluripotent stem cell biology expertise with VistaGen's proprietary Human Clinical Trials in a Test TubeTM stem cell technology platform. The platform delivers clinically relevant indications of how humans will respond to new drug candidates early in the drug development process. Dr. Ralph Snodgrass, VistaGen's President and Chief Scientific Officer, and Dr. Keller, who is chairman of VistaGen's Scientific Advisory Board, co-founded VistaGen in 1998, with the goal of using stem cell technologies to transform the way new drugs are discovered and developed.

"Our unique relationship with UHN and Dr. Keller is dynamic, innovative and directly supports the drug rescue capabilities of our Human Clinical Trials in a Test Tube™ platform," said Shawn Singh, VistaGen's Chief Executive Officer. "This research partnership gives us direct access to cutting-edge stem cell research conducted by one of the world's leading stem cell researchers at one of the world's top stem cell research institutions."

Dr. Christopher Paige, UHN's Vice President, Research, said, "We are very pleased with the progress Dr. Keller's lab and VistaGen are making in our cooperative research effort. VistaGen's support of Dr. Keller and his team, and its commitment to commercializing these technologies, give us confidence that we will soon see the remarkable promise of our collaborative stem cell research translated into therapeutic realities that will improve patients' lives."

The amended UHN agreement includes five key programs that will further support VistaGen's core drug rescue initiatives and potential cell therapy applications.

Research conducted at UHN and VistaGen labs will include the development of stem cell-based drug discovery and drug rescue technologies, using mature cardiac, liver and pancreatic beta-islet, blood and cartilage cells. The program will also focus on large-scale production of these cell types, each derived from human-induced pluripotent stem cells (hiPS cells), which are potentially suitable for in vivo transplantation studies and cell therapy applications.

Additionally, VistaGen and UHN scientists plan to further enhance current methods used to produce cell types derived from both human embryonic stem cells (hES cells) and hiPS cells. The research alliance also aims to establish preclinical proof-of-concept for the use of iPS cell-derived articular chondrocytes for cell therapy repair and regeneration of autologous cartilage, as well as the use of iPS cell-derived precursor cells to produce lymphocytes, granulocytic cells, red cells and blood platelets.

BioSante Pharmaceuticals, Inc. (BPAX)

In recent news, BioSante Pharmaceuticals announced that it has been granted a new U.S. patent covering the "method of use" of LibiGel (testosterone gel) for treating female sexual dysfunction (FSD) and hypoactive sexual desire disorder (HSDD). The patent covers methods for treating FSD and HSDD and also includes using a metered dosage device to deliver the defined dose of the testosterone formulation in LibiGel.

"We are very pleased that this new LibiGel patent has issued. The patent protects the use of LibiGel in treating FSD and HSDD, and the bottle we used in our clinical work, as well as in the intended commercial product, and extends our patent protection to the end of 2028," commented Stephen M. Simes, BioSante president and CEO. "Our objective has been to continue to strengthen our intellectual property covering LibiGel and this patent is a major achievement in that direction."

About BioSante Pharmaceuticals, Inc. (BPAX)

BioSante Pharmaceuticals, Inc. has a strong portfolio of specialty products/candidates in the areas of oncology and sexual health. Employing a shrewd, collaborative framework of strategic partners/licensees, BioSante's experienced development team has grown extremely proficient at identifying valuable opportunities and then leveraging the extended resources of the company's partner network in order to progress rapidly from candidate towards a successfully branded product.

Lead products like LibiGel® (Phase III), a once-a-day transdermal gel engineered to absorb quickly into the skin after it is rubbed on the upper arm, show tremendous potential in targeted markets. In this case where women suffering from HSDD (hypoactive sexual desire disorder, characterized by lowered sex drive) benefit both from reduced skin reaction customary in other transdermal delivery solutions and the ability of the proprietary formulation of testosterone to alleviate HSDD symptoms, increasing sexual desire and satisfaction, while lowering sexual distress.

BioSante's Elestrin™ gel, marketed in the US by BPAX licensee Azur Pharma, is an ultra-low dose prescription formulation of estrogen (estradiol) for hot flashes associated with menopause and engineered along emerging guidelines for such treatments from estrogen therapy/gynecology experts at the FDA, NAMS (North American Menopause Society) and ACOG (American College of Obstetricians and Gynecologists), who recommend the lowest dosage possible for the shortest interval. Fast-drying and colorless, this clear gel product contains a form of estradiol identical to that in the body; a single dose rubbed into the upper arm or shoulder is enough to treat moderate-to-severe hot flashes.

Rounding out the BioSante portfolio are three other offerings. The Pill-Plus™, an oral contraceptive that is currently under development, featuring a triple component formulation which adds an androgen (similar to testosterone) to the typical estrogen/progestin combination and has shown results in trials of increased sexual activity. Bio-T-Gel™, a once-daily transdermal formulation of testosterone engineered to treat male hypogonadism, typically characterized by impotence, osteoporosis, and weakness of the muscles, in addition to a general lack of sex drive. And finally, a series of ongoing cancer vaccine work with multiple offerings in various Phase I and II clinical trials, work that has been supercharged by the 2010 FDA approval of Provenge for the treatment of prostate cancer.

FluoroPharma Medical, Inc.
(FPMI)

FluoroPharma Medical announced it has received additional patent protection in the U.S. and China. The patents will expand the company's intellectual property protection in these important growth markets where diagnostic imaging is playing an increasingly significant role in the early detection of disease. In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, and Ireland.

Thijs Spoor, FluoroPharma's President and Chief Executive Officer, stated, "Strong composition of matter patents in both the U.S. and high growth markets like China are very important to the commercial potential for BFPET and AZPET. China represents one of the most significant sources for growth of PET technology and therefore PET imaging agents. This patent grant along with the others in our growing patent estate should add to the value of FluoroPharma's technology and be recognized by potential partners."

About FluoroPharma Medical, Inc. (FPMI)

FluoroPharma Medical, Inc. is a biopharmaceutical company focused on discovering and developing patented Positron Emission Tomography (PET) imaging products to improve patient management by evaluating cardiac disease at the cellular and molecular levels. The company is currently advancing two products in clinical trials to fulfill critical unmet medical needs. The agents will provide clinicians important tools for detecting and assessing pathology before critical manifestations of disease.

The company's proprietary molecules labeled with the radioactive isotope of fluorine combined with PET scanning provide non-invasive, highly specific and efficient assessment of heart metabolism and physiology. FluoroPharma's cardiovascular program addresses the largest segment of the nuclear medicine market.

Molecular imaging fulfills numerous unmet needs in diagnosis by enabling visualization, characterization and measurement of biological processes at the molecular and cellular level. Unlike traditional imaging modalities – MRI, CT, and Ultrasound – that reveal the anatomical abnormalities and cause for disease, PET provides insight into physiology and can detect disease before anatomical manifestation is identified. According to GAI, the market for molecular imaging agents currently exceeds $1.7 billion annually and promises rapid growth for the foreseeable future.

FluoroPharma's comprehensive technology platform was developed by scientists at the Massachusetts General Hospital. To date, the company has been issued four US patents and has seven applications pending in addition to strong international protection. With a solid and experienced management team in place and the necessary resources to advance clinical development, FluoroPharma is well positioned to capitalize on its superior imaging technology.

VistaGen Therapeutics, Inc.
(VSTA)

VistaGen Therapeutics recently announced the expansion of its existing collaborative pluripotent stem cell research and development program with University Health Network (UHN), and extended it through September 2017. The amended UHN agreement includes five key programs that will further support VistaGen's core drug rescue initiatives and potential cell therapy applications.

Shawn Singh, VistaGen's Chief Executive Officer, said, "Our unique relationship with UHN and Dr. Keller is dynamic, innovative and directly supports the drug rescue capabilities of our Human Clinical Trials in a Test Tube™ platform. This research partnership gives us direct access to cutting-edge stem cell research conducted by one of the world's leading stem cell researchers at one of the world's top stem cell research institutions."

About VistaGen Therapeutics, Inc. (VSTA)

VistaGen Therapeutics, Inc. is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of promising drug candidates that have been discontinued during preclinical development ("put on the shelf") due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.

VistaGen's versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential toxicity of promising new drug candidates long before they are ever tested on humans. VistaGen's human pluripotent stem cell-based bioassay systems more closely approximate human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development.

Using mature human heart cells produced from pluripotent stem cells, VistaGen leveraged its Human Clinical Trials in a Test Tube™ platform to develop CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. The Company now plans to use CardioSafe 3D™ to build a pipeline of small molecule drug rescue variants of once-promising drug candidates that have been "put on the shelf" by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite positive efficacy data signaling their potential therapeutic and commercial benefits.

VistaGen is also developing LiverSafe 3D™, a novel predictive liver toxicity and drug metabolism bioassay system for drug rescue applications. In parallel with drug rescue activities, the company is funding early-stage nonclinical studies focused on potential cell therapy applications of its Human Clinical Trials in a Test Tube™ platform. Each of these nonclinical studies is based on the proprietary human pluripotent stem cell differentiation and cell production capabilities of VistaGen's Human Clinical Trials in a Test Tube™ platform.

 
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