For Thursday, January 8th
SMAS, PNTV, CBAI, LJPC, GTCB, RMTD
Our Stocks to Watch tomorrow include Somatic Systems Inc. (OTC: SMAS), Players Network Inc. (OTCBB: PNTV), Cord Blood America Inc. (OTCBB: CBAI), La Jolla Pharmaceutical Co. (Nasdaq: LJPC), GTC Biotherapeutics Inc. (Nasdaq: GTCB) and Remote Dynamics Inc. (OTCBB: RMTD).
SOMATIC SYSTEMS INCORPORATED (OTC: SMAS)
"Up 100.00% on Wednesday"
Somatic Systems is the worldwide center for Clinical Somatics™, the groundbreaking drug-free, non-surgical approach to pain relief. This proprietary system uses natural, non-invasive movement techniques — conducted through one-hour hands-on sessions, therapeutic exercises classes, and home exercises lasting as little as 5 minutes a day — to relieve pain and limitation resulting from accident, trauma and repetitive stress, including back pain, knee pain, joint problems, carpal tunnel syndrome, TMJ, scoliosis, bursitis, sciatica, headaches, tendonitis and more. Clinical Somatics™ also provides performance gains and injury prevention for casual and professional athletes. Somatic Systems is pursuing a 3-part growth strategy, consisting of a nationwide rollout of pain management Somatics Clinics; increased production and distribution of therapeutic videos, books, and other retail self-help Somatics Products; and expanded Somatics Training Programs to supply Clinic practitioners serving medical and orthopedic professionals and institutional and corporate programs. The company operates a suite of web sites offering Somatics information, products, resources and opportunities at www.somatics.org.
January 7 - Somatic Systems, Inc. Approved for Healthcare National Provider Registry
Somatic Systems, Inc. (OTC: SMAS) announced that it has been approved and is now listed in the National Provider registry, and the company has received its National Provider Identifier (NPI) code by the United States Centers for Medicare and Medicaid Services.
This is a significant step in the process of Somatic Systems becoming fully approved by US military health insurance, a system that provides treatment for more than 70 million soldiers, veterans, and dependents. The NPI assignment and acceptance in the NPI Registry is required to be covered by government and military health insurance. Somatic Systems' application was submitted, reviewed, and approved.
Somatic Systems stated it is currently moving forward with the next phases of the approval process, and furthering its military contracts efforts via discussions and strategic partnerships with key military and related personnel. This week, company representatives are meeting with the Veterans Administration and the Disabled American Veterans organization, to discuss their provision of treatment services.
The Military Chronic Pain Crisis
Somatic Systems has been working to provide its proprietary Clinical Somatics pain-care services for US military hospitals and the Veterans Administration. In addition to seeking in-house arrangements at bases and facilities, the company also announced that it is preparing to rollout multiple clinics at military base locations throughout the US, to provide easy access to Clinical Somatics services at a time when the US military is strongly seeking satisfactory pain treatment solutions such as Clinical Somatics — and following a wave of legislation including the Military Pain Care Act of 2008, which requires the Department of Defense, Veterans Affairs, and Health and Human Services and the Surgeon General of the United States to implement and maintain a pain care initiative in all military health care facilities and for all active and retired military personnel, dependents, and survivors.
Nearly 26 million living Americans have served in the military, and pain is the most common symptom and cause of disability amongst veterans, with more than 40% of returning service members reporting musculoskeletal pain-related problems and symptoms. Additionally, long-term sufferers as well as family members and other dependents of all ages also face pain and other musculoskeletal problems; and this population totals over 70 million people, served by the Veterans Administration. In the face of this, military officials, medical authorities, and government officials have reported frustration that the military does not yet have a satisfactory pain care program in place.
PLAYERS NETWORK INCORPORATED (OTCBB: PNTV)
"Up 122.22% on Wednesday"
Players Network is a Digital Media Company that focuses on the Las Vegas and Gaming Lifestyles, producing and distributing original content for its own VOD Channels on television in over 22,000,000 homes, for its Broadband Network at www.playersnetwork.com, Blinkx, Google, YouTube and Yahoo Video, for DVD Home Video, mobile platforms, and through worldwide television syndication. Players Network has a 10-year history of providing consumers with quality Gaming and Las Vegas Lifestyle content, and the gaming industry with strategic partnership services in Las Vegas, Atlantic City, and throughout the worldwide Gaming Industry.
January 7 -
Players Network Enters in Revenue Sharing Distribution Agreement With Sling Media
Players Network (OTCBB: PNTV), the leading Digital Media 3-Screen Network dedicated to Las Vegas Entertainment and the Gaming Lifestyle, announced that it has entered into a content syndication and revenue sharing agreement with the Sling Media, Inc., a wholly owned subsidiary of EchoStar Corporation. Sling.com is an online Video Entertainment platform that provides high quality full-length shows, movies and clips with user customization and community features.
Players Network will have its own branded channel on Sling.com where users will have free access to Players Network's extensive library of over 1,500 original Gaming and Las Vegas lifestyle programs. Sling.com users will be able to subscribe to the Players Network Channel and choose to engage in the social community built around the content. In addition to Sling.com, Players Network broadband distribution includes Hulu.com, Blinkx.com, Google Video, Yahoo Video, YouTube, and PlayersNetwork.com. Players Network also has extensive television distribution on Comcast Cable, Direct TV, AT&T's U-Verse, Verizon FiOS, and Tivocast.
"We are so excited to have been chosen to participate in the initial launch of Sling.com," says Mark Bradley, CEO of Players Network. "This new platform will expand Players Network's distribution using brand new technology that poises Sling.com to be an industry leader."
ABOUT SLING MEDIA
Sling Media, Inc., a wholly owned subsidiary of EchoStar Corporation, is a leading digital lifestyle company offering consumer services and products that are a natural extension of today's digital way of life. Sling Media's product family includes the internationally acclaimed, Emmy award-winning Slingbox(TM) that allows consumers to watch and control their living room television shows at any time, from any location, using PCs, Macs, PDAs and smartphones and the revolutionary new SlingCatcher(TM), a universal media player that seamlessly delivers broadcast TV, Internet video and personal content to the TV. Sling Media is also the company behind the video entertainment web site, Sling.com, offering consumers a wide variety of popular TV shows, movies and other entertainment free for viewing online or on the TV using SlingCatcher. For more information on Sling Media, the Slingbox or the SlingCatcher, visit www.slingmedia.com. To watch your favorite TV shows and movies, check out www.sling.com.
CORD BLOOD AMERICA INCORPORATED (OTCBB: CBAI)
"Up 94.12% on Wednesday"
Cord Blood America is the parent company of CorCell, which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Its mission is to be the most respected stem cell preservation company in the industry. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and potentially life-saving resource for treating a growing number of ailments, including cancer, leukemia, blood, and immune disorders.
January 6 - Cord Blood America Engages Social Media and Starts Conversation Regarding Stem Cells
Exponential Growth of Social Media Cannot Be Ignored; Cord Blood America to Engage Clients and Investors on Social Media Platforms
Cord Blood America, Inc. (OTCBB: CBAI), announced that the Company will begin to engage its clients, prospective clients, shareholders and prospective investors via social media. Cord Blood America is currently on Twitter, Facebook and soon to be available on FriendFeed. Cord Blood America will use social media platforms to develop relationships and build networks as well as answer questions regarding their business. Cord Blood America's Twitter address is www.twitter.com/cbai.
"It's time to start the conversation," said Cord Blood America's founder and CEO Matthew Schissler. Cord Blood America will have a running dialog via these social media outlets, to translate the daily news about stem cells to such a degree that the global population can become informed and participate. "The word 'stem cells' invokes many thoughts, yet we have found that the vast majority of the population still does not know what they are, where they come from or how they dramatically impact almost all aspects of life as we know it. To most, 'stem cells' is a scientific term that has no direct impact on the individual. It's our belief that most people want to understand in a practical fashion, how stem cells affect their family directly. This is the purpose of the social media, to deliver in a user friendly fashion, practical information about stem cells. We intend to look at the issue from multiple angles, including medically from the eyes of the patients and health care practitioners, fundamentally from the scientists, economically from the investor and business perspective, and socially from a public policy perspective."
Schissler continued, "Social media is growing explosively and this trend, according to all authorities is going to continue. We believe that building a network of clients and investors in two-way communication via social media will establish ourselves and our business as market leaders of the future. We invite you to join us in the conversation at the outlets previously mentioned. Additionally we have set up a social media newsroom at Intelligendo.com; we will leverage this newsroom and Intelligendo to further our relationship and network building efforts."
LA JOLLA PHARMACEUTICAL COMPANY (NASDAQ: LJPC)
"Up 81.35% on Wednesday"
La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company's leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions.
January 6 -
BioMarin and La Jolla Pharmaceutical Sign Worldwide (Excluding Asia Pacific) Development and Commercialization Agreement for Riquent
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) and La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced that they have entered into an agreement to develop and commercialize Riquent®, La Jolla's investigational drug for lupus nephritis, in the United States, Europe and all other territories of the world, excluding the Asia Pacific region. Following a successful Phase 3 trial, the parties will share equally in all losses and profits. In the United States, BioMarin and La Jolla will jointly commercialize Riquent. In Europe and other territories outside of Asia, BioMarin will be responsible for all commercialization activities.
Jean-Jacques Bienaime, Chief Executive Officer of BioMarin commented, "We are very pleased to become La Jolla Pharmaceutical's partner for Riquent. The development history of Riquent has been long and challenging, but we feel the current study addresses the shortcomings of prior studies and provides the best possible opportunity to demonstrate that Riquent reduces the frequency of renal flares in lupus nephritis patients. The ASPEN Phase 3 study is the largest clinical study ever conducted in lupus nephritis and there is increasing evidence that Riquent targets one of the most important underlying causes of kidney disease in lupus patients, antibodies to double stranded DNA.
Mr. Bienaime continued, "This product opportunity also represents an exceptionally good strategic fit for BioMarin. Lupus nephritis is a serious and potentially fatal orphan disease treated by specialists, primarily nephrologists and rheumatologists, and there are no products specifically approved to treat lupus renal disease. Importantly, if the ASPEN study is successful, Riquent provides BioMarin the opportunity to launch a product in the 2010 and 2011 timeframe in regions where we can leverage existing commercial operations."
"BioMarin is a proven leader in successfully bringing value-added therapies to patients suffering from orphan diseases and we are very pleased to have BioMarin as a partner to develop and commercialize Riquent in the U.S., Europe, the Middle East and Latin America," said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla Pharmaceutical Company. "This is an outstanding partnership for us as it not only provides significant near term funding towards the completion of the ASPEN trial but also facilitates La Jolla's plans to build a U.S. commercial infrastructure going forward. 2009 is a pivotal year for La Jolla and we are pleased to start the year with this positive announcement. We look forward to the first interim analysis of the ASPEN trial data which is expected to occur later in this quarter," continued Dr. Gillespie.
Overview of Deal Terms
Under the terms of the agreement, BioMarin will receive a co-exclusive license to develop and commercialize Riquent and La Jolla could receive up to $289 million in cash through milestones and equity purchases by BioMarin. Specific payments include: $15 million upfront, up to approximately $92.5 million related to clinical milestones, $55 million for regulatory milestones, and up to approximately $126 million for achieving specified annual net sales milestones beginning at $250 million in sales.
At each of the two interim efficacy analyses (the first expected in the first quarter of 2009 and the second expected in mid-2009) or when the ASPEN study comes to a successful completion, BioMarin may exercise its option to fully participate and share all losses and profits on a 50:50 basis. Prior to BioMarin's decision to participate fully, La Jolla will fund 100% of all costs. La Jolla expects consideration from the deal to significantly cover the remaining costs of the Phase 3 ASPEN study. The collaboration also provides La Jolla an ability to participate equally in sales and marketing responsibilities in the United States to facilitate building its commercial infrastructure. La Jolla will maintain primary manufacturing responsibility, and work collaboratively with BioMarin to maximize supply chain and process efficiencies.
Upon signing, BioMarin will pay La Jolla a total upfront payment of $15 million, $7.5 million in cash and $7.5 million for the purchase of 3,391,035 preferred shares at a price per share of $2.21171. The preferred shares are initially convertible at a rate of three shares of common stock for every one preferred share. This is equivalent to a common stock purchase price of $0.73724, a 20% premium to the average closing price for La Jolla's common stock over the previous 20 trading days.
Depending on the outcomes (non-futile or achievement of p-value, p<0.001) of two predefined interim efficacy analyses in the Phase 3 ASPEN study as well as the complete Phase 3 clinical results, BioMarin will pay La Jolla up to an additional $47.5 to $92.5 million in clinical milestone and full participation payments prior to approval. BioMarin may apply up to $20.0 million of these pre-approval clinical milestones toward additional purchases of La Jolla preferred stock. If the first interim efficacy analysis results in a non-futile determination by the Data Monitoring Board, BioMarin will pay a milestone of $15 million to maintain its license option. If the second interim efficacy analysis results in a non-futile determination by the Data Monitoring Board, BioMarin will pay a milestone of $22.5 million to continue its license option, $5 million of which may be used to purchase additional equity.
Riquent is being evaluated in the international Phase 3 ASPEN trial designed to demonstrate that Riquent treatment delays the time to renal flare and reduces proteinuria in patients with lupus renal disease. The Riquent Phase 3 program is the subject of a special protocol assessment and has fast track designation from the Food and Drug Administration and Orphan Drug designation in the United States and Europe. The first and the second interim efficacy analysis are expected to occur in the first quarter of 2009 and mid- 2009, respectively. The final efficacy analysis is expected to occur in the second half of 2009. Assuming a positive outcome of the ASPEN Phase 3 trial, a New Drug Application is expected to be submitted in the first half of 2010. If approved, Riquent would be the first new drug approved specifically for lupus in more than 45 years.
ABOUT LUPUS NEPHRITIS
Lupus nephritis is a life-threatening, antibody-mediated disease and is characterized by periods of extreme, acute inflammation or renal flares which often require treatment with high-dose corticosteroids, immunosuppressive agents and hospitalization. Over time, lupus nephritis can lead to deterioration of kidney function and end-stage kidney disease, requiring long-term renal dialysis or kidney transplantation, and often results in morbidity and mortality.
Riquent is being developed to specifically treat lupus renal disease by preventing or delaying renal flares, a leading cause of sickness and death in lupus patients. It is also being studied to assess whether Riquent treatment improves proteinuria, as was observed in previous clinical trials. Proteinuria is an indicator of abnormal renal function. Riquent has been well tolerated in all 14 clinical trials, with no overall difference in the adverse event profiles for Riquent-treated patients compared with placebo-treated patients. Riquent specifically reduces circulating levels of anti-dsDNA antibodies and is also designed to specifically suppress the B cells that make these antibodies. Decreases in these antibodies are believed to be associated with a decreased risk of renal flare. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials in which they were measured.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises three approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; and Kuvan® (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany. Other product candidates include 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of peripheral arterial disease and sickle cell disease, and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase 1 clinical development for the treatment of PKU.
GTC BIOTHERAPEUTICS INCORPORATED (NASDAQ: GTCB)
"Up 22.83% on Wednesday"
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in Europe and has begun the review process in the United States under a Biologics License Application. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa and IX, which are used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC is collaborating with LFB on the factor VIIa, factor IX, alpha-1 antitrypsin, and CD20 monoclonal antibody programs. GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes.
December 23 -
GTC Closes $15 Million Convertible Debt Financing from LFB
GTC Biotherapeutics, Inc. (Nasdaq: GTCB) ("GTC") has closed on the agreement with LFB Biotechnologies for a $15 million financing in which GTC issued convertible debt and warrants to purchase shares of GTCB common stock on the terms previously disclosed. The net proceeds at closing, after transaction costs and establishment of a restricted cash account, were approximately $10 million.
REMOTE DYNAMICS INCORPORATED (OTCBB: RMTD)
"Up 50.00% on Wednesday"
Remote Dynamics, Inc. markets, sells and supports a state-of-the-art asset tracking and fleet management solution that contributes to higher customer revenues, enhanced operator efficiency and improved cost control. Combining the technologies of the global positioning system (GPS) and wireless communications, the company's solution improves our customers' operating efficiencies through real-time status information, exception-based reporting, and historical analysis. The company is based in Plano, Texas.
January 6 -
Morrow Equipment Selects Remote Dynamics as Partner to Manage Fleet of Cranes and Hoists
Remote Dynamics, Inc. (OTCBB: RMTD), a leading provider of GPS vehicle tracking solutions, announced Morrow Equipment has selected Remote Dynamics to be its fleet management partner.
REDIview is used by hundreds of service, construction and equipment rental companies for real-time asset tracking, maintenance management, billing and security monitoring. REDIview operates on a wide variety of vehicles and construction equipment including tower cranes, mobile cranes and construction hoists.
"Being selected by an industry leader like Morrow Equipment is quite an honor," said Gary Hallgren, CEO of Remote Dynamics. "Our REDIview solution has been optimized for large fleets of vehicles and equipment and we look forward to a long relationship as the one-stop-shop for their fleet management needs."
"We are excited to be working together with Remote Dynamics," said Christian Chalupny, President of Morrow Equipment. "They have put together a comprehensive offering which works across our product line and it will be a very valuable management tool for us."
ABOUT MORROW EQUIPMENT
Morrow Equipment owns and operates the largest fleet of tower cranes in North America. Morrow delivers construction and material handling customers to a wide range of services at 23 locations in the United States, Canada, Mexico, Australia and New Zealand.