AMNE, AVZA, ANDS, GNTA, CHTR, EFGU
Our Stocks to Watch tomorrow include American Green Group Inc. (OTC: AMNE), Aviza Technology Inc. (Nasdaq: AVZA), Anadys Pharmaceuticals Inc. (Nasdaq: ANDS), Genta Inc. (OTCBB: GNTA), Charter Communications Inc. (Nasdaq: CHTR) and Empire Film Group Inc. (OTC: EFGU).
AMERICAN GREEN GROUP INCORPORATED (OTC: AMNE)
"Up 211.11% on Thursday"
AMNE is moving into the six billion building insulation business by becoming a cutting edge chemical sales company. The company is creating a new, wholly owned subsidiary to operate this business which will be headed by Terry Mixon, who plans on implementing this business strategy by using the web, mailing, telephone marketing, and television advertising campaign to grow our associate applicator membership to at least 5 distributor companies in each state. AMNE will begin by recruiting known successful application companies in each state then begin a web-based associate membership drive. The corporation will offer equipment, training and great pricing plus marketing support through the web program to all new associates.
January 8 - AMNE's Provides Outlook for 2009
American Green Group, Inc. (OTC: AMNE) begins 2009 with an optimistic outlook for the year and building shareholder value. AMNE is positioned for tremendous growth in 2009 in the foam business. Currently only 6-7% of the US housing market uses foam insulation (even though the use of foam is safer and more efficient) as compared to Canada where the foam insulation market is 70%.
The foam market is set for huge gains in the coming years although energy prices have dropped in the country and the world is still in the "GREEN" frame of mind. AMNE, through its pending acquisition of Paradigm, will have all GREEN products that can be used for insulation and packaging. The term GREEN has been used for years and many people have risen to the challenge of creating products that do not contain petroleum. In 2003 Gary Grey, the President of Paradigm, developed and patented one of the first Soy-based foam formulas, the cornerstone of Paradigms product line.
The government is determined to use GREEN products in all new construction as well as all renovations. The choice of products is based on the "most GREEN" not the best bid. Even though the economy has come to a stand still and new construction is down to its lowest levels in years, the foam insulation market has not been affected, in fact it is growing.
AMNE looks forward to being able to report earnings in the near future and being able to grow those earnings organically and through additional acquisitions.
AVIZA TECHNOLOGY INCORPORATED (NASDAQ: AVZA)
"Up 185.99% on Thursday"
Aviza Technology, Inc. designs, manufactures, sells and supports advanced semiconductor capital equipment and process technologies for the global semiconductor industry and related markets. The company’s systems are used in a variety of segments of the semiconductor market, such as advanced silicon for memory devices, advanced 3-D packaging and power integrated circuits for communications. Aviza is headquartered in Scotts Valley, Calif., with manufacturing, R&D, sales and customer support facilities located in the United Kingdom, Germany, France, Taiwan, China, Japan, Korea, Singapore and Malaysia.
January 7 -
Aviza Technology Updates Guidance for First Quarter Fiscal 2009 Retains Needham & Company to Explore Financial and Strategic Options
Aviza Technology, Inc. (Nasdaq: AVZA), a supplier of advanced semiconductor equipment and process technologies for the global semiconductor industry and related markets, announced that it expects to exceed its previously announced adjusted net income guidance for the first quarter of fiscal 2009, which ended on December 26, 2008, and that it has retained Needham & Company, LLC to assist the Company in reviewing its financial and strategic options.
Aviza expects that net sales for the first quarter of fiscal 2009 will be at the low end of the original guidance range of $25 million to $32 million. However, Aviza expects that adjusted net income for the first quarter of fiscal 2009 will be in the range of $1 million to $4 million, a substantial improvement over the original guidance range of $50,000 to an adjusted net loss of $4 million. The improvements were a result of the faster impact of cost reduction measures and favorable currency exchange translation.
Additionally, the company has decided to engage Needham & Company to explore partnering, financing and business development options.
“We believe the results of our December quarter will reflect our ongoing efforts to improve our financial performance in the face of an extremely challenging macroeconomic environment. We are pleased that we’ve been able continue to decrease operating costs while maintaining our focus on our served markets with our single-wafer products.” said Jerry Cutini, President and Chief Executive Officer of Aviza Technology. "Additionally, we’ve decided to engage Needham & Company to assist us in evaluating our financial and strategic options. We are looking forward to working closely with them as we move through a very difficult and unpredictable economy. Aviza and Needham & Company have a long history of working together and more importantly, they have a significant depth of experience in the semiconductor capital equipment industry.”
ANADYS PHARMACEUTICALS INCORPORATED (NASDAQ: ANDS)
"Up 114.66% on Thursday"
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing two potentially complementary agents, ANA598, a non-nucleoside polymerase inhibitor and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer.
January 8 -
ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
Patients treated at the initial dose in an ongoing Phase Ib trial demonstrated a 2.5 log10 median viral load decline after three days
Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced results from the first cohort of an ongoing Phase Ib clinical trial of ANA598, the Company's investigational non-nucleoside polymerase inhibitor. ANA598 was very well-tolerated and demonstrated potent antiviral activity in patients infected with chronic Hepatitis C virus (HCV) in this first cohort of the study.
Patients in the first cohort received 200 mg ANA598 (n=8) or placebo (n=2), twice-daily (bid) for three days. At the end of the treatment period, the median viral load decline was 2.5 log10 (>99%), with a range of 1.4-3.4 log10, for the eight patients who received ANA598. Three patients who received ANA598 were genotype 1a and demonstrated a median viral load decline of 1.6 log10, while five patients who received ANA598 were genotype 1b and demonstrated a median viral load decline of 2.6 log10. All eight patients who received ANA598 demonstrated a rapid decline in viral load, and no patients demonstrated viral rebound while on study drug. In addition to the robust viral load decline, ANA598 was very well-tolerated and there were no serious adverse events in the first dose cohort, although conclusions regarding longer-term safety and tolerability cannot be made until the results of future clinical trials of longer duration in more patients are known. Patients are currently being enrolled in the second cohort (400 mg bid) of the study. Anadys expects to report detailed data from multiple cohorts of the study at an upcoming medical conference.
"We are very pleased with the antiviral activity and safety of ANA598 at this first dose tested in the Phase Ib study," commented James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "We believe this early data continues to position ANA598 as a leading non-nucleoside polymerase inhibitor in development for the treatment of HCV and we look forward to investigating ANA598 in longer-term studies in combination with current standard of care."
"The clinical and preclinical profile of ANA598 observed to date is very impressive," said Steve Worland, Ph.D., President and CEO of Anadys. "The magnitude of viral load drop reported today for ANA598 is greater than has been reported for any other non-nucleoside HCV inhibitor in a monotherapy study. Furthermore, the rate of initial viral load decline, believed to be associated with direct inhibition of viral replication, is greater than has been reported previously for all classes of HCV polymerase inhibitors, including nucleosides. This demonstrated antiviral potency holds significant promise for the future use of ANA598 in combination with other anti-HCV agents."
Anadys retains worldwide rights to ANA598, which was fully discovered at the Company. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In December 2008, Anadys announced that the FDA granted fast track designation to ANA598 for the treatment of chronic HCV.
In October 2008, Anadys initiated patient dosing in the Phase Ib study of ANA598 in HCV patients. In the double-blind, randomized placebo-controlled Phase Ib study, treatment-naive genotype 1a and 1b patients are to receive oral capsules of ANA598 over three days at doses of 200 mg bid (twice-a-day), 400 mg bid or 800 mg bid. Ten patients are to be enrolled at each dose level, eight receiving active drug and two receiving placebo.
In a Phase I study in healthy volunteers, ANA598 was administered as capsules at single oral doses of 400 mg, 800 mg, 1400 mg, 2000 mg (fed and fasted) and 3000 mg. In addition, a separate cohort received two 800 mg doses 12 hours apart. ANA598 was well tolerated at all doses and there were no serious adverse events or withdrawals from the study. All reported adverse events were classified as mild or moderate, with no apparent dose relationship. The pharmacokinetic profile demonstrated sustained plasma levels of ANA598 consistent with the potential for once-daily or twice-daily oral dosing.
In the preclinical program, ANA598 was well tolerated at all doses tested in 28-day GLP toxicology studies. In September 2008, Anadys initiated long-term, chronic toxicology studies of ANA598.
If ANA598 is successful in early stage development, the Company anticipates completion of the clinical, toxicology and manufacturing activities required to initiate Phase II studies of ANA598 in combination with current standard of care in mid-2009.
Clinical Need and Market Opportunity in HCV Infection
Chronic HCV infection is a serious public health concern affecting approximately 3.2 million people in the United States and approximately 170 million people worldwide. HCV causes inflammation of the liver, which can lead to fibrosis and cirrhosis, and may ultimately lead to liver failure and/or liver cancer if not successfully treated. Cirrhosis of the liver resulting from chronic HCV infection is the leading indication for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV.
The current standard of care is a combination of pegylated interferon and ribavirin. Inadequate response rates, in particular for patients infected with genotype 1 HCV, along with significant side effects of approved therapy, support the medical need for improved treatment options. It is estimated that fewer than 5% of people with chronic HCV infection living in the U.S. are under treatment today. Most infected individuals are unaware of their infection status and the large majority of individuals who know their condition do not currently receive drug therapy. There is also a growing number of individuals who have failed interferon-based regimens who may be successfully treated with combinations of two or more direct antivirals. It is expected that the next generation of therapies for treatment of HCV will include small molecules, such as ANA598, that directly act upon specific viral enzymes to inhibit viral replication. These new therapies are expected to improve overall therapy by increasing cure rates and potentially improving tolerability and convenience of treatment if doses of currently used agents can be reduced or eliminated.
GENTA INCORPORATED (OTCBB: GNTA)
"Up 38.00% on Thursday"
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta’s Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Ganite and Genasense are available on a “named-patient” basis in countries outside the United States.
January 8 -
Genta Announces Issuance of Two Key U.S. Patents for its Gallium Products Franchise
Genta Incorporated (OTCBB: GNTA) announced that two new patents related to the Company’s franchise in gallium-containing products have issued in the United States. Applications similar to these patents are pending worldwide, and several additional applications that address other compositions and uses have been filed in the U.S. and other territories. These patents and filings provide for claims of compositions and uses of gallium compounds that can be taken by mouth over extended periods for treatment of skeletal diseases as well as other indications.
The two new patents, US 7,354,952B2 and US 7,456,215B2, provide for the therapeutic use of gallium complexed with various agents that increase the oral bioavailability of the active ingredient and yield superior pharmacokinetics compared with the active ingredient used alone.
G4544 is a new, clinical-stage, tablet formulation that enables oral absorption of the active ingredient contained in Ganite® (gallium nitrate injection), a drug that is marketed by Genta and approved in the U.S. for treatment of cancer-related hypercalcemia. Genta is developing G4544 in collaboration with Emisphere Technologies, Inc. (NASDAQ: EMIS - News). The initial clinical study -- a dose-ranging, single-dose evaluation of G4544 in normal subjects – has been completed. Genta is the IND Sponsor and is directing the clinical development program.
“The active ingredient in G4544 has shown a consistently high level of clinical activity across a range of skeletal diseases,” said Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. “We believe that the emerging safety issues with long-term bisphosphonate therapy can potentially be avoided with G4544. Our goal is to establish bioequivalence to our IV drug in repeat-dose studies that may lead to rapid approval in hypercalcemia. We also foresee the potential for subsequent approvals in other diseases, such as bone metastases, Paget’s disease, and osteoporosis.”
G4544 was developed to enable extended administration of the active ingredient in Ganite, which may greatly improve patient convenience and avoid the current need for intravenous pumps or hospitalization. The initial focus of clinical studies with G4544 will be to establish its bioequivalence with the intravenous product, potentially enabling rapid regulatory approval of the oral formulation via a 505(b)(2) application in the U.S. Genta holds or has exclusively licensed the intellectual property related to G4544.
CHARTER COMMUNICATIONS INCORPORATED (NASDAQ: CHTR)
"Up 26.47% on Thursday"
Charter Communications, Inc. is a leading broadband communications company and the third-largest publicly traded cable operator in the United States. Charter provides a full range of advanced broadband services, including advanced Charter Digital Cable® video entertainment programming, Charter High-Speed® Internet access, and Charter Telephone®. Charter Business™ similarly provides scalable, tailored, and cost-effective broadband communications solutions to business organizations, such as business-to-business Internet access, data networking, video and music entertainment services, and business telephone. Charter’s advertising sales and production services are sold under the Charter Media® brand.
December 30 -
Charter Adds Major League Baseball Network
Charter Communications, Inc. (Nasdaq: CHTR) announced the addition of the Major League Baseball (MLB) Network to the digital portion of its Expanded Basic line-up, when MLB Network officially launches on January 1, 2009.
“We feel MLB Network will add a significant amount of value to our line-up, and increase our customers’ enjoyment of Charter’s video service,” commented Rich DiGeronimo, Vice President of Product Management for Charter. “We listen to our customers, and access to MLB Network has been high on their list. Our ability to deliver America’s national pastime in this way further elevates the value of Charter’s home entertainment services.”
As Major League Baseball’s first 24-hour channel, the Network has big plans for its in-season and off-season programming. MLB Network is set to provide over 1,400 hours of live shows, led by MLB Tonight, airing six to seven hours per night during the baseball season.
In-season, the network will carry mostly live programming, covering stories across the entire league, while the off-season programming will focus more on archival programming. Its new Hot Stove show will air five nights a week to catch fans up on all the speculated trades, roster changes, managerial changes and off-season awards. 30 Clubs in 30 Days, a special series which will air during baseball’s spring training sessions, will feature a different MLB club during each of the thirty days, focusing on the up-coming season and the status of the team and its players.
Twenty-six regular season game telecasts are scheduled for showing during the baseball season on the Network.
Over the past year, Charter has invested over a billion dollars to continue providing state-of-the-art services throughout its cable systems nationwide. Charter is committed to investing in its communities, providing an advanced network on which residential and commercial customers rely for their communications needs, and delivering value to all its customers by offering high-quality products and services backed up by superior customer care.
EMPIRE FILM GROUP INCORPORATED (OTC: EFGU)
"Up 40.00% on Thursday"
Empire Film Group, Inc. engages in the finance, production, and distribution of films. It films in various locations worldwide that include Los Angeles, Vancouver, Calgary, Toronto, France, Spain, Romania, Czech Republic, Israel, Costa Rica, Venezuela, Puerto Rico, Colombia, Cuba, Dominican Republic, Mexico, and various locations throughout the United States. The company would also co-produce and co-finance with other producers and production companies. It was formerly known as Environmental Construction Products International, Inc. and changed its name to Empire Film Group, Inc. in November 2007. The company is based in Beverly Hills, California.
January 8 -
Empire Pacts With Industry-Works and Vivendi Entertainment for Canadian Release of Hounddog
Empire Film Group, Inc. (OTC: EFGU) (www.empirefilmgroup.com) has entered into a venture with Vancouver-based Industry-Works International and Toronto-based Vivendi Entertainment Canada for the release of the company's highly anticipated feature, “Hounddog,” starring Dakota Fanning. Vivendi, a division of Universal Music Group and Universal Studios, will release the film to mass merchants and other video retailers throughout Canada on March 3, in both DVD and Blu-Ray formats.
“This represents a further expansion of our relationship with Industry-Works,” said Empire CEO Dean Hamilton-Bornstein. “We have been impressed with their team as we have progressed with ventures together covering international sales and co-productions. To utilize Industry-Works for the release of some of our Empire films into the Canadian market makes a lot of sense, especially when partnered with the highly respected team at Vivendi-Universal.”
“It's tracking to be a significant hit for the Canadian video market,” said Craig Adlard, VP of Sales for Industry-Works. “Initial orders and response from the key retailers indicate that 'Hounddog' will be one of the top selling independent films on video for the entire industry this quarter.”
“Hounddog” was released theatrically in the U.S. marketplace by Empire Film Group, Inc., where it will be released February 3rd by wholly-owned divisions Empire Home Entertainment and Hannover House. The film played at theaters in 25 key U.S. markets, and garnered unanimous praise from major film critics for the powerful and inspiring performance of young actress Dakota Fanning in the leading role. Andrew Sarris, veteran film reviewer for the New York Observer, included “Hounddog” in his 2008 annual recap of top movies for the year.
“Hounddog” was written and directed by Deborah Kampmeier, and produced by Kampmeier, Jen Gatien and Scott Franklin. The film tells the story of a 12-year old girl in the late 1950's who finds comfort in the music of Elvis Presley as an escape from a dysfunctional and abusive family life. The DVD and Blu-Ray units have a running time of 99 minutes (excluding bonus features), and will be released in widescreen format (1:1.85 aspect ratio) and Dolby 5.1 Stereo. The film's MPAA rating is “R.”