Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, September 6, 2013

GenVec, GNVC, Profile, Summary

GenVec | GNVC | Profile | Summary

GenVec, (GNVC) is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of the company's strategy is to develop and commercialize products through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns.

GenVec’s development programs address therapeutic areas such as hearing loss, balance disorders, and cancer; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus type 2 (HSV-2), dengue fever, influenza, malaria, and human immunodeficiency virus (HIV).

The GenVec's Advantage
The company's core technology has the important advantage of localizing protein delivery in the body. This is accomplished by using adenovector platform to locally deliver genes to cells, which then direct production of the desired protein. This approach reduces side effects typically associated with systemic delivery of proteins. For vaccines, the goal is to induce an immune response against a target protein or antigen. This is accomplished by using an adenovector to deliver a gene that causes production of an antigen, which then stimulates the desired immune reaction by the body.

GenVec’s novel proprietary adenovectors
No pre existing immune recognition
Built on rare human and nonhuman adenovirus serotypes
New GC technology shows superior performance for genetic vaccines
Multiple capsid modified vectors -AdH technology
Multiple genes/multiple antigens
Targeted and specific delivery Proprietary adenovectors and cell lines
Novel proprietary non replicating adenovirus vectors
Very low sero -prevalence in humans
Outstanding gene/antigen delivery properties
Cell line master banks and master file with FDA

Hearing Restoration Molecular Therapeutic
Dengue Virus Genetic Vaccine
Foot and Mouth Virus Genetic Vaccine
Malaria Genetic Vaccine
RSV Genetic Vaccine
HSV Molecular Therapeutic and Genetic Vaccine

A platform of adenovirus vectors built to meet product needs for molecular therapeutics and genetic vaccines


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Monday, May 6, 2013

Titan Pharmaceuticals, TTNP, Profile

Titan Pharmaceuticals, TTNP, Profile


Titan Pharmaceuticals, TTNP, is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of serious medical disorders.
Titan’s principal asset is Probuphine®, the first slow-release implant formulation of buprenorphine hydrochloride (“buprenorphine”), designed to maintain a stable, round-the-clock blood level of the medicine in patients for up to six months following a single treatment. The outpatient treatment of opioid dependence with daily dosed sublingual buprenorphine formulations represents a $1.3 billion market in the U.S., and a seven day transdermal patch formulation of buprenorphine for the treatment of chronic pain was launched in the U.S. in 2011. This novel implant formulation is inserted subdermally in a patient’s upper arm providing continuous medication, and has the potential to enhance patient compliance to treatment, and limit diversion for illicit use and accidental exposure to the sublingual formulations.
The New Drug Application (NDA) was submitted to the FDA in October, 2012 seeking approval for treatment of opioid dependence. In December 2012, Titan entered into a license agreement with Braeburn Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive commercialization rights to Probuphine® in the United States and Canada. Titan received a non-refundable up-front license fee of $15.75 million and will receive a $50 million milestone payment upon the approval of the NDA by the FDA. Additionally, Titan will be eligible to receive up to $130 million upon achievement of specified sales milestones and up to $35 million in regulatory milestones in the event of future NDA submissions and approvals for additional indications, including chronic pain. Titan will receive tiered royalties on net sales of Probuphine ranging from the mid-teens to the low twenties.
Probuphine is the first product to utilize ProNeura™, a novel, proprietary, long-term drug delivery technology. The ProNeura technology has the potential to be used in developing products for the treatment of other chronic conditions, such as Parkinson’s disease, where maintaining stable, round-the-clock blood levels of a drug can benefit the patient and improve medical outcomes.
Finally, Titan is also entitled to royalty revenue of 8-10% of net sales of Fanapt® (iloperidone), an atypical antipsychotic compound being marketed in the U.S. for the treatment of schizophrenia by Novartis Pharma AG (“Novartis”) under a sub-license agreement based on a licensed U.S. patent that expires in October 2016 (does not include a possible six month pediatric extension). Substantially all of this future royalty revenue has been sold to Deerfield Management (“Deerfield”), a healthcare investment fund, in exchange for cash and debt considerations which have been used to advance the development of Probuphine and for general corporate purposes.

Sunday, September 2, 2012

Hemispherx Biopharma, HEB, Profile, Summary

Hemispherx Biopharma | HEB | Profile | Summary
Hemispherx Biopharma (HEB) is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental immunotherapeutics/antivirals Ampligen®.
Hemispherx’s platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in New Brunswick, New Jersey.

ALFERON
Alferon N Injection® is the company's registered trademark for its injectable formulation of Natural Alpha Interferon, and is approved by the FDA for a category of STD infection.  Alferon N Injection® (interferon alfa-n3 human leukocyte derived) is a highly purified, natural source, glycosylated, multispecies alpha interferon product, composed of eight forms of high-purified alpha interferon.
Alferon LDO® (Low Dose Oral) is a new experimental drug delivery platform for the Company’s highly purified, natural source alpha interferon.
ALFERON N Injection® is the only highly purified, natural-source, multispecies alpha interferon product currently sold in the U.S. and is also approved for sale in Argentina.
Clinically Effective:
All warts disappeared in 54% of patients.3
No recurrence in 76% of complete responders at follow-up.3
Completely cleared 73% of all treated warts.3,4
No human antibodies to interferon alfa-n3 detected in clinical trails.3,4
Provides a spectrum of multiple alpha interferon subtypes.1,

What's in the Pipeline?
Ampligen® (poly I:poly C12U) is a synthetic specifically configured double-stranded RNA containing regularly occurring regions of mismatching.  Ampligen® and Oragens® experimental nucleic acids are being developed for the potential treatment of globally important viral diseases and disorders of the immune system including HPV, HIV, Chronic Fatigue Syndrome (CFS), Hepatitis and influenza.

Watch This!
On July 31, 2012 Hemispherx submitted its complete response to the FDA’s Complete Response Letter in support of Ampligen®’s New Drug Application for Chronic Fatigue Syndrome (“CFS”).
Its too early to tell what the FDA's response would be, however, the response from investors has been very positive. We alerted our members and followers last week and we believe this company should be on your radar!
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we received or expecting compensation from the featured company. Our firm, principals and staff may own/buy/sell/trade stock/securities of this company. Always Read the full Disclosure/Disclaimer. Thanks.

Monday, June 20, 2011

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FSIN - Fushi Copperweld manufactures and markets copper-clad aluminum (CCA) and copper-clad steel (CCS). Its CCA and CCS conductors are used as a substitute for solid copper conductors in applications where specific electrical or physical attributes are necessary. The company markets its products under Copperweld and Fushi brand names to telecommunication, electrical utility, and transportation markets. Looking for a big bounce back, keep an eye!
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