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ACCP Satz 15-01

 
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ValuEngine Industry Report for Medical-drugs

 
28.01.14 09:16
Number of Tickers: 209
Date: 27-Jan-14
Contributor:§ValuEngine, Inc.
    Title:§ValuEngine Industry Report for Medical-drugs
Document Size: 18 pages
Price: $49
Document Type: Adobe Acrobat Reader®
Download free Adobe Acrobat Reader®
reports.finance.yahoo.com/w0?r=50217055:1
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Access Pharmaceuticals is an emerging

 
28.01.14 09:17
biopharmaceutical company specializing in products for cancer and supportive care. Access currently has one product that has been approved for marketing in China and S. Korea, and with marketing clearance in Europe and the U.S. The company also has three products in preclinical development. The company's products are based on Access' proprietary nanopolymer technologies which provide enhanced drug delivery options for both new and approved pharmaceutical active ingredients.www.accesspharma.com/
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Access' primary focus is in oncology and cancer

 
28.01.14 09:18
supportive care. Mucositis is a frequent side-effect of cancer therapy for which there is no established treatment. MuGard® is Access' proprietary nanopolymer formulation for the management of mucositis. This ready-to-use rinse provides a soothing oral coating.www.accesspharma.com/
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Access recently announced a license agreement with

 
28.01.14 09:20
AMAG Pharmaceuticals, Inc. related to the commercialization of MuGard® in the US and its territories. For more information on MuGard®, US visitors to this website should select the MuGard.com button, below. Non-US visitors should select the right-hand button:
MuGard.com§
MuGard.com
For US residents
For non US-residents
Access is focusing its development effort on its Cobalamin™ technology. Cobalamin™ is Access' proprietary nanopolymer oral drug delivery technology. Using a 'Trojan Horse' approach, the technology uses the body's natural vitamin B12 uptake mechanism in the gut to transport drugs that otherwise would have little or no oral bioavailability. The company is currently developing products for the oral delivery of insulin and human growth hormone (HGH), and is collaborating with a number of companies to develop additional formulations of various other pharmaceutically-active compounds. Cells involved in certain diseases such as cancer often have an increased demand for vitamin B12 which results in a large increase in receptors for vitamin B12 on their surface. Another aspect of the Cobalamin™ technology therefore focuses on increasing the amount of drugs reaching sites of disease by making use of this higher receptor density. Application of the Cobalamin™ technology to enhance oral drug delivery has been named CobOral®, while application of the technology to target disease sites has been named CobaCyte®.www.accesspharma.com/
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Investor Relations

 
28.01.14 09:22
Corporate Governance
Audit Committee Charter
Code of Ethics
Nominating and Corporate Governance Committee Charter
Compensation Committee Charter
Corporate Governance Committee Charter
Whistleblower Policy
Downloads
2013 Proxy Statement
2013 Annual Report
ACCP Corporate Presentation
Cobalaminâ„¢ Fact Sheet
www.accesspharma.com/investor-relations/
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SEC Filings

 
28.01.14 09:23
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Stock Quote

 
28.01.14 09:24
ACCPLast Trade0.38Change-0.0001 Open0.39BidN/AAskN/AVolume11503
www.accesspharma.com/investor-relations/sec-filings/
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Access Pharmaceuticals, Inc. is an emerging

 
28.01.14 09:25
biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients.www.accesspharma.com/newsroom/
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Latest News & Events

 
28.01.14 09:27
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schreib mal

 
28.01.14 09:29
2600 Stemmons Freeway,
Suite 176
Dallas, TX 75207-2107
Tel: (214) 905-5100
info@accesspharma.com
@Kosmonova buran,ISS Orbit
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Access Pharmaceuticals Announces Publication

 
16.03.14 19:50
Of MuGard Clinical Data In Cancer Journal14:36 18.02.14


PR Newswire

NEW YORK, Feb. 18, 2014

NEW YORK, Feb. 18, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced the online early publication of the final results of its post-approval marketing study of MuGard® in Cancer, the journal of the American Cancer Society and one of the oldest peer-reviewed journals in oncology. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.  The publication discusses data on Access' post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck.

MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression. In the trial, MuGard met the primary endpoint, achieving a statistically significant reduction in mouth and throat soreness associated with oral mucositis. MuGard also achieved significance in a secondary endpoint, the measure of mucositis severity at the end of radiation treatment using a physician-based assessment of severity (WHO score). Additional secondary endpoints where MuGard demonstrated superiority were reduced opioid use and weight loss.

"Oral mucositis is one of the most challenging adverse side-effects we face when treating our cancer patients," stated Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in the MuGard trial, continued "From a patient quality-of-life perspective, the reduction in mouth-and-throat soreness and reduced dependence upon opioids are extremely important. Patients using MuGard showed better weight maintenance, indicative of a superior nutritional status during the intensive cancer treatment regimen. As a physician, I was particularly impressed by the fact that the reduction of oral mucositis severity and mouth-and-throat soreness in the MuGard group was statistically significant."

"Oral mucositis continues to be a significant unmet medical need with horrific symptomatic consequences. This multi-institutional study provides strong evidence of MuGard's effectiveness in reducing pain associated with radiation-induced injury," stated Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "Access' commitment to demonstrate MuGard's benefit through a rigorous clinical trial process separates MuGard from currently available rinses and sets a new standard for evidence-based use of agents in this class."

No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.

"Access is extremely pleased with the outcome and publication of this clinical study of MuGard, and thank the many participating clinicians, sites and authors for the participation in this important trial," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Raising the level of visibility for MuGard should expand its usage, and availability, both domestically and abroad.  Access is actively seeking additional marketing agreements in Europe, the Far East and in other un-licensed territories and will keep all stakeholders apprised as to developments in this area."

About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.

About MuGard:  MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.

About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyteâ„¢-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

Company and Media Contact:

Scott Nogi

Vice President

Access Pharmaceuticals, Inc.

(212) 786-6203

SOURCE Access Pharmaceuticals, Inc.


Quelle: PR Newswire

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Access Pharmaceuticals Announces MuGard License

 
16.03.14 19:52
Agreement With Hanmi Pharmaceutical In Korea13:55 11.03.14


PR Newswire

NEW YORK, March 11, 2014

NEW YORK, March 11, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) today announced that it had entered into an exclusive license agreement with HANMI PHARMACEUTICAL CO., LTD. (KSE: 128940) related to MuGard commercialization in South Korea.  Under the terms of the license agreement, Access will receive an upfront licensing fee and double digit royalties on net sales of MuGard in the licensed territory. MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients in the US alone developing the condition each year.

"Access is pleased to announce this partnership with Hanmi Pharmaceuticals, a leader in Korea, as we believe that international expansion and licensing is critical to the commercial success of MuGard," said Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Hanmi's international presence, resources and strategic emphasis on expansion makes them an ideal partner for MuGard. With the recent publication of MuGard clinical data, completion of this third marketing partnership, and active discussions with additional partnerships abroad, Access is laying the foundation for MuGard growth globally."

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PR Newswire

 
28.04.14 22:46
Access Pharmaceuticals Advances Development of ProctiGardâ„¢ for Radiation Proctitis
13:35 21.03.14

PR Newswire

NEW YORK, March 21, 2014

NEW YORK, March 21, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced that it has advanced development of a new proprietary product, called ProctiGardâ„¢, for the treatment of radiation proctitis. Radiation proctitis ("RP") is a significant unmet medical need, with no well-established standard of care. It is estimated that there are in excess of 250,000 new cases of prostate, cervical, rectal, testicular, bladder and endometrial cancer diagnosed each year. Approximately 50% of these patients require radiation therapy, and roughly 75% of patients undergoing pelvic irradiation experience radiation proctitis. Access is actively seeking marketing partners globally for ProctiGardâ„¢.

"Access is actively developing follow-on products to MuGard® that leverage our powerful mucoadhesive polymer hydrogel drug delivery technology, and ProctiGardâ„¢ is the first example of this development effort," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Radiation proctitis is a condition somewhat analogous to oral mucositis, concerning the damage and ulceration of the mucosal tissue of the digestive tract.  The development of ProctiGardâ„¢ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for this debilitating oncology side effect."

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28.04.14 22:47
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NEW YORK

 
28.04.14 22:48
Access Pharmaceuticals Provides Strategic Update On Mucoadhesive Polymer Hydrogel Technology
14:20 01.04.14

PR Newswire

NEW YORK, April 1, 2014

NEW YORK, April 1, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided investors with a strategic update on its programs and plans for its proprietary mucoadhesive hydrogel platform technology. Access' patented technology surrounds a unique aqueous pseudoplastic liquid with a defined viscosity range, which is beneficial to the treatment of disorders of mucosal tissue, and includes the ability to act as a delivery system for a variety of active agents, including drugs.

The mucoadhesive hydrogel technology is the basis for its product MuGard® which is indicated for conditions of the oral mucosa, including oral mucositis, and Access Pharmaceuticals is expanding its potential application in other mucosal tissues including the esophagus, the lower intestinal tract and the vagina. The Company is exploring formulations with active agents that may include anesthetics, such as benzocaine, anti-fungal agents, anti-inflammatory drugs and medical foods and supplements. Combinations of Access' technology and active agents could take advantage of expedited regulatory pathways, such as the 505(b)(2) and 510(k) pathways, and offer extended patent protection for generic agents or those soon to lose patent protection.

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Access Pharmaceuticals Provides Update

 
28.04.14 22:49
On Development Of LexaGard, A Proprietary Formulation Of Amlexanox
14:35 08.04.14

PR Newswire

NEW YORK, April 8, 2014

NEW YORK, April 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGardâ„¢, for the treatment of inflammatory and ulcerative conditions of the esophagus. Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been approved and used in the US, Japan and other countries, in numerous formulations, for the treatment of a variety of conditions including recurrent aphthous ulceration (RAU), bronchial asthma and allergic rhinitis. Amlexanox is known to inhibit formation and release of histamine, TNF-alpha and leukotriene from mast cells, basophils and neutrophils, and has strong anti-inflammatory effects in mucosal tissue with few adverse effects. By formulating amlexanox in its proprietary mucoadhesive polymer hydrogel delivery system, Access has a patented and protectable formulation of this interesting pharmaceutical active.

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Positive Results

 
28.04.14 22:51
Of MuGard Study In Erosive Oral Lichen Planus Presented At International Oral Medicine Meeting
14:35 15.04.14

PR Newswire

NEW YORK, April 15, 2014

NEW YORK, April 15, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biotechnology company, announced today that positive results from a study conducted at Nova Southeastern University were presented recently at the Frontiers in Oral Medicine 2014 conference, hosted by the American Academy of Oral Medicine, in Orlando, Florida. The poster, entitled "Effectiveness of a Polymer-Based Muco-Adhesive (MuGard®) in the Healing of Oral Ulcers in Erosive Lichen Planus: A Pilot Study" reflected results of a randomized, doubled-blinded study (1:1 randomization into MuGard® or bicarbonate rinse arm) of 20 patients with biopsy proven oral lichen planus. Patients in the MuGard® arm had statistically significant improvement in ulcerations and pain, and the changes in pain were closely related to the health of the ulcers. There was no statistically significant change in erythema.

"Oral lichen planus is a significant unmet medical need, that presents similarly to oral mucositis, with inflammation, erosive ulceration and significant pain," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The results of this study, like others previously announced by Access, add to the growing body of clinical evidence of the significant benefits offered by MuGard®to patients suffering with a variety of conditions of the oral cavity."

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22.07.14 12:30
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DALLAS and NEW YORK, July

 
22.07.14 12:31
Access Pharmaceuticals Awarded Hong Kong Patent For MuGard
17:00 08.07.14

PR Newswire

DALLAS and NEW YORK, July 8, 2014

DALLAS and NEW YORK, July 8, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, has received notification from the Hong Kong Patent Office that a patent for MuGardâ„¢ has been granted.  The patent (HK1126134) protects a wide range of liquid formulations for the prevention and treatment of mucosal diseases and disorders.  

"Being awarded the Hong Kong patent further expands and further strengthens our global MuGard patent portfolio position," commented Jeffrey Davis, President and CEO of Access. "We are actively seeking additional marketing partners worldwide and bolstering MuGard patent protection in areas like Hong Kong is in line with this licensing strategy."

MuGard provides the oral mucosa with a thin protective hydrogel layer which has been demonstrated in several clinical studies of mucositis to benefit patients in terms of reduced pain and discomfort as well as a reduction in objective mucositis scores.

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14:35 22.07.14 news

 
22.07.14 15:40
Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGardâ„¢
14:35 22.07.14

PR Newswire

DALLAS and NEW YORK, July 22, 2014

DALLAS and NEW YORK, July 22, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a developer of new products for oncology supportive care, announced today that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for ProctiGardâ„¢, its novel treatment for symptomatic management of rectal mucositis. The Company indicated its development of ProctiGardâ„¢ is a direct response to dialogue with the oncology community that is looking for better, more effective treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class treatment option that addresses a significant unmet medical need. Access currently holds global commercialization rights for ProctiGard.

"This second FDA marketing clearance is an important milestone for Access following the decision to focus on the development and commercialization of a portfolio of follow-on proprietary products," said Jeffrey Davis, CEO of Access Pharmaceuticals. He continued, "Rectal mucositis and radiation proctitis, presenting as inflammation and damage to the lower part of colon, is a common adverse event of the radiotherapy of tumors in the abdominal and pelvic region with no well-established effective standard of care.  With the introduction of ProctiGardâ„¢, we look forward to providing cancer patients with an important treatment that manages this debilitating disease."

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