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Many investors have raised concerns with regards to Access Pharmaceuticals (OTCQB:ACCP) being on the OTC. Indeed more than half the time companies which are not listed on a major exchange tend to lie, cheat and do just about anything possible in order to stimulate investor demand. They will reach out to stock promoters, make deals with various PR companies and even go as far as releasing their own false press releases — usually involving buyouts.

Folks, you need not worry, Access Pharma takes part in none of these illegal activities in order to induce demand, rather fhe company focuses on a solid and sound business strategy which will slowly take it into the promised land. Patience is a virtue.

MuGard is an interesting product with a lot of potential, and we truly believe that it is only a matter of time before this drug gains worldwide success from the ongoing marketing campaigns.

Oral Mucosis
Oral mucositis is a frequent complication of cancer chemotherapy or radiation therapy to the head and neck region. Currently available therapy is usually inadequate, and a more effective treatment to minimize the extent and duration of mucositis is clearly needed.

  • Mucositis can affect most patients receiving cancer therapy.
  • Addressable market estimated at over $1 billion.
  • MuGard is polymer solution which provides coating for oral cavity.
  • Dispensed as a ready-to-use viscous liquid.
  • Potential expansion to other markets, such as dental market, oral surgery, etc.

Clinical Study

The clinical study was conducted at 11 centers.

Patients rinsed up to 6 times a day with MuGardTM during a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks.

Patient mucositis was evaluated 3 times a week according to the Oral Mucositis Assessment Scale (OMAS), a validated assessment scale

MuGardTM data were compared with data from two similar sets of patients receiving standard care. Statistical analysis comparing the mean maximum OMAS score of the MuGardTM group to each of the untreated groups was performed using two-sided tests at the 0.05 level of significance.

42% of patients in the MuGardTM Rinse group did not develop significant mucositis during the 6-7 week radiation treatment cycle compared with only 9% in the historical control group.

Summary

  • MuGard has a US 510(k) FDA marketing allowance and European CE Mark approval.
  • Access has recently announced agreements with SpePharm for the EU, Milestone for the US, JCOM in Korea, and RHEI for China and other Southeast Asian countries.
  • “Prevention” positioning yields significant sales potential and lessens the number of competitive products.
  • In patients receiving radiation therapy for head and neck cancer, 42% of patients using MuGard Rinse group did not develop significant mucositis compared with only 9% in a historical control group.
  • Simple ready to use formulation is major competitive advantage.

MuGard Entering Europe (Extensive Market)

Access Pharmaceuticals announced that its European partner, SpePharm has commenced commercial launch of MuGard in Greece. This follows previous commercial launches in Germany, Italy and the UK. Under a license from Access Pharmaceuticals, SpePharm is responsible for manufacturing, regulatory approval and commercialization in the 27 countries of Europe. SpePharm plans to launch MuGard in the rest of Europe over the coming 12 to 18 months. The license agreement includes royalties on net sales to Access.

Additionally, the Company announced that two MuGardTM patents have been issued from the United States Patent and Trademark Office, as US Patent numbers 7,544,348 and 7,547,433. The second patent includes claims on formulations with actives against mucocutaneous disorders, which provides protection of product line extensions.

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.

MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

Bonus Conference Call Audio with CEO, Jeff B. Davis

Please visit this link. You will be taken to the original source of the mp3 file where your automatic preset media player should make the file play.

In conclusion, some persistence will go a long with with this small yet flourishing company. Yes, indeed, patience is a virtue which is all too often forgotten.

Source: Why Access Pharmaceutical's MuGard Will Be Successful