Access Pharma: ProLindac, MuGard Updates

On 9/10/09, Access Pharma (ACCP.OB) announced that its clinical development team recently met with its partners Aosaikang Medicinal Group (ASK) in China and JCOM, Ltd. (JCOM) in Korea, along with key opinion leaders in oncology indications to discuss the protocols for the three planned ProLindac combination studies. Access and its partners are finalizing development plans and protocols for clinical trials strategically designed to examine ProLindac in combination with gemcitabine and/or taxol in hepatocellular carcinoma (a form of liver cancer), pancreatic cancer, and recurarent ovarian cancer.

Below is a summary from an update article posted in late August at BioMedReports.com based on information provided by the President and CEO of Access Pharma, Jeffrey B. Davis.

Access is working with the leading cancer doctors in China and Korea, together with the clinical teams at ACCP, ASK and JCOM, to put together protocols and plans for up to three combination trials for ProLindac in combination with gemcitabine in hepatocellular carcinoma and pancreatic cancer, and in combination with gemcitabine/Taxol in recurrent ovarian cancer (and be able to get first or second relapse patients in recurrent ovarian, in contrast to the very heavily pre-treated population which was part of our mono-therapy trial).

Access will be working closely with the KOL and with in-country regulators, with the goal of enrolling the first patients by year-end, depending upon regulatory approvals of the trial protocols and certain other matters. The company’s director of clinical development, Esteban Cvitkovic, is excited about these new indications, and believes that they represent a much quicker registration pathway to approval in Europe, and possibly the U.S., than going after colorectal cancer.

On 9/11/09, Access announced that it entered an agreement with a leading commercial manufacturer which specializes in liquid formulations to produce MuGard for distribution in North American markets. Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world’s largest pharmaceutical and consumer products companies.

Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed, and the company hopes to finalize these protocols and begin one or more market seeding studies during 4Q09. Below are additional development milestones and catalysts expected before year-end for Access:

1. Final results (all 280 patients over the entire seven-week duration) for SpePharm's UK post-approval marketing study of MuGard with interim results demonstrating no cases of oral mucositis in 140 patients with head and neck cancer being treated with radiation therapy. Also, a continuous flow of clinical data (including journal publications and presentations at medical/scientific conferences) for MuGard expected throughout 2H09 as SpePharm is also conducting post-approval marketing studies in Germany and Italy. Access also expects to initiate similar marketing assessment studies within three months (mid-November) in North America as well.
2. Listing on either the AMEX or NASDAQ exchanges
3. MuGard commercial launch in Asia
4. North American Commercialization Strategy for MuGard: The company's strategy is to initiate GMP manufacturing of MuGard; continue to put the reimbursement strategy in place (get codes, etc.); and then go back to about 5-6 leading OM doctors to conduct US-based post-approval marketing studies. Access will proceed "as-if" preparing for a commercial launch alone while taking a position with potential new North America partners that they can do a new license deal (with better economics for Access, but give them control to do it all themselves), or a "co-promote" deal where Access retains the rights to co-promote MuGard in North America.
5. Licensing discussions for the company's cobalamin-based nanopolymer drug delivery technology for the oral administration of a basal (long-acting) insulin product following mid-June announcement that two bio-pharmaceutical companies will conduct preclinical, animal studies before proceeding to more formal negotiations. The results of these preclinical studies will be made public, including one North American biotech company and one European biotech company. Access is providing the oral insulin while the two interested companies will conduct one animal study each (including a rat and dog model) with data expected before year-end. Ongoing discussions with these companies may result in the evaluation of other drugs utilizing this delivery platform, including human growth hormone (hGH) and erythropoietin (EPO).

Please visit the stock research section of BioMedReports.com to view or download my latest 19-page PDF research report for Access Pharma published on 8/14/09, which includes an earnings model for MuGard through 2012 and key upcoming catalysts for the company that are expected to unlock substantial shareholder value. The stock research section also includes an updated report for Access written by Griffin Securities with a buy rating and $11 price target in addition to the most recent corporate presentation for the company.

Check out Access Pharma's Newsroom site for a compilation of links, videos, presentations, articles, and social media sites for the company and its executive leadership team. OneMedPlace also features a corporate profile page for Access Pharma, including a video interview conducted in mid-August with Mr. Davis regarding the clinical success of MuGard and the latest news surrounding its commercial launch. Access will be presenting at the Rodman & Renshaw 11th Annual Healthcare Conference in NY City at 10:45 am on Friday, September 11th. This year, a first, they will webcast video (rather than just audio with the slides) and Access will participate with that as well.

Disclosure: Long ACCP.OB.

Comments

[Mike Havrilla:]

hoopgooberz, you would have done much better to buy Access when I started covering the company and bought it in May around $1.50. There is still time to buy now with many catalysts before year-end, but you obviously have a personal vendetta against the company, me or both . . . of course I am sure that you only have the investing public's best interest fueling your anonymous stalking/posting. Maybe this will help you understand how BioMedReports earns subscriber revenue (although I doubt you will accept this) and we are not paid by the companies we cover.
biomedreports.com/comp...




On Sep 13 08:57 AM [e-mail] wrote:

> How much does Access pay you for these articles? This is an awful
> company but maybe if you put out 1,000 pieces on it you can get it
> up to $10.
>
> Recurrent isn't spelled recurarent.

Sep 13 09:22 AM

[Mike Havrilla:]

If you are for real, why weren't you at the Rodman conference asking tough questions after the presentation this past Friday -- or is your due diligence limited to looking for typos in my articles? I am open to hearing the bearish case for any of my long positions and actively seek this out as part of my research in addition to contacting my network of doctors, pharmacists, etc. in the clnical oncology space, the management teams of the company and related companies, and others in the financial/fund management space to get a full spectrum of views.


On Sep 13 08:57 AM [e-mail] wrote:

> How much does Access pay you for these articles? This is an awful
> company but maybe if you put out 1,000 pieces on it you can get it
> up to $10.
>
> Recurrent isn't spelled recurarent.

Sep 13 09:56 AM

[Docs:]

Mike, you really don't have to reply to such posts, when their posts find spelling mistakes. You are a good analyst and your followers know that. I have been following you for long time and recovered about 30-40 % of my portfolio that I lost last year following your tips. For example, CTIC, HEB, ADLS, VION and NEPH. These were my best picks this year.

Sep 13 11:32 AM

[BambamPoop:]

Mike,

I can see how hoopdreamer feels this way.
You have to admit that it looks fishy when a stock rises 54% on no news immediately before you publish an article. Look at IMGG on Friday Sept. 11. Your article for subscribers, and the other one for the general public hit the Biomedreports today, just before the next trading day. While I appreciate your services, especially the calendar, and I am a subscriber, Sometimes I have to do a doubletake at the "coincidence" of events.

Bam

Sep 13 10:42 PM

[Mike Havrilla:]

Bam, The FDA Calendar is my idea and reason for launching BioMedReports.com as a co-founder. I am responsible for maintaining this database and try to cover as many stocks as possible with pending FDA decisions or clinical trial results. You can visit my personal blog at MikeHavRx.com for my stock coverage universe, which does not include stocks like IMGG that make huge moves without news. I have several opportunities pending from connections made by writing the past three years as a way to gain exposure and the subscription model at BioMedReports is going well enough to allow me to be a full-time entrepreneur. I am not sure what path I will take, but I can assure you that I have plans to move beyond the publishing business in the near-term (with no ownership stake in BioMedReports or any other site) and my business model does not include front-running stocks like IMGG.


On Sep 13 10:42 PM BambamPoop wrote:

> Mike,
>
> I can see how hoopdreamer feels this way.
> You have to admit that it looks fishy when a stock rises 54% on no
> news immediately before you publish an article. Look at IMGG on Friday
> Sept. 11. Your article for subscribers, and the other one for the
> general public hit the Biomedreports today, just before the next
> trading day. While I appreciate your services, especially the calendar,
> and I am a subscriber, Sometimes I have to do a doubletake at the
> "coincidence" of events.
>
> Bam

Sep 14 09:09 AM

[BambamPoop:]

I can appreciate that. I have been to mikehavrx.com and checked it out. I already knew you had no position in IMGG from your disclosure at the end of the article. Still, you have to admit that on the face of it, it appears that someone planned to benefit from the IMGG article's publication. I advise my friends to be very wary of the articles at BMR, and only trust the FDA Calendar for investing purposes. The rest of it seems like simple pumping. I hope that the Calendar will be kept up-to-date by someone else if you depart.

Bam

Sep 14 11:11 AM

[Mike Havrilla:]

Bam, I will still maintain the FDA Calendar since this is a useful resource to me as well and a royalty-based agreement is possible for providing this function to the site. I understand your viewpoint on the other stuff at the site and will leave it to the respective authors to respond since I cannot speak for them. My future articles may still be published at BioMedReports, but I will have no ownership stake or editorial function at the site. I will be solely responsible only for the content at my personal blog site in addtion to maintaining the FDA Calendar as an objective data source of upcoming FDA decisions and clinical trials. Mike


On Sep 14 11:11 AM BambamPoop wrote:

> I can appreciate that. I have been to mikehavrx.com and checked it
> out. I already knew you had no position in IMGG from your disclosure
> at the end of the article. Still, you have to admit that on the face
> of it, it appears that someone planned to benefit from the IMGG article's
> publication. I advise my friends to be very wary of the articles
> at BMR, and only trust the FDA Calendar for investing purposes. The
> rest of it seems like simple pumping. I hope that the Calendar will
> be kept up-to-date by someone else if you depart.
>
> Bam

Sep 14 11:29 AM

[BambamPoop:]

That works for me, Good luck. and we will see you at MikeHavRX.com

Sep 15 12:57 AM