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[mahmissa]

Just added this to my watch list.

Stock Ticker: ACCP - Access Pharmaceuticals, Inc. - Google Finance
Website: Access Pharmaceuticals, Inc.
Board of Directors: Access Pharmaceuticals, Inc.

ACCP: A Cancer Biotech Option Trade
Written by Mike Havrilla
BioMedReports.com
Wednesday, 27 May 2009 06:35

Access Pharma (OTC: ACCP.OB) is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to an FDA approved treatment for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining). Up to 40% of all patients receiving chemotherapy and/or radiation therapy 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.

Valued at roughly $30M on a fully diluted basis, ACCP has multiple shots at goal in its clinical pipeline in addition to a reduced risk profile because the compounds in development are improved versions of existing drugs with established mechanisms of action. With a stock price that has hovered in the $1.30-$1.50 range over the past several weeks, ACCP represents a call option trade despite having a FDA approved treatment for mucositis and a deep pipeline (relative to its small market cap) of promising compounds focused on the treatment of cancer.

MuGard is the Company's FDA-approved product which functions like a liquid Band-Aid to protect the lining of the oral cavity in cancer patients who develop mucositis as a side effect of radiation or chemotherapy. By 3Q09, the product will be launched in all major global markets with estimated peak sales of $350M and a scaled royalty rate of 20-25% (which translates into royalties of $70M for ACCP based on marketing partner peak sales estimates, which is over 2X the current market cap). Access has already announced marketing agreements with SpePharm for the EU, Milestone for the U.S., JCOM in Korea, and RHEI for China and other Southeast Asian countries.

On 5/27/09, ACCP announced that MuGard(TM), its proprietary oral mucositis product has been launched in Germany, Italy, UK, Greece, and the Nordic countries by its European commercial partner, SpePharm, a pan-European specialty pharmaceutical company dedicated to the provision of high medical value medicines in supportive and critical care. The Company has previously announced commercialization agreements in North America, China and eight Southeast Asian countries and Korea, and is actively seeking additional marketing partners in other regions; MuGard expects commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement gets established regionally.

MuGard is a polymer solution which provides a protective coating for the oral cavity when swirled gently around the mouth that could be expanded into related markets, including dental applications, oral surgery, and other related medical interventions requiring protection of the oral mucosa. The product is formulated as a ready-to-use viscous liquid which is easy to use and carries the added benefit of preventing the incidence of mucositis. In patients receiving radiation therapy for head and neck cancer, 42% of patients using MuGard Rinse did not develop significant mucositis, as compared to just 9% in a historical control group.

A very promising, next-generation platinum anti-cancer compound in the Company's pipeline is known as ProLindac, which includes a proprietary nano-polymer delivery vehicle that allows for over 10X the dose of platinum to be delivered to cancer cells with a much better safety profile compared to standard platinum-based drugs which cause significant and cumulative neurotoxicity. The unique nano-polymer delivery system selectively releases the platinum in a targeted manner to cancer cells, which reside at a low pH (acidic).

ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5B in 2008 for Sanofi-Aventis (NYSE:SNY). In addition to having more side effects than ProLindac, Eloxatin is available on an off-patent basis in Europe. ACCP also employs Esteban Cvitkovic as their director of oncology R&D - who has over 30 years of experience in this area and played a key role at SNY in the development and approval of Eloxatin.

Preliminary data from a Phase 2 clinical trial in patients with relapsed ovarian cancer demonstrated that over 12X the dose of ProLindac was delivered compared to Eloxatin and the final data from this trial is still pending. Despite the much larger platinum dose delivered by ProLindac, the drug demonstrated an excellent safety profile in the trial among patients receiving nine or more cycles of therapy.


Thiarabine is the Company's next-generation nucleoside analogue (e.g. fludarabine, cladrabine) designed for the treatment of blood-based cancers such as lymphoma and leukemia. Once again, ACCP is working with the leader in this field - in this case, Dr. Hagop Kantarjian, who is Head of the Leukemia Department at the M.D. Anderson Cancer Center in Houston (which is the primary treatment centre in the U.S. for leukaemia and lymphoma). The Company is currently finalizing clinical trial protocols based on previously gathered data to evaluate the drug in a variety of leukaemia and lymphoma subtypes.

ACCP also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's Avastin. Angiolix targets a specific portion of a protein called lactadherin that is only expressed on solid tumors. Angiolix has a dual mechanism of action, which includes (1) inhibiting angiogenesis (blood vessel proliferation which feeds tumor growth) via the lactadherin target and (2) inducing a process known as apoptosis or programmed cell death in cancer cells which are dividing and growing in an unregulated manner. Unlike Avastin, Angiolix has an anti-proliferative effect on cancer cells when used by itself in addition to when it is used in combination with other chemo drugs.

The Company also offers a nano-polymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO). This novel delivery mechanism utilizes the body's vitamin B12 absorption system in a Trojan Horse manner with the potential to eliminate the need for injections. This drug delivery technology involves coating a nano-particle with a B12 analog (cobalamin) that binds to intrinsic factor in the gut and triggers binding to cellular receptors which absorb the entire package and its contents of large molecule drugs not normally available by oral administration (e.g. insulin, hGH, EPO). This process increases the cellular uptake in the gut of such large molecule drugs by a factor of 1,000X to 1,000,000X.

Given a very low cash burn rate of about $4M per year, a diverse/late-stage pipeline, extensive partnership agreement, and the pending global commercialization of MuGard by 3Q09 with a 20-25% royalty rate on worldwide sales, the current market valuation of around $30M does not appear to fully account for both the breadth and depth of the pipeline in addition to the large commercial markets the compounds are designed to serve. If MuGard reaches just $20M in global sales at a 20% royalty rate, this alone would cover the current low rate of cash burn itself.

[GypsyDRB]

I've had this on a TDA watchlist ever since the Havrilla article got posted and it was @ 1.50, but never pulled the trigger (was waiting to move some post HEB approval funds into it).

I still like and will eventually buy in if the pps stays below $2.75. Any thoughts as to when you think this is "expensive"?

[mahmissa]

I think this could be a good long term trade. I am looking for a pullback below 2 if possible, to buy more, given that it's up about 80% since I originally posted this.

[garyd]

Personally I would like to see more volume in this one; It makes me antzy when the chart flat lines for over an hour.

[SK_]

From Mike Havrilla (love this guy! Writes for SeekingAlpha as well) at BioMedReports:

Since I last wrote about Access Pharma (OTC:ACCP) two weeks ago as a cancer biotech call option trade, the Company has issued two updates on its clinical development pipeline and two updates for MuGard - which is an oral rinse product for the management of a common side effect of many cancer therapies, mucositis. In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece, and the Nordic countries by its European commercial partner, SpePharm, with expected launches in North America, Asia, and other regions slated for later this year. On 6/10/09, ACCP.OB also announced that the Company received issue notifications from the United States Patent and Trademark Office for two US patents (numbers 7,544,348 and 7,547,433).

A video presentation is available at ProActiveNewsRoom.com for MuGard, in addition to more information and links at the landing page for Access Pharma at the Pro-Active Global Media website. Please visit the research section of BioMedReports.com to view or download the PDF stock research report for ACCP written by Griffin Securities, in addition to the Company's corporate presentation. Access Pharma also has a social media presence on Facebook and Twitter for investors and other interested parties to stay informed on the latest developments for the Company.

On 6/4/09, ACCP announced that new thiarabine preclinical data will be published shortly in the journal "Cancer Chemotherapy and Pharmacology" which demonstrates that thiarabine combined with clofarabine provides much greater anti-tumor activity than achieved by either agent used alone (e.g. in one colorectal cancer model, 66% of mice were cured of their tumors). The publication is based on work conducted by the Company's collaborators at the Southern Research Institute, and the paper is entitled "Enhancement of the in vivo antitumor activity of clofarabine by 1-beta-D-[4-thio-arabinofuranosyl]-cytosine" (thiarabine).

President and CEO, Jeffrey Davis, stated that, "Thiarabine has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. Access is working with leukemia and lymphoma specialists at M.D. Anderson Cancer Center in Houston to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and other indications. Additionally, we are actively seeking co-development partners, and believe that thiarabine could have applications in certain solid tumors as well."

On 6/1/09, Access provided an update on its clinical development plan for ProLindac, which is a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. The Company recently announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.

ACCP has scaled-up manufacturing in order to begin the next phase of clinical development for Prolindac and the Company plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners. Access is currently in discussion with potential North American and European partners for co-development of ProLindac while the Company is working with its existing partners in Asia to design and manage new clinical trials for the compound.

Since I first wrote about Access in early May and compared the Company to Cell Therapeutics (NASDAQ:CTIC), the average volume and share price have made steady progress with increases of about 100% and 50%, respectively, as the small and micro-cap bio-pharma space is currently very popular with investors and traders. Even with the increase in share price, ACCP trades at a fully diluted market cap of just $48M at the closing price of $2.20 today, accounting for 11.3M shares outstanding and 10.6M shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance).

ACCP projects that it will have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through 1Q10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments. At the end of 1Q09, ACCP we had convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. During 2H09, Access plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan), which could provide additional upside catalysts for the stock price and cash to fund the continued development of the Company's pipeline.

[schwi105]

Gaining Momentum - Access Pharmaceuticals (OTC:ACCP) |

Looks like our old friend StocksHaven is promoting this company as well. Be careful; however, Mike Havrilla (I love this guy) can be trusted. This stock should see some action soon.

Darin

[GypsyDRB]

i bought a little over 7500 shares around the current price in my IRA 2-3 days ago...it is probably one of the "safer" speculative bets out there in the biopharma space.

[mahmissa]

I have a small position in ACCP- hoping to see some action today as a result of StocksHaven and biomedreports.

[blue]

I wouldn't touch this with a ten foot pole. It's promoted by StocksHaven, who can be hired to promote a stock. It has NO volume. When I see a stock trading 5000 shares in the first hour of trading......yikes! If you buy it, will there be anyone to buy it from you when you want to get out? No liquidity. That can make for big moves if anyone buys or sells, but it won't help you when you are on the selling side and have a large position to unload.

Good luck to those who own it, I'm just talking about ME.

[GypsyDRB]

Originally Posted by blue I wouldn't touch this with a ten foot pole. It's promoted by StocksHaven, who can be hired to promote a stock. It has NO volume. When I see a stock trading 5000 shares in the first hour of trading......yikes! If you buy it, will there be anyone to buy it from you when you want to get out? No liquidity. That can make for big moves if anyone buys or sells, but it won't help you when you are on the selling side and have a large position to unload. Good luck to those who own it, I'm just talking about ME.

I respect this stance ref: Stockshaven

...however in fairness it has been on Havrilla's radar for several months now (look at the research reports and write-ups he done @ biomedreports). He seems like a pretty good egg, and I really like his biomedreports site which is why I ended up buying some.