|Saturday, 29 August 2009 14:08|
Corporate Profile has posted a video interview on YouTube with the President and CEO of Access Pharma (OTC:ACCP), Jeffrey B. Davis, which summarizes the compelling investment opportunity represented by his Company. Mr. Davis provides an overview of Access Pharma, explaining that it is not a development-stage company because MuGard has already received marketing clearance by the FDA in the U.S. along with similar approvals worldwide and is in the early stages of its global commercial launch and the Company expects multiple catalysts before year-end which have the potential to significantly enhance shareholder value over the near to intermediate term.
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.
Below is an update from the President and CEO of Access Pharma, Jeffrey B. Davis, which is current as of 8/29/09 in response to my inquiry earlier this week on the status of the Company’s development pipeline and corporate milestones outlined in my latest report.
1.) ProLindac: Our clinical team, headed by Esteban Cvitkovic, MD, just returned from meetings with our partners Aosaikang Medicinal Group ("ASK") in Nanjing, China, and JCOM, Ltd. ("JCOM") in Seoul, Korea. The purpose of the meeting was to discuss progress on ProLindac manufacturing, which is going quite well. Additionally, they had Clinical Meetings with Key Opinion Leaders ("KOL") from the leading cancer centers in China and Korea. The purpose of these KOL meetings was to discuss clinical protocols with the goal of zeroing in on what protocols, in which tumors, should ASK/Access and JCOM/Access go after.
Initially, there was a strong desire from both ASK and ACCP to look at colorectal cancer – for the obvious reason that Sanofi's (NYSE:SNY) Eloxatin was approved for metastatic colorectal cancer (in combination with 5-FU and leucovorin - FOLFOX) – and recall that ProLindac is basically a new and improved version of Sanofi's Eloxatin (Access has found a way to deliver more of the Eloxatin active drug, DACH platinum, without the acute neurotoxicity side effects).
However, coming out of the meetings in Nanjing and Seoul, there was basic agreement that perhaps going "head to head" against Eloxatin in colorectal cancer was going to be a lengthier and more difficult pathway to approval. Not that ProLindac wouldn't be successful there, but given all the history and clinical data with Eloxatin in colorectal cancer, why not go somewhere else where you don't have such a well entrenched competitor.
As such, much of the discussion was looking at other solid tumors where Eloxatin (or Oxaliplatin) is used very effectively, and in combination wit h other chemos. There is a significant body of published scientific work looking at the successful use of a GEMOX regimen (oxaliplatin and gemcitabine, or GEMOX) in hepatocellular carcinoma (one form of liver cancer). This is similarly true in pancreatic cancer, and in recurrent ovarian cancer (both Eloxatin in combination with gemcitabine, and Eloxatin in combination with Taxol).
As such, we are 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). We will work closely with the KOL and with in-country regulators, with the goal of enrolling the first patients by year-end. 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.
2.) MuGard: We continue to receive interest in partnering MuGard in North America, following our announcements pertaining to the ongoing marketing assessment s studies in the United Kingdom, Germany and Italy. We expect to continue to receive data from those trials throughout the remainder of the year. Additionally, we have made initial contacts to key opinion leaders in oral mucositis in the U.S., and hope to start some additional marketing seeding studies within the next 60 to 90 days (predicated upon the availability of GMP manufactured MuGard here in the US).
Along those lines, we have leveraged the work done by Frank Jacobucci and his team in identifying the best company to manufacture MuGard here in the U.S. (they looked at four potential sources, each of which had FDA approved manufacturing facilities for liquids). We hope to finalize and announce our manufacturing relationship in the next week or so, and we're excited about working with this company which has a great track record, does only liquids, has great experience with products like MuGard, and works as a manufacturing source for leading pharmaceutical companies. More news is expected by the Company shortly on that development.
We've also been working with a very unique e-Marketing company to help "get the word out" on MuGard. I hope to give you more details on this shortly, but I think a comprehensive online e-Marketing effort will be a very cost effective way to get MuGard marketing material and samples, into the hands of radiation oncologists, oncologists, and cancer-nurses, etc. Because Access needs to "spread the gospel" about thinking about oral mucositis in a preventative way (and treating it prophylactically, rather than waiting for oral mucositis to occur), this e-Marketing platform will be key to the education component of marketing MuGard.
Access will be able to push educational material, and provide doctors with the capability to request samples, speak to a expert at Access, etc., in a very cost effective manner. Additionally, in the very likely event that Access re-partners or finds a co-promotion partnership in North America, we believe the agreement will be flexible enough to support both Access and the partner's efforts on a go-forward basis. It's a win-win, and these e-Marketing efforts are becoming a key component to how big pharma and specialty pharma help promote their new drugs and therapies.
3.) Rodman Conference: Access is presentation 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