Access Pharma (OTC: ACCP.OB) provided an update today on the status of the North American commercial launch for its FDA cleared treatment for oral mucositis, MuGard, which is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In addition, Access signed an e-Marketing deal with iMedicor (OTC: VMCI.OB) in early October as a cost-efficient and highly targeted means of reaching over 200,000 oncologists in the U.S. market.
The e-Marketing deal and pending domestic MuGard launch is part of the Company’s strategy that includes simultaneous discussions for potential co-promotion agreements with oncology-related bio-pharmaceutical companies and the development of a sales team with experience in the supportive treatment of cancer patients. Access is also working with consultants to finalize third-party reimbursement for MuGard from insurance plans, Medicare, Medicaid, etc.
iMedicor’s ClearLobby is an application within the NaviNet healthcare communications portal that includes a network of more than 700,000 physicians. Doctors, healthcare providers, and support staff included in this network have the ability to access information on new medications and medical devices, in addition to medical / scientific journals, clinical trials, webinars, and continuing education programs. Sponsored products such as MuGard go beyond simply providing information, including the capability to order samples and make specific inquiries about the product at their convenience through 24 / 7 access.
The combination of liquid contract manufacturing (Accupac), e-Marketing (iMedicor) / dedicated oncology sales team, and the pending post-approval marketing data from Europe positions Access to launch MuGard in North America on its own in a highly targeted and cost-efficient manner without giving away a large chunk of sales as part of a licensing agreement. In addition, the pending capital raise is likely to be in the $10-15 million range (40-60% of the $25 million maximum in the recent SEC S-1 filing) to further strengthen the balance sheet, fund the MuGard launch, and ultimately improve the Company’s negotiating position for a potential MuGard co-promotion agreement(s).
European MuGard partner, SpePharm, is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany, and Italy. SpePharm anticipates that data from these studies will be made on a rolling basis throughout late 2009 to early 2010 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. According to SpePharm, initial patient and clinician feedback has been very positive for MuGard, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer.
Access is also developing its own strategy for similar post-marketing studies in the U.S., if required, to support the use of MuGard as a preventative measure for oral mucositis arising from chemo / radiation therapy in addition to expanding the scope of use for all types of oral trauma such as canker sores, ulcers, and oral surgery complications.
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Disclosure: Long ACCP.OB
Access Pharma (OTC: ACCP.OB) provided an update today on the status of the North American commercial launch for its FDA cleared treatment for oral mucositis, MuGard, which is expected to occur during 1Q10 in conjunction with the availability of initial product inventory by its liquid contract manufacturing partner, Accupac. In addition, Access signed an e-Marketing deal with iMedicor (OTC: VMCI.OB) in early October as a cost-efficient and highly targeted means of reaching over 200,000 oncologists in the U.S. market.[More...]
On 8/3/09, Access Pharma (OTC:ACCP) (ACCP.OB) provided an update on its clinical development strategy for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Access has commenced a new clinical study of ProLindac in France. The study will examine dose levels and regimens of ProLindac mono-therapy in cancer patients, provide additional data to support design of combination studies, and extend the safety database for the drug.
Two ovarian cancer patients have been enrolled in the study to date, and the Company expects to enroll 6-12 patients this year before beginning to enroll patients in clinical trials evaluating ProLindac in combination with other chemotherapies (likely to involve ProLindac plus paclitaxel--Taxol and/or gemcitabine--Gemzar).
Access recently announced data from a recurrent ovarian cancer trial that showed that ProLindac was more active than currently available platinum drugs in that patient population, and that the drug was very well tolerated. ProLindac is a novel DACH platinum drug that has shown to be active in many solid tumors in human clinical studies. Platinum drugs are one of the most clinically and commercially successful class of chemotherapies and generated more than $3 billion in revenue globally in 2008. Access believes that ProLindac, as a well-tolerated and active DACH platinum, represents a important improvement in the design and tolerability of platinum chemotherapies.
Later this month, an Access management and clinical development team is meeting with Access' partner, Aosaikang Medicinal Group (Ask-Pharm) and several key oncology opinion leaders to finalize plans for ProLindac development in China. In addition, Access is meeting with its Korean partner, JCOM of Seoul, South Korea to finalize development plans in that territory. Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of protocols in both China and Korea. Further, Access has reported receipt of additional milestone payments from its Far East partners in the ordinary course under their collaborative agreements.
"Our Chinese partner, Ask-Pharm, has made great progress on manufacturing scale-up of ProLindac and advancing the Regulatory process with the sFDA. We are excited about finalizing protocols with Ask-Pharm and leading oncologists in China, and look forward to their continued progress," stated Jeffrey B. Davis, Access' President and CEO. "Additionally, we are meeting this month with JCOM and key opinion leaders in Korea, and hope to get the combination trials started in Korea as soon as reasonably possible."
Access intends to design all clinical studies of ProLindac in accordance with FDA standards and intends to use the clinical data from all three planned clinical trials in the Far East to further development in North America and Europe. Access has the right to all clinical data generated in the Far East under the agreements entered into with their Far East partners, and as previously announced, believes that these trials run by its ProLindac partners will save Access between $20-30 million in clinical development expenses.
Access is currently in discussion with potential partners for development and commercialization of ProLindac in additional territories. The Company has previously announced that it has licensed ProLindac to Ask-Pharm for the Greater China Region and to JCOM, Ltd for South Korea. Under these agreements both of these partners will be conducting Phase 2 combination studies with ProLindac in specific tumor types at their expense based on these results.
ProLindac is a very promising, next-generation platinum anti-cancer compound which includes a proprietary nano-polymer drug delivery vehicle that allows for over 10X the dose of platinum to be delivered in a targeted manner 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 because they reside at a low pH (acidic).
Pharmacology studies conducted outside of living, human tissue (ex-vivo) within comparable environments (e.g. acidic or low pH) to the tumors being treated by ProLindac have demonstrated that about half (50-60%) of the platinum is released over a period of 96 hours (four days) from a single administration. Thus, a single dose of ProLindac not only delivers over 10X the platinum dose in a targeted manner to cancer cells, but also mimics a four-day continuous infusion as the drug persists at the tumor site.
ProLindac is meant to be a safer, more effective replacement for Eloxatin (oxaliplatin), which posted estimated global sales of $2.5 billion 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. Access 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. Access previously 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.
Please visit the stock research section of BioMedReports.com to view or download my 15-page PDF stock profile report for Access Pharma, which includes an earnings model for MuGard through 2012 and other key milestones for the Company. 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 Pro-Active News Room site for a compilation of links, videos, presentations, and social media sites for the Company.
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.
On 9/10/09, Access Pharma (OTC: 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 recurrent 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. Disclaimer: See my full disclaimer at MikeHavRx.com (bottom of page). BioMedReports.com does not receive compensation from the companies covered on the site and earns subscriber revenue for premium access to our FDA Calendar database and other subscriber-only content. The BioMedReports.com FDA Calendar includes a database of over 300 entries and tracks (with daily updates) pending FDA decisions (e.g. NDA, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending FDA filings or resubmissions, and pending clinical trial results. I have a long-only writing and investing strategy bias and am bullish on the small and micro-cap healthcare and clean-tech space as a proxy for innovation and as acquisition or partnership targets.
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