Access Pharma (OTC: ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment called MuGard that is cleared for marketing in the U.S., Europe, and other key global markets for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining).
In addition, the Company is developing earlier stage compounds in its pipeline and has an oral cobalamin nanopolymer drug delivery technology which has demonstrated positive results for the delivery of insulin by mouth in preclinical animal models.
Access expects to maintain a low cash burn rate of approximately $5 million during 2010, as compared to an operating budget of approximately $35 million – reflecting the significant benefit provided by partner funding such as the clinical development of ProLindac in the Asia-Pacific region. In addition, the current cash and expected milestone payments this year provides adequate funding for all development and commercialization plans through at least mid-2011, which does not take into account MuGard royalties from SpePharm in Europe and pending sales of the product in North America.
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Access Pharma (OTC: ACCP.OB) provided an update today on the status of its cobalamin-based oral drug delivery product development programs. The BioMedReports.com research downloads section and the ProActive News Room website for Access both contain the most recent research reports and presentation for the Company, following its presentation last week at the OneMed Forum in San Francisco, which was held in conjunction with the JP Morgan Healthcare Conference.
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I had the opportunity last week to discuss the updated strategy and expected milestones for ImmunoCellular Therapeutics (OTC: IMUC.OB) in 2010 and beyond with CEO, Manish Singh, following the conclusion of the OneMed, JP Morgan, and other healthcare conferences in San Francisco. IMUC is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells, based on two technology platforms that include active (therapeutic cancer vaccines) and passive (monoclonal antibodies) approaches.
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Below are some updates and developments from the past week, which I spent in San Francisco for the OneMed, JP Morgan, and other healthcare conferences.
I had the opportunity to meet with the CEO (Ron Bentsur) and CFO (James Oliviero) of Keryx Biopharma (NASDAQ: KERX) on Wednesday and was impressed with the Company’s focused strategy and upcoming milestones for 2010 and beyond. As outlined in my overview article last week, I have purchased shares of KERX over the past week on weakness at a slightly higher price range ($2.70-2.75) than I originally projected.
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During the second week of January, Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) shareholders overwhelmingly voted in favor of the Company’s U.S. relocation. Unilife is now in the final stages of preparation for a NASDAQ: UNIS stock market trading debut, which is expected to occur by the end of February in conjunction with the Company’s re-domiciliation to Central Pennsylvania. Unilife is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injected medications, sharps safety devices for healthcare facilities, and contract manufacturing services.
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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is an emerging, small-cap biopharma company that has a pair of lead compounds in late-stage, Phase 3 development for the treatment of cancer (perifosine) and renal disease (Zerenex) under Special Protocol Assessment (SPA) agreements with the FDA.
In addition, Keryx is well capitalized with no debt / convertibles, $41 million in cash / equivalents plus long-term investment securities, and approximately 56 million shares of common stock outstanding (70 million shares fully diluted). Keryx has retained all key commercial rights for its two lead compounds and has the resources to complete Phase 3 development for both of its lead compounds, which provides more leverage in partnership discussions. The estimated cash burn rate for 2010 is $1.3 million per month or approximately $4 million per quarter and $16 million for the entire year.
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Delcath Systems (NASDAQ: DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath’s Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient’s entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects.
Last August, Delcath announced that the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient’s entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.
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