Cell Therapeutics, Inc. (Nasdaq: CTIC) announced that the Ninth Circuit Court of Appeals reversed a U.S. District Court order and ruled that CTI should be allowed to pursue all of its claims against The Lash Group, sending the case back to the District Court for trial. CTI filed a complaint against The Lash Group, CTI's former third-party reimbursement consultant for CTI's product TRISENOX, in 2007 seeking $22.8M in damages for expenses already incurred related to the investigation, defense and a settlement of claims by the U.S. government concerning Medicare reimbursement for TRISENOX and other business losses.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
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Cell Therapeutics’ (CTIC) third quarter loss per share came in at 8 cents compared to a loss of $1.14 reported in the year ago period. The company does not have any marketed product at present; it derives revenues primarily in the form of license and contract revenues. Cell Therapeutics recorded revenues of $0.02 million compared [...]
CellTherapeutics’ (CTIC) third quarter loss per share came in at 8 cents compared to a loss of $1.14 reported in the year ago period. The company does not have any marketed product at present; it derives revenues primarily in the form of license and contract revenues. Cell Therapeutics recorded revenues of $0.02 million compared to $2.6 million in the third quarter of 2009.
Revenues in the year ago period consisted of product sales of Zevalin, which the company sold to Spectrum Pharmaceuticals earlier in 2009. Operating expenses during the quarter increased 32.5% to $27 million primarily on account of more than 150% increase in SG&A expenses. Cell Therapeutics has started preparing for the launch of pixantrone in 2010 by recruiting key persons and conducting market research; which has pushed SG&A expenses higher.
As a reminder, in August, the US Food and Drug Administration (FDA) had accepted for review the New Drug Application (NDA) filed by Cell Therapeutics. The company is seeking FDA approval (NDA filed in June 2009) for pixantrone for the treatment of relapsed and refractory non-Hodgkin’s lymphoma (NHL). We believe current investor focus is more on the outcome of the US Food and Drug Administration’s (FDA) decision regarding its lead candidate pixantrone, which is Cell Therapeutics’ lead pipeline candidate. The company was granted a ten month standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
Additionally, in July 2009, Cell Therapeutics initiated the process of obtaining marketing approval for pixantrone in Europe for the treatment of relapsed or refractory aggressive NHL.
Although the picture is not so gloomy on the product development front, we remain concerned about Cell Therapeutics’ liquidity position. Cash and cash equivalents including securities available for sale were $54.9 million. The company is under great pressure to raise additional cash to fund its operations, especially at a time when the company is preparing for the potential launch of pixantrone in 2010.
During the quarter, Cell Therapeutics reduced debt through the exchange of $4.5 million principal in debt for common stock resulting in a total of $57.4 million principal reduction in debt through exchanges so far in 2009. Although the company has brought down its debt burden by exchanging it against common stock, we remain concerned about significant dilution in shareholder value. Read the full analyst report on "CTIC" Zacks Investment Research
On 6/10/09, Access 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) for MuGard and related product line extensions. 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.
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. 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. 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.
In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece (launched in late June), 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 with expected commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement becomes established in each region.
Commercial partner estimates for MuGard include global annual peak sales potential of $350 million with a scaled royalty rate of 20-25% for Access, which translates into royalties of $70M or about 1.5X the Company's current fully-diluted 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 7/7/09, Access announced new preclinical data demonstrating that thiarabine shows remarkable efficacy in the prevention and treatment of rheumatoid arthritis (RA). In a well-established animal model for RA, an exceptional restoration of joint structure was observed in the studies, which were conducted at Wayne State University School of Medicine and at Southern Research Institute.
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 leukemia and lymphoma subtypes.
As a therapeutic treatment of established disease, thiarabine demonstrated a highly significant, dose-dependent amelioration of arthritis. Thiarabine treatment resulted in a broad inhibition of disease pathology, with reduction of both inflammatory and erosive disease parameters, as well as protection from loss of cartilage matrix proteins. When used as a preventative treatment, thiarabine blocked the development of joint disease at the 60 mg/kg/day dose level and exhibited a significant reduction in disease incidence and severity at 20 mg/kg/day.
In a therapeutic study comparing thiarabine to methotrexate, a commonly used clinical drug for RA treatment, high resolution 3-D images from an X-ray microtomograph were used along with histological scoring to evaluate joint and bone destruction. Thiarabine demonstrated statistically significant anti-arthritic efficacy comparable to that of methotrexate President & CEO Jeffrey B. Davis, stated, "Our current development focus for thiarabine is for the treatment of hematological cancers, but we believe these new RA data provide compelling evidence that thiarabine should be developed for rheumatoid arthritis as well."
In early June, ACCP announced that new thiarabine preclinical data will be published 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).
Access is currently working with leukemia and lymphoma specialists to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and B-Cell lymphomas. These studies will seek to determine the optimal dosage regimen and most susceptible malignancies for future trials with data expected around mid-2010 to serve as the basis for partnership discussions for further development and commercialization. The IND for thiarabine has been transferred to Access and the Company is awaiting FDA clearance of study protocol and drug recertification before initiating RA trials, in addition to seeking co-development partners for the drug across all therapeutic indications.
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.
Access has scaled-up its manufacturing in order to begin the next phase of clinical development for Prolindac and the Company plans to conduct several combination Phase 2 trials during 2H09 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.
Access also has a monoclonal antibody (MAb) with encouraging preclinical results in comparison to Roche's (OTC:RHHBY) 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.
Finally, Access has demonstrated promising results for 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 of widely used drugs such as insulin, hGH, and EPO. 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, resulting in 1,000 to 1,000,000-fold increases in absorption through the gut of large molecule drugs typically administered by injection.
Access anticipates an expense of about $2 million and about 12-15 months to get an IND filed to initiate clinical trials in humans for the nano-polymer drug delivery system; although this timeline could be shortened if such trials were conducted outside of the U.S. (e.g. India). A long-acting, basal insulin product (similar to the activity profile of Lantus insulin) is the most advanced in terms of achieving oral bioavailability of about 80-90% after initially achieving results in the 30-40% range. hGH, which is about 3X larger than insulin on a molecular basis, is currently in the 30-40% bioavailability range in preclinical animal models.
In mid-June, Access announced that the Company has signed evaluation agreements with two bio-pharmaceutical companies for its Cobalamin Oral Drug Delivery Technology. Under the terms of the agreements, both companies plan to evaluate the Company's oral insulin product in preclinical, animal models before entering licensing discussions. Access previously announced an agreement with a large pharmaceutical company to evaluate the oral delivery of hGH.
Access trades at a fully diluted market cap of about $40 million at the closing price of $1.84 on 7/13/09, which includes 11.3 million shares outstanding and 10.6 million shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance). At the end of 1Q09, Access also had a convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. Access should have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through at least 2H10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments from additional partnerships and MuGard royalties.
During 2H09, the Company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail - topical econazole and Pexiganan - a novel topical anti-infective) for an additional source of non-dilutive funding. If MuGard reaches just $20 million in global sales at a 20% royalty rate, this would generate positive operating cash flow during 2010. Between non-dilutive funding, partnerships, and MuGard royalties; the fully diluted share count should stay below 25 million at the time Access achieves positive operating cash flow so that existing shareholders will not be diluted into oblivion. Access is also in the process of obtaining an AMEX listing for its shares for greater visibility and liquidity compared to the OTCBB trading.
A video presentation for MuGard is available at YouTube, in addition to more information and links at the Company's newsroom website. Please visit the research section of BioMedReports.com to view or download PDF stock research reports for Access written by Griffin Securities from April 2009 with a 12-month price target of $7.50 (which equates to a fully diluted market cap of about $164 million) and Dawson James from July 2009 with a $4 price target (3X estimated 2011 revenue), in addition to the Company's most recent corporate presentation. Access also has a proactive management team which holds a large financial stake in the Company and has established a social media presence on Facebook, Twitter, and LinkedIn.
The list below (Data Sources: Yahoo! Finance, SEC Filings as of 7/12/09) includes a valuation comparison, upcoming catalysts, and pipeline comments for several other small and micro-cap cancer biotechs, including Aeterna Zentaris (NASDAQ:AEZS), Allos Therapeutics (NASDAQ:ALTH), Cell Therapeutics (NASDAQ:CTIC), GTx Inc. (NASDAQ:GTXI), Lixte Biotech (OTC:LIXT), Spectrum Pharma (NASDAQ:SPPI), SuperGen (NASDAQ:SUPG), and YM BioSciences (AMEX:YMI).
A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.
With shares of Human Genome Sciences (NASDAQ:HGSI) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. Click here for more info at the FDA website regarding the regulatory approval process for medical devices.
On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.
On 5/29/09, Theratechnologies (TSE:TH) (PINK:THTCF) ($2.00) filed a New Drug Application (NDA) with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is expected to occur in late 1Q10.
On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron, which is already approved by the Agency.
On 7/14/09, Genta (OTC:GETA) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta's recently completed Phase 3 trial of Genasense in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication.
On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe.
On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.
On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.
This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010.
Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). The stock price for JAV has increased by about 24% in the last five trading days and the volume was over 2X its average on 7/20/09.
In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa.
On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.
Hemispherx Biopharma (AMEX:HEB) ($2.49): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09. On 5/26/09, HEB announced that the FDA advised the Company that it may require up to 1-2 additional weeks to take action beyond the original PDUFA action date of 5/25/09. Click here for an exclusive interview of HEB's CEO, Dr. William A. Carter, which was posted at BioMedReports.com on 6/12/09.
On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09.
On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09, and the Company's share price has increased by about 58% in the past month.
On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09. Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.
On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission. Shares of SOMX have increased by about 239% over the past three months and the Company raised $6 million in a private placement in early July - providing adequate liquidity through 2Q10.
On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) ($1.39) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.
On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. CTIC is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.
Nuvo Research (PINK:NRIFF) (TSE:NRI) ($0.36) has a pending NDA re-submission for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10 million and is also eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA.
Advanced Life Sciences (OTC:ADLS) ($0.46): Cethromycin NDA (a once-daily antibiotic for the treatment of community acquired pneumonia - CAP) with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).
On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed Pharma announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed's New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).
The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date during 4Q09 for a possible FDA decision.
On 7/8/09, Transdel Pharma (OTC:TDLP) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in 4Q08. Vical expects the trial to be completed during 4Q09 with final data available during 1H10.
On 11/14/08, Nephros (OTC:NEPH) ($1.25) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.
The encouraging interim results thus far for MuGard in the first 140 patients include some that have completed all seven weeks and others who are still pending completion in the study, and the final numbers for all 280 patients enrolled in the study are expected in several weeks. More than 90% of patients who receive radiation therapy and about 40% of patients receiving chemotherapy experience OM while those receiving radiation for head and neck cancer tend to experience the most severe cases.
In the MuGard clinical trial conducted by Access, 50% of patients did not experience OM while the other 50% had less severe and shorter cases of OM. The excellent interim results announced today in SpePharm's trial (affording complete protection from the incidence of OM) may be the result of beginning MuGard administration earlier at one week before radiation therapy (rather than starting at the same time). This may have resulted in an additive effect with each subsequent dose and/or make patients more compliant as they became conditioned to using MuGard before radiation therapy started.
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.
MuGard 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, and the product has already received marketing clearance from the FDA through the 510(k) route. The product was cleared for marketing by the FDA through the 510(k) route because the product does not include any active pharmacological agent. Therefore, the experience with MuGard to date has revealed no safety concerns, no drug interactions, no side effects (even if swallowed), and no cases of overdose.
The news today follows an announcement yesterday that the Company will be presenting at the Jesup & Lamont 2009 Growth Stock Conference organized by the LifeTech Capital Group on 7/30/09 at 10:45am (ET). The presentation will occur live and will be held at the Waldorf Astoria Boca Beach Club in Boca Raton, FL. Jeffrey Davis also stated in the press release yesterday that the commercial launch of MuGard has achieved "very significant and positive initial results and feedback" and that "clinical feedback and experience exceeds our expectations."
In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece (launched in late June), 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 with expected commercial launches in these regions throughout the remainder of 2009 as manufacturing and reimbursement becomes established in each region.
Initial commercial partner estimates for MuGard included global annual peak sales potential of $350 million with a scaled royalty rate of 20-25% for Access. The Company 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. However, these preliminary estimates may prove to significantly underestimate the potential for MuGard if it is confirmed as a preventative treatment for patients undergoing radiation therapy and chemo.
Based on National Cancer Institute statistics, the incidence (number of diagnoses) of cancer in the U.S. is expected to be about 1.5 million people in 2009. Please note this number does not even include any patients receiving chemo or radiation therapy who were previously diagnosed with cancer (prevalence includes individuals who are newly diagnosed, in active treatment, have completed active treatment, and those living with progressive symptoms of their disease). The World Health Organization (WHO) estimates that cancer rates (incidence) could further increase by 50% to 15 million new cases in 2020 from 10 million new cases diagnosed globally in 2000. Developed nations with the highest overall cancer rates include the U.S., Italy, Australia, Germany, The Netherlands, Canada, and France.
MuGard is priced at about $150 per week of treatment, which translates into about $1,000 per patient who receives a six-week treatment course of radiation and/or chemotherapy (the latter treatment may last for much longer than six weeks). Using a conservative estimate of $1,000 per six-week treatment course (of radiation therapy and/or chemo), MuGard would reach $1 billion in annual sales by adding the product to 1 million six-week treatment cycles per year (please note that a single patient could receive multiple treatment cycles or receive treatment for longer than six weeks so this number could be reached by treating less than 1 million unique patients on a global basis).
One million six-week treatment cycles represents less than the number of new cancer diagnoses expected in the U.S. alone in 2009 (1.5 million people), 10% of the 10 million new cancer diagnoses on a global basis in 2000, and less than 7% of the estimated 15 million new cases of cancer on a global basis in 2020. Also, the $1,000 pricing for MuGard in a six-week treatment cycle is a fraction of the cost for most anti-cancer therapeutics and less than the cost of treating the complications of severe cases of mucositis (e.g. intravenous feeding/hydration, pain medications, extended hospital stays, and antibiotics for infections that may arise from open sores in the mouth and GI tract).
MuGard sales of $1 billion would translate into royalties for Access exceeding $200 million based on a scaled royalty rate of 20-25% on a global basis through regional marketing partners. Assuming 25 million shares of fully diluted common stock in 2012, MuGard royalties of $200 million, and operating expenses + taxes of $100 million; Access would have potential earnings power in excess of its current stock price - about $4/share in just three years. If final clinical results and future experience with MuGard confirms the positive results announced today, it would become part of the standard of care for patients receiving radiation therapy and/or chemo associated with OM as there would be no legitimate reason for NOT using MuGard because of the excellent safety profile due to its non-drug composition and low cost.
Access trades at a fully diluted market cap of about $45 million at the closing price of $2.07 on 7/22/09, which includes 11.3 million shares outstanding and 10.6 million shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance). At the end of 1Q09, Access also had a convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. Access should have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through at least 2H10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments from additional partnerships and MuGard royalties.
During 2H09, the Company plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail - topical econazole and Pexiganan - a novel topical anti-infective) for an additional source of non-dilutive funding. Between non-dilutive funding, partnerships, and MuGard royalties; the fully diluted share count should stay below 25 million at the time Access achieves positive operating cash flow (which only requires global MuGard sales of about $25 million) so that existing shareholders will not be diluted into oblivion. Access is also in the process of obtaining an AMEX listing for its shares for greater visibility and liquidity compared to the OTCBB trading.
A video presentation for MuGard is available at YouTube, in addition to more information and links at the Company's newsroom website. Please visit the research section of BioMedReports.com to view or download free PDF stock research reports for Access written by Griffin Securities from April 2009 with a 12-month price target of $7.50 (which equates to a fully diluted market cap of about $164 million) and Dawson James from July 2009 with a $4 price target (3X estimated 2011 revenue). Access also has a proactive management team which holds a large financial stake in the Company and has established a social media presence on Facebook, Twitter, and LinkedIn.
According to Google Finance statistics on 7/22/09, the year-to-date stock price returns for a basket of small and micro-cap cancer biotechs includes: Access (+109%), Cell Therapeutics (NASDAQ:CTIC) (+1,064%), Spectrum Pharma (NASDAQ:SPPI) (+332%), SuperGen (NASDAQ:SUPG) (+46%), and Aeterna Zentaris (NASDAQ:AEZS) (+327%).
Click here for the most recent overview article on Access Pharma at BioMedReports from mid-July including a review of the Company's deep pipeline and promising oral cobalamin drug delivery technology (including encouraging results for the delivery of insulin by mouth in preclinical animal models) which make the stock a compelling risk/reward trade at its current market cap of below $50 million given the study results for MuGard announced today.
Biotech stocks have also been reignited this week with shares of Human Genome Sciences (NASDAQ:HGSI) up about 4X since reporting positive clinical trial results on Monday for its lupus treatment. Also, last night Bristol-Myers make a $16/share all cash offer to acquire Medarex (NASDAQ:MEDX) for over $2 billion, which follows a deal by JNJ two months ago for cancer biotech Cougar for $1 billion.
The Micros Report is the only LIVE IPTV feed dealing with financial news focused expressly on microcap investment analysis, and it streams to every area of the world. Hosted by Mike “the Analyst” Willingham and "Forex" Rick Wright, The Micros Report provides traders, brokers, investors, and market makers the necessary information to trade intelligently in the penny stock market.
Segment 1:
Rick talked about some of the movers from Friday, July 13, also what looked to be starting a move today, including: a forex report, and CTIC (Cell Therapeutics)
Segment 2:
In the second segment, Rick discussed some of the stocks mentioned on yesterday's shows that moved, and a few that were positioning themselves for a move today: MRDY (Mobile Ready), SZSN( Shandong Zhouyuan Seed and Nursery Co.), MBIR (MobiClear, Inc.)
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