FDA Calendar November Stocks: Turkeys or a Happy Thanksgiving?

By Mike Havrilla
ProActive Newsroom

On 7/15/09, Cadence Pharma (NASDAQ: CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company’s 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever.

The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S.

On 8/4/09, Nuvo Research (TSX: NRI.TO) (OTC: NRIFF.PK) announced that the FDA issued a new PDUFA action date for Pennsaid (diclofenac sodium) topical solution 1.5% of 11/4/09. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application (NDA). As a result, the FDA has extended its action date by three months to provide time for a full review of the submission.

On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) which granted 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$10M and is also eligible to receive a US$15M milestone payment on Pennsaid’s approval by the FDA, which will increase to US$20M if certain labeling criteria are agreed to by the FDA.

In addition, Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100M. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010.

On 10/20/09, Human Genome Sciences (NASDAQ: HGSI) and GlaxoSmithKline (NYSE: GSK) announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The data demonstrate that, in BLISS-52, belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.

Study results also show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. HGSI stated that these data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points and included a greater percentage of patients receiving BENLYSTA that were able to reduce their use of steroids. Belimumab is an experimental drug and the first in a new class of drugs called BLyS-specific inhibitors being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

Results from BLISS-76, the second Phase 3 trial of belimumab, will be announced on 11/2/09. Assuming the results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the United States, Europe and other regions during 1H10.

On 8/5/09, NeurogesX (NASDAQ: NGSX) announced that the FDA extended the PDUFA action date by three months to 11/16/09 for the Company’s pending new drug application (NDA) for Qutenza which is seeking approval to manage pain associated with post-herpetic neuralgia (PHN). The extension resulted from the Company’s recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline.

The information submitted in July includes a report from the Company’s recently completed C123 Study, which was performed at the request of the FDA. On 7/24/09, NGSX announced preliminary results of Study C123, which evaluated Qutenza in patients with PHN following pre-treatment with an FDA approved topical anesthetic. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely.

NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.

On 9/29/09, Cerus Corp. (NASDAQ:CERS) announced that it will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA’s Blood Products Advisory Committee (BPAC). The Committee meeting is open to the public and discussion of the INTERCEPT trial is scheduled to occur the afternoon of November 16.

“The proposed Phase III clinical trial design that we’ll discuss with the Advisory Committee was created through close collaboration between Cerus and the FDA Office of Blood Review,” said Carol Moore, Cerus’ vice president of regulatory affairs, quality and clinical affairs. “We look forward to presenting the result of this joint effort to BPAC, and hearing their views on this significant step forward toward defining a US approval pathway for INTERCEPT pathogen inactivated platelets.”

Cerus has previously announced that an additional Phase III platelet trial was anticipated to be necessary for US approval. The INTERCEPT platelet system was granted CE mark registration in 2002, and subsequently received additional European regulatory approvals in France (Afssaps), Switzerland (Swissmedic), Germany (Paul Ehrlich Institute marketing authorization for the German Red Cross).

XenoPort (NASDAQ: XNPT) has a pending NDA for Solzira (gabapentin enacarbil) Extended Release Tablets seeking approval for the treatment of moderate to severe restless leg syndrome, which was accepted for review by the FDA on 3/16/09 and includes collaboration agreements with Glaxo and Astellas Pharma with an expected FDA decision on 11/9/09. Solzira is a new chemical entity that was developed by XNPT to improve upon the absorption characteristics of gabapentin (in a once-daily formulation) through specific transport mechanisms in the GI tract.

On 10/19/09, BioElectronics (OTC: BIEL.PK) announced the initial results from the pilot section of its ongoing acetaminophen comparison study. The study, which is expected to be complete during early November, compares the effects of ActiPatch Therapy to acetaminophen in the form of Extra Strength Tylenon for the treatment of delayed onset muscle soreness (DOMS).”Thus far, results from the pilot section of this study seem to be highly statistically significant with the ActiPatch group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group,” commented principal investigator Sheena Kong, M.D.

The study, which is Institutional Review Board (IRB) supervised, is currently ongoing with full study results expected during early November 2009. On 8/24/09, BioElectronics announced it would sponsor a clinical study comparing the effects of its ActiPatch Therapy to Tylenol for the treatment of muscle pain and soreness. The study is conducted in two locations utilizing three groups of subjects, including: 1) a control group, 2) a group that will utilize ActiPatch Therapy, and 3) a group that will be given acetaminophen in the form of Tylenol.

Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. PRX302 is a genetically engineered version of a protein (proaerolysin) that is secreted by a specific type of bacteria (Aeromonas hydrophilia).

PRX302 is the Company’s lead PORxin drug, which are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 is activated by prostate-specific antigen (PSA), an enzyme that is over-produced in patients suffering from BPH and prostate cancer. PRX302 represents a potentially new treatment option for BPH and other prostate conditions with blockbuster potential based on $3 billion in annual sales for BPH drugs (e.g. Flomax, Avodart, Proscar) and the 575,000 surgical procedures that are performed each year in the top seven markets worldwide.

This approach avoids side effects and other negative factors of drug therapy for BPH, including (1) the need for lifetime therapy on a daily basis; (2) the potential for sexual dysfunction; (3) fatigue / dizziness / low blood pressure; (4) the potential for drug interactions. In contrast to drug therapy and surgical procedures, PRX302 is minimally invasive and administered as a single treatment that involves a 10-minute procedure that can be conducted in a doctor’s office with no catheterization required. Advantages for physicians include no capital investment, ultrasound-guided delivery, and a short procedure time.

On 9/10/09, Protox announced positive 12-month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. The International Prostate Symptom Score (IPSS) is a validated accepted clinical end-point used to assess the treatment benefit in BPH clinical studies. This index is measured on a 0-35 scale with 0 defined as having no problems and 35 defined as the high end of severe symptoms.

In this Phase 2 open-label volume optimization study, 13 of the 18 patients received the optimum PRX302 dosing of (greater than)-1mL per deposit. A total of 11 of the 13 patients were evaluable at 12-months and continued to show a statistically significant and sustained improvement in IPSS of 12.1 points (which is in a similar range to surgical procedures and much better than drug therapy, which results in an improvement of about 4-7 points) representing a 55% improvement when compared to screening.

No safety issues were identified in this study, as increasing volumes of PRX302 were seen to be well tolerated. No PRX302 related serious adverse events or Grade 3 or greater adverse events have been reported to date. The PRX302 related adverse events were mild to moderate, transient in nature (resolved within days) and localized to the urinary tract. In addition, no sexual dysfunction has been reported in any of the subjects dosed to date. Detailed 12-month results from this Phase 2 open-label clinical trial will be presented at the 30th World Congress of the Societe Internationale d’Urologie from November 1-5, 2009.

On 9/8/09, Protox announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. The Company recently provided guidance for reporting top-line results from the TRIUMPH study during 4Q09.

Access Pharma (OTC: ACCP.OB) provided an update in mid-October on the clinical and commercial status of MuGard, which has already been launched by its partner, SpePharm, in five European countries for the prevention and treatment of oral mucositis. 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 4Q09-1Q10 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. Initial patient and clinician feedback has been very positive, according to SpePharm’s President / CEO, Jean-Francois Labbe, 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.

The number of patients being evaluated in the European post-marketing studies is more than originally anticipated and Access will be able to utilize the data in North America for both marketing and licensing negotiations. A steady stream of data is expected to occur over the next 3-6 months now given the larger patient population being analyzed and compiled by SpePharm. I have confirmed with Access President / CEO, Jeffrey Davis, that data is expected in a matter of weeks with the final UK results expected first, followed by data from Germany.

On 10/7/09, NeoStem (AMEX: NBS) announced that the SEC declared effective its Registration Statement on Form S-4 filed with the Commission, which is being used in connection with the proposed acquisition of China Biopharma (which owns a 51% controlling interest in Suzhou Erye). The acquisition is subject to customary closing conditions – including approval by the shareholders of each company at upcoming meetings scheduled on 10/29/09. NeoStem is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of anti-aging / cosmetic medicine and other stem cell technologies.

1.) NeoStem (U.S.) includes an exclusive worldwide license to VSELs, a strong IP sourcing network for innovative stem cell / pharmaceutical products and AMEX listing for the stock in addition to its position in the domestic market as a leading adult stem cell banking network.

2.) Suzhou Erye is a high-growth generic pharmaceutical manufacturer in China with a strong core business / profitable revenue base amidst booming demand and growth in the Chinese market.

3.) NeoStem (China) has strong support from the Chinese government for commercialization of cosmetic / regenerative medicine applications which will also expedite the process of U.S. development as the Company becomes a vertically integrated stem cell operation in a permissive regulatory environment that incldues strong government support.

Check out NeoStem’s News Room Page for a compilation of links, videos, articles, news feeds, and more for the Company and click here for my overview article outlining the three-part post-merger strategy. Other companies in my stock coverage universe with news room landing pages include Access Pharma and Protox Therapeutics. has relocated / forwarded to my new home at with 20 stock indexes, stock research landing pages, and more. . .Subscribe by email or feed reader at the Feedburner site for my ProActive News Room blog at Also, I will continue to manage the FDA Calendar service at and contribute articles, reports, etc. as previously.

Disclosure: Long ACCP.OB, PTXRF.PK

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