Below are extreme trades among 30 companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 292 entries as of 8/1/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
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. 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. <font> Click here for more info </font> at the FDA website regarding the regulatory approval process for medical devices.
Ereska is a non-opiate pain drug being developed by (1) Javelin Pharma (AMEX:JAV)($1.90) 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).
On 5/7/09, (2) Avanir Pharma (NASDAQ:AVNR) ($2.15) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.
On 5/11/09, (3) Acadia Pharma (NASDAQ:ACAD) ($4.07) provided the following update along with its quarterly financial results: Enrollment was completed in the Company’s first pivotal Phase 3 trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.
On 3/9/09, (4) Angiotech Pharma (NASDAQ:ANPI) ($1.68) presented complete data for the Bio-Seal study at the 2009 Society of Interventional Radiology in San Diego, CA. The trial hit its primary end point with clinical success in 85% of the treatment patients compared to 69% for the control patients (p=0.002). Based on info in the Company's 10Q filing on 5/8/09, data from this clinical trial study has been submitted to the FDA, which has responded to the submission with additional questions about the study. ANPI has responded to the FDA and upon further review by the agency, ANPI may either receive 510(k) clearance to market Bio-Seal in the U.S. or be required to respond to additional questions or conduct additional clinical studies. The product has already received CE Mark approval for marketing in Europe. The Bio-Seal Lung Biopsy Tract Plug System is a novel technology designed to prevent air leaks in patients having lung biopsies by plugging the biopsy track with an expanding hydrogel plug. On contact with moist tissue, the hydrogel plug absorbs fluids and expands to fill the void created by the biopsy needle puncture.
On 6/19/09, (5) BioElectronics (BIEL.PK) ($0.056) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.
On 7/29/09, BIEL.PK announced that preliminary data on a heel and foot pain study show strong efficacy and 100% safety using the ActiPatch device. The study also showed study participants were able to significantly reduce their use of acetaminophen (Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs). Clinical studies in the areas of breast augmentation, Cesarean section, Uveitis, and several areas of surgical recovery are quickly coming to a close with data expected over the coming months. With the data provided by the Genecov study, the management team plans to accelerate its FDA 510(k) pre-marketing clearance filing for general musculoskeletal complaints designed to lead to over-the-counter approval. In addition, the Company will soon submit an additional application of 510(k) pre-marketing clearance for general surgical recovery.
On 5/15/09, (6) INVO BioScience (IVOB.OB) ($0.10) provided the following update on obtaining FDA marketing clearance for its fertility technology. INVO technology assists infertile couples in having a baby. In-vitro fertilization (IVF) is an effective treatment option for most infertile couples, and the Company’s patented and proven INVOcell technology is a low cost alternative to IVF that is much simpler to perform. INVO uses a device, the INVOcell, which is currently priced at $75-225 to distributors in developing countries and $125-300 in Europe and U.S. While IVOB penetrates the infertility markets in Europe, Canada, and select developing countries, the Company has also completed the first step for medical device companies who manufacture Class 2 devices with the filing of a Premarket Notification 510 (k) submission with the FDA. Technically, the FDA does not “approve” Class 1 and 2 medical devices for sale in the U.S. as the Agency issues “clearance” for them to be sold and marketed. IVOB hopes to receive U.S. marketing clearance by 2010 upon completion of its clinical trial.
On 5/12/09, (7) Pharmos (PARS.PK) ($0.40) reported 1Q09 results and announced that it advanced a Phase IIb trial of its lead non-serotonergic compound, dextofisopam, in female irritable bowel syndrome (IBS) patients. The Phase IIb trial was fully enrolled on 4/9/09 at 324 patients. All patients in the trial are expected to complete treatment by mid-2009 and top-line results are expected in early September 2009.
On 5/15/09, (8) Novavax (NASDAQ:NVAX) ($4.34) announced that enrollment has been completed in the second Phase II clinical trial of its trivalent virus-like particle (VLP) seasonal influenza vaccine. This Phase IIa randomized, placebo-controlled study is evaluating a VLP vaccine against the H3N2, H1N1, and B influenza strains that circulated in the 2008-2009 influenza season. This clinical trial represents another step in the development of Novavax's VLP seasonal influenza vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new set of influenza strains. As announced in December of 2008, the first Phase II study evaluated a trivalent VLP vaccine against the seasonal influenza strains that circulated in the 2005-2006 influenza season.
Specifically, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximately 220 healthy adults between the ages of 18 and 49 years. Subjects have received a single injection of either a placebo or the VLP vaccine at doses of 15 mcg or 60 mcg per strain. The results of this study will be used to help select a dose for further evaluation in a clinical trial involving adults 65 years of age and older later this year and in a subsequent Phase III efficacy study. The completion of enrollment keeps NVAX on track for reporting top-line data for the 2008-2009 vaccine during 3Q09 and selecting a dose for a Phase II trial in older adults later in 2009.
On 7/27/09, (9) Neoprobe (NEOP.OB) ($1.30) announced the Company will receive $3.5 million from a warrant exercise by Montaur Life Sciences with the proceeds being used to complete the development of Lymphoseek and to prepare for the commencement of a new Phase 3 evaluation of the Company’s RIGS technology in colorectal cancer. Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping. A Phase 3 multi-center clinical trial for Lymphoseek in patients with breast cancer or melanoma has been successfully completed and a protocol for a second Phase 3 clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck cancer has been initiated at clinical sites.
Neoprobe has successfully completed a Phase 3 evaluation of Lymphoseek in breast cancer and melanoma patients and the warrant exercise affords the resources to complete the Lymphoseek development program and to prepare and submit the regulatory submissions to secure marketing clearances for Lymphoseek from FDA and EMEA. The RIGS system is a proprietary technology that utilizes tumor specific radiolabeled antibodies that localize to disease involved tissue and where the tissue is identified during the course of a patient’s cancer surgery. Neoprobe is initiating manufacturing initiatives for the RIGS technology consistent with the most recent favorable scientific advice assessment received from the EMEA while awaiting a review of the RIGS program by FDA.
On 6/1/09, (10) GenVec (NASDAQ:GNVC) ($0.80) announced that overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec's ongoing Phase 3 Pancreatic Cancer Clinical Trial with TNFerade (PACT) were presented at ASCO. The analysis concluded that TNFerade appeared to be safe and well-tolerated, indicating a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone. In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.
On 6/1/09, (11) Antigenics (NASDAQ:AGEN) ($2.19) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010. In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma. AGEN expects a decision on its European marketing application by late 2009 and the Company has not yet filed for U.S. marketing approval with the FDA.
On 6/15/09, (12) Aeterna Zentaris (NASDAQ:AEZS) ($2.62) reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010. AEZS has also announced recently that patients completing two years of therapy with cetrorelix in the first efficacy study (study 033), will be eligible to continue with the cetrorelix treatment, according to treatment regimen of the ongoing Phase 3 study, until the end of 2011.
On 6/17/09, (13) BioSante Pharma (NASDAQ:BPAX) ($1.83) announced that based upon a review of study conduct and blinded data from the LibiGel Phase 3 Cardiovascular and Breast Cancer Safety Study, the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel Phase 3 clinical program. A very low cardiovascular event rate has occurred thus far in the clinical trials. The Executive Committee evaluated study information from over 1,000 women enrolled totaling approximately 600 women-years of exposure in the Phase 3 LibiGel safety study. BPAX stated that its objective is to submit a NDA for FDA approval of LibiGel in late 2010 or early 2011 for the proposed treatment of hypoactive sexual desire disorder (HSDD) in menopausal women after the expected completion of the Phase 3 studies by mid-to-late 2010. In addition to the Phase 3 cardiovascular and breast cancer safety study, BPAX is conducting two LibiGel Phase 3 efficacy trials.
The Phase 3 efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement). (14) Antares (AMEX:AIS) has a mid-single digit royalty percentage and milestone sharing rights in the U.S. AND exclusive marketing rights in Europe and elsewhere since LibiGel is based on the Company's Advanced Transdermal Delivery (ATD) gel technology.
On 7/7/09, (15) CEL-SCI Corp. (AMEX:CVM) ($0.50) provided the following updates in a letter to shareholders. The Company’s three business units include: (1) Vaccines/treatment: H1N1 (swine) and other influenza viruses, as well as a vaccine for rheumatoid arthritis; (2) Late-stage non-toxic cancer immunotherapy, Multikine, designed to make the first cancer treatment more successful; and (3) Unique contract manufacturing services using new manufacturing facility. CVM recently completed its $22 million manufacturing facility, which is expected to be validated within the next 3 months (i.e. early October 2009) for the manufacture of Multikine for the Company’s pending Phase III trial and subsequent sale if approved for marketing.
CVM stated that the validation of this facility is a critical step to starting the pivotal Phase 3 trial for Multikine. CVM stated that the Phase 3 study protocol was designed in consultation with the FDA and is expected to enroll about 800 patients to assess overall patient survival as the primary outcome. The Company also stated that the FDA has granted Multikine Orphan Drug status in the USA, and (if the Phase 3 study is successful) Multikine would be on course to become the recommended first-line treatment for head and neck cancer. On 6/30/09, CVM announced that it completed a registered direct offering under which it raised gross proceeds of $5.85 million.
On 7/8/09, (16) Transdel Pharma (TDLP.OB) ($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 7/15/09, (17) Health Enhancement Products (HEPI.OB) ($0.44) announced preliminary results of its study to confirm the efficacy of the ProAlgaZyme (PAZ) (a liquid product drawn from living algae grown in purified water) bioactive compound in managing LDL and HDL cholesterol levels. The Company awarded a grant on 3/30/09 to the Department of Nutrition and Food Science of Wayne State University (WSU), which ranks among the nation's top 50 public universities engaged in basic and applied biomedical research by the National Science Foundation. The WSU study confirmed that the PAZ organic compound was found to reduce LDL (bad) cholesterol levels from 131.7mg/dL to 79.57mg/dL and improve HDL (good) cholesterol from 105.27mg/dL to 138.67mg/dL in test animals (hamsters).
Upon completion of the study, WSU will publish a scientific paper describing the final results, as well as the means and methods employed, to be authored by the principal investigator, Smiti Gupta, Ph.D., assistant professor of Nutrition and Food Science at WSU. The cholesterol findings are initial results of a larger study, which also includes investigating the effect of PAZ organic compounds on the management of generalized inflammation. Those results are pending and will be released as they are completed by WSU.
On 7/20/09, (18) Labopharm (NASDAQ:DDSS) ($1.99) 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. No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Gruppo 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.
On 7/29/09, DDSS confirmed that Gruppo Angelini submitted a plan to the FDA addressing issues at a production plant raised in the Agency’s CRL. The next step is for the FDA to accept the resubmission and issue either a Class I (60-day) or Class II (six-month) review period for a decision on the NDA. DDSS will host a conference call on Friday, August 7, 2009 at 8:30 a.m. (ET) to discuss its second quarter 2009 financial results. Labopharm will report its second quarter 2009 financial results via news release at approximately 7:00 a.m. the same day.
On 4/14/09, (19) Marshall Edwards (NASDAQ:MSHL) ($0.76) announced that it will be undertaking an un-blinded analysis of the data from its Phase 3 clinical trial known as OVATURE (OVArian TUmor REsponse). On 6/17/09, Independent Data Monitoring Committee (IDMC) created to oversee the conduct of the OVATURE Trial announced that completion of data collection and database lock will likely require a further six months for analysis of the primary efficacy endpoint of Progression Free Survival. Per the study protocol, the secondary endpoint, overall survival, cannot be analyzed until 18 months after the last patient was randomized, or sooner if there are no patients surviving. The Company decided to conduct an un-blinded analysis of the data in order to assess the clinical and commercial opportunities for phenoxodiol and to enable the continuing funding from current resources.
Phenoxodiol is being developed by MSHL as a chemo-sensitizing agent in combination with platinum drugs for late-stage, chemo-resistant ovarian cancer and as a mono-therapy for prostate and cervical cancers. MSHL is majority owned (71.3%) by (20) Novogen (NASDAQ: NVGN) ($3.10) , an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. The Company intends to allocate its current funds of approximately $23 million to completing the OVATURE data analysis of 142 patients, pursuing negotiations for out-licensing phenoxodiol should evidence of efficacy and safety emerge from the OVATURE analysis, maintaining other ongoing phenoxodiol ovarian and prostate cancer clinical trials, initiating the triphendiol clinical program, and in-licensing further promising anti-cancer compounds from Novogen.
On 7/31/09, (21) Advanced Life Sciences (ADLS.OB) ($0.48) announced that it received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for Restanza (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). ADLS.OB will continue to pursue approval of Restanza in CAP and believes that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. In parallel, the Company will continue to advance Restanza as a bio-defense agent against anthrax, plague and tularemia.
On 6/2/09, the FDA Anti-Infective Drugs Advisory Committee voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, but voted that Restanza did not demonstrate efficacy in the treatment of CAP. ADLS.OB is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information and expects to start the additional Phase 3 program during 1H10. On 7/31/09, ADLS.OB announced that it expects to report key data from the Company's ongoing pivotal studies in plague and tularemia by the end of 2009. ADLS.OB plans to submit an NDA amendment seeking marketing approval for the bio-defense indications during 1Q10.
On 7/30/09, (22) Anadys Pharma (NASDAQ:ANDS) ($2.67) announced finalization of the protocol for the Company's Phase 2 trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the FDA and patient dosing is expected to commence within the next several weeks. In the Phase 2 study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.
The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR). Ninety patients are planned to be enrolled in this study - thirty patients receiving ANA598 and fifteen receiving placebo at each dose level. Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end 2009 and additional on-treatment safety and response data from both cohorts during the first two quarters of 2010.
(23) EnteroMedics (NASDAQ:ETRM) ($3.31) is developing implantable systems to treat obesity and other gastrointestinal disorders. VBLOC Therapy intermittently blocks nerve signaling between the brain and stomach over the vagus nerves using high-frequency, low-energy electrical impulses. The vagus nerves are known to control digestive functions including food processing and feelings of hunger and fullness. The effect of VBLOC Therapy has been demonstrated in early clinical trials, where patients reported reduced time to feelings of fullness at meals, as well as reduced feelings of hunger between meals out to six months with resultant reduced calorie intake.
Clinical weight loss results reported to date include mean excess weight loss of 28.1% for the first 17 patients to reach 12 months of therapy and 37.6% for the first 9 patients to reach 18 months in a 38 patient feasibility study. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008 under an FDA-approved Investigational Device Exemption (IDE) for the clinical trial. ETRM expects to report top-line results from the study during 4Q09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance and is currently recruiting patients outside of the U.S. for a feasibility study examining the effects of VBLOC Therapy on blood glucose levels in diabetics.
On 7/23/09, (24) Columbia Labs (NASDAQ:CBRX) ($1.19) announced that the Company signed an agreement with PharmaBio Development, Inc. under which Columbia can extend its final royalty payment on sales of Striant (testosterone buccal system) from November 2010 to November 2011. The final payment is estimated at approximately $16.4 million. CBRX stated that the deal will allow the Company to focus its energy on the PREGNANT Study, which is a Phase 3 clinical trial of Prochieve 8% for the prevention of preterm birth in women with a short cervix at mid-pregnancy. CBRX expects to complete enrollment by late 2009, report results in mid-2010 and, if the results are positive, obtain FDA approval in mid-2011.
On 7/23/09, (25) Aradigm (ARDM.OB) ($0.204) announced it received clearance from the FDA for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The initial clinical protocol under this IND is an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE). This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the U.S. The Phase 2b study will enroll 96 patients and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs. placebo for a four-week treatment period. Secondary endpoints will include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes will be monitored for safety.
(26) Vion Pharma (VION.OB) ($2.20) has a pending NDA for Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) seeking approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA will receive a standard (10-month) review by the FDA with a PDUFA action date of 12/12/09 for a possible FDA decision.
On 6/9/09, (27) Santarus (NASDAQ:SNTS) ($3.14) announced that Schering-Plough HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole + sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market. The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone upon approval, a low double-digit royalty on net sales of OTC Zegerid, and may receive up to an additional $37.5 million in sales milestones.
On 4/6/09, SNTS filed NDA for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products with an expected FDA decision during late 4Q09. In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
On 7/1/09, (28) CombinatoRx (NASDAQ:CRXX) ($0.87) and Neuromed Pharma (privately held) 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).
On 7/22/09, (29) Hemispherx Biopharma (AMEX:HEB) ($2.13) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.
On 7/29/09, (30) Cell Therapeutics (NASDAQ:CTIC) ($1.48) announced that it was notified by the European Medicines Agency (EMEA) that pixantrone is eligible to be submitted for a Marketing Authorization Application (MAA) through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union member states. The EMEA also designated pixantrone as a New Active Substance, which would be eligible for a 10-year market exclusivity period in EU member states upon approval. CTIC will request a meeting with the EMEA to discuss the submission of the MAA for pixantrone to treat aggressive non-Hodgkin's lymphoma (NHL) in the EU member states.
On 7/7/09, CTIC announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.
On 6/24/09, CTIC 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. The Company 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.
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