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.

Disclosure: No positions.

On 3/30/09, Arena Pharma (NASDAQ:ARNA) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfied the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. Arena is on track 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) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa. Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.

Topiramate is better known as Topamax, which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.

Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms being evaluated in Phase 3 clinical trials, with more than 4,500 patients currently enrolled in late-stage studies for weight loss and Type 2 diabetes control. Last year, Vivus reported results for Qnexa from the 28-week EQUATE Phase 3 clinical trial which met its primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the drugs used individually and placebo.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) 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.

OREX is continuing to follow patients in a Phase 2b clinical trial of Empatic (zonisamide SR/bupropion SR), ZB-202. The trial is designed to build on the results from a previous Phase 2b trial of Empatic, ZB-201. In the current trial, which measures weight loss after 24 weeks of treatment, two different dosages of Empatic are being studied along with the individual constituents. The Company expects to report results from this Phase 2b clinical trial during 3Q09.

EnteroMedics (NASDAQ:ETRM) 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. In blocking nerve function, VBLOC is designed to help patients feel hungry less and feel full sooner, therefore reducing how much they eat.

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. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008. ETRM expects results from the blinded portion of the study during 2H09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance.

On 6/8/09, NeuroSearch (CPH:NEUR) announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.

The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.

Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.

Disclosure: No positions

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported, highly significant top-line results from the BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) trial.

BLOSSOM confirms the results previously reported for the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial and completes the lorcaserin Phase 3 pivotal registration program of 7,190 patients evaluated for up to two years. Arena plans to submit a New Drug Application, or NDA, for lorcaserin to the US Food and Drug Administration, or FDA, in December.

In the one-year BLOSSOM trial, lorcaserin met all primary efficacy and safety endpoints. Patients achieved highly significant categorical and absolute weight loss. Lorcaserin was very well tolerated and was not associated with depression or suicidal ideation. The integrated echocardiographic data set from BLOSSOM and BLOOM rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Treatment with lorcaserin also resulted in significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk.

“Today there are extremely limited options to meet the needs of physicians and patients in the real world clinical practice of weight management,” said Steven R. Smith, M.D., Executive Director of the Florida Hospital Clinical Research Institute. “Physicians need options that have the potential to help the typical obese patient lose significant weight by staying on a safe and well-tolerated treatment. The clinical data show lorcaserin is a solution that could provide physicians with a weight-loss medication applicable for broad use in the majority of their patients who need to lose weight and improve their health. BLOSSOM demonstrated that nearly two-thirds of lorcaserin patients lost a medically meaningful amount of body weight while avoiding unwanted side effects and a complicated titration program.”

“History has taught us that the marriage of efficacy and safety is of critical importance in treating patients. Neither is sufficient without the other. With its excellent safety and tolerability profile, we expect lorcaserin to change the way primary care doctors treat the broad cross-section of overweight and obese patients with pharmacotherapy,” said Jack Lief, Arena’s President and Chief Executive Officer. “With the completion of our robust Phase 3 pivotal program, we will focus on the NDA filing, work with the FDA during the review process and prepare for the commercialization of lorcaserin.”

Arena plans to present detailed data from both the BLOOM and BLOSSOM trials at the 27th Annual Scientific Meeting of The Obesity Society, scheduled for October 24-28 in Washington, D.C.

Efficacy

Per Protocol Results

Lorcaserin was highly effective in helping patients achieve significant weight loss using multiple measurements. Patients treated with 10 mg of lorcaserin dosed twice daily (BID) who completed the 52-week trial according to protocol demonstrated the benefit of long-term treatment with lorcaserin:

· 63.2% of patients lost at least 5% of their body weight (p<0.0001);

· 35.1% of patients lost at least 10% of their body weight (p<0.0001);

· Patients lost an average of 17.0 pounds, or 7.9% of their body weight; and

· The quartile of lorcaserin patients with the greatest weight loss (among those with a Week 52 weight recorded) lost an average of 35.1 pounds, or 16.3% of their body weight.

Of the placebo patients who completed the trial, 34.9% and 16.1% achieved at least 5% and 10% weight loss, respectively, and the average weight loss was 8.7 pounds, or 3.9%. The top quartile of lorcaserin patients lost 36% more body weight than the top quartile of placebo patients.

For the patients treated with 10 mg of lorcaserin dosed once daily (QD) and completing the 52-week trial according to protocol, 53.1% lost at least 5% of their body weight and 26.3% lost at least 10% of their body weight. The average weight loss in the lorcaserin 10 mg once daily group was 14.3 pounds, or 6.5%. As with the higher dose, all results were highly statistically significant (p<0.0001 compared to placebo).

Intent-to-Treat Last Observation Carried Forward (ITT-LOCF) Results

Measurements of efficacy using ITT-LOCF analysis also showed that lorcaserin met all primary endpoints. This analysis includes all patients who were randomized and returned for at least one weight measurement. Patients treated with 10 mg of lorcaserin once or twice daily achieved highly statistically significant categorical and average weight loss after 12 months:

Lorcaserin 10 mg Twice Daily

· 47.2% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 5% of their body weight compared to 25.0% for placebo (p<0.0001). This result satisfies the efficacy benchmark in the most recent FDA draft guidance which provides that a weight-management product can be considered effective if the proportion of patients who lose at least 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant;

· 22.6% of patients treated with 10 mg of lorcaserin dosed twice daily lost at least 10% of their body weight compared to 9.7% for placebo (p<0.0001);

Lorcaserin 10 mg Once Daily

· 40.2% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 5% of their body weight (p<0.0001); and

· 17.4% of patients treated with 10 mg of lorcaserin dosed once daily lost at least 10% of their body weight (p<0.0001).

Patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo (p<0.0001). Similarly, patients who took lorcaserin 10 mg once daily achieved an average weight loss of 4.8% of their body weight (p<0.0001).

BLOSSOM Confirms BLOOM

In BLOSSOM, as in BLOOM, lorcaserin’s excellent tolerability allowed patients to begin treatment at the full dose immediately, without a titration period, and achieve rapid weight loss. As in BLOOM, significant weight loss compared to placebo was shown at the first trial visit, two weeks following randomization.

The efficacy for the BLOOM and BLOSSOM trials after one year of treatment are summarized in the table below.

BLOOM                   BLOSSOM

-----                   -------

10 mg BID*  Placebo  10 mg BID*  10 mg QD*  Placebo

----------  -------  ----------  ---------  -------

>/=5% weight loss

(Per protocol)       66.4%     32.1%     63.2%       53.1%     34.9%

---------------       ----      ----      ----        ----      ----

>/=5% weight loss

(ITT-LOCF)           47.5%     20.3%     47.2%       40.2%     25.0%

---------------       ----      ----      ----        ----      ----

>/=10% weight loss

(Per protocol)       36.2%     13.6%     35.1%       26.3%     16.1%

----------------      ----      ----      ----        ----      ----

>/=10% weight loss

(ITT-LOCF)           22.6%      7.7%     22.6%       17.4%      9.7%

----------------      ----       ---      ----        ----       ---

Mean weight loss

(Per protocol)        8.2%      3.4%      7.9%        6.5%      3.9%

-------------          ---       ---       ---         ---       ---

Mean weight loss

(ITT-LOCF)            5.8%      2.2%      5.9%        4.8%      2.8%

---------             ---       ---       ---         ---       ---

•        p<0.0001 compared to placebo

“Lorcaserin demonstrated consistent results in the BLOOM and BLOSSOM trials, which together evaluated nearly 7,200 patients for up to two years,” said William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer. “These results support lorcaserin’s potential to meet the need for a safe, effective and well-tolerated weight loss medication. There are only two drugs that are approved by the FDA for long-term treatment, and new mechanistic and better tolerated approaches could greatly improve the treatment of patients who are obese or significantly overweight.”

Safety and Tolerability Profile

Lorcaserin was very well tolerated. No adverse event rate in the lorcaserin group exceeded the placebo group by more than 4%. The most frequent adverse events and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: upper respiratory infection (12.7%, 14.5%, 12.6%); nasopharyngitis (12.5%, 11.7%, 11.8%) and headache (10.0%, 10.5%, 7.6%).

Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group. Serious adverse events, or SAEs, occurred infrequently: one death occurred in the placebo group, no SAEs of seizure were reported and the number of neuropsychiatric SAEs in lorcaserin patients did not exceed the number in the placebo group.

Cardiovascular Safety

The integrated BLOOM and BLOSSOM echocardiography data set rules out a risk of valvulopathy in lorcaserin patients according to criteria requested by the FDA. Echocardiographic evaluations showed no association between lorcaserin and the development of heart valve insufficiency. Rates of new FDA-defined valvulopathy in BLOSSOM at Week 52 were as follows: lorcaserin 10 mg twice daily (2.0%), 10 mg once daily (1.4%) and placebo (2.0%).

“The echocardiographic safety data show no risk of valvulopathy,” commented Neil J. Weissman, M.D., Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. “In the individual and combined BLOOM and BLOSSOM data sets there is no evidence of a difference in the development of valve disease in lorcaserin patients versus control for up to two years of continuous use. No prospective echocardiographic program has ever studied this many patients for this period of time.”

Secondary Endpoints

Treatment with lorcaserin over one year was associated with significant improvements or strongly favorable trends compared to placebo in multiple secondary endpoints, including blood pressure and lipids.

Patient Disposition

BLOSSOM evaluated 4,008 patients with an average body mass index, or BMI, of 35.9 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin 10 mg twice daily (57.2%) and 10 mg once daily (59.0%) compared to patients on placebo (52.0%). Discontinuations for adverse events were low and as follows: lorcaserin 10 mg twice daily (7.2%), 10 mg once daily (6.2%) and placebo (4.6%).

Conference Call & Webcast

Arena will host a conference call and webcast presentation to discuss the results at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) on September 18, 2009. Jack Lief, President and Chief Executive Officer; Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer; William R. Shanahan, M.D., Vice President and Chief Medical Officer; and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call and webcast.

The conference call may be accessed by dialing 888.312.3047 for domestic callers and 719.325.2234 for international callers. Please specify to the operator that you would like to join the “Lorcaserin BLOSSOM Trial Results” conference call. The conference call and slide presentation will be webcast live under the investor relations section of Arena’s website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

BLOSSOM Trial Design

BLOSSOM is a double-blind, randomized, placebo-controlled trial that enrolled 4,008 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients (BMI 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include dose titration or a run-in period. Patients were randomized at baseline in a 2:2:1 ratio to lorcaserin 10 mg twice daily, placebo or lorcaserin 10 mg once daily. Patients received echocardiograms at baseline, month 6 and at the end of the trial to assess heart valve function over time. In contrast to the BLOOM trial, there were no echocardiographic exclusion criteria for entry into BLOSSOM and there was no oversight or interim data review monitoring by an independent safety monitoring board.

Phase 3 Program Overview

The lorcaserin Phase 3 program consists of three trials: BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). Enrollment in the lorcaserin Phase 3 program is complete with approximately 7,800 patients. Positive results from BLOOM were presented at the 69th Scientific Sessions of the American Diabetes Association in June 2009. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program and will be the basis for the lorcaserin NDA submission. BLOOM-DM, which is planned as a supplement to the NDA, is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US.

A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program’s hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids, markers of inflammation and insulin resistance, and in the BLOOM-DM trial, other indicators of glycemic control.

About the FDA Draft Guidance

The FDA draft guidance document “Developing Products for Weight Management” dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.

About Lorcaserin

Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

About Weight Management

The National Institutes of Health reported in 2007 that about 65% of US adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the US to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena has a broad pipeline of novel compounds targeting G protein-coupled receptors, an important class of validated drug targets, which includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Arena Pharmaceuticals® and Arena® are registered service marks of the company. “APD” is an abbreviation for Arena Pharmaceuticals Development.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the significance of the BLOSSOM and BLOOM results and the completion of the lorcaserin Phase 3 pivotal registration program; the development, advancement, therapeutic indication, tolerability, safety, selectivity and efficacy of lorcaserin; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the engineering of weight management drug candidates; the FDA’s guidance, process and requirements; the potential of the lorcaserin Phase 3 program and its results to satisfy the FDA’s approval requirements, including with regard to efficacy and safety; the risk of developing valvulopathy; future activities, results and announcements relating to lorcaserin, including submitting an NDA for lorcaserin, working with the FDA during the review process, submitting the BLOOM-DM results as a supplement to the NDA, and commercializing lorcaserin; lorcaserin’s commercial and other potential, including in managing weight, changing treatment, improving health and generating interest; the impact of weight loss on health; the treatment of patients with new mechanistic and better tolerated approaches; lorcaserin’s patent coverage; and Arena’s focus, strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Arena’s lorcaserin program and other of its research and development programs; results of clinical trials or preclinical studies may not be predictive of future results and top-line results are preliminary; clinical trials and studies may not proceed at the time or in the manner Arena expects or at all; Arena’s ability to partner or commercialize lorcaserin or other of its compounds or programs; the timing and ability of Arena to receive regulatory approval for its drug candidates; Arena’s ability to obtain additional funds; Arena’s ability to obtain and defend its patents; and the timing and receipt of payments and fees, if any, from Arena’s collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc.     Media Contact: Russo Partners

Jack Lief

President and CEO                        David Schull, President

david.schull@russopartnersllc.com

858.717.2310

Cindy McGee

Manager, IR and Corporate Communications Anthony J. Russo, Ph.D., CEO

858.453.7200, ext. 1479                  tony.russo@russopartnersllc.com

212.845.4251

www.arenapharm.com

 

 

For Immediate Release

Chicago, IL – November 3, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Clorox Company (CLX), Arena Pharmaceuticals (ARNA), Vivus Inc. (VVUS), Orexigen Therapeutics (OREX) and Amylin Pharmaceuticals (AMLN).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Monday’s AnalystBlog:

Clorox Cleans Up in 1Q

The Clorox Company (CLX) reported strong results for the first quarter of fiscal 2010 with earnings of $1.11 per share. Earnings were well above the Zacks Consensus Estimate of 95 cents and up 23.3% year-over-year.

Net sales for the quarter were almost flat year-over-year, declining marginally by 0.8%. The decline was primarily attributable to unfavorable foreign exchange rates, unfavorable product mix and higher trade-promotion spending. These factors were partially offset by the benefit of price increases, especially in the International segment.

Total volume increased 1%, primarily due to higher shipments of disinfecting wipes and bottled salad dressing, which were largely offset by lower shipments of trash bags and the company's exit from its private-label food bags business.

Amylin Strikes First on Obesity

Almost all of the news in the obesity race has been made recently by three small biotech companies -- Arena Pharmaceuticals (ARNA), Vivus Inc. (VVUS) and Orexigen Therapeutics (OREX), but yesterday it was mid-cap Amylin Pharmaceuticals (AMLN) that signed the first partnership in what was originally perceived to be a three-horse race.

Amylin and Takeda Pharmaceutical Company Limited entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pramlintide/metreleptin and davalintide, two phase II compounds for the treatment of obesity. As part of the transaction, Amylin will receive a one-time up-front payment of $75 million from Takeda.

Amylin is also eligible to receive additional payments based on development, commercialization and sales-based milestones that could exceed $1 billion. The agreement also provides for future tiered, double-digit royalty payments to Amylin based on global product sales.

In July 2009, Amylin presented phase II data from a phase II study in 149 patients testing pramlintide / metreleptin vs. placebo over a 28-week program. The data show that patients taking the pramlintide / metreleptin combination lost an average of 22 lbs (11% body weight) vs. only 4 lbs (2%) for the placebo. These are clearly impressive results.

An extension study with pramlintide / metreleptin in around 600 patients (six month study) should offer data before the end of the year. Also, management is testing pramlintide in a phase II trial with two commonly used anti-obesity agents, phentermine and sibutramine.

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