XenoPort, Inc. (Nasdaq:XNPT) announced today preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil (also known as AP) as adjunctive therapy in patients with gastroesophageal reflux disease (GERD) who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors (PPI). In this study, subjects who experienced GERD symptoms despite PPI therapy were randomized to receive a PPI plus placebo, or a PPI plus one of four AP dose regimens (20 mg or 40 mg of AP dosed once daily (QD), or 20 mg or 30 mg of AP, dosed twice daily (BID)), for six weeks. None of the AP doses showed statistically significant improvements over placebo in the analysis of the primary endpoint. Analyses of key secondary endpoints did not yield consistent results when AP doses were compared to placebo.

Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer, stated, “We are disappointed that AP failed to demonstrate clear efficacy over placebo in this trial. While we will continue to analyze the data, at this time, we do not believe the efficacy results of this study warrant our investment in further development for AP in GERD. We believe the AP safety profile observed in this study continues to support our planned Phase 3 development program for AP in patients with spasticity.”

The randomized, double-blind, placebo-controlled Phase 2b clinical trial was conducted at 58 sites in the United States and Canada. The trial included a run-in period of up to four weeks whereby GERD patients with a history of incomplete response to a PPI were monitored while on PPI therapy. Subjects (n=460) who continued to experience four or more heartburn events over at least three days during baseline assessment in the third week of the run-in period, and who met other eligibility requirements, were randomized into a six-week double-blind phase of the study. Subjects received PPI therapy plus placebo, or PPI plus 20 mg QD, 40 mg QD, 20 mg BID or 30 mg BID of AP. The six-week treatment period included an up-titration period, and at the end of six weeks, subjects were tapered off treatment.

The primary efficacy endpoint was percent change from baseline in heartburn events per week with the primary analysis evaluating percent change from baseline in heartburn events at week six. Percent change in weekly heartburn events was analyzed using a repeated measures ANCOVA model. At week six, subjects in the placebo group showed a mean percent reduction in heartburn events of 68%. Although there were trends for improvement over placebo in the AP dose groups, none of the comparisons to placebo reached statistical significance.

AP was safe and generally well tolerated at all dose levels. There were six treatment emergent serious adverse events in five subjects, including one death that was due to arteriosclerosis, but none were assessed as related to AP. The most common adverse events in the combined AP dose groups were somnolence, dizziness and nausea that occurred in 16%, 13% and 11% of subjects, respectively, compared to 2%, 3% and 6% of subjects in the placebo group. Most reported adverse events were mild or moderate in severity. Withdrawals due to adverse events were 6% in subjects receiving placebo and 16% in subjects receiving AP. The most common reasons for withdrawal were nausea, somnolence, dizziness and headache, none of which exceeded 5%.

Conference Call and Webcast Information

XenoPort will host a conference call at 9:00 a.m. Eastern Time today to discuss the Phase 2b clinical trial results and plans for AP development. To access the conference call via the Internet, go to www.XenoPort.com. To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 706-679-1417. The reference number to enter the call is 53835577.

Position Targets and Safety Risk

XenoPort, Inc. (XNPT): Nasdaq are a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transporter mechanisms to improve the therapeutic benefits of drugs. Our most advanced product candidate is currently being evaluated in a Phase 3 clinical program for the treatment of restless legs syndrome, or RLS. RLS is a common, under-diagnosed neurological condition that frequently manifests itself as a sleep disorder. This product candidate has also successfully completed a Phase 2a clinical trial for the management of post-herpetic neuralgia, or PHN. PHN is a chronic type of neuropathic pain, which is pain resulting from nerve damage. Our second product candidate has generated positive data in a Phase 2a clinical trial for reducing the number of reflux episodes in patients with gastroesophageal reflux disease, or GERD.

Upcoming Catalysts for the first half of 2011

Catalyst 1
Arbaclofen placarbil also known as XP19986 is in Phase 2b clinical development for the treatment of gastroesophageal reflux disease, or GERD, and for the symptoms of spasticity. XenoPort currently holds all rights to this product candidate and top-line results are expected from now to the end of the 1st quarter of 2011  (NCT00978016).

Arbaclofen placarbil also known as XP19986

Catalyst 2
XP13512, Brand Name, Horizant(TM). The Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for Horizant for the treatment of moderate-to-severe primary restless legs syndrome (RLS) is April 6, 2011. Horizant is licensed to GlaxoSmithKline in the United States and several other countries.

Horizant(TM) also known as XP13512

About Horizant(TM) and FDA Approval
As most new drugs, Horizant(TM) has had its fair share of problems with the FDA on getting an approval. On Feb 17, 2010 they received the dreaded CRL letter issued by the FDA’s Center of Drug Evaluation and Research in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time. FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks. This of course had a devastating effect of the share price of XenoPort, Inc. sending the $19.60 share price to a new all-time low of $6.39 with a close of $6.67. As with most crushed drug stocks it rebounded over the coming months never recovering from the major blow by the FDA.

On Nov 05, 2010 XenoPort, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted for review GSK’s response to FDA’s Complete Response letter for Horizant(TM) (gabapentin enacarbil) Extended-Release Tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has designated the resubmission as a Class 2 response and set a new Prescription Drug User Fee Act goal date of April 6, 2011.

Ok, so what’s different and why was XNPT given another PDUFA date?. In the resubmission of Horizant to the FDA it also included safety updates and information in the clinical trials in patients who have been treated with Horizant(TM), and GSK amended the NDA from a 505(b)(1) to a 505(b)(2) application. What this means is that XenoPort, Inc. is now going for a 505(b)(2) application and will be able to use outside published non-clinical and historical studies and data for the FDA to consider, specifically studies to show if there is an association of gabapentin use with pancreatic cancer. Studies show high doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle.  You can find more in-depth information provided by GlaxoSmithKline here at the ClinicalTrials.gov NCT01138124.

Financings

As of September 30, 2010, XNPT had cash and cash equivalents of $14,512,000 and they also did a finance deal on Dec 09, 2010 for 4,000,000 shares of its common stock at a price to the public of $7.15 per share and a 30-day option to purchase up to an aggregate of 600,000 additional shares of common stock.

Shares Outstanding

As of October 15, 2010; 30,576,614 shares of the registrant’s common stock were outstanding.

Shares Short

Shares Short (as of Jan 31, 2011) were 2.48M shares. Shares short prior month was 2.29M this is an approximate figures.

Trading Range

The 52 week trading range is $5.66 – $11.82. Shares finished at $7.45 on Friday 18th Feb 2011.

Analyst Ratings

Although the ratings are more than 7 months old the price targets for XNPT range from $6.00 low end to a high end of $26.00.

Investor Relations

XenoPort, Inc.
3410 Central Expressway
Santa Clara, CA 95051
Phone: 408-616-7200 E-mail: IR@XenoPort.com

In our opinion, XenoPort, Inc. would be a risky trade to hold through the PDUFA date, but short term, we could or might see some value as the share price is not trading too much higher than the finance deal they completed in December for $7.15. Also, we have the Phase 2b that could come at anytime on XP19986. A little more risk is involved by buying before the data is released, but even if the data is good the markets seem to be selling on the news, no matter what or how good the data is. The PDUFA catalyst could or might start to add shareholder value to XenoPort, Inc., we have 33 trading days left before the X date. We like to think we might even see a pre X price range of $9.00 to $9.50 + if the markets hold up and there are no delays in the PDUFA date. XNTP has yet to start its run up, although we feel that there is more risk involved with the 2b data. This could or might start the catalyst whatever way the clinical results fall. Ways that one could play this, sit back and wait for the GERD 2b data and if it is negative buy in at a cheaper price for a run up for the PDUFA best way and much safer. But on the other side of the coin if the GERD results are overly positive it could be a start of a nice run little more risk as no one knows when the results will be released.

Always use your stop loss to limit your downside and know your sell targets before you trade if you trade any securities.

Pennystockpicksus may feature company’s for informational and research purposes only and does not recommend you Buy or Sell any company’s we feature or list on our website.
Please read our disclaimer at the top of the page.

Pennystockspicksus has received no compensation for this feature.
Article by http://www.pennystockpicksus.com (c)

ACUROX(R) Tablets New Drug Application Accepted for Filing With a Priority Review Classification
Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King’s New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) with a Priority review classification and a Prescription Drug User Fee Act (PDUFA) date of June 17, 2011. In addition to filing acceptance and assignment of a Priority review classification, the FDA’s filing communication letter to King also includes preliminary comments about potential review issues relating to an intranasal abuse liability study included in the NDA and requests additional information relating to this study and other issues. The preliminary notice of potential review issues is not indicative of deficiencies that may be identified during the FDA’s review of the NDA. No assurance can be given that any issues raised as part of the FDA’s review of the ACUROX® NDA (including the potential review issues in the FDA’s filing communication letter) will be addressed to the FDA’s satisfaction or that the ACUROX® NDA will be approved by the FDA.

About ACUROX® Tablets

ACUROX® is a patented, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient. ACUROX® is intended for oral administration with a targeted indication for the relief of moderate to severe pain. ACUROX® Tablets utilize Acura’s patented Aversion® Technology which is designed to limit or impede opioid abuse via intravenous injection of dissolved tablets and nasal snorting of crushed tablets. ACUROX® Tablets do not contain niacin.

About Priority Review Classifications

The FDA may assign an NDA a Priority review classification if its assessment of conditions and information available at the time the application is filed indicates the drug product has the potential to provide, among other things, significant improvements compared to marketed products. A Priority review classification by the FDA determines an NDA’s review timeline under PDUFA and is not intended to predict FDA approval of a drug or its market acceptance or sales potential.

About Acura Pharmaceuticals, Inc.

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates intended to provide abuse deterrent features and benefits utilizing the Company’s proprietary Aversion® and Impede™ Technologies, and other novel technologies. Acura entered into a License, Development and Commercialization Agreement with King (a wholly owned subsidiary of King Pharmaceuticals, Inc.) in October 2007 pursuant to which Acura and King would jointly develop ACUROX® Tablets (with and without niacin) and three additional opioid analgesic product candidates utilizing Aversion® Technology. On October 11, 2010, King entered into an agreement and plan of merger with Pfizer Inc. and on January 31, 2011 Pfizer announced the closing of the tender offer and that the completion of its acquisition of King through a short-form merger would occur on or about February 28, 2011. Upon completion of the merger, King will become a wholly-owned subsidiary of Pfizer.

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine. The filing of the Exelbine NDA means the FDA has made a threshold determination that it is sufficiently complete to permit a substantive review.

“We are pleased to have reached this important milestone, and look forward to working with the FDA on moving Exelbine toward approval in 2011,” said Brian M. Culley, Chief Executive Officer of ADVENTRX.

About Exelbine

ADVENTRX is seeking approval of Exelbine for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer. ADVENTRX submitted the NDA as a 505(b)(2) application that relies in part on the FDA’s findings of safety and effectiveness of a reference drug. The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by ADVENTRX to be bioequivalent.

ADVENTRX retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan. In March 2010, the FDA conditionally accepted “Exelbine” as the proposed proprietary name for ANX-530. The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims will issue in January 2011 and expire in November 2027.

Corcept Therapeutics Incorporated (NASDAQ:CORT – News) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing’s Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% responding in the glucose intolerant group and 43% in the hypertensive group. An initial review of safety data indicates that CORLUX was well tolerated by Cushing’s Syndrome patients in this Phase 3 study. “The results of the study demonstrate that CORLUX has the potential to become an important treatment option for patients suffering from Cushing’s Syndrome,” said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. “We remain on track to submit a New Drug Application (NDA) to the FDA for CORLUX in Cushing’s Syndrome by the end of the first quarter of 2011 and continue to work toward our goal of making CORLUX available to patients with this severe disease.”

Primary Endpoints Met in Both Patient Groups

Each group in the study had its own primary endpoint. The primary analysis is a responder analysis. In the “glucose intolerant group” (patients with diabetes or carbohydrate intolerance) a responder was defined as a patient who achieved a 25% or greater improvement in glucose tolerance as measured by a standard 2-hour glucose tolerance test at 24 weeks (or at the early termination visit) compared to baseline. In the “hypertension group” (patients with a diagnosis of hypertension) a responder was defined as a patient who achieved a 5 millimeter or greater improvement in diastolic blood pressure at 24 weeks (or at the early termination visit) compared to baseline.

The protocol for the trial dictates that if a sufficient number of patients in either the glucose intolerant group or the hypertension group are responders, such that the lower limit of the exact one-sided 95% binomial confidence interval (CI) for the responder rate is greater than 20%, then the trial will have demonstrated efficacy for the treatment of Cushing’s Syndrome. The calculation, which was predetermined in the study design, is based on analyzing the response rates in a modified intention to treat group (mITT) defined as those patients treated for at least 30 days (the mITT group).

•15 of 25, or 60%, of patients in the glucose intolerant group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate (lower bound of the 95% CI = 41.7 which equates to p < 0.0001).
•9 of 21, or 43%, of patients in hypertension group responded to treatment with CORLUX, significantly higher than the 20% hurdle rate (lower bound of the 95% CI = 24.5 which equates to p < 0.01).

CORLUX Was Well Tolerated In The Trial

CORLUX was well tolerated in the trial population. Although the detailed analysis of the safety data from the study has not yet been completed, the tolerability of CORLUX in the treatment of Cushing’s Syndrome in the Phase 3 study met our expectations. Adverse events related to treatment included symptoms of adrenal insufficiency, endometrial thickening, and hypokalemia, all of which were consistent with earlier published reports. The majority of the serious adverse events (SAEs) reported in the study were not related to CORLUX treatment, as determined by the clinical investigators. Of those that were related to treatment, all resolved with clinical management. We plan to present detailed safety data at scientific conferences during 2011.

Ninety percent of the patients who completed the Phase 3 study opted to enter the long-term extension study.

About the Phase 3 Trial Design

The Phase 3 trial was a 50-patient open-label study in endogenous Cushing’s Syndrome patients conducted at 17 clinical sites in the United States. Patients met the trial enrollment criteria if they were either not eligible for, had failed or had relapsed from surgery and were glucose intolerant or were diagnosed with hypertension at entry. Patients in the Phase 3 study were placed in one of two groups: those with glucose intolerance and those who were diagnosed with hypertension but were not glucose intolerant. In the trial, each patient’s CORLUX dose was titrated by their study investigator to the level necessary to achieve clinical benefit. The FDA indicated that this trial may provide a reasonable basis for the submission of an NDA for the treatment of endogenous Cushing’s Syndrome.

In addition to the primary endpoints described above, the key secondary endpoint in the trial was global clinical improvement, designed to capture the broader clinical benefit CORLUX may confer in this patient population. This endpoint is based on the evaluation of broader clinical outcomes by a Data Review Board, an independent three-member panel of academic physicians with expertise in Cushing’s Syndrome. Data on this key secondary endpoint is expected to be available in the first quarter of 2011.

Additional secondary measures of efficacy include changes from baseline to the end of the study in fasting plasma glucose, hemoglobin A1c (HgbA1c), change in glucose lowering medications, systolic blood pressure, change in antihypertensive medications, body composition, weight, bone turnover and bone density, cognitive/psychiatric assessments, metabolic functions, Quality of Life (SF-36 questionnaire), muscle strength and physical function. Detailed data, including data on these secondary endpoints is expected to be announced at scientific conferences during 2011.

CORLUX Regulatory Status Update

Corcept is planning to submit an NDA to the FDA late in the first quarter of 2011 based on the positive results of this Phase 3 study. The final Phase 3 trial design and our statistical analysis plan reflect the feedback Corcept received in discussions with the FDA.

CORLUX was granted Orphan Drug Designation by the FDA for the treatment of endogenous Cushing’s Syndrome in 2007. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.

We have added Cardium Therapeutics, Inc. (CXM): NYSE Amex to our featured and our watch list today. As our subscribers know we just love the pharma tech plays specially the smaller ones as they could have potential for some big moves.

Cardium Therapeutics, Inc. (CXM): NYSE Amex

Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative biomedical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetization’s. Cardium’s investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications.

Possible Upcoming Catalysts

As most know cardium submitted an FDA 510(k) application for the use of Excellagen ™ in the potential treatment of diabetic and other chronic wounds on the 4th of December 2009 and have been waiting over a year to date for the approval. The FDA do not give any guide lines for 501k device approvals, so the news could come any time as there are no set dates.

About Excellagen ™

Excellagen™ is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen (Type I), which is modified to reduce immunogenicity and promote its usefulness in wound settings. Excellagen is designed for use by health care professionals in patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. In December 2009, the Company filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen product candidate based on positive data from the Company’s recently completed Phase 2b clinical trial that demonstrated substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting for the treatment of larger soft tissue or tunneling wounds that may occur with pressure, venous and diabetic ulcers, and surgical wounds. The ExcellagenFX flowable matrix product allows for deeper administration and direct intimate contact with the wound bed in more complex, irregular and difficult to access wounds. Other categories of advanced wound care products are manufactured with alginates, hydrogels and hydrocolloids in structured, membrane or granular product configurations, or require hydration, mixing and reconstitution immediately prior to patient administration. The Company’s Excellagen fibrillar collagen protein gel is a physiologic formulation consisting of a bioactive and biodegradable material that promotes effective wound management by providing a moist protective barrier and stimulates the natural wound healing process through the promotion of cell migration and capillary in-growth to support tissue regeneration. The Company plans to develop additional new product opportunities by incorporating other agents into Excellagen formulations, including antimicrobials, DNA and/or other biologics, which are designed to address particular wound healing and other tissue repair applications.

Excellarate Clinical Study

The Company recently reported data from the multi-center Matrix Phase 2b clinical trial of Excellarate™ for the potential treatment of patients with chronic non-healing diabetic foot ulcers. The study evaluated patients treated with the Excellarate product candidate (combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone compared to patient who received only the protocol specified standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. In addition to overall wound closures by 12 weeks, the Phase 2b study also evaluated wound closure rates and trajectories following product administration in order to assess the timing and extent of bioactivity. The data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks.

” Click To Enlarge”

Product Development Pathway

Market for Excellagen

In a article back in may 2008 in Genengnews.com about active products in the wound care market costs the U.S healthcare system over $7 billion in 2007. If Cardium can even get a small part of that money from Excellagen™ that could mean some very interesting revenue for Cardium.

Financings

As of September 30, 2010 CXM had $7,700,648 in cash and cash equivalents and $1,425,000 in restricted cash.

Shares Outstanding

As of November 5, 2010; 78,566,750 shares of the registrant’s common stock were outstanding.

Shares Short

Shares Short (as of Nov 15, 2010) 3.15M Shares short prior month was 3.23M they are approximate figures and may not be 100% right.

Trading Range

The 52-wk trading range is $0.30 – $0.84 Shares finished at $0.40 yesterday 7th Dec 2010.

About Cardium

Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative biomedical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium’s investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications.

The Company’s business model is designed to create multiple opportunities for success while avoiding reliance on any single technology platform or product type, and to leverage Cardium’s skills in late-stage product development in order to bridge the critical gap between promising new technologies and product opportunities that are ready for commercialization. Consistent with our long-term strategy, we continue to pursue cost-effective acquisitions with strong value enhancement potential as our product opportunities and businesses are advanced and corresponding valuations established. We intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.

Investor Relations
Bonnie Ortega
Director of Investor Relations/Public Relations
12255 El Camino Real
Suite 250
San Diego, CA 92130
Phone: 858-436-1018
E-mail: investorrelations@cardiumthx.com

WebSite
http://www.cardiumthx.com/

In our opinion CXM could or may be a high return speculative play, with a possible FDA approval some time soon “No Time Frame” on its new and exciting product Excellagen ™ that could help millions of people world wide with this serious condition. There are many factors that are built into this speculative play like a possible delisting from the AMEX or more dilution for share holders. We think priced at $0.40 and a possible catalyst that could happen anytime this could be a fairly high risk and specutilive reward play.

Pennystockpicksus may feature companies for informational and research purposes only and does not recommend you Buy or Sell any companies we feature or list on our website.
Please read our disclaimer at the top of the page.

Pennystockspicksus has received no compensation for this feature. 
Article by http://www.pennystockpicksus.com (c)

We have added Biosante Pharmaceuticals, Inc. (BPAX): Nasdaq to our featured and our watch list today. As our subscribers know we just love the pharma tech plays specially the smaller ones as they could have potential for big moves.

Biosante Pharmaceuticals, Inc. (BPAX): Nasdaq focuses on products for female sexual health, menopause, contraception, and male hypogonadism. BPAX’s pipeline includes LibiGel, a transdermal testosterone gel for the treatment of female sexual dysfunction, Bio-T-Gel, a transdermal testosterone gel for the treatment of hypogonadism, and The Pill-Plus for the treatment of female sexual dysfunction in women using oral or transdermal contraceptives.

Upcoming Catalysts in 2010

BIO-T-Gel Biosante Pharmaceuticals, Inc. Hopes to announce the submission for a NDA application for the BIO-T-Gel by year end or early 1Q11 by TEVA

The Pill-Plus™ has Phase II data that the company hopes to announce by the end of 4Q10.

GVAX: Expect clinical hold to be lifted (to partial hold) soon w/ new prostate CA trial at Hopkins anticipated to begin in 4Q10.

LibiGel: Expected enrollment of 2,500 to 4,000 for completion for safety trial 3Q10 with data 3Q11, est enrollment completion for both pivotal trials 4Q10 with data 3Q11

Shares of Biosante Pharmaceuticals, Inc. are trading at $1.71 and have a 52 week low of $1.29 and a 52 week high of $1.69

Financings

As of September 30, 2010, the Company had $35.5 million of cash and cash equivalents.

In 1Q10 they had a net loss of $10.5M and $10.8M net loss in 2Q10

As of August 12, 2010, 70,802,894 shares of common stock and 391,286 shares of class C special stock of the registrant were outstanding.

Trading Range

The 52-wk trading range is $1.29 – 2.50. Shares finished at $1.46 yesterday.

Latest News 13/09/2010

Roth Capital initiates coverage on BioSante Pharmaceuticals (Nasdaq: BPAX) with a Buy rating. PT $4.

Biosante’s Pipe Line ” Click To Enlarge”

About Biosante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel^® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development is a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, currently in several Phase II clinical trials, at minimal cost to BioSante. Other products in development are Bio-T-GeI™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ: TEVA) and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies.

Investor Relations
Tricia Swanson
The Trout Group LLC
Phone: (646) 378-2953
E-Mail: tswanson@troutgroup.com
 

Web Site
http://www.biosantepharma.com

Pennystockpicksus may feature companies for informational and research purposes only and does not recommend you Buy or Sell any companies we feature or list on our website.
Please read our disclaimer at the top of the page.

Pennystockspicksus has received no compensation for this feature.
Article by http://www.pennystockpicksus.com (c)

Due to the fact that there was a article on seekingalfa followed by 18 million share pipe deal after the close we have removed our feature on BPAX,

Myrexis. (Nasdaq: MYRX) a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced a poster presentation of its lead product candidate Azixa(TM) (verubulin, MPC-6827) at the 2010 Society for Neuro-Oncology Scientific Meeting and Education Day in Montreal, Canada.

Dr. Sean Grimm of the Northwestern University Brain Tumor Institute was the lead author on a poster titled, “Phase 2 study of Azixa (MPC-6827) for the treatment of glioblastoma after bevacizumab failure,” which highlighted updated results from a subset of patients in the ongoing, open-label Phase 2 monotherapy study of Azixa in treatment-experienced patients with recurrent glioblastoma multiforme (GBM).

Azixa monotherapy was well-tolerated and demonstrated anti-tumor activity with a mean overall survival of 105 days in patients who had failed prior Avastin(R) (bevacizumab) treatment. In this cohort, one patient, in his twelfth month of Azixa treatment and whose treatment is continuing, has seen tumor regression of more than 80%, and four additional patients experienced stable disease.

“The overall prognosis for GBM patients who fail second-line Avastin therapy is extremely poor. We believe that the best approach to improving the prognosis of GBM is to treat patients with Azixa earlier in their disease,” said Dr. Adrian Hobden, President and Chief Executive Officer of Myrexis Inc. “Azixa represents a novel therapeutic with high CNS penetration and encouraging signs of activity in GBM patients. We intend to initiate a study of Azixa in combination with temozolomide and radiation therapy in newly diagnosed patients with GBM.”

The poster focused on the subset of patients with the poorest prognosis, whose disease progressed following both first- and second-line treatments, including Avastin. Another subset of patients had only failed first-line therapy, which consists of temozolomide and radiation therapy. Data from this second arm will be reported next year. In addition to this ongoing Phase 2 Azixa monotherapy study in treatment-experienced GBM patients with recurrent disease, Myrexis plans to initiate enrollment in a Phase 2b clinical study of Azixa in front-line GBM patients later this year. The planned two-arm, randomized, controlled study will evaluate Azixa in combination with standard of care, which consists of temozolomide plus radiation therapy, compared to standard of care alone.

About Azixa (verubulin, MPC-6827)

Azixa is the lead product candidate under development by Myrexis for the treatment of primary brain cancers. Azixa is a novel small molecule that acts as a microtubule destabilizing agent, causing an arrest of cell division with subsequent programmed cell death, or apoptosis, in cancer cells. Several currently marketed clinically effective drugs share the identical mechanism of action. Importantly, however, Azixa has two unique, distinguishing characteristics. In non-clinical studies, Azixa has demonstrated the ability to effectively cross the blood-brain barrier and accumulate in the brain at levels as much as 30 times that measured in the plasma. In addition, Azixa does not appear to be subject to multiple drug resistance (MDR) mechanisms.

In June of 2010, Myrexis presented data from two Phase 2a clinical studies that demonstrated Azixa, in combination with standard chemotherapy, resulted in durable responses with no additive toxicity in patients with glioblastoma multiforme (GBM) and metastatic melanoma.

Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company’s new drug application (NDA) for Linjeta�cent; (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.

The CRL stated that the FDA’s review cycle is complete and that the application cannot be approved in its present form. Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company’s next steps and requirements for approval of Linjeta�cent;.

The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.

With regard to efficacy, the FDA stated that, in the type 1 trial analysis, excluding data from India was post-hoc and therefore not sufficient for establishing conclusive evidence of efficacy. In the type 2 trial analysis, the FDA acknowledged that non-inferiority was established in the completer population but stated that non-inferiority was not established in the intent-to-treat population because the agency did not consider a post-hoc modification of the statistical model as establishing conclusive evidence of efficacy. With regard to safety, the FDA commented that unequivocal non-inferiority needs to be achieved in order to compare the risk of hypoglycemia. The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration.

The FDA also requested additional data related to stability and manufacturing. In addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.

Dr. Errol De Souza, Biodel’s president and chief executive officer, stated: “We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward. We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes.”

Biodel’s senior management will host a conference call today to discuss the CRL.

8:15 am EDT:
Conference call participants should dial:

+1 (877) 303 – 8028 (United States) or

+1 (760) 536 – 5167 (International)

8:30 pm EDT:
Conference call begins

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena’s New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >/= 30) or patients who are overweight (BMI >/= 27) and have at least one weight-related co-morbid condition.

The FDA has completed its review of the NDA and determined that it cannot approve the application in its present form. In the CRL, the FDA outlined the non-clinical and clinical reasons for their decision.

The non-clinical issues identified by the FDA included diagnostic uncertainty in the classification of mammary masses in female rats, unresolved exposure-response relationship for lorcaserin-emergent mammary adenocarcinoma, and unidentified mode of action and unclear safety margin for lorcaserin-emergent brain astrocytoma.

The CRL included the following requests related to the non-clinical issues: provide a detailed accounting of all slides prepared from female rats that contributed to mammary tumor incidence data in each update to the FDA and to the final study report; in consultation with the FDA, identify an independent pathologist or group of pathologists to re-adjudicate all mammary and lung tissues (neoplastic and nonneoplastic lesions) from all female rats; demonstrate that the apparent increase in aggressiveness of adenocarcinoma in rats administered lorcaserin is reasonably irrelevant to human risk assessment; and provide additional data/information regarding the distribution of lorcaserin to the CNS in animals and human subjects that would clarify or provide a better estimate of astrocytoma exposure margins.

With respect to the clinical reasons, the FDA stated in the CRL that the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal and recommended that Arena submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in DiabetesMellitus) trial. The FDA also stated in the letter that in the event evidence cannot be provided to alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin’s benefit-risk profile.

The BLOOM-DM trial evaluated lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus. The trial is complete, and Arena expects to announce top-line results in the next few weeks and to have a completed study report by the end of the year.

Additionally, the FDA stated in the CRL that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete preclinical studies that may lead to a different recommendation.

“This is an important step for us toward the FDA’s approval of lorcaserin,” said Jack Lief, Arena’s President and Chief Executive Officer. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline. We will work with the agency to address the issues with our NDA as quickly as possible.”

Arena intends to request a Type A meeting with the FDA to clarify its requests, and, if the meeting is granted, the FDA’s guidance states that it should occur within 30 days of the request.

Lonnel Coats, President and Chief Executive Officer of Eisai Inc., stated, “Eisai is committed to collaborating with Arena to address the FDA’s requests. Obesity is an epidemic in America, and our goal is to bring lorcaserin to physicians and patients who need additional weight loss options.”

Conference Call & Webcast

Arena will host a conference call and webcast on Monday, October 25, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the “Lorcaserin” conference call. The conference call 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.

Lorcaserin New Drug Application

The lorcaserin NDA is based on a data package from lorcaserin’s development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years.

About Lorcaserin

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.