Regeneron soars on eye drug study results. Apricus submits SPA for cancer study. OraSure surges on HIV test update Print E-mail
By Staff   
Monday, 22 November 2010 19:32


Below is a look at some of the headlines for companies that made news in the healthcare sector on November 22, 2010.

Apricus Biosciences, Inc., (Nasdaq:APRI) today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for liver cancer with the FDA. The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which the FDA would give approval for the trial’s design, clinical endpoints and statistical analysis. The Phase 3 study is expected to take about 12-24 months depending on the recruitment of patients. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug Application for marketing approval of PrevOnco in the U.S.

Shares of Apricus soared 24% or 65 cents to close the day at $3.35. Earlier in the day the stock hit an intra-day high of $4.12.

Shares of Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) shot up Monday after the company, along with Bayer HealthCare today announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab, which is marketed by Roche under the trade name Lucentis. The disease usually effects older adults results in vision loss as new blood cells grow beneath the retina, leaking blood and fluid and causing retina damage and distorted vision and can eventually continue to blindness. The block buster drug Lucentis is currently the only FDA approved treatment for Wet AMD.

Shares of Regeneron gained $4.86, nearly 20%, to finish Mondays trading session at $29.53

OraSure Technologies, Inc. (Nasdaq:OSUR), surged more than 11% today after the company, a market leader in oral fluid diagnostics, announced that the U.S. Food and Drug Administration has granted an investigational device exemption (IDE) for the Company to conduct the final phase of clinical testing for FDA approval of its OraQuick Rapid HIV-1/2 Antibody Test. If eventually approved the company intends to market the device for sale in the consumer or over-the-counter ("OTC") market.

Receipt of the IDE will allow the Company to proceed with the final phase of clinical testing which consists of a study in which individuals will conduct unsupervised self-testing using the investigational OTC version of the OraQuick HIV test with an oral fluid collection.

Shares jumped 50 cents or 11.14% to $4.99 on volume of more than 1 million.

Heavy volume pushed shares of Advanced Cell Technology, Inc. (OTCBB:ACTC) up more than 42% today. As reported earlier today on BioMedReports, the company announced that the US Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt’s Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

Clinical Data, Inc. (NASDAQ:CLDA), today announced that data from clinical trials of vilazodone the companys novel investigational compound for the treatment of major depressive disorder (MDD) were presented at the annual meeting of the United States Psychiatric & Mental Health Congress. The presentations include results from two placebo-controlled Phase III clinical trials of vilazodone, as well as from a long-term safety study demonstrating vilazodone’s therapeutic profile as a potential treatment for MDD.

"These data demonstrate the clinical profile of vilazodone, including its effects on overall sexual function, which was shown to be similar to placebo when measured by validated scales," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Its unique mechanism of action as both a Serotonin 1A receptor Partial Agonist and Reuptake Inhibitor (SPARI), would make vilazodone, if approved, the first compound with a new mechanism to treat depression in well over a decade."

A New Drug Application for vilazodone was accepted for review by the FDA on May 21, 2010 with a January 22, 2011 PDUFA date.

Shares of Regenicin, Inc. (OTC Bulletin Board:RGIN.ob) were up 14% today. The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm for the treatment of severe burns among U.S. troops and civilians. Regenicin has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm. The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process. PermaDerm an engineered skin substitute grown from a patient's own skin cells, has already been used to treat more than 150 pediatric, catastrophic burn victims through an Investigation Device Exemption issued by U.S. Food and Drug Administration (FDA). This is PermaDerm's first clinical trial to be conducted on adults, a major milestone for achieving pre-market approval by the FDA.

The initial trial will contain 10 patients, both male and female, between the ages of 18 and 40, who suffer third-degree burns. These trials and future trials will take place at the United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined.

After the bell shares of Maxygen, Inc. (Nasdaq:MAXY), were up more than 11% after the biotechnology company focused on the development of improved protein drugs, announced that it will distribute substantially all of the shares of the common stock of Codexis, Inc. (Nasdaq:CDXS) that it owns, as well as approximately $30.0 million in cash, by way of pro rata special distributions to Maxygen’s stockholders. Maxygen stockholders will receive approximately 0.19 of a share of Codexis common stock for each outstanding share of Maxygen common stock they own at the close of business on December 3, 2010.

Also Monday:

Assisted Living Concepts, Inc. (NYSE: ALC) stated today that it is disappointed with recent actions taken by the New Jersey Department of Health and Human Services and disputes allegations in an order issued by the Department on Friday, November 19, 2010.

BioNeutral Group, Inc. (OTC Bulletin Board:BONU), a specialty technology-based life science company, today announced it has signed a "Stand Still" agreement with a leading pharmaceutical company, DFB Pharmaceuticals, Inc. (DFB).

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced the preliminary results of a phase II study of paclitaxel poliglumex (OPAXIO) combined with temozolomide (TMZ) and radiotherapy (RT) in patients with newly diagnosed high-grade gliomas.

China PharmaHub Corp. (OTC Bulletin Board:CPHB), a biopharmaceutical acquisition and development company, announced today that it has retained Stern Investor Relations, Inc. to develop and implement a comprehensive investor relations program for the Company.

Cord Blood America, Inc. (OTC Bulletin Board:CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, today said revenues for the third quarter ended September 30, 2010, increased 14 percent to $958,449 compared to $838,238 in the same period in 2009.

Esterline Technologies (NYSE: ESL) plans to announce financial results for its 4th quarter 2010 on Thursday, December 9, 2010. Esterline will host a conference call featuring remarks by Brad Lawrence, President and Chief Executive Officer, and Bob George, Vice President and Chief Financial Officer.

Hard to Treat Diseases, Inc. (PINK SHEETS:HTDS) announces that the merger negotiations with the Canadian Biotechnology company are proceeding well, and that the merger candidate permitted HTDS to release the name and additional information about the candidate:

Healthmed Services, Ltd. (PINKSHEETS: HEME) is pleased to announce the launch of "HealthTrac" software. HealthTrac is a Web-based open-source practice management solution for hospitals and physicians focusing on creating practice management as well as sales and marketing.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that that the company's exhibition of its barcoded syringe locking device generated overwhelming interest at the annual Medica 2010 Conference in Dusseldorf Germany, held November 16-19.

Patient Safety Technologies, Inc. (OTC Bulletin Board:PSTX) today announced financial results for its third quarter of 2010 and for the nine months ended September 30, 2010.

Pfizer Inc. (NYSE:PFE) today announced that its wholly-owned subsidiary, Parker Tennessee Corp., has extended the expiration date of its tender offer for all outstanding shares of common stock of King Pharmaceuticals, Inc. (NYSE: KG) for $14.25 per share, net to the seller in cash, without interest thereon and subject to any required withholding taxes.

Neuro-Biotech Corp. (PINKSHEET: MRES) (OTCQB: MRES) published answers to the most frequently asked questions.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that Alex V. Lukianov, Chairman of the Board and Chief Executive Officer, is scheduled to present at the Piper Jaffray "Unplugged" Health Care Conference at The New York Palace Hotel in New York, NY, on Wednesday, December 1, 2010, at 8:30 a.m. ET.

NxStage® Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today commented on the just- released findings of the Frequent Hemodialysis Network (FHN) Daily Trial that compared in-center hemodialysis administered under a three times per week schedule ("conventional dialysis") versus six shorter sessions per week ("short daily dialysis").

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today its business update, unaudited results and filing of its Form 10-Q with the Securities and Exchange Commission for the third quarter 2010.

Soligenix, Inc. (OTC Bulletin Board:SNGX) a late-stage biopharmaceutical company, announced today that the United States Patent and Trademark Office (USPTO) has granted patent #7,829,668, entitled "Compositions and methods for modifying toxic effects of proteinaceous compounds."

Transgenomic, Inc. (OTC Bulletin Board: TBIO) today announced that it has postponed its third quarter financial results and business update conference call and webcast previously scheduled for 5:00 Eastern time today.announced today that will acquire privately-held Ardian, Inc. Medtronic will make an up front cash payment of $800 million, plus commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Medtronic had previously invested in Ardian and currently holds an 11 percent ownership stake in the Company. Ardian develops catheter-based therapies to treat hypertension and related conditions.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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