MELA Sciences flys on PMA date. Anadys Pharma seeks strategic alternatives. After the bell Alexza rises on positive clinical study results, InterMune sheds workforce by 40 percent Print E-mail
By BioMedReports.com Staff   
Wednesday, 26 May 2010 19:30
Below is a list of the companies that made news in the healthcare sector on Wednesday, May 26, 2010.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) rose after the bell after the company reported positive results of clinical studies in patients with schizophrenia or bipolar disorder demonstrated that Staccato loxapine (AZ-004) reduced agitation in patients, regardless of the level of agitation at baseline. Improvement in agitation levels were observed as early as 10 minutes after dosing on the standard components of agitation as measured by the Positive and Negative Syndrome Scale - Excited Component (PEC). Staccato loxapine also had no significant hemodynamic effect in subjects taking chronic antipsychotic treatment and did not significantly prolong the QT interval at therapeutic doses. These and other efficacy and safety data from clinical trials involving more than 700 patients and subjects were presented in poster presentations today at the Annual Scientific Sessions of the American Psychiatric Association meeting in New Orleans, LA.

In a separate announcement the company said it has obtained a committed equity financing facility under which it may sell up to $25 million of its registered common stock to Azimuth Opportunity, Ltd. over a 24-month period. Alexza is not obligated to utilize any of the $25 million facility and remains free to enter into and consummate other equity and debt financing transactions. This facility replaces a similar facility that was established in March 2008 and expired after its 24-month term.

Shares of Alexza were up nearly 6% in the extended session.

InterMune, Inc. (Nasdaq:ITMN) announced after the bell that the company will reduce its workforce by 40 percent. The company said the jobs cut will affect 60 employees in the commercial and discovery research area. InterMune expects to realize about $12 million per year in savings.

InterMune was hit hard earlier in the month after the FDA denied approval of the company's experimental drug pirfenidone which was developed to treat idiopathic pulmonary fibrosis (IPF) a disease that causes lung scarring.

Shares of InterMune fell 31 cents or 3.49% in the after hours session.

In news from earlier in the day:

MELA Sciences, Inc. (NASDAQ:MELA) soared today after the company announced that the company's pre-market approval (PMA) application for MelaFind will be reviewed by the General and Plastic Surgery Devices Panel appointed by the U.S. Food and Drug Administration on August 26, 2010.

"We are so pleased to see the MelaFind review process move forward," said Joseph V. Gulfo, MD, President & CEO. "We and our advisors look forward to the Panel meeting with great anticipation. We have had positive and constructive interactions with the agency culminating in the submission of our formal response to the FDA's questions regarding the PMA application earlier this month. We are now fully focused on preparing for the August 26th panel meeting and firmly believe that MelaFind will be found to be a valuable tool to help dermatologists detect melanoma at the earliest, most curable stage."

The company also reported the results of its internet-based US reader study performed by 155 physicians, including 110 dermatologists, on images and clinical information derived from 130 lesions (melanomas and non-melanomas) enrolled in the MelaFind pivotal trial. The average sensitivity of dermatologists was 72%. The sensitivity of MelaFind was 96.9%, which was statistically significantly superior to dermatologists at p-value of less than 0.0001. The Company plans to submit the results of the reader study to a peer review journal for publication.

The panel will review the MelaFind PMA application, which the company submitted to the agency in June 2009. It is based on the positive results of the company's landmark pivotal study, which included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection. Prior to the start of the study, the company and the FDA entered into a binding protocol agreement to stipulate the study design, including the sensitivity and specificity endpoints that should be used to determine the safety and effectiveness of MelaFind. The company believes that the results of the pivotal study met and exceeded the pre-defined endpoints.

As previously reported, the company received a letter from the FDA on March 19, 2010 with a series of questions regarding the MelaFind PMA application. The Company was advised that the application was not approvable at that time, and that the review process had been extended by a period of up to 180 days following the submission of the response to the FDA action letter.

A draft response was submitted to the FDA in mid-April. In addition, the Company also had an in-person meeting with the Agency to review its draft response and to clarify several questions. The final formal response to all questions provided by the FDA was submitted to the Agency on May 7, 2010.

Shares of MELA Sciences soared more than 25% or $1.53, closing the day at $7.57.

Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) rose more than 5% today after announcing that it has retained Lazard Freres & Co. LLC as its strategic advisor as it pursues various avenues aimed at value recognition for its stockholders from its non-nucleoside polymerase inhibitor, ANA598, in development for the treatment of hepatitis C. Anadys recently released positive safety and antiviral response data at the conclusion of 12 weeks of dosing ANA598 in combination with pegylated interferon and ribavirin (current standard of care, or SOC) in an ongoing Phase II study.

"The impressive safety and antiviral response data we recently released establish a very attractive profile for ANA598," said Steve Worland, Ph.D., President and CEO of Anadys. "We look forward to working with Lazard as we pursue options to maximize recognition of the value inherent in the ANA598 program."

A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced that it has hired a leading consulting practice in pharmaceutical regulatory affairs to lead the U.S. Food and Drug Administration review process and formed a special committee of the Board to oversee the Company’s regulatory affairs. These actions have been taken to maximize the probability of approval by the FDA of APF530, its lead product candidate for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. APF530 is a long-acting formulation of granisetron that utilizes the Company’s proprietary Biochronomer drug delivery system. In March 2010, A.P. Pharma received a Complete Response Letter from the FDA regarding its New Drug Application submitted in May 2009. The Complete Response Letter outlined several issues that would need to be addressed prior to FDA approval of APF530. "In going forward, we have one goal in mind: to thoughtfully and thoroughly address FDA’s remaining concerns as outlined in the March 2010 Complete Response Letter so that we may best facilitate the approval of our lead product," stated Paul Goddard, Ph.D., Chairman of the Board.

Cord Blood America, Inc.(OTC Bulletin Board:CBAI.ob), announced today its stem cell processing and storage subsidiary, CorCell, is launching "Afford-A-Cord," which reduces the initial cost of storing umbilical cord blood stem cells from $2075 to $495 plus medical courier service. The Afford-A-Cord program will be offered as an additional payment option to CorCell's long standing traditional payment programs.

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced a definitive agreement to sell its Specialty Chemicals business to an affiliate of New Mountain Capital, L.L.C. for a cash purchase price of $280 million.

Covidien’s Specialty Chemicals business, headquartered in Phillipsburg, New Jersey, manufactures and markets high-purity chemicals and related products and services under two well-known and respected brand names, J.T.Baker and Mallinckrodt Laboratory Chemicals. These products are widely used in research and quality control laboratories, microelectronics, environmental testing laboratories and universities, and for manufacturing in the pharmaceutical, biotechnology and other industrial markets.

The decision to divest Specialty Chemicals is consistent with Covidien’s strategy to streamline its portfolio and reallocate resources to its faster-growing, higher-margin businesses, where the Company has or can develop a global competitive advantage.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that the targeted enrollment in a Phase IIb trial for EpiCept NP-1 in chemotherapy-induced peripheral neuropathy (CPN) has been attained. The trial is being conducted by National Cancer Institute (NCI)-funded Community Clinical Oncology Program. EpiCept NP-1 is a patented topical cream formulation of two FDA- approved drugs, 4% amitriptyline and 2% ketamine, and is intended to provide long-term relief from the pain of peripheral neuropathies. CPN may affect 50% of women undergoing treatment for breast cancer.

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360 System in treating coronary arteries.

IGI Laboratories, Inc. (NYSE Amex: IG), edged higher after the company today announced that it has entered into a product development and supply agreement with Impax Laboratories of Hayward, CA, a leading marketer of prescription pharmaceutical products. Under the agreement, IGI will be responsible for developing two topical drug products, obtaining FDA marketing approvals, and manufacturing the commercial products for Impax. IGI President and CEO Charlie Moore commented, "IGI is proud to announce this partnership with a prestigious pharmaceutical company such as Impax. We hope this will lead to further opportunities for cooperation in the topical products arena."

Kensey Nash Corporation (Nasdaq:KNSY),moved higher after the company today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its second extracellular matrix (ECM) product, the Meso BioMatrix™ product. The clearance allows for the use of Meso BioMatrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair, plastic and reconstructive surgery, and urologic, gynecologic and gastroenterologic applications.

Micro Identification Technologies, Inc. (OTC.BB:MMTC) jumped higher today after the company announced that it has signed an Agreement with OSI Optoelectronics (OSIO), a subsidiary of OSI Systems (NASDAQ:OSIS) to manufacture its microbial rapid identification system, the MIT 1000. OSIO has manufacturing facilities in California, Malaysia and India. "All of OSIO's world class facilities are ISO 9001:2000 certified and FDA registered and GMP compliant making them a perfect company to fabricate MIT's systems for its current food safety applications and its planned pharmaceutical and clinical diagnostic applications," stated John Ricardi, MIT's Executive Vice President and Chief Operating Officer. In addition, OSIO fabricates the photodiode detectors that are used in the MIT 1000 and has the ability to supply other components. OSIO's vast experience in MIT's targeted markets will also enable them to assist MIT in future product designs to both accelerate and ensure those products meet the stringent requirements of those industries. "We are pleased to work with MIT as we feel their innovative product will become a valuable tool to help prevent widespread bacterial contamination," stated Manoocher Mansouri, OSIO's President.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Valacyclovir Hydrochloride Tablets, 500 mg (base) and 1000 mg (base), the generic version of GlaxoSmithKline's Valtrex, a treatment for the herpes virus infection. The product is being distributed by Mylan Pharmaceuticals Inc. and is shipping to customers.

Valacyclovir Hydrochloride Tablets had U.S. sales of approximately $2.15 billion for the 12 months ending March 31, 2010, according to IMS Health.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) announced today that the Cancer Therapy & Research Center at the University of Texas Health Science Center in San Antonio (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with gemcitabine (Gemzar(R)) in patients with advanced pancreatic cancer. The Principal Investigator is Dr. Monica Mita of the CTRC.

"Pancreatic cancer has a dismal prognosis and no drugs have shown significant clinical benefit when added to gemcitabine for this patient population," said Dr. Mita. "We are extremely pleased to initiate this study and to have this promising treatment option for our patients."

Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has acquired rights to Novel Laboratories' pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets), indicated for the cleansing of the colon as a preparation for colonoscopy in adults. Annual sales for the Braintree Laboratories brand were approximately $80 million according to Wolters Kluwer.

Rosetta Genomics, Ltd. (NASDAQ:ROSG ), jumped more than 11% today after the developer and provider of microRNA-based molecular diagnostic tests, announces new data from two studies using the Company’s miRview mets test to predict the tissue of origin (ToO) in patients with cancer of unknown primary site (CUP) will be presented in a poster session and in the abstract book at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting to be held at the McCormick Place Convention Center in Chicago from June 4-8, 2010.

Researchers from the University of Texas, M. D. Anderson Comprehensive Cancer Center, considered a leading tertiary referral hospital which handles some of the more challenging CUP cases, will hold a poster presentation to discuss an ongoing prospective study conducted in collaboration with Rosetta Genomics. In the study involving 90 tissue samples, miRview mets demonstrated high concordance with the clinical diagnosis determined by the clinicians at M. D. Anderson.

Synovis Life Technologies, Inc. (Nasdaq: SYNO), rose nearly 7% today after the company reported record revenue for the second quarter ended April 30, 2010.

For the 2010 fiscal second quarter, net revenue rose to $17.6 million, a 19 percent increase over $14.8 million in the year-ago period. Net income was $1.2 million, or $0.11 per diluted share, in the fiscal second quarter, versus net income of $2.1 million, or $0.18 per diluted share, in the year-earlier period. As expected, net income was lower than last year, chiefly due to the expansion of the Surgical direct sales force in the second half of 2009 and the incremental operating costs of Synovis Orthopedic and Wound.

"We are pleased to announce strong second quarter revenues – a direct result of our investment in the expanded Surgical sales force, high demand in the marketplace for our Veritas products, and our increasingly effective and maturing Microsurgical sales team," said Richard W. Kramp, Synovis Life Technologies’ president and chief executive officer. "Our Surgical sales team is focused on the large opportunities in the hernia and breast reconstruction markets, while our Microsurgical sales professionals continue to demonstrate the benefits of our proven Coupler technology, along with our unique micro clips and instruments, to the microsurgery market."

Tengion Inc. (Nasdaq:TNGN) today announced that its scientists have presented new research data in three podium presentations at the 16th Annual Meeting of the International Society for Cellular Therapy (ISCT) which was held May 23-26 in Philadelphia. These presentations highlighted key findings in Tengion's Neo-Urinary Conduit and Neo-Kidney Augment programs and provided further information about the company's work with various cell types -- adipose-derived smooth muscle cells and human kidney cells -- that support its current and planned clinical development programs.

Also Wednesday:

Advanced Plant Pharmaceuticals, Inc. (PINKSHEETS: APPI) announced today that in preparation for the company's new business plan, APPI has reduced its corporate short term and long term debt approximately 90% through the conversion of debt to equity and the company is now largely debt free to provide the future financial flexibility to build the company's business in the rapidly growing sector of biofuels.

ARTEC, Inc., (Pink Sheets: ATKJ), has improved Tubercin T-5 an immunostimulant. In the last two years, Artec asserts that Tubercin has improved significantly and tested in Africa, in the company's opinion, with positive results on human patients afflicted with HIV/AIDS.

BioElectronics Corporation (PINKSHEETS: BIEL), developers of innovative electromagnetic pain-relieving medical devices, announced today that it has expanded distribution of its clinically-proven ActiPatch, Recovery Rx and Allay dermal patch systems to Russia through an agreement with The Netherlands' OMEC B.V.

BioScrip, Inc. (Nasdaq: BIOS) today announced that the Company will present at two upcoming conferences.

CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that its shareholders elected Robert Forrester to the Board of Directors at the CPEX 2010 Annual Meeting of Stockholders.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that company management will present at three investor conferences during June 2010 to discuss the Company's business activities, financial outlook, and current news.

CVS Caremark (NYSE:CVS), the nation's leading pharmacy health care provider, has surpassed its 10-year "Pathways to Pharmacy" goal of introducing one million youths to pharmacy as a potential career and met its target of $4 million in summer internship wages for high school students since 2000, the company reported today to Congress's Joint Economic Committee chaired by Rep. Carolyn B. Maloney of New York and with Sen. Charles E. Schumer of New York serving as Vice Chair from the Senate.

HealthWarehouse.com, Inc. (OTC Bulletin Board: HEWA), a leading retail mail-order pharmacy, announced today it has received Verified Internet Pharmacy Practice Sites(CM) (VIPPS(CM)) accreditation from The National Association of Boards of Pharmacy (NABP).

ImmunoCellular Therapeutics. Ltd. or "IMUC" (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, issued a Letter to Shareholders today updating company developments.

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has entered into a product development and supply agreement with IGI Laboratories, Inc., a formulation and manufacturing company.

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it will present at the Jefferies 2010 Global Life Sciences Conference at 8:00 a.m. Eastern Time on June 9, 2010, in New York, NY.

The Board of Directors of McKesson Corporation (NYSE:MCK) at its meeting today approved a change in its dividend policy by increasing the amount of the Company's regular quarterly dividend by 50%.

Macada Holding, Inc. (PINKSHEETS:MCDA) announced that its subsidiary Lyfetec, Inc. has signed a purchase agreement which will help minimize or help prevent staph infections and most infectious bacteria.

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative biomedical surgical oncology products, today announced that its Board of Directors has nominated Brendan A. Ford and Eric K. Rowinsky, M.D. to serve as members of Neoprobe's Board of Directors.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB), a developer of alternative drug delivery systems, announced today that the paper entitled, "Open-label study to assess the safety and pharmacodynamics of five oral insulin formulations in healthy subjects," authored by Dr. Roy Eldor, Dr. Miriam Kidron and Dr. Ehud Arbit, was accepted and published in the Diabetes, Obesity and Metabolism (DOM) journal.

Pfizer Inc. (NYSE:PFE) named Mikael Dolsten, M.D., PhD, President of Pfizer Worldwide Research and Development, as the Company completes its integration of these functions following the Wyeth acquisition.

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, will be presenting at the UBS Global Specialty Pharmaceuticals Conference.

PPD, Inc. (Nasdaq: PPDI) today announced it has launched Expert Community, an online, interactive area on its corporate website, where company and other industry professionals can engage in a robust exchange of ideas and opinions regarding important clinical research topics and trends.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.




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