AVEO Pharma drug receives EMA orphan status. After the bell: MannKind up on positive AFREZZA study. Jazz announces advisory committee review date Print E-mail
By BioMedReports.com Staff   
Thursday, 24 June 2010 18:40
Below is a list of the companies that made news in the healthcare sector on Thursday, June 24, 2010.

MannKind Corporation (NASDAQ: MNKD) after the bell today reported that a study, showing that AFREZZA Inhalation Powder, combined with basal insulin is comparable to standard insulin therapy in controlling post-meal blood sugar levels in adult patients with Type 2 diabetes, and offers the added benefits of significantly less weight gain and lower risk of hypoglycemia, will be presented on Saturday, June 26, at a special symposium co-hosted by The Lancet and the American Diabetes (ADA), at the American Diabetes Association’s 70th Scientific Sessions®. The study will also be published in the June 26 issue of The Lancet, one of the world’s leading medical journals.

"Insulin therapy is often a delayed strategy in patients with Type 2 diabetes, because it is associated with weight gain, hypoglycemia and the need for subcutaneous injections," said Daniel L. Lorber, M.D., F.A.C.P., C.D.E., Medical Director of the Diabetes Control Foundation, Diabetes Care & Information Center in Flushing, NY, and co-author of the published study. "Our findings show that mealtime AFREZZA, in combination with once-daily injected glargine, provides equivalent glucose control with fewer injections, less hypoglycemia and less weight gain than does twice-a-day, premixed insulin."

After jumping more than 10% earlier in the day, shares of MannKind rose another 24 cents to $6.80 after the bell.

Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) after hours announced that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

In February 2010, the FDA accepted for filing and review the New Drug Application of JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

Shares of Jazz were up 15 cents to $8.34 in extended trading.

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted antibody-based anticancer products, announced after the bell that sanofi-aventis has initiated a Phase I clinical trial with SAR650984, an investigational antibody that targets cancer cells expressing the CD38 protein antigen. This event triggers a $1 million milestone payment to ImmunoGen.

Developed under a research collaboration between ImmunoGen and sanofi-aventis, SAR650984 is being evaluated as a potential treatment for a number of hematological (blood) tumors, including acute and chronic lymphocytic leukemia, acute and chronic myeloid leukemia, multiple myeloma and non-Hodgkin’s lymphoma. In preclinical testing, SAR650984 has been found to be an effective anticancer agent.

ImmunoGen moved 11 cents to $9.95 after hours.

In news from earlier in the day:

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced it has received orphan medicinal product designation for tivozanib, its oral, triple VEGF receptor inhibitor, for the treatment of renal cell carcinoma by the European Medicines Agency. According to the EMA, tivozanib was awarded orphan medicinal product designation based on the prevalence of renal cell carcinoma among people in the European Union; the life-threatening nature of the disease particularly for those with advanced or metastatic renal cell carcinoma; and the assumption that tivozanib may provide significant benefit for patients with renal cell carcinoma, and may be more potent and specific than existing treatments with similar mechanism of action as supported by preliminary clinical results.

Abbott (NYSE:ABT) Following the recent clearance of its FreeStyle Lite® blood glucose test strips, the company today announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips. The new FreeStyle test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath® labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.

Biomoda is seeking Food and Drug Administration approval of its screening technology as a Class III medical device. In addition to FDA approval, Biomoda President John Cousins said the company is pursuing a CE Mark to commercialize CyPath® in Europe. CyPath® is currently for investigational use only.

DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) announced today that the United States Patent and Trademark Office has completed its re-examination of US Patent No. 5,079,262, "Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid." In its latest communication, the USPTO issued a Notice of Intent to Issue Ex Parte Re-examination Certificate which affirms the patent's original seven claims and adds eight claims. This patent covers the use of aminolevulinic acid, the active ingredient in DUSA's Levulan Kerastick, for the treatment of actinic keratoses with light.

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations. The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

"Emergent recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism," said Allen Shofe, senior vice president public affairs of Emergent BioSolutions. "As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments."

Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, today announced that patients are being enrolled in a Phase 1 clinical trial evaluating IPI-493 in patients with advanced hematologic malignancies. This multi-center study is the second clinical trial of IPI-493, Infinity's oral heat shock protein 90 (Hsp90) chaperone inhibitor.

Kensey Nash Corporation (Nasdaq:KNSY), a regenerative medicine company, and Arthrex, Inc., a worldwide leader in sports medicine product development and educational services for orthopaedic surgeons, today announced a strategic agreement regarding products developed from Kensey Nash's unique extracellular matrix (ECM) technology.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL® Tablets, a treatment for angina and/or hypertension.

Nifedipine Tablets had U.S. sales of approximately $234 million for the 12 months ending March 31, 2010, according to IMS Health.

Nektar Therapeutics (Nasdaq:NKTR) announced today that the first patients have been dosed in a new Phase 1 dose-escalation clinical study to evaluate NKTR-102, the company's lead oncology compound, in combination with 5-fluorouracil (5-FU)/leucovorin in refractory solid tumor cancers. The study is being conducted at University Hospitals Case Medical Center of the Case Comprehensive Cancer Center in Cleveland, Ohio.

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative biomedical surgical oncology products, today announced that Ohio’s Third Frontier Commission has voted to award a grant of $1 million to fund ongoing development of Neoprobe’s Lymphoseek® radiopharmaceutical initiative, subject to the review of the State Controlling Board. The Ohio Third Frontier grant will be used to accelerate clinical testing for Neoprobe’s Phase 3 trial in patients diagnosed with head and neck squamous cell carcinoma. This trial is intended to expand the proposed product labeling for Lymphoseek following an initial broader product label. Neoprobe was among eight companies awarded Medical Imaging Program grants by the Commission. Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping.

NexMed, Inc. (Nasdaq: NEXMD) today announced that the Japanese Patent Office has issued the Decision to Grant a Patent for NexMed’s patent application entitled, "Prostaglandin Compositions for the Treatment of Male Erectile Dysfunction." This patent, when issued, will provide Japanese patent protection to September 2021 and is one in a series of patents and pending applications that NexMed owns on Vitaros® and the underlying NexACT technology.

Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, today announced the availability of an independent research report that was issued yesterday with a "Strong Buy" recommendation and a 12- to 18-month price target of $4.75.

Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of patient dosing and database lock in a double-blind, placebo-controlled, multiple dose, crossover study of bremelanotide, its subcutaneously administered melanocortin agonist for treatment of erectile dysfunction (ED). Palatin expects to report top-line data in the next calendar quarter.

The endpoints in the study are evaluation of plasma exposure and blood pressure, at rest and under exercise stress, in men between 45 and 65 years old, the target demographic. A total of 49 subjects were dosed in the study.

Radient Pharmaceuticals Corporation (AMEX:RPC) and Jaiva Technologies, Inc., a US-based biotechnology company focused on the research and development, distribution, marketing and sales of promising third-party healthcare technology products, including RPC's CIT cancer therapy and vaccine, announced today that Jaiva plans to submit a clinical trial application to the Central Drugs Standard Control Organization (CDSCO) in India to commence human phase II trials for RPC's Combination Immunogene Therapy (CIT) technology as a vaccine therapy for non-small cell lung carcinoma (NSCLC).

In Jaiva's submission, they are taking a targeted approach with RPC's CIT technology using allogenic cells to develop a general NSCLC therapy and vaccine.

Spherix Incorporated (Nasdaq:SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, announced that it will explore triglycerides as a potential therapeutic opportunity for its D-tagatose therapy, pending a review of data from a Phase 3 clinical trial the Company is conducting on the use of D-tagatose as a treatment for Type 2 diabetes. Reduction of triglyceride levels is a secondary endpoint of the Phase 3 trial. Results from the trial are expected later this summer.

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy™ Cool Path™ Ablation Catheter. This marks the company’s first entry into the irrigated catheter ablation market in Japan.

Ventas, Inc. (NYSE: VTR) said today that it has entered into a definitive agreement to acquire 100 percent of Lillibridge Healthcare Services, Inc. and real estate interests in 95 medical office buildings and ambulatory facilities ("MOBs"). Lillibridge, a premier Chicago-based, fully-integrated healthcare real estate company, owns, develops and manages MOBs, and offers strategic, financial and operational real estate advisory services, principally for highly rated, not-for-profit healthcare systems nationally. The purchase price is between $300 million and $400 million.

Also Thursday:

AmbiCom Holdings, Inc., (OTCBB: ABHI), today announced it has received its initial purchase order worth US $250,000 under a four-year exclusive manufacturing agreement with a major pharmaceutical and medical device company to supply the WL54-CF Wi-Fi cards for this company's blood glucose meters.

Axxess Pharma, Inc. (PINKSHEETS: AXXE), a pharmaceutical company specializing in the marketing and distribution of both prescription and non-prescription medical products in a multi-billion dollar industry, is pleased to announce they have signed a Letter of Intent to acquire a Canadian based pharmaceutical manufacturer.

Baxter International Inc. (NYSE: BAX) today released its 2009 Sustainability Report – Our Priorities for a More Sustainable Future, marking the 11th consecutive year the company has released a sustainability report about its social, economic and environmental performance.

The board of directors of Medtronic, Inc. (NYSE:MDT), today approved a cash dividend of $0.225 per share of the company’s common stock; an increase of 9 percent from the prior dividend paid to shareholders.

PharmaGap Inc. (TSX VENTURE:GAP) (OTCBB:PHRGF) today announced 80% average growth inhibition (at 20 micromolar dose) in in vitro testing of its lead cancer drug GAP-107B8 in Ocular and Cutaneous Melanoma at Memorial Sloan-Kettering Cancer Center (MSKCC).

WuXi PharmaTech (Cayman) Inc. (NYSE:WX) today announced that the Grand Court of the Cayman Islands has scheduled a hearing for June 29, 2010 in connection with WuXi's proposed cash-and-stock transaction with Charles River Laboratories International, Inc. (NYSE: CRL).

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.

"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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