Akorn jumps on another FDA approval. After the bell Delcath soars on postive Phase III results Print E-mail
By BioMedReports.com Staff   
Wednesday, 21 April 2010 18:39
Below is a list of the companies that made news in the healthcare sector on Wednesday, April 21, 2010.

Akorn, Inc. (NASDAQ:AKRX) surged today on heavy volume as the niche generic pharmaceutical company announced that the U.S. FDA has granted approval of the Company’s Abbreviated New Drug Application (ANDA) supplement for Erythromycin Ophthalmic Ointment USP 3.5 g. The company intends to begin shipping the product immediately.

Raj Rai, the Interim Chief Executive Officer of Akorn stated, "We identified an opportunity to re-launch Erythromycin as ongoing market shortages have made this an attractive product which is complementary to the other ophthalmic ointments Akorn currently sells."

According to IMS Health, the annualized U.S. sales for Erythromycin 3.5 g based on fourth quarter 2009 data, were approximately $26 million.

Last week Akorn recieved FDA approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP® 10mg/ml Injection.

Shares jumped 22 cents or 11.58%, closing the day at $2.12.

Delcath Systems, Inc. (Nasdaq:DCTH), jumped after the bell. The company announced that its Phase III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis. Comparing treatment with the Delcath PHP System™ with melphalan to Best Alternative Care (BAC), based on independent core lab review of patient scans, the statistical analysis revealed that the PHP patients had a statistically significant longer median hPFS of 214 days compared to 70 days in the BAC arm (p=0.001). This reflects a 144-day prolongation of hPFS over that of BAC control arm, with less than half the risk of progression and/or death in the PHP group compared to the BAC group (Hazard Ratio = 0.46).

The company will present full trial data on June 5th at the American Society of Clinical Oncology's (ASCO) 2010 Annual Meeting. The endpoints announced today are results of the independent core lab analysis, which will be submitted to support Delcath's New Drug Application (NDA) for its drug and proprietary treatment system to the U.S. Food and Drug Administration (FDA). Delcath expects to initiate its rolling NDA submission to the FDA within the next 30 days.

"We believe that these data support that the Delcath PHP System may provide a significantly better treatment option for patients suffering from melanoma metastases in the liver," said Eamonn P. Hobbs, President and CEO of Delcath. "With the treatment arm having a median hPFS of more than three-fold that of the control arm, we easily exceeded our expectations of clinical trial success. This is a major step forward in our plan to introduce what we believe is an effective treatment for patients who currently have very few viable options."

In the after hours session shares of Delcath shot up more than 30%, moving $3.28 to $14.19.

Also after the bell:

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today reported a first quarter 2010 net loss of $4.0 million or $0.09 per share compared to net loss of $1.3 million or $0.03 per share for the first quarter 2009. As of April 20, 2010, we had cash and cash equivalents of approximately $26.9 million with no term indebtedness.

Amgen (Nasdaq:AMGN) reported adjusted earnings per share (EPS) of $1.30 for the first quarter of 2010, an increase of 20 percent compared to $1.08 for the first quarter of 2009. Adjusted net income increased 14 percent to $1,282 million for the first quarter of 2010 compared to $1,120 million for the first quarter of 2009. Total revenue increased 9 percent for the first quarter of 2010 to $3,592 million versus $3,308 million for the first quarter of 2009.

"We are off to a good start in 2010 with solid first-quarter results," said Kevin Sharer, Chairman & CEO. "We are optimistic about Prolia in the U.S. and EU and will take appropriate steps to manage the impact of the new U.S. health care reform law."

Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) presented data from its pipeline programs at the 2010 AACR (American Association for Cancer Research) annual meeting in Washington, DC. "We are pleased to present new data from our novel pipeline programs. Our Customized PEG linkers continue to improve the delivery of cytotoxic molecules," said Dr. Ivan Horak, President of Research and Development and Chief Scientific Officer of Enzon. "Additionally, our novel locked nucleic acid (LNA)-based mRNA antagonists continue to show promise for inhibition of tumor growth in a variety of cancers."

Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced the appointment of Wendy Dixon, Ph.D. to its board of directors. Dr. Dixon brings 30 years of pharmaceutical development and commercial experience to the Orexigen board. This experience includes commercialization strategy, new product launches and portfolio evaluation in cardiometabolic and primary care markets with Bristol-Myers Squibb Company (BMS), Merck, and SmithKline & French (now a part of GlaxoSmithKline). Most recently, she was the President of Global Marketing and Chief Marketing Officer at BMS Company..

In news from earlier in the day:

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), a biopharmaceutical company specializing in products for cancer and supportive care, announced today that it will present data from the ongoing work involving its lead product, MuGard, and host an oral mucositis symposium at the MASCC conference being held in Vancouver, B.C. on June 24-26, 2010. MuGard is Access Pharma's FDA-approved product for the management of oral mucositis, a debilitating side effect of many anticancer treatments.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), edged higher today after the biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preclinical data which demonstrate that its Notch1-specific monoclonal antibody is a highly potent inhibitor of Notch1 function in both in vitro and in vivo models. These data were presented today at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010.

Bionovo, Inc. (Nasdaq:BNVI) jumped more than 16% today. Tuesday after the bell the company announced that the US Patent and Trademark Office (USPTO) has issued a patent covering a method of using Bionovo's proprietary drug candidate Bezielle® (BZL101) for the treatment of metastatic breast cancer. The patent issued today is Bionovo's second issued patent, with over 70 other patent applications currently pending. Shares continued higher in the after hours market.

Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that CDX-1127, a preclinical therapeutic antibody program for oncology indications, is the subject of a poster presentation at the 2010 American Association for Cancer Research (AACR) 101st Annual Meeting. "The CDX-1127 antibody program demonstrates our development capabilities, and will add to our growing pipeline of product candidates in our Precision Targeted Immunotherapy Platform," said Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc..

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced the European Medicines Agency Pediatric Committee recommended the Company submit an updated Pediatric Investigation Plan ("PIP") for pixantrone following discussions with the Company about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancer. The Company expects to submit a revised PIP to the EMEA by the end of the second quarter of 2010. The PIP outlines how the Company proposes to study the drug in children in order to benefit child health.

China Sky One Medical, Inc. (Nasdaq:CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced it had commenced the commercial launch of Oxymetazoline Hydrochloride Nasal Drops and Moschus Liniment for Pain Relief.

Oxymetazoline Hydrochloride Nasal Drops, a generic drug, is to treat acute and chronic rhinitis, sinusitis and allergic rhinitis. Moschus Liniment for Pain Relief is a TCM product developed in-house, which is used to relieve the pain from scathe, wound, rheumatism and arthrosis.

The two products, quite reliable and convenient for consumers' use, are estimated to have a market size of over $300 million each. The Company will analyze and summarize the marketing and sales activities following the trial stage and establish a formal sales plan soon.

Clarient, Inc. (Nasdaq:CLRT), today announced that data from a new study suggest that the Clarient Insight Dx Pulmotax™ assay may effectively predict which lung cancer patients will respond favorably to chemotherapy. The study, titled "TLE3 expression is predictive of response to chemotherapy in NSCLC," included 368 samples from carcinoma patients. The majority of advanced-stage patients who were treated with chemotherapy received a treatment regimen containing a taxane class agent.

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that data provided in a presentation entitled, "Antitumor activity of single small molecule agent targeting PI3K/mTor and HDAC," were presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010, which is being held in Washington, DC April 17-21. The poster highlights data on the Company’s novel research compound CU-906, which is designed to inhibit HDAC and PI3K/mTOR targets simultaneously.

Dendreon Corporation (Nasdaq:DNDN) shares moved higher today. The company announced the presentation of additional data from the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical trial showing evidence of immune responses in patients treated with PROVENGE® (sipuleucel-T) and supporting its proposed mechanism of action. The data were presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C. "These data strongly support our understanding of the proposed mechanism of action of active cellular immunotherapies," said David Urdal, Ph.D., senior vice president and chief scientific officer of Dendreon. "There is clear evidence that PROVENGE primes the T-cell component of the immune system in vivo through ex vivo activation, generating a successful and long-lasting immune response."

Genzyme Corp. (NASDAQ: GENZ) today reported that first-quarter revenue was $1.07 billion, compared with $1.15 billion in the same period last year, reflecting limited shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta) due to product supply constraints.

Icagen, Inc. (Nasdaq:ICGN) today announced that results from a study of ICA-105665 in patients with photosensitive epilepsy will be presented at the Tenth Eilat Conference on New Antiepileptic Drugs on Tuesday, April 27, 2010 in Eilat, Israel. The presentation will be made by Dorothee Kasteleijn-Nolst Trenite, MD, University Medical Centre Utrecht and Universita di Roma Sapienza II, Rome, Italy. Dr. Kasteleijn-Nolst Trenite is an internationally recognized expert on studies of photosensitivity as proof of concept for new anti-epileptic drugs and served as the central electroencephalogram (EEG) reader for the study. The topline results of the study were the subject of a previous press release by Icagen.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today that the Company has entered into a sponsored research agreement and an option agreement with The University of Pennsylvania to support process development and manufacturing in a planned Phase II clinical trial of ICT-107, the Company’s dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM). GBM is the most common and aggressive form of brain cancer. In a Phase I clinical trial, ICT-107 demonstrated the ability to significantly extend in patients their overall survival time as well as tumor free survival time compared to the current standard of care.

Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, today announced that it has initiated a randomized Phase 1b/2 clinical trial evaluating IPI-926, its novel, oral Hedgehog pathway inhibitor, in combination with gemcitabine in patients with pancreatic cancer. In addition, Infinity reported new preclinical data on IPI-926 during the 2010 American Association of Cancer Research (AACR) Annual Meeting demonstrating that IPI-926 delays tumor re-growth after regression of the tumors by chemotherapy and by targeted therapy, further supporting the potential for Hedgehog pathway inhibition by IPI-926 in a broad range of difficult to treat cancers.

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today introduced INTELLITAB(TM), the brand name for its proprietary abuse and misuse-deterrent technology platform. The INTELLITAB(TM) platform, which can deliver one or more therapeutic drugs in combination over periods of up to 24 hours, has the potential to provide a patient with a controlled release medication while minimizing the risk of intentional abuse or accidental misuse.

Medtronic, Inc. (NYSE: MDT), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the Complete SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities.

"The Complete SE Vascular Stent System provides physicians with a new treatment option that offers significant benefits for patients with narrowed iliac arteries due to peripheral vascular disease," said Robert Molnar, M.D., of Michigan Vascular Research Center in Flint, Mich. "The system enables highly accurate stent placement in the iliacs, reducing the likelihood of stent ’jumping,’ which we commonly see during deployment with the use of many self-expanding stent systems."

Micromet, Inc. (Nasdaq:MITI) a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, announced today that it has achieved a milestone under its collaboration agreement with Bayer Schering Pharma AG. The milestone was triggered by Micromet's achievement of pre-clinical proof of concept for a BiTE antibody for the treatment of solid tumors. Under the terms of the collaboration agreement Micromet is primarily responsible for the pre-clinical development of the BiTE antibody, and will collaborate with Bayer through the completion of phase 1 clinical trials. Bayer is responsible for product development beginning in phase 2, and for all manufacturing and commercialization activities. Micromet is entitled to receive progress dependent milestone payments of up to 285 million Euros and up to double digit royalties on net sales. In addition, Micromet will be reimbursed for its R&D expenses.

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, today announced three data presentations at the AACR 101st Annual Meeting 2010 demonstrating the breadth of potential applications for the company's phospholipid-targeting technologies. Peregrine's lead phosphatidylserine (PS)-targeting antibody bavituximab is currently in Phase II clinical trials in non-small cell lung cancer (NSCLC) and advanced breast cancer, with additional results expected by mid-year 2010..

Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced that for the first quarter ended March 31, 2010, income from continuing operations was $163 million, or $0.89 per diluted share, compared to $169 million, or $0.89 per diluted share, in the first quarter of 2009. Earnings comparisons were impacted by a 2010 first quarter charge of $0.06 per share principally associated with workforce reductions, and $0.05 due to the estimated impact of severe weather.

Radient Pharmaceuticals Corporation (AMEX:RPC) announced today, through its US-based subsidiary AMDL Diagnostics Inc, that it will be presenting at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 4-8, 2010. AMDL Diagnostics will feature its Onko-Sure™ in vitro diagnostic (IVD) cancer test to conference attendees on the exhibition floor and in private briefings. The 2010 ASCO Annual Meeting will focus on advancing quality of clinical oncology through Innovation. More than 30,000 cancer specialists from around the world will gather at the meeting to discuss the latest innovations in research, quality, practice and technology in cancer.

Seattle Genetics, Inc. (Nasdaq: SGEN) and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today reported preclinical data with ASG-5ME, an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors. In models of human prostate and pancreatic cancer, ASG-5ME was found to have potent and long lasting antitumor activity. The findings were presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced results of a pre-clinical study conducted by the National Cancer Institute of belinostat in the treatment of small-cell lung cancer that was presented in a poster session on Wednesday, April 21, 2010 at the 101st Annual Meeting of the American Association for Cancer Research (AACR)."Based on the data presented today at AACR, we believe belinostat may be an effective treatment option for small-cell lung cancer," said Rajesh C. Shrotriya, MD, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "While we continue to enroll patients into the 100-evaluable patient registrational trial for belinostat in peripheral T-cell lymphoma (PTCL), being conducted under a Special Protocol Assessment by the FDA, we are exploring potential clinical trial design options for the treatment of lung cancer."

StemCells, Inc. (Nasdaq:STEM) announced today that it has submitted a protocol to the FDA for initiation of a second clinical trial of its proprietary HuCNS-SC human neural stem cells in neuronal ceroid lipofuscinosis (NCL), which is also often referred to as Batten disease. NCL is a genetic disorder characterized by the absence of a critical enzyme, which leads to the loss of neurons and the eventual death of the patient. The Company completed a Phase I clinical trial in NCL in January 2009 and reported the results to the FDA in September 2009.

Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has signed a binding agreement to acquire a privately-held pharmaceutical company located in Brazil, for 97 million Brazilian reals (approximately US$56 million). The company primarily focuses on branded generics and over the counter (OTC) products and had annual sales of approximately 49 million Brazilian reals in 2009. Over the past five years, the company has delivered a compound annual growth rate of approximately 15% in Brazilian reals.

Also Wednesday:

Adolor Corporation (NasdaqGM:ADLR) today announced that it will hold a conference call at 8:45 a.m. EDT on Wednesday, April 28, 2010, to discuss its first quarter 2010 financial results.

Applied DNA Sciences, Inc. (OTCBB: APDN), a provider of DNA-based security solutions, announced that the forensic strength of SigNature® DNA continues to prove instrumental in sending violent criminals to prison in the UK.

BioCryst Pharmaceuticals (NASDAQ: BCRX) today announced that its first quarter 2010 financial results will be released on Wednesday, April 28, 2010.

Boston Scientific Corporation (NYSE:BSX) is scheduled to participate in the upcoming Bank of America Merrill Lynch Health Care Conference in New York City on May 12.

Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has received Leadership in Energy and Environmental Design (LEED®) Silver certification for its biologics manufacturing facility in Devens, Massachusetts.

Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Wednesday, April 28, 2010, to discuss its financial results and company progress for the first quarter ended March 31, 2010.

ForeverGreen Worldwide Corp. (OTCBB:FVRG) today announced fourth quarter and its 2009 full year financial results.

Manhattan Scientifics, Inc. (OTCBB: MHTX) announced today that its "early cancer detection" technology, developed by Edward R. Flynn, Ph.D. is expected to identify breast cancer three years earlier than the current gold standard mammogram test.

Masimo Corporation (Nasdaq: MASI), the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced it will release first quarter 2010 financial results for the period ended April 3, 2010, after the market closes on May 4, 2010.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will host a DDW2010 Investor Event on Monday, May 3 2010 from 9:00 p.m. to 10:00 p.m. Central Time (10:00 p.m. to 11:00 p.m. ET).

ViroPharma Incorporated's (Nasdaq: VPHM) first quarter financial results for 2010 are expected to be released on Wednesday, April 28, 2010 before the open of the U.S. financial markets.

WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genetic analysis systems, today announced that it has launched its SmartChip Multi-Sample Dispenser to enable significant speed and cost advantages for biomarker validation using gene expression and genotyping.

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