Medicines Company surges. After the Bell: Dendreon jumps, Depomed says no lawsuit by Pfizer Print E-mail
By BioMedReports.com Staff   
Tuesday, 03 August 2010 17:24
Those companies and others that made news in the healthcare sector on Tuesday, August 3, 2010 are found in this recap.

Dendreon Corporation (Nasdaq:DNDN) today after the market close reported results for the quarter ended June 30, 2010. Revenue for the quarter ended June 30, 2010 was $2.8 million compared to $25,000 for the quarter ended June 30, 2009. Revenue for the six months ended June 30, 2010 was $2.8 million compared to $55,000 for the six months ended June 30, 2009. Over the first three months of launch, the company has seen revenue from sales of PROVENGE® (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC) grow from $340 thousand in May to $2.45 million in June and $5.2 million in July.

"We have established a strong foundation for the launch of PROVENGE, based on the month-over-month revenue growth and positive coverage guidelines published by local Medicare carriers and private payers," said Hans Bishop, executive vice president and chief operating officer. "Demand for PROVENGE is strong, as we have already received prescriptions for more than 500 patients during the first three months. In addition, we are on track with the expansion of all of our manufacturing facilities in order to provide PROVENGE to more patients in 2011."

Dendreon's total operating expenses for the second quarter of 2010 were $68.4 million compared to $20.9 million in 2009. Dendreon's total operating expenses for the six months ended June 30, 2010 were $126.1 million compared to $37.9 million for the same period in 2009. The net loss for the quarter ended June 30, 2010 was $142.6 million, or $1.04 per share which includes a $0.55 charge associated with the revaluation of warrants, compared to $126.7 million, or $1.20 per share for the quarter ended June 30, 2009, which included a $1.00 charge for warrant revaluation. The net loss for the six months ended June 30, 2010 was $268.3 million, or $2.00 per share which includes a charge associated with the revaluation of warrants of $1.06, compared to $142.1 million, or $1.41 per share for the six months ended June 30, 2009, which included a $1.02 charge for warrant revaluation.

As of June 30, 2010, Dendreon had $492.4 million in cash, cash equivalents, and short-term and long-term investments compared to $606.4 million as of December 31, 2009.

Shares of Dendreon were up after the bell, rising $1.47 to $35.30.

Depomed, Inc. (Nasdaq:DEPO) after the bell today announced that pursuant to the Hatch-Waxman Act, the 45-day period for filing a patent infringement suit under the Act, and thus initiating a 30-month stay on the FDA's ability to approve the DM-1796 NDA, has expired. Depomed has confirmed with Pfizer Inc. that no suit under the Act has been filed. DM-1796 is an extended release, once-daily tablet formulation of gabapentin for post-herpetic neuralgia developed by Depomed.

"We look forward to a potential approval of DM-1796 in the first quarter of next year," commented Carl A. Pelzel, Depomed's president and chief executive officer.

Shares of Depomed soared more than 16% in extended trading, rising 46 cents to $3.29.

The Medicines Company (NASDAQ:MDCO) today announced that the U.S. District Court for the Eastern District of Virginia has granted the Company's motion for summary judgment and ordered the United States Patent and Trademark Office "to consider the Medicine[s] Company's patent term extension application timely filed."

The Court awarded summary judgment to the Company in the Company's lawsuit challenging the U.S. Patent and Trademark Office (PTO) denial of the application for an extension of the term of U.S. Patent No. 5,196,404, the U.S. composition of matter patent that covers Angiomax.

Shares of The Medicines Company shot up more than 33% on the news, rising $3.14 to $12.47.

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS.ob), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has applied for a cash grant under the Qualifying Therapeutic Discovery Project which was created by Congress as part of the Patient Protection and Affordable Care Act of 2010. The Company has submitted an application for its development of Restanza™, a novel once-daily oral antibiotic for the treatment of community acquired bacterial pneumonia (CABP).

ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo Co., Ltd. (TSE 4568) today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

"The decision to advance ARQ 197 into Phase 3 clinical testing underscores the success of our partnership with Daiichi Sankyo," said Paolo Pucci, chief executive officer of ArQule. "ArQule and Daiichi Sankyo signed the ARQ 197 partnership in December 2008, and in less than two years, we are requesting an SPA for a Phase 3 trial with this potential first-in-class molecule."

Celsion Corporation (Nasdaq:CLSN) announced today that the consensus recommendations of the National Cancer Institute (NCI) Clinical Trials Planning Meeting (CTPM) for Hepatocellular Carcinoma have been released and published in the August 2010 issue of Journal of Clinical Oncology, the official publication of American Society of Clinical Oncology (ASCO). In addition to evaluating the current standard of care, the NCI panel also recommended Celsion's Phase III ThermoDox ® HEAT Study as a Priority Clinical Trial for HCC.

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers. CUDC-101 is a first-in-class small molecule drug candidate that has been designed as an inhibitor of histone deacetylase (HDAC), epidermal growth factor receptor (EGFR) and epidermal growth factor receptor 2 (Her2).

FONAR Corporation (NASDAQ:FONR), Shares surged more than 10% today after The Inventor of MR Scanning, announced the purchase of an UPRIGHT® Multi-Position MRI by Medserena, of Germany. It is the fourth purchase by Medserena. The Other UPRIGHT® MRI scanners in Germany owned by Medserena are located in Cologne, Hanover and Munich.

Orexigen Therapeutics, Inc. (Nasdaq:OREX) announced the online publication of results from its COR-BMOD trial of Contrave (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification (BMOD) plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients. The addition of Contrave to BMOD delivered significant incremental weight loss and improvements in measures of cardiometabolic risk. Results showed that patients taking Contrave lost 9.3% of their body weight compared to 5.1% for patients on placebo, on an intent-to-treat basis. For those who completed 56 weeks of treatment, patients taking Contrave plus BMOD lost 11.5% of their body weight compared to 7.3% for those taking placebo.

PerkinElmer, Inc.(NYSE: PKI), a global leader focused on the health and safety of people and the environment, today announced that it has acquired VisEn Medical, Inc., an in vivo molecular imaging technology company based in Bedford, Massachusetts.

The acquisition enables PerkinElmer to enhance its cellular imaging business, by expanding the Company's technologies and capabilities downstream into preclinical research undertaken in academic institutes and pharmaceutical companies. VisEn's proprietary fluorescence molecular imaging systems and reagents are currently used in applications involving research into cancer, inflammation, cardiovascular, skeletal and pulmonary diseases.

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics(TM), today announced that it has added to its program for inflammatory disorders by entering into an exclusive worldwide license agreement with Cornerstone Therapeutics Inc. (Nasdaq:CRTX). The agreement grants Targacept rights to Cornerstone’s NNR-based patents, as well as its library of preclinical compounds that act on the alpha7 or other nicotinic receptors. The technology licensed from Cornerstone by Targacept arose from work done at The Feinstein Institute for Medical Research led by Kevin J. Tracey, M.D.

Also Tuesday:

 

A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) is pleased to provide an update on the company's business development activities for the month of July.

Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP), today announced it has initiated a Phase I/II dose-escalating study of its proprietary, anti-cancer drug, Thiarabine, a nucleoside analog for patients with hematologic malignancies (cancers of the blood).  

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced its financial results for the second quarter of 2010.

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a late-stage drug development company specialized in oncology and endocrinology, today announced that its Senior Vice President and Chief Medical Officer, Paul Blake, MD, will present a corporate overview at the upcoming Canaccord Genuity 30th Annual Growth Conference on Thursday, August 12, 2010, at 3:00 p.m. ET, in the Montreal Room of the InterContinental Boston, in Boston.

Agilent Technologies Inc. (NYSE: A) today signed a Memorandum of Understanding (MoU) with the Government of Malaysia through the Malaysian Institute of Pharmaceuticals and Nutraceuticals (IPHARM), an agency under the Ministry of Science, Technology and Innovation (MOSTI), to promote and develop cooperation in biotechnology.

Akorn, Inc. (NASDAQ:AKRX), a niche generic pharmaceutical company, today reported financial results for the second quarter ended June 30, 2010.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that management will present an overview of the company at the Canaccord Genuity 30th Annual Global Growth Conference on August 10, 2010 at 9:00 a.m. ET.

Amarin Corporation plc (Nasdaq:AMRN) has scheduled a conference call for Tuesday, August 10, 2010 at 4:00 pm UTC/GMT + 1 hour (11:00 am Eastern Time) to discuss selected financial results and provided a progress update of the Company's MARINE and ANCHOR, the two Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.  

AmerisourceBergen Corporation (NYSE: ABC) today announced the promotion of Barbara A. Brungess to Vice President, Corporate & Investor Relations, effective immediately.

Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that the company is scheduled to present at the BMO Capital Markets 10th Annual Focus on Healthcare Conference on Thursday, August 5, 2010, at 3:00 p.m. Eastern Time (12:00 p.m. Pacific Time) at the Sheraton New York Hotel & Towers in New York City.

Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the fourth quarter and full year of fiscal 2010 on Monday, August 9, 2010, and will hold a conference call on Tuesday, August 10, 2010 at 9:00 a.m. eastern time to discuss these results.

AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced that the Company will present at the 30th Annual Canaccord Genuity Growth Conference on Tuesday, August 10th at 5:00 p.m. Eastern time (2:00 p.m. Pacific time) at the InterContinental Hotel in Boston.

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announces that it has filed a 510(K) application with the U.S. Food and Drug Administration to expand market clearance for its RecoveryRx and ActiPatchRx® products.

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that the Company plans to release its financial results for the three months ended June 30, 2010, on Thursday, August 5, 2010 after the close of market.

Biotechnology company MabCure, Inc. (OTCBB: MBCI) today announced the company has filed a provisional patent application for its ovarian cancer diagnostic antibodies with the U.S. Patent and Trademark Office.

Boston Scientific Corporation (NYSE:BSX) today announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY Coronary Stent.

Bruker Corporation (NASDAQ: BRKR) today announced the election of Charles F. Wagner, Jr. to its Board of Directors and Audit Committee.

Celsion Corporation (Nasdaq:CLSN), a biotechnology drug development company, today announced financial results for the second quarter and six months ended June 30, 2010 and addressed the progression of the clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin.

China Pharma Holdings, Inc. (NYSE Amex:CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that it plans to release its second quarter 2010 financial results before the market opens on Tuesday, August 10, 2010.

Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced its financial results for the second quarter of 2010. For the second quarter of 2010, Enzon reported a loss from continuing operations of $5.4 million or $0.09 per diluted share, as compared to a loss of $19.7 million or $0.43 per diluted share for the second quarter of 2009.

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced today that it will host a conference call to discuss second quarter 2010 operating and financial results on Friday, August, 6, 2010 at 9:00 a.m. Eastern time.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at the Canaccord Genuity 30th Annual Global Growth Conference, which is being held Aug. 10 12, 2010, at the InterContinental Boston.

GenSpera, Inc. (OTCBB: GNSZ) announced that it has acquired a patent application from the Johns Hopkins University and the University of Copenhagen for technology relating to medical imaging.

GLG Life Tech Corporation (TSX:GLG)(NADSAQ:GLGL), the vertically integrated leader in the agricultural and commercial development of stevia extracts, announces that the Company will release 2010 second quarter financial results on Monday, August 9, 2010 before market open.

Kopin Corporation (NASDAQ: KOPN) today announced financial results for the second quarter ended June 26, 2010.

Lotus Pharmaceuticals, Inc. (OTC Bulletin Board:LTUS) a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China, announced today that it has completed production of active pharmaceutical ingredient and tablets of R-Bambuterol for use in clinical trials according to China's State Food & Drug Administration ("SFDA")'s stringent regulations with regards to the preparation of active trial medication.

Luminex Corporation (Nasdaq:LMNX) today announced that management will present at Canaccord Adams 30th Annual Global Growth Conference to be held August 10-12, 2010, in Boston, Massachusetts.

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today announced financial results for the second quarter ended June 30, 2010.

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced today it has initiated the application process for listing on the NYSE: AMEX stock exchange.

PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB: HRGF) today announced favorable safety and pharmacokinetic results in rats with its lead cancer drug GAP-107B8.

POZEN Inc. (NASDAQ:POZN) today announced results for the second quarter ended June 30, 2010.

Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that Professor Rudolph Tanzi, Professor of Neurology at Harvard Medical School, co-founding scientist of Prana Biotechnology, and current member of Prana's R&D Board, was quoted in the July 29th, 2010 article in New Scientist titled, "Alzheimer's Unlocked: New Keys to a Cure."

Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial results for the second quarter and six months ended June 30, 2010.

Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, has announced the launch of its MedChem Studio software for drug discovery.

Smokefree Innotec, Inc. (Pinksheets:SFIO) Thomas Schroepfer, CEO, announced today that the Company has executed a Joint venture agreement with a Colorado research and development corporation focusing on natural holistic and herbal medical compounds, operating out of laboratory facilities located in Colorado Springs.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, today announced that Eric Bjerkholt, Senior Vice President, Corporate Development and Finance, will be presenting at the BMO Capital Markets 10th Annual Focus on Healthcare Investor Conference on Thursday, August 5, 2010 at 11:15 A.M. Eastern Time at the Sheraton New York Hotel & Towers in New York City.

Techne Corporation's (Nasdaq:TECH) consolidated net earnings for the quarter ended June 30, 2010 increased 2.0% to $25.9 million or $.69 per diluted share compared with $25.4 million or $.68 per diluted share for the quarter ended June 30, 2009.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the Company received approval from the European Commission to proceed with its acquisition of ratiopharm.

Titan Pharmaceuticals, Inc. (OTC Bulletin Board:TTNP) today announced that patient enrollment is more than 60% complete in the confirmatory Phase 3 clinical study of Probuphine for the treatment of opioid addiction, and the study is expected to complete enrollment by early fourth quarter of this year, which is almost three months ahead of schedule.

VIVUS, Inc. (Nasdaq:VVUS) today announced that data on Qnexa®, an investigational drug candidate, will be featured in two poster presentations at the 37th Annual American Association of Diabetes Educators (AADE), being held in San Antonio, TX from August 4 - 7, 2010.

Volcano Corporation (Nasdaq:VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today that it will be participating in the 30th Annual Canaccord Genuity Growth Conference on Tuesday, August 10.

Walgreens (NYSE, NASDAQ: WAG), the largest retail provider of flu prevention services with more than 24,000 certified immunizers, has introduced the card as a way to help more Americans stay well throughout the upcoming flu season by giving the gift of a flu shot.

West Pharmaceutical Services, Inc. (NYSE:WST) today announced its financial results for the second quarter of 2010.

ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported substantially improved financial results for the quarter ended June 30, 2010. For the second quarter of 2010, the company's net loss declined to $3.8 million, or $0.04 per share, a $23.2 million improvement from the $27.0 million loss, or $0.39 per share, reported for the second quarter of 2009.

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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