Pharmacotherapy News

News and FDA Updates for Impax (NASDAQ:IPXL), Insmed (Nasdaq:INSM), Inspire (NASDAQ:ISPH)

Tue, 16 Mar 2010 14:21:00 +0000

Pasadena, CA -- BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors has Healthcare stock news and updates to its calendar database of Clinical Trials and upcoming FDA approvals & decisions.

A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com

On 03/15/10, Impax Laboratories, Inc. (NASDAQ:IPXL) confirms it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg.

On 03/15/10, Insmed Inc. (Nasdaq:INSM), a biopharmaceutical company, reported results for the fourth quarter and full-year ended December 31, 2009.

On 03/15/10, Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced the results from two Phase 2 clinical trials with AZASITE (azithromycin ophthalmic solution) 1% for the treatment of blepharitis. Inspire will conduct additional clinical work to continue pursuing...

News and FDA Updates for Kendle (Nasdaq:KNDL), Medco (NYSE:MHS), NeoStem (NYSE:NBS)

Tue, 16 Mar 2010 14:21:00 +0000

A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com

On 03/15/10, Kendle (Nasdaq:KNDL) a leading, global full-service clinical research organization, announced its affiliate in China, Beijing KendleWits Medical Consulting Company Ltd. (KendleWits), has obtained ISO 9001:2008 certification from the International Organization for Standardization, validating the quality and consistency of its operations in this growing region.

On 03/15/10, Brian T. Griffin, group president for health plans at Medco Health Solutions, Inc. (NYSE:MHS), is scheduled to address the Barclays Capital 2010 Global Healthcare Conference in Miami on Tuesday, March 23, 2010.

On 03/15/10, NeoStem, Inc. (NYSE:NBS), an international biopharmaceutical company with operations in the...

News and FDA Updates for CytRx (NASDAQ:CYTR), GTx (Nasdaq:GTXI), iCAD (Nasdaq:ICAD)

Tue, 16 Mar 2010 14:21:00 +0000

A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com

On 03/15/10, CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, reported financial results for the twelve months ended December 31, 2009 and affirmed its 2010 milestones of commencing up to five Phase 2 clinical trials with its oncology drug candidates.

On 03/15/10, GTx, Inc. (Nasdaq:GTXI) provided a company update and reported financial results for the fourth quarter and full year 2009.

On 03/15/10, iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, announces upcoming educational initiatives for physicians who diagnose and treat...

Human Genome Sciences Utilizes Aegis’ Discoverant for Manufacturing Data Management, Analysis ...

Tue, 16 Mar 2010 12:00:00 +0000

LAFAYETTE, Colo.--(BUSINESS WIRE)-- Aegis Analytical Corp., the leading provider of Enterprise Manufacturing Intelligence software, announced today that Human Genome Sciences, Inc. will deploy Aegis’ Discoverant ^® as its data management, analytics and reporting solution in the scale-up and production of BENLYSTA™ (belimumab), an investigational drug for the treatment of systemic lupus that has successfully completed Phase 3 trials. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the second quarter of 2010.

...

ARIAD Reports Development Progress and Fourth Quarter and Year-End 2009 Financial Results

Tue, 16 Mar 2010 11:35:00 +0000

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2009 and provided an update on corporate developments.

Phase 3 Sarcoma Data in 2010

ARIAD expects to have results this year from the Phase 3 SUCCEED trial of oral ridaforolimus -- its investigational mTOR inhibitor -- in patients with metastatic soft tissue and bone sarcomas, who have had a favorable response to chemotherapy. Patient enrollment in the 650-patient, randomized, placebo-controlled study was...

Research and Markets: Target Product Profiles 2009: Physician Insights on Key Attributes: ...

Tue, 16 Mar 2010 10:57:00 +0000

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/92a14d/target_product_pro ) has announced the addition of Decision Resources, Inc.'s new report "Target Product Profiles 2009: Physician Insights on Key Attributes: Erectile Dysfunction" to their offering.

Erectile Dysfunction: A therapy that provides greater improvement in erectile function than vardenafil in ED patients with hypertension, as measured by the Sexual Encounter Profile (SEP) questions 2 and 3

Using Target Product Profiles in Your Market Strategy

Our Target Product Profiles...

LILLY (ELI) & COMPANY - Lilly to Acquire Global License to AXIRON

Tue, 16 Mar 2010 07:00:00 +0000

Date: March 15, 2010

For Release: Immediately

Refer to: Lilly - Mark E. Taylor, (317) 276-5795, mark.taylor@lilly.com 

Acrux - Dr Richard Treagus, +61 417 520 509, richard.treagus@acrux.com.au 

  Lilly to Acquire Global License to AXIRON Testosterone Solution from Acrux

AXIRON NDA currently under review by U.S. FDA for the treatment of testosterone
                               deficiency in men

INDIANAPOLIS, IN and MELBOURNE, AUSTRALIA -- Eli Lilly and Company (NYSE:LLY)
and Acrux (ASX: ACR) announced today that they have entered into an exclusive
worldwide license agreement for the potential commercialization of Acrux's
experimental underarm testosterone solution (proposed tradename AXIRONTM). The
new drug application for AXIRON is currently under regulatory review by the
U.S. Food and Drug Administration (FDA) for the treatment of testosterone
deficiency (hypogonadism) in men.

Under the terms of the agreement,...

Hitachi and NextDocs Form a Partnership in Document Management Solutions for Pharmaceutical ...

Tue, 16 Mar 2010 02:00:00 +0000

TOKYO--(BUSINESS WIRE)-- Hitachi, Ltd. (NYSE: HIT / TSE: 6501) and NextDocs Corporation today announced their newly formed partnership in document management solutions for pharmaceutical manufacturers.

Specifically, NextDocs and Hitachi will provide NextDocs Document Management System to the life sciences companies in Japan. NextDocs will provide software licenses and solutions to customers and Hitachi will provide supporting services including business consulting, system integration, training, operation, and validation support for drug regulations. NextDocs will provide necessary support to Hitachi sales, marketing and technical personnel.

...

Cadence Pharmaceuticals reports 4Q loss

Mon, 15 Mar 2010 21:32:00 +0000

SAN DIEGO -- Cadence Pharmaceuticals Inc. on Monday reported a fourth quarter loss on higher expenses related to a pain and fever drug that has yet to receive government approval.

In the fourth quarter, the biopharmaceutical company lost $15.3 million, 30 cents per share, compared with a loss of $14 million, or 37 cents per share, in the same period the year before.

Analysts polled by Thomson Reuters expected a loss of 29 cents per share.

Operating expenses increased by $1.6 million to $15.1 million due to a jump in sales and marketing expenses as the company establishes its infrastructure in preparation for the launch of Ofirmev, an intravenous drug that would treat pain and fever.

The Food and Drug Administration in February did not approve the drug because of manufacturing problems at a facility where it is made. A response has been submitted to the FDA by the manufacturer, and Cadence plans...

Icagen Reports Positive Results for ICA-105665 in Patients With Photosensitive Epilepsy

Mon, 15 Mar 2010 21:00:00 +0000

RESEARCH TRIANGLE PARK, N.C., March 15, 2010 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN) today reported positive results in its Phase IIa epilepsy study of ICA-105665, the Company's novel orally available small molecule KCNQ potassium channel agonist.

The photosensitive epilepsy study was a placebo-controlled, single blind study conducted at two clinical research centers in the United States with specialized expertise in the conduct of this study. The study was designed in collaboration with a group of international experts including members of the Epilepsy Study Consortium, and followed a standardized protocol that has been utilized in the development of several anti-epileptic agents. The photosensitive epilepsy model is considered by experts in the field to be useful in establishing proof-of-concept for the treatment of epilepsy. Many currently marketed anti-epileptics have been shown to be effective in these patients.

Eligible subjects were those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation and...

Medivation Reports Fourth Quarter and Year-End 2009 Financial Results and Provides Corporate Update

Mon, 15 Mar 2010 20:05:00 +0000

SAN FRANCISCO, March 15 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the year ended December 31, 2009.

"We are disappointed by the results of the Phase 3 CONNECTION trial in Alzheimer's patients, and it is our highest priority to work with our colleagues at Pfizer to further analyze the data and determine next steps," said David Hung, M.D., president and chief executive officer of Medivation. "Despite this setback, we remain well positioned as a company – we have late-stage clinical development programs in three large potential commercial indications and a strong financial position. In 2010, our goal is to complete enrollment in three of our ongoing Phase 3 trials, CONCERT, a 12-month combination study of dimebon and Aricept in mild-to-moderate Alzheimer's patients, HORIZON, a six-month study of dimebon in Huntington disease patients, and AFFIRM, a study of MDV3100 in castration-resistant...

Sucampo Pharmaceuticals Reports Full Year and Fourth Quarter 2009 Financial Results

Mon, 15 Mar 2010 20:00:00 +0000

BETHESDA, Md.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its consolidated financial results for the fourth quarter and year ended December 31, 2009, outlined key highlights for 2010 and reported that it filed a demand for arbitration of its agreement with its U.S. partner, Takeda Pharmaceutical Company Limited, or Takeda.

For the full year, Sucampo recorded a net loss of $0.8 million, or $0.02 per diluted share, compared with a net income of $25.0 million, or $0.59 per diluted share, for 2008. Sucampo reported a net income of $1.3 million, or...

Trubion Pharmaceuticals, Inc. Reports Fourth-Quarter and Year-Ended 2009 Financial Results

Mon, 15 Mar 2010 20:00:00 +0000

SEATTLE, March 15 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) today announced financial results for its fourth quarter and year ended Dec. 31, 2009.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO )

Fourth-Quarter and Year-Ended 2009 Financial Results

Revenue for the fourth quarter of 2009 was $5.2 million compared with $4.3 million for the fourth quarter of 2008. Revenue for the year ended Dec. 31, 2009, was $18.0 million compared with $16.5 million for the year ended Dec. 31, 2008. The increase in 2009 revenue resulted primarily from Trubion's strategic collaboration with Facet Biotech, including $0.8 million for recognition of the $20 million upfront fee and $1.4 million equity premium, and $1.3 million for collaborative research funding.

The increase in revenue related to the Facet Biotech collaboration was partially offset by a decrease in revenue recognized from Trubion's collaboration with Pfizer. The decrease in revenue related to an extension of the recognition period of the upfront...

Insmed reports 4Q profit as expenses fall

Mon, 15 Mar 2010 18:41:00 +0000

RICHMOND, Va. -- Insmed Inc. on Monday reported a fourth-quarter profit as it cut research and development expenses following the sale of its biosimilars unit.

The biopharmaceutical company earned $2.3 million, or 2 cents per share, compared with a loss of $4 million, or 3 cents per share, during the period a year prior. Revenue fell to $2.5 million from $2.9 million.

The company said operating expenses fell $4.5 million, mainly on lower manufacturing expenses from research and development. The company sold assets, including its biosimilar unit, to Merck & Co as part of a $130 million deal in 2009. Biosimilars are copies of biotech-based drugs.

For the full year, the company earned $118.4 million, or 93 cents per share, compared with a loss of $15.7 million, or 13 cents per share, in 2008. Revenue fell to $10.4 million from $11.7 million.

Shares of Insmed fell 11 cents, or 9.2 percent, to $1.09...

ERT Offers a New Self-Rated Version of the C-SSRS, Facilitating Prospective Suicidality Monitoring

Mon, 15 Mar 2010 15:00:00 +0000

PHILADELPHIA, March 15 /PRNewswire-FirstCall/ -- ERT (Nasdaq: ERES), a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces a pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors. The validated eC-SSRS solution, developed in collaboration with the scale lead author, is a cost-effective method of prospectively monitoring for suicidality. It has been designed, in line with anticipated FDA requirements, to reliably and reproducibly assess suicidality in clinical trials; thereby, protecting patient safety while significantly reducing the burden on study sites.

In recent years, there has been increased focus on treatment-emergent suicidality and the development of a reliable assessment method for use in clinical trials to enhance effective patient-safety monitoring. The FDA is developing guidance on regulatory requirements for suicidality monitoring. In light of concerns regarding the burdens...

Arena Pharmaceuticals Q4 net loss narrows

Mon, 15 Mar 2010 11:22:00 +0000

Mar 15, 2010 (Datamonitor via COMTEX) -- Arena Pharmaceuticals, a biopharmaceutical company, has reported that net loss allocable to common stockholders was $29.77 million, or $0.32 per share, for the fourth quarter ended December 31, 2009, compared to a net loss allocable to common stockholders of $62.48 million, or $0.84 per share, for the fourth quarter ended December 31, 2008.

For the fourth quarter of 2009, total revenues were $2.68 million, compared to $2.7 million for the fourth quarter of 2008.

Net loss allocable to common stockholders for the year ended December 31, 2009 was $153.2 million, or $1.82 per share, compared to a net loss allocable to common stockholders of $239.48 million, or $3.24 per share, for the year ended December 31, 2008.

For the year 2009, total revenues were $10.39 million, compared to $9.81 million for the year 2008.

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Omeros Corporation to Host Conference Call on Fourth Quarter and Full Year 2009 Results on March 31

Mon, 15 Mar 2010 11:00:00 +0000

SEATTLE, March 15 /PRNewswire-FirstCall/ --Omeros Corporation (Nasdaq: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it will hold a conference call on Wednesday, March 31, 2010 to discuss the Company's fourth quarter and full year 2009 results and provide a corporate update. Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros, will host the call beginning at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). A press release for the fourth quarter and full year ended December 31, 2009 will be released on March 31.

To access the live call by telephone, please dial 888-500-6973 (United States and Canada) or 719-457-2637 (International). In addition, the live conference call is being webcast and can be accessed on the "Events" page of the Company's website at http://www.omeros.com .

A replay of the webcast will...

GTx Provides Corporate Update and Reports 2009 Financial Results

Mon, 15 Mar 2010 11:00:00 +0000

• Reacquires SARM program and plans Ostarine™ Phase III clinical trials for cancer cachexia

• Held End of Review meeting with FDA for toremifene 80 mg

• Announces last patient completed toremifene 20 mg Phase III high grade PIN clinical trial in February

• Initiates Phase II clinical trial for GTx-758 for first line treatment of advanced prostate cancer

MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (Nasdaq: GTXI) today provided a company update and reported...

Insmed Announces Fourth Quarter and Full-Year 2009 Financial Results

Mon, 15 Mar 2010 11:00:00 +0000

RICHMOND, Va., March 15 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today reported results for the fourth quarter and full-year ended December 31, 2009.

Revenues for the fourth quarter ended December 31, 2009 were $2.5 million, as compared to $2.9 million for the corresponding period in 2008. The decrease was a result of a reduction of $0.9 million in cost recovery from our IPLEX™ Expanded Access Program ("EAP") for Amyotrophic Lateral Sclerosis ("ALS") in Europe, which was partially offset by $0.5 million of IPLEX™ grant revenue that was recognized in the fourth quarter of 2009. The reduction in IPLEX™ cost recovery was due to the Company's decision in July 2009 to cease supplying IPLEX™ to new ALS patients in order to preserve the remaining IPLEX™ inventory for ALS patients currently receiving the drug. The $0.5 million in grant revenue relates to the timing of a grant received from...

News and FDA Updates for NeurogesX (Nasdaq:NGSX), Home Diagnostics (NASDAQ:HDIX), Pacific ...

Mon, 15 Mar 2010 09:57:00 +0000

A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com

On 03/12/10, NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced it will hold a conference call on Thursday, March 18, 2010 at 4:30 p.m. ET (1:30 p.m. PT) to report results for its fourth quarter and full year ended December 31, 2009.

On 03/12/10, Nipro Corporation and Home Diagnostics, Inc. (NASDAQ:HDIX) announced the successful completion of the offer to purchase all outstanding shares of the common stock of Home Diagnostics, Inc. by Nipro's wholly-owned subsidiary, Nippon Product Acquisition Corporation (the "Purchaser").

On 03/12/10, Pacific Biomarkers,...