RxNews Recap for Monday 03-15-10. After the bell ICAgen soars on epilepsy study results. Sequenom falls after earnings miss. Print E-mail
By BioMedReports.com Staff   
Monday, 15 March 2010 18:57

Below is a list of the companies that made news in the healthcare sector on Monday, March 15, 2010.

Icagen, Inc. (Nasdaq:ICGN) saw its shares soar after the bell today after the company 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.

"The trial met its endpoints," noted Jacqueline A. French, M.D., Professor and Director of the Clinical Trials Consortium at the NYU Comprehensive Epilepsy Center. "While more studies will be required to establish the potential utility of this compound in the treatment of epilepsy, the results of this photosensitive epilepsy model provide important proof-of-concept data for this novel drug candidate."

In light of the results of this study as well as those of previously reported studies, the Company plans to consult with the FDA to determine next steps for the development of ICA-105665. The Company plans to report the complete results of this study at an appropriate medical conference.

In the after hours market shares of Icagen surged 84.84%, rising 46 cents to $1.00.

Sequenom, Inc. (Nasdaq:SQNM) was off sharply in the after hours session after the company reported its financial results for the fourth quarter and year ended December 31, 2009. The company posted a wider-than-expected quarterly loss, hurt by rising costs and lower average selling price for its systems in the genetic analysis business. Shares fell more than 19% in the session, down $1.48.

In other news after the market closed:

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) after the bell announced that clinical evaluation is now allowed under an Investigational New Drug application filed with the U.S. Food and Drug Administration for a benzodiazepine product candidate utilizing our Aversion(R) Technology. The primary active ingredient in this product candidate is intended for the treatment of anxiety disorders. Aversion(R) Technology is a unique mixture of active and functional inactive ingredients, intended to minimize abuse liability potential of the primary active ingredient. Benzodiazepine products are classified as Schedule IV for potential abuse by the U.S. Drug Enforcement Administration. Acura has now opened three INDs for Aversion(R) Technology product candidates.

Cadence Pharmaceuticals, Inc. (Nasdaq:CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the fourth quarter and year ended December 31, 2009.

During 2009, Cadence completed its clinical development program and submitted a New Drug Application (NDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, which was accepted for filing and designated for Priority Review by the U.S. Food and Drug Administration (FDA). On February 10, 2010, the company received a Complete Response letter from the FDA, which stated that the NDA could not be approved in its present form due to deficiencies observed during an FDA inspection of Cadence's third-party manufacturer. A response to the inspectional observations was submitted to the FDA by the third party manufacturer on February 18, 2010, and Cadence plans to re-submit the NDA for OFIRMEV once it has been determined that the inspectional observations are resolved.

"Our third party manufacturer has now submitted its response to the FDA's observations, and we will be prepared to re-submit our NDA for OFIRMEV at the earliest possible opportunity," stated Ted Schroeder, President and CEO. "We believe it is important to note that no safety or efficacy deficiencies were noted in the Complete Response letter and the FDA did not request that any additional clinical trials be completed in order to obtain approval of the NDA. As a result, we believe that we have sufficient capital resources to fund our operations through re-submission of the NDA and approval of OFIRMEV."

Eli Lilly and Company (NYSE:LLY) and Acrux (ASX:ACR.ax) 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 AXIRON™). 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.

EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced today that it has submitted an Investigational Device Exemption (IDE) application with the US Food and Drug Administration (FDA) for the Company's next-generation Maestro® RC System in the treatment of morbid obesity using VBLOC® vagal blocking therapy. The submission is the first step in the iterative IDE review process in support of a possible Premarket Approval (PMA) application.

"This IDE submission marks an important next step in advancing our Maestro RC System toward a pivotal study in obesity," said President and CEO Mark B. Knudson, Ph.D. "We look forward to working through the IDE review process with the FDA. We expect to be in a position to provide an update on our strategy after this process has reached a conclusion."

Medivation, Inc. (Nasdaq:MDVN) after the market close 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 prostate cancer."

SenoRx, Inc. (Nasdaq:SENO) today with great sadness announced the death of its Chairman and Chief Executive Officer, Lloyd H. Malchow. Mr. Malchow passed away Sunday evening, March 14. The company extends its deepest condolences to his family.

It had been announced on February 8 that Mr. Malchow was taking an indefinite medical leave of absence to undergo medical treatment for cancer. Mr. Malchow is survived by his wife and two daughters.

"Lloyd was an exceptional leader, business colleague and friend," said John Buhler, SenoRx President, Chief Operating Officer and Acting Chief Executive Officer. "He leaves a legacy of excellence and accomplishment as a business leader. His SenoRx family will miss him tremendously. He will always be remembered for his passion and commitment to both his work and his family. Through his compassion and tenacity he inspired all of us to be our best."

Watson Pharmaceuticals, Inc. (NYSE:WPI) today announced that its subsidiary, Watson Laboratories, Inc. – Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately.

Diltiazem Hydrochloride Extended-Release tablets are indicated for the treatment of hypertension. For the 12-months ending December 31, 2009, Cardizem® LA had total U.S. sales of approximately $94.1 million, according to IMS Health.

In other news Monday:

Abbott (NYSE:ABT) today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events (MACE(1) rate of 2.0 percent) at 30 days. These results build on the long-term success Abbott has seen with the BVS technology in the first phase of the ABSORB trial, which has generated positive data on 30 patients out to three years. Data from the second phase of the trial was presented at the American College of Cardiology's 59th annual scientific session in Atlanta.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the presentation of new pre-clinical data from its hypercholesterolemia program, performed in collaboration with scientists at the University of Texas Southwestern Medical Center at Dallas. The data were presented at the PCSK9 Conference: From Gene to Therapeutics held in Nantes, France from March 11-13, 2010. Alnylam has an ongoing development program focused on using RNAi therapeutics targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, as a novel strategy for reducing LDL (or "bad") cholesterol. The new data demonstrated durable reductions of cholesterol levels in both rodents and non-human primates with an RNAi therapeutic targeting PCSK9 using second generation lipid nanoparticle (LNP) formulations. Further, data also showed the ability to utilize siRNA combination approaches to achieve efficient silencing of separate and distinct genes to achieve cholesterol lowering.

AMICAS, Inc. (Nasdaq:AMCS), a leader in image and information management solutions, announced today at the 59th Annual Scientific Session of the American College of Cardiology (ACC.10), that the company has signed contracts for more than 90 clinical knowledge bases for Web-based structured reporting for cardiology.

Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (Nasdaq:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide for extended-release injectable suspension).

In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.

"This is a significant step forward in our ability to bring this important therapy to patients," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."

Shares of Amylin shot up 15.99%, rising $3.24 to $23.50.

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) shot up today after the company announced that its corporate partner, Boston Scientific Corporation (NYSE:BSX), reported 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS(R) Element(TM) Paclitaxel-Eluting Stent System compared to the TAXUS(R) Express(2)(TM) Paclitaxel-Eluting Stent System. The results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the TAXUS Element Stent compared to a historical control group of patients receiving the Express(R) bare-metal stent. "We are very encouraged by the one-year data demonstrating positive safety and efficacy outcomes for the TAXUS Element Stent and its innovative platinum chromium alloy," said Dr. Kereiakes. "In my experience, the TAXUS Element Stent offers increased flexibility, visibility and deliverability compared with currently available products. The PERSEUS data confirm that the proven TAXUS drug and polymer combination has been successfully transferred to the Element platform with excellent performance and comparable safety." Shares rose 11.11% or 12 cents to close Monday's session at $1.20.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) shares moved higher today after the company announced the receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.

"The Orphan Drug designation of GVAX Pancreas Vaccine for the treatment of pancreatic cancer is BioSante’s first GVAX regulatory submission and response from the FDA since acquiring this portfolio of cancer vaccines last October," said Stephen M. Simes, BioSante’s president & CEO. "It is our intention to find ways to continue the development of our GVAX Pancreas Vaccine using the benefits conferred by gaining Orphan Drug designation. Further, this designation alerts the FDA that we are dedicated to bringing better cancer therapy to patients in need. Currently, GVAX Pancreas Vaccine clinical trials are ongoing at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. In addition, clinical trials of GVAX vaccines against many different cancer types are being conducted, including leukemia and breast cancer. We value our collaborative relationship with the researchers at the Cancer Center and intend to work with them to advance the development of these potentially life-saving therapies."

Boston Scientific Corporation (NYSE:BSX) dropped after the company announced today that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The Company has determined that some manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA). At this time, the company has identified two instances of changes that, while successfully validated, were not submitted to the FDA. Boston Scientific has informed the FDA and plans to work closely with the agency to resolve this situation as soon as possible.

The Company has no indication that the manufacturing process changes pose any risk to patient safety, and it is not recommending explantation of the devices.

Product families included in this advisory include: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. The Company's pacemakers and other products are not affected by this advisory.

"A planned process review revealed that two manufacturing process changes were not submitted for FDA approval," said Ray Elliott, President and Chief Executive Officer of Boston Scientific. "We are acting voluntarily and expeditiously to resolve this situation, and we have seen no evidence of any risk to patient safety. We apologize for the inconvenience these actions will cause patients and physicians."

Caliper Life Sciences, Inc. (Nasdaq:CALP), a leading provider of tools and services for drug discovery and life sciences research, today announces that it has entered into a settlement agreement with Shimadzu Corporation and its wholly owned subsidiary Shimadzu Scientific Instruments, Inc., resolving a lawsuit filed by Caliper in the United States District Court for the Eastern District of Texas that claimed that Shimadzu's MultiNA microchip-based electrophoresis system infringed several U.S. patents relating to Caliper's microfluidic LabChip® technology. Shimadzu denies infringement, but has discontinued sales of the MultiNA system in the United States. The terms of the settlement were not disclosed.

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today 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.

"Our ability to achieve our many milestones last year advanced CytRx into a full-fledged oncology company," said Steven A. Kriegsman, CytRx President and CEO. "This year we have set a very aggressive clinical and regulatory agenda that reflects our clear focus on rapidly commercializing our oncology drug portfolio. We plan to initiate three Phase 2 proof-of-concept clinical trials with INNO-206 and two additional Phase 2 proof-of-concept clinical trials with bafetinib, while continuing to execute our development plans for tamibarotene as a treatment for acute promyelocytic leukemia (APL).

"Given the potential of our diverse oncology portfolio and strength of our corporate infrastructure, we are highly optimistic about reaching our near-term prospects as well as our longer-term goal of building CytRx into a major oncology company," he added. "Our drug candidates, which offer advantages over currently marketed drugs, are based on known mechanisms of action, which can minimize development risk. Our clinical strategy calls for trials to be conducted in patients with advanced-stage cancers, allowing for more rapid assessment of efficacy data, and we expect substantial progress toward proof-of-concept in multiple clinical trials by late this year and next year as well. Additionally, our oncology portfolio could address multiple cancers, several of which have blockbuster potential with revenue opportunities exceeding $2 billion. We have a highly experienced team with extensive expertise to advance this agenda and believe that our current cash resources, including our holdings in RXi Pharmaceuticals, Inc. (Nasdaq:RXII) will be sufficient to fund our operations for the foreseeable future."

Shares of CytRx rose 6 cents or 5.08% to $1.24 while shares of RXi shot up 10.20% or 61 cents to close at $6.59

Dynavax Technologies Corporation (NASDAQ:DVAX) announced today the successful completion of negotiations relating to Merck's reimbursement obligations under the former partnership agreements covering the clinical development and commercialization of HEPLISAV™, Dynavax's enhanced hepatitis B vaccine. Merck has agreed to make a $4.0 million payment to Dynavax covering expenses for the wind down period that followed its December 2008 written notification of the collaboration's conclusion.

Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that data from a phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were published in The Lancet. This study met its primary endpoint, resulting in an average LDL-C reduction of greater than 100 mg/dL in this very high-risk patient population.

"Currently available treatments do not provide adequate lipid lowering for hoFH patients, leaving them at extraordinarily high risk for cardiovascular events," said Professor Frederick J. Raal, M.D., Ph.D., Director of the Carbohydrate and Lipid Metabolism Research Unit at the University of the Witwatersrand in South Africa, and the study’s primary investigator. "Mipomersen has the potential to set a new standard of care for this difficult-to-treat disease."

Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008. This $1,219,000 increase in loss was primarily due to increased research and development expenses associated with preparing the New Brunswick, New Jersey manufacturing plant for increased production plus efforts employed in supporting the New Drug Application ("NDA") and employee compensation awards. Cash and cash equivalents were $58,072,000 as of December 31, 2009 reflecting an increase of $51,953,000 since year end 2008 due primarily to equity financing during 2009. Cash used in operating activities for the year ended December 31, 2009 was $9,297,000 compared to $9,358,000 for the same period in 2008, a reduction of $61,000.

Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that 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.

Impax filed its Abbreviated New Drug Application containing a paragraph IV certification for a generic version of TRILIPIX® with the U.S. Food & Drug Administration. Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification.

MannKind Corporation (Nasdaq:MNKD) dropped sharply today after the company announced that it has received a Complete Response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.

"We are currently reviewing the Complete Response letter and fully expect that we will be able to respond to the FDA's requests in a timely manner," said Alfred Mann, Chairman and Chief Executive Officer. "We had always planned to follow the original NDA for AFREZZA with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device. We will discuss with the FDA whether it is appropriate to use what would otherwise have been a supplemental NDA submission, which we had planned to make during the second quarter of this year, to address the agency’s requests. If this approach is acceptable, we believe that this regulatory action will not have a significant impact on the timing of the commercial launch of AFREZZA. We will work closely with the FDA to answer quickly the agency’s questions and satisfy the requirements. We are committed to working with the FDA to make AFREZZA available to patients as soon as possible." Shares fell 24.71% or $2.59 to close the day at $7.89.

MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, today announced enhanced efficacy for tumor reduction when two UsiRNA were combined within a single formulation. The UsiRNAs targeted two proteins survivin, a protein involved in cell division and inhibition of apoptosis, and PLK1 (Polo-like Kinase 1), a protein involved in cell mitosis and tumor progression. Both UsiRNA were encapsulated in the Company's proprietary DiLA2-based formulation, and delivered directly to the bladder (intravesical) in an orthotopic cancer model. At an equivalent total dose, tumor bioluminescence with a combination approach was significantly lower (~30%), when compared to a single UsiRNA. Additionally, the Company also announced another early collaborative effort with a major international pharmaceutical company bringing the total number of early collaborative efforts to three.

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced that its Board of Directors, after careful review and consideration with the assistance of OSI’s management and outside legal and financial advisors, has unanimously rejected the unsolicited, conditional tender offer from Astellas US Holding, Inc., a wholly-owned subsidiary of Astellas Pharma Inc., to acquire all outstanding shares of OSI common stock for $52.00 per share in cash. The OSI Board unanimously recommends that OSI stockholders reject the offer and not tender their shares into the offer.

Poniard Pharmaceuticals, Inc. (Nasdaq:PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced the sale of 4,229,000 of its common shares to Commerce Court Small Cap Value Fund, Ltd. for gross proceeds of approximately $6.3 million, or approximately $1.49 per share, under its existing committed equity financing facility with Commerce Court. Poniard intends to use the approximately $6.1 million in net proceeds from this offering to fund the company's regulatory and partnering strategies focused on the continued development of picoplatin in small cell lung cancer and other indications. Based on its existing cash and investment securities, together with the net proceeds from this offering, Poniard believes it has adequate resources to fund operations at least through the end of 2010.

Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) today announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA™ (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. "We believe that this resubmission combined with the submissions made and planned by our third party contract manufacturer fully addresses the deficiencies and observations raised and provides the additional materials requested in the Complete Response Letter that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009," stated Paul Hamelin, President of Savient.

Sigma-Aldrich® (Nasdaq:SIAL) today announced that it has entered into an agreement with Pfizer (NYSE: PFE)under which Sigma-Aldrich will sell approximately 100 Pfizer-developed small molecule compounds to life science researchers for target characterization, assay development, screening and in vivo animal model applications.

St. Jude Medical, Inc. (NYSE:STJ) today announced several updates to its PressureWire platform, including a new marketing agreement with Siemens Medical Solutions USA, for the wireless PressureWire Aeris and the availability of the next-generation of PressureWire Certus technology, at the American College of Cardiology (ACC) and the Society of Interventional Radiology (SIR) annual meetings. The enhanced capabilities make the company's leading Fractional Flow Reserve (FFR) measurement technology, which aids in the diagnosis and treatment of coronary artery blockages, more versatile and accessible for physicians around the world. The PressureWire Aeris and Certus provide FFR measurements, which indicate the severity of blood flow blockages in the coronary arteries. This physiological measurement helps physicians to better identify which specific lesion or lesions are responsible for a patient's ischemia, a deficiency of blood supply to the heart caused by blood restriction.

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the initiation of a Phase 2 clinical trial of XOMA 052, its antibody to interleukin-1 beta (IL-1 beta), in Type 1 diabetes patients. Funding for the trial is being provided by the Juvenile Diabetes Research Foundation International (JDRF), the largest patient advocacy organization of Type 1 diabetes research worldwide. XOMA is the study sponsor and will provide XOMA 052 drug product for the trial.

In a separate release the company also announced results demonstrating that a murine equivalent of XOMA 052, its novel, high-affinity antibody to interleukin-1 beta (IL-1 beta), significantly reduced adverse consequences that usually lead to the development of congestive heart failure in a mouse model of acute myocardial infarction (heart attack). The results were presented today at the American College of Cardiology 59th Annual Scientific Sessions in Atlanta.

YM BioSciences Inc. (NYSE Amex: YMI, TSX:YM), today announced that two posters have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting to be held from April 17-21 in Washington, DC. The first poster describes the results of the previously reported collaboration with researchers at the University of Toronto for the development of highly potent antibody-radionuclide conjugates for use in the treatment of cancer. The poster will describe activity of 111In-NLS-nimotuzumab against breast cancer cells with high and low EGFR expression. 111In-NLS-nimotuzumab was highly active against cells over-expressing EGFR whereas the nimotuzumab conjugate spared toxicity toward cells with EGFR expression similar to that on most normal epithelial cells.

ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of resuscitation devices and related software solutions, today reported that A. Ernest Whiton, its Chief Financial Officer and Vice President of Administration, is entering into a 10b5-1 sales plan for the sale of shares of ZOLL common stock over an approximate 12-month period.

Also Monday:

Agilent Technologies Inc. (NYSE:A) today announced the availability of new ion exchange and size exclusion columns specifically designed for the analysis of bio-molecules including monoclonal antibodies, recombinant proteins, peptides, vaccine products and DNA/RNA.

Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2009.

A.P. Pharma, Inc. (NASDAQ: APPA), a specialty pharmaceutical company, today reported financial results for its fourth quarter and full year ended December 1, 2009.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that its President and CEO Michael Bonney will be honored with the second annual Massachusetts Biotechnology Council (MassBio) Innovative Leadership Award. Mr. Bonney will receive this recognition at an awards luncheon at the MassBio Annual Meeting on March 31st at the Seaport World Trade Center in Boston.

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

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 patients with breast and prostate cancers.

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

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today 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 a potential indication for treatment of anterior and posterior forms of blepharitis.

Kendle (Nasdaq: KNDL) a leading, global full-service clinical research organization, today 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.

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.

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.

PPD, Inc. (Nasdaq: PPDI) today announced Simon Britton, vice president of clinical development, Asia Pacific, is a guest speaker at the World Pharma Trials 2010 conference in Singapore.

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces the appointment of Bill Burns to its Board as a Non Executive Director with immediate effect. Mr Burns has also been appointed a member of Shire's Remuneration Committee.

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.

Vermillion, Inc. (Pink Sheets: VRML) today announced that due to the positive response to the national launch of its OVA1™ test this past week, the company's leadership will be attending the Society of Gynecologic Oncologists' (SGO) 41st Annual Meeting on Women's Cancer in San Francisco rather than presenting at the Roth 22nd Annual OC Growth Stock Conference in Laguna Niguel.

Walgreens (NYSE: WAG) (NASDAQ: WAG) will release its fiscal 2010 second quarter earnings results at 7:30 a.m. Eastern time Tuesday, March 23, followed by a conference call with Walgreens management beginning at 8:30 a.m. Eastern time.

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