|RxNews Recap for Thursday 02-25-10. Mylan up on positive earnings/guidance. NewCardio soars on another patent.|
|By BioMedReport Staff|
|Thursday, 25 February 2010 19:43|
Below is a list of the companies that made news in the healthcare sector on Thursday, February 25, 2010.
Mylan Inc. (Nasdaq:MYL) shares made a significant, positive move today as they announced financial results for the three and twelve months ended December 31, 2009.
Highlights from the report were: *Adjusted diluted earnings per share (EPS) of $0.33 and $1.30 for the three and twelve months ended December 31, 2009, compared to $0.26 and $0.80 for the same prior year periods; *Total revenues of $1.35 billion for the three months ended December 31, 2009; *Total revenues of $5.09 billion for the year ended December 31, 2009; *On a GAAP basis, earnings per diluted share of $0.01 for the three months ended December 31, 2009; *On a GAAP basis, earnings per diluted share of $0.30 for the year ended December 31, 2009.
Mylan's Chairman and CEO Robert J. Coury said; "we are reaffirming our 2010 guidance of $1.50 to $1.70, which I fully expect will translate into an industry-leading EPS growth rate over the 2008 to 2010 period. I anticipate that this strong growth will continue, and we are projecting revenues in excess of $8.5 billion in 2013, representing a top-line CAGR of 15%, from 2010. We are also projecting EPS in excess of $2.75 in 2013, which represents a CAGR of 20%. Additionally, I fully expect we will be able to deliver EPS in excess of $2 in 2011. We also anticipate generating cumulative operating cash flows of approximately $4 billion by the end of 2013. With that said, we expect to continue to lead the sector in EPS growth, which we believe will benefit all shareholders and other stakeholders.
Shares closed up 6.59% or $1.28 to $20.70 as 27 million shares traded hands, more than 4 times the daily average.
NewCardio, Inc. (OTC Bulletin Board:NWCI.ob)as reported today here on BioMedReports announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering technology relating to NewCardio's Cardio3KG solution (formerly VisualECG or Visual3Dx). This represents the core patent for NewCardio's anticipated emergency/urgent care solution, Cardio3KG.
In addition, the company outlined in its 10K filing that they are working on partnerships that could potentially bring the company significant capital infusion.
Shares of NewCardio jumped 18.57% or 26 cents to close the day at $1.66 on heavy volume.
In news after the bell:
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and year ended December 31, 2009, and company highlights.
"We made great strides in 2009 as we continue to lead the industry’s efforts in the discovery and development of RNAi therapeutics. Notable in our year’s efforts was the significant progress we made in the advancement of our clinical pipeline and our major breakthroughs in delivery with a new second generation lipid nanoparticle platform. Overall, we believe we continue to lead the world in the translation of RNAi into clinical studies and that we will extend this leadership in the translation of these innovative medicines to the marketplace," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "As we start what we believe could be viewed as an ‘RNA Decade,’ we have positioned ourselves well to continue advancing RNAi therapeutics as a whole new class of medicines, and execute on our strategy of building a top-tier biopharmaceutical company founded on RNAi."
Amicus Therapeutics (Nasdaq:FOLD)today announced that it has entered into definitive agreements dated February 25, 2010 with a select group of institutional investors to sell 4.95 million shares of its common stock and warrants to purchase 1.85 million shares of its common stock in a "registered direct" offering. The shares of common stock and warrants are being offered in units consisting of one share of common stock and one warrant to purchase 0.375 shares of common stock at a price of $3.74 per unit. The warrants have a term of four years and are exercisable any time on or after the six month anniversary of the date they are issued, at an exercise price of $4.43 per share. The gross proceeds of the offering are expected to be approximately $18.5 million to Amicus, before deducting placement agent fees and estimated offering expenses.
eResearchTechnology, Inc. (ERT), (Nasdaq:ERES),a leading provider of centralized ECG, ePRO, and other services to the bio/pharmaceutical, medical device and related industries, announced today results for the fourth quarter and twelve-month period ended December 31, 2009.
"The fourth quarter saw our second consecutive quarter of strong bookings of over $40 million, which demonstrated the desire of our clients to increase their spending on cardiac safety," commented Dr. Michael McKelvey, President and CEO of ERT. "In the third quarter of 2009, bookings were primarily derived from large bio/pharmaceutical companies; in the fourth quarter of 2009, bookings from mid-sized bio/pharmaceutical companies started to pick up. The strength of our business model was again demonstrated as margins continued to increase sequentially as did our ability to generate strong cash flows even in a relatively flat revenue environment."
Genoptix, Inc. (Nasdaq:GXDX)after the market closed today announced that it will participate in Aetna's (AET) national provider network to offer specialized laboratory and comprehensive diagnostic services designed to optimize the care of patients suffering from hematomalignancies, or cancers of the blood and bone marrow, including leukemia and lymphoma. In a seperate release after the bell, the company reported strong results for the Q4 and Full-Year 2009 as annual year over year growth was 59%. Revenues of $49.1 million and $184.4 million for the fourth quarter and full year of 2009, respectively. Net income was $7.4 million, or $0.41 per diluted share, and $30.6 million, or $1.71 per diluted share, for the fourth quarter and full year 2009, respectively.
"We managed nearly 57,000 patient cases throughout the year, an increase of approximately 48% from the number of cases managed in 2008, a trend indicative of the demand for personalized service on the part of the community physicians we serve," said Tina S. Nova, Ph.D., President and CEO of Genoptix. "Our annual growth and continued performance reflect a year of exceptional execution."
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX),a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2009. At December 31, 2009, Idenix's cash, cash equivalents and marketable securities totaled $48.1 million.
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA)announced today that the U.S. Patent and Trademark Office has issued a notice of allowance for its patent application of a microsphere, long-acting injectable formulation of its antipsychotic product, Fanapt™ (iloperidone). When issued, this U.S. patent will expire on October 30, 2022, and in addition, the U.S. Patent and Trademark Office has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.
In other news Thursday:Acorda Therapeutics, Inc. (Nasdaq: ACOR)today announced that Ron Cohen, M.D., President & CEO, will participate in a panel entitled “New Developments in Neurology” at the upcoming RBC Capital Markets Healthcare Conference on Tuesday, March 2, 2010 at 9:00 a.m. Eastern Time at the New York Palace in New York, NY.
Adamis Pharmaceuticals Corporation (OTCBB: ADMP)today announced the signing of a definitive agreement to acquire exclusive license agreements covering three small molecule compounds, named CPC-100, CPC-200 and CPC-300, for the potential treatment of human prostate cancer (PCa), from privately-held Colby Pharmaceuticals, in exchange for shares of Adamis stock.
Adolor Corporation (NasdaqGM: ADLR) today reported a net loss of $47.9 million, or $(1.03) per basic and diluted share, for the year ended December 31, 2009, compared to a net loss of $30.1 million, or $(0.65) per basic and diluted share, for the year ended December 31, 2008.
BioClinica™, Inc., (NASDAQ: BIOC),a global provider of clinical trial management services, today announced the launch of BioClinica Optimizer, a breakthrough for clinical supply planning and management that it believes has the potential to transform clinical trial supply forecasting and management.
BioReference Laboratories, Inc. (NASDAQ: BRLI) announced today it plans to issue earnings results for the first quarter of fiscal 2010 before the open of market trading on Thursday, March 4, 2010.
Biovail Corporation (NYSE/TSX: BVF) today announced financial results for the three-month and 12-month periods ending December 31, 2009. To the extent that this press release contains forward-looking statements, investors are cautioned that these are based on our current views, and actual outcomes are not certain. Please see the note on forward-looking information following the conference-call details below.
"I am pleased by our strong financial and operational performance in 2009 and by our significant progress with our specialty CNS strategy," said Biovail Chief Executive Officer Bill Wells. "Since embarking on our strategy only 21 months ago, we’ve completed seven transactions designed to build both the near-term and longer-term growth prospects of the Company. The most recent transaction, licensing U.S. and Canadian rights to Staccato® loxapine, provides us with a late-stage, unique product that has been filed with the FDA, targets a significant unmet medical need, and could provide the basis for the deployment of an internal U.S. sales force – a key component of our long-term business strategy.
Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX)announced that it will be making a presentation today at the 2010 Epilepsy Pipeline Update Conference, an in-depth, two day forum being held at the Hyatt Embarcadero Hotel in San Francisco.
CryoPort, Inc. (OTCBB: CYRXD), today announced the pricing of a public offering of units consisting of 1,666,667 shares of CYRX common stock and 1,666,667 warrants to purchase one share of common stock at an exercise price of $3.30, for gross proceeds of $5,000,001 and net proceeds of approximately $4,237,850.
Derma Sciences, Inc. (Nasdaq: DSCI),a specialty medical device/pharmaceutical company focused on advanced wound care, today announced that it has finalized a definitive set of agreements with Comvita New Zealand Ltd. (Comvita) of Paengaroa, New Zealand, giving Derma Sciences perpetual and exclusive worldwide licensing rights for MEDIHONEY® professional wound care and skin products covering distribution and sales to all markets outside of the over the counter (OTC) market.
Dynavax Technologies Corporation (NASDAQ:DVAX)announced today that it has selected a clinical vaccine candidate for its novel Universal Flu program, completed key preclinical studies, and is reviewing clinical plans with the FDA in anticipation of initiating a Phase I study by mid-year. Dynavax also said that the trial will be conducted at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH). Specifically, Dynavax will collaborate with Dr. Robert B. Belshe, Principal Investigator of the VTEU at St. Louis University in St. Louis, MO and with Dr. Wendy A. Keitel, Principal Investigator, of the VTEU at Baylor University in Houston, TX. Dynavax made its comments today in connection with a Workshop on Influenza Vaccinology sponsored by the President's Council of Advisors on Science and Technology in Washington, D.C.
Elan Corporation, plc (NYSE: ELN) today announced the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2009.
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),today announced that a Phase III study showed the combination of Avastin® (bevacizumab) and chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone. A preliminary assessment of safety noted adverse events previously observed in pivotal trials of Avastin. Data from the study will be submitted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
Genta Incorporated (OTCBB: GETA)announced that the Company has initiated a new dose-ranging study of tesetaxel, the Company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
ICON (NASDAQ:ICLR) (ISIN:IE0005711209),a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the fourth quarter ended December 31, 2009. Commenting on the results, CEO Peter Gray said "We are pleased with our performance in what has been a challenging year. Revenues increased by 3%, margins improved significantly from 11.5% to 13.1% and EPS was up 18%. With our backlog at $1.84bn and with a strong balance sheet, we have entered 2010 in a good position. While external factors are challenging, and many governments are endeavoring to reduce healthcare costs, including pharmaceutical prices, we remain positive, though cautious, as 2010 commences. As a result we are issuing revenue guidance for 2010 in the range of $890 - $940 million and EPS guidance in the range of $1.44 - $1.60."
Impax Laboratories, Inc. (NASDAQ: IPXL)today reported its strongest financial results in its history due to record sales from its Global products sales channel. Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: "We are delighted with our record-breaking financial results. Our fourth quarter and full year 2009 results demonstrate our ability to capitalize on the significant investments we continue to make in research and development. The solid customer relationships we have developed were beneficial in producing strong sales from our fenofibrate products and the October 1 launch of generic Adderall XR®. Certain market disruptions caused by product supply shortages in the fourth quarter may have benefited sales of our Global Pharmaceutical Division’s generic Adderall XR® product, therefore fourth quarter sales may not be indicative of any future periods."
Incyte Corporation (Nasdaq:INCY)announced today it will present at the Cowen and Company 30th Annual Health Care Conference on Monday, March 8, 2010 at 3:15 p.m. ET. Presenting for Incyte Corporation will be Paul Friedman, M.D., president and chief executive officer.
KV Pharmaceutical Company (NYSE: KVa/KVb) shares shot up today after the company announced that it has reached an agreement, subject to court approval, with the United States Attorney for the Eastern District of Missouri and the Office of Consumer Litigation of the United States Department of Justice to resolve an investigation regarding certain activities of ETHEX Corporation, its generic pharmaceutical marketing and distribution subsidiary, which occurred in 2008. Under the terms of the settlement, ETHEX will plead guilty to criminal charges, and will be required to pay a fine and restitution of $25.8 million. ETHEX also will not contest an administrative forfeiture of $1.8 million.
"This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward," said David Van Vliet, interim CEO of KV Pharmaceutical. "Management and the Board have been working diligently to address this issue and we are looking forward to having this matter resolved. Looking ahead, we remain focused on working alongside the FDA in accordance with our consent decree and demonstrating cGMP compliance so we can resume manufacturing and return our products to market."
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products.
Shares were halted earlier in the day prior to the news. They opened significantly higher and settled the day up 10.63% or 32 cents to close at $3.33. Volume was more than double the average daily.
Omnicare, Inc. (NYSE:OCR), one of the nation’s leading providers of pharmaceutical care for the elderly, today reported financial results for its fourth quarter and full year ended December 31, 2009.
OncoGenex Pharmaceuticals (NASDAQ:OGXI) announced today that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's development plan for OGX-011 (also known as custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC). The input received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall agreement with OncoGenex's development plan regarding the proposed preclinical studies and both the study designs and analyses for the Phase III trials. The CHMP also agreed that the intended safety database would enable a sufficiently qualified risk-benefit assessment for market approval.
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP)announced today that OSI Management will present at the RBC Capital Healthcare Conference in New York, NY on Tuesday, March 2nd at 2:30pm (Eastern Time) and will provide an overview on the Company’s product portfolio and business developments.
Palatin Technologies, Inc. (NYSE Amex: PTN)announced today that it has entered into definitive agreements with certain accredited investors to sell in a registered direct offering 9.6 million units at a price of $0.27 per unit for gross proceeds of $2.6 million, before deducting placement agent fees and other offering expenses. Palatin Technologies, Inc. is a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonists with a focus on melanocortin and natriuretic peptide receptor systems. Palatin's internally developed drug pipeline utilizes proprietary approaches to discover potent rigid conformers from flexible peptide starting points. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.
PDI, Inc. (Nasdaq: PDII), a leading provider of sales and marketing support to U.S. health care companies, today announced that it will release its fourth quarter and full year 2009 financial results on Thursday, March 4, 2010 after the market close.
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN)will participate in a webcast panel discussion on the topic "Building a Proprietary and Partnered Pipeline of Antibodies" at the RBC Capital Markets Healthcare Conference on Wednesday, March 3, 2010.
Regulus Therapeutics Inc., co-owned by Alnylam Pharmaceuticals (Nasdaq:ALNY) and Isis Pharmaceuticals (Nasdaq:ISIS)today announced the establishment of a new collaboration with GlaxoSmithKline (GSK) to develop and commercialize microRNA therapeutics targeting microRNA-122 in all fields with Hepatitis C Viral infection (HCV) as the lead indication. Under the terms of the new collaboration, Regulus will receive additional upfront and early-stage milestone payments with the potential to earn more than $150 million in miR-122-related combined payments, and tiered royalties up to double digits on worldwide sales of products.
"This new collaboration with GSK demonstrates the clear scientific leadership that Regulus has established in advancing a whole new frontier of pharmaceutical research. microRNA therapeutics target the pathways of human diseases, not just single disease targets, and hold considerable promise as novel therapies across a broad range of unmet medical needs," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus. "It also further validates Regulus’ microRNA product platform built on fundamental biology of human diseases and intellectual property, and also extends the therapeutic scope of our existing collaboration formed with GSK in 2008. Furthermore, the funding from this alliance supports Regulus’ efforts in advancing high impact, novel medicines based on microRNA biology to patients." Regulus is targeting microRNAs as a new class of therapeutics by working with a broad network of academic collaborators and leveraging oligonucleotide drug discovery and development expertise from its founding companies Alnylam and Isis.
Roche NimbleGen (Pink Sheets: RHHBY) (SWX:RO) (SWX:ROG) is pleased to announce that imaGenes GmbH, located in Berlin, Germany, has passed the certification process to qualify as a Roche NimbleGen Certified Service Provider (CSP) for DNA Methylation Analysis.
SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, today announced it was awarded a $2.8 million contract with options for up to $9.9 million from the Department of Defense's Transformational Medical Technologies Initiative (TMTI) through the Defense Threat Reduction Agency (DTRA) to support the preclinical development and Investigation New Drug (IND) filing of ST-669, a broad spectrum antiviral that has demonstrated in vitro antiviral activity against several different viral families. The first contract year provides for $2.8 million of funding with options for additional funding over the following four years, bringing the total value of the contract up to $12.7 million.
Dr. Dennis Hruby, SIGA's Chief Scientific Officer, stated, "While still in the early stages of development, ST-669 is showing promise as a treatment for several dangerous diseases and this award will help us further our development of this program. There is a real need for a broad-spectrum antiviral like ST-669 to treat both the military and general population in the event of an outbreak. Although the disease itself may come from sources that are unpredictable, like a bioterror attack or an emerging virus, both origins highlight the necessity for a safe and effective countermeasure."
Shares rose 2.78% or 18 cents to close the day at $6.65.
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI),a commercial-stage biotechnology company with a focus in oncology, announced today that Rajesh C. Shrotriya MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, will be a panelist on the topic of “Gearing Up For Launch” at the RBC Capital Markets’ Healthcare Conference on Tuesday, March 3, 2010, at 9:00am Eastern Time.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a result of these meetings, Sunesis intends to proceed with its plan to conduct a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. This trial will evaluate the overall survival of voreloxin in combination with cytarabine, a widely used chemotherapy in AML, compared to cytarabine with placebo, in patients with relapsed or refractory AML. Sunesis anticipates initiating this multi-national, Phase 3 trial in the second half of 2010.
Sunesis also reported today that, as part of its global development strategy, a pre-submission meeting has been scheduled for the current calendar quarter with the European Medicines Agency (EMA) to obtain EMA's scientific advice on the development program for voreloxin, including the proposed Phase 3 trial.
Supelco, a division of Sigma-Aldrich® (Nasdaq: SIAL), announced today the launch of Ascentis Express Peptide ES-C18 a high-speed, high-performance liquid chromatography (HPLC) column based on a new 160 angstrom Fused-Core™ particle design.
Symmetry Medical Inc. (NYSE:SMA), a leading independent provider of products to the global orthopaedic device industry and other medical markets, announced fourth quarter and full year 2009 financial results for the period ended January 2, 2010. Brian Moore, President and Chief Executive Officer of Symmetry Medical, stated, "Our fourth quarter and full year 2009 results are broadly in line with our expectations. The decrease in our bottom-line performance resulted from our decision to maintain certain fixed operating costs while experiencing lower volume. We are confident that our strategy of maintaining capacity during market softness in 2009 and into the current environment will be a competitive advantage in enabling us to meet customer demand as volume improves. We are also pleased to report that our SSI direct sales operations exceeded their goals, resulting in record revenue during the fourth quarter of 2009."
Synta Pharmaceuticals Corp. (NASDAQ: SNTA),a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it will release its fourth-quarter and year-end 2009 financial results before the market opens on Thursday, March 11, 2010.
Teleflex Incorporated (NYSE:TFX),a leading global provider of medical technology products, today announced that it has entered into a definitive agreement to sell its SSI Surgical Services Inc. ("SSI") business to a privately-owned multi-service line healthcare company for approximately $25 million. The transaction is subject to customary closing conditions and is expected to close before the end of the first quarter of 2010. "The decision to divest SSI was made following a review of our portfolio and it was determined that SSI was not a strategic fit. This allows us to continue to reallocate resources to our higher margin businesses," stated Jeffrey P. Black, chairman and chief executive officer.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the publication of data from the 15-year clinical study with Copaxone® (glatiramer acetate injection), which is the longest prospective and continuous evaluation ever conducted in relapsing-remitting multiple sclerosis (RRMS) patients. The data were published in the February issue of the journal Multiple Sclerosis.
The 15-year clinical study demonstrated that more than 80 percent of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS. Patients who remained in the study over a mean of 15 years showed a reduction in annualized relapse rate (ARR) from baseline as well as minimal increase in Expanded Disability Status Scale (EDSS). On average, the ARR in the ongoing cohort declined from 1.12 ± 0.82 to 0.25 ± 0.34 at the 15-year analysis.
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