|RxNews Recap for Wednesday 02-24-10. ViroPharma (VPHM) jumps on positive earnings.|
|By BioMedReports.com Staff|
|Wednesday, 24 February 2010 19:40|
ViroPharma Incorporated (Nasdaq:VPHM) jumped over 10% as the company reported today its financial results for the fourth quarter and year ended December 31, 2009.
Highlights from the fourth quarter of 2009 were: *Delivered record $88 million in net product sales including $36 million in net sales of Cinryze; *Achieved adjusted net income of $26 million; GAAP net income reached $12 million; *Improved working capital to $406 million as of December 31, 2009, including cash and cash equivalents of $332 million; and * Delivered positive cash flows from operations of $43 million for the quarter ended December 31, 2009.
"As we provide Cinryze to patients to prevent attacks of hereditary angioedema, we put ourselves in a position to drive great value for our shareholders," commented Vincent Milano, ViroPharma's chief executive officer. "Throughout the year, we made great strides toward our ultimate goal of providing Cinryze to every patient who needs it. I'm pleased that during 2009 alone, over 400 patients' lives were transformed by initiating Cinryze therapy. For these patients, starting on prophylaxis with Cinryze marks the beginning of an entirely new prevention-minded routine in which they can look forward to reducing the length, frequency and severity of attacks of HAE, and the ability to utilize this therapy in the comfort of their own homes. This early success of Cinryze, combined with another solid year of Vancocin® sales, contributed to our record net product sales during 2009 of $310 million. We believe that the momentum we have generated since the launch of Cinryze, along with our newly expanded rights for Cinryze, will serve as a springboard for new levels of growth as we seek to impact the lives of many more patients with diseases marked by C1 esterase inhibitor deficiency through global expansion, additional disease states, and potential new formulations."
VPHM closed at $11.65, up $1.10 or 10.43% from its previous close.
AMICAS, Inc. (Nasdaq:AMCS), a leader in image and information management solutions, today announced that it has received from Merge Healthcare Incorporated (Nasdaq:MRGE) a proposal to acquire all of the outstanding shares of AMICAS for $6.05 per share in cash, which has been updated to include an executed definitive commitment letter for $200 million of financing from Morgan Stanley and confirmation that Merge will place a portion of the pre-funded proceeds received from its mezzanine investors into an escrow account directly accessible by AMICAS.
As previously announce, on December 24, 2009 AMICAS entered into a definitive merger agreement to be acquired by an affiliate of Thoma Bravo, LLC (the "Thoma Bravo Merger Agreement") for $5.35 per share in cash. The AMICAS Board of Directors, in accordance with its fiduciary duties and the terms of the Thoma Bravo Merger Agreement, will evaluate the updated Merge proposal to determine the appropriate next steps. AMICAS will advise stockholders of the Board's recommendation in due course, and stockholders are advised to take no action at this time. There can be no assurance that a transaction with Merge will result.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The PDUFA date is the target date for the FDA to complete its review of an NDA.
"The FDA's acceptance of the lorcaserin NDA is a significant milestone towards our goal of providing physicians and their patients with a new mechanistic approach to achieve sustainable weight loss in a well-tolerated manner," said Jack Lief, Arena's President and Chief Executive Officer. "We look forward to working with the FDA to facilitate a thoughtful and efficient review of the lorcaserin NDA."
BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics that has entered into a collaborative agreement with Hadassah Medical Center to conduct its ALS clinical trials, will be featured on today’s MSNBC News program Shuster Live with David Shuster between 10:00-11:00 AM EST.
Caliper Life Sciences, Inc. (Nasdaq:CALP), a leading provider of tools and services for drug discovery and life sciences research, and its wholly owned subsidiary Xenogen Corporation, today announced the filing of a patent infringement lawsuit in the U.S. District Court for the Eastern District of Texas. In the suit, filed with Stanford as a co-plaintiff, Caliper Life Sciences and Xenogen seek a finding of willful infringement by Carestream Health, Inc. of Rochester, NY, compensatory damages, a trebling due to willfulness, a permanent injunction and attorneys' fees against Carestream for the ongoing, unauthorized and willful use of a number of United States patents that Caliper, through Xenogen, exclusively licenses from Stanford University.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced development, Food and Drug Administration (FDA) approval/licensure and delivery of Medical Radiation Countermeasure (MRC). In a statement to the press, Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, commented that the DoD's RFP described a countermeasure as one that would be administered following exposure to ionizing radiation that will decrease incapacity and prolong survival by treating the gastrointestinal sub-syndrome of ARS. "We believe our radiation protection drug candidate, CBLB502, fits these and other listed criteria," noted Fonstein.
Conceptus, Inc. (Nasdaq: CPTS), developer of the Essure® procedure, the first proven non-surgical permanent birth control method available, today announced that Gregory Lichtwardt, executive vice president and chief financial officer, will present at the Raymond James Institutional Investors Conference on Tuesday March 9, 2010, at 3:25 p.m. ET.
Lorus Therapeutics Inc. (TSX:LOR Other OTC: LRUSF.PK), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, today announced a publication demonstrating the antitumor activity of a novel cytokine interleukin 17E (IL-17E). The article entitled "IL-17E, a pro-inflammatory cytokine, has antitumor efficacy against several tumor types in vivo" was published in the peer-reviewed journal, Cancer Immunology Immunotherapy and is currently available online on the Journal's website.
In this article, Lorus' scientists demonstrated the antitumor effects of IL-17E alone and in combination with a number of approved anticancer agents in preclinical models. The studies showed that IL-17E alone had potent antitumor activity in a number of solid tumors, including melanoma, breast, colon, pancreatic, and non-small cell lung cancers. In combination studies, IL-17E was compatible with a wide variety of approved anticancer drugs, including Avastin, Tarceva, Taxol, Cisplatin, Dacarbazine, Irinotecan, and Gemzar. Furthermore, the combination of IL-17E with each of these anticancer agents showed greater anticancer efficacy than either agent alone without additional toxicity.
Shares rose over 50% on the OTC and more than 75% on the Toronto exchange.
MannKind Corporation (Nasdaq: MNKD) today announced that James S. Shannon, MD, MRCP (UK) has joined the company's Board of Directors. Dr. Shannon is a recognize pharmaceutical industry leader with more than 20 years of experience in senior leadership positions, including serving as Head of Global Development at Novartis Pharma AG in Basel, Switzerland.
Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the pricing of a public offering of 4,250,000 shares of its common stock.
Pfizer Inc (NYSE:PFE) announced today that the United States Centers for Disease Control and Prevention's (CDC’s) Advisory Committee on Immunization Practices (ACIP) has recommended the use of Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for healthy children aged 2 months through 59 months for the prevention of invasive pneumococcal disease caused by the 13 pneumococcal serotypes included in the vaccine. "We are pleased that the Advisory Committee has recommended the use of Prevnar 13, with coverage for 13 important invasive disease-causing serotypes, in infants and young children in the United States," says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. "The incidence of disease caused by serotypes not included in Prevnar has been increasing in children younger than 5 years of age in the United States, including 19A , the most common serotype."
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that new data from the Company's Valortim® anthrax anti-toxin program were presented at the 8th Annual ASM Biodefense and Emerging Diseases Research Meeting, held in Baltimore, Maryland, February 21-24, 2010. Dr. Cross remarked, "Our latest research using human immune cells provides additional evidence of the role Valortim® may play in enhancing the elimination of B. anthracis to potentially minimize the severity of infection. We hypothesize that Valortim® may protect against lethal anthrax infection by its toxin neutralization activity that allows the development of a potent adaptive immune response that facilitates the elimination of harmful bacteria in a host organism.
PositiveID Corporation (NASDAQ:PSID) as earlier reported here on BioMedReports, announced today that it has entered into a partnership with FIS™ (NYSE:FIS), one of the world’s largest providers of banking and payments technology, to launch the Company’s next generation Health Link personal health record ("Health Link"). The new Health Link, which is now live, will be interoperable with Microsoft HealthVault and Google Health, as well as numerous electronic medical records systems in use throughout the country. Shares jumped 47.46% on the news.
PPD, Inc. (Nasdaq: PPDI) today announced its wholly-owned subsidiary, Furiex Pharmaceuticals, Inc., filed a Form 10 registration statement with the Securities and Exchange Commission, or SEC, in connection with its previously announced spin-off.
Synovis Life Technologies, Inc. (NASDAQ: SYNO), today reported financial results for the first fiscal quarter ended Jan. 31, 2010. First quarter milestones include marketing Veritas® in Europe after receiving CE Mark approval in the previous quarter, receiving FDA 510(k) marketing clearance for the new Flow Coupler® device and hiring eight sales representatives for the recently acquired Orthopedic and Wound business.
Vical Incorporated (Nasdaq:VICL) announced today the publication in the online edition of Vaccine1 detailed data from two Phase 1 trials of the company's Vaxfectin(R)-adjuvanted DNA vaccines for H5N1 (avian-origin) influenza, demonstrating the potential of DNA vaccines for rapid deployment in future pandemics.
"Our Phase 1 results clearly demonstrated the ability of DNA vaccines against H5N1 avian-origin influenza to achieve antibody responses in the same range as conventional vaccines," said Larry Smith, Ph.D., Vical's Vice President of Vaccine Research and the lead author on the paper. "These trials are key to expanding the use of our Vaxfectin(R) adjuvant as they provided its first successful safety evaluations in humans. We seized the opportunity to further demonstrate the potential of our technology during the 2009 H1N1 pandemic influenza outbreaks. We completed successful pilot lot production and initiated animal immunogenicity testing of a Vaxfectin(R)-adjuvanted DNA vaccine for H1N1 pandemic influenza before conventional vaccine manufacturers even received the seed virus needed to start production. We published these data in late 2009, and expect to begin a U.S. government-funded Phase 1 clinical trial of our H1 pandemic influenza vaccine soon."
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, today announced that it will report its operating results for the fourth quarter and all of fiscal 2009 on Wednesday, March 3.
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