RxNews Recap for Monday 02-22-10. AMICUS (AMCS) spurns Merge's (MRGE) buyout offer Print E-mail
By Mary Davila   
Monday, 22 February 2010 19:56

Below is a list of the companies that made news in the healthcare sector on Monday, February 22, 2010.

AMICAS, Inc. (Nasdaq:AMCS), a leader in image and information management solutions, today responded to a press release issued earlier today by Merge Healthcare Incorporated (Nasdaq:MRGE) ("Merge") regarding Merge's acquisition proposal. AMICAS Board of Directors has already considered and publicly rejected Merge's acquisition proposal.

AMICAS believes that Merge's press release is an eleventh-hour attempt by Merge to insert itself into a process that is well underway, and to disrupt AMICAS' definitive merger agreement with Thoma Bravo, damage AMICAS' operations, and mislead AMICAS stockholders.

This news came today after Merge announced a $6.05 cash per share offer for AMICAS, Inc. Merge’s proposal, for an aggregate of $248 million, represents a 13% premium to the previously-announced offer for AMICAS from a newly-formed affiliate of Thoma Bravo, LLC for $5.35 cash per share. Merge’s current offer follows its offer of $6.00 cash per share that was made during the "go-shop" period contemplated by AMICAS’ merger agreement with Thoma Bravo. Last week, Merge intervened in Massachusetts litigation challenging the adequacy of AMICAS’ disclosures relating to this transaction, as well as the process by which its proposals have been considered by the AMICAS Board of Directors.

Merge has received a signed bridge financing commitment from Morgan Stanley to provide $200 million of debt financing, and is subject only to standard and customary conditions. Based on that commitment and available cash, including $40 million of pre-funded equity investments from mezzanine investors, Merge has proposed to commence a $6.05 cash per share tender offer for all AMICAS shares and to close the acquisition as quickly as possible thereafter.

Shares of AMICUS were up 41 cents or 7.64% to close the day at $5.78. Shares of Merge closed up a penny to $2.46.

After the bell today:

Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) and Takeda Pharmaceutical Company Limited (TSE:4502.to) announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

"There is an enormous unmet need to help reduce the individual and economic burden of obesity," said Christian Weyer, M.D., vice president, medical development at Amylin Pharmaceuticals. "Through our global co-development and commercialization agreement with Takeda, we are committed to developing innovative therapies to help the millions of people who need better solutions to manage obesity. Today's announcement is an important step forward in helping us make good on that commitment."

Dendreon Corporation (Nasdaq:DNDN) today reported results for the year and quarter ended December 31, 2009. Revenue for the year ended December 31, 2009 was $101,000 compared to $111,000 for year ended December 31, 2008. Revenue for the fourth quarter of 2009 was $21,000 compared to $28,000 for the quarter ended December 31, 2008.

The net loss for the year ended December 31, 2009 was $220.2 million, or $2.04 per share, compared to $71.6 million, or $0.79 per share for the year ended December 31, 2008. This loss includes a non-cash fair value adjustment of $118.8 million or $1.10 per share associated with a change in the fair value of our warrants The size of this re-measurement is directly related to the price increase our common stock experienced this year. Net loss in the fourth quarter of 2009 was $32.5 million or $0.28 per share, compared to a net loss of $8.8 million, or $0.09 per share, for the same period in 2008. Dendreon's total operating expenses for the year ended December 31, 2009 were $100.1 million compared to $70.6 million in 2008.

As of December 31, 2009, Dendreon had approximately $606 million in cash, cash equivalents, and short-term and long-term investments compared to $111 million as of December 31, 2008.

In news from earlier in the day:

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has initiated a Phase IIb trial in adult lung transplant patients with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection.

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that Mark K. Oki has been promoted to Vice President, Finance and Controller.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report unaudited consolidated financial results for the fourth quarter and year ended December 31, 2009 before the U.S. financial markets open on March 1, 2010.

AmStem Corporation (OTCBB: SCII) Announced that Histostem Ltd. of South Korea ("Histostem"), has participated in a successful preclinical study of the use of its proprietary Human Umbilical Cord Blood-Derived Mesenchymal Stem Cells (HMSCs) in the treatment of cirrhosis of the liver.

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, is extremely pleased to Bristol-Myers Squibb Company (NYSE:BMY) will provide a business update to the investment community from 1 p.m. to 5 p.m. (EST) on Thursday, March 4, 2010.

In addition the company announced today that it has entered into a collaborative agreement with Hadassah Medical Center to conduct its ALS clinical trials at the Hadassah Ein Kerem Hospital.

CEL-SCI Corporation (NYSE AMEX: CVM) and their scientific collaborators announced today that the Company's CEL-2000 vaccine demonstrated that it is able to block the progression of rheumatoid arthritis (RA) in a mouse model. The results were published in the scientific peer-reviewed Journal of International Immunopharmacology (online edition) in an article titled "CEL-2000: A Therapeutic Vaccine for Rheumatoid Arthritis Arrests Disease Development and Alters Serum Cytokine / Chemokine Patterns in the Bovine Collagen Type II Induced Arthritis in the DBA Mouse Model" with lead author Dr. Daniel Zimmerman. The study was co-authored by scientists from CEL-SCI, Washington Biotech, Northeastern Ohio Universities Colleges of Medicine and Pharmacy (NEOUCOMP) and Boulder BioPath. Geert Kersten, Chief Executive Officer of CEL-SCI said, "These experimental results were achieved through a reduction of the inflammatory response that is known to attack the patients' joints. The mode of action of CEL-2000 in RA appears to be similar to our new investigational therapy for H1N1 hospitalized patients, as it attempts to avoid the excess TNF-alpha and other pro-inflammatory cytokines. We feel that this new data is encouraging both for this rheumatoid arthritis vaccine as well as in support of our H1N1 treatment currently under development."

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the appointment of Leon (Lonnie) Moulder Jr. to its Board of Directors. Most recently, Mr. Moulder served as Vice Chairman, President and Chief Executive Officer of Abraxis BioScience, Inc. from April 2009 to January 2010.

DARA BioSciences, Inc. (Nasdaq:DARA) announced that the results of its Phase 2 study has been identified by Cambridge Healthtech Institute ("CHI") for inclusion in its Annual "Targeting Pain with Novel Therapeutics" Conference.

Linda Jett, MSN, Clinical Director, Drug Development, DARA BioSciences will present a talk entitled "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain in Patients with Cancer" as part of the Drug Discovery Innovation Summit.

The presentation will provide an overview of the favorable clinical results of this Phase 2 study in reaching its primary endpoint and statistical significance for KRN5500 compared to placebo. The study was a blinded, randomized, placebo controlled, dose escalation study in patients with advanced cancer.

During November 2009, DARA announced that an abstract on KRN5500 results had been accepted for presentation at the "12th International Conference on the Mechanisms and Treatment of Neuropathic Pain" Meeting held in San Francisco.

Endo Pharmaceuticals (Nasdaq:ENDP) today reported financial results for the fourth quarter and full-year 2009.

Total revenues during the fourth quarter of 2009 increased 13 percent to $391 million, compared with $347 million in the same quarter of 2008. Net income for the three months ended December 31, 2009 was $148 million, compared with $73 million in the comparable 2008 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended December 31, 2009, was $95 million, compared with $86 million in the same period in 2008. Reported diluted earnings per share for the quarter ended December 31, 2009, were $1.25 compared with $0.62 in the fourth quarter of 2008. Adjusted diluted earnings per share for the same period were $0.81, compared with $0.74 reported in 2008.

Total revenues for the year were $1.46 billion, compared with $1.26 billion in the comparable 2008 period. Reported diluted earnings per share for the year ended December 31, 2009, were $2.27, compared with $2.06 in the comparable period of 2008. Full-year adjusted diluted earnings per share were $2.84, compared with $2.47 reported in 2008. "We had an excellent year with record revenues and earnings," said Dave Holveck, president and CEO of Endo. "Not only did we continue to build a strong base business, we also expanded our therapeutic focus beyond pain into urology and oncology. We have committed ourselves to an aggressive growth strategy and in 2010 we will continue to pursue our strategy of diversifying the company through a combination of new product or company acquisitions, new promotional investments and strategies to drive additional growth from our commercial portfolio, and further investment in our R&D pipeline."

EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm: EPCT) announced today that it will host a conference call to discuss fourth quarter and full year 2009 operating and financial results on Thursday, February 25, 2010 at 9:00 a.m. Eastern time.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV1) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced that it has entered into an agreement with its strategic partner, LFB Biotechnologies (LeUlis, France), pursuant to which LFB has agreed to provide $7 million of new loan financing to GTC.

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $12.2 million for the fourth quarter ended December 31, 2009. This compares to $7.5 million in revenues for the third quarter ended September 30, 2009. For the 2009 fiscal year, the Company reported $24.2 million in revenues, compared with $332,000 in 2008.

"Since our first international commercial sale in March 2009, we have continued to receive positive physician feedback -- both in approved international markets, where physician acceptance continues to build, and also in the U.S., where the pace of enrollment in our clinical study accelerated toward year end," explained HeartWare President and Chief Executive Officer Doug Godshall. "Today we have 20 sites implanting the HeartWare HVAD pumps internationally and, importantly, our U.S. bridge-to-transplant trial recently completed enrollment, paving the way for a submission to the FDA for pre-market approval in the second half of this year."

Jiangbo Pharmaceuticals, Inc. (OTC Bulletin Board: JGBO) (the "Company" or "Jiangbo"), a pharmaceutical company with its principal operations in China, today announced that the Company will host a conference call at 8:30 a.m. Eastern on Friday, February 26, 2010 to discuss financial results for the second quarter ended December 31, 2009 of its fiscal year 2010.

Life Technologies Corporation (NASDAQ: LIFE) today announced it will be webcasting management presentations to investors as part of the UBS West Coast Life Sciences Bus Tour which is being held at the company’s headquarters in Carlsbad on Monday March 15th at 8:15 AM PST.

NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) a cardiac diagnostic technology provider, announced today that the Heart Rhythm Society (HRS) has accepted an abstract detailing the superior performance of NewCardio's patented CardioBip™ technology for remote wireless monitoring and detection of atrial fibrillation (AF). The study results, which discuss the use of CardioBip for improved AF monitoring and detection, are scheduled for oral presentation at the Heart Rhythm Society 31st Annual Scientific Sessions, May 12-15, 2010, in Denver, Colorado.

The abstract, titled "Three-dimensional Atrial Signal Reconstruction Facilitates Remote Detection Of Atrial Fibrillation," was written by Alexei Shvilkin, MD, PhD, Dejan Vukajlovic, MD, Vladan Vukcevic, MD, Ihor Gussak, MD, PhD, Bosko Bojovic, PhD, Uros Mitrovic, MS and Goran Simic, MS. The abstract highlights a new AF detection algorithm based on NewCardio's proprietary 3-D ECG processing platform.

Alexei Shvilkin, MD, PhD, of Beth Israel Deaconess Medical Center and Harvard Medical School, the abstract's first author and principal investigator, commented, "Reliable detection of AF represents an important clinical objective that could improve outcomes for remotely monitored patients. Because of the low amplitude of atrial electrical activity and noise associated with use of remote monitoring, current systems predominantly rely on heart rate variability to detect AF. As a result, some patients may be misdiagnosed, especially those undergoing post-ablation AF monitoring. In this study, we showed that NewCardio's CardioBip-based wireless technology enables the assessment of atrial activity by using ensemble signal processing, 12-lead ECG reconstruction, and 3-D processing of atrial activity. The new algorithm detects the difference in atrial activity between AF and sinus rhythm and does not rely on heart rate variability measurements. It has the potential to improve patient monitoring outcomes by differentiating AF from other confounding arrhythmia (e.g. atrial flutter, atrial tachycardia) that may occur after AF ablation."

OPKO Health, Inc. (NYSE Amex: OPK) today announced the signing of a letter of intent to collaborate with the Centro de Investigación y Asistencia Tecnológica y Diseño del Estado de Jalisco (CIATEJ), a preeminent technology and research center in the State of Jalisco, Mexico.

PositiveID Corporation (NASDAQ:PSID), in conjunction with its development partner RECEPTORS LLC (“Receptors"), announced today that it has successfully completed Phase I development of its rapid virus detection system, a non-invasive, point-of-care test to test patient samples and identify various forms of influenza within minutes.  

PPD, Inc. (Nasdaq: PPDI) today announced it has appointed Lee E. Babiss, Ph.D., as executive vice president of global laboratory services.

Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that the Company will present at three health care investment conferences during March 2010.

SDIX (Nasdaq: SDIX) a leading provider of biotechnology-based detection solutions for a broad range of food, water, agricultural, industrial, environmental and scientific applications, expects to release its fourth quarter and full year 2009 results at approximately 4 p.m. ET on Thursday, February 25, 2010.

SuperGen Inc. (Nasdaq:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that it will release its 2009 fourth quarter and fiscal year-end results on Monday, March 1, 2010.

Urigen Pharmaceuticals, Inc. (OTCBB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that Prof. Lowell Parsons, MD will give a presentation at Noon in Atlanta on Thursday, February, 25th.  

Walgreens (NYSE: WAG) (NASDAQ: WAG) vice president of online merchandising and operations Miguel Almeida will deliver a keynote address at the eTail West 2010 conference in Palm Desert, Calif., on Wednesday, Feb. 24 at 10:30 a.m.Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that Jeffrey Buchalter has resigned as Chief Executive Officer and Director of Enzon, effective immediately, and has been replaced by a newly formed executive committee of the Board.

Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

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