AVEO surges on higher revenues. CytRx gains after Orphan Drug designation. SurModics shares jump on revenue growth. FDA panel backs Vertex Hep C drug Print E-mail
By BioMedReports.com Staff   
Thursday, 28 April 2011 18:55

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 28, 2011.

Shares of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) shot up more than 15% today after the company revealed key first quarter accomplishments and reported consolidated financial results for the first quarter of 2011.

“AVEO began 2011 with significant momentum with the commencement of our collaboration with Astellas to develop and commercialize tivozanib outside of Asia, and this collaboration is off to a strong start,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “We also continue to increase the visibility and interest in tivozanib, as well as ficlatuzumab and our pipeline of monoclonal antibodies, through presentations at various medical and scientific meetings.”

Mr. Ha-Ngoc added, “We look forward to reviewing top-line data from TIVO-1, our pivotal Phase 3 trial for tivozanib, later this year. As an oncology trial with the primary endpoint of progression-free survival, the timeline for TIVO-1 is entirely dependent upon the accumulation of qualifying events. Based upon the current event-rate, we do not anticipate top-line TIVO-1 data until at least the fourth quarter of this year.”

Total collaboration revenues for the first quarter ended March 31, 2011 were $133.6 million compared with $10.9 million for the first quarter of 2010. The primary driver for the increase was revenue recognized in conjunction with AVEO’s collaboration agreement with Astellas. In February, AVEO and Astellas Pharma, Inc. entered into a worldwide agreement to develop and commercialize tivozanib outside of Asia. Under the terms of the agreement, AVEO received $125 million in up-front payments from Astellas. AVEO is also eligible to receive approximately $1.3 billion in potential milestones comprised of $575 million in clinical and regulatory milestones, including $90 million in connection with regulatory filings and marketing approval in North America and Europe for tivozanib as a monotherapy in first-line renal cell carcinoma (RCC), as well as more than $780 million in commercial milestones. In addition to the ongoing Phase 3 TIVO-1 trial and Phase 1b combination studies of tivozanib, AVEO and Astellas will jointly conduct and fund the accelerated expansion of tivozanib clinical development into additional solid tumor types beyond RCC prior to top-line TIVO-1 data.
 
Shares of AVEO gained $2.07 to $15.82.
 
CytRx Corporation (Nasdaq:CYTR), gained nearly 12% today after the biopharmaceutical company specializing in oncology, announced that its tumor-targeting pro-drug candidate INNO-206 has been approved for orphan drug designation for the treatment of patients with pancreatic cancer by the FDA. CytRx holds the exclusive worldwide development and commercialization rights to INNO-206.

“This designation represents an important and exciting step in the overall development program for INNO-206. We are delighted with the FDA’s decision to grant INNO-206 this special status, particularly given that treatment with INNO-206 resulted in a statistically significant, three-fold reduction in the average primary tumor size in an animal model of pancreatic cancer,” said Steven A. Kriegsman, President and CEO of CytRx. “Only a handful of drugs have shown any benefit for the treatment of patients suffering from this rapidly progressing, deadly cancer, and INNO-206 outperformed both doxorubicin and the current standard of care gemcitabine in the animal trial. We are now arranging advancement of INNO-206’s development for pancreatic cancer in a Phase 2 clinical trial.”
 
Shares of CytRx surged 10 cents or 11.9% to $0.94.
 
Shares of SurModics, Inc. (Nasdaq:SRDX) soared more than 22% after the company today said second-quarter net income was $2.49 million, or 14 cents a share, compared to a loss of $427,000, or 2 cents a share, from a year ago.
The company reported $17.5 million compared to last year’s $18.4 million. Adjusted earnings were 8 cents a share, analyst had been expecting zero cents per share. The company is forecasting a loss of 21 cents a share to 8 cents a share for the year, which is up from its previous forecast of a loss of 53 cents a share to 33 cents a share. SurModics, Inc. is a leading provider of drug delivery and surface modification technologies to the healthcare industry. “We are pleased to announce 15% sequential revenue growth in the second quarter,” said Gary Maharaj, SurModics' president and chief executive officer. “All three business units generated sequential revenue growth, even as we carefully managed expenses. As a result of this strong performance across the Company, we are updating our guidance for the fiscal year. I want to congratulate our teams at SurModics for delivering such a solid performance in the second quarter.”
 
Shares of SurModics surged $2.70 to $14.91
 
An FDA panel voted 18-0 today in favor of Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) hepatitis C drug. The panel said that the drug, telaprevir, is a safe and effective treatment for the disease. Shares of Vertex were halted for at $55.54 during Wednesday's trading session and as of this writing had not yet re-opened.
 
Apricus Biosciences, Inc. (Nasdaq:APRI) announced today that it has filed a marketing application in Europe for Vitaros as a treatment for patients with erectile dysfunction ("ED"). Approval of the application would give Apricus the right to sell Vitaros in multiple chosen countries in the European Union. "Our goal is to help millions of patients suffering with erectile dysfunction in Europe," said Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio.
Vitaros has already been approved in Canada for the treatment of erectile dysfunction. Warner Chilcott, which owns the U.S. rights to Vitaros for ED, has submitted a New Drug Application to the U.S. Food and Drug Administration, requesting approval in the U.S.
 
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today that Chairman and CEO, Mr. Douglas MacLellan, and Mr. Akio Ariura, RPC's Chief Operating Officer and CFO, will serve as the lead presenters during the main evening reception at this year's Aegis Capital Emerging Growth Conference, Thursday, April 28, 2011. The conference will take place between April 28 and April 30, 2011 at the Palazzo Hotel in Las Vegas, NV.

RPC's executives will discuss Radient Pharmaceutical's latest business developments, including clinical test results for its US FDA-cleared Onko-Sure® in vitro diagnostic (IVD) cancer test. Additionally, the two executives will share recent Company achievements, market position, new business initiatives and FY2011 - FY2012 growth plans.
 
Also Thursday:

AquaStar Holdings, Inc. (Pink Sheets:RPPR) is pleased to announce that the United States Patent and Trademark Office has issued patent number 7,708,944 for the Ultra-Sensitive, Portable Capillary Sensor technology utilized by the Capwave Enzyme-Linked Immuno-Sorbent Assay (ELISA) platform.

China Green Material Technologies, Inc. (OTC Bulletin Board:CAGM); "CAGM" or "the Company", a China-based leader in developing and manufacturing starch-based biodegradable, disposable containers, tableware and packaging materials, today announced that the Company has appointed Marcum Bernstein & Pinchuk LLP ("MBP") as its independent registered public accounting firm, replacing Goldman Kurland and Mohidin LLP.

CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today its results for the first quarter of 2011.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the following conferences:  Deutsche Bank Annual Health Care Conference, Boston, MA on May 4, 2011 at 8:40 a.m. ETBank of America Merrill Lynch Health Care Conference, Las Vegas, NV on May 10, 2011 at 8:40 a.m. PT

Gen-Probe Incorporated (NASDAQ:GPRO) today reported financial results for the first quarter of 2011, highlighted by record total revenues of $143.0 million and non-GAAP earnings per share (EPS) of $0.54, 13% higher than in the prior year period.

InterMune, Inc. (NASDAQ:ITMN) today announced results from operations for the first quarter ended March 31, 2011.  

Keryx Biopharmaceuticals (Nasdaq:KERX) today announced the final dataset from the Phase 3 short-term clinical trial of Zerenex™ (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis.  

Oncothyreon Inc. (NASDAQ:ONTY) today announced its intention to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.

Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR) announced that additional data from the DIFICID™ Phase 3 trials will be presented at the following medical meetings:  Digestive Disease Week (DDW), McCormick Place, Chicago, IL.  May 7-10, 2011.

PAREXEL International Corporation (NASDAQ:PRXL), a leading global biopharmaceutical services provider, which serves on the Program Committee for "The Future of Biosimilars in the U.S." conference, today announced distinguishing features of this event, which the Drug Information Association (DIA) will host in cooperation with the Food and Drug Law Institute (FDLI).  

PDI, Inc. (Nasdaq:PDII) today announced that it will release its first quarter 2011 financial results on Tuesday, May 3, 2011 after the market close and host a conference call on Wednesday, May 4, at 8:30 am Eastern time to discuss the results.

Sequenom, Inc. (NASDAQ:SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the acceptance for publication of the manuscript, "Clinical Validation of a Genetic Model to Estimate the Risk of Developing Choroidal Neovascular Age-related Macular Degeneration."

Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease, today announced that a conference call will be held on Monday, May 2, 2011 at 8:30 a.m. EDT to discuss results for the first quarter ended March 31, 2011 and a business outlook for the remainder of 2011.




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