RxNews Recap for Thursday 03-04-10. GenVec rallies on PreClinical Study. After the bell Cryolife gets crushed, Depomed bounces and Emergent BioSciences surges. Print E-mail
By BioMedReports.com Staff   
Thursday, 04 March 2010 19:43

 

Below is a list of the companies that made news in the healthcare sector on Thursday, March 4, 2010.

After the bell Thursday:

CryoLife, Inc. (NYSE:CRY) shares were hammered after the bell today after it was reported that The German Federal Patent Court in Munich has indicated their intention to nullify the German patent DE 693 31 011 (German Kowanko patent) assigned to CryoLife, of Kennesaw, GA. This is the German part of the European Patent 0 650 512 and is key intellectual property relating to the BioGlue Surgical Adhesive which is marketed worldwide by CryoLife, Inc.

BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE Marked in the European Community and approved in Canada and Australia for use in soft tissue repair. Shares traded down $1.30 or 17.45% in the after hours market.

Depomed, Inc. (NASDAQ:DEPO) rose in the after hour session as the company reported positive news related to thier financial results for the fourth quarter and year ended December 31, 2009.

"The fourth quarter of 2009 saw the completion of Phase 3 development of DM-1796 for postherpetic neuralgia, and encouraging results in our Phase 3 program in Serada for menopausal hot flashes. We look forward to the filing of an NDA for DM-1796 for postherpetic neuralgia before the end of the first quarter, and to initiating a Phase 3 trial for Serada by the end of April 2010. We are very pleased to report a cash and marketable securities balance of $81.8 million at the end of 2009, which is flat relative to 2008 and marks our second consecutive year of positive or flat cash flow without equity financing," stated Carl A. Pelzel, president and chief executive officer of Depomed.

Emergent BioSolutions Inc. (NYSE: EBS) jumped after the bell after the company reported better than expected financial results for the full year ended December 31, 2009.

For the full year 2009, total revenues were $234.8 million as compared to $178.6 million in 2008, and net income was $31.1 million, or $1.02 per share, as compared to $20.7 million, or $0.69 per share, in 2008. The 2009 performance was primarily driven by sales of BioThrax® (Anthrax Vaccine Adsorbed), the company’s FDA licensed vaccine for the prevention of anthrax disease, including $34.0 million related to the approval of four-year expiry dating for BioThrax®.

For the fourth quarter 2009, total revenues were $53.8 million as compared to $35.8 million in 2008, and net income was $4.2 million, or $0.14 per share, as compared to net income of $1.5 million, or $0.05 per share in 2008.

R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, "Our 2009 financial performance reflects our continued success in growing revenue from the sale of BioThrax® under multi-year procurement contracts with the US government while managing our expenditures. We expect to continue these trends in the current year, as evidenced by our forecast for 2010 of total revenues of $235 to $255 million and net income of $20 to $30 million." Shares rose more than 7% in the after hours market.

Also after the bell....

Bristol-Myers Squibb Company (NYSE: BMY - News) and Pfizer Inc. (NYSE: PFE - News), reported that Apixaban, an oral anticoagulant being developed by the two companies, was statistically superior to 40 mg once daily enoxaparin in reducing the incidence of venous thromboembolism in patients undergoing elective total knee replacement surgery, according to the ADVANCE-2 study results published today in The Lancet. The study results also showed numerically lower rates of major and clinically relevant non-major bleeding in patients treated with apixaban compared with those treated with enoxaparin. These results did not meet statistical significance.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced that it is offering to sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is the sole book-running manager for this offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Earlier in the day:

GenVec, Inc. (Nasdaq:GNVC) rallied today after the company announced the publication of new preclinical research revealing mechanisms by which TNFerade(TM) suppresses cancer metastases through activation of the immune system.

This preclinical study, "Ad.Egr-TNF and Local Ionizing Radiation Suppress Metastases by Interferon-Beta-Dependent Activation of Antigen-specific CD8+ T Cells," authored by investigators from the University of Chicago and Harvard Medical School, appears in the recent issue of Molecular Therapy. The results illustrate that local treatment of an animal tumor with TNFerade suppresses metastases to lymph nodes by activating CD8+ T cells. Activation of these anti-tumor cells is mediated by Interferon-Beta, a known potent immune regulator.

"Although enhanced local control of cancer can contribute to improvements in patient survival, any suppression of metastases is an important aspect of cancer treatment. These exciting preclinical data may help explain the encouraging results being seen with TNFerade in the clinic," noted Mark Thornton, M.D., M.P.H., Ph.D., GenVec's Senior Vice President of Product Development. Shares rose almost 5% to close at $2.74 after reaching a high of $2.94 earlier in the session.

Insmed Incorporated (Nasdaq:INSM), a biopharmaceutical company, today announced that it has received notification from The NASDAQ Stock Market that it has regained compliance with the minimum $1.00 per share bid price requirement, and further, that it currently complies with all other applicable standards for continued listing.

To regain compliance with the bid price rule, the Company was required to evidence a closing bid price of $1.00 per share or more for a period of at least 10 consecutive trading days. On March 2, 2010, the closing price of the Insmed's common stock was $1.20 per share, the tenth consecutive day the stock price had closed above $1.00 per share.

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today financial results for the fourth quarter and year ended December 31, 2009, reporting a net loss of $2.6 million or ($0.03) per share for the fourth quarter and a net loss of $40.0 million or ($0.60) per share for the full year.

Total revenue for the fourth quarter of 2009 was $29.6 million, as compared to $18.9 million for the fourth quarter of 2008, reflecting an increase of 57%. Revenue from AZASITE® (azithromycin ophthalmic solution) 1% totaled $12.1 million in the fourth quarter of 2009, an increase of 67% compared to $7.3 million recognized in the fourth quarter of 2008. Inspire estimates that approximately $2.0-$2.5 million of fourth quarter 2009 AZASITE revenue was associated with hospital usage of AZASITE as a substitute therapy during a supply shortage of erythromycin ophthalmic ointment (0.5%).

Natus Medical Incorporated (Nasdaq:BABY) today announced financial results for the fourth quarter and full year ended December 31, 2009.

For the fourth quarter ended December 31, 2009, Natus reported revenue of $51.6 million, compared to $43.4 million reported in the comparable quarter of the previous year. Net income was $4.3 million, or $0.15 per diluted share, for the fourth quarter of 2009, compared with net income of $6.3 million, or $0.22 per diluted share, for the fourth quarter of 2008.

For the year ended December 31, 2009, Natus reported revenue of $166.5 million, compared to $161.8 million reported in 2008. Net income was $11.1 million, or $0.39 per diluted share for the year ended December 31, 2009, compared to net income of $17.5 million, or $0.66 per diluted share in 2008.

"Overall I am very satisfied with our fourth quarter and 2009 results," said Jim Hawkins, President and Chief Executive Officer of the Company. "As we entered 2009, we were facing a rapidly weakening economy and significant uncertainty in the worldwide medical device capital equipment markets. As a result, hospitals were significantly reducing purchases of medical equipment. Confronted with this unprecedented environment, we lowered our performance expectations for the year and put on hold pending acquisitions as we were unable to comfortably assess the extent of the declining sales and economic conditions and how they might impact valuations."

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has received commitments from two institutional investors to purchase $18 million of securities in a registered direct offering. The investors are Great Point Partners, LLC and Deerfield Management Company. BioSante expects to receive net proceeds of approximately $17.5 million after deducting placement agent fees and other offering expenses. BioSante has entered into securities purchase agreements with these investors pursuant to which BioSante has agreed to sell an aggregate of approximately 10.4 million shares of its common stock and warrants to purchase up to approximately 5.2 million additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.5 of a share of common stock, will be sold for a purchase price of $1.73, which is equal to the closing price of BioSante’s stock yesterday on the NASDAQ Stock Market.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced the publication of data on a proprietary, Mesd (Mesoderm development)-based peptide, also known as WntTide(TM), licensed by Raptor from Washington University in St. Louis, in the March 1 Early Addition of Proceedings of the National Academy of Sciences. The paper, titled, "LRP6 Overexpression Defines a Class of Breast Cancer Subtype and Is a Target for Therapy," presents findings from studies conducted by the lab of Dr. Guojun Bu, the inventor of the peptide, and Professor of Pediatrics, Cell Biology and Physiology at Washington University in St. Louis.

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy. The TROPIC trial compared the combination of cabazitaxel plus prednisone/prednisolone to the active agent mitoxantrone plus prednisone/prednisolone.

For many patients with metastatic hormone-refractory prostate cancer, their disease continues to progress despite prior chemotherapy. Currently, there are no approved therapies to treat these patients.

"These are significant results in the development of this investigational drug," said Dr. Oliver Sartor, North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans. "Improved overall survival was demonstrated in this trial – and these are the first data to show a statistical improvement in overall survival in patients with this difficult-to-treat and aggressive form of prostate cancer."

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia, following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration to grant 5-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

Watson Pharmaceuticals, Inc. (NYSE:WPI) today announced an agreement to expand their Women's Health brand product portfolio with the acquisition of the exclusive U.S. rights to Columbia Laboratories, Inc.'s bioadhesive progesterone gel products currently marketed under the trade names CRINONE® and PROCHIEVE® for the indications of infertility and secondary amenorrhea. The two companies will collaborate in the ongoing Phase 3 development program toward a new indication for these products for the prevention of preterm birth in women with a short cervix, as well as a global development program for second-generation products for this indication and infertility. Watson will also acquire 11.2 million shares of Columbia common stock.


In other news Thursday:


ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it will present at the Cowen and Company 30th Annual Health Care Conference in Boston on March 9, 2010 at 1:30 pm Eastern.

Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that it has executed a license and supply agreement with Intas Pharmaceuticals Limited (Intas), one of the top 20 pharmaceutical companies in India. Intas plans to launch a double-blind, placebo-controlled Phase 3 clinical trial of ABI's orally administered interferon-alpha lozenges in India by the end of March.

Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer will present at the Cowen and Company 30th Annual Health Care Conference on Wednesday, March 10, 2010 at 8:45 a.m. ET (Eastern Time).

ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Cowen and Company 30th Annual Health Care Conference on Tuesday, March 9, 2010, at 2:15 p.m. eastern time.

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced its schedule of events at the Orthopedic Research Society (ORS) and the American Academy of Orthopedic Surgeons (AAOS) meetings.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Company will hold its 2010 annual stockholders meeting on June 8, 2010 in Buffalo, NY for stockholders of record as of April 9, 2010.The Company will distribute proxy materials to all eligible stockholders.

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that results from a clinical trial of Caldolor® (ibuprofen) Injection will be presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, Louisiana.

Enzo Biochem Inc. (NYSE:ENZ) announced today that Robert Boorstein, MD, PhD, an Associate Professor of Pathology at the NYU School of Medicine, has been appointed Medical Director of Enzo Clinical Labs, a full service clinical reference laboratory serving the metropolitan New York City medical community.

Exelixis, Inc. (NASDAQ:EXEL) announced today that George A. Scangos, PhD, the company’s president and chief executive officer, will present at the Cowen and Company 30th Annual Healthcare Conference at 10:15 a.m. EST / 7:15 a.m. PST on Wednesday, March 10, 2010 in Boston. Dr. Scangos will discuss the company’s corporate strategy, development pipeline, financial results and financial outlook.

iBio, Inc. (OTCBB:IBPM) announced today the appointment of Vidadi Yusibov, Ph.D. as Chief Scientific Officer. Dr. Yusibov is the Executive Director of the Fraunhofe USA Center for Molecular Biotechnology (CMB) in Newark, Delaware, a position he will continue to hold.

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will provide an update of their business at the Cowen & Co. 30th Annual Health Care Conference on Tuesday, March 9th, at 3:45 p.m. Eastern Standard time.

Kyto Biopharma Inc. (“Kyto”), (OTCBB: KBPH), is pleased to announce that it has signed a licensing agreement with the Research Foundation of the State University of New York, (“RFSUNY”).

Luna Innovations Incorporated (NASDAQ: LUNA), a company focusing on sensing, instrumentation and nanotechnology, today announced its financial results for the fourth quarter and year ended December 31, 2009.

OmniComm Systems, Inc. (OTCBB:OMCM), a global provider of eClinical solutions announced that it released TrialOne, a fully integrated, MS .NET, web-based solution designed to automate the Phase I Clinical Trial Process.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce its fourth quarter and year ended December 31, 2009 financial results on Tuesday, March 9, 2010 before the markets open.

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ("Court"), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE") exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today certain organizational and leadership changes designed to support future growth by better meeting customer needs, leveraging its multiple competencies across the organization, and building on its pharmaceutical industry experience.

UnitedHealth Group (NYSE: UNH) today released the following statement from Stephen J. Hemsley, the company’s president and chief executive officer, after he and other industry representatives met at the White House with Kathleen Sebelius, Secretary of the Department of Health and Human Services:  "We sought to make clear our longstanding commitment to expanding access to quality care for all Americans, and also to discuss the many factors that are driving up the cost of care for millions of people across the United States.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

 




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