|RxNews Recap for Friday 02-19-10. ARYx (ARYX) explores strategic options. GenVec (GNVC) rises on Homeland Security contract.|
|By Mary Davila|
|Friday, 19 February 2010 20:34|
Below is a list of the companies that made news in the healthcare sector on Friday, February 19, 2010.
ARYx Therapeutics Inc. (NASDAQ: ARYX), plunged more than 47% today after the company announced that it has retained Cowen and Company to explore strategic options for the company. While discussions continue with pharmaceutical companies regarding the licensing of its oral antiarrythmic agent, budiodarone, the companies with whom ARYx was engaged in advanced discussions have recently indicated that they do not intend to proceed to an agreement. As a result, it has become clear that ARYx will not complete a partnership on the product in the near term. By retaining Cowen, ARYx will explore the possibility of capturing full near-term value for its three lead programs rather than pursuing licensing deals that provide value over an extended period of time.
In conjunction with this action, ARYx has also completed a substantial reorganization of the Company, reducing the number of employees to fewer than 20. The focus of this retained group is to work with Cowen to optimize the value of the late-stage assets of the Company in the most efficient manner.
"When we reached the point that it became clear we will not be completing a partnership in the near term, we reviewed many strategic alternatives before deciding to retain the services of an investment bank," said Dr. Paul Goddard, chairman and chief executive officer of ARYx. "We have three products at proof of concept stage and amongst these three programs we have treated more than two thousand people with our drugs. For each of these products, we have made substantial progress in characterizing both their safety and efficacy, and we remain convinced that they have substantial value. It is for this reason that we have retained the services of Cowen with the objective of realizing optimal value on behalf of our stockholders."
Shares fell $1.37 or 48.24% to close the session at $1.47.
GenVec, Inc. (Nasdaq:GNVC) shares rose over 5% today after the company announced a new contract with the Department of Homeland Security (DHS) to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center. Under this new agreement, GenVec will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract.
Under this contract, GenVec will use its adenovector technology to develop additional FMD-serotype candidate vaccines. GenVec will also explore methods to increase the potency and simplify the production process of FMD vaccines developed under this contract as well as its previous contract with the DHS announced in 2007.
"This contract expands our ongoing efforts to develop adenovector-based FMD vaccines," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new contract with the DHS will support new vaccine discovery and technology improvement for this important threat."
Shares closed up 12 cents to end the day at $2.45.In other news Friday:
Advaxis, Incorporated (OTCBB: ADXS), the live, attenuated Listeria monocytogenes immunotherapy company, has just submitted its annual statement for fiscal year 2009.
Allstar Restaurants (OTC Bulletin Board: AREN) ("Allstar" or the "Company"), today announced that effective on February 12, 2010, the Company’s wholle-owned subsidiary merged with China Qinba Pharmaceuticals, Inc.
A.P. Pharma, Inc. (Nasdaq:APPA), a specialty pharmaceutical company, today announced the appointment of Stephen Davis to its board of directors. Mr. Davis was the chief executive officer for Neurogen Corporation, which was recently acquired by Ligand Pharmaceuticals. His appointment brings the number of A.P. Pharma board members to seven.
Biovail Corporation (NYSE/TSX: BVF) today acknowledged that separate Complaints have been filed against the Company by S.A.C. Capital Advisors, LLC and Gradient Analytics, Inc. The Complaints, filed in the U.S. District Court for the District of Connecticut and the U.S. District Court for the District of Arizona, respectively, allege malicious prosecution related to Biovail’s 2006 filing of a lawsuit against them and others.
Biovail believes the Complaints are without merit and intends to defend itself vigorously.
"After tremendous effort to move Biovail forward from all legacy litigation and regulatory matters, it is unfortunate that we now must deal with these Complaints," said Biovail Chief Executive Officer Bill Wells. "However, this will not distract us from the ongoing execution of our business strategy, or from our goal of moving Biovail to high growth."
Bruker Corporation (NASDAQ: BRKR) announced today that it plans to release its fourth quarter and fiscal year 2009 financial results on Thursday, February 25th, 2010 before the market opens. Bruker will then host an operator-assisted earnings conference call that morning at 9:00 AM Eastern Time.
Depomed noted that unlike Horizant, Depomed’s proprietary extended release formulations of gabapentin are not new chemical entities that require additional carcinogenicity or other toxicology studies. Depomed expects an NDA for DM-1796 will be filed in the first quarter of this year under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. Depomed believes that no additional carcinogenicity studies will be required for the DM-1796 NDA because it will reference the same toxicology package that formed the basis of the approval of Neurontin® (gabapentin) for epilepsy and postherpetic neuralgia.
Depomed noted that gabapentin is a well-characterized compound that has been marketed for epilepsy since 1993 and PHN since 2002. The compound has not shown a carcinogenicity signal in post-marketing experience involving approximately 20 million prescriptions annually.
Genoptix, Inc. (Nasdaq:GXDX), a specialized laboratory service provider, and HistoRx, Inc. (privately held), a diagnostics company, today announced a multi-year licensing agreement for AQUA® technology and several diagnostic assays based on it. Genoptix has obtained exclusive commercial laboratory rights in the United States to develop and perform three solid tumor assays using HistoRx's proprietary technology for analysis of fluorescent immunohistochemistry (fIHC), enabling quantitative assessment of specific biomarkers for patients with certain solid tumors.
Hologic, Inc. (Nasdaq:HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced it has entered into a settlement agreement with Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson company. The settlement agreement resolves all outstanding litigation between EES and Hologic, including two lawsuits filed by EES on October 5, 2007 and August 6, 2009 against the Company and its wholly-owned subsidiary, Suros Surgical Systems, Inc., alleging patent infringement by the ATEC and EVIVA biopsy products, as well as a lawsuit filed by Hologic on April 30, 2009 against EES, alleging patent infringement by the MAMMOTOME MR biopsy product.
IGI Laboratories, Inc. (NYSE AMEX:IG), a premier provider of topical formulation development, analytical, manufacturing and packaging services today announced that effective February 12, 2010, Charles E. Moore has joined the Company in the newly created position of Executive Vice President of Technical Operations.
Physio-Control Inc., a wholly-owned subsidiary of Medtronic, Inc. (NYSE: MDT), announced today it received notice from the U.S. Food and Drug Administration (FDA) that having successfully met requirements for improvements to the quality system, the company may resume unrestricted worldwide shipments of its external defibrillators.
In May 2008, Physio-Control signed a Consent Decree with the FDA to address issues the Agency raised during inspections of the company’s quality system. Under the terms of this agreement, Physio-Control was permitted to ship a limited number of products to emergency care providers to meet public health and safety needs until quality system improvements were completed.
Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing clean, sustainable solutions for plastics, chemicals and energy, announced today that it will be releasing its fourth quarter and full year fiscal 2009 financial results after the market close on Wednesday, March 10, 2010.
Novartis AG BASEL (NYSE:NVS) announced today that thier drug Tasigna has received FDA priority review for newly diagnosed patients with early-stage chronic myeloid leukemia. Tasigna 200 mg capsules has been granted priority review by the FDA for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Tasigna demonstrated that significantly fewer patients progressed to more advanced stages of the disease than the standard of care Gleevec tablets at 12 months. Tasigna also showed a statistically significant improvement over Gleevec in every other measure of efficacy in the trial, including major molecular response and complete cytogenetic response at 12 months.
Novavax, Inc. (Nasdaq:NVAX) today presented to the world's leading pandemic influenza vaccine experts a summary of the recent preliminary safety and immunogenicity data from its Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study in Mexico. The presentation of the results were made by Maria Allende, M.D., at the invitation-only 6th World Health Organization (WHO) Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials, held at the WHO headquarters in Geneva, Switzerland.
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "The data presented today suggest that our H1N1 VLP vaccine is well tolerated and has a robust immune response even at a low dose of 5 mcg. This is remarkable given that our vaccine does not contain any adjuvant. Stage B enrollment of 3,000 subjects, which is more than fifty percent complete, coupled with subjects previously enrolled in Stage A of this trial and other clinical trials should provide us with a sizeable database of safety information that is key to progressing our vaccine to ultimate regulatory approval and commercialization worldwide."
PanGenex Corporation (Pink Sheets:PGCX), a global nutraceutical and dietary supplement manufacturer and marketer, today provided information in response to inquiries about Soft Tissue Calcification ("STC") and the Company's products.
Shire plc (LSE: SHP, NASDAQ: SHPGY) shares rose sharply as the global specialty biopharmaceutical company today announced better than expected results for the year to December 31, 2009.
Angus Russell, Chief Executive Officer, commented:
"In this challenging and transformational year for Shire, I believe these excellent results reflect the success of our focused strategy and business model.
Strong fourth quarter sales growth of 36% from our core product portfolio, supported by our increasing international reach, has contributed significantly to our full year Non GAAP diluted earnings per ADS of $3.49. Our recent decision to lower our best estimate of the Medicaid sales rebates for ADDERALL XR contributed 32 cents to these earnings, which was not previously anticipated in our guidance framework.
Our growth prospects remain excellent and our core product portfolio currently has robust exclusivity protection. We have launched INTUNIV successfully in the US, we plan to launch velaglucerase alfa (VPRIV) imminently, and there is also an opportunity for REPLAGAL to enter the US market. We have already seen encouraging signs for the future success of these three products. REPLAGAL has increased its share in ex-US markets and we expect this momentum to increase.
VYVANSE, our leading ADHD treatment with a current monthly US ADHD market share of 13.6%, continues to grow and build strong brand recognition in the US and has recently been launched in Canada. ADDERALL XR continues to generate value from both product sales and a considerable royalty stream.
We have also demonstrated a pro-active approach to cost management in 2009 as promised, and have the opportunity to leverage our existing infrastructure to deliver expanding margins in the future. We enter 2010 with a strong balance sheet and excellent cash generation. This will allow us to continue to expand our international presence and consider potential acquisitions and in-licensing opportunities that fit our strategy.
We look forward to growing revenues and earnings in 2010 and re-iterate our aspirational target of mid-teen revenue growth on average between 2009 and 2015."
United Therapeutics Corporation (Nasdaq:UTHR) announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser solution for the treatment of pulmonary arterial hypertension (PAH) in the European Union.
United Therapeutics submitted its MAA for Tyvaso to the European Medicines Agency (EMA) in December 2008. The data included in the MAA is based upon clinical work performed from 2005 to 2007 by United Therapeutics' wholly-owned subsidiary Lung Rx, LLC. The MAA was withdrawn following communication from the Committee for Medicinal Products for Human Use (CHMP) of the EMA citing a major objection. The major objection noted that findings of non-compliance with good clinical practices (GCP) at two clinical sites would preclude a recommendation by the EMA for approval of the MAA for Tyvaso.
"Notwithstanding the fact that the EMA's major objection noted findings of non-compliance with good clinical practices, it is important to note that there were no major objections related to the safety or efficacy of Tyvaso," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.
"Our revenue growth targets are unaffected by the withdrawal," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "We have long based our growth targets on the estimated 30,000 diagnosed PAH patients in the US, including approximately 12,000 New York Heart Association Class III patients."
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