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Ardea Biosciences Inc. (RDEA) reported third quarter net loss of $2.47 million, or 13 cents per share, which was significantly lower than the Zacks Consensus Estimate of 47 cents. The company reported a net loss of $14.2 million or 95 cents in the year-ago period. The lower loss was attributable to the higher revenues coupled [...]

(RDEA) Ardea Biosciences Inc. Lowers Loss

Ardea Biosciences Inc. (RDEA) reported third quarter net loss of $2.47 million, or 13 cents per share, which was significantly lower than the Zacks Consensus Estimate of 47 cents. The company reported a net loss of $14.2 million or 95 cents in the year-ago period. The lower loss was attributable to the higher revenues coupled with lower operating expenses recorded in the quarter. 

Revenues came in at $9.17 million as against none in the year-ago quarter. The revenues resulted from the recognition of a portion of the upfront payment of $35 million under the global agreement, with Bayer HealthCare focused on the development of MEK inhibitors for the treatment of cancer. 

Operating expenses for the quarter decreased 21.4% to $11.4 million primarily due to reduced research and clinical development expenditures. Research and development expenses decreased to $9 million from $11.5 million in the third quarter of 2008. This is because the company is concentrating its resources on the further development of its gout candidate, RDEA594, which is in a mid-stage study. Furthermore, during the reported quarter, Ardea saved approximately $1.1 million following the restructuring which saw a 47% workforce reduction to conserve cash. The decrease in operating costs was partially offset by severance-related restructuring charges of approximately $0.1 million. 

The company exited the quarter with $59.6 million in cash, cash equivalents and short-term investments compared to $57.7 million as of Dec 31, 2008. The increase was due to the $35.0 million non-refundable, upfront license fee from Bayer, partially offset by cash usage to fund clinical programs, personnel costs apart from costs for other general corporate purposes. 

Ardea expects to end 2009 with a cash balance of $50−$55 million. Management expects the cash balance to be sufficient to fund operations till the first quarter of 2011, exclusive of any additional partnering revenues. 

Currently we are Neutral on Ardea.
Read the full analyst report on "RDEA"
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Helix BioMedix, Inc. (OTC:HXBM), a developer of bioactive peptides, announced financial results for the third quarter ended September 30, 2009.

Laboratory Corporation of America® Holdings (NYSE:LH) announced William B. (Brad) Hayes, Executive Vice President and Chief Financial Officer, is scheduled to speak at the Credit Suisse 18th Annual Healthcare Conference in Phoenix AZ.

Oncolytics Biotech Inc. (NASDAQ:ONCY) announced updated results from a Phase II study of intravenous REOLYSIN(R) in patients with sarcomas metastatic to the lung in a poster presentation at the 15th Annual Connective Tissue Oncology Society Meeting held in Miami Beach, Florida, from November 5th to 7th.

PPD, Inc. (Nasdaq:PPDI) announced it has completed its acquisition of Excel PharmaStudies, Inc., the market leader and one of the largest contract research organizations in China.

Imagenetix, Inc. (OTC:IAGX), announced today that William Spencer, President and CEO of Imagenetix, will be presenting the Company's store at the 2nd annual LD MICRO Conference on Thursday, December 3rd, at 10:30 AM PST at the Luxe Sunset in Los Angeles.

Amarin Corporation plc (NASDAQ:AMRN) announced the appointment of John F. Thero as the Company’s Chief Financial Officer.

Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the Mass Technology Leadership Council, Inc. named Phase Forward Private Sector Company of the Year at the 2009 Mass Technology Leadership Awards in Boston last night.

BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, announced its financial results for the third quarter ended September 30, 2009.

Caraco Pharmaceutical Laboratories, Ltd. (NYSE:CPD) has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA) for generic Acular® ophthalmic solution on the first day following patent expiration.

Stellar Pharmaceuticals Inc. (OTC:SLXCF), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announced its financial results for the third quarter ended September 30, 2009.

Cyberonics, Inc. (Nasdaq:CYBX) announced the company will report financial results for the second quarter ended October 23, 2009 of its fiscal year ending April 30, 2010 on Wednesday, November 18, 2009 at 5:00 PM EST.

GeoVax Labs, Inc. (OTC:GOVX), an Atlanta-based, biopharmaceutical company developing human vaccines for disease caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced its third quarter 2009 financial results and provided an operational update.

Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the third quarter and nine months ended September 30, 2009.

Covidien (NYSE:COV), a leading global provider of healthcare products, announced the successful completion of its tender offer through its subsidiary, Transformer Delaware Corp., to purchase all of the outstanding shares of common stock of Aspect Medical Systems, Inc.

PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced Gregory S. Weisner, Chief Executive Officer, will make a presentation regarding the Company at the Credit Suisse 18th Annual Healthcare Conference in Phoenix, Arizona, on Wednesday, November 11, 2009, at 10:00 a.m. Mountain Time.

Ferro Corporation (NYSE:FOE) announced it has closed on its previously announced common stock offering. The total number of shares sold was 41,112,500, including 5,362,500 shares issued in connection with the exercise of the underwriters’ over-allotment option to purchase additional shares.

Boston Scientific Corporation (NYSE:BSX) announced it has reached an agreement in principle with the U.S. Department of Justice (DOJ) related to product advisories issued by its Guidant subsidiary in 2005.The alleged conduct and product sales occurred prior to Boston Scientific's 2006 acquisition of Guidant.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) will hold a conference call on Tuesday, November 10, 2009 at 8:30 a.m. EST to discuss the third quarter 2009 financial results and business outlook for the remainder of 2009.

The Quigley Corporation, (Nasdaq:QGLY), www.quigleyco.com, announced it would issue its third quarter results at 8:30 AM (ET) on Thursday, November 12, 2009.

On 7/21/09, STAAR Surgical (NASDAQ:STAA) announced that it has been informed by the FDA Division of Bioresearch Monitoring that the restrictions of the integrity hold put in place by the Agency on 8/3/07 have been removed. The removal of the integrity hold enables the FDA to resume scientific review of the Company's application for the Toric Implantable Collamer Lens (TICL) for Myopic/Astigmatic patients. This application is a PMA Supplement to the Visian ICL which the FDA approved on 12/22/05. Pursuant to the terms of the integrity hold, between September 2007 and May 2009, STAA initiated and completed the following actions required by the FDA. The Company retained Promedica International (PMI) to perform a comprehensive systems audit and data audit related to the TICL application.

PMI performed the required audits of 100% of data of patient records at all seven clinical sites and a systems audit of the Company from December 2007 to October 2008. PMI prepared a systems audit report dated 10/8/08 and submitted the report to the FDA. In addition, PMI prepared a final field audit report dated 3/13/09 and submitted it to the FDA. Based on these reports, STAA submitted a Corrective Action Plan to the FDA on 5/22/09 to address the findings included in the PMI audit reports and provide assurances that all future studies would be conducted in accordance with applicable laws, regulations and good clinical practices.

On 7/21/09, Spectrum Pharma (NASDAQ:SPPI) and Allergan (NYSE:AGN) announced that the FDA has granted Fast Track Designation for the investigation of apaziquone (EOquin) for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer. Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer (affecting an estimate of more than 1 million patients in the U.S. and Europe ). EOquin has two Phase 3 trials underway with a primary endpoint of tumor recurrence at Year 2 under defined registration paths for the U.S. and Europe . EOquin is expected to complete enrollment in ongoing Phase 3 pivotal trials by the end of 2009 with more than 1,000 patients enrolled at more than 120 sites. SPPI also expects to initiate trials for EOquin in BCG-Failure bladder cancer patients by the end of 2009.

EOquin is a targeted pro-drug that is bio-activated by enzymes which are over-expressed in bladder tumors to focus the drug activity at the site of the bladder cancer. On 11/6/08 , SPPI announced a licensing deal with AGN for $41.5 million upfront additional milestone payments possible for up to $304 million. SPPI retained exclusive rights in Asia ( Japan , China , India ) while AGN received exclusive rights to apaziquone in the rest of the world ( U.S. , Canada , Europe ). In the U.S. , the two companies will co-promote apaziquone and share in its profits and expenses. AGN will pay royalties to SPPI on EOquin sales outside of U.S. SPPI agreed to conduct EOquin clinical trials with AGN bearing 65% of these expenses.

On 7/21/09, Incyte Corp. (NASDAQ:INCY) announced that it reached agreement with the FDA on a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The SPA provides agreement that the study design and planned analysis of the Phase 3 trial adequately address objectives in support of a regulatory submission.

COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment), is a double-blind, placebo-controlled Phase 3 trial comparing the efficacy and safety of INCB18424 to placebo in approximately 240 patients with PMF, PPV-MF or PET-MF.. COMFORT-I is expected to begin in August while COMFORT-II (a second Phase 3 trial being conducted in Europe ) began patient enrollment in July. INCY expects to file a New Drug Application for INCB18424's use in MF in late 2010 or early 2011, assuming that results from the pivotal study are positive.

On 7/20/09, Ardea Biosciences (NASDAQ:RDEA) announced that it has initiated a Phase 2b clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a next-generation URAT1 inhibitor, as a development candidate for the same indication. The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more).

The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (marketed as Uloric by Takeda Pharma and Adenuric by Ipsen), and a study in patients with renal impairment, are expected to begin shortly.

Disclosure: Long SPPI

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