RxNews Recap for Tuesday 02-09-10. Seattle Genetics (SGEN) pops after hours. RTI Biologics (RTIX) rolls on positive results. Print E-mail
By Mary Davila   
Tuesday, 09 February 2010 20:03

Below is a list of the companies that made news in the healthcare sector on Monday, February 09, 2010.

Seattle Genetics, Inc. (Nasdaq:SGEN) after the bell announced financial results for the fourth quarter and year ended December 31, 2009. The company also highlighted recent product development activities and planned milestones and provided its 2010 financial outlook.
Net loss for the quarter was $12.1 million, or 12 cents per share, compared with a net loss of $30.6 million, or 38 cents per share, in the year-ago quarter.

Revenue for the fourth quarter grew more than 115 percent to $21.8 million. According to Thomson Reuters, analysts were expecting the company to post a loss of 23 cents a share on revenue of $11.71 million.

The increases in revenues were primarily driven by the earned portion of payments received under its cancer drug collaboration with Genentech. Shares of Seattle Genetics were up almost 3% on the day and jumped another 4.9% in the after hours market.

Also after the bell.....

AspenBio Pharma, Inc. (NASDAQ:APPY) after the bell reported conclusions from its pre-planned, independent, interim analysis of the Company's ongoing supplemental clinical trial of AppyScore, the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis, and outlined next steps for its AppyScore 510(k) filing with the U.S. Food and Drug Administration (FDA). Based on the interim analysis, the trial, currently with over 600 patients enrolled, will continue enrollment to approximately 800 patients with completion anticipated in March of 2010. Given the time estimate to complete the current trial and related data analysis, the Company has withdrawn its 510(k) on file with the FDA and will submit a new 510(k) with full results from the ongoing clinical trial. This clinical trial is statistically sized to stand alone and thereby becomes the pivotal trial to support the new 510(k) submission. Shares were off more than 5% after hours.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) shares jumped in the after market session after the company announced that the first patent covering the composition and method of use of Intermezzo® (zolpidem tartrate sublingual tablet), their lead product candidate, had been issued by the United States Patent and Trademark Office. Transcept announced the issuance of a Notice of Allowance for claims under the application for this patent, U.S. Patent Application Serial No. 11/060,641, on December 14, 2009. The newly issued patent, U.S. Patent No. 7,658,945, titled "Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof," will expire no earlier than February 2025. The most advanced Transcept product candidate is Intermezzo®, for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. In October 2009, Transcept received a Complete Response Letter from the FDA on the Intermezzo® NDA and is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States.

XenoPort, Inc. (Nasdaq:XNPT) announced after the bell that the U.S. Food and Drug Administration (FDA) will not be taking an action today on the Horizant (gabapentin enacarbil) new drug application (NDA) for moderate-to-severe primary Restless Legs Syndrome (RLS), due to the fact that the federal government has been closed for the past two days. The FDA has indicated that the new Prescription Drug User Fee Act (PDUFA) goal date is Thursday, February 11, 2010, assuming that there are no further federal government closings this week. The FDA indicated that if there are additional federal government closings this week, the goal date for this NDA will likely be extended further. Shares were up over 2% in the after hours market.

Movers from earlier in the day:

RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading processor of orthopedic and other biologic implants, reported operating results for the fourth quarter and full year ending Dec. 31, 2009. “In a very challenging and difficult-to-predict environment, we were able to increase our revenues by 12 percent,” said Brian K. Hutchison, chairman and CEO of RTI. “Our sports medicine and surgical specialties businesses have been the fastest-growing businesses over the year, offsetting a decline in dental business. We worked very diligently over the past 12 months to leverage our operational strengths and make steady improvements in our profitability while meeting the needs of our surgeons and distributors. These improvements should help us with our goals of delivering significant gains in profitability in 2010.” Shares of RTI traded higher on heavy volume closing the day at $3.29, up 5.79%.

Aastrom Biosciences (Nasdaq:ASTM) announced today that its board of directors has approved a one-for-eight reverse stock split of the company's common stock effective on February 18, 2010. The company has filed an amendment to its articles of incorporation to effect the reverse stock split, which was authorized by shareholders at Aastrom's annual meeting in December 2009. Following the reverse stock split, the company expects to have approximately 28.3 million shares of common stock outstanding.

Tim Mayleben, Aastrom's president and chief executive officer, stated, "We believe a reverse stock split will help our shares reflect the value we are creating through our clinical programs and help us attract more institutional ownership of our stock at an exciting time in our company's history. We are currently conducting late-stage clinical trials of our cardiac and vascular repair cell technology and look forward to reporting the results of our limb ischemia clinical trial later this month and our dilated cardiomyopathy study later this year. As a result of our recent $13.5 million stock offering and much stronger balance sheet, we now have the resources to complete patient enrollment in these trials, initiate new clinical studies in these indications this year and execute these programs successfully."

The reverse stock split is intended to increase the per share trading price of Aastrom's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on NASDAQ and to attract greater institutional ownership of the company's shares. As a result of the reverse stock split, every eight shares of the company's common stock that were issued and outstanding immediately prior to the opening of trading on February 18, 2010, will automatically be combined into one issued and outstanding share without any change in the par value of such shares and the number of authorized but unissued shares of the company's common stock will be proportionally reduced. Investors reacted negativley to the news, send shares of Aastrom down over 12%.

Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2009 results. The company said its profit rose 48 percent in the fourth quarter due to higher sales of its drug Tysabri, a treatment for multiple sclerosis and Crohn's disease.

The biotechnology company also forecast a profit for this year that is above current Wall Street estimates.“Biogen Idec delivered strong financial and operational performance in 2009. We recorded our sixth consecutive year of double-digit EPS growth, TYSABRI became Biogen Idec’s third blockbuster product and we advanced two programs into registrational trials,” said James C. Mullen, Biogen Idec’s President and CEO. “We are confident that our continued focus on our products, robust pipeline and disciplined use of cash will fuel future earnings growth and drive value for Biogen Idec shareholders.” Shares of Biogen were up $1.25 to close the regular session $54.09.

BSD Medical Corporation (NASDAQ:BSDM) shares were up as much as 5% today as the company reported the initiation of a randomized, multicenter Phase III clinical study using the BSD-2000 Hyperthermia System in combination with chemotherapy for the treatment of pancreatic cancer patients after R0/R1 surgical resection of their tumor (complete removal or only microscopic tumor remaining). The coordinating investigator is Rolf D. Issels, MD PhD, Department of Medical Oncology, Klinikum Grosshadern, Munich University Medical School, Munich, Germany. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.

The Phase III study was initiated following completion of a Phase II study that utilized chemotherapy and hyperthermia to treat 21 inoperable pancreatic patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis. There was one complete response (complete disappearance of the tumor), 3 partial responses (more than 50% tumor reduction), and 7 patients with stable disease (no tumor growth). The study results demonstrated a low toxicity rate and an overall survival of 16.9 months. By comparison, the median survival for inoperable pancreatic cancer patients after gemcitabine treatment is only 6 months. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology (ESHO), will compare hyperthermia with chemotherapy (gemcitabine) to chemotherapy (gemcitabine) alone.

Pancreatic cancer is one of the deadliest and hardest to treat cancers and is the fourth leading cause of cancer-related death. There were an estimated 42,470 Americans and 60,000 Europeans diagnosed with pancreatic cancer during 2009 and approximately 80% are inoperable. The median survival period from the time of diagnosis until death is 3.5 to 6 months, depending on treatment, and less than 5 percent survive to five years. Advanced pancreatic cancer patients currently have few treatment options.

Shares fell back at the end of the day but still closed up more than 2.5%

Cerus Corporation (NASDAQ:CERS) announced today that it has entered into a collaborative agreement with France's national transfusion service, the Etablissement Français du Sang (EFS), for the development of the company's INTERCEPT Blood System for red blood cells. Terms of the agreement call for the EFS to co-invest by contributing its facilities, personnel and resources in support of clinical and commercial product development, validation, and both CE mark and French regulatory approvals. In return, EFS has certain royalty rights on future product revenue. The EFS plans to conduct the collaboration at four regional EFS establishments in France, with candidate locations including Strasbourg, Besançon, St-Etienne, Tours, Montpelier, and Marseille.

"Cerus welcomes this opportunity to collaborate with a leading national transfusion service as we advance the INTERCEPT red blood cell program into the European market," said Claes Glassell, president and CEO of Cerus. "Our experience commercializing the INTERCEPT platelet and plasma systems has shown us the value of working directly with our future potential customers, such as EFS, to establish the safety, efficacy and operational requirements of new pathogen inactivation technologies." Shares of Cerus shot up over 4.5% or 9 cents to close at $2.11.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced several updates related to its Phase III registration program in neurogenic orthostatic hypotension (NOH), including the selection and preliminary approval by the FDA of Northera as the U.S. brand name for Droxidopa in this indication. "Northera demonstrated broad symptomatic benefit in the treatment of neurogenic orthostatic hypotension in our first Phase III trial," said Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We are fortunate to now have this opportunity to directly incorporate the key findings from Study 302 into our registration program by changing the primary endpoint and increasing enrollment in Study 301 and further validating these findings in an enriched trial focused on Parkinson's patients with symptomatic neurogenic orthostatic hypotension, the strongest responders to Northera in Study 302 and our largest potential market. We look forward to the outcome of both trials and believe the data will clearly support a robust NDA filing and strong market launch." Shares of Chelsea Therapeutics traded down on the day to close at $2.53.

International Stem Cell Corporation (OTCBB:ISCO), saw its shares shoot up over 39% on no apparent news. Volume was 4 times the average for this California-based biotechnology company involved in creating human stem cell lines from unfertilized eggs.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced financial results for the three and 12 months ended December 31, 2009, and reviewed business highlights of the fourth quarter of 2009 and early 2010.

“2009 was an exceptional year for Ligand with many scientific, business and financial accomplishments. The year culminated with positive Phase Ia trial data for our SARM program, our partners receiving European approvals for Fablyn® and Conbriza™ (Viviant), milestone payments from fully-funded collaborations with GlaxoSmithKline, Merck and Pfizer and the acquisitions of Neurogen and Metabasis,” said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.

“Ligand has assembled an unparalleled partnership portfolio of 33 externally-funded programs with the potential to earn significant revenues. We are simultaneously advancing our internal pipeline toward additional news events and possible out-licensing opportunities in 2010,” added Higgins.

Ligand posted a profit of $3 million, or 3 cents per share. In the fourth quarter of 2008, it lost $69.6 million, or 72 cents per share, mostly due to a $72 million charge connected to its purchase of biotechnology company Pharmacopeia.

Revenue grew 13 percent to $14 million from $12.4 million. Ligand said its royalty revenue dropped to $1.8 million from $5.4 million, but collaborative research and development and other revenue jumped to $12.2 million from $7 million.

For the full year, Ligand cut its loss to $1.9 million, or 2 cents per share, from $98.1 million, or $1.03 per share, in 2008. Revenue grew 43 percent, to $38.9 million from $27.3 million.

Shares of Ligand rose more than 5% to close at $1.66.

Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) saw its shares rise over 23% on no news. Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer.

In other news Tuesday:

AstraZeneca (NYSE: AZN) shares rose today as the company announced that the US Food and Drug Administration (FDA) has approved a new indication for CRESTOR® (rosuvastatin calcium): to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men greater than or equal to 50 and women greater than or equal to 60), high-sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease. "Not only is this approval a significant milestone for AstraZeneca, but it is also important for the patients who could now benefit from CRESTOR therapy under this approved indication," said Howard Hutchinson, MD, Chief Medical Officer, AstraZeneca. "This new indication adds to the significant body of evidence physicians use to evaluate CRESTOR as a treatment option."

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the appointment of Jeffrey W. Winkelman, Ph.D., J.D. as vice president, oncology programs. His primary responsibilities will be management of BioSante’s oncology products including collaborations with John Hopkins Sidney Kimmel Cancer Center, contracts, licensing and intellectual property.

“We are very pleased that Jeff has agreed to join BioSante,” said Stephen M. Simes, president and CEO of BioSante. “Jeff brings a wide range of experience especially related to BioSante’s recently acquired GVAX vaccines and related technologies. He also is experienced in the areas of intellectual property, contracts and business development activities. We believe Jeff will prove valuable for BioSante in many ways including maximizing the value of these newly acquired technologies. Since Jeff was a vice president at Cell Genesys before we acquired that company, and very involved in all aspects of the business, Jeff is familiar with all acquired products and technologies as well as with the 95 patents and 85 patent applications that cover the newly acquired technologies as a result of the acquisition.”

Cannabis Science Inc. (OTCBB: CBIS), a pharmaceutical cannabis company in the US, is pleased to announce it is finalizing agreements with suppliers, manufactures, and research institutions that it expects will close within days and weeks to come.

Chattem, Inc. (NASDAQ: CHTT) announced that, pursuant to the terms of the indentures (the “Indentures”) governing its 2.00% convertible senior notes due 2013 and 1.625% convertible senior notes due 2014 (collectively, the “Notes”), a Fundamental Change (as such term is defined in the respective Indentures) occurred on February 9, 2010 (the “Fundamental Change Effective Date”) as a result of the successful completion of the tender offer, commenced by River Acquisition Corp., a Tennessee corporation and an indirect wholly-owned subsidiary of sanofi-aventis, a French société anonyme, on January 11, 2010, for all outstanding shares of common stock of Chattem for $93.50 per share, net to the seller in cash, without interest and less any required withholding taxes pursuant to the Agreement and Plan of Merger, dated December 20, 2009, among Chattem, sanofi-aventis and River Acquisition Corp.

Enzon Pharmaceuticals, Inc. (NASDAQ: ENZN) announced today that it will report its financial results for the quarter ended December 31, 2009, on Wednesday, February 17, 2010 at approximately 8:00 am Eastern Time (ET).

IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today announced fourth-quarter 2009 revenue of $599.2 million, up 3 percent year over year and down 3 percent constant dollar, compared with $580.9 million in the 2008 fourth quarter.

Incyte Corporation (Nasdaq: INCY) announced today that it has scheduled its fourth quarter and year-end 2009 financial results conference call for 8:30 a.m. ET on Thursday, February 18, 2010.

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its fourth quarter and year-end 2009 financial results will be released on February 23, 2010, after the markets close.

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, provided an overview of its 2010 clinical milestones in a presentation by President & C.E.O., Nicholas Landekic at the 2010 BIO CEO & Investor Conference.

PPD, Inc. (Nasdaq: PPDI) today announced its global central lab operations in Singapore has earned accreditation by the College of American Pathologists (CAP), validating its ability to deliver high-quality, reliable data that meet the highest standard of excellence in enhancing patient safety and speeding drug development.

SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its first quarter of fiscal year 2010, ended December 31, 2009.

Skilled Healthcare Group, Inc. (NYSE:SKH) today reported consolidated revenues for the year ended December 31, 2009 of $759.8 million, an increase of 3.6 percent compared to 2008. Consolidated revenues were $189.0 million for the three-month period ended December 31, 2009, compared to $189.8 million for the three-month period ended December 31, 2008.

Targeted Genetics Corporation (Pink Sheets:TGEN) today announced that it has completed the technology transfer portion of the September 2009 asset sale transaction executed between the Company and Genzyme Corporation (Nasdaq:GENZ) and has received the full $7.0 million provided for in the asset purchase agreement. As previously announced, the Company received $3.5 million from Genzyme at the closing of the transaction and was eligible to receive up to an additional $3.5 million upon the achievement of seven technology transfer milestones. The Company completed all seven technology transfer milestones and received aggregate payments from Genzyme of $2.5 million in the fourth quarter of 2009 and $1.0 million in the first quarter of 2010 for a total of $3.5 million.

In addition, the Company reported today that it received a $750,000 milestone payment from Amsterdam Molecular Therapeutics B.V. This milestone payment was received pursuant to a patent license agreement between the Company and AMT and was triggered by AMT’s filing for marketing approval of Glybera®, a product candidate for the treatment of lipoprotein lipase deficient patients. AMT announced the regulatory filing with the European Medicines Agency on January 11, 2010.

USANA Health Sciences, Inc. (NASDAQ: USNA) today announced financial results for its fiscal fourth quarter and full-year ended January 2, 2010.

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that enrollment is underway in a 325-patient Phase 2b dose-ranging clinical trial of its antibody candidate, XOMA 052, in Type 2 diabetes patients. The randomized, placebo-controlled trial will be conducted at up to 70 U.S. sites, will evaluate multiple dose levels of XOMA 052 over six months and is intended to guide Phase 3 development. XOMA estimates that top-line results from the study will be available in the first quarter of 2011. "XOMA 052, an antibody to interleukin-1 beta, is a potential paradigm-shifting treatment for Type 2 diabetes and cardiovascular disease and other inflammatory diseases," said Steven B. Engle, XOMA Chairman and Chief Executive Officer. "The Phase 2b trial initiation is another major milestone in the XOMA 052 program."

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