M. E. Garza's  Instablog

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 Given the time estimate to complete the current trial and related data analysis, the Company has withdrawn its 510(k) on file with the FDA and will submit a new 510(k) with full results from the ongoing clinical trial.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.

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.

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.

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.

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.

Overall rates of adverse events and serious adverse events, including infections, were generally similar between the two arms. Osteonecrosis of the jaw was infrequent (22 patients receiving denosumab as compared with 12 patients receiving Zometa) and there was no statistically significant difference between treatment arms. As with previous studies in advanced cancer patients, hypocalcemia was more frequent in the denosumab arm. Both overall survival and the time to cancer progression were balanced between treatment arms. Shares of Amgen jumper nearly 3% in the after hours market.

This study was conducted in approximately 100 clinical sites throughout North America and Europe. Optimer plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

The San Diego based company focuses on discovering, developing, and commercializing anti-infective products that treat gastrointestinal infections and related diseases

Optimer shares gained 68 cents, or 5.73 percent, to close the day at $12.54. Earlier in the day, shares traded as high as $13.70.    

After the bell today:

 
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), shot up after hours as the biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use. The company reported that the number of serious adverse events seen with the product was in line with what would be expected from the intravenous drug. Shares of AMAG fell 16 percent on Thursday on concerns about the safety of its Feraheme anemia treatment. AMAG shares rose to $39.00 in the after hours session from their Friday close of $37.77.

Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced after the bell through its wholly owned subsidiary, Strativa Pharmaceuticals, that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

Due to an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time. The FDA advised that they will schedule and perform an inspection of these sites as soon as possible. Strativa will continue to work with the FDA on completing these site inspections and finalization of product labeling. No issues related to the study data or film product were identified. Shares of Par were off 2.27% in the after hours market.

In news from earlier in the day:

Alkermes Inc.(Nasdaq: ALKS) gained 6.27% today after Jeffries analyst issued an upgrade from Hold to Buy based on strong sales of its schizophrenia drug during the third quarter. Alkermes is an integrated biotechnology company, offering extended-release injectable, pulmonary, and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction, and diabetes. It primarily develops, manufactures, and commercializes VIVITROL, an extended-release Medisorb formulation of naltrexone for the treatment of alcohol dependence, as well as for the treatment of opioid dependence. The company also manufactures RISPERDAL CONSTA, a formulation of risperidone for the treatment of schizophrenia and bipolar disorder.

Amicus Therapeutics (Nasdaq: FOLD) announced today that its Board of Directors has elected John F. Crowley as Chairman of the Board in addition to his current role as Chief Executive Officer (CEO), effective immediately. Mr. Crowley will succeed Donald J. Hayden, Jr., who will become the Lead Independent Director of the Board. Amicus Therapeutics is developing orally-administered, small molecule drugs called pharmacological chaperones, a novel, first-in-class approach to treating a broad range of diseases including lysosomal storage disorders and diseases of neurodegeneration. Amicus' lead program is in Phase 3 for the treatment of Fabry disease.

Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that Barry D. Quart, Pharm.D., president and chief executive officer, will present at the 12th Annual BIO CEO and Investor Conference.

AVI BioPharma Inc (Nasdaq:AVII) announced Friday that its experimental drug for the treatment of genetic muscle-wasting disease received an orphan drug status from the European Medicines Agency (EMEA).

The designation may provide AVI BioPharma up to 10-year market exclusivity in Europe, following marketing approval, for its AVI-5038 product.

Duchenne muscular dystrophy (DMD) is a disease characterised by progressive muscle degeneration, affecting young children, almost exclusively boys. It leads to paralysis and death in young adulthood.

In 2008, AVI BioPharma received an orphan drug status from the EMEA for another drug, AVI-4658, to treat DMD.

Products granted an orphan drug designation by the EMEA are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the EU.

Shares closed the day unchanged at $1.42.

BioTime, Inc.(NYSE Amex:BTIM) today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.“The U.S. Army has deployed Hextend for initial resuscitation of battlefield casualties because less Hextend is required compared to commonly used saline solution to achieve the same plasma volume expansion effect. This offers a major logistic advantage for a combat medic who has to carry all his supplies in his backpack,” said Dr. Proctor. “Our team was one of the first to evaluate the potential use of Hextend as a resuscitation fluid in the laboratory but no one had evaluated the safety and efficacy specifically in trauma patients even though there had been several other studies by other investigators in various other types of surgical patients.” Dr. Proctor cautioned that their “...study design has several limitations, but that the results are encouraging and warrant a randomized controlled clinical trial.” He also stated that it is “...extremely rewarding to provide solid evidence that our heroes in Iraq and Afghanistan are receiving state of the art fluid resuscitation on the battlefield.”

EpiCept Corporation (Nasdaq: EPCT) announced today that it has established an at-the-market program through which it may sell, from time to time and at its sole discretion, shares of its common stock having an aggregate offering price of up to $15 million. Maxim Group LLC is acting as sales agent on the program.

Health Discovery Corporation (OTCBB: HDVY) as reported earlier today on BioMedReports, announced today that the Company has entered into an exclusive agreement with the Pancreas, Biliary and Liver Surgery Center of New York at Saint Vincent Catholic Medical Centers in New York City to develop new molecular diagnostic tests for the early detection of pancreatic cancer. HDVY shares were up over 9% on the day to close at $.36.

Human Genome Sciences, Inc. (NASDAQ: HGSI) saw its shares rise on renewed rumors that circulated today regarding a speculated takeover by either Amgen (Nasdaq: AMGN) or GlaxoSmithKline (NYSE:GSK) . Options activity was particularly brisk as the FEB Calls experienced heavier than normal volume for the $28,29,30,31,32 strikes. Shares of HGSI finished the day up 2.49% to close at $26.75.
 

Pfizer Inc. (NYSE: PFE) and DxS (a wholly owned subsidiary of QIAGEN N.V.) (NASDAQ: QGEN); (Frankfurt, Prime Standard: QIA) today announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM). Financial terms of the diagnostic agreement have not been disclosed. “We look forward to collaborating with QIAGEN's DxS unit in the development of this important diagnostic tool that could potentially help physicians better define the most appropriate treatment for patients who suffer from glioblastoma multiforme,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit.

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced that Ronald Martell, chief executive officer, will provide a corporate overview at the 12th Annual BIO CEO and Investor Conference on Tuesday, February 9, 2010 at 1:00 p.m. Eastern Time at the Waldorf-Astoria in New York City.

Regenerex Biopharmaceutical, Inc. (Amex:RGN) announced today that a research team in Washington, D.C. has found that dystrophin-deficient Mdx mice, treated twice a week for six months with Tβ4, showed a significant increase in skeletal muscle regenerating fibers compared to untreated mice. No effects related to muscle function or fibrosis and no adverse reactions were observed in the mice. Mdx mice are used as models for Duchenne muscular dystrophy to evaluate potential therapeutic compounds. According to the research team, “In exercised dystrophin deficient mice, chronic administration of Tβ4 increased the number of regenerating fibers in skeletal muscle and could have a potential role in the treatment of skeletal muscle disease in Duchenne muscular dystrophy.” Because Tβ4 stimulates cell migration and anti-apoptosis pathways in skeletal muscle cultures, these data further suggest a role for Tβ4 in muscle degenerative diseases and injury.

“This study is particularly important as it provides the first direct correlation of gene expression data with in vivo administration and histological localization of Tβ4 in muscle tissue,” stated Dr. Allan L. Goldstein, Professor of Biochemistry and Molecular Biology at the George Washington University Medical Center, Washington, DC, and RegeneRx’s chief scientific advisor. Shares of Regenerex closed up more than 11% to 59 cents.

Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI), a commercial-stage biotechnology company with a focus in oncology, announced today that Rajesh C. Shrotriya MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, will provide an overview of the Company’s business strategy at the 2010 BIO CEO Investor Conference on Tuesday, February 9, 2010, at 11:30am Eastern Time.

Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today that it was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of an aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency. AAT deficiency is a chronic, hereditary condition that increases the risk of certain diseases, especially emphysema, which typically emerges in the fourth decade of life. Currently, there are no approved, inhaled treatments available for the treatment of AAT deficiency.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts.