Below is a list of the companies that made news in the healthcare sector on Wednesday, February 10, 2010.
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.
Athersys, Inc. (Nasdaq:ATHX) saw its shares rally over 14% as the company announced today that it has been granted U.S. patent 7,659,118 that covers non-embryonic multipotent stem cells, their isolation and expansion, and related pharmaceutical compositions. Athersys also announced that it has been granted and the opposition period has cleared EP patent EP1218489B1 that covers non-embryonic pluripotent stem cells, their isolation, expansion, and usage.
The issued patents cover Athersys' proprietary scalable MultiStem® technology, which is an investigational stem cell therapy that has demonstrated therapeutic potential to treat a broad range of diseases and indications, including acute myocardial infarction, inflammatory bowel disease (IBD), bone marrow transplant support and ischemic stroke. Athersys announced in December 2009 a strategic partnership with Pfizer under which the companies will jointly develop MultiStem for IBD.
"These patents further expand our stem cell IP estate and offer additional validation of the strength and breadth of the Athersys IP portfolio," said William (B.J.) Lehmann, President and COO of Athersys. "We believe that these patents are especially important as they extend the coverage of the composition, isolation, differentiation and scalable manufacturing of non-embryonic stem cells that are core to our technology and product portfolio."
Shares of Athersys were trading up as much as 32% in the pre-market and ended the day up 41 cents or 14.24% to close at $3.29.
China-Biotics, Inc. (Nasdaq: CHBT) saw its shares soar after the bell as the leading Chinese firm specializing in the manufacture, research, development, marketing and distribution of probiotics products, today announced its financial results for the third quarter of its 2010 fiscal year ended December 31, 2009 including revenues that exceeded expectations.
"Our robust fiscal third quarter revenue and earnings growth reflect the Company's continued expansion of our bulk and retail customer bases," said Mr. Jinan Song, Chairman and Chief Executive Officer of China-Biotics. "Commercial production at our Qingpu production plant is scheduled to begin by the end of February and we continue to expect to reach approximately 50% capacity utilization by the end of calendar year 2010. With rising demand from the dairy and animal feed manufacturers, and movement by the government to encourage the use of probiotics, China continues to be a very favorable environment to grow our bulk and retail probiotics business in 2010 and beyond." Mr. Song went on to say "The Company is reiterating its fiscal year 2010 revenue growth guidance of at least 50% and expects overall gross margin to remain approximately 70%. "We will continue to seek a balance between current production capacity and sales to new customers until our new facility begins commercial production. We look forward to the continued expansion of our retail distribution network and outlets. Once the Qingpu facility comes online, we will have the capacity to accommodate new orders as scheduled, which will begin contributing to our financial results in the fourth quarter of fiscal 2010."
China-Biotics, Inc., a leading manufacturer of biotechnology products and supplements, engages in the research, development, marketing and distribution of probiotics dietary supplements.
Shares were up in the after hours session $1.10 or 8.30% to $14.34.
Other news after the market closed:
Hanger Orthopedic Group, Inc. (NYSE: HGR) jumped after the bell as the company announced net sales of $205.1 million for the quarter ended December 31, 2009, an increase of $19.6 million, or 10.6%, from $185.5 million in the prior year. Earnings per share for the fourth quarter of 2009 were $0.37 per diluted share compared to proforma earnings per diluted share of $0.26 for the same period in 2008, a 42.3% increase. "The year 2009 presented a challenging environment due to the uncertainty surrounding proposed changes to federal health care regulations and reimbursement and the impact of the ongoing recession. In spite of these challenges, we delivered record sales, profits and cash flows," commented Thomas F. Kirk, President and Chief Executive Officer of Hanger Orthopedic Group. Mr. Kirk added, "The combination of an 8.1% increase in revenue and a focused effort on expense management generated an 80 basis point improvement in our operating margin. I am proud of our employees' efforts in 2009 and I am optimistic about our opportunities in 2010."
Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative drug discovery and development company, announced after the market closed that it has commenced clinical development of its fourth internally discovered drug candidate, IPI-940, a novel inhibitor of the enzyme fatty acid amide hydrolase, or FAAH. In addition, Infinity announced progression of its oncology programs consistent with its 2010 guidance, and 2009 financial results.
"We believe we are well positioned to show the impact that all four of our clinical candidates can have in patients' lives," added Adelene Q. Perkins, president and chief executive officer. "Infinity is financially strong, with a cash runway into 2013. We remain focused on using this strength to continue building Infinity's product pipeline through investment in internal and potential external opportunities."
In news from earlier in the day:
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation (NYSE: BVF), to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. "We are very excited to be partnering our lead program with Biovail. Their key strategic focus and their CNS commercial plans match our view of an ideal partner for AZ-004," said Thomas B. King, Alexza President and CEO. "We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients' desire for quickly and comfortably gaining control of their agitation, and the clinicians' goal of rapidly and reliably calming an agitated patient.
Angeion Corporation (NASDAQ: ANGN) today announced that it will release its fiscal 2010 first-quarter results on Wednesday, February 24, 2010, at market close.
A.P. Pharma, Inc. (Nasdaq:APPA) shares jumped 17.85% or $.29 to close at $1.99 on heavy volume and no apparent news. A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s primary focus is on its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The New Drug Application (NDA) for APF530 was submitted to the U.S. Food and Drug Administration (FDA) in May 2009 and accepted for review in July 2009, at which time the FDA set a Prescription Drug User Fee Act (PDUFA) date of March 18, 2010.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the United States Patent and Trademark Office (USPTO) has issued the Company a new patent for its lead drug candidate Zenvia™ (dextromethorphan/quinidine), extending the period of patent protection in the United States into late 2025. U.S. patent number 7,659,282 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" was issued on February 9, 2010.
BioClinica™, Inc. (NASDAQ: BIOC), a global provider of clinical trial services, today announced its financial results for the quarter and year ended December 31, 2009.
BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere” or the “Company”) - the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy – today reported financial results for the three and 12 months ended December 31, 2009.
Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc. BLS has acquired the U.S. and Canadian rights to commercialize AZ-004 – a novel formulation of loxapine administered via deep lung inhalation using Alexza’s proprietary Staccato® device. AZ-004 is initially targeted for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
Candela Corporation, a Syneron company (Nasdaq: ELOS), announced today that the SFDA (State Food and Drug Administration) of China has approved the Alex TriVantage® multi-wavelength, Q-switched laser system and the GentleMax® multiple wavelength workstation for sale throughout the People's Republic of China, including Hong Kong. The receipt of the SFDA Certificates will allow Candela to begin the sales process and launch official marketing programs for these products, creating a host of new market opportunities.
Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial. Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.
Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced the commercial launch of a new lung cancer test, Clarient Insight® Dx Pulmotype® Test, that helps physicians classify specific types of lung cancer to identify which therapies may be most effective. The new test has been clinically validated to use in the sub-classification of patients with non-small cell lung cancer (NSCLC), which accounts for approximately 85 percent of the more than 200,000 lung cancer cases diagnosed each year.
"Pulmotype provides pathologists with a valuable new tool to help their oncologist clients understand which patients are eligible for a number of new therapies now available for the treatment of NSCLC," said Chief Executive Officer Ron Andrews. "Its ability to accurately sub-classify lung cancer will enable physicians to make much more informed and effective therapy decisions. We have built a very strong breast cancer franchise and established Clarient as the 'go-to' laboratory for complex breast cancer testing. Pulmotype allows us to offer a similar compelling reason for pathologists and oncologists faced with critical decisions in lung cancer to send the primary tumor samples to Clarient. Having the lung cancer sample in our hands at the beginning of the diagnostic process allows us to assist the pathologist and the oncologist throughout the patient care process by delivering information on additional molecular markers, such as EGFR mutation and KRAS."
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that a medicinal chemistry paper related to the discovery of CUDC-101, Curis’s HDAC, EGFR and Her2 inhibitor, was published online in the Journal of Medicinal Chemistry and also will be published in an upcoming print version of the journal. The paper describes the structure-based rational drug design, synthesis and structure-activity relationship (SAR) of a class of novel compounds that included CUDC-101 and the identification of CUDC-101 as a clinical candidate. Related in vitro and in vivo data associated with these compounds are also included.
Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Wednesday, February 17, 2010, to discuss its financial results and company progress for the fourth quarter and year ended December 31, 2009.
Genta Incorporated (OTCBB: GETA) announced that it has received $2.8 million in non-dilutive cash proceeds from the sale of net operating tax losses and research tax credits generated in prior tax years as part of the Technology Business Tax Certificate Program sponsored by the New Jersey Economic Development Authority (NJEDA), pursuant to the rules, regulations and stipulations set forth by the program.
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.
All of the 124 patients in the study had pre-existing coronary artery disease, were taking a maximally tolerated dose of a statin and in many cases additional lipid-lowering drugs. Patients’ average LDL-C at baseline was 150 mg/dL. Patients treated with mipomersen had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing therapeutic regimens.
“The average reduction in LDL-C of 28 percent in these high-risk, difficult-to-treat patients with severe inherited high cholesterol is very encouraging,” said Evan A. Stein, M.D., Ph.D., Director of the Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, and an investigator on the study. “The nearly 50 mg/dL additional decrease in LDL-C when added to maximally tolerated statin therapy is above what we have seen with any other agent in this population, and the side effect profile of mipomersen continues to be acceptable.”
But shares of both companies fell with Isis getting hit particularly hard as it dropped 18.66% as a possible signal of liver toxicity seen in prior trials re-emerged.
Health Discovery Corporation (OTCBB: HDVY) as reported earlier today on BioMedReports announced 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 provide clinical specimens to be utilized to complete the final validation of HDC's molecular diagnostic test for colon cancer. This test demonstrated a 93% Sensitivity and a 93% Specificity in a previous validation study.
Today’s announcement is in addition to last week’s press release announcing a new collaboration with the Pancreas, Biliary and Liver Surgery Center of New York related to the discovery of a new molecular diagnostic test for pancreatic cancer.
There are an estimated 1.2 million new cases of colorectal cancer worldwide and approximately 637,000 deaths from the disease.
“We are very excited about the results of our previous validation study and look forward to achieving the same success in this final validation," said Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation. “If we are successful in finding the molecular signature in blood as we were in tissue, HDC will have both a tissue-based colon cancer test to be used on biopsy specimens as well as a blood test which can be used as a screening test for colon cancer,” said Dr. Barnhill.
Under the terms of the agreement, the Pancreas, Biliary and Liver Surgery Center of New York will provide specimens from their collected specimen banks, as well as blood and tissue specimens on all new patients along with all associated clinical and outcomes data.
Health Discovery Corporation owns all of the intellectual property and commercialization rights to this molecular diagnostic test for colon cancer and HDC intends to partner with a large clinical laboratory for development, marketing and commercialization of this new colon cancer test.
In developing this new molecular diagnostic test for colon cancer, Health Discovery Corporation employed the same discovery process that led to the urine-based prostate cancer test that is licensed for development and commercialization to Quest Diagnostics (NYSE: DGX ) and Abbott (NYSE: ABT) on a royalty-based, world-wide co-exclusive basis.
Hythiam, Inc. (NASDAQ:HYTM) announced today that the results of a double-blind, placebo-controlled study on the impact of the medical component of the PROMETA® Treatment Program on methamphetamine dependent subjects were published in the Journal of Psychopharmacology, a peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides a forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The article was recently released and is titled, “A Controlled Trial of Flumazenil and Gabapentin for Initial Treatment of Methylamphetamine Dependence,” Urschel III, Harold C., Hanselka, Larry L., and Baron, Michael, J Psychopharmacol OnlineFirst, November 25, 2009, doi:10.1177/0269881109349837. The results of the 30-day study were analyzed on an intent-to-treat basis that included all randomized participants, and missing days were counted as positive for methamphetamine use. The final data demonstrated that the medical component of the PROMETA Treatment Program achieved a statistically significant reduction in the combined craving score for methamphetamine when compared to placebo, and that craving was a significant predictive factor for subsequent drug use.
The results are the first to be published in a peer-reviewed scientific journal from a double-blind, placebo-controlled study conducted to assess the impact of the PROMETA Treatment Program on methamphetamine dependence.
Lung Rx, LLC, a wholly-owned subsidiary of United Therapeutics Corporation (Nasdaq: UTHR), announced today that it has entered into a Development Agreement with ImmuneWorks, Inc. to pursue development of ImmuneWorks' lead compound, IW001, a purified bovine Type V Collagen oral solution for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and Primary Graft Dysfunction (PGD) in patients receiving lung transplant. The parties expect to commence human clinical testing in 2010. In November 2009, the U.S. Food and Drug Administration granted orphan drug exclusivity to IW001.
MDS Inc. (TSX: MDS; NYSE: MDZ), a leading provider of products and services to the global life sciences markets, today announced that it has signed agreements to divest its remaining MDS Pharma Services Early Stage business, which provides Discovery through Phase IIa clinical trial services to biotechnology and pharmaceutical companies, for $45 million and certain minority equity interests. The $45 million purchase price includes a five-year, $25 million note and $20 million in cash that will be adjusted for working capital and other items; after currently projected adjustments, the $20 million cash payment is estimated to result in net cash proceeds of approximately $7 million.
At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.
NMT Medical, Inc. (NASDAQ: NMTI) today announced that it expects to report full year 2009 revenues of approximately $13.2 million – within the Company’s previously-announced guidance range of $13 million to $14 million.
NeuroMetrix, Inc. (Nasdaq: NURO), a health care company transforming patient care through neurotechnology, today announced its financial results for the three months and year ended December 31, 2009.
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval of its USB cellular adaptor for the [email protected]™ transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new USB adaptor allows patients using a [email protected] transmitter to transfer data to their physician over the cellular network, in addition to the existing landline service previously available.
“The USB cellular adaptor allows patients who frequently travel or relocate to be free of the restrictions of a traditional telephone line,” said Dr. Helen Høgh Petersen, of Rigshospitalet in Copenhagen, Denmark. “This addition to the remote monitoring system helps to ensure that patients can stay connected with their device follow-up clinic wherever they may live or travel.”
StemCells, Inc. (Nasdaq:STEM) announced today that its proprietary HuCNS-SC® human neural stem cells have been used to treat the first patient enrolled in its Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that afflicts male children. The stem cells were administered yesterday at the University of California, San Francisco (UCSF) Children's Hospital by direct injection into the brain of a patient with connatal PMD, the most severe form of the disease.This marks the first time that neural stem cells have been transplanted as a potential treatment for a myelination disorder, and the second clinical trial involving the use of HuCNS-SC cells in a neurodegenerative disease.
Strategic Diagnostics Inc. (Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, today announced it will be doing business as SDIX (Strategic Diagnostics Inc. d/b/a SDIX).
Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) will release its fourth quarter and full year 2009 financial results on February 23, 2010, after the stock market closes, and will host a conference call at 8:30 AM Eastern Time on February 24, 2010.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it will release its fourth quarter financial results on February 22, 2010 at approximately 4:30 p.m. Eastern Time.
YM BioSciences Inc. (Amex: YMI, TSX:YM), announced that it has been granted two additional patents in the US for AeroLEF(R), the Company's proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe acute pain. US patent numbers 7,648,981 and 7,648,982 extend the life of YM's AeroLEF patent estate in the US to 2024. The Company also announced that AeroLEF's patent estate has expanded to include other territories with the issuance of European patent number 1,603,533 and several patent allowances in China, India, Mexico and other territories.
"These patents strengthen and extend the patent protection for AeroLEF in the US, and also expand the global market for this unique and potentially first in class product," said David Allan, CEO of YM BioSciences. "The scientific pedigree and unique advantages of this product have been established and its safety and efficacy have been demonstrated in numerous clinical trials. AeroLEF has met all endpoints in each of its trials including a randomized Phase II trial and is currently being prepared for late-stage development internationally."
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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