|Aeterna Zentaris and Keryx receive positive EMA advice on perifisone trial. EpiCept submits NDA for leukemia maintenance drug. After the bell: Cubist reports urinary tract drug hits study goals|
|By BioMedReports.com Staff|
|Tuesday, 29 June 2010 18:09|
Below is a list of the companies that made news in the healthcare sector on Tuesday, June 29, 2010.
Cubist Pharmaceuticals, Inc.(NASDAQ: CBST), a leading acute care therapeutics company, today after the market close announced that the recently-completed Phase 2 study of CXA-101, a novel cephalosporin, compared to ceftazidime for the treatment of complicated urinary tract infections (cUTI) in adults met its study objectives. Cubist is developing CXA-201 as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections in the hospital, including those caused by multi-drug resistant Pseudomonas aeruginosa. CXA-201 is a combination of CXA-101 and the beta-lactamase inhibitor tazobactam. Cubist acquired rights to CXA-101, and products which incorporate CXA-101, through its purchase of Calixa Therapeutics Inc. in December 2009.
The study met its objectives of assessing safety and efficacy of CXA-101 in comparison to ceftazidime. CXA-101 additionally demonstrated favorable microbiological and clinical outcomes at the Test of Cure Visit, 6 – 9 days after end of therapy, which were the primary and secondary outcome measures in this study, respectively.
Cubist’s Chief Medical Officer, Santosh Vetticaden, PhD, MD said, "We are pleased with the results of this trial, which provide information that we intend to utilize in developing appropriate Phase 3 registration studies for CXA-201 in cUTI in consultation with the FDA."
EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, after the market closed announced that its Board of Directors has approved a 1-for-6 reverse split of its common stock, to be effective upon the close of trading on July 9, 2010. The reverse split is part of the Company's plan to regain compliance with the $1.00 minimum bid price required for continued listing on the NASDAQ Capital Market. The Company's common stock will begin trading on a split adjusted basis on the NASDAQ Capital Market when the market opens on July 12, 2010.
MELA Sciences, Inc. (NASDAQ:MELA) after the bell today announced its intention to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. The Company also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. The Company intends to use the net proceeds from the sale of the shares to fund the pursuit of its pre-market approval application (PMA) for MelaFind®, the continued development and, if and when approved by the U.S. Food and Drug Administration (FDA), the commercialization of MelaFind®, and for general corporate purposes, including working capital.
TomoTherapy Incorporated (NASDAQ:TOMO), after the bell the maker of advanced radiation therapy solutions for cancer care, announced that it has signed an equipment supply group purchasing agreement with Premier Purchasing Partners, L.P., the group purchasing unit of Premier Inc. The agreement provides TomoTherapy greater reach into Premier's not-for-profit hospitals and health centers, which includes 2,300 U.S. hospitals and more than 67,000 other healthcare facilities, while enabling Premier members to access special pricing and terms for innovative radiation oncology solutions and establishing a streamlined purchasing solution for them.
TomoTherapy's radiation therapy solutions enable high treatment quality for a broad patient population, with capabilities to treat cancers throughout the body.
In news from earlier in the day Tuesday:
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer. The trial is being sponsored by Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ:KERX), Aeterna Zentaris' licensee for perifosine in North America. Aeterna Zentaris has also out-licensed rights for perifosine to Handok for South Korea while retaining rights for the rest of the world. The Scientific Advice from the EMA indicates that the ongoing study, in conjunction with safety data generated from other clinical studies with perifosine, is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in advanced colorectal cancer. Therefore, the Company does not intend to initiate any additional study with perifosine for this indication.
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission. Ceplene was approved for this indication by the European Commission in October 2008 and is currently available in the United Kingdom, Germany and Austria. Ceplene is expected to be available throughout most of the European Union within twelve months.
In its application, EpiCept requested priority review of the NDA. If granted, priority review should result in an FDA decision date in late December 2010. A decision with respect to the granting of priority review must be made within 45 days of the filing date. Ceplene has been granted orphan drug status in the United States, providing seven years’ marketing exclusivity from the NDA approval date.
"This filing is a very important milestone in our strategy for Ceplene, and we are delighted to submit the NDA consistent with the timetable we publicly announced," stated Jack Talley, President and Chief Executive Officer of EpiCept. "There are an estimated 9,000 deaths caused by AML each year in the U.S. with no effective maintenance therapy currently available. We believe that Ceplene, if approved, would favorably impact the prognosis of patients with this lethal disease."
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study. ALN-TTR01 is a systemically delivered RNAi therapeutic being developed for the treatment of transthyretin (TTR)-mediated amyloidosis, a hereditary disease caused by a genetic mutation.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.
Dr. Reddy’s Laboratories (NYSE:RDY) today announced that it has launched anastrozole tablets, (1mg), a bioequivalent generic version of Arimidex® (anastrozole tablets) in the US market on 28 June 2010.
Arimdiex® had annual sales ending April 2010 of $927 million in the United States.
Hythiam, Inc. (OTCBB:HYTM) as reported earlier today on BioMedReports, announced today that the Company has entered into a multi-year agreement with Health Plan of Nevada, Inc., a UnitedHealthcare® company and a leading health insurer in Nevada, to provide the Catasys® integrated substance dependence solution to its enrolled members. UnitedHealthcare is one of the largest health benefit plan providers in the United States.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the peer-reviewed journal Molecular Therapy has published a paper entitled "IL-28B/IFN-lambda3 Drives Granzyme B Loading and Significantly Increases CTL Killing Activity in Macaques."
The paper, co-authored by researchers from Inovio and collaborators from University of Pennsylvania School of Medicine, notes that co-delivery of Inovio’s immunoadjuvant, a DNA plasmid encoding interleukin (IL)-28B, with an Inovio optimized SynCon™ DNA vaccine using its proprietary electroporation (EP) technology significantly enhanced antigen-specific killer T cell responses in rhesus monkeys.
Micromet, Inc. (Nasdaq:MITI), today announced the publication of pre-clinical data in the Proceedings of the National Academy of Sciences (PNAS), demonstrating the potency of new product candidates based on the Company's proprietary BiTE® antibody technology. BiTE antibodies are a new class of agents designed to harness a patient's T cells to kill cancer cells.
Results published in PNAS characterize new BiTE antibodies generated to target epidermal growth factor receptor 1 (EGFR), a protein expressed on the surface of most solid tumors. An EGFR-directed BiTE antibody based on cetuximab demonstrated potent anti-tumor activity against cetuximab-resistant tumors in animal models. Unlike the monoclonal antibody cetuximab, the cetuximab-based BiTE antibody did not show evidence of skin toxicity usually attributed to anti-EGFR therapies.
NeoStem, Inc. (NYSE Amex: NBS) as reported earlier today on BioMedReports, today announced that its 51% owned Suzhou Erye pharmaceutical unit in China passed government inspection by that country's State Food and Drug Administration and is now fully functional ready to produce penicillin and cephalosporin powder for injection.
Omeros Corporation (Nasdaq:OMER) today announced that it has successfully identified compounds that interact with three orphan G protein-coupled receptors (GPCRs) linked to cancer, metabolic disorders and appetite control. This breakthrough demonstrates Omeros' unique capability to introduce a large number of new drug targets to the pharmaceutical industry, which could lead to the development of novel therapeutics across a wide range of diseases and disorders. GPCRs represent the premier family of drug targets, with more than 30 percent of currently marketed drugs targeting only 46 GPCRs. There are approximately 120 orphan GPCRs, and Omeros expects to unlock a large percentage of these for drug development.
GPCRs, which mediate key physiological processes in the body, are the most valuable family of drug targets. Annual worldwide drug sales exceed $700 billion and, according to Insight Pharma Reports, GPCR-targeting drugs represent 30 to 40 percent of marketed pharmaceuticals. Examples include Claritin® (allergy), Vicodin® (pain), Lopressor® (high blood pressure), Imitrex® (migraine headache) and Reglan® (nausea) as well as all other antihistamines, opioids, alpha and beta blockers and serotonergics.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex® Tablets, a treatment for early breast cancer.
Anastrozole Tablets had U.S. sales of approximately $917 million for the 12 months ending March 31, 2010, according to IMS Health. The product is available for immediate shipment.
Perrigo (Nasdaq: PRGO; TASE) today announced that it has acquired the exclusive U.S. store brand rights to sell and distribute OTC versions of Fexofenadine HCl 180 mg and 60 mg tabs, plus Fexofenadine HCl 60 mg and Pseudoephedrine 120 mg tabs, the generic versions of Sanofi-Aventis' Allegra and Allegra D-12 products. Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) currently has Rx approval for these products, and Teva and Sanofi-Aventis have settled their Paragraph IV/Hatch-Waxman litigation.
Allegra 180 mg, 60 mg, and Allegra D-12 are indicated for the relief of symptoms associated with seasonal allergies. Sanofi-Aventis has applied to the FDA for the Rx-to-OTC switch of these drugs. Prior to generic competition entering the Fexofenadine Rx market in 2005, Allegra 180 mg and 60 mg had combined annual sales of approximately $1.5 billion, and in 2009, Allegra D-12 had annual sales of $600 million according to data provided by Wolters-Kluwer.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's strategic focus on making quality healthcare more affordable to American consumers by introducing new Rx-to-OTC switch products."
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences (NASDAQ:ALIM) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Iluvien® for Diabetic Macular Edema. Iluvien, developed by pSivida and licensed to Alimera Sciences in 2005, is a sustained release drug delivery system releasing the steroid flucocinolone acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year.
Dr. Paul Ashton, President and CEO of pSivida, said, "There are currently no drugs approved to treat DME, one of the leading causes of vision loss. Iluvien’s clinical trials have demonstrated that Iluvien can significantly improve vision in DME patients."
Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced positive Phase 2 clinical data from its ZFP Therapeutic™ program to develop SB-509 as a treatment for diabetic neuropathy (DN) at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA), held in Orlando, FL from June 25-29, 2010. Data from Sangamo's SB-509-601 and SB-509-701B Phase 2 clinical trials demonstrated that SB-509 treatment resulted in clinically beneficial improvements in subjects with moderate and severe DN as compared to placebo. The data, which were described in three oral presentations, provided direct histological evidence of SB-509's dual effect on both blood vessel and nerve growth and validated the strategy of the use of multi-endpoint disease severity criteria that have been established for enrollment into the company's ongoing Phase 2b trial in subjects with moderately severe DN.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today U.S. Food and Drug Administration approval of Venlafaxine HCl ER Capsules, the Company’s generic version of Wyeth’s antidepressant Effexor XR®. Shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth.
As the first company to file an Abbreviated New Drug Application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
The brand product had annual sales of approximately $2.75 billion in the United States, based on IMS sales data.
Uroplasty, Inc. (NYSE Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, announced today that it has been approved for listing on the NASDAQ Capital Market under the symbol "UPI."
Trading on the NASDAQ Capital Market is expected to commence on July 12, 2010. The Company's common stock will continue to trade on AMEX until the market close on July 9, 2010.
"We are pleased to announce the Company's listing on the NASDAQ Capital Market," commented David Kaysen, President and Chief Executive Officer. "We believe the move to NASDAQ will improve the visibility of our stock, enhance trading liquidity in our shares, and provide the Company with greater exposure to institutional investors."
Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board:AOLS) reported that researchers from National Jewish Health and the University of Colorado Anschutz Medical Campus have completed studies demonstrating that AEOL 10150 provides statistically significant protection of the skin in the 2-chloroethyl-ethylsulfide (CEES; half mustard) model of mustard gas exposure in mice and in a human cell culture model.
Agilent Technologies Inc. (NYSE:A) and the Agilent Foundation today announced that Professor Pauline Rudd has received an Agilent Thought Leader Award in support of her emerging glycomics research.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today provided a regulatory and clinical update for Feraheme® (ferumoxytol) Injection for intravenous (IV) use.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the company has been added to the Russell 2000® Index, as part of the annual reconstitution of the entire Russell family of indexes that took place on June 25, 2010 following the close of the market.
BioElectronics Corporation (PINKSHEETS: BIEL), developers of innovative pain-relieving medical devices, announced today that its Allay™ Menstrual Pain Therapy product has been approved for over the counter sale by Health Canada for the treatment of menstrual pain symptoms, including cramps and abdominal pain, and for reducing the use of pain medication associated with menstruation, while ActiPatch™ is now approved by the South Korea Food and Drug Administration (KFDA) for reduction of muscle pain.
Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) will present on its proprietary CyPath® diagnostic assay for the detection of early-stage cancers at OneMedPlace's mid-year finance forum in New York on Wednesday, June 30, 2010.
China Cord Blood Corporation (NYSE:CO) today announced that it joined the Russell Global Index after the market close on Friday, June 25, 2010.
CorMedix Inc. (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced that CorMedix has been added to the broad-market Russell Microcap® Index when Russell Investments reconstituted its comprehensive set of U.S. and global equity indexes on June 25, 2010.
Covidien plc (NYSE: COV) will report third-quarter results before trading begins on July 29, 2010. The Company will hold a conference call for investors at 8:30 a.m. ET.
Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ) announced today that APP Pharmaceuticals will immediately begin marketing Anastrozole tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited (NSE:FKONCO) (BSE:532545).
King Pharmaceuticals, Inc. (NYSE: KG) announced today a modification to its strategic alliance with Pain Therapeutics, Inc. (NASDAQ: PTIE) for REMOXY®.
Omnicell, Inc., (Nasdaq: OMCL) a leading provider of system solutions to acute healthcare facilities, today announced that its OmniCenter® server has achieved VMware Ready™ status.
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced company Chairman and CEO Robert Weiler has received the Ernst & Young Entrepreneur Of The Year® 2010 Award in the Healthcare IT category in New England.
PPD, Inc. (Nasdaq: PPDI) today announced it will ring the Nasdaq Stock Market Opening Bell on July 1 at 9:30 a.m. ET to commemorate PPD's history as one of the world's leading contract research organizations.
Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced that the Company plans to launch a new biopharmaceutical product, Ginseng and Deer Antler Extract in August 2010.
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