|RxNews Recap for Monday 04-05-10. Keryx and Aeterna Zentaris jump after FDA fast track designation. NeurogesX moves higher on shingles-pain patch|
|By BioMedReports.com Staff|
|Monday, 05 April 2010 19:59|
Below is a list of the companies that made news in the healthcare sector on Monday, April 05, 2010.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) soared today after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a Special Protocol Assessment (SPA) with the FDA.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "We believe that this Fast Track designation adds substantial value to perifosine's development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011. With the SPA and Fast Track designation in place, we believe that commercialization of perifosine in this indication could potentially commence by mid-2012." In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track designation granted.
Shares of Keryx shot up more than 22% or 61 cents, closing the day at $3.35.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna Zentaris, commented, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012. These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."
Shares of Aeterna Zentaris rose more than 19% on the news, moving up 15 cents to close the day at 95 cents.
NeurogesX, Inc. (Nasdaq:NGSX) moved higher after the company reported that Qutenza® (capsaicin) 8% patch, the first and only product containing prescription-strength capsaicin, is now available. Clinical studies have shown that a single one-hour Qutenza application can provide three months relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles. In November 2009, Qutenza was approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with PHN. Qutenza, the first product from NeurogesX, is now available through selected specialty distributors and a specialty pharmacy.
Wedbush Morgan Securities analyst Gregory Wade said in a research note: "At $10 per share the market capitalization of NeurogesX is $177 million, a level which appears to us to overly discount the likelihood for commercial success for the product," Wade also said that he would not be surprised to see NeurogesX stock trade closer to $20 over the coming 12 months.
Shares traded as high as $10.57 Monday, pulling back later in the day to close at $9.42, up 81 cents or 9.41%. The stock continued to trade higher in the after hours session.
After the market closed Monday:
Cephalon, Inc. (Nasdaq:CEPH) announced that it has completed its previously announced acquisition of biotechnology company Ception Therapeutics, Inc. and that Ception is now a wholly-owned subsidiary of Cephalon.
Cephalon Chairman and CEO Frank Baldino Jr., Ph.D., said "We are fortunate to have the opportunity to advance CINQUIL™ (reslizumab) into Phase III studies for patients with eosinophilic asthma. CINQUIL, in addition to our other biologics, peptides and small molecule compounds, provides Cephalon with a robust pipeline of opportunities to bring new therapies to patients over the next several years."
Nabi Biopharmaceuticals (Nasdaq:NABI) announced that the European Patent Office (EPO) upheld the Company's opposition to European Patent No. 1,329,226 (Hapten Carrier Conjugates for Use in Drug Abuse Therapy) requesting revocation of this patent. The EPO revoked this patent in its entirety.
The patent was filed by Xenova Research Limited, which was subsequently acquired by Celtic Pharma in 2005. On February 15, 2008, Nabi, along with four other parties, filed an opposition against this patent, requesting revocation of the Xenova patent in its entirety. As a result of this EPO decision, Celtic Pharma has lost its exclusive patent rights to nicotine conjugate vaccine technology in Europe. Xenova Research Limited, still named as the proprietor of the patent, has the opportunity to file a Notice of Appeal within a period of two months from the March 29, 2010 date of the EPO written decision.
In news from earlier Monday:
CareFusion Corp. (NYSE:CFN), a leading, global medical device company, today announced an agreement to acquire privately held Medegen, a leading innovator in clinically differentiated needleless access valves and administration sets that deliver intravenous (IV) medication to patients, for $225 million in cash. "Medegen is an ideal strategic fit with CareFusion due to the complementary nature of our infusion product lines, R&D investments, and our focus on products that are backed by clinical evidence and differentiation," said David Schlotterbeck, chairman and CEO of CareFusion. "With a global opportunity of more than $2 billion for disposable IV sets, Medegen will expand our clinically differentiated product line and add a new dimension to our existing infection prevention portfolio. We will continue to invest in these products to help hospitals reduce catheter-related blood stream infections and catheter occlusions." Medegens products have been shown to reduce catheter-related infections by up to 70%. CareFusion became a public company in September 2009 after it was spun off from Cardinal Health ( NYSE:CAH).
China Biologic Products, Inc. (Nasdaq:CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced that its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., has been recognized as one of Shandong's National Centers of Excellence for New Drug and Technology Development by the Department of Science and Technology of Shandong Province.
Edwards Lifesciences Corporation (NYSE:EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that a federal jury today found that Edwards' U.S. Andersen transcatheter heart valve patent is valid and that Medtronic CoreValve LLC willfully infringes it. Edwards will move vigorously to enforce this verdict and intends to seek a permanent injunction. The jury also awarded Edwards $74 million in damages, and the willfulness finding allows Edwards to seek increased damages of up to three times that amount. Medtronic, Inc. (NYSE:MDT), announced today that it will appeal the jury verdict.
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced the execution of multiple commercial supply agreements with its existing manufacturing partners. Halozyme amended an existing commercial supply agreement with Avid Bioservices, Inc., entered into a new commercial supply agreement with Avid and entered into a new commercial supply agreement with Cook Pharmica LLC. These three agreements are expected to cover the commercial production of recombinant human hyaluronidase (rHuPH20) to be used in the manufacture of both current products as well as certain partnered product candidates such as subcutaneous Herceptin® and GAMMAGARD® with rHuPH20. Subcutaneous Herceptin and GAMMAGARD with rHuPH20 are both currently in Phase 3 clinical trials.
MDRNA, Inc. (NASDAQ:MRNA), moved higher today after announcing a study effort with Pfizer (NYSE:PFE - News). The relationship will focus on the evaluation of MDRNA's proprietary di-alkylated amino acids (DiLA2) platform and UsiRNA constructs for RNA interference (RNAi). MDRNA will be responsible for formulating Pfizer's oligonucleotides in DiLA2 formulations for in vivo preclinical evaluation to be performed at Pfizer. Additionally, MDRNA's research team will design and synthesize UsiRNAs directed against targets specified by Pfizer.
"We are extremely pleased to be working with Pfizer, a world leader in the pharmaceutical industry," said Michael French, President and CEO of MDRNA. "As Pfizer has made a commitment to the research and development of RNAi therapeutics, this is a significant opportunity for MDRNA to again demonstrate the broad capabilities of its world-class research team and proprietary drug discovery engine for RNAi-based therapeutics." Shares moved up more than 9% on heavy volume and continued to move forward after the bell.
Micro Identification Technologies, Inc. (OTC.BB:MMTC) announced that effective on March 31, 2010 it concluded a $500,000 Convertible Redeemable Private Placement that was introduced on November 18, 2009. The prospective investors were Accredited Investors (as defined in Regulation D promulgated under the Act) and their total investment in the Placement did not exceed 10% of any investor's net worth. This equity financing was offered solely by the Company. Micro Identification Technologies was profiled today, here on BioMedReports as a spectulative play.
National Dentex Corporation (NASDAQ: NADX), soared today after the owner/operator of dental laboratories in North America, announced that it has entered into a definitive agreement and plan of merger to be acquired by GDC Holdings, Inc. (GDC), which is a holding company of GeoDigm Corporation (GeoDigm), a technology based manufacturing and laboratory company and a portfolio company of Welsh, Carson, Anderson & Stowe XI, L.P. (Welsh Carson).
Under the terms of the merger agreement, National Dentex’s shareholders will receive $17.00 in cash for each share of National Dentex common stock they hold, representing a premium of approximately 70% over National Dentex’s most recent closing share price of $10.02 on April 1, 2010.
NeoStem, Inc. (NYSE Amex: NBS), as reported earlier today on BioMedReports, moved higher today after the company announced that its Suzhou Erye Pharmaceutical subsidiary recently received approval from the State Food and Drug Administration (SFDA) in China to manufacture the sterile active pharmaceutical ingredient (API) of the anti-infective cloxacillin sodium. Cloxacillin sodium, a generic form Cloxapen, in finished dosage form is listed in China's National Medical Reimbursement Insurance List and thus is eligible for reimbursement by the government's healthcare programs.Robin Smith, commented, "Cloxacillin sodium is the second of seven drugs in Erye's pipeline to be approved since the acquisition of our 51% interest in Erye and is an important addition to the company's product offerings.
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) today announced the publication of data showing phosphatidylserine (PS)-targeting antibodies can block one of the key ways the AIDS virus gains entry into certain blood cells. The data were generated by scientists at Duke University as part of their ongoing AIDS vaccine research. The article titled "Anti-Phospholipid Human Monoclonal Antibodies Inhibit CCR5-Tropic HIV-1 and Induces Beta-Chemokines" is available online today and will be published in the April 12, 2010 edition of the Journal of Experimental Medicine. Peregrine's PS-targeting antibodies are currently in clinical development for the treatment of cancer and HCV infections. Also, in a separate release today the company announced that Avid Bioservices, Inc., a wholly-owned subsidiary of Peregrine, has expanded its commercial supply relationship with Halozyme Therapeutics, Inc. with new manufacturing agreements. The companies have also entered into a long-term strategic relationship with Halozyme designating Avid a preferred supplier for future products requiring Avid's process development and biomanufacturing capabilities and expertise.
PharmAthene, Inc. (NYSE Amex: PIP), surged today after the biodefense company developing medical countermeasures against biological and chemical threats, today announced the appointment of Thomas R. Fuerst, Ph.D., as the company's Senior Vice President, Chief Scientific Officer. In this newly created role, Dr. Fuerst will oversee PharmAthene's research and development programs and provide strategic scientific direction for the Company. Prior to joining PharmAthene, Dr. Fuerst was Director, Vaccines and Biologics (2004-2007), and Senior Science and Technology Advisor (2007-present) for the U.S. Department of Health and Human Services (HHS). In these positions, he led the development and acquisition of vaccines and biotherapeutic products for biodefense and other emerging public health threats, including anthrax, smallpox, botulism, and pandemic flu. During his tenure at HHS, Dr. Fuerst helped establish the Biomedical Advanced Research and Development Authority (BARDA) and oversaw the planning, implementation, and monitoring of medical countermeasure development and acquisition, while managing a budget of approximately $3.0 billion.
Repros Therapeutics Inc. (NasdaqCM:RPRX) moved higher today after they announced that the company has requested a lift of the full clinical hold on its oral drug Proellex® being developed for the treatment of uterine fibroids and endometriosis. On August 4, 2009, the FDA noted that further testing of Proellex® was placed on full clinical hold due to findings of serious adverse events associated with liver toxicity. Previously, on August 3, 2009, Repros unilaterally suspended its then-ongoing Proellex® studies. The company said today that it believes a smaller dose of the oral drug -- 12.5 milligrams or less -- would be safe and effective without the risk of side effects. It also said the side effects that were observed in the study -- liver damage and high levels of liver enzymes -- went away over time.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), as mentioned earlier today on BioMedReports, the company announced that it has submitted a Phase II protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin® for the treatment of Parkinson’s disease (PD). Shares at one point were up more than 20% on the news, then settled at $1.79, up 16 cents or 9.82% on the day.
Rosetta Genomics, Ltd. (NASDAQ:ROSG), moved higher today after the developer and provider of microRNA-based molecular diagnostics, announced today that starting April 1, 2010 physicians are able to send FNA cell block samples to Rosetta Genomics’ CLIA-certified and CAP-accredited laboratory in Philadelphia for analysis using Rosetta’s miRview squamous test. FNA is a less invasive method to obtain tumor cells compared with tumor resections or biopsies. This breakthrough will enable patients and physicians to benefit from a highly accurate diagnostic assay without having to undergo a more invasive procedure.
miRview squamous is a molecular diagnostic test that measures the expression level of a single microRNA to accurately differentiate squamous from non-squamous NSCLC. The test offers patients and physicians a highly accurate diagnostic tool that produces standardized and reproducible results.
Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that China's State Food and Drug Administration ("SFDA") issued a statement on its investigation into the human use rabies vaccine manufactured by Jiangsu Yanshen Biological Technology Stock Co., Ltd. Simcere obtained a controlling stake in Jiangsu Yanshen in October 2009. As a result of the investigation conducted by the local food and drug regulatory authority and local police department the SFDA found that the four batches of human use rabies vaccine, which were manufactured by Jiangsu Yanshen and released into the market between July and October 2008, had an insufficient amount of active compound. It was found that illegal activities were conducted at Jiangsu Yanshen, whereby inadequate quality control processes were in place, and there was misrepresentation and avoidance of regulatory inspection, which caused substandard vaccine to be released into the market.
Warner Chilcott plc (Nasdaq:WCRX) and Sanofi-Aventis (EURONEXT: SAN and NYSE: SNY) announced today an amendment to the Actonel® global collaboration agreement with respect to the parties' arrangement in the United States and Puerto Rico. Under the terms of the amendment, Warner Chilcott will take full operational control over the promotion, marketing and R&D decisions for Actonel in the United States and Puerto Rico, and will assume responsibility for all associated costs relating to those activities.
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the 17th Annual Future Leaders in the Biotech Industry conference on Thursday, April 8, 2010 at 3:00 p.m. eastern time.
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.