|Radiant surges on expanded partnership. AspenBio to delay 510k submission. Talecris Biotherapeutics soars on buyout. After the bell Depomed jumps on NDA acceptance|
|By BioMedReports.com Staff|
|Monday, 07 June 2010 18:42|
Below is a list of the companies that made news in the healthcare sector on Monday, June 7, 2010.
Depomed, Inc. (Nasdaq:DEPO) surged after the bell today after the company announced that the New Drug Application for DM-1796 was accepted by the U.S. Food and Drug Administration for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
"We are pleased the NDA was accepted for DM-1796. The acceptance triggers a $10 million milestone payment from our licensee," said Carl Pelzel, president and chief executive officer of Depomed. "We look forward to the approval of DM-1796, which we believe can provide significant clinical benefits to patients."
Shares of Depomed jumped nearly 11% or 32 cents in the extended session.
Hospira, Inc. (NYSE:HSP), a global specialty pharmaceutical and medication delivery company, and DURECT Corporation(Nasdaq:DRRX), today announced after the bell today that the companies have entered into a licensing agreement to develop and market DURECT's POSIDUR™(SABER™-bupivacaine) a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials. Hospira will co-develop the drug and would have exclusive marketing rights in the United States and Canada following regulatory approval.
Under terms of the agreement, Hospira will make an upfront payment of $27.5 million, with the potential for up to an additional $185 million in performance milestone payments based on the successful development, approval and commercialization of POSIDUR. For the U.S. and Canada, the two companies will jointly direct and equally fund the remaining development costs, while Hospira will have exclusive commercialization rights with sole funding responsibility. In addition, Hospira will pay DURECT a royalty on product sales.
In news from earlier in the day:
AspenBio Pharma, Inc. (NASDAQ:APPY) reported today that the Company is performing additional data analysis on its recently completed pivotal clinical trial. As a result, the submission of its 510(k) application for AppyScore with the Food and Drug Administration will not occur as previously anticipated by late June 2010. The Company has determined that additional data analysis is necessary, as there was unexplained variability in results from site to site in the initial draft of the statistical analysis report. The continued analysis of these data and related work is AspenBio's highest priority and, upon completion, the Company will provide additional information.
"There is significant variability among clinical sites that we must reconcile to fully understand the results," said Steve Lundy, AspenBio Pharma's President and Chief Executive Officer. "Our commitment is to conduct a rigorous data analysis and we will report on this analysis as soon as we are able."
AspenBio's stock plunged 53% on the news, dropping $1.81 to close Mondays trading session at $1.57.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today its partner Provista Life Sciences LLC (PLS), a diagnostics development and commercialization firm based in Phoenix, Arizona, is developing requisite clinical data through a validation study of DR-70 reagents for the introduction of RPC's Onko-Sure™ In Vitro Diagnostic (IVD) cancer test as a laboratory developed test for general cancer screening.
PLS has acquired more than 350 blood samples covering cancers ranging from breast to lung to uterine cancer for this landmark clinical study to demonstrate the diagnostic capabilities of the Onko-Sure test as a general cancer screening tool. The study is expected to be completed in June 2010.
According to William Gartner, President and CEO of Provista, "Provista is dedicated to developing new molecular diagnostics for early disease detection and we are extremely pleased to work with Radient on this particular study. Radient's Onko-Sure IVD cancer test is already US FDA-approved for colon-rectal cancer recurrence monitoring and has demonstrated high levels of accuracies in detecting other cancers as well. It is our hope that our study will also validate Onko-Sure as a general cancer screening tool."
Shares of Radiant surged nearly 11% on the news, moving up 13 cents to $1.35.
Talecris Biotherapeutics (Nasdaq:TLCR) today announced that they have signed a definitive agreement through which Grifols (GRF.MC), a global healthcare company and leading producer of plasma protein therapies, will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.
The combination of Grifols and Talecris will create a vertically integrated and diversified international plasma protein therapies company, bringing together complementary geographic footprints and products, as well as increased manufacturing scale. Grifols' leading global footprint will benefit from Talecris' strong presence in the United States and Canada. Grifols' available manufacturing capacity will enable Talecris to increase production in the near term. As a result, the combined company will be better able to meet the needs of more patients with under-diagnosed disease states around the world. Shares of Talecris surged more than 25% on the news, jumping $4.10 to $20.01.
Adeona Pharmaceuticals, Inc. (Amex:AEN) announced the completion of 50% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2). The CopperProof-2 study represents the first controlled clinical study of oral zinc cysteine for the dietary management of Alzheimer's disease and mild cognitive impairment.
Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it presented positive efficacy and safety data for its doxorubicin targeted conjugate compound, AEZS-108, in ovarian cancer. The presentation was made by Prof. Günter Emons, Chairman, Department of Obstetrics & Gynaecology Georg-August University Göttingen, Germany, during last Saturday's poster session at the American Society of Clinical Oncology meeting. AEZS-108 is currently in a Phase 2 trial conducted in Europe by the German AGO Study Group (Study AGO-GYN5), in advanced ovarian and endometrial cancer, with final results expected by year-end.
In a separate announcement the company today announced that Phase 1 data of perifosine (KRX-0401) in recurrent pediatric solid tumors was presented yesterday in the pediatric solid tumor poster discussion session held at ASCO. Perifosine is the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. This study, conducted by the Memorial Sloan-Kettering Cancer Center pediatric group, marks the first time that perifosine has been administered in a pediatric patient setting. Perifosine is also currently in Phase 3 trials in multiple myeloma and colorectal cancer, as well as in Phase 2 trials for multiple types of cancer.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data from an ongoing Phase 1 study of its investigational pan-BCR-ABL inhibitor, AP24534, in patients with resistant and refractory chronic myeloid leukemia (CML). The data confirm strong clinical evidence of hematologic, cytogenetic and molecular anti-leukemia activity of AP24534, a multi-targeted kinase inhibitor, in heavily pretreated patients with CML, including those with the T315I mutation of the target protein, BCR-ABL.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months. Additionally, PFS was similar between those patients who were treatment naïve, and those who had received prior therapy with cytokines and/or chemotherapy. These data are being presented today at the 46th Annual Meeting of the American Society of Clinical Oncology.
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA’s Office of Orphan Products Development.
"We continue to develop our vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center," said Stephen M. Simes, president and chief executive officer of BioSante. "Clinical trials of GVAX cancer vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. In addition, we recently announced reinitiation of the GVAX Prostate cancer vaccine program."
As previously reported, in a clinical study, the GVAX CML vaccine was administered to 19 CML patients with measurable cancer cells, despite taking Gleevec® for at least one year (range of 13-53 months). Each patient was given a series of four vaccines administered in three-week intervals while remaining on a stable dose of Gleevec. After a median of 72 months of follow-up, the number of remaining cancer cells declined in 13 patients, eight of whom had increasing disease burden before vaccination. Twelve patients reached their lowest levels of residual cancer cells to date following vaccination. Seven CML patients had complete remission. Patients receiving the GVAX CML vaccine experienced relatively few side effects that included injection site pain and swelling, occasional muscle aches and mild fevers.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the presentation of promising clinical data on CDX-011 in metastatic melanoma at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. The Phase 2 study has met its primary endpoint and the results support additional studies in this indication. CDX-011 is an antibody-drug conjugate (ADC) in Phase 2 development for the treatment of melanoma and advanced breast cancer. In addition, in a separate presentation today at ASCO, the Company presented the study design for its recently initiated Phase 2 trial of CDX-1307 in bladder cancer. CDX-1307 is an antibody-based cancer vaccine candidate and is being evaluated as a treatment for bladder cancer.
"Both CDX-011 and CDX-1307 have demonstrated tremendous potential for the treatment of the most difficult to treat cancers," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "Further development is warranted for both candidates and we look forward to reporting additional clinical data in the near future."
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced today that updated phase II study results of OPAXIO (paclitaxel poliglumex) in patients with advanced esophageal cancer demonstrated that 38% (15/40) patients receiving OPAXIO in combination with cisplatin and concurrent radiation achieved a pathologic or endoscopic complete response. A pathological complete response, observed in 32% of patients, is recorded only when the esophagus is surgically removed after therapy and no tumor can be found microscopically. In historical studies, pathologic complete response has correlated with prolonged survival. Pathologic complete response rates with the current U.S. standard regimen of 5FU + cisplatin chemotherapy with concurrent radiation for patients with esophageal cancer are approximately 15% with 40% of patients experiencing severe (grade 3-4) inflammation and ulcers in the esophagus and stomach necessitating tube feeding. The results were presented by Kimberly Perez, M.D., Warren Alpert School of Medicine, Brown University, at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. CTI plans to meet with the U.S. Food and Drug Administration in the second half of 2010 to explore a potential phase III registration study based on these results.
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that it has received a milestone payment from Fovea Pharmaceuticals, a division of Sanofi Aventis, relating to Fovea’s initiation of Phase 2b clinical testing of PrednisporinTM (FOV1101) in subjects with persistent allergic conjunctivitis. Prednisporin™ is a CombinatoRx-derived combination drug candidate that was exclusively licensed to Fovea by CombinatoRx. In addition to this $500,000 milestone, CombinatoRx will be eligible to receive further development and regulatory based milestone payments for Prednisporin of up to approximately $40.0 million and if commercialized, tiered royalty payments of up to 12% of net sales.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced today interim response data from a Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) that have failed hypomethylating agents. The data were presented at an oral poster discussion session at the 2010 American Society of Clinical Oncology .
CytRx Corporation (NASDAQ: CYTR) today announced the granting by the U.S. Patent and Trademark Office (USPTO) of U.S. Patent 7,728,131 for oncology drug candidate bafetinib, encompassing claims related to bafetinib’s pharmaceutical compound and composition in all indications, as well as for use in methods for treating acute and chronic myelogenous leukemia and acute lymphoblastic leukemia. The Issue Notification for the patent, which has a September 2025 expiration date, was received by CytRx’s licensor, Nippon Shinyaku Co., LTD. CytRx holds the exclusive rights to bafetinib in all indications in the U.S. and throughout the world, with the exception of Japan.
Dyax Corp. (NASDAQ: DYAX) announced today the publication of results from its second Phase 3, placebo-controlled trial, known as EDEMA4®, evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE). The results, published in the June 2010 issue of the Annals of Allergy, Asthma, and Immunology, indicate that KALBITOR is effective in ameliorating HAE attacks, resolving associated symptoms and preventing attack progression. KALBITOR, a selective plasma kallikrein inhibitor that was discovered and developed by Dyax, is available in the U.S. for the treatment of acute attacks of HAE in patients 16 years of age and older.
Hana Biosciences Inc., (OTCBB:HNAB), today announced complete data from its pivotal, Phase 2 RALLY clinical trial for Marqibo(R) (vincristine sulfate liposome injection) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY trial demonstrated compelling evidence of single-agent, anti-leukemic activity in an advanced, heavily pre-treated, adult ALL population.
Separately the company announced that it has entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company's largest existing shareholder prior to this financing. The sale of $40 million of preferred stock under the Investment Agreement closed today.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that GlaxoSmithKline (GSK) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).
The MAA submission includes the results of two pivotal Phase 3 clinical trials in autoantibody-positive patients with SLE showing that belimumab met its primary endpoint.
Micromet, Inc. (Nasdaq:MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced the presentation of updated interim results from a Phase 1 trial of the Company's BiTE antibody MT110 in patients with advanced solid tumors. MT110 is designed to direct a patient's T cells, the immune system's most potent killer cells, against cancer cells that express the epithelial cell adhesion molecule (EpCAM).
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that in collaboration with OXiGENE, Professor Gordon Rustin and colleagues from the Mount Vernon Cancer Research Centre, UK and other institutions in the United Kingdom, reported positive final data from an investigator-sponsored Phase 1 study of OXi4503 in patients with solid tumors. Data from a dose escalation study of 45 patients with advanced solid tumors who had declined or were refractory to standard treatment were presented at the 2010 Annual Meeting of the American Society of Clinical Oncology.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, announces new, interim data from an ongoing prospective study conducted in collaboration with researchers from the University of Texas, M. D. Anderson Comprehensive Cancer Center (MDACC), and presented at ASCO 2010. The ongoing study is designed to examine the ability of miRview mets to identify the most likely primary origin of metastases in patients with cancer of unknown primary (CUP). This was achieved by correlating the predicted primary origin assigned by miRview mets with the comprehensive diagnostic work-up conducted at MDACC, which included surgical pathology, laboratory tests, imaging and a treatment-response follow-up.
Out of the 89 patients who participated in the study to date, data reported at ASCO 2010 demonstrated miRview mets was able to identify the most likely origin of metastases origin in 84% of the 62 cases that were successfully processed.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced updated clinical data from Phase 2 clinical studies of the Company's lead drug candidate, voreloxin, in acute myeloid leukemia (AML) and platinum-resistant ovarian cancer.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced that clinical results for two Phase 1 trials of STA-9090 in solid tumors, as well as 12 month updated survival results from the SYMMETRY trial of elesclomol in metastatic melanoma, were presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). STA-9090 is a potent, second generation, small molecule Hsp90 inhibitor that has shown strong activity in a broad range of preclinical solid and hematologic cancer models, including models highly resistant to treatment.
Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) today announced results from Phase 1/2 clinical trials in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented during the American Society for Clinical Oncology
VIVUS, Inc. (Nasdaq:VVUS) today announced positive results from the phase 3 REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The study also demonstrated a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions for food or alcohol intake.
These results follow the avanafil data presentation at the American Urological Association (AUA) 2010 Annual Meeting last week, highlighting positive results from the company's first pivotal phase 3 study of avanafil evaluating treatment in men with a history of general ED.
Illumina, Inc. (NASDAQ:ILMN) moved higher today after the company announced that the Broad Institute has purchased 51 HiSeq 2000s, Illumina’s market leading high-throughput next-generation sequencing system. The HiSeq 2000s will replace an equal number of Genome AnalyzerIIx systems in the current installed base as the Broad upgrades and expands its sequencing capacity.
Allergan, Inc. (NYSE: AGN) has received CEO Cancer Gold Standard™ accreditation, recognizing the organization's commitment to taking concrete actions to reduce the cancer risk of its employees and their families through screenings, early detection, and healthy changes in lifestyle and in the workplace.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today preliminary clinical data from its ongoing Phase I trial with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.
Biogen Idec (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced that the Board of Directors is in the final stages of selecting a Chief Executive Officer and expects to announce the appointment in the coming weeks.
Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate).
Celgene International Sàrl (NASDAQ:CELG) today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.
Exelixis, Inc. (Nasdaq:EXEL) today reported updated interim data from three ongoing trials of XL147 (SAR245408), a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K).
Genta Incorporated (OTCBB: GETA) announced today the presentation of combined data on early endpoints from the Company’s randomized Phase 3 trials of Genasense® (oblimersen sodium) Injection plus chemotherapy in patients with advanced melanoma.
Geron Corporation (Nasdaq:GERN) today announced the presentation of data from the clinical trial of imetelstat (GRN163L), the company's telomerase inhibitor drug, in combination with paclitaxel and bevacizumab in patients with breast cancer at the 2010 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
GTx, Inc. (Nasdaq: GTXI) today presented additional results from the Ostarine™ Phase IIb study demonstrating an improvement in quality of life (fatigue and anorexia) in cancer patients with muscle wasting (cancer cachexia) who demonstrated improvement in functional performance as measured by stair climb.
In a letter today to CVS Caremark Corp. (NYSE: CVS), Walgreens (NYSE: WAG)(NASDAQ: WAG) said that it will not participate as a provider in any new and renewed prescription drug plans awarded after June 7 to CVS Caremark's pharmacy benefit manager (PBM).
Genta Incorporated (OTCBB: GETA.OB) announced today the presentation of results from two dose-ranging trials of tesetaxel, the Company’s novel oral tubulin inhibitor.
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of the first clinical data for the Company's IMGN388 anticancer compound at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, IL.
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV) today announced that on June 4, 2010, Javelin received notice from Hospira, Inc. that Hospira will fund a $2 million loan to Javelin on June 10, 2010 under the existing loan agreement between Javelin and Hospira.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Bank of America Merrill Lynch Smid Cap Conference in Boston on Wednesday, June 9, 2010, at 8:50 a.m. Eastern Time.
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today presented the design and rationale of an ongoing phase 1 trial of its prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) therapy at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Proteonomix, Inc. (PINKSHEETS:PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced that it has retained Wolfe Axelrod Weinberger Associates LLC as its investor relations agency effective immediately.
PhotoMedex, Inc. (Nasdaq: PHMD) announced today that John Koo, MD will be the principal investigator in a clinical study assessing the efficacy of the XTRAC Velocity® excimer laser in the treatment of generalized psoriasis when used in combination with Clobex® spray.
Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI), a commercial-stage biotechnology company with a focus in oncology and hematology, announced today that an overview of the Company's business strategy will be given at two upcoming Investor Conferences.
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.