|Columbia Lab jumps after Phase III results. Caraco Pharma going private. After the bell: strong results send Spectrum higher, Abiomed drops on canceled study|
|By Mary Davila|
|Monday, 06 December 2010 19:35|
After the bell shares of Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) moved higher on heavy volume after the company released updated data from its Phase III trial for ZEVALIN injection for intravenous use First-line Indolent Trial (FIT).
Spectrum said the late-stage trial of the drug showed nearly three years of progression-free survival benefit in patients with NHL after partial or complete response to first-line chemotherapy. In addition, the company said that patients who were given a single dose of Zevalin without upfront chemo treatment showed a response rate of 84%.
"ZEVALIN is in my opinion the most effective single drug available with an acceptable hematological toxicity profile for the treatment of patients with low-grade malignant follicular non-Hodgkin's lymphoma," said Anton Hagenbeek, M.D., Ph.D., Professor of Hematology, Academic Medical Center, Amsterdam and principal investigator of the FIT trial who presented the updated data in an oral presentation at ASH. "Hematologists should seriously consider this cost-effective treatment modality, which is relatively easy to administer, for their patients in first remission."
After the bell shares of Spectrum spiked 56 cents or 10.35% to $5.97. More than 65k shares traded hands.
Shares of Abiomed, Inc. (NASDAQ:ABMD) fell in extended trading after the company reported that is ending a study that was likely to fall short of its main endpoints. The Impella Cardiac Assist Device system was being compared to patients receiving support with an intra-aortic balloon pump in a study with high risk angioplasty patients. The company ended the sudy based on a report from an independent monitoring board.
After the bell shares of Abiomed dropped $1.69 or 13.86% to $10.50.
The drug is also sold under the name Crinone as an infertility treatment and for secondary amenorrhea, or the lack of a menstrual period.
The administration of PROCHIEVE 8% vaginal progesterone gel was associated with a statistically significant reduction in the rate of preterm birth at less than or equal to 32 6/7 weeks gestation, the primary endpoint of the study, compared to placebo gel. There was also evidence of improvement in infant outcome. The incidence and profile of adverse events in patients receiving PROCHIEVE 8% was comparable to placebo, which was as expected given the product's documented safety history.
"Based on the significantly lower incidence of preterm birth among women treated with PROCHIEVE 8% in this clinical trial, we believe PROCHIEVE 8% will be an important drug in helping to reduce the incidence of preterm birth. We intend to file an NDA for PROCHIEVE 8% in this new indication in the second quarter of 2011," said Frank C. Condella, Jr., Columbia's president and chief executive officer. "On behalf of the Columbia team, I want to thank the NICHD of the NIH for its collaboration on the PREGNANT Study, as well as the many physicians, medical professionals and especially patients who participated in this important study."
Shares of Columbia closed the day at $1.69 up 18 cents. Intra-day shares climbed as high as $2.00.
Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) reports receipt of a proposal from Sun Pharmaceutical Industries Ltd. and Sun Pharma Global, Inc for a going private transaction by which Sun, Sun Global, and/or one or more of their affiliates would acquire all of the outstanding shares of Caraco common stock not held by Sun or Sun Global for a per share consideration of $4.75 in cash. This represents a 5% premium over the closing price of Caraco Common Stock on Dec 2, 2010. Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.
Shares of Caraco closed Monday trading at $5.13, up 59 cents or 13%.
Aeterna Zentaris Inc. (NASDAQ:AEZS) today announced Phase 2 data presented for the first time on perifosine, its lead novel oral anti-cancer compound, showing promising clinical activity, safety and tolerability in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). The data were presented over the weekend at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.
In two Phase II studies the company reported that its experimental drug perifosine achieved objective responses and high rates of stable disease as a single-agent in the treatment of CLL, and, in combination with sorafenib, in the treatment of relapsed/refractory Hodgkin's Lymphoma (HL).
On heavy volume, shares hit an intra-day high of $1.69 before settling at $1.60, up 6 cents or 4%.
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) surged more than 7% today after the company announced updated clinical data from a fully enrolled and ongoing Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). The study demonstrated that in chronic-phase CML patients treated with ponatinib, 66 percent of patients in the trial achieved a major cytogenetic response, including 100 percent of patients who also had a T315I mutation.
Shares closed Monday trading at $4.39, up 29 cents.
Seattle Genetics, Inc. (Nasdaq:SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502.to), today announced positive results from the pivotal trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of Hodgkin lymphoma.
"Up to thirty percent of all patients diagnosed with Hodgkin lymphoma will relapse. These patients have limited treatment options beyond autologous stem cell transplantation and represent a significant unmet medical need," said Dr. Robert Chen, Assistant Professor, Hematology & Hematopoietic Cell Transplantation at City of Hope. "Based on these data, brentuximab vedotin has the potential to change the treatment paradigm for relapsed or refractory Hodgkin lymphoma patients, and could be the first treatment approved for these patients in more than 20 years."
"I have rarely seen such response rates in this relapsed or refractory disease population," said Dr. Andreas Engert, Professor of Internal Medicine, University of Cologne, Germany. "These data highlight brentuximab vedotin as a potential addition to the treatment options for Hodgkin lymphoma patients."
Synergetics USA (NASDAQ: SURG) soared more than 17% or 61 cents Monday after a new "Buy" rating was issued by Craig-Hallum. A price target of $6.00 was set by the firm. Shares closed at $4.10.
Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL) , a specialty biopharmaceutical company, today announced that The Journal of Hand Surgery (JHS) has published in its December online edition the Company's pivotal CORD II phase III clinical trial of XIAFLEX® (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of adult Dupuytren's contracture patients with a palpable cord.
Biodel Inc. (Nasdaq:BIOD) will issue its fourth quarter fiscal year 2010 financial results on December 9, 2010.