|Eli Lilly Discontinues Phase 3 Rheumatoid Arthritis Program; Avanir Announces Positive Interim Data From Pharmacokinetic Study|
|By Staff and Wire Reports|
|Thursday, 07 February 2013 19:56|
Eli Lilly and Company (NYSE: LLY) announced it will discontinue the Phase 3 rheumatoid arthritis (RA) program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns. The tabalumab Phase 3 program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.
In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.
Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors.
Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase 2 and Phase 3 RA studies will be stopped.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase 3 tabalumab lupus program."
The decision to stop the current RA program for tabalumab is expected to result in a first-quarter charge to research and development expense of approximately $50 million. The company's previously issued financial guidance for 2013 remains unchanged.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786, a drug product containing a deuterium modified form of dextromethorphan. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923 (dextromethorphan hydrobromide and quinidine sulfate). The company has requested a meeting with the FDA to discuss the full development path for AVP-786.
"The results of this study are very encouraging," said Joao Siffert, MD, chief scientific officer for Avanir. "We were able to successfully replicate the steady-state plasma levels of AVP-923, but with a substantially lower dose of quinidine. Given these results, we believe that AVP-786 would be an ideal candidate to test in one or more of our ongoing clinical programs."
Avanir also announced today that the company intends to modify the enrollment target of its ongoing phase II clinical study of AVP-923 in central neuropathic pain in multiple sclerosis to 200 patients.
"With the encouraging pharmacokinetic results in hand, we have made the decision to accelerate the completion of the PRIME study, as we believe AVP-786 has the potential to be a preferable development compound," said Joao Siffert, MD. "We plan to use the data from the PRIME study to guide the further development of AVP-786."
As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced it will present at the 15th Annual BIO CEO & Investor Conference on February 11th at 9:30am EST in the Basildon room at the Waldorf=Astoria in New York City.
Allergan, Inc. (NYSE: AGN) (“Allergan”) and MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) (“MAP”) today announced that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to the tender offer for all of the outstanding shares of common stock of MAP by Groundhog Acquisition, Inc. (“Purchaser”), a wholly-owned subsidiary of Allergan.
Amgen (NASDAQ: AMGN) today outlined the company's long-term strategy during a Business Review meeting with analysts and investors in New York City.
Anthera Pharmaceuticals, Inc.(Nasdaq: ANTH) a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced Paul F. Truex, Anthera's President and Chief Executive Officer, will present at the 2013 Leerink Global Healthcare Conference in New York, NY on Thursday, February 14, 2013 at approximately 8:00 am Eastern Time.
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Leerink Swann Global Healthcare Conference on Thursday, February 14, 2013 at 1:30 p.m.
CEL-SCI Corporation (NYSE MKT: CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 2013 BIO CEO & Investor Conference on Monday, February 11, 2013 at 11:00 a.m.
China Cord Blood Corporation (NYSE: CO) ("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced the completion of the previously announced transaction with Cordlife Services (S) Pte. Ltd., a subsidiary of the Company's strategic affiliate, Cordlife Limited (CBB.AU) ("Cordlife"), a cord blood and tissue banking services provider listed on the Australian Securities Exchange.
CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announces the receipt of notice on February 1, 2013 from the NYSE MKT LLC (the “NYSE MKT”) that the NYSE MKT granted it an extension until April 15, 2013 to regain compliance with the continued listing standards of the NYSE MKT.
Digirad Corporation (NASDAQ: DRAD) announced today R. King Nelson, former Chairman, and Gerhard F. Burbach have tendered their resignations from the Board of Directors after more than a decade of service to the Board and management team at Digirad.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced results from its randomized ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity.
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, has appointed Mohan Gopalkrishnan as Vice President - Operations.
GTx, Inc. (NASDAQ: GTXI) today announced that it will host a conference call and webcast to provide a corporate update and discuss the Company's fourth quarter and full year 2012 financial results on Thursday, February 21, at 9:00 a.m. Eastern Time.
iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the Company will release financial results for the three and twelve months ended December 31, 2012, following the close of the market on Tuesday, February 19, 2013.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with patented proprietary medical technology for the growing $55 Billion US home healthcare industry, is pleased to announce that Charles Vorwaller, a consultant with Ingen, has introduced Thomas Childers to the company and has agreed to help create sales of the Smart Nasal Cannula and Oxyview oxygen flow meter to his government clientele.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the fourth quarter and full year 2012 on February 27, 2013 after the close of the financial markets.
KaloBios Pharmaceuticals, Inc. (NASDAQ: KBIO) today announced the completion of its initial public offering of 8,750,000 shares of common stock at $8.00 per share.
LiveWire Ergogenics, Inc. (OTCQB: LVVV) has provided a corporate update of the company's activities and accomplishments in 2012 during which LiveWire completed the transition from a private company to a fully reporting public company with audited financials.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, announced today the expansion of its pharmaceutical manufacturing Centre of Excellence, based in Hemer, Germany.
MiMedx Group, Inc. (OTC: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its results for the fourth quarter ended December 31, 2012, will be released before the opening of the market on Thursday, March 7, 2013.
Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of clinically-relevant fluorescence imaging solutions for use in surgical procedures, today announced financial results for its fourth quarter and full year ended December 31, 2012.
Omeros Corporation (NASDAQ: OMER) today announced data from toxicology studies evaluating OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin associated serine protease-2 (MASP-2) program.
Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that it will report financial results for the fourth quarter and full year 2012 ended December 31, 2012 after market closes on Thursday, February 21, 2013.
Opexa Therapeutics, Inc. (NASDAQ:OPXA) a company developing Tcelna™ (imilecleucel-T), a novel T-cell therapy for multiple sclerosis (MS), today announced it has priced an offering of shares of its common stock and warrants to purchase common stock in a private registered offering of 1,083,334 units at a price of $3.00 per unit, for gross proceeds of $3,250,000.
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced it will report fourth quarter and fiscal year 2012 financial results after the NASDAQ Global Market closes on February 28.
Oramed Pharmaceuticals Inc. (OTCQB: ORMPD), a developer of oral drug delivery systems, announced today that NASDAQ has approved the company's application to list its shares of common stock on the NASDAQ Capital Market.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will be presenting at two upcoming investor conferences.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced financial results for its first fiscal quarter ended December 31, 2012.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 15th Annual BIO CEO & Investor Conference.
RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic and other biologic implants, reported operating results for the fourth quarter and full year of 2012.
SurePure, Inc. (OTCBB: SURP) a global leader in liquid photopurification, announced that Sigma Alimentos, a major Mexican food producer, would purchase at least three of its SurePure ultraviolet (UVC) photopurification systems.
Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its blood-based appendicitis test, APPY1, today announced it has signed its first European commercial development agreement with Netherlands-based EMELCA Bioscience for the initial phase of Venaxis' EU launch.
YM BioSciences Inc. (NYSE MKT: YMI) (TSX: YM), today reported operational and financial results for the second quarter of fiscal 2013, ended December 31, 2012.