|Navidea Says PDUFA Goal Date for Lymphoseek 2nd Quarter 2013; Celgene Reports Improvement Across Primary-Secondary Endpoints from PALACE-1|
|By Staff and Wire Reports|
|Tuesday, 13 November 2012 20:23|
Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the Company's October 30, 2012 resubmission of its New Drug Application (NDA) for Lymphoseek (Technetium Tc 99m Tilmanocept) Injection.
In its acknowledgment, FDA noted that it considers the filing a complete, class 2 response to its September 10, 2012 action letter and has set a Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2013. Lymphoseek is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancer. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) presented the results from PALACE-1, the Company's first Phase III study in psoriatic arthritis, at the American College of Rheumatology annual meeting in Washington, D.C.
The company previously announced statistical significance for the primary endpoint of ACR20 for patients receiving apremilast in the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company's novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE-1 is the first phase III study demonstrating statistical significance in a psoriatic arthritis patient population that included both prior biologic exposure (23.6%) and biologic failures (9.3%).
In the study, apremilast demonstrated statistically significant and higher ACR20 responses at week 16 in patients receiving either apremilast 20 or 30 mg BID monotherapy (31.5% and 50.8% respectively vs. 10.5% for placebo; P<0.05 and P≤0.0001), with no meaningful advantage to adding oral DMARDs to apremilast. A higher ACR20 response at week 16 was also demonstrated in biologic-naïve subjects receiving apremilast 30 mg BID monotherapy compared with placebo (59% vs. 12%; P<0.005).
Across the entire study population, statistically significant changes in reducing signs and symptoms of PsA, as measured by the primary endpoint of ACR20 at week 16, were achieved for patients receiving apremilast 30 mg BID vs. placebo (41.01% vs. 19.4%; P≤0.0001). This was further supported by a robust and consistent response (P≤0.0001) across all arthritis-related secondary endpoints, including ACR50, ACR70, DAS-28, good or moderate EULAR response achievement and CDAI at week 24. Statistically significant results were also demonstrated in measures of physical function (HAQ-DI, SF-36 physical function domain score) at week 16 (P=0.0015 and P=0.0049 respectively) and these results were maintained at week 24.
The overall safety profile was consistent with previous experiences in the phase II program. Importantly, no opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. Apremilast was generally well tolerated. The majority of AEs (>95%) were mild or moderate, with serious AEs and discontinuations due to AEs similar across all treatment arms.
AdCare Health Systems, Inc.(NYSE MKT: ADK), a leading long-term care provider, reported results for the third quarter ended September 30, 2012.
Adherex Technologies Inc. (TSX:AHX)(OTCQB:ADHXF), a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, today reported its financial results and positive developments for the third quarter ended September 30, 2012.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company"), an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs, today reported financial and operating results for the third quarter ended September 30, 2012.
AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today announced that it will present at the 9th Annual Lazard Capital Markets Healthcare Conference, held November 13-14, 2012, at the Pierre Hotel in New York City.
Atrion Corporation (NASDAQ: ATRI) today announced that its Board of Directors has declared a special cash dividend of $10.00 per share on its outstanding common stock.
BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced record revenue for the third quarter ended September 30, 2012.
Can-Fite BioPharma (TASE: CFBI, OTC: CANFY), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it designated the CF602 drug, which was licensed from the Leiden University, to be developed for the treatment of sexual dysfunction.
Cardium Therapeutics (NYSE MKT: CXM) today announced the presentation of two Excellagen® poster presentations at the Desert Foot 2012 High Risk Diabetic Foot Conference being held November 14-16, 2012, in Phoenix, AZ.
CollabRx, Inc. (NASDAQ: CLRX), a data analytics company focused on genomics, today announced that it is scheduled to present at the National Investment Banking Association (NIBA) Conference November 14-16, 2012, at The Venetian Resort Hotel-Casino in Las Vegas.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that the U.S. Court of Appeals for the Federal Circuit today affirmed an April 2010 federal jury decision that Medtronic CoreValve LLC is willfully infringing Edwards' U.S. Andersen transcatheter heart valve patent.
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) today announced 24-week results from the continuation of an ongoing Phase IIb study of baricitinib, an orally available janus kinase (JAK) inhibitor, in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to treatment with methotrexate.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the initiation of dosing in a Phase 1 trial of IMO-8400. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8 and 9, and is the second clinical candidate in Idera’s autoimmune disease program. Idera expects to develop IMO-8400 for the treatment of lupus as an initial indication.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based clinical development solutions, today announced that Bryan Spielman, executive vice president of strategy and corporate development, and Cory Douglas, chief financial officer, will present at the 2012 Credit Suisse Healthcare Conference on November 15, 2012 at 9:30 a.m. EST (7:30 a.m. MST) in Phoenix, AZ.
Omeros Corporation (NASDAQ: OMER) has noted the fall in its share price over the last week of trading. Omeros is not aware of any reason that justifies this decrease.
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that Health Canada has approved the Company's Clinical Trial Application (CTA).
Quture (OTCQB: QUTR) announced today the new hire of Paul L. Rudisill as the company's first Chief Business Development Officer.
Sigma-Aldrich® Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC® (www.safcglobal.com), has added more than 25 new raw materials to its portfolio of PharmaGrade products.
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today reported its financial results for the third quarter ended September 30, 2012 and provided a business update.
Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today that Dr. John R. Valvo, M.D., F.A.C.S., the Company's Vice President of Medical Affairs, will present at the 24th Annual Piper Jaffray Healthcare Conference to be held on November 27-28, 2012 at The New York Palace Hotel in New York City.
VisualMED Clinical Solutions Corp. (PINKSHEETS: VMCS) (FRANKFURT: VA6) announces that its Transitional Care solution has now been completed and is available for immediate deployment for both independent institutions as well as regional health agencies.