|Avanir Announces Listing Of Additional NUEDEXTA Patent; Pfizer: Study Shows Toviaz Is Effective In Reducing Urge Urinary Incontinence|
|By Staff and Wire Reports|
|Friday, 03 August 2012 18:45|
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced an additional patent covering Avanir's NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) product has been listed in the U.S. Food and Drug Administration's (FDA) Orange Book.
The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant, seeking FDA approval for a generic version of NUEDEXTA prior to expiration of the patent, to notify Avanir of its ANDA filing before it can obtain FDA approval.
Avanir Pharmaceuticals now has three patents listed in the FDA Orange Book:
Patent number: RE38,115 which expires in 2016 Patent number: 8,227,484 which expires in 2023 Patent number: 7,659,282 which expires in 2026
Pfizer Inc. (NYSE: PFE) announced a Phase 4 study assessing the efficacy and safety of Toviaz(R) (fesoterodine fumarate) in patients with overactive bladder (OAB) met its primary endpoint. Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal response (less than 50 percent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition. UUI is the involuntary leakage of any amount of urine, associated with or immediately preceded by a sense of urgency.
The 14-week randomized, parallel group, placebo-controlled, double-blind multicentre study assessed Toviaz 8 mg in patients with OAB who had been taking Detrol LA 4 mg for two weeks and had less than 50 percent reduction in urge urinary incontinence episodes. After open-label treatment with Detrol LA 4 mg, treatment with Toviaz 4 mg was started for one week, followed by treatment with Toviaz 8 mg.
The study demonstrated that Toviaz 4 mg for one week followed by Toviaz 8 mg statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA 4 mg. The safety and tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatment-emergent adverse events for both fesoterodine and tolterodine were dry mouth and constipation. Further analyses will be conducted and a publication of the comprehensive results is planned at a later date.
Assisted Living Concepts, Inc. (NYSE: ALC) reported a net loss of $25.1 million in the second quarter of 2012 as compared to net income of $6.3 million in the second quarter of 2011.
Bioheart, Inc. (OTCBB: BHRT) has renegotiated the terms of a Company note in the amount of $572,000 held by NorthStar Biotech, LLC, a consortium of Bioheart Directors and Shareholders, led by Bioheart Director Chuck Hart. To preserve cash, NorthStar has agreed to suspend the requirement of principal payments by Bioheart and to allow payment of interest-only in restricted stock.
BioMed Realty Trust, Inc. (NYSE: BMR) announced today that the company has closed on an amendment to its senior unsecured term loan facility which converts $156.4 million of the $400 million principal amount outstanding to 100 million pounds sterling and provides for the base rate index on this portion of the facility to be GBP 1-month LIBOR.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today reported financial results for the second quarter and six months ended June 30, 2012.
Champions Oncology, Inc. (OTC: CSBR), a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, today announced that James Martell has resigned from the Company's Board of Directors
China Biologic Products, Inc. (NASDAQ: CBPO), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release second quarter 2012 financial results on Thursday, August 9, 2012 after the market closes.
Daxor Corporation (NYSE MKT: DXR), an investment company with medical instrumentation and biotechnology operations, today announced the sale of a BVA-100 Blood Volume Analyzer.
ExamWorks Group, Inc. (NYSE: EXAM), a leading provider of independent medical examinations ("IMEs"), peer reviews, bill reviews and related services, today reported financial results for the second quarter of 2012.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it will present at the Canaccord Genuity Annual Growth Conference in Boston, Massachusetts. Parker H. "Pete" Petit, Chairman and CEO, William C. Taylor, President and COO and Michael J. Senken, Chief Financial Officer, are scheduled to present on Wednesday, August 15th, at 3:30 p.m. Eastern Time at the InterContinental Boston Hotel.
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 second quarter ended June 30, 2012.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced financial results for its second quarter and six months ended June 30, 2012 and provided an overview of the clinical development activities of its two product candidates, custirsen and OGX-427.
Origin Agritech Limited (NASDAQ: SEED) ("Origin" or the "Company"), a technology-focused supplier of hybrid and genetically modified crop seeds in China, today announced that the Company will report results for its fiscal year 2012 third quarter ended June 30, 2012, before the market opens on Tuesday, August 7, 2012.
PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today reported financial results for the second quarter and six months ended June 30, 2012.
Rosetta Genomics Ltd. ("Rosetta") (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced the pricing of an underwritten public offering of 5,500,000 ordinary shares at a public offering price of $5.00 per share.
ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that the independent committee of the Company's board of directors (the "Independent Committee"), consisting of three of the Company's independent directors, Mr. Yuk Lam Lo, Mr. Julian Ralph Worley and Mr. Benson Tsang, has retained J.P. Morgan Securities (Asia Pacific) Limited ("J.P. Morgan") as its financial advisor.
SurgiCount Medical, Inc., the wholly-owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB: PSTX, OTCQB: PSTX), today announced that use of its Safety-Sponge® System surpassed an estimated 100 million Safety-Sponges® successfully used in nearly 5 million procedures.