|Furiex Wins Fast Track Designations for Avarofloxacin; Affymax Drops to All-Time Low After OMONTYS Recall|
|By Staff and Wire Reports|
|Monday, 25 February 2013 20:13|
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced today that avarofloxacin (USAN adopted, INN approval pending), has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). Avarofloxacin is a Phase III-ready broad-spectrum fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin-structure infections, community-acquired pneumonia and has proven to be effective in treating methicillin-resistant staphylococcus aureus (MRSA) infections.
The designations should enable Furiex and/or any future collaborator with respect to the compound to benefit from certain incentives for the development of new antibiotics, including priority review and additional five-year market exclusivity, as provided under the Generating Antibiotic Incentives Now (GAIN) Act, which is incorporated within the FDA Safety and Innovation Act of 2012.
It's been a rough few months for Affymax (NASDAQ: AFFY). After a steady climb to nearly $25 in late November, the Palo Alto, California biotech firm has been on a backslide. The stock fell into the mid-teens by mid-February and hovered there through Friday.
Then, on Saturday, Affymax and Takeda Pharmaceutical Company (OTC: TKPYY) announced a voluntary recall of all lots of OMONTYS Injection. The companies did so in response to post marketing reports regarding serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis is the same reaction some experience after being stung by a bee or wasp and it can be fatal.
Letters have been issued to healthcare professionals indicating that the drug should not be administered to any new or existing patients.
Scope of the Problem--OMONTYS was approved by the FDA 11 months ago. As such, it is unclear why the drug was ever approved or why the recall is happening now instead of sooner. According to Affymax, 25,000 patients have been injected with OMONTYS in the post marketing setting. Overall, approximately 0.2 percent of patients have experienced hypersensitivity to the drug. Around a third of such cases have been serious enough to require immediate medical attention and/or hospitalization.
And, to date, 0.02 percent of patients have experienced a fatal reaction within 30 minutes of their first dose of the drug. There have been no deaths after subsequent doses. Based on these figures, approximately 50 people have experienced hypersensitivity to the drug and five have died.
One Trick Pony?--Unfortunately for Affymax and its investors, the company relied heavily on the success of OMONTYS. The company's reliance on this product was to the tune of over 93 of its total revenue during the third quarter of 2012, with $10.4 million of its $13.6 million coming from a profit equalization payment from Takeda related to sales of the drug. Another $2.25 million came from a milestone payment from Takeda as a result of the “commercial progress achieved with OMONTYS during its product launch.”
Affymax Approaching Penny Stock Status--After closing at $16.52 on Friday, Affymax has embarked on a free-fall on Monday. The stock has dropped around 85 percent. As of this writing, Affymax has plunged to an all-time low. It rests around $2.44 per share in the morning hours of trading on Monday.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the Cowen and Company 33rd Annual Health Care Conference on Monday, March 4, 2013, at 1:30 p.m. Eastern Time at the Boston Marriott Copley Place.
Affymax, Inc. (Nasdaq: AFFY) will host a teleconference and webcast at 5:30 a.m. Pacific Time; 8:30 a.m. Eastern Time today, February 25, to discuss the voluntary recall of OMONTYS® (peginesatide) Injection.
Amarantus BioScience, Inc. (OTCQB:AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, and Banyan Biomarkers, the leader in developing in vitro diagnostic products to detect TBI, today announced that the companies will be making a joint poster presentation March 6-7, 2013 at The 3rd Annual Traumatic Brain Injury (TBI) Conference in Washington, DC (www.tbiconference.com).
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that it will host a conference call and webcast to provide a corporate update and discuss fourth quarter and full year 2012 financial results before the NASDAQ Global Select Market opens on Monday, March 4, 2013.
Atossa Genetics, Inc. (NASDAQ: ATOS) (“Atossa” or the “Company”) received a Warning Letter (“Letter”) from the FDA on February 21, 2013, regarding its Mammary Aspirate Specimen Cytology Test (MASCT) System and MASCT System Collection Test (together, the “System”).
Mark Lowenthal, President and CEO of BioNeutral Group, Inc. (OTCBB: BONU), a specialty technology-based life-science company, announced today that following an extensive product development and testing period, the initial reception of its products in the marketplace has far exceeded the Company's initial expectations.
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT) conference.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to provide shareholders an update on Kevetrin™, the Company's novel drug in development for multi-drug resistant cancers, and Prurisol™, the Company's anti-psoriasis drug in development set to commence mid-stage clinical trials.
CEL-SCI Corporation (NYSE MKT: CVM) announced today that its Taiwanese partner, Orient Europharma, has added two additional Taiwanese clinical centers in CEL-SCI’s Phase III head and neck cancer clinical trial for Multikine® (Leukocyte Interleukin, Injection), the Company’s flagship investigational immunotherapy.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Adynxx, Inc. announced today that they have entered into an option agreement under which Cubist has the exclusive right to acquire Adynxx following the data readout of Adynxx’s Phase 2 trial for its lead product candidate, AYX1.
Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company, today announced that it will report its financial results for the year ended December 31, 2012 after market close on Thursday, March 7, 2013 and will host a conference call at 5:00 p.m. Eastern Time to discuss those results.
EasyMed Services Inc. (CNSX:EZM) (PINKSHEETS:EMYSF)(MUN:EY6) ("EasyMed" or the "Company") announces the launch of a new smartphone application for its International Medical Passport on the iOS platform.
Genomic Health, Inc. (Nasdaq: GHDX) today announced the results of two studies demonstrating that DNA strand-of-origin information can help further refine the identification of prognostic biomarkers, and that tumor specific gene mutations can be effectively examined using archival fixed paraffin embedded tumor (FPET) tissue, enabling an improved and more practical process of tumor analysis.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and year ended December 31, 2012.
Hydromer, Inc. (OTC Pink: HYDI) announced that during the last 30 days it entered into License Agreements with two non-USA based medical device manufacturers.
Innophos Holdings, Inc. (NASDAQ: IPHS) today announced that its annual meeting of stockholders will take place on Friday, May 17, 2013 at the Crowne Plaza Hotel in Jamesburg, New Jersey.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced it has launched its clinical next generation sequencing assay, GeneSeq®: Cardio for genetic causes of familial cardiac disease.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that Brian Zambrowicz, Ph.D., executive vice president and chief scientific officer, will present at the RBC Capital Markets Healthcare Conference on Wednesday, February 27, at 8:00 AM EST in New York City.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces receipt of a $1.4 million milestone payment from Retrophin, Inc. (OTCQB: RTRX) under the terms of a license agreement signed in February 2012 for the development and commercialization of Retrophin’s lead clinical candidate RE-021.
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has been invited to present data from its Lpathomab™ program in models of central nervous system injury, including traumatic brain injury (TBI), at Arrowhead's 3rd Annual Traumatic Brain Injury Conference.
Medidata Solutions (NASDAQ: MDSO) signed Purdue Pharma L.P. to a multi-year enterprise agreement that significantly broadens its already wide use of Medidata’s cloud-based solutions, to further improve clinical trial operational efficiencies, resource savings and decision making.
Medifocus Inc. (OTCQX: MDFZF) (TSX VENTURE: MFS) is pleased to announce it has obtained a newly allowed patent to add to its extensive intellectual property portfolio of over 100 issued and/or pending US and foreign patents covering its two platform technologies for the treatment of breast, rectal, ovarian cancer and prostate diseases.
Medivation Inc. (NASDAQ: MDVN) and Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (TSE: 4503), announced that the companies are providing additional support to the Chronic Disease Fund (CDF).
MMRGlobal, Inc. (OTCQB: MMRF) today announced it will launch an Integrated Wellness Mobile App in response to customer requests to integrate wellness services with a Personal Health Record (PHR), at the HIMSS 2013 Annual Conference and Exhibition, booth #3363, starting March 3rd in New Orleans.
Oncolytics Biotech Inc.("Oncolytics") (TSX:ONC; NASDAQ: ONCY) announced today that it has closed its previously announced underwritten public offering of 8.0 million common shares, at a public offering price of US$4.00 per common share.
Dr. Matt Coffey, Chief Operating Officer of Oncolytics Biotech Inc. (TSX: ONC) (NASDAQ: ONCY), will present at the 2013 RBC Capital Markets Healthcare Conference on Tuesday, February 26, 2013 at 3:35 p.m. ET.
OvaScienceSM, (OTC: OVSC), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today reported fourth quarter and full year 2012 financial results, and highlighted key accomplishments.
PLC Systems Inc. (OTCBB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported that it has raised $4,040,000 in gross proceeds through the sale of 26,933,333 shares of common stock and common stock equivalents at a price of $0.15 per share and five-year warrants to purchase 26,933,333 shares of common stock at an exercise price of $0.20 per share.
Pluristem Therapeutics, Inc. (NASDAQ: PSTI) (TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that William R. Prather RPh, MD, its Senior VP of Corporate Development, will be presenting the Company at the Accredited Members Spring Small Cap/Micro Cap Conference, being held at the JW Marriott Resort and Spa on February 27th, 28th and March 1st.
Psychemedics Corporation (NASDAQ: PMD) today announced fourth quarter and year-end financial results for the period ended December 31, 2012.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) has completed development of a new analysis product for cardiac Magnetic Resonance Imaging (CMR) based on its VMS™ platform.
Viropro, Inc. (OTC: VPRO) and Oncobiologics, Inc. announced today the signing of a biosimilar collaboration agreement. Under the agreement, Viropro will have the rights to manufacture six monoclonal antibody products being developed by Oncobiologics for commercialization in more than 70 emerging market countries (excluding China).