|Sagent Announces the Reintroduction of Adenosine Injection; Revance Announces Positive Results From the RT002|
|By Staff and Wire Reports|
|Monday, 21 April 2014 19:48|
Sagent Pharmaceuticals, Inc. (Nasdaq: SGNT) announced the reintroduction of Adenosine Injection, USP, an antiarrhythmic agent, now in improved prefilled plastic syringes. According to IMS, for the 12 months ending February 2014, the US market for Adenosine Injection, USP approximated $28 million. As with all products in Sagent's portfolio, Adenosine features Sagent's PreventIV MeasuresSM packaging and labeling, designed to help reduce medication errors.
About Adenosine Injection, USP -- Adenosine Injection, USP is indicated for conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration.
Revance Therapeutics, Inc. (Nasdaq: RVNC) announced positive data from its Phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines. RT002 is Revance's proprietary, injectable botulinum toxin investigational product that incorporates the patented TransMTS® technology and is designed to provide a longer lasting duration of effect. In the study, RT002 met its primary efficacy and safety endpoints. The open-label, dose escalating, Phase 1/2 study enrolled 48 adults in four cohorts. All subjects had Severe or Moderate wrinkles at baseline, measured using the 4-point Global Line Severity Scale (GLSS). In summary, the data showed:
* 94% of subjects were rated with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the GLSS as assessed by the clinical investigator. 83% of subjects assessed themselves as achieving None or Mild wrinkles at maximum frown at the same time point. * In the final cohort, the only one where duration of effect was measured, RT002 achieved a median duration of 29.4 weeks or 7.3 months based on both investigator and subject assessments. * RT002 was well tolerated, and there was no evidence of spread beyond the treatment site at any dose.
Based on the results of this study and previous findings from pre-clinical data, we plan to continue studying RT002 in a Phase 2 active comparator study. Data from the study is anticipated in 2015.
"RT002 was easy to administer and very well received by patients," said Enrique Garcia-Murray, MD lead investigator for the RT002 study. "As the study progressed, we were most impressed by the duration of effect. Patients typically see three to four months of benefit from current botulinum toxin treatments, but we saw an effect that was significantly longer than that. My patients were extremely happy about this increased duration."
"The results of this study are extremely encouraging from both safety and efficacy perspectives," said Jacob Waugh, MD, Chief Scientific Officer and Medical Director. "This data aligns well with previously reported preclinical studies which established less unwanted spread and longer duration. We look forward to expanding our evaluation of RT002 further in Phase 2 studies."
Safety and Tolerability -- Across all cohorts, RT002 was shown to be generally safe and well tolerated with minimal adverse events. An independent Data Safety Committee (DSC) composed of experts from neurology, dermatology, and internal medicine, reviewed the data after each cohort and confirmed the safety of dose escalation prior to each successive higher dose. Adverse events were generally mild, localized and transient. The most common adverse events observed were headache and injection site reactions. There was no evidence of spread beyond the treatment site at any dose. There were no serious adverse events or evidence of any systemic exposure based on clinical laboratory results and related evaluations. Adverse event rates did not change in frequency, severity, or type with increasing doses.
Clinical Study Design -- RT002-CL001 was a Phase 1/2 dose escalating, open-label study for the treatment of moderate to severe glabellar (frown) lines. The study was conducted in Mexico City and enrolled 48 patients across four dose cohorts, ranging from approximately half the labeled dose to approximately twice the labeled dose of commercially available neurotoxins based on potency assays commonly used in the industry.
The study objective was to establish a safe dose and evaluate safety, efficacy and durability after a single administration of RT002 for the treatment of glabellar (frown) lines. Efficacy was assessed at maximum frown by the investigator and the subjects using the 4-point GLSS at the 2 and 4-week time points for all cohorts. The final cohort, consisting of 10 subjects, was also measured for duration of effect at the six, seven and eight month time points.
About RT002 -- RT002, an investigational product, is a novel, injectable form of botulinum toxin type A currently under evaluation for the treatment of moderate to severe glabellar (frown) lines. RT002 combines our proprietary, pure 150kD botulinum toxin type A molecule without any accessory proteins or animal derived components with the patented TransMTS^® peptide technology. It is designed to be more targeted and longer lasting than currently available botulinum toxin injectable products. It is being developed to treat both aesthetic and therapeutic conditions where deeper, more targeted delivery is required or longer duration is desired.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that it has entered into a definitive agreement to acquire Sanofi's Cell Therapy and Regenerative Medicine (CTRM) business for a purchase price of $6.5 million, with $4 million payable in cash at closing and $2.5 million payable in the form of a promissory note.
Alliqua, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, announces new data from the Company's sorbion® product line will be presented at the Spring 2014 Symposium on Advanced Wound Care to be held at the Gaylord Palms Hotel and Convention Center in Orlando, Florida on April 23-27.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, today reported financial results and developmental progress for the year ended December 31, 2013.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today the reimbursement of prostate cancer treatment procedures using High Intensity Focused Ultrasound ("HIFU") by the French health authorities.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today details relating to the release of its first quarter 2014 financial results, which will take place on Wednesday, April 30, 2014 after the close of the market.
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 issued a stay for the preliminary injunction that was ordered on April 11 to limit the sale of Medtronic's CoreValve system in the United States. According to the court's two-to-one decision, the injunction has been placed on hold "pending further notice."
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that on April 18, 2014 the US Patent and Trademark Office ("USPTO") issued a final decision in the inter partes reexamination of Neptune Technologies & Bioressources, Inc. (Nasdaq:NEPT) 8,030,348 patent rejecting all of the claims.
Groupe Athena, Inc. (OTC Pink: GATA) (PINKSHEETS: GATA) announced today revenues of $14,471,625 for the period ending March 31, 2014, an increase of $1,093,173 over the same period in 2013.
Islet Sciences, Inc. (OTCQB:ISLT) today announced the appointment of Dr. William Wilkison, COO of Islet Sciences, to Islet's Board of Directors.
Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (Nasdaq:KIPS), announced that on April 12, 2014, the first commercial implant of an eSVS Mesh was performed at the Military Institute of Medicine in Warsaw, Poland.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announced today that the United States Patent and Trademark Office ("USPTO") recently issued a Right of Appeal Notice in an inter partes reexamination of Neptune's U.S. Patent No. 8,030,348 ("the '348 Patent").
Oncologix Tech Inc. (OTCQB: OCLG), a medical device and healthcare service holding company announced today its Second Quarter and YTD Fiscal 2014 results.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on April 17, 2014 it granted non-statutory stock options to purchase an aggregate of 9,800 shares of its common stock to four new employees.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced execution of an exclusive commercial agreement with the Knight Diagnostic Laboratories at Oregon Health & Science University (OHSU) for a proprietary next generation sequencing panel for lung cancer.
Revance Therapeutics, Inc. (Nasdaq:RVNC), today announced positive data from its Phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines.
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced the reintroduction of Adenosine Injection, USP, an antiarrhythmic agent, now in improved prefilled plastic syringes.
SANUWAVE Health, Inc. (OTCQB:SNWV) today announced that Joseph Chiarelli, the Company's Chief Executive Officer, is no longer employed by the Company effective April 15, 2014.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) today announced the appointment of Paul Smith to its senior management team in the newly created position of Vice President, International.
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced that the Company will release its financial results for the fourth quarter and full year fiscal 2014, ended March 31, 2014, after the market closes on Monday, April 28, 2014.