|PTC Shares More Than Double Following CHMP's Positive Opinion On Translarna(TM); Durata Confirms FDA Approval of DALVANCE(TM)|
|By Staff and Wire Reports|
|Friday, 23 May 2014 18:52|
Shares of PTC Therapeutics (NASDAQ: PTCT) have surged an astounding 120 percent in Friday's pre-market session following the issuance of a press release earlier. About a half hour ahead of the opening bell, PTC shares last traded at $33; the stock closed at $15.32 on Thursday afternoon.
The company reported the Committee for Medicinal Products for Human Use in Europe gave a positive opinion related to PTC's application for conditional marketing authorization of TranslarnaTM.
A source cited in the company's press release, Dr. Craig McDonald of the Physical Medicine and Rehabilitation at the University of California, Davis, said, "Translarna is the first treatment for the underlying cause of nonsense mutation DMD to receive a positive opinion from the CHMP. The Phase 2b clinical trial provided strong evidence that Translarna slows disease progression as measured by the 6-minute walk test. A clinically meaningful 31.3 meter benefit in 6-minute walk distance, relative to placebo, was achieved in 48 weeks of treatment in patients five years and older and this was supported by positive trends in multiple secondary efficacy endpoints. In addition, in the prespecified group of patients with less than a 350 meter baseline 6-minute walk distance, a 68 meter benefit was observed in patients treated with 40 mg/kg Translarna given daily, relative to placebo."
PTC said the positive opinion "will form the basis for a European Commission (EC) decision as to whether to formally grant the conditional marketing authorization. The European Commission will review the positive opinion from the CHMP and generally delivers its final decision within three months."
Durata Therapeutics, Inc. (Nasdaq: DRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved DALVANCETM (dalbavancin) for injection for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.
"We are proud to bring DALVANCE to market for the millions of Americans who may benefit from an innovative treatment option for ABSSSI in today's evolving health care environment," said Paul Edick, Chief Executive Officer of Durata Therapeutics. "DALVANCE's unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, health care professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions." Mr. Edick continued, "We are executing on all fronts to complete the necessary activities required to launch and ensure success. The time to build out and train a first-class salesforce, complete packaging and final qualification activities keeps us on track to begin shipping in the third quarter."
For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions.
"Health care providers and hospitals are under enormous pressure to contain costs while still delivering high-quality care that does not compromise patient outcomes," said David Talan, MD, FACEP, FIDSA, Chairman, Department of Emergency Medicine and Faculty, Division of Infectious Diseases, Olive View-UCLA Medical Center. "The approval of DALVANCE is significant in this regard because it allows physicians to provide continuity of care across treatment settings for patients with ABSSSI as it helps reduce, or in some cases, may eliminate, the time patients spend in hospitals by providing an opportunity for care in an ambulatory setting. These outpatient settings may offer a more convenient and potentially less costly treatment experience while still delivering high-quality care and proper follow up."
The entire DALVANCE clinical program encompassed 21 clinical trials with five Phase 3 trials evaluating nearly 3,000 patients. Two Phase 3 trials, DISCOVER 1 and DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), were conducted under a Special Protocol Assessment (SPA) with the FDA and included more than 1,300 patients with ABSSSI. The clinical trials showed DALVANCE was non-inferior to the comparator regimen and met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, and clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever. DALVANCE was granted priority review as a Qualified Infectious Disease Product (QIDP), in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which was passed by Congress in 2012 to help make antibiotic development processes smoother.
"A 2013 report from the CDC warned that antimicrobial resistance is one of the most serious health concerns in the U.S., and the FDA recognized the need for new antibiotics by granting DALVANCE priority review with QIDP status," said Michael Dunne, MD, Chief Medical Officer of Durata Therapeutics. "DALVANCE is the first antibiotic approved for ABSSSI under the GAIN Act. It performed very well in clinical trials relative to the current standard, vancomycin, in studies designed to be consistent with guidance provided by the FDA for antibiotic development with efficacy defined by an early response in 48 to 72 hours, as well as clinical success at the end of treatment."
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced that Dr. Jonathan Rubin, Chief Medical Officer of Alcobra, will provide an oral presentation on Metadoxine Extended Release (MDX) clinical studies, as well as a poster presentation with new pre-clinical data at the Fragile X and Autism-Related Disorders Gordon Research Conference, being held June 1-6, 2014 at the Mount Snow Resort in West Dover, Vermont.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today it will be a featured presenter at the 3rd Annual Marcum MicroCap Conference on Thursday, May 29, 2014 in New York City at the Grand Hyatt Hotel.
Curis, Inc. (Nasdaq:CRIS), an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced that its collaborators, Roche/Genentech and Debiopharm Group™ will present results from clinical studies of Erivedge® and Debio 0932, respectively, at the 50th Annual Meeting of American Society of Clinical Oncology (ASCO) to be held from May 30th to June 3rd in Chicago, IL.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that Dr. Ariel Katz, President and Chief Executive Officer, and Oren Bryan, Vice President and Chief Financial Officer, will present at the Jefferies 2014 Global Healthcare Conference on Thursday, June 5, 2014 at 11:00 a.m. ET in New York, NY.
Epicore BioNetworks Inc. (TSX-V:EBN) revenue for Q3 at $2.2 million was 44% higher than last year's Q3 and set a new company Q3 record.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Ryan Dunlap, Vice President and Chief Financial Officer, will present a corporate update at the Marcum MicroCap Conference.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), today announced that Mike Kosloske, Chief Executive Officer, Jim Dietz, Chief Financial Officer, and Michael Hershberger, SVP of Finance and Development, of HII will present an overview of the company at the Jefferies 2014 Global Healthcare Conference, on Monday, June 2, 2014 at 4:30 p.m. EDT.
Singapore International Water Week will take place June 1-5, 2014, in Singapore, and GE (NYSE: GE) will have experts from its water and process technologies business on-site to present technical papers and posters.
Integra LifeSciences Holdings Corporation (Nasdaq: IART) today announced that it will present at the following conferences next month: At 8:00AM ET on Tuesday, June 3, 2014, Mr. Peter Arduini, President and Chief Executive Officer of Integra, will present at the Jefferies 2014 Global Healthcare Conference in New York City. This presentation will be webcast.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO) and NeuroBioPharm Inc. today jointly announce the appointment of Andre Godin as interim President and Chief Executive Officer of Neptune, Acasti and NeuroBio with immediate effect.
NPS Pharmaceuticals, Inc. (Nasdaq:NPSP), a global biopharmaceutical company pioneering and delivering innovative therapies that transform the lives of patients with rare diseases, will visit the NASDAQ MarketSite in Times Square to commemorate the 20th anniversary of the company's initial public offering and listing on the NASDAQ.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing novel cancer therapeutics, today announced that it has entered into definitive agreements with institutional investors to purchase an aggregate of $16 million of registered shares of OXiGENE common stock in an at-the-market direct offering at $ 2.9625 per share.
Propanc Health Group Corporation (OTCQB:PPCH) an emerging healthcare company focused on the development of new and proprietary treatments for cancer patients, today announced that it has made substantial progress in connection with their ongoing efforts to secure acceptance and approval of patent applications filed around the world.
SANUWAVE Health, Inc. (OTCQB:SNWV) announced the Company will present at the 3rd Annual Marcum MicroCap Conference on Thursday, May 29, at the Grand Hyatt Hotel in New York City.
VitaCig, Inc. and mCig, Inc. (Stock Symbol:MCIG) Company welcomes the release of the results of University College London's five-year survey of nearly 6,000 smokers in England.