Report Cites Advantages of Veloxis’ LCP-Tacro™, a Once-Daily Formulation of Tacrolimus for the Treatment of Kidney Transplant Patients
Report is Available for Download at http://www.lifesciadvisors.com/clients/veloxis/
NEW YORK--(BUSINESS WIRE)-- LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Veloxis Pharmaceuticals A/S ("Veloxis") (OMX: VELO), a specialty pharmaceutical company focused on the development of pharmaceutical products in the immunosuppression and specialty therapeutic areas. Veloxis’ lead pipeline candidate in Phase III, LCP-Tacro, is a once-daily formulation of tacrolimus for the prophylaxis of organ rejection in patients receiving an allogenic kidney transplant.
“A once-daily tacrolimus formulation is a long sought after goal in transplant management,” stated Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “With the successful completion of the first Phase III study, Veloxis’ LCP-Tacro is the first-ever once-daily tacrolimus formulation to accomplish the goal of equivalence to the twice-daily formulation of Prograf, a $2 billion product. By applying the Company’s MeltDose technology, Veloxis has ‘flattened’ the 24-hour pharmacokinetic curve of tacrolimus, conferring advantages of once-daily dosing, reduced dose requirements, improved bioavailability, and limited peak-to-trough fluctuations that typically lead to an improved side effect profile of this narrow therapeutic index drug. Post-approval, we believe LCP-Tacro’s advantages over existing therapies will result in capture of significant share of the $5 billion transplant market.”
In a 57-page Initiation Report by LifeSci Advisors, the clinical achievements of LCP-Tacro to date are detailed and put into context with the current leading therapies for patients receiving kidney transplants. Veloxis completed multiple Phase I studies that included head-to-head studies of LCP-Tacro with Prograf and Advagraf. In these studies, LCP-Tacro demonstrated 40% higher bioavailability, which can help reduce the events of organ rejection. Phase II studies in stable and de novo renal transplant patients demonstrated LCP-Tacro’s flat 24-hour pharmacokinetic profile that lacked the potentially problematic troughs and peaks found with Prograf. In June 2011, Veloxis reported positive Phase III data from a 12-month, open-label, Prograf-conversion study (3001) that enrolled 326 stable kidney transplant patients. The study met all endpoints and demonstrated a numerical trend towards lower rejection rates (LCP-Tacro=0.6%, Prograf=3.1%). The second Phase III registration study (3002) for LCP-Tacro is underway and expected to enroll 540 de novo renal transplant patients. This is a randomized, double-blind, 12-month study comparing BID Prograf to QD LCP-Tacro using a combined treatment failure composite for the primary efficacy endpoint that was also used in Study 3001. The trial is being conducted under a Special Protocol Assessment (SPA) with the FDA and results are expected in the fourth quarter of 2012 with NDA/MAA fillings expected in the beginning of 2013.
The research report also includes a detailed background of LCP-Tacro and the kidney transplant space, an immunosuppressive drugs market overview, a walkthrough of the Advagraf story, and an analysis of the competitive landscape.
Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, http://lifesciadvisors.com/clients/. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company’s website, www.lifesciadvisors.com.
Important Disclosures:
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, http://lifesciadvisors.com/disclaimer/, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
Forward-looking statements:
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.
CONTACT:
Media Contact
Mike Rice, 201-408-4923
[email protected]
or
Veloxis Pharmaceuticals Contact:
John Weinberg, 732-321-3208
[email protected]
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