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  • Unilife Begins the Supplying of Product to Sanofi
    Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) issued a significant piece of news today with the announcement that it has commenced the initial supply of validated product of the Unifill® syringe to Sanofi, as per the terms of the industrialization agreement between both parties.
    Unilife is now in a position to also commence initial sales of the Unifill syringe to other pharmaceutical companies. Upon the receipt of the Unifill syringe, these pharmaceutical customers will typically conduct drug compatibility and stability studies that will test the device in combination with their injectable drugs. The resulting data is then filed as the last step in completing the regulatory process for the drug-device combination product. 
    Mr. Alan Shortall, CEO of Unilife stated in the release:
    "The start of initial sales of the Unifill syringe is arguably the most significant achievement in our company's history. We very much appreciate the support of Sanofi since 2003, when they had the initiative and vision to approach us to develop a new generation of prefilled syringes that can help to improve patient care, while also enhancing and saving the lives of healthcare workers. The Unifill syringe is generating strong interest from an increasing number of pharmaceutical companies for use in therapeutic classes outside of those retained by Sanofi. These pharmaceutical companies recognize the significant potential of the Unifill syringe to help generate powerful brand differentiation for their injectable drugs within competitive therapeutic drug classes."

    Since signing the Exclusive Agreement in July 2008, Sanofi has paid Unilife a total of approximately $40 million, comprising a $16 million fee in exchange for the exclusive right to negotiate the purchase of the Unifill syringe, and to help fund the Industrialization Program for the device up to a maximum of $24 million. Sanofi has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines, plus an additional four smaller sub-groups, until June 30, 2014.
    Jul 15 12:07 PM | Link | Comment!
  • The True Value of a SPA: An Inside Look at CorMedix, Inc. ($CRMD)
    The granting of a Special Protocol Assessment (“SPA”) by the U.S. Food and Drug Administration is certainly not something to overlook. According to Wikipedia, a SPA “is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.”  The written agreement from the FDA also covers the scope and size of the patient population, the safety assessments and the duration of treatment of the always pivotal Phase 3 trial to support an efficacy claim in a New Drug Application (NDA).

    Within the definition of a SPA lie critical points that grab the attention of a savvy investor. For starters, the drug in development is in Phase III clinical trials. The early years of determining dosing levels and safety (Phase I) are well behind the drug and more advance, larger-scale trials (Phase II) have shown that the drug is proving a clinical benefit and worthy of research to determine if it is better than other drugs on the market today. Additionally, the SPA is providing acknowledgment of the drug’s potential and helps define a regulatory strategy for the drug maker to drive towards commercialization.
    CorMedix, Inc. (AMEX: CRMD; StockTwits: $CRMD) recently was the recipient of a SPA agreement with the U.S. FDA for their drug, Deferiprone, as an indication for Contrast-Induced Acute Kidney Injury. The SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol. Scheduled to be conducted in over 80 centers worldwide an encompassing more than 800 patients, the study will assess the efficacy and safety of Deferiprone (CRMD001) in the reduction of morbidity and mortality in patients with Chronic Kidney Disease (CKD) undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent.
    According to research by Somjot S. Brar et al. published in the Clinical Journal of the American Society of Nephrology,
    “Contrast-induced acute kidney injury (CI-AKI) is probably the most common iatrogenic cause of acute kidney injury and a common complication of iodinated contrast medium exposure, with a published incidence ranging from 2 to 50%. It results in increased morbidity, prolonged hospital stay, and increased healthcare expenditure and is associated with a higher mortality.”

    Normally, that information combined with the late-stage research that CorMedix is conducting under the SPA would be enough to deem it a value proposition with its paltry market cap of $16 million. The Company could be filing for an NDA and, upon approval, be commercialized in the multi-billion dollar industry in 2013. In the terms of biotech investing, that’s a blink of an eye.
    What gives CorMedix even more luster, however, is the fact that it could be generating revenue even before Deferiprone hits desks as a NDA at the FDA through another drug in its pipeline, Neutrolin®. Following their business strategies of attacking cardiorenal diseases, Neutrolin® (CRMD003) is proposed as a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients. CorMedix has slated clinical studies for Neutrolin® in the second half of 2011 and has filed a Request For Designation with the FDA. Moreover, CorMedix expects to complete its initial submission of the Neutrolin Design Dossier to the European notified body by the end of the second quarter 2011 and anticipates a European launch in the first half of 2012, pending CE mark approval. CorMedix is actively pursuing European partnerships to maximize revenue potential in the near term.
    Given the uniqueness and latter stages of the CorMedix pipeline, it is a bit of a quandary as to the low price of the stock presently. The lower volume can certainly be explained by the fact that there are only 10 million shares of CRMD available for free trading, a double-edged sword for true traders as shares can move quickly on very little pressure, but slowly until that pressure arrives. When it comes to companies in Phase III clinical trials that are targeting an area of great unmet need, conducting the trials under a SPA, and have more in the control that could produce a strong, international cash flow, one would be hard-pressed to find many companies the caliber of CorMedix. This all goes without mentioning that, unlike so many biotechs, CorMedix has cash on hand to the tune of over $6 million in the bank presently.
    Jun 29 12:33 PM | Link | Comment!
  • Unilife Device Headed to Clinical Trials
    Unilife Device Chosen for Clinical Trial
    The trend shift towards drug delivery devices becoming a regular part of the FDA approval process took another step forward today as Unilife Corporation (NASDAQ:UNIS) announced one of its portfolio devices was selected by a leading global pharmaceutical company for clinical trials in conjunction with a pipeline biologic drug for targeted organ delivery. The clinical trial is planned to commence within the fourth quarter of 2011 to the first quarter of 2012.
    An initial quantity of devices was delivered by Unilife to the pharmaceutical customer in April 2011 for clinical evaluation, based on an initial agreement that was signed with the pharmaceutical customer. The terms of that agreement and the pharmaceutical customer are confidential at this time. The follow-on clinical supply agreement for final development of the clinical device units and their delivery for the upcoming clinical trial is expected to occur shortly.
    Unilife Chief Executive Officer, Alan Shortall, stated,
    "Targeted organ delivery is one of the key technology platforms within Unilife's rapidly expanding device portfolio. This initial agreement with another leading global pharmaceutical company signals the start of our expansion into other high-value segments in advanced drug delivery systems. 

    Our rapidly expanding platform of proprietary devices is being driven in direct response to the emerging and unmet needs of our pharmaceutical customers. The drug delivery market is now being driven by a new paradigm whereby pharmaceutical companies want innovative devices that are customized to meet the specific needs of highly specialized biologics and the target patient population. Pharmaceutical companies especially desire devices with superior safety and functionality features that can enable their drug products to generate powerful brand differentiation within competitive markets. 

    We are able to secure agreements like this because of the successful commercialization of the Unifill® syringe. Our entire business is now fully aligned around addressing the unmet needs of pharmaceutical customers with an unparalleled level of speed, innovation and performance.
    "We are now replicating our success with the Unifill syringe on a grand scale, with the development of a rich and expansive portfolio of additional pipeline devices. Every one of these products has the potential to revolutionize the delivery of therapeutic drugs within its respective class. Because of our fortitude and foresight in aligning our business to fully serve the needs of our customers early in their clinical development pipeline, we anticipate significant returns as these products are commercialized a few years down the road.”
    Jun 07 8:29 AM | Link | Comment!
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