RXi Pharmaceuticals Corporation and Ethicor Ltd. Announce the Signing of a Distribution Agreement for RXI-109 in the European Union under the "Specials" Provision
WESTBOROUGH, Mass., Nov. 18, 2013 /PRNewswire/ -- RXi Pharmaceuticals Corporation (OTCQX: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced that they have signed a distribution agreement with Ethicor Ltd., a UK based unlicensed medicinal products ("Specials") pharmaceutical company. The agreement provides Ethicor with the distribution rights to RXI-109 in the European Union, with the possibility to extend it to other regions of the world, excluding the United States, Canada and Mexico, prior to and until the registration of the product in the different countries covered by the agreement.
Under the European medicines legislation (Directive 2001/83/EC, Article 5(1)), Ethicor will be able to supply, prior to regulatory approval, RXI-109 as a "Special." A "Special" may be requested by an authorized health-care professional to meet the special needs of an individual patient under their direct responsibility. Specials cannot be actively promoted to health-care professionals.
Under the terms of the agreement, the gross profit generated from this "Specials" sale will be shared between RXi Pharmaceuticals and Ethicor. Once RXI-109 becomes an approved drug in a given country, the marketing rights to the approved product in that country revert back to RXi.
"We are very pleased to be working with Ethicor on this opportunity for RXI-109, because the Ethicor management team has a broad and deep experience in commercializing Specials," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that: "This collaboration is important for health-care professionals and patients who can get safe controlled early access to a developmental drug that could be transformational for patients' lives. It is also a significant milestone for RXi Pharmaceuticals because, in addition to some possible early revenue, the increased exposure for RXI-109 may be a key in accelerating the development of our drug, and in making other companies aware of the business development potential of RXi's unique proprietary self-delivering platform of RNAi oligonucleotides."
RXi Pharmaceuticals' first clinical program involves RXI‑109, a self-delivering RNAi compound (sd‑rxRNA®) developed for the reduction of dermal scarring. RXI‑109 is designed to reduce the expression of CTGF, a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin. The first clinical trials of RXI‑109 showed excellent safety and tolerability with ascending single or multiple doses.
RXi's sd‑rxRNA oligonucleotides are designed for therapeutic use and have drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. These hybrid oligonucleotide molecules combine the beneficial properties of conventional RNAi and antisense technologies. This allows sd‑rxRNAs to achieve efficient cellular uptake and potent, long-lasting intracellular activity.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (OTCQX: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to down-regulate, the expression of a specific gene that may be over-expressed in a disease condition. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the RXi Scientific Advisory Board, RXi's first RNAi product candidate, RXI‑109, targets connective tissue growth factor (CTGF) to reduce dermal scarring (fibrosis), entered into human clinical trials in June 2012. For more information, please visit www.rxipharma.com.
About Ethicor Ltd.
Ethicor Pharma Ltd ("Ethicor") is a specialty pharmaceutical company committed to the development and distribution of unlicensed medicinal products ('specials') on request from healthcare professionals to meet the clinical needs of individual patients when authorized medicines are not a suitable or appropriate treatment option. 'Specials' are unlicensed medicines that are produced in limited or medium bulk quantities and are primarily used for the unmet clinical needs of an individual doctor's patient, particularly where authorized medicines are inappropriate or simply not available. Ethicor is active in markets worldwide excluding the US and has a portfolio of both generic and IP protected unlicensed products.
Please visit www.ethicorpharma.com for more information on Ethicor.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, including future expectations regarding our NASDAQ listing, planned and future development of RXi Pharmaceuticals Corporation's products and technologies. Forward-looking statements about expectations and development plans of RXi's products involve significant risks, and uncertainties: risks that RXi may not be able to successfully develop RXI-109 and our other product candidates, or that development of RNAi-based therapeutics may be delayed or not proceed as planned, or that we may not develop any RNAi-based product; risks that the development process for our product candidates may be delayed, risks related to development and commercialization of products by our competitors, risks related to our ability to control timing and terms of collaborations with third parties; the possibility that other companies or organizations may assert patent rights preventing us from developing our products; risks related to our ability to successfully list our securities on a national securities exchange and statements about other future expectations. Actual results may differ from those contemplated by these forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
RXi Pharmaceuticals Corporation
Tamara McGrillen, 508-929-3646
SOURCE RXi Pharmaceuticals Corporation