Linear IgA Bullous Dermatosis

Antagonist anti-CD89 will be developed for the treatment of Linear IgA Bullous Dermatosis. WARSAW, Poland--(BUSINESS WIRE)-- JJP Biologics, a company that specializes in the development of proprietary biologic agents for personalized medicine approaches, has announced that the European Commission has approved the company’s application for designation of its product candidate JJP-1212 as an orphan medicinal product for treatment of Linear IgA Bullous Dermatosis (LABD). Following the European Medicines Agency’s recommendation, the European Commission has confirmed that the intention to treat this condition with JJP-1212 justified orphan drug status based on in vitro and in vivo non-clinical data showing the reduction in the influx of granulocytes into the basement membrane zone of the skin and reduction of inflammatory biomarkers, addressing the key elements of LABD skin blistering pathogenesis. LABD is a chronically debilitating disease and may lead to blindness and blister formation. Moreover, currently no approved treatments are available for LABD in the European Union. The European Commission has confirmed that, as of the day of submitting the application, LABD could affect approximately 0.3 in 10,000 persons in the European Union.1 “The orphan drug designation of JJP-1212 by the EMA validates the scientific and business choices of JJP Biologics. It was confirmed that JJP-1212 targets the central mechanism in LABD by antagonizing the IgA-CD89 interaction” according to Louis Boon, the Chief Scientific Officer at JJP Biologics. “We are very excited to offer a potential novel therapy for patients suffering from this ultra-rare skin disease with currently unmet needs”. Having this drug classified into the group of orphan medicinal products provides scientific advice and protocol assistance of the agency. “This decision by the European Commission has also a substantial streamlining effect on the clinical development timeline. We feel the responsibility to translate this decision into prompt availability of the therapy for patients” states Paweł Szczepański, the Chief Operations Officer at JJP Biologics. About JJP Biologics: JJP Biologics sp. z o.o. is a biotechnology company that specializes in the development of proprietary biologic agents accompanied by companion diagnostics to allow therapy personalization. JJP Biologics is a privately funded biotech which pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners. The company’s programs target general immune pathways that have application in autoimmune diseases and cancer. JJP Biologics currently has a range of programs including the most advanced JJP-1212 program and an anti-CD270 program for immune oncology. 1 JJP Biologics performed a systematic review of the published literature and the relevant EU databases (list items)

Frustrated by the challenges of giving her young son his daily asthma treatments, Sarah Cota came up with an idea. Why not ease the burden of using a nebulizer by taking away the mask and using it while the child is sleeping? That’s the idea behind the JettPak, the flagship product being developed by Bend, Oregon startup JettStream Inc. It’s a hands-free, mask-free add-on for nebulizers currently on the market. Intended to deliver medication to the child while he’s sleeping, the base of the device can slide under a pillow or mattress. The JettPak has an adjustable arm that delivers the medication next to the child’s face. According to a July blog post from Jim Harrer, an entrepreneur and chief operations officer of the company, it will retail for about $200. Cota didn’t return a call last week, but she told the Cascade Business News earlier this month that the estimated launch date for the device was spring 2013. Right now, the startup is raising money for the launch; it’s already secured $115,000 in debt and equity, and could raise up to $750,000, according to a recent U.S. Securities and Exchange Commission filing. As the company’s website notes, it has already done lab testing that shows the device delivers the same doses of medicine as a nebulizer alone, and it’s planning to do a clinical trial with 50 devices at Bend Memorial Clinic. Asthma is the most common chronic childhood disease and affects nearly 5 million U.S. children. In addition to quick-relief medications, long-term control medications taken daily are often prescribed. Many of these medications can be used with a nebulizer for asthma sufferers who are too sick or young to use an inhaler effectively. But some children show resistance to these administration methods, as detailed in Cota’s blog. She’s working with a former product development executive, Matt Smith, and Harrer to bring the device to market. Companion to the device is JettEducation, an online database being developed for parents, and JettCommunity, a digital support community.