Archive: Company News
Company News: InDex Pharmaceuticals Strengthens IP Position for Kappaproct
– Novel patent for Phase III lead drug candidate filed in the EU, US –
InDex Pharmaceuticals today announced the filing of a new patent with the United States Patent and Trademark Office and with the European Patent Office. The company thereby continues to strengthen the company’s intellectual property portfolio around its lead drug candidate Kappaproct. The newly filed patent with the title “Methods for prevention of colectomy” covers methods for preventing or reducing the need of colectomy using an oligonucleotide with a specific core sequence and has the potential to extend patent protection on Kappaproct to 2032. Kappaproct is a DNA-based synthetic oligonucleotide, which functions as an immunomodulatory agent by targeting TLR9. Kappaproct is currently in a phase III study in Europe for the treatment of chronic, active, treatment-refractory ulcerative colitis. InDex Pharmaceuticals already holds broad patent protection for Kappaproct for the treatment of steroid-resistant inflammatory diseases in both Europe and the US through at least 2027, with the possibility of a 3 to 5-year term extension after market approval.
In June 2012, InDex Pharmaceuticals reported positive data from the Company’s compassionate use program with its lead compound Kappaproct. The findings published in the peer-reviewed journal Inflammatory Bowel Diseases showed that more than two years post treatment, all but one of the treated patients had avoided the need for colectomy, with the longest patient being in symptom-free remission for over 27 months.
Company News: Curetis AG and Cempra, Inc. Collaborate on the Detection of Community-Acquired Bacterial Pneumonia Pathogens
– Cempra to use Curetis’ Unyvero™ solution in its Phase III trial of its antibiotic solithromycin (CEM-101) –
Curetis AG and Cempra Inc. (NASDAQ: CEMP) today announced a research and development collaboration to incorporate Curetis’ Unyvero™ molecular diagnostic system into Cempra’s upcoming global Phase 3 trial of the oral formulation of solithromycin in patients with community-acquired bacterial pneumonia (CABP).
Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings.
Cempra’s randomized, double-blind Phase 3 trial comparing solithromycin against a comparator drug is expected to enroll over 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero™ Solution and the CE-marked Unyvero™ P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero™ Solution will be paired with clinical and traditional microbiology data to enhance the pathogen diagnosis rate in the trial. The trial is expected to start during the fourth quarter of 2012 and enrollment is expected to be completed in 2014.
Company News: PharmaEngine and Nanobiotix Sign Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3
– Partnership will accelerate NBTXR3 clinical program and develop Asian market –
French Nanobiotix S.A. announced today that it entered into a strategic partnership with PharmaEngine, Inc. for the rapid development of NBTXR3, the lead product from the NanoXray pipeline of Nanobiotix. Nanobiotix is a nanomedicine company developing novel cancer nanotherapeutics, while PharmaEngine is a specialty pharma company focused on the development of in-licensed oncology drugs.
The partnership aims to accelerate the global clinical development of NBTXR3 as PharmaEngine will add its Asia-based complementary clinical development strengths and will conduct further clinical studies.
Under the terms of the agreement, PharmaEngine will receive exclusive rights to develop and commercialize NBTXR3 in the Asian-Pacific region, including Australia, China, India, Japan, Korea, Taiwan and other countries, while Nanobiotix retains exclusive rights for the rest of the world. Nanobiotix retains an option to re-acquire the rights for the entire Asian-Pacific territory except for China and Taiwan, according to pre-defined conditions in exchange for termination payments and agreed-upon royalties.
Nanobiotix will receive an initial upfront payment of US$ 1 million and is eligible for further development and commercialization milestone payments which may amount to a total of US$ 56 million plus tiered, up to double-digit royalties on net product sales in the Asian-Pacific region.
PharmaEngine will further fund the clinical development of NBTXR3 in three different indications. The clinical studies will be initiated according to an agreed upon time schedule and development plan with the goal to commence clinical studies in two indications within 18 months. The parties have agreed to share the data to enable an efficient and focused global development in multiple indications.
Company News: Curetis AG Signs Distribution Deal in Middle East with ATC
– Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for the six Gulf Cooperation Council (GCC) countries and the Lebanon.
Placement of instruments will start in the third quarter this year. A clinical evaluation project of the Unyvero™ Solution has been approved by the Kuwait Ministry of Health and will take place at leading clinical sites in the country. Curetis, ATC and the clinical investigators will cooperate closely during this phase, and are planning to publish evaluation data in 2013 at a renowned international medical conference.