Archive: Company News
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.
Company News: Merus Receives EP Patent Covering the Expression of Defined Antibody Combinations
Merus B.V., a biopharmaceutical company focused on multispecific human antibody therapeutics, announced today that it has been granted the first European patent covering its Oligoclonics® technology from a patent family that already comprises 4 issued US patents. The Oligoclonics® technology entails the manufacturing of at least three antibodies with different specificities by a single production cell line, thereby providing for combinations of human antibodies as a single therapeutic.
It has been demonstrated in clinical trials and disease models that combinations of antibodies are more efficacious than therapies based on single monoclonal antibodies alone. The Oligoclonics® technology is designed to provide important developmental and therapeutic value. It offers a platform for the stable, high-yield production of fully human, natural IgG antibody combinations by a single cell line using strategies currently exploited for conventional monoclonal antibodies in a manner that is cost-effective and acceptable to regulatory authorities.
“The therapeutic antibody field is moving towards combination therapies, either by combining individual monoclonal antibodies or by applying bispecific formats, to overcome the limited potency of monoclonal antibodies often observed in indications like oncology,” said Ton Logtenberg, CEO of Merus. “The Oligoclonics® technology provides a platform that allows for the cost-effective development and manufacturing of multispecific combinations of antibodies with more potent clinical effects. The key to the Oligoclonics® technology is that all antibodies produced by the clonal manufacturing cell line share a common light chain (cLC). With our recent announcement of MeMo®, a transgenic mouse for the generation of human cLC monoclonal antibodies, we are complementing our technology base with the aim to expand our pipeline of innovative cLC antibody products.”