Sanofi-Aventis and Novozymes have signed a development and marketing collaboration for a potential new antibiotic. The drug candidate is an antimicrobial peptide named Plectasin NZ2114 that targets the treatment of severe infections, such as pneumonia and septicaemia, caused by bacteria like Staphylococcus and Streptococcus.

SA has been granted an exclusive worldwide license for the development, registration and commercialization of the drug. The two companies will  work to develop and implement commercial-scale manufacturing of the drug substance, with the goal of introducing a recombinant process building on Novozymes' proprietary expression technology.

"Plectasin NZ2114 is the first drug candidate that Novozymes has outlicensed for further preclinical and clinical development. Teaming up with one of the largest pharmaceutical companies in the world is the type of collaborations we were looking for," said Per Falholt, executive vice president, R&D, Novozymes.

"The innovative mechanism of action of Plectasin NZ2114 makes it potentially active against bacteria resistant to currently available treatments. We are looking forward to developing Plectasin NZ2114 for the treatment of severe infections such as pneumonia, septicaemia, and complicated skin and soft tissue infections," said Dr. Marc Cluzel, senior vice president, R&D, Sanofi-Aventis.

AstraZeneca and MAP Pharmaceuticals have formed an exclusive worldwide agreement to develop and commercialize Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary nebulized formulation of budesonide. UDB is being developed by MAP Pharmaceuticals as a potential treatment for pediatric asthma and is currently in Phase III. UDB has the potential to be nebulized more quickly and at a lower nominal dose than the commercially available product.

AZ will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the currently ongoing Phase III study. MAP is also eligible to receive as much as $240 million in other potential development and regulatory milestones, as well as additional progressively demanding sales performance-related milestone payments of as much as $585 million in the event the product is a "considerable commercial success," according to an AZ statement.

MAP and AZ will develop UDB in the U.S. and AZ has rights to develop and commercialize UDB outside of the U.S. MAP is eligible to receive significant double-digit royalty payments on net sales of UDB worldwide, and AZ will support and fund the establishment of a MAP sales force to co-promote UDB in the U.S. for a certain period of time after product launch.

AZ will be responsible for future UDB development costs and will reimburse MAP for the costs of future UDB development activities with respect to U.S. registration.

David Brennan, AZ's chief executive officer, remarked, “MAP Pharmaceuticals’ advancement in UDB represents an important potential new option for treating children confronting asthma. AstraZeneca’s heritage in treating pediatric asthma, combined with MAP’s expertise can open new areas of opportunity for both companies and has the potential to bring significant medical benefit to the wider community.”

UDB is being developed utilising a license to Elan's proprietary NanoCrystal Technology. The small size and stability of NanoCrystal drug particles are designed to enable improved delivery efficiency of drug formulations to the lung via nebulization, according to AZ.

Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking approval for treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA contains data from six Phase III trials involving more than 11,000 patients, according to Amgen.

"Two Phase III pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce fracture, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "This submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies."

Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.

News from our sister sites