Merck (NYSE: MRK), known as MSD outside the US and Canada, and AiCuris have announced that they have entered into an exclusive worldwide licensing agreement for AiCuris’ novel portfolio of investigational medicines targeting Human Cytomegalovirus (HCMV), including letermovir (AIC246), an oral, late-stage antiviral candidate being investigated for the treatment and prevention of HCMV infection in transplant recipients.
“There is a significant need for additional medicines for the treatment of HCMV infection, which is one of the most common viral infections affecting organ and bone marrow transplant patients,” said Dr. Roger Pomerantz, senior vice president, Worldwide Licensing and Knowledge Management, and Infectious Disease Franchise Head, Merck Research Laboratories. “AiCuris has built a leading portfolio of innovative antiviral HCMV candidates that are designed to address novel targets and offer the potential for HCMV prophylaxis. This portfolio complements Merck’s broad antiviral portfolio.”
Under the agreement, Merck, through a subsidiary, will gain worldwide rights to develop and commercialise candidates in AiCuris’ HCMV portfolio. AiCuris will receive a €110 million upfront payment and is eligible for milestone payments of up to €332.5 million based on successful achievement of development, regulatory and commercialisation goals for HCMV candidates, including letermovir, an additional back-up candidate as well as other Phase I candidates designed to act via an alternate mechanism. In addition, AiCuris will be entitled to receive royalty payments reflecting the advanced stage of the clinical program on any potential products that result from the agreement, Merck will be responsible for all development activities and costs.
“This is the first development deal derived from AiCuris’ strong pipeline, and we are very pleased to have Merck, a major global player in healthcare, be our license partner,” commented Dr. Thomas Strüngmann, majority investor in AiCuris.
“Merck´s ongoing commitment to infectious disease research, combined with its experience in developing and marketing antiviral products, makes them an excellent partner for AiCuris´ unique HCMV portfolio,” added Dr. Helga Rübsamen-Schaeff, AiCuris’ CEO. “We very much look forward to working with the scientists and clinical development teams at Merck to maximise the therapeutic potential of these candidates for patients.”
Closing of the transaction is contingent upon obtaining clearance from the relevant authorities.
Letermovir (AIC246) is an investigational oral, once-daily candidate for the prevention and treatment of HCMV infection. It is a potentially first in class molecule derived from a novel chemical class (quinazolines) and is designed to inhibit the HCMV viral terminase. In April 2012, AiCuris announced that a randomised, placebo controlled Phase IIb clinical trial evaluating the safety and efficacy of letermovir in HCMV-seropositive allogeneic human blood precursor cell recipients (bone marrow transplant patients) met all primary efficacy endpoints. Letermovir has received Orphan Drug Status in the European Union and the United States, where it has also been granted Fast Track Designation.
The Human Cytomegalovirus (HCMV) is widely spread in the human population and can cause severe, life-threatening infections in cases of immune incompetency or immune deficiency, such as, for example, cases in transplant recipients, newborn babies and HIV/AIDS patients. HCMV infection is characterised by fever, leucopenia (very low white blood cell count) and thrombocytopenia (very low platelet numbers) with or without specific organ dysfunction. Two main strategies to prevent HCMV infection have been adopted: anti-HCMV drug prophylaxis or pre-emptive treatment of transplant recipients who are at risk and have evidence of HCMV infection upon screening.
AiCuris GmbH & Co KG (name derived from Anti-Infective Cures) was founded in 2006 as a spin-off from Bayer Healthcare AG. With its deep roots in Bayer´s long history of successful anti-infectives drug research and development, AiCuris is focused exclusively on the discovery, research and development of novel, resistance breaking antiviral and antibacterial agents for the treatment of severe and potentially life-threatening infectious diseases. Majority investors are Drs. Strüngmann, founders and former owners of the pharmaceutical company Hexal. Besides the HCMV program, AiCuris is pursuing several other candidates in various stages of clinical development including a novel anti Herpes simplex compound ready for Phase III clinical testing. For more information, please visit www.aicuris.com.
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