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Seen but not heard
August 2011
by Amy Swinderman  |  Email the author


AMSTERDAM, The Netherlands—Sanofi has partnered with Audion Therapeutics, a private biopharmaceutical company focused on developing treatments for conditions affecting the ear, to develop potential treatments for hearing loss through the optimization of small molecules by using a regenerative medicine approach.  
The companies announced their partnership with little fanfare on June 16, and are not granting media interviews. However, their collaboration holds significant promise, as hearing loss is a condition with a significant unmet patient need. According to the World Health Organization (WHO), approximately 500 million people worldwide suffer from some form of it, and there are currently no prescription products for a disease-modifying treatment.  
According to the WHO, of people aged 65 to 74, nearly 33 percent have hearing loss and close to 50 percent of people over the age of 75 are affected. Of people over the age of 85, almost everyone is affected to some extent.  
Current estimates have approximately 900 million people suffering from age-related hearing loss by 2050—but younger people are reportedly suffering more as well, due to frequent exposure to excessive noise. And according to the National Institutes of Health and the Centers for Disease Control and Prevention, the total annual costs of hearing loss are approximately $50 billion per year in the United States alone.
That's a tall order for Audion, whose science and drug discovery platform originate from the Massachusetts Eye and Ear Infirmary (MEEI) , a specialty hospital providing patient care for disorders of the eye, ear, nose, throat, head and neck. The MEEI also has a leading international reputation in hearing loss research and is a teaching partner of Harvard Medical School.  
The company's founders include Albert Edge, associate professor at Harvard Medical School, Helmuth van Es (who is also the co-founder of Galapagos NV) and Rolf Jan Rutten. Audion's technologies originated from Edge's research at the MEEI and are exclusively licensed to Audion.  
Audion approaches hearing loss by focusing on the regeneration of sensory hair cells in the inner ear, which are lost in the vast majority of hearing loss cases. To achieve this, the company has a validated industrialized screening cascade and a critical path to identify, verify and develop new small-molecule compounds. The company also has a broad patent portfolio that covers its drug discovery platform, screening cascades, molecular targets and new compounds.  
Under its agreement with Sanofi, Audion will use the technology developed at the MEEI in the Eaton-Peabody Laboratory by Edge. Sanofi has an option to license technology rights from Audion related to research conducted under the collaboration. No further details were made available.  
"This alliance with Sanofi validates our thinking around developing small-molecule regenerative drugs for the treatment of hearing loss. We are very excited about this collaboration," said Jan Rutten and van Es in a statement released by the companies. "Sanofi's interest in the hearing loss field plus its vast experience and infrastructure in small-molecule drug discovery make them the perfect partner to move this program forward as diligently as possible."
Jan Rutten, however, hinted to ddn that the company will be making headlines again before year's end: "We are focusing our attention on the collaboration and the build-up of our pipeline at this time, and we would rather put ourselves in the media again when we have more news," he said via e-mail.

Sanofi, Rib-X ink deal to seek antibiotics for multi-drug resistant pathogens
NEW HAVEN, Conn.—In other news from Sanofi last month, the pharma and Rib-X Pharmaceuticals Inc. have signed an exclusive worldwide research collaboration agreement and option for license for novel classes of antibiotics that result from Rib-X's RX-04 program for treating resistant Gram-positive and Gram-negative pathogens. Per the terms of the collaboration agreement, Rib-X will receive $10 million from Sanofi in an upfront payment, and is also eligible to receive up to $9 million in near-term research milestones. Rib-X will also be eligible for further payments, based on the achievement of certain research, preclinical, regulatory and commercial milestones.  
Sanofi will have the right to develop multiple products under the agreement. With the exclusion of the assets licensed to Sanofi through the agreement, Rib-X will retain the rights to the discovery platform as well as its future programs. Rib-X retains a co-promotion option within the United States on one of the molecules resulting from the collaboration, as well. Development and regulatory milestones could result in up to $86 million on a per product basis, while commercial milestones could result in over $100 million on a per product basis. Royalty rates on net sales could reach low double-digit figures.  
"We could not be more excited about partnering with a preeminent global pharmaceutical company such as Sanofi," said Mark Leuchtenberger, president and CEO of Rib-X, in a press release regarding the agreement. "This partnership reflects our shared commitment to staying ahead of the growing problem of antibiotic resistance by delivering new standards of care for patients in need."   
The proprietary approach of Rib-X's RX-04 program is one of rational drug design and creates new families of compounds, specifically ones with demonstrated efficacy at low, single doses in murine infection models. The program has demonstrated antibacterial activity against several difficult-to-treat, clinically important, multi-drug resistant Gram-negative and Gram-positive pathogens. Rib-X's RX-04 program specifically targets bacterial ribosomes within the cells, the site of protein synthesis. Recent data confirms that these novel classes of compounds impact ribosome function directly, with their anti-bacterial activity working to interfere with the synthesis of proteins.   
"The RX-04 program's completely novel classes of antibiotics should lead to true breakthrough therapies and we look forward to working in partnership with Sanofi to advance these treatments into the clinic and eventually bring them to the global market. Importantly, this agreement will enable Rib-X to aggressively advance our clinical stage candidates, delafloxacin and radezolid, towards pivotal trials and support additional discovery-stage programs like RX-05 and RX- 06," said Leuchtenberger.
Multi-drug resistant bacteria are one of the faster growing crises in public health. Bacteria come in two main classes and are defined by their appearance when they are stained and viewed under a microscope: Gram-negative, which appear pink, and Gram-positive, which look violet blue and generally lack the outer membrane found in Gram-negative bacteria. According to the World Health Organization, at least 25,000 people in the European Union alone die from infections caused by multi-drug resistant bacteria every year.  
"We are very enthusiastic about entering into this collaboration with Rib- X," said Dr. Elias Zerhouni, president of global R&D at Sanofi, in a press release about the agreement. "The clinical need for new antibiotics is reaching crisis level, yet the antibiotic pipeline is running dry and fewer and fewer companies are working to develop drugs in this space. This partnership exemplifies Sanofi's commitment to translate novel approaches for treatment into patient solutions addressing the global critical need to combat the rising threat of antibiotic drug resistance."
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