Advancing a Drug Candidate and a Career:
Merck's Commitment to Partnering Does Both

In the early 1990s, Merck was taking steps to establish a strategic initiative aimed at facilitating collaborations in the earlier stages of drug development. Much of this had been driven by the explosion of interest in the biotechnology industry that had empowered scientists across the world to advance their discoveries. The development of medicines was no longer the sole domain of the pharmaceutical companies. Merck realized that important research and discovery efforts were taking place outside of their labs and the company began to make early scientific partnering a component of R&D.

Around the same time, a group of talented scientists at Khepri Pharmaceuticals in San Francisco were working on cathepsin K, the protease involved in the degradation of the collagen component of bone. Cathepsin K had validation as a target by virtue of a human mutation in the enzyme that results in a disease called pycnodysostosis. The painter Toulouse-Lautrec had this disease, resulting in short, thick bones. The Khepri scientists reasoned that by targeting this protease they might be able to develop a novel approach to inhibiting bone resorption. Their experiments succeeded in identifying several small molecule inhibitors. In 1995, the company was acquired by Arris Pharmaceuticals and the work was further advanced and published in several notable scientific publications.

Seeking the Best Science... Internally and Externally

Scientists at Merck, who had great expertise in the area of bone resorption, took notice. They realized that Arris' know-how in the field of cysteine proteases combined with Merck's expertise in bone biology, enzymology, and medicinal chemistry could result in the development of a cysteine protease-inhibiting drug, a potentially novel approach to treating osteoporosis. A phone call from Merck to Arris set off a rapid chain of events.

Merck's Dr. Greg Wiederrecht, a bench scientist from Merck's Immunology area who had recently transferred to Merck's External Scientific Affairs group, helped lead the licensing efforts.

"I recall the excitement and energy from our scientific teams over this particular program. It was evident that significant scientific work had already been done and that by combining our strengths we truly had the chance to advance this work into something that could be an important new therapy."

The deal was done very quickly — within six weeks due diligence was completed and the deal was signed. In 1996, Arris merged with Sequana Therapeutics to form AxyS Pharmaceuticals. AxyS was later acquired by Celera. Despite these changes in ownership, the original agreement remained intact. The working relationship was exceptional, with both sides meeting face-to-face several times each year to work through a particularly difficult development obstacle that could have halted the program. Today Merck's and Celera's efforts have paid off and the drug candidate derived from this collaboration, MK-0822 (odanacatib), is being evaluated in phase III clinical trials.

Experience and Leadership

Similarly, Dr. Wiederrecht's career has advanced as well. Today he serves as vice president heading the External Scientific Affairs (ESA) team, a group of more than 80 senior scientists and other professionals — located around the globe — who are charged with identifying and evaluating external drug development opportunities. With more than 60 percent of Merck's 2009 revenue attributable to licensed products or patents, the work that Dr. Wiederrecht's team does is highly valued.

"Starting out as a bench scientist, I was very focused on my specific project, trying to make a better FK-506 (immunosuppressive drug). Moving to ESA was scientifically broadening as I was responsible for reviewing opportunities across therapeutic areas," said Dr. Wiederrecht.

While his focus is on finding the best science — wherever in the world it may be — he also understands the importance of building partnerships that benefit all parties involved. He has worked hard to establish Merck as the partner of choice that companies seek out when they want to collaborate.

"Merck's licensing organization was recently ranked as first among 14 of the largest BioPharma licensees in an independent survey on partnering and capability attributes. 'Combining our strengths and sharing our successes' is more than just a tagline to us. It is how we approach each opportunity," said Dr. Wiederrecht.

An Ongoing Partnership

Based on the success of the odanacatib partnership, Celera and Merck continue to work together on a number of projects.

"Throughout the years of working together on developing odanacatib, Merck has shown exceptional levels of commitment and dedication to the science behind our common candidate drug," says Kathy P. Ordonez, CEO of Celera. "For Celera and its team, Merck has been the ideal partner for odanacatib and other collaborations."

"Collaboration is key to modern-day drug discovery and development," says Dr. Wiederrecht. "Merck is committed to identifying and nurturing successful partnerships in order to create the drugs that benefit people around the world."

Read more about the clinical study data presented at the American Society for Bone and Mineral Research Annual Meeting in October 2010.