Life Science Leader Magazine

APR 2013

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Pharma Management afford to finance its own R&D; and believes it will launch at least one blockbuster drug: a long-acting antipsychotic (with J&J;), treatments for alcoholism and MS, or a monthly Diabetes 2 drug. For all the startups with big dreams, this company offers plenty of inspiration. Rib-X We visited off-site with this nonpresenting company, one of the few players in ribosomal drugs. Rib-X uses rational drug design (remember that?) based on crystallography, computation, and other new tools to construct small-molecule antibiotics that target bacterial ribosomes and thereby impede drug resistance. Just to be a player in antibiotics these days is to belong in an elite group, following major retreats from the field by the likes of Roche and Lilly. That any new antibiotic must employ a novel drug mechanism is a given, but less obvious is how long it will take for the bacteria to adapt. We will be following the progress of Rib-X and will return to it as it reaches future milestones. Bayer Healthcare A major division of the now diverse and global corporation, presenting company Bayer Healthcare had a good year financially with 4% overall growth and 6% in EBITA, led by its pharma business. Singledigit growth was once nothing to crow about, but nowadays, growth is growth. It is intriguing that Bayer's top-selling product is Betaseron, an early biotech product that goes back to Schering AG and mighty little Triton Biosciences of the Bay Area in the 1980s. Primary care is a shrinking business in the West, however; Bayer is moving its PC headquarters from Berlin to Beijing because China bucks the trend. It is also ending further contraception and Betaseron research, expecting sales declines. The future apparently belongs to the now-booming cardiology and oncology areas, with remaining areas following along opportunistically. Watch Bayer in OTCs, where emerging markets are now one-third of its business vs. one-fourth in the U.S. dividend, and funding pipeline development, according to Chairman John Lechleiter. The first steps began in 2004: reducing the workforce, expanding in emerging markets, and replenishing the pipeline. 2008 brought a large acquisition of ImClone, restructuring into five business areas, and creation of Lilly's Center of Excellence research arm. A major collaboration with Genzyme came in 2010. The pipeline now has 13 products in Phase 3 and 20 in Phase 2. Lechleiter argues that existing products have now achieved double-digit growth, workforce is down 16%, and the company will meet or exceed financial goals in 2014. Such performance may yet vindicate Lilly's spending "at an appropriate level" for R&D;, though higher than its peer companies with deflating research budgets. AstraZeneca Not that I was prescient at this presentation — AstraZeneca replaced its head of discovery a few days later — but I did sense an uneasiness in the CFO's discussion of the company's pipeline as he spoke about the "opportunity to replenish" the Phase 3 stage of its platform from the ample stable of candidates in Phase 2. He also emphasized the company's "sustainable base" of off-patent products such the "resilient" Zoladex and Synagis/Flumist. AZ places much hope for new products in its Medimmune division and in an aggressive partnership program seeking "scale and reach" in R&D; (40% of its pipeline is partnered, and at least eight of its partners are Big Pharmas). But a lot appears to be on the line with its decision to realign its discovery organization. LEAVING FOR THE FUTURE Metabolon Another nonpresenting company, Metabolon, met with us to describe how its end product — metabolic biomarkers for drug discovery and manufacturing — demands a deep understanding of therapeutic areas where biomarkers play a growing role, such as obesity, diabetes, and cancer. The company serves a base of 500 customers, including most top pharmas and biopharmas, all aiming at new treatments. It uses multivariate analysis and biochemistry, not genomic tools, to identify biomarkers and evaluate biochemical for potential therapeutic safety and efficacy. Numerous companies and individuals deserve mention here, though most will have to wait for another day. Meetings and presentations produced fuel for much future editorial coverage. Among all the stories I heard, however, I noticed a few general trends: • Cancer remained the dominant area of development this year, but targeted therapies seemed to give some ground to immunotherapeutic approaches in the proportion of total company programs presented. • More companies, big and small, mentioned manufacturing as a key strategic concern and the target of efficiency and optimization initiatives. • Companies seemed to widen the practice of branding clinical trials, not only with acronyms but with word-play collages and colorful logos. Why? Lilly Expiration of top-product Zyprexa in 2009 has dominated Lilly's strategy, as well as external comment, since well before then. The goal was to replace the lost multibillion-dollar revenue mainly by maximizing existing-product sales, increasing productivity, maintaining the stock By the end of the meeting, I had composed the following tweet to sum up this year's event but decided to save it for this report — "JPMHC: A 4-day nonstop steep-hill trek for body and mind." Most people who braved it would likely agree, but I bet they would also say it was well worth the journey. 60 LifeScienceLeader.com April 2013

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