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The handful of firms with established bioprocessing capabilities has dominating advantages in antibody drug development. Because process varies little from one antibody to another, they can wait for and quickly pounce on fast-follower opportunities, expanding production capacity in a modular fashion as demand requires--and in this way minimize target risk. Meanwhile, smaller companies, which cannot buy their way into the game nor compete in the more mature world of fast followers, are using their technology development expertise to come up with good drugs against novel targets in diseases where no antibody treatments currently exist, hoping that the novelty of the resulting products will give them the kind of leverage they haven't been able to get from platform dealmaking.
Benefiting from lessons learned during the more than two decades of futile efforts to develop a sepsis treatment, Lilly is primed to launch the first sepsis therapeutic. Lilly's apparent success reflects a revised view of the disease as multi-factorial in nature, involving not only the body's inflammatory processes--long thought to be at the heart of the disease--but also its interlocking coagulation and clot-busting systems. Zovant's development is also marked by a series of business decisions that could have long-term implications for the company, including a renewed commitment to large molecule drugs and the creation of a critical care business. Critical care pharmaceuticals and protein therapeutics are, in many ways, complementary pursuits for Lilly that could help the company maintain its independence by generating big money products that won't require the huge commercialization costs associated with mass-marketed drugs.
Growth of the biopharmaceutical market is going to create critical shortages in protein manufacturing capacity with severe consequences for pharmaceutical companies' ability to deliver products and meet rising market expectations. Companies whose pipelines are heavily reliant on expression systems with limited capacity are particularly vulnerable and should now be making strategic make/buy/collaborate decisions. Indeed, in the short term as capacity tightens, contract manufacturing organizations will gain greater leverage, enabling them to negotiate more strategic business relationships with higher financial returns. In the longer term, however, innovator companies are looking beyond cell culture to alternative technologies such as transgenic animals as a future production platform, in part, because they provide greater flexibility.
Unceremoniously dumped by its partner Johnson & Johnson in early 1998, Amylin struggled to carry on developing amylin--a hormone once hyped as "the missing link" in diabetes treatment. After twice failing to produce clinical evidence that the peptide benefitted diabetic patients, Amylin laid off 80% of its employees, and fell off Nasdaq's big board. Most investors dismissed the company, and their stake in it, as a lost cause. Amylin got a second chance in March 1999, via a private Series A financing. It's too soon to say whether the leap of faith by Amylin's new investors will be rewarded. The firm's aspirations for its lead drug are more modest now than in earlier days. It has no partner, and knows uncertainty still exists in the FDA process. Meanwhile, competitors' oral drugs are helping many Type 2 diabetics.