Barcelona, Spain | March 13, 2006 | The Business Intelligence firm La Merie S.L. reported today that the 2005 insulin market is characterized by an ongoing conversion from recombinant human (rhu) insulin to rhu insulin analogs. The three insulin giants Eli Lilly, Novo Nordisk and Sanofi-Aventis booked record sales of more than US$ 7.2 bln. in 2005 with double digit growth rates of their short- and long-acting insulin analogs. Only Lilly’s insulin portfolio lacks a long-acting analog. The recent approval of inhaled insulin Exubera from Pfizer with technology from Nektar Therapeutics marks the beginning of the new era of needle-free insulin administration and the entry of a fourth Big Pharma player into the lucrative insulin market. Novo Nordisk and Eli Lilly have their own inhaled insulins in phase III, Sanofi-Aventis lost it by the merger due to a change-of-ownership clause. This opens the opportunity to reassess the needle-free insulin alternatives and to make the partnering choice among providers of inhaled, nasal, transdermal and oral insulins. These results and more were found in a search conducted by La Merie Business Intelligence. The competitor analysis can be acquired at www.pipelinereview.com, La Merie’s News Center and Online Store. More information will be provided in the insulin miniseries published in the FREE daily R&D Newsletter of PipelineReview.com beginning March 20 .
Among the needle-free insulin technologies, inhalation with deep lung delivery is the most advanced and validated technology. One approved, three phase III and three phase II and I products characterize the advanced stage. Intranasal delivery seems to become the lower cost alternative of the alliance between Bentley Pharmaceuticals and Biocon from India. Nasal delivery of insulin may have a several-fold higher bioabsorption than pulmonary inhalation of insulin. However, there is scepticism about nasal sprays due to the small area of absorption in the nose and the number of variables that could interfere with dosing such as mucous, colds and allergies.
Transdermal delivery technologies using gels, patches and additional aiding systems to allow penetration of the skin seem to be stuck in early development stages. Oral insulins include buccal sprays, enteric coated tablets and gel capsules and are in mid stage clinical development. Emisphere Technologies recently initiated a phase II study with 3-months treatment to evaluate if the technology is able to produce consistently and sufficiently high blood levels of insulin. Engineered insulins with the aim to prolong the half-life beyond that of insulin analogs have not yet reached clinical evaluation.
The demand for insulin is expected to substantially grow in the coming years due to the rising number of insulin-dependent diabetics and the exploding need for alternative insulin delivery technologies. Inhalation of insulins requires at least five-fold more insulin than injection due to the poor bioabsorption. Availability of high volume supply of insulin at a reasonable price will be a key issue to meet this expansion in demand. Production of insulin in transgenic plants may be an alternative. SemBioSys Genetics is aiming to initiate clinical testing of its safflower produced insulin in 2006. Alternative manufacturers of follow-on rhu insulins in Poland, Russia and especially India are scaling up their manufacturing capacities.
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