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The irresistible sirene’s
chant of needle-free insulins
Insulin analogs are conquering the
insulin market, inhaled insulins are the next generation, and
oral insulins might bypass other delivery technologies
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
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.
About R&D Pipeline News
R&D Pipeline News is a premier information source about research and
development projects in the pipeline of the biopharmaceutical industry. The
periodical is directed to all stakeholders in R&D. The weekly publication comes
in a rapid- and easy-to-screen tabular format and provides access to the
original information source via hyperlinks. R&D Pipeline News covers all
relevant treatment modalities and is directly delivered to the desktop via
e-mail. More information about the journal, a free trial and subscriptions are
available via La Merie’s Business Intelligence Center
www.pipelinereview.com .
About La Merie
La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide
high quality R&D information to the biopharmaceutical industry. La Merie offers
individual consultancy services and publishes reports and periodicals.
They publish two weekly
newsletters - apply for a FREE three week trial:
R&D Pipeline News is a premier
information source about research and development projects in the pipeline of
the biopharmaceutical industry and is directed to all stakeholders in R&D. The
weekly publication comes in a rapid- and easy-to-screen tabular format and
provides access to the original information source via hyperlinks. R&D Pipeline
News covers all relevant treatment modalities and is directly delivered to the
desktop via e-mail.
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