The partnership with Amylin is one aspect of an overall strategy by Eli Lilly to build its manufacturing base for biotechnology-based
drugs. In October 2006, Eli Lilly completed the first phase of a $560-million expansion to its biotech complex in Indianapolis,
Indiana. The first phase included the opening of a bioproducts pilot manufacturing plant that manufactures small-scale amounts
of drug for use in clinical trials and a research-support facility. Construction of a third facility, a bioproducts research
and development laboratory was scheduled for completion in the first quarter of 2007.
Also, in January, Eli Lilly announced plans to expand its site in Kinsale, County Cork, Ireland to manufacture active ingredients
for future biotech products and to expand its parenteral operations in Indianapolis so that site can convert the biotech active
ingredients made in Kinsale into their final dosage form.
Eli Lilly, however, decided not to proceed with a planned insulin manufacturing plant in Prince William County, Virginia because
it expects to meet expected growth in insulin demand with existing sites and new insulin capacity that is being built in Sesto,
β peptides and chemical litigation advance peptide research
Takeda Pharmaceutical Company Limited (Osaka, Japan) is partnered with the biopharmaceutical company Affymax, Inc. (Palo Alto, CA) for developing "Hematide," a synthetic, pegylated peptide functioning as an erythropoiesis-stimulating agent.
The drug is in Phase II studies.
Affymax and Takeda are collaborating on the development of Hematide and will cocommercialize the product in the United States.
Takeda has been granted an exclusive, royalty-bearing license to develop and commercialize Hematide outside the United States,
including Japan. Under the pact, Affymax received $132 million in upfront and milestone payments, $10 million from the sale
of equity, and is eligible to receive development and regulatory milestone payments of as much as an additional $345 million
and commercial milestone payments of up to $150 million.
Affymax is responsible for manufacturing the active ingredient in Hematide, and it intends to establish long-term commercial
supply agreements with at least two contract manufacturing organizations, according to company information. Takeda is responsible
for the fill-and-finish of Hematide.
Last year, American Peptide Company (APC, Sunnyvale, CA) formed a clinical supply agreement with Affymax for production under current good manufacturing practices
(CGMP) of Hematide. APC had previously manufactured preclinical lots of Hematide for Affymax.
Affymax and Takeda are positioning Hematide in the $13-billion market for recombinant erythropoietic proteins (EPOs).
This market is led by Amgen, Inc.'s (Thousand Oaks, CA) "Aranesp" (darbepoetin alfa) and Johnson & Johnson's (New Brunswick, NJ) "Procrit" (epoetin alfa).
Although Hematide has the erythropoietic activity characteristic of naturally occurring EPOs, its amino-acid sequence is unrelated
to EPO, recombinant EPO, or other known naturally occurring erythropoietic proteins. Two current types of ESAs, epoetin alfa
and epoetin beta, are biologically engineered hormones produced in mammalian cells by recombinant DNA technology. Both are
relatively short-acting forms of recombinant EPO that typically require frequent dosing. Darbepoetin alfa is a biologically
engineered hormone product closely related to and functionally similar to epoetin alfa. Darbepoetin alfa, however, has a terminal
half-life approximately three times longer than epoetin alfa, as a result of the addition of sialic acid to stabilize the
protein, according to Affymax's annual report.
Roche and Novo Nordisk.
Roche (Basel, Switzerland) is partnered with Ipsen (Paris, France) to license, develop, and market "BIM 51077," an analogue of the peptide hormone GLP-1 to treat diabetes.
Ipsen's technology platform involves the ability to combine the engineering of therapeutic peptides with parenteral sustained-release
delivery technologies. Roche is responsible for manufacturing the product. A Phase II study to confirm the efficacy and safety
of this compound in a sustained-release formulation is expected for this year.