Download Takeda Takes Global Hematide Rights in $535m Affymax Deal

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Industry Watch
Japan
Takeda Takes
Global Hematide Rights
in $535m Affymax Deal
A
ffymax Inc. and Japan’s Takeda Pharmaceutical Co. announced that they have
agreed to globally develop and commercialize Affymax’s anemia drug Hematide
in a deal that could be worth more than US$500 million.
Palo Alto-based Affymax will get US$105 million upfront from Osaka, Japan-based
Takeda. If development goes well, Takeda will pay Affymax an additional $280 million
plus up to US$150 million more for successful sales of the drug. The companies will
co-commercialize Hematide in the United States. Takeda will have an exclusive license
to develop and commercialize the drug in the rest of the world.
Entering its first major global partnership, privately held Affymax Inc. turned to its
Japanese partner Takeda Pharmaceutical Co. Inc. to grant the rest-of-the-world rights
to its anemia drug, Hematide. Within the US, the companies will share development
costs, with Takeda taking on the greater burden. If Hematide reaches the US market,
Affymax will build its own sales force for co-promotion and will share profits equally
with Takeda. Affymax will manufacture and supply the drug substance, and Takeda will
be responsible for final packaging and distribution. While the royalties on Japanese sales
were previously disclosed to be in the double digits, the companies did not specify a
royalty level for sales in other areas outside of the US.
In a statement, Arlene Morris, president and CEO of Palo Alto, CA-based Affymax,
said Takeda is an ideal partner because of its development experience and commercial
capabilities. “Takeda has already shown its commitment to Hematide with the rapid
filing of an investigational new drug application in Japan,” she said, “and we believe
will bring a similar dedication to the development of Hematide globally.”
Hematide is a synthetic, peptide-based erythropoiesis-stimulating agent (ESA)
designed to stimulate the production of red blood cells. ESAs represent a US$12 billion
market worldwide and as much as a $1 billion market in Japan. Existing ESAs on the
market include Thousand Oaks, CA-based Amgen Inc.’s Epogen and Aranesp, as well
as New Brunswick, NJ-based Johnson & Johnson’s Procrit.
As a second-generation ESA, Hematide could hit the US market sometime in 2010.
It is in Phase 2b trials for anemia in dialysis, pre-dialysis, and cancer chemotherapy
patients. The most advanced trial should be completed later this year, positioning Affymax
to enter a pivotal Phase 3 study in kidney disease in the second quarter of 2007. That
trial would be followed by a study in cancer patients, a program that is about 9 to 12
months behind kidney disease.
ESA therapy has reduced the need for blood transfusions and the frequency and
severity of anemia-associated morbidity. The market could grow beyond US$12 billion
if Hematide is approved for oncology indications. Currently, ESAs are approved only
for renal diseases.
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An advantage of Hematide is its once-a-month injection, compared to current
therapies that are injected several times a week or, at the very least, once every two
or three weeks. The product also has an amino acid sequence that is unrelated to
erythropoietin and is, therefore, unlikely to generate antibodies, Affymax said.
About Takeda
Takeda is a research-based global company with its main focus on pharmaceuticals.
Ethical drugs are Takeda’s core business, constituting about 81.5% of total net sales.
Takeda has an international marketing network including Japan and 13 overseas bases
in the US, Europe and Asia. From these bases, Takeda markets its original products
such as the anti-prostatic cancer agent leuprolide acetate (marketed as Lupron Depot®,
Enantone®, Prostap®, and Leuplin®), the anti-peptic ulcer agent lansoprazole (marketed as
Prevacid®, Ogast®, Takepron®, and other names), the anti-hypertensive agent candesartan
cilexetil (marketed as Blopress®, Kenzen®, and Amias®) and the anti-diabetic agent
pioglitazone hydrochloride (marketed as Actos®). Including sales through licensees,
Takeda’s pharmaceuticals are available in over 100 countries worldwide.
About Affymax
Affymax is a clinical-stage pharmaceutical company that is developing a rich pipeline
of synthetic peptide-based drugs against clinically validated targets for the treatment of
kidney diseases and cancer. Affymax’s mission is to accelerate the drug discovery and
development process through innovative technologies based on novel applications of
chemistry and biology. This will expedite advancement to clinical development and
commercialization. In August 2001, a collaboration of several venture firms created
Affymax as an independent company—a spin-out from GlaxoSmithKline. The company
has leveraged its exceptional foundation to become a powerful developer of peptide
drugs.
Contact Details:
Takeda Pharmaceutical Company Limited
Address: 1-1, Doshomachi 4-chome
Chuo-ku
Osaka 5408645
Tel:
+81 6 6204 2111
Fax:
+81 6 6204 2880
URL:
www.takeda.com
Affymax Inc.
Address: 4001 Miranda Avenue
Palo Alto
CA 94304
Tel:
+1 650 812 8700
Fax:
+1 650 424 0832
Email: [email protected]
URL: www.affymax.com
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