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The Industry Insider: May 2007

By Prachi Petal-Predd
Published: Thursday, Aug 12, 2010
THE INDUSTRY INSIDER

Multiple Deals for Affitech

Affitech AS, a privately held human recombinant antibody developer in Oslo, Norway, has made a string of announcements regarding agreements and contracts. The first three product candidates in the Affitech pipeline are fully human antibodies for cancer, and the company expects at least one of these to enter the clinical phase of development by 2008.

On March 28, Affitech announced that it has signed an agreement with Micromet AG, a developer of antibody-based products for cancer based in Munich, Germany, for a non-exclusive worldwide sublicensable research license for Micromet and Enzon Pharmaceutical, Inc’s complementary patent estates in the field of single-chain antibodies (SCA). The agreement terms give Affitech the rights to conduct research involving SCA technology as well as sublicense rights to third parties for conducting research, or to develop or use an SCA product that Affitech creates.

Affitech followed with another license agreement announcement on April 3, this time with Pharmexa, a Danish  immunotherapeutic and vaccine company. Through the agreement, the companies plan to promote a bi-specific single chain antibody (diabody) technology to third parties for further product development. Pharmexa and Affitech will share all proceeds from such third-party agreements. In addition, Pharmexa has granted Affitech a worldwide exclusive license for certain intellectual property rights to diabodies, and Affitech will utilize the technology for its own research. “Because of the built-in dual specificity, diabodies are extremely interesting in the field of cancer research,” said Martin Welschof, Affitech’s chief executive officer. “Therefore, we see them as having great potential in our chosen field of oncology therapeutics.”

Soon after the Affitech-Pharmexa agreement, Affitech and ProBioGen AG, a biotechnology company headquartered in Berlin, Germany, made a joint announcement on April 11 stating that they have entered an agreement for a producer cell line to be developed by ProBioGen. The cell line would be used for high-level production of one of the lead antibody candidates in Affitech’s oncology antibody pipeline. ProBioGen will combine its cell generation process for biopharmaceutical cell lines with an automated cloning process to identify and develop a high producer line. The companies did not disclose the financial details of the agreement.





Pfizer's Sutent Wins European Association of Urology Support

The  European Association of Urology (EAU) has recommended Pfizer’s Sutent (sunitinib malate) as first-line treatment in patients with metastatic renal cell carcinoma of intermediate risk. The EAU recommendation and guidelines make Sutent the first multi-targeted tyrosine kinase inhibitor to be approved for first-line use in the EU. The recommendation closely  follows EU marketing authorization for Sutent—in January 2007, the European Commission had granted full marketing authorization

for Sutent as a first-line therapy in patients suffering from advanced and/or metastatic renal cell carcinoma (mRCC).

The US Food and Drug Administration had approved Sutent in January 2006 for the treatment of advanced mRCC as well as gastrointestinal stromal tumor, a type of stomach cancer. According to Pfizer, Sutent’s approval was the first time that the FDA had approved a new cancer medicine for two indications at the same time.

The oral therapy drug sunitinib malate attacks cancer by starving tumors of blood and nutrients needed for growth and killing cancer cells in tumors. Phase II clinical studies have shown that patients with resistant renal cell tumors who received the drug have high response rates and delayed tumor progression.

The full marketing authorization for Sutent that came two months ago in the EU was based on the results of a large,  nternational phase III trial, results of which were published in the January 11 issue of The New England Journal of Medicine. In this study, 750 patients received sunitinib malate or the current standard care therapy, interferon alfa. Sunitinib malate more than doubled prolonged progression-free survival as first-line treatment in patients with mRCC—11 months as opposed to 5

months for interferon alfa. In addition, sunitinib malate led to a five times higher objective response rate and was better tolerated with fewer discontinuations.


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