AMGEN
Vectibix • Panitumumab • ABX-EGF (formerly known as clone E7.6.3)
Affiliate(s):
Japan Tobacco
The XenoMouse technology platform, used to generate ABX-EGF, was originally developed by Xenotech LP, an equally owned limited partnership formed in 1991 by Cell Genesys and JT America, Japan Tobacco's (JT)USA subsidiary. When Cell Genesys created Abgenix in 1996 as a wholly owned subsidiary, Cell Genesys assigned its interest in Xenotech to Abgenix, and in December 1999, Abgenix became sole owner of the XenoMouse technology platform by acquiring all of JT America's interest in Xenotech. Abgenix paid $47 million to JT America for its 50% interest as well as $10 million as compensation to JT to relinquish certain option and license rights to which it was entitled. JT obtained a research license to use XenoMouse technology and options to license the technology for a small number of antigen targets each year. Abgenix will also provide JT with licenses to related technology, obtaining $10 million in return. JT also retains options to, or licenses on, several antigen targets it previously nominated under the Xenotech structure. For all antibody products generated using XenoMouse technology and developed by JT, JT will make license fee payments to Abgenix as well as royalty payments on any product sales. JT and its subsidiaries are estimated to have invested more than $40 million in the creation of the XenoMouse technology; however, JT's emphasis will now be on generating antibody products for its pharmaceutical division to market itself rather than on creating a royalty based income stream.
Lonza Biologics (terminated 6/03)
In June 2003, Abgenix terminated the Agreement with Lonza based on expansion of its own manufacturing capability.
In July 2001, Abgenix and Lonza entered into an agreement giving Abgenix right to enter into exclusive negotiations with Lonza for an additional manufacturing supply agreement for Lonza to make available to Abgenix, for a period of up to 5 years, extendable for an additional 2-year period, approximately 25% of the annual capacity of a cell culture production suite for large scale manufacturing of products that was under construction. The exclusive negotiation period was extended to expire no earlier than June 30, 2002. Financial terms of the agreements were not disclosed.
In November 2000, Abgenix and Lonza Biologics entered into a manufacturing supply agreement for Lonza to make available exclusively to Abgenix, for a period of 5 years, a cell-culture production suite, with associated purification capacity, within Lonza's UK facility. The agreement included an option to extend the initial 5-year term. This dedicated cell culture production suite became available to Abgenix in the third quarter of 2001. Abgenix gained access to production capacity, and scheduling flexibility, Lonza retained responsibility for, and control over, the facility's employees, and its operation.
Takeda Pharmaceutical C
In February 2008, Amgen and Takeda Pharmaceutical Company entered into an agreement under which Takeda will develop and commercialize for the Japanese market up to 13 molecules from Amgen's pipeline (one of which is included as an option), including Vectibix (panitumumab). Amgen retains certain co-promotion rights in Japan on all programs.
Current as of: February 12, 2010 |
Approved (9/06) and launched (10/06) USA - colorectal cancer expressing the epidermal growth factor receptor (EGFr), metastatic, refractory, third line
Approved (12/07) EU - colorectal cancer, metastatic, refractory to fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy regimens, third line, expressing EGFr with non-mutated K-ras
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BAYER
Nexavar • Sorafenib tosylate • 4-[4-[[4-Chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide; C21H16ClF3N4O3 • BAY 43-9006 Affiliate(s):
Onyx Pharmaceuticals
Sorafenib is being co-developed by Bayer Pharmaceuticals and Onyx Pharmaceuticals. The co-development collaboration calls for Onyx to fund 50% of the development and marketing costs for sorafenib worldwide, except in Japan. In return, Onyx has a 50/50 profit share in the USA, where the companies plan to co-promote the product if approved. In all other countries (except Japan) Bayer has exclusive marketing rights and Onyx's profit share is less than 50%. In Japan, Bayer will fund product development and Onyx will receive a royalty.
In September 2002, initiation of the phase II clinical program earned Onyx a $5 million loan milestone payment.
In April 1996, the agreement was amended to allow, that during the research term, Onyx and Bayer, to propose additional cancer research targets or programs outside of ras for inclusion, by mutual agreement, in the research collaboration. No additional targets have been proposed by either party during the period ended December 31, 1996. In addition, Bayer agreed that the research collaboration would continue for its full five-year scheduled term (through January 1999), subject only to termination for breach or in the event of the acquisition of Onyx. The agreement provides for Bayer to pay Onyx an aggregate of $25.0 million to fund research efforts over the five-year research term, of which $5.2 million was recorded by the Company as revenue in 1996, $5.2 million in 1995, and $5.5 million in 1994. In addition, Bayer made a $13.5 million equity investment in Onyx in 1994. Under the agreement, compounds that demonstrate the required level of activity in collaboration assays, as established by the Joint R&D Committee (JRDC), are subject to exclusive rights under the collaboration. Bayer will funds all preclinical work necessary to determine which compounds to take into clinical development and to obtain approval for conducting clinical trials. The parties will share equally all costs of developing each product worldwide (excluding Japan), subject to each party's right to elect not to pay such costs. Under the agreement, Bayer shall make substantial payments to Onyx, based on achievement of development milestones, which are subject to repayment by Onyx out of its share of marketing profits and royalties, subject to certain annual limitations.
Bayer shall market the products worldwide (excluding Japan), and Onyx has the option to co-promote such products in the USA, provided that Onyx share equally all costs of development in which case its expenses would be paid out of product sales. Onyx and Bayer will share equally the profits or losses from jointly developed commercialized products. Bayer has the sole and exclusive right to develop and market these compounds as royalty bearing products in Japan, and will bear all related development expenses. Furthermore, Bayer has the sole and exclusive right to develop and market any compounds active against Bayer-proposed targets as royalty bearing products. In addition, either party may independently develop a compound as a royalty bearing product if the JRDC declined such party's proposal to select the compound for joint development.
In February 1994, Onyx entered into a collaboration with Bayer relating to the ras program. Onyx is responsible for conducting research on the ras signaling pathways, identifying leads for drug screening and developing drug discovery assays. Bayer will screen its compound libraries, synthesized analogs of identified leads and conduct preclinical and clinical trials. In addition, Bayer will fund Onyx' research.
Chiron
When Onyx was established in April 1992, Chiron transfered to Onyx the drug discovery program, primarily in the field of ras research, being conducted at Chiron by Dr. Frank McCormick, the scientific founder of Onyx, and his research team. As part of such transaction, Chiron and Onyx executed a Technology Transfer Agreement dated April 24, 1992, pursuant to which Chiron consented to the transfer of such research program, including the research team, and its trade secrets and materials used in this research. Chiron also granted a license to Onyx under certain patent rights held by Chiron useful in such research. As part of such agreement Chiron agreed not to re-establish a research program in this field for a period of three years. In May 1994, in connection with the formation of the collaboration between Bayer and Onyx, the Transfer Agreement was amended to make Onyx the sole licensee under one of the research assays transferred from Chiron until January 1, 1999, in consideration of which the covenant against Chiron re-establishing its research program in the field was eliminated.
In addition, through April 2007, Chiron has an option to obtain a royalty-bearing license with respect to diagnostic and vaccine products, developed by Onyx in this field. Such license would be exclusive unless an arbitrator determines that Chiron does not have the ability to commercialize the product in question so as to provide Onyx with a reasonable return, in which case such license will be co-exclusive. If Chiron does not exercise such option rights with respect to a particular product, then prior to the completion of phase II clinical trials of the product, the Onyx may seek a third party licensee of the product in question, subject to a right of first refusal in favor of Chiron, and after the completion of phase II clinical trials, the option rights of Chiron expire.
The Transfer Agreement also provides that Onyx may propose collaborations to Chiron in the field of gene therapy. Such proposal would require that Onyx disclose to Chiron the material information known to Onyx regarding the program in question, and also propose a set of terms. If such a proposal is made, and Onyx and Chiron do not reach agreement within 60 days after the proposal by Onyx, then Onyx may, within 120 days thereafter, enter into an agreement regarding such program with a third party on terms no more favorable taken as a whole, to the third party than the terms which Onyx offered to Chiron. Chiron has advised Onyx that it believes the foregoing provision, in the context of other provisions of the Transfer Agreement, imposes an obligation on Onyx to offer gene therapy programs to Chiron pursuant to this mechanism before it licenses any such program to a third party. The Company does not agree that such provision imposes an obligation on Onyx to make such proposals. However, Chiron has agreed that this provision does not apply to the p53 program for therapeutic applications.
In addition, Chiron agreed to fund the Company's research and operating activities up to a maximum of $3.95 million. As of December 31, 1993, all such amounts were earned and paid to Onyx. Chiron also made equity investments in Onyx totaling $402,000 in 1992.
Current as of: June 28, 2010 |
Approved and launched (12/05) USA; approved Switzerland, Chile, Brazil, Korea, Argentina, approved (4/06) Mexico; as of November 2009, Nexavar had been approved in over 80 countries worldwide - kidney cancer, advanced, refractory
Approved and launched (3/06) Switzerlend; approved (7/06) EU - renal cell carcinoma (RCC), advanced, refractory to interferon (IFN)-alpha or interleukin (IL)-2-based therapy or not suitable for such therapy
Approved (11/07) USA; approved (10/07) Europe; approved (7/08) China; as of November 2009, Nexavar had been approved in 90 countries worldwide. - hepatocellular carcinoma (HCC), advanced or metastatic, inoperable, first line
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