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Collaborations And Other Agreements
9 Months Ended
Sep. 30, 2011
Collaborations And Other Agreements 
Collaborations And Other Agreements

Note 4. Collaborations and Other Agreements

Collaboration Agreement with GlaxoSmithKline

During 2006, the Company entered into a license agreement with GSK for the co-development and commercialization of BENLYSTA arising from an option GSK exercised in 2005, relating to an earlier collaboration agreement. The agreement grants GSK a co-development and co-commercialization license, under which both companies are jointly conducting activities related to the development and sale of products in the United States and abroad. The Company and GSK share Phase 3 and 4 development costs, and share sales and marketing expenses and profits of any product commercialized under the agreement. The Company has primary responsibility for bulk manufacturing and for commercial manufacturing of the finished drug product. In partial consideration of the rights granted to GSK in this agreement, the Company received a non-refundable payment of $24,000 during 2006 and recognized this payment as revenue over the remaining clinical development period, which ended in 2010. In March 2011, the FDA approved BENLYSTA and in July 2011 the European Commission granted marketing authorization for BENLYSTA.

GSK's share of the collaboration profit with respect to BENLYSTA in the U.S. and HGS' share of the ROW collaboration expense incurred by GSK are included in the Commercial collaboration expenses line in the consolidated statements of operations for the three and nine months ended September 30, 2011.

Research and development expenses for the three months ended September 30, 2011 and 2010 are net of $2,420 and $17,802, respectively, of costs reimbursed by GSK. Research and development expenses for the nine months ended September 30, 2011 and 2010 are net of $14,270 and $48,838 of costs reimbursed by GSK. The Company shares certain research and development costs including personnel costs, outside services, clinical manufacturing and overhead with GSK under cost sharing provisions in the GSK collaboration agreement.

U.S. Government Agreement

In July 2009, the USG agreed to purchase 45,000 additional doses of raxibacumab for the SNS, to be delivered over a three-year period beginning in 2009. The Company expects to receive a total of approximately $142,000 from this order as deliveries are completed. The Company recognized $12,048 and $7,295 in product revenue related to raxibacumab during the three months ended September 30, 2011 and 2010, respectively. The Company recognized $38,944 and $33,963 in product revenue related to raxibacumab during the nine months ended September 30, 2011 and 2010, respectively. The Company recognized $799 and $600 in manufacturing and development services revenue related to the work to conduct animal studies and other raxibacumab activities during the three months ended September 30, 2011 and 2010, respectively. The Company recognized $2,169 and $1,438 in manufacturing and development services revenue related to the work to conduct animal studies and other raxibacumab activities during the nine months ended September 30, 2011 and 2010, respectively. The Company is entitled to receive approximately $20,000 under the contract with the USG upon FDA licensure of raxibacumab.

 

Aegera Agreement

During 2007, the Company entered into a collaboration and license agreement with Aegera under which the Company acquired exclusive worldwide rights (excluding Japan) to develop and commercialize certain oncology molecules and related backup compounds to be chosen during a research period extended through 2011. Under the agreement, the Company paid Aegera an aggregate of $20,000 for the license and for an equity investment in Aegera. The Company incurred and expensed research costs of $593 and $579 related to the Aegera agreement during the three months ended September 30, 2011 and 2010, respectively, and $1,816 and $1,748 during the nine months ended September 30, 2011 and 2010, respectively.

During March 2011, the Company determined that its investment in Aegera had incurred an other-than-temporary impairment based on changes in Aegera's business activities and wrote down its investment of approximately $3,150 to approximately $240. The impairment loss is included in Other income (expense) on the consolidated statement of operations for the nine months ended September 30, 2011. In May 2011, Aegera was acquired by Pharmascience and the Company received proceeds of approximately $320 resulting in a gain on the sale of the investment of approximately $80, which is included in Other income (expense) on the consolidated statement of operations for the nine months ended September 30, 2011.

Morphotek Agreement

During 2009, the Company entered into an agreement with Morphotek, Inc. to discover, develop and commercialize therapeutic monoclonal antibodies in the fields of oncology and immunology that specifically target antigens discovered by the Company. With respect to each antibody candidate, the Company and Morphotek have the right to opt in to participate in development and commercialization. The Company and Morphotek currently share research and development costs with respect to one collaboration product and the Company has primary responsibility for manufacturing clinical supplies of that product. Research and development expenses for the three and nine months ended September 30, 2011 are net of $1,033 and $3,419, respectively, of costs reimbursed by Morphotek. No research and development expenses were shared during the nine months ended September 30, 2010.

FivePrime Therapeutics Agreement

In March 2011, the Company entered into an agreement with FivePrime Therapeutics, Inc. ("FivePrime") to develop and commercialize FivePrime's FP-1039 product candidate for multiple cancers. The Company paid FivePrime an upfront license fee of $50,000, which is reflected in research and development expenses in the consolidated statement of operations for the nine months ended September 30, 2011. The Company's policy is that upfront and milestone payments made to third parties for in-licensed products that have not yet received marketing approval and for which no alternative future use has been identified are expensed as incurred. The Company may be required to pay up to $445,000 in future development, regulatory and commercial milestone payments, as well as royalty payments on net sales if the product is commercialized. HGS has exclusive rights to develop and commercialize FP-1039, now known as HGS1036, for all indications in the United States, Canada and the European Union ("EU"). FivePrime has an option to co-promote HGS1036 and any next-generation products in the United States, and retains full development and commercialization rights in all other regions of the world outside the U.S., Canada and the EU. The Company incurred research and development expenses of $628 and $1,407 related to the FivePrime agreement during the three and nine months ended September 30, 2011, respectively.

 

Collaboration Agreement with Novartis

During 2006, the Company entered into an agreement with Novartis International Pharmaceutical Ltd. ("Novartis") for the co-development and commercialization of ZALBINT M. Based on regulatory feedback received during 2010, the Company and Novartis decided to end development of ZALBIN in September 2010.

Under the agreement, Novartis had paid the Company $207,500 through the end of 2009. The Company was recognizing these payments as revenue ratably over the estimated remaining development period. The Company recognized revenue of $36,133 and $82,806 during the three and nine months ended September 30, 2010, respectively, under this agreement. Research and development expenses for the three and nine months ended September 30, 2011 are net of $233 and $1,035, respectively, of adjustments relating to the close out of the ZALBIN collaboration. The Company's share of Novartis-incurred research and development expenses was $2,510 during the three months ended September 30, 2010. Research and development expenses for the nine months ended September 30, 2010 are net of $1,158 of costs reimbursed by Novartis.