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BUSINESS AND REGULATORY NEWS http://biotech.nature.com MAY 2001 VOLUME 19 nature biotechnology 399 More or less cash for US biotech On April 9, the Bush administration sub- mitted a detailed version of his fiscal year (FY) 2002 budget request, boosting his ini- tial proposal for the US National Institutes of Health (NIH; Bethesda, MD) by more than $1.5 billion to $24.674 billion (Nat. Biotechnol. 19, 290, 2001). Highlights of biotech interest within the revised NIH budget proposal include $40 million for the new National Institute of Biomedical Imaging and Bioengineering, and a 12% increase (to $427 million) for the National Human Genome Research Institute. Meanwhile, within the National Science Foundation (Arlington, VA), the overall budget request for biological sciences research remains unchanged at $483 mil- lion, as does plant genome funding at $65 million; however, $20 million of that will go toward the Arabidopsis thaliana functional genomics effort, up from $5 million in 2001. Funds for new collaborations have been suspended within the Commerce Department’s Advanced Technology Program (Gaithersburg, MD)—which includes biotech research—but prior year awards will continue. The broader program within the Department of Energy that sup- ports genome research will drop 10% to $443 million. JF Business and Regulatory News Briefs written by Jackie Barlow, Aaron Bouchie, Emma Dorey, Jeffrey L. Fox, Sabine Louët, and Eric Niiler. New Product Approvals Product Companies Details Pegintron Enzon On March 28, SGP received European approval (pegylated (Piscataway, NJ) for Pegintron and Rebetol combination therapy interferon α2b) Schering-Plough for both relapsed and previously untreated chronic with Rebetol (SGP; Kenilworth, NJ) hepatitis C patients. Pegintron is currently marketed (ribavirin) as a monotherapy in Europe and the United States, and the Pegintron/Rebetol combination therapy was given priority review status in the United States on March 23. Chronic hepatitis C affects an estimated 10 million people worldwide. Fasturtec Sanofi-Synthélabo Given marketing approval in Europe on March 29, (rasburicase) (Paris, France) Fasturtec is a recombinant urate oxidase that lowers uric acid concentrations to prevent renal failure in patients with hematological malignancies such as leukemia and lymphoma. Fasturtec is currently under review in the United States, and in clinical development in Japan. Sanofi-Synthélabo estimates yearly worldwide sales will reach 100 million ($90 million) in 2005. AB EPA considers new Bt crop lines Late in March, officials of the US Environmental Protection Agency (EPA; Washington, DC) announced that they will review formal requests from Monsanto (St. Louis, MO) to register new varieties of corn and cotton engineered to express new versions of Bacillus thuringiensis (Bt) insecticidal proteins. Monsanto has produced a Cry3Bb Bt corn that targets the coleopteran corn rootworm— the leading target for insecticide use in the US corn belt—setting this variety apart from the now plentiful series of commercial Bt-producing corn lines that target the European corn borer and other lepidopteran pests. Not only is the Cry3Bb Bt corn line considered a different form of insecticide, but its target is a more serious pest (and potentially a larger market) in terms of the damage it can do to commercial corn crops, both as larvae feed- ing on roots as well as adults feeding on leaves and silks. Monsanto is also asking the EPA to consider an engineered cotton line with two “stacked” Bt-encoding genes to broaden the crop’s insect pest resistance. Meanwhile, Mycogen (Indianapolis, IN) and Pioneer Hi- Bred (Des Moines, IA) also have a similar rootworm-resistant Bt corn at an earlier stage of commercial development. JF © Marlin Rice Effort to map human proteome In an ambitious quest to map and produce a database of the interactions of all human proteins by 2004, Myriad Genetics (Salt Lake City, UT) has formed Myriad Proteomics (Salt Lake City, UT) through a joint collaboration with electronics firm Hitachi (Tokyo), software provider Oracle (Redwood Shores, CA), and high-tech investment banking firm Friedl Corporate Finance (Zurich). Myriad will own 50% of the subsidiary, providing it with scientific management and its proteomics, bioinfor- matics, and automation technologies worth $82 million. Between them, the other companies will contribute $18 million in technology, including hard- ware, software, and storage capability, and another $85 million in cash—enough to last about 18 months, according to vice president of research Sudhir Sahasrabudhe. The subsidiary has rights to market the resulting database, while Myriad Genetics will retain rights to use the resulting data in its drug discovery efforts. “Myriad effectively gets full use of the technology, the data, and all that is generated by this joint venture which is funded by external money,” says Charles Duncan, analyst at Prudential Vector (Deerfield, IL). Myriad’s shares leapt over 20% to $41.05 a week after the April 4 announcement. AB OGT, Affymetrix call truce On March 23, Affymetrix (Santa Clara, CA) and privately held Oxford Gene Technology (OGT; Oxford, UK) settled their various transatlantic microarray patent battles, end- ing all litigation between the companies. The legal war began in 1999, when Affymetrix was accused of infringing upon patents developed by OGT founder Ed Southern, and was found guilty in November 2000 of infringement before its purchase of rights from Beckman Coulter (Fullerton, CA). The settlement terminates OGT’s appeal that Affymetrix did not acquire rights with its purchase of Beckman’s microarray business, as well as Affymetrix’s claims that the “Southern patents” are invalid (Nat. Biotechnol. 19, 13, 2001). Financial details of the settlement were not disclosed, but in a Securities Exchange Commission filing Affymetrix recorded an approximate $19 million charge as a result of the settlement, far less than the $300 million OGT initially asked for. Affymetrix shares rose about 14% on the news to just over $30. AB © 2001 Nature Publishing Group http://biotech.nature.com © 2001 Nature Publishing Group http://biotech.nature.com

More or less cash for US biotech

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BUSINESS AND REGULATORY NEWS

http://biotech.nature.com • MAY 2001 • VOLUME 19 • nature biotechnology 399

More or less cash for US biotech

On April 9, the Bush administration sub-mitted a detailed version of his fiscal year(FY) 2002 budget request, boosting his ini-tial proposal for the US National Institutesof Health (NIH; Bethesda, MD) by morethan $1.5 billion to $24.674 billion (Nat.Biotechnol. 19, 290, 2001). Highlights ofbiotech interest within the revised NIHbudget proposal include $40 million for thenew National Institute of BiomedicalImaging and Bioengineering, and a 12%increase (to $427 million) for the NationalHuman Genome Research Institute.Meanwhile, within the National ScienceFoundation (Arlington, VA), the overallbudget request for biological sciencesresearch remains unchanged at $483 mil-lion, as does plant genome funding at $65million; however, $20 million of that will gotoward the Arabidopsis thaliana functionalgenomics effort, up from $5 million in2001. Funds for new collaborations havebeen suspended within the CommerceDepartment’s Advanced TechnologyProgram (Gaithersburg, MD)—whichincludes biotech research—but prior yearawards will continue. The broader programwithin the Department of Energy that sup-ports genome research will drop 10% to$443 million. JF

Business and Regulatory News Briefs writtenby Jackie Barlow, Aaron Bouchie, EmmaDorey, Jeffrey L. Fox, Sabine Louët,and Eric Niiler.

New Product ApprovalsProduct Companies Details

Pegintron Enzon On March 28, SGP received European approval (pegylated (Piscataway, NJ) for Pegintron and Rebetol combination therapy interferon α2b) Schering-Plough for both relapsed and previously untreated chronic with Rebetol (SGP; Kenilworth, NJ) hepatitis C patients. Pegintron is currently marketed (ribavirin) as a monotherapy in Europe and the United States,

and the Pegintron/Rebetol combination therapy was given priority review status in the United States on March 23. Chronic hepatitis C affects an estimated 10 million people worldwide.

Fasturtec Sanofi-Synthélabo Given marketing approval in Europe on March 29, (rasburicase) (Paris, France) Fasturtec is a recombinant urate oxidase that lowers

uric acid concentrations to prevent renal failure inpatients with hematological malignancies such as leukemia and lymphoma. Fasturtec is currently underreview in the United States, and in clinical development in Japan. Sanofi-Synthélabo estimates yearly worldwide sales will reach € 100 million ($90 million) in 2005. AB

EPA considers new Bt crop lines

Late in March, officials of the US EnvironmentalProtection Agency (EPA; Washington, DC)announced that they will review formal requests fromMonsanto (St. Louis, MO) to register new varieties ofcorn and cotton engineered to express new versions ofBacillus thuringiensis (Bt) insecticidal proteins.

Monsanto has produced a Cry3Bb Bt corn that targets the coleopteran corn rootworm—the leading target for insecticide use in the US corn belt—setting this variety apart fromthe now plentiful series of commercial Bt-producing corn lines that target the Europeancorn borer and other lepidopteran pests. Not only is the Cry3Bb Bt corn line considered adifferent form of insecticide, but its target is a more serious pest (and potentially a largermarket) in terms of the damage it can do to commercial corn crops, both as larvae feed-ing on roots as well as adults feeding on leaves and silks. Monsanto is also asking the EPAto consider an engineered cotton line with two “stacked” Bt-encoding genes to broadenthe crop’s insect pest resistance. Meanwhile, Mycogen (Indianapolis, IN) and Pioneer Hi-Bred (Des Moines, IA) also have a similar rootworm-resistant Bt corn at an earlier stageof commercial development. JF

©M

arlin

Ric

e

Effort to map human proteome

In an ambitious quest to map and producea database of the interactions of all humanproteins by 2004, Myriad Genetics (Salt Lake City, UT) has formed Myriad

Proteomics (Salt Lake City, UT) through ajoint collaboration with electronics firmHitachi (Tokyo), software provider Oracle(Redwood Shores, CA), and high-techinvestment banking firm Friedl CorporateFinance (Zurich). Myriad will own 50% ofthe subsidiary, providing it with scientificmanagement and its proteomics, bioinfor-matics, and automation technologiesworth $82 million. Between them, theother companies will contribute $18 million in technology, including hard-ware, software, and storage capability, andanother $85 million in cash—enough to last about 18 months, according to vice president of research SudhirSahasrabudhe. The subsidiary has rights tomarket the resulting database, whileMyriad Genetics will retain rights to use

the resulting data in its drug discoveryefforts. “Myriad effectively gets full use of the technology, the data, and all that isgenerated by this joint venture which isfunded by external money,” says CharlesDuncan, analyst at Prudential Vector(Deerfield, IL). Myriad’s shares leapt over20% to $41.05 a week after the April 4announcement. AB

OGT, Affymetrix call truce

On March 23, Affymetrix (Santa Clara, CA)and privately held Oxford Gene Technology(OGT; Oxford, UK) settled their varioustransatlantic microarray patent battles, end-ing all litigation between the companies. Thelegal war began in 1999, when Affymetrixwas accused of infringing upon patentsdeveloped by OGT founder Ed Southern,and was found guilty in November 2000 ofinfringement before its purchase of rightsfrom Beckman Coulter (Fullerton, CA). Thesettlement terminates OGT’s appeal thatAffymetrix did not acquire rights with itspurchase of Beckman’s microarray business,as well as Affymetrix’s claims that the“Southern patents” are invalid (Nat.Biotechnol. 19, 13, 2001). Financial details ofthe settlement were not disclosed, but in aSecurities Exchange Commission filingAffymetrix recorded an approximate $19million charge as a result of the settlement,far less than the $300 million OGT initiallyasked for. Affymetrix shares rose about 14%on the news to just over $30. AB

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© 2001 Nature Publishing Group http://biotech.nature.com