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NOVO NORDISK HEALTH CARE GROUP SALES INCREASE 8% TO $586.5 MIL. IN FIRST HALF; FIRM TO "FINALIZE" U.S. NDAs FOR LOGIPARIN, NOVOSEVEN, NORDITROPIN IN 1993

Executive Summary

Novo Nordisk health care group sales increased 8% in the first half of 1993 to $586.5 mil. (3.81 bil. Danish Krone). "Sales increased in the health care group's largest markets: Japan, U.S., Germany and the U.K.," Novo Nordisk reported Aug. 11. "The increase was due to a better insulin product mix and larger volumes, especially of insulin and gynecological products," the company added. Sales of the human growth hormone product Norditropin were "only marginally higher in the first half of 1993 than in the corresponding period in 1992, which was positively impacted by inventory build-up by a major distributor." Norditropin is marketed overseas; in the U.S. Novo Nordisk is barred from marketing the product until orphan drug exclusivity for Lilly's Humatrope expires in March 1994. Novo Nordisk may face another hurdle to Norditropin marketing thereafter: Genentech, in a complaint currently before the International Trade Commission, claims that Norditropin (and Bio- Technology General's BioTropin) infringes its patents for production of recombinant proteins ("The Pink Sheet" March 29, T&G-14). Norditropin will be marketed in the U.S. through Novo Nordisk Pharmaceuticals, Inc. The Princeton, N.J. firm, with a staff of 325, currently markets Novo Nordisk's insulin products. "One out of every four Americans with diabetes relies on Novo Nordisk insulin, and that number is growing," the company's recently released annual report states. The firm expects its Clayton, N.C. genetically engineered insulin plant to come on line in 1994. The facility, with a staff o 135, will supply insulin to the U.S. market and to other countries in North and South America. Worldwide, the company says it produces approximately half of the global insulin supply. Novo Nordisk total diabetes care division sales in 1992 were about DKK 5 bil. (approximately $770 mil.). The introduction of Norditropin will help Novo Nordisk diversify its North American product line. "Looking forward, Novo Nordisk Pharmaceuticals will be responsible for U.S. sales and marketing of other Novo Nordisk products, including among others human growth hormone, hematology products and hormones for gynecological uses," the annual report states. Hematology compounds under development include the recombinant Factor VIIa product NovoSeven and the low molecular weight heparin Logiparin. Novo Nordisk expects "to finalize applications for registration of NovoSeven, Logiparin and Norditropin" in the U.S. by the end of the year. A longer-term hematology project is Factor XIII, described in the annual report as "a potential treatment for bleeding disorders, such as cranial hemorrhages in premature infants." Novo Nordisk's Seattle subsidiary ZymoGenetics is developing Factor XIII. The gynecological products Trisequens and Kliogest are among Novo Nordisk's top-selling products overseas. "Development studies are currently in progress with a view to filing for registration in the U.S.," the annual report states. Also in development is a nasal formulation of Norditropin. "The development of growth hormone for nasal administration looks promising, but is still at an early stage," the annual report states. Last year, the company abandoned development of a nasal insulin after Phase II trials ("The Pink Sheet" Dec. 21, 1992, In Brief). Novo Nordisk continues to develop a nasally delivered glucagon, the annual report states. The company is also continuing studies of various insulin analogs and platelet-derived growth factor for treatment of diabetic ulcers. ZymoGenetics is currently conducting Phase II trials of PDGF. Novo Nordisk's newest research focus is in central nervous system disorders. The company developed the antidepressant paroxetine (Paxil) in conjunction with SmithKline Beecham and is receiving royalties on U.S. sales of the drug, the annual report indicates. The anticonvulsant tiagabine, licensed to Abbott in the U.S., "was shown to be an efficacious and safe product in Phase II clinical trials," the annual report states. "The next step is a large-scale Phase III study which will include testing on newly diagnosed patients." Novo Nordisk is also developing muscarinic agonists for treatment of senile dementia and pain relief in collaboration with an unnamed partner. Preclinical studies for dementia are complete. In addition, Novo Nordisk has identified "two interesting dopamine D1-receptor antagonists" that it plans to study for schizophrenia. "A development project with neuronal calcium blockers for the treatment of stroke was abandoned as the compounds in question failed to show sufficient effect in the preclinical trials," the annual report states. "Research continues within this field." Novo Nordisk is collaborating with SmithKline Beecham on the calcium blocker research. CNS research accounted for 19% of R&D spending by Novo Nordisk's health care group, the annual report states. Growth & blood products accounted for 37% of spending while diabetes care research accounted for 33%. Novo Nordisk corporate sales increased 6% to $882.3 mil. (DKK 5.74 bil.) in the first half, the company said. Earnings were up 8% to $91.5 mil. (DKK 595 mil.), the company added. "Prices generally remained stable, but currency had a negative impact on sales of approximately 3%," Novo Nordisk said.

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