12/14/23, 8:31 PM
`
`Serono Purchases Rights To Experimental MS Drug - WSJ
`
`This copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For
`non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1(cid:102)800(cid:102)843(cid:102)0008 or visit www.djreprints.com.
`
`https://www.wsj.com/articles/SB1035995148253461151
`
`Serono Purchases Rights To
`Experimental MS Drug
`
`By Carey SargentDow Jones Newswires
`Oct. 31, 2002 12:01 am ET
`GENEVA -- Serono SA, Europe's biggest biotechnology company, said it has
`bought from Ivax Corp. rights to an experimental drug to treat multiple
`sclerosis, with the aim of developing the first multiple-sclerosis treatment that
`can be taken orally.
`
`Currently, MS drugs have to be injected, because the active protein in them is
`destroyed in the digestive system.
`
`Under the terms of the deal, Serono will make a series of undisclosed milestone
`payments to the U.S. company and get royalties on sales of the product,
`Cladribine, if it makes it to market.
`
`"Formulating Cladribine for oral use looks less daunting than doing it with other
`compounds; there's nothing about the drug to suggest it can't be administered
`orally," said Leon Bushara, Serono's head of business development.
`
`Still, the project is risky. The drug's development is in the early stages, and there
`is no sign that oral formulations of MS drugs work. Also, an injectable version of
`the drug has made an abortive bid for approval by the U.S. Food and Drug
`Administration before.
`
`The drug previously won FDA approval for use against hairy-cell leukemia in
`1993 and is still on the market as Leustatin. The company developing the drug at
`the time, Ortho Biotech, a division of Johnson & Johnson
`, also
`JNJ 0.69%
`asked the FDA for permission to market the injectable version for use against
`MS, but withdrew the application.
`
`Mr. Bushara said J&J dropped the project because of the need for more data
`rather than because the available data weren't good. He added he wasn't
`
`https://www.wsj.com/articles/SB1035995148253461151
`
`Merck 2058
`Hopewell v Merck
`IPR2023-00480
`
`1/2
`
`

`

`12/14/23, 8:31 PM
`Serono Purchases Rights To Experimental MS Drug - WSJ
`concerned about the drug's history. "On the contrary, we've reviewed that data
`extensively, and that's one of the reasons we think the drug is so promising," he
`said.
`
`Serono's Rebif for multiple sclerosis posted sales of $380 million in 2001, while
`Biogen Inc.'s Avonex, another MS treatment, had sales of $972 million.
`
`Separately, the FDA slapped Biogen on the wrist for making "misleading claims"
`about Avonex. The claims, made in brochures and ads intended for doctors,
`boast that Avonex has the highest rate of satisfaction among patients. But the
`statement is based on tables that "misrepresent the results of the survey,"
`according to an FDA letter to the company dated Oct. 24.
`
`Biogen said it is talking with the agency about the issue.
`
`Write to Carey Sargent at carey.sargent@dowjones.com
`
`https://www.wsj.com/articles/SB1035995148253461151
`
`2/2
`
`