IBJNews

Cancer tools help Roche with Alzheimer's drug

Back to TopCommentsE-mailPrintBookmark and Share

Roche Holding AG is focusing part of its pipeline on the riskiest area of drug development: the human brain.

The Swiss drugmaker had its last top-selling brain therapy when Valium revolutionized anxiety treatment in the 1960s. Now Roche is betting it can use the tools that have since made it the world’s biggest maker of cancer drugs to penetrate the “black box” of Alzheimer’s and autism, CEO Severin Schwan said.

“If you think back 15 years, a cancer tumor was like a black box,” Schwan said in an interview at the company’s Basel headquarters. “The brain has been a black box until recently. And now we start to understand what is happening on a molecular basis in the brain.”

The stakes are different now than when Valium inventor Leo Sternbach was cooking up his new class of medicines. Roche’s brain drugs are just one component in a late-stage pipeline packed with risky projects, said Karl Heinz Koch, a Helvea SA analyst. Treatments for central nervous system diseases also have an “enormous” potential payoff, said Andrew Baum, a London-based analyst for Citigroup Inc.

“The central nervous system will remain the highest of the high-hanging fruit,” Baum said.

A hint of whether the gamble may pay off is due in the second half of this year. Indianapolis-based Eli Lilly and Co. and Pfizer Inc. plan to announce results for Alzheimer’s drugs that attack the same protein as Roche’s experimental drug, called gantenerumab. If the Lilly therapy succeeds, its sales may exceed $9 billion a year by 2020, according to analysts at Sanford C. Bernstein Ltd.

The path to patients may be rockier than Valium’s. Sternbach’s anxiety drug took just five years to progress from the test tube to its approval in 1963. That’s less than half as long as the process is likely to take under current testing standards, which are more stringent, according to Tufts Center for the Study of Drug Development research.

Roche needs new pipeline prospects after the failure this month of a good-cholesterol pill that UBS AG analysts might have had estimated peak sales of $6.8 billion.

“For the company to create value medium- to longer-term, you need the ex-oncology business to take shape,” Koch said. Yet investors have even lower expectations for Roche’s central nervous system pipeline than they did for the cholesterol drug, he said. “That pipeline is just very risky.”

The Roche brain drug furthest along in the patient testing process, a schizophrenia medicine, didn’t have statistically significant results in an earlier trial if all patients who entered the trial were measured, Koch said. The compound had an effect on patients who stuck with it and who followed study protocols perfectly.

The Swiss drugmaker is also running clinical trials on treatments for depression and autism. Meanwhile, the field of Alzheimer’s, where four of Roche’s 10 brain drugs in patient testing are concentrated, is littered with failures.

The last new therapy for Alzheimer’s was Namenda, a Forest Laboratories Inc. medicine approved in 2003, according to data compiled by Bloomberg. Namenda, like all other Alzheimer’s drugs on the market, addresses symptoms without slowing the disease’s march through the brain.

Lilly’s solanezumab, which is similar to Roche’s Alzheimer’s drug, has at most a one-in-five chance of success, according to Bernstein’s Anderson. Lilly said on April 25 that one final-stage trial of the drug had finished that month, with a second slated to complete in June. The first look at the results could come in July, Anderson said in a note to clients.

Both the Lilly and Roche medicines target a reduction in beta amyloid, a protein that accumulates in the brains of Alzheimer’s patients. Pfizer, Johnson & Johnson and Elan Corp. are also expecting to release results in the third quarter for a drug to target beta amyloid, bapineuzumab, and have said they’ll seek regulators’ approval by the end of the year if it’s successful.

The cloud hanging over all three drugs is the earlier failure of a Lilly drug called semagacestat, which tried to zap beta amyloid by inhibiting an enzyme called gamma secretase that’s tied to the production of the protein. The pill actually worsened patients’ ability to do day-to-day activities, Lilly said in 2010. The U.S. company gave up on the medicine that year.

Lilly has said that semagacestat failed not because beta amyloid isn’t the right target, but because gamma secretase wasn’t the right way to go after the protein.

Still, investors expect both the new Lilly and Pfizer drugs to fail just as the older Lilly compound did. Two-thirds of 209 analysts and fund managers in a survey conducted last month by New York-based ISI Group thought neither would succeed in this year’s trials.

“There was a lot of hope riding on these types of approaches,” said Cord Dohrmann, chief scientific officer of Evotec AG, a German biotech working with Roche on another therapy for the disease. “There was no obvious success. People are wondering, are we really on the right track.”

The Evotec-partnered drug started out with Roche, which licensed the compound to Evotec in 2006. The German biotech tested it unsuccessfully as an anti-smoking drug. After it failed to help smokers quit, Roche signed a deal last September to finish developing the drug in Alzheimer’s instead.

“The original plan was always Alzheimer’s,” Dohrmann said. Smoking was an easier indication for a small biotech to pursue, with shorter, less expensive clinical trials, he said. And the drug did show itself to be safe--an important characteristic, he said.

By taking the drug back, Roche gave itself a candidate that doesn’t go after beta amyloid, he said. Instead it targets monoamine oxidase type B, or MAO-B, an enzyme that breaks down dopamine in the brain and contributes to the production of free radicals.

“It is such a wide-open market,” Dohrmann said. “People have made estimates that just slowing progression for a year would have a huge economic impact. That is saying a lot for a disease that people have for many, many years.”

Roche is forging ahead with beta amyloid as well. Gantenerumab isn’t as far along in the testing process as the Lilly and Pfizer drugs--it’s in the second of the three stages of clinical trials usually required for regulatory approval in the U.S. Roche is recruiting patients for a two-year, 360-person trial. If that’s successful, the company will test the compound in a larger patient group, with the aim of having it on the market after 2016.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. Uh, sorry Johnnie, but you are incorrect. Despite the assertions by yourself and various defenders and captains, sports attendance is NOT off significantly at most sporting events in the US. Variances in attendance has been in the range of single digits, both + & - for years now. MLB has had most of its best overall attendance nubers in the last decade, and that trend has been consistent for most major sporting events. The number one issue cited by most fans when asked about attendance is the overall cost of attending. The presence of HD and big screen televisions in home doesn't even register, as a factor for not attending an event. VALUE in the product is the key, and apparently is something lacking in the current ICS. What other explanation is there when with what is routinely touted as the "best" racing on the planet, fans are staying away in DROVES. A "close" title battle into the last event at Fontana, with the "cars and stars" of the ICS, and who showed up? MAYBE 8K. Sorry, but HD TV isn't to blame for that kind of fan apathy.

  2. Do you need finance to establish your business ? Are you interested in getting a loan at 3% from our private company? If so please Email: suntrust_oil@blumail.org

  3. If she was worth the $ the public outcry over direct tv dropping them would have kept them on their dishes as we have seen with other companies. I too quit watching channel 13 after she showed up since I left channel 8 because of her all show rather than production results. When Randy on 8 corrected her she had a big head and incorrectly challenged his correction for pronunciation of a city. Other antics while she matures was too much for me with her very inaccurate forecasts. All the forecasters were predicting rain until Thursday except Chris. They predicted sunny on Thursday but instead of rain until Thursday upon which the sun would finally make it out in full glory Chris was right on the money just as I too predicted looking at the radar on weather.gov. One thing I love about Angela is the fear you can see in her every time it thunders in the winter. It far exceeds the entertainment value of her body language (high heel noise drags, depression, etc) when her forecasts are so incorrect. Her hair stands on end, you have to see it!!!

  4. Good Day, Apply For A Loan I am Mr Fernadez Antonio, a private Loan lender and a cooperate financial for real estate and any kinds of business financing. I also offer Loans to individuals, Firms and cooperate bodies at 3% interest rate We offer any kind of loans. email us via fernadezloaninvest@outlook.com LOAN APPLICATION FORM First name:......................... Middle name:......................... Last name:........................................ Date of birth (yyyy-mm-dd):....................... Gender:........................................... Marital status:................................... Total Amount Needed............................... Loan Duration.................................... Address:.......................................... City:............................................. State/province:................................... Zip/postal code:.................................. Country:.......................................... Phone:............................................ Fax:.............................................. Mobile/cellular:.................................. Monthly Income.................................... Occupation:....................................... Best Regard, Mr Fernadez Antonio.

  5. i will love to share my testimony to you all the people in world i got married to my husband about 2 year ago we start having problems at home like we stop sleeping on the same bed,fighting about little things he always comes home late at night,drinking too much and sleeping with other women out side i have never love any man in my life except him. he is the father of my child and i don't want to loose him because we have worked so hard together to become what we are and have today .few month ago he now decided to live me and the kid,being a single mother can be hard sometimes and so i have nobody to turn to and i was heart broken.i called my mom and explain every thing to her,my mother told me about DR.okoro how he helped her solve the problem between her and my dad i was surprise about it because they have been without each other for three and a half years and it was like a miracle how they came back to each other. i was directed to DR. okoro on his email:okorospell@gmail.com and explain everything to him,so he promise me not to worry that he will cast a spell and make things come back to how we where so much in love again and that it was another female spirit that was controlling my husband he told me that my problem will be solved within two days if i believe i said OK So he cast a spell for me and after two days my love came back asking me to forgive him i Am so happy now. so that why i decided to share my experience with every body that have such problem contact Dr okoro the great spell caster on his email addresses spellcasterforlove@outlook.com

ADVERTISEMENT