IBJNews

Eli Lilly's Cialis faces faster-acting competition

Back to TopCommentsE-mailPrintBookmark and Share

A Vivus Inc. pill that is supposed to provide erections within 15 minutes, about half the time or less than Eli Lilly and Co.'s Cialis or Pfizer Inc.’s Viagra,  has received U.S. regulatory approval.

The Food and Drug Administration on Friday cleared the erectile dysfunction treatment, called Stendra, the agency said in a statement. Erectile dysfunction is the inability to get or keep an erection firm enough for sexual intercourse.

The drug, known chemically as avanafil, is the sole product on the market for Mountain View, Calif.-based Vivus, which is seeking a partner to sell the medicine in the United States.

New York- based Pfizer’s Viagra, the top-selling erectile dysfunction pill with $2 billion in sales last year, works in 30 minutes to an hour, according to the drug’s website.

Cialis, which works in 30 minutes or less, had worldwide sales of $1.88 billion in 2011, accounting for 8 percent of Indianapolis-based Lilly's revenue.

“I do think it’s a differentiated product,” Michael King, an analyst with Rodman & Renshaw LLC in New York, said about Stendra. Unlike competitors, Vivus’s drug features “rapid onset; rapid off.”

Avanafil may have $68 million in sales next year, according to the average estimate of six analysts compiled by Bloomberg. Revenue may peak at $459 million in 2017, King said.

Sales may be slowed at first by Vivus’s capacity to market the drug. The company is discussing deals with potential partners to sell the medicine, Vivus said.

The erectile dysfunction drug also will soon face generic competition. Patents for Cialis and Levitra expire in 2016 and 2018, respectively. Cialis is likely to see generic competition in 2017, and in generic Viagra is expected to be available in 2019, King said.

Vivus “will be rolling a rock up a hill on the generic side,” King said in a telephone interview.

The National Institutes of Health estimates that erectile dysfunction affects as many as 30 million men in the U.S.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the prepared statement.

Stendra in some rare cases may cause color vision changes and sudden loss of vision in one or both eyes, according to the FDA. The most common side effects are headache, redness of the face, nasal congestion, cold-like symptoms and back pain. The drug also shouldn’t be used by men who take nitrates, which are used to treat chest pain, because the combination may cause a sudden drop in blood pressure, the agency said.

The pill’s side effects are similar to other erectile dysfunction drugs on the market, Barbara Troupin, vice president of medical affairs for Vivus, said last month at a conference.

Vivus made the Muse penile suppository before selling the rights in November 2010 to Meda AB, a specialty pharmaceutical company in Solna, Sweden, for about $23.5 million.

In addition to avanafil, Vivus is awaiting a July 17 FDA decision on Qnexa, which potentially would be the first obesity pill approved in 13 years.

Vivus is competing with Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc. to bring the first weight-loss drug to market since Roche Holding AG’s Xenical in 1999. FDA advisers voted Feb. 22 in favor of Vivus’s Qnexa, while raising concerns that the drug may potentially contribute to heart risks and birth defects.

The company submitted earlier this month a risk evaluation and mitigation strategy in an effort to win approval for the obesity drug.

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:
 
thisissue1-092914.jpg 092914

Subscribe to IBJ
  1. Cramer agrees...says don't buy it and sell it if you own it! Their "pay to play" cost is this issue. As long as they charge customers, they never will attain the critical mass needed to be a successful on company...Jim Cramer quote.

  2. My responses to some of the comments would include the following: 1. Our offer which included the forgiveness of debt (this is an immediate forgiveness and is not "spread over many years")represents debt that due to a reduction of interest rates in the economy arguably represents consideration together with the cash component of our offer that exceeds the $2.1 million apparently offered by another party. 2. The previous $2.1 million cash offer that was turned down by the CRC would have netted the CRC substantially less than $2.1 million. As a result even in hindsight the CRC was wise in turning down that offer. 3. With regard to "concerned Carmelite's" discussion of the previous financing Pedcor gave up $16.5 million in City debt in addition to the conveyance of the garage (appraised at $13 million)in exchange for the $22.5 million cash and debt obligations. The local media never discussed the $16.5 million in debt that we gave up which would show that we gave $29.5 million in value for the $23.5 million. 4.Pedcor would have been much happier if Brian was still operating his Deli and only made this offer as we believe that we can redevelop the building into something that will be better for the City and City Center where both Pedcor the citizens of Carmel have a large investment. Bruce Cordingley, President, Pedcor

  3. I've been looking for news on Corner Bakery, too, but there doesn't seem to be any info out there. I prefer them over Panera and Paradise so can't wait to see where they'll be!

  4. WGN actually is two channels: 1. WGN Chicago, seen only in Chicago (and parts of Canada) - this station is one of the flagship CW affiliates. 2. WGN America - a nationwide cable channel that doesn't carry any CW programming, and doesn't have local affiliates. (In addition, as WGN is owned by Tribune, just like WTTV, WTTK, and WXIN, I can't imagine they would do anything to help WISH.) In Indianapolis, CW programming is already seen on WTTV 4 and WTTK 29, and when CBS takes over those stations' main channels, the CW will move to a sub channel, such as 4.2 or 4.3 and 29.2 or 29.3. TBS is only a cable channel these days and does not affiliate with local stations. WISH could move the MyNetwork affiliation from WNDY 23 to WISH 8, but I am beginning to think they may prefer to put together their own lineup of syndicated programming instead. While much of it would be "reruns" from broadcast or cable, that's pretty much what the MyNetwork does these days anyway. So since WISH has the choice, they may want to customize their lineup by choosing programs that they feel will garner better ratings in this market.

  5. The Pedcor debt is from the CRC paying ~$23M for the Pedcor's parking garage at City Center that is apprased at $13M. Why did we pay over the top money for a private businesses parking? What did we get out of it? Pedcor got free parking for their apartment and business tenants. Pedcor now gets another building for free that taxpayers have ~$3M tied up in. This is NOT a win win for taxpayers. It is just a win for Pedcor who contributes heavily to the Friends of Jim Brainard. The campaign reports are on the Hamilton County website. http://www2.hamiltoncounty.in.gov/publicdocs/Campaign%20Finance%20Images/defaultfiles.asp?ARG1=Campaign Finance Images&ARG2=/Brainard, Jim

ADVERTISEMENT