IBJNews

Eli Lilly's Cialis faces faster-acting competition

Back to TopCommentsE-mailPrint

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:
 
Subscribe to IBJ
  1. So the Mayor adds another non value added layer to having a vehicle towed? Whereby the City Government RECIEVES AN ILLEGAL KICKBACK FROM A LGOISTICS COMPANY THAT SUBS THE WORK TO LOCAL TOW COMPANIES? What is the service the City performs for receiving the "tribute"? This is RICO!!!!! What a corrupt and unnecessary layer. What a dirtbag Mayor and his cronies.

  2. Owner occupied housing. Clear enough?

  3. So people think I am paranoid. It's from experience in dealing with puds requested by developers who make major donations themselves to representatives, have nice fund raisers for those running for office and hide through pac's. then there are the public relation firms. You will note some pr comments below. You there Clyde Lee? My opinion. Commercial along 421, great. Multifamily housing, terrible idea that will change the town. Senior condos or zero lot line homes west, great. I suggest keeping all entries to commercial areas at 421. All entries to owner occupied on sycamore. Will keep the traffic on sycamore down some. Two other things. You can't trust what will be there in 10 years. Steve builds quality stuff, but areas change over time. Look at the changes at the wall mart center at 86th and 421 over the last 10 years. Look at the apartments and neighborhoods behind St Vincent's. Raintree properties WILL decrease in value if commercial and multifamily goes in near. It has already been happening around the bridges area. The houses that have been sold recently are way below market. Several deals not closed due to the Illinois construction and the whole unsurety of the bridges. It's pretty simple, Zionsville will approve the whole thing because the city council has been groomed over a LONG period of time for this. I might even suggest some are in their position as a result of this.

  4. Esta, do you have a dog in this fight? You seem to really want to knock anyone against this project. No, I didn't move to Indiana for the architecture. I moved here for that red barn in the field. The horses and fields of corn. A place that is NOT overdeveloped. There are plenty of nearby places in Indianapolis that could be REDEVELOPED instead.

  5. RKW - OK, we get it, you're paranoid. The question is, are you paranoid enough? Greg - Yes, Pittman(s) is (are) at it again. They are developers, they build things. It's what they do. So when you go to work tomorrow, Greg, you're at it again too. Cliff - Really? You moved to Indiana for its progressive architecture? That's like moving to England for the cuisine. Zionsvillain - The house you moved to was once a field or woods. I'm willing to bet folks were upset when that ground was plowed under and a house was built. But I guess now that you are in, everything should stop? "My house was OK, but the next one is sprawl." SE Guy - Please don't paint us with such a wide brush. Most reasonable Zionsville residents welcome planned, measured development.

ADVERTISEMENT