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J&J wins OK for first in new class of diabetes drugs

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Johnson & Johnson, the world’s largest seller of health-care products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals including Eli Lilly and Co. that are developing similar medicines.

The U.S. Food and Drug Administration cleared the drug, known as canagliflozin, to treat adults with Type 2 diabetes, the agency said Friday in a written statement. It may generate $800 million annually in peak sales, Tony Butler, an analyst at Barclays Plc in New York, said in a telephone interview.

The treatment, to be sold under the name Invokana, expels sugar in the urine after the kidneys filter it from the blood. The FDA has required New Brunswick, N.J.-based J&J to conduct five post-market studies to track possible health risks, including to the heart, bones and pancreas.

“Bringing a new class to market is exciting,” said Kirk Ways, the drug’s development team leader, in a telephone interview. “We need to do better as a nation treating diabetes. Bringing canagliflozin to market will give patients and physicians another option.”

Invokana is part of a family of medicines known as SGLT2 inhibitors intended to have fewer side effects, such as low blood sugar and weight gain, than currently approved diabetes drugs. The company is trying to beat to market similar drugs being developed by Lilly, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co. and AstraZeneca Plc.

Diabetes is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The disease, defined by high levels of sugar in the blood, affected almost 26 million people in the U.S. in 2010, or about 8.3 percent of the population, the Atlanta-based CDC said.

While J&J has struggled with recalls and lawsuits over products such as metal hip implants and over-the-counter children’s medicines, the company has gained approval the past two years for new prescription drugs such as the tuberculosis tablet Sirturo, the prostate cancer pill Zytiga and the blood thinner Xarelto. Zytiga generated $961 million in 2012 sales.

For canagliflozin, J&J must study the medicine’s effect on patients’ hearts while the drug is on the market. J&J is working on a cardiovascular study called Canvas that the company plans to complete in 2017, Ways said.

During the first 30 days of treatment, 13 cardiovascular events occurred out of 2,886 patients on canagliflozin in the Canvas trial and one of 1,441 patients taking placebo, according to a January report from FDA staff. The drug raises LDL, or bad cholesterol, which may lead to the heart risk, despite favorable changes in HDL, or good, cholesterol, blood pressure and body weight, staff said.

Invokana probably will be used by doctors as an option after patients fail current therapies, such as Merck & Co’s $4.1 million best-seller Januvia, and cheaper generics including metformin, Butler said.

“What we tried to do with our development program was look across the spectrum,” Ways said. “What we tried to do is arm physicians with the information to prescribe this drug for patients they thought would benefit best.”

Butler’s sales estimate is lower than other diabetes drugs because of the medication’s link to an increased risk of urinary tract infections, particularly in women. Females also experienced an increased risk of vaginal infections.

“I worry its use in women will be somewhat minimal,” Butler said.

Most diabetes treatments on the market stimulate the pancreas to secrete insulin or improve the body’s sensitivity to insulin, a hormone that helps control blood sugar. As the first to work on the kidneys, SGLT2 inhibitors, like the one J&J developed, can be combined with other diabetes medications.

Boehringer, based in Ingelheim, Germany, and Lilly, based in Indianapolis, submitted an application for FDA approval of their SGLT2 inhibitor empagliflozin, the companies said in a March 25 statement. Astellas Pharma Inc. is also working on an SGLT2 inhibitor known as ipragliflozin.

New York-based Bristol-Myers and London-based AstraZeneca are working to address FDA concerns with their product dapagliflozin. The FDA sought more data on dapagliflozin after advisers determined the risks of bladder and breast cancer outweigh the benefits of the medicine.

J&J’s canagliflozin doesn’t show an increased risk of such malignancies, FDA staff said.
 

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  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

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