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Exelixis, Inc. Message Board

jake_10977 10 posts  |  Last Activity: Jul 8, 2014 5:30 PM Member since: Feb 3, 2009
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  • Reply to

    Interesting post off a much better board

    by jake_10977 Jul 8, 2014 5:29 PM
    jake_10977 jake_10977 Jul 8, 2014 5:30 PM Flag

    Continued:

    6. Afreeza has a chance to be successful- I think it will be, but the journey ahead will not be easy. We all know Afreeza cannot be compared to Exubera, but physicians minds are going to go to Exubera right away. Sales and marketing will have an uphill battle changing this perception.

    7. I increasingly think the partnership will not be with one of the big guys, but rather (and sadly) with a smaller pharma company that has a Salesforce.

    8. If I am wrong and there is a big pharma play, my bets (for specific reasons I am willing to share if anyone is interested) are: a. Merck. b. J&J. c. AZ

  • I work in the diabetes marketplace for a pharmaceutical company and wanted to put done context to some of the rumors:

    1. Eli Lilly is hiring up for the launch of their SGLT-2 and weekly GLP-1, both of which will likely be approved this year.

    2. Humalogs patent is expiring soon, but to date, no generic company has EVER produced an insulin. The problem is that the FDA requires clinical studies when approving insulin- even when it's generic. This cost, added to the high manufacturing cost has deterred the generic industry from entering the marketplace. With the growing insulin market, some generic companies are considering entering, but nothing is formal and it would be years off.

    3. After Exubera was pulled, Eli Lilly and Novo Nordisk cancelled their inhaled programs (both of which had devices and data better than Exubera). It's hard to imagine either companies deciding to enter back into the inhaled insulin market, especially as they will be competing primarily with themselves (Humalog ~45% SOM, Novolog ~55% SOM).

    4. Google is not going to enter this space. There has been a lot of talk on these boards about mnkd not needing a sales force and using more modern methods of marketing. This will not work. The BP industry spends billions marketing drugs. Why- because it works. The marketplace has changed in the past decade, but marketing and a Salesforce still deliver results. Plenty of great treatments don't gain market share because of the Salesforce and marketing of competitors. It simply isn't true to say "a good product will sell itself" in this industry.

    5. Pfizer will never be a bidder. Exubera was to big of a failure and investors/management will not stomach the risk. Plus, they have no current presence in the diabetes space.

  • jake_10977 jake_10977 Jul 4, 2014 8:08 PM Flag

    NP

    Continued is it a game changer:

    Is this a game-changer for people with diabetes?

    Some experts think so, but others are taking a wait-and-see approach.

    “I think it is,” Campbell says. He says the inhaler for Afrezza is better designed and easier to use than a more cumbersome one used with another inhaled insulin, Exubera, he says.

    Exubera was approved by the FDA in 2006 but withdrawn from the market by its maker, Pfizer, in 2007, in part due to low sales.

    Health care providers had to spend a half hour or so just to explain how to use the Exubera inhaler, Campbell says. The Afrezza inhaler, he says, ”is really small, easy to use, and it takes less than a minute to train a patient how to use the insulin.”

    Marie McDonnell, MD, director of the Brigham Diabetes Program at Brigham and Women’s Hospital, says Afrezza has promise if “we can show there is no risk to the lung tissue and the mouth and esophagus.”

    “It works faster than both of the injected insulins we have now, the regular and the rapid-acting,” she says. “This might mean you will need less insulin [overall] to get the same effects.” And that may lessen the weight gain that often occurs in new users, she says.

    She plans to prescribe it, but on a case-by-case basis.

    George King, MD, chief scientific officer at Joslin Diabetes Center, says it may be helpful for some. “I think inhaled insulin would be good for people who are really adverse to needles,” he says. But he estimates only 10% or 15% of people on insulin fit that category.

  • How is Afrezza different than other insulin?

    “Afrezza is rapidly absorbed from the cells in the lungs [to the blood stream],” says R. Keith Campbell, RPh. He’s a certified diabetes educator and distinguished professor emeritus in diabetes care and pharmacotherapy at Washington State University College of Pharmacy. He has studied the drug but has no ties to its developer.

    “From the time you inhale it to the time it actually peaks [in the blood] is 15 to 20 minutes,” Campbell says. Injected insulin taken before a meal, he says, takes about an hour to peak.

    The body also clears Afrezza more quickly than insulin injected at mealtime, says Bruce Bode, MD. He’s a diabetes specialist in Atlanta who did a clinical trial funded by MannKind Corporation, the drug’s developer.

    Besides its rapid peak, the drug is ”pretty much gone in 2 or 3 hours,” Bode says. Rapid-acting injected insulins, he says, usually ”hang around for about 4 hours. Afrezza is fast in, fast out. It is emulating, in essence, what the pancreas does.”

    How does Afrezza work compared to rapid-acting injected insulins?

    In a 24-week study, Bode compared Afrezza with a rapid-acting, injected insulin in more than 500 patients with type 1 diabetes. Afrezza and injected insulin controlled blood sugar equally well, he says. But he found that those using Afrezza were less likely to get very low blood sugar, a complication of insulin use.

    With Afrezza, “there is also less weight gain,” Bode says. He credits that to the shorter time Afrezza remains in the body.

    In another study, researchers found that people with type 2 diabetes who weren’t getting enough control of blood sugar with oral medications did better when they added inhaled insulin before meals.

  • NEW YORK (AVAFIN) -- MannKind options contracts experienced interesting call activity during the last session. There were 3.1 calls traded for every put contract yielding a 0.32 put/call ratio. Specifically, 15,803 put and 49,336 call contracts were traded.
    The ratio skew implies that investors are hedging their positions in anticipation of a stock move. Today's unusual volume activity confirms that traders are re-balancing their portfolios.
    MannKind is a development-stage biotech focused on researching treatments for diabetes and cancer. Its lead product candidate, Afrezza, is a rapid-acting inhaled insulin currently awaiting approval by the Food and Drug Administration. The development of MannKind's early-stage pipeline, including testing its proprietary inhalation technology in other diabetes treatments and developing several early-stage immunotherapy and oncology therapeutics, has been put on hold until Afrezza's approval.

    The trading volume of 16.84M is above the 90 day average volume of 14.07M shares. Shares of MannKind edged down $0.44 (4.26%) to $9.88. The price of the stock ranged between a low of $9.71 and $10.10 respectively.

  • Reply to

    The Deal is Done

    by jimbering Jul 2, 2014 12:25 PM
    jake_10977 jake_10977 Jul 2, 2014 4:17 PM Flag

    Forgive me i'm long and hope your right, but you also said you have a contact at SEC. Sounds like way to many contacts to take you serious.

  • Suvannavejh says MannKind CEO Al Mann claimed over lunch at a conference in mid-June "that he was already in possession of multiple term sheets" for partners who can help bring the drug to market. Now, more are likely to come.

    Of course, Afrezza could grab significant share in the diabetes market. Keith Markey, an analyst at Griffin Securities, sees positives in the FDA decision. By seeking further studies of the drug's impact on children, "the request suggests the FDA thinks the drug will be widely used by pediatric patients and it must be fairly comfortable with the drug's safety profile," writes Markey, who has a Buy rating and a $15 price target.

  • jake_10977 jake_10977 Jun 30, 2014 1:59 PM Flag

    dept? Moron

  • Apologies if already posted.

    RBC Capital Markets analyst Adnan Butt said that Afrezza is a convenient alternative to insulin shots and that annual sales of the inhalable insulin can be anywhere from $5 billion to $7 billion.

    Needles No More: FDA Approves Inhalable Insulin For Diabetics
    On Friday, the Food and Drug Administration approved inhalable insulin medication for diabetes patients.

    Los Angeles-based inventor Alfred Mann worked on the inhalable insulin for more than 10 years and has used almost $1 billion of his own money for the development of the drug. Mann’s company, MannKind Corp., got approval from the FDA to sell Afrezza.

    Afrezza is geared towards patients with Type 1 or Type 2 diabetes. The LA Times, however, reported that diab

  • NEW YORK (TheStreet) -- TheStreet's Jim Cramer says he has not liked Dendreon (DNDN_) but it may not be dead in the water because of Merck's (MRK_) acquisition of Idenix Pharmaceuticals (IDIX_) and because of what's happening with MannKind MNKD.

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