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  • Who Is The Devil? Will Gilead Fall Or Soar In 2015? [View article]
    Everybody wants their pills to cost $1 or less. That's what the SECOND pill costs. The first one cost $1 billion or more. Who pays for THAT one?
    Dec 24, 2014. 07:42 AM | 2 Likes Like |Link to Comment
  • Who Is The Devil? Will Gilead Fall Or Soar In 2015? [View article]
    Right, I saw that. Terrible. I was, however, looking for verification regarding the high percentage of patients who might need ribavirin. Should have been clearer. If the number is really that high, it's going to be a rough ride. I can almost see the lawyer ads on television now.
    Dec 23, 2014. 12:17 PM | 2 Likes Like |Link to Comment
  • Who Is The Devil? Will Gilead Fall Or Soar In 2015? [View article]
    BTW, I saw that the Wm. Blair analyst, John Sonnier, in a note yesterday, stated: "Moreover we estimate that about 75% of patients taking Viekira Pak will need the addition of ribavirin, which has been associated with significant adverse events.”

    Could you comment on this, Pharma Doc (or someone)?
    Dec 23, 2014. 11:35 AM | 2 Likes Like |Link to Comment
  • Who Is The Devil? Will Gilead Fall Or Soar In 2015? [View article]
    Re your comment:

    VIEKIRA PAK must not be taken if people:

    1. have severe liver problems
    2. take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) - carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) - efavirenz (Sustiva®, Atripla®) - ergot containing medicines including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) - ethinyl estradiol-containing medicines - gemfibrozil (Lopid®) - lovastatin (Advicor®, Altoprev®, Mevacor®) - midazolam (when taken by mouth) - phenytoin (Dilantin®, Phenytek®) - phenobarbital (Luminal®) - pimozide (Orap®) - rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) - sildenafil citrate (Revatio®) when taken for pulmonary artery hypertension (NYSE:PAH) - simvastatin (Zocor®, Vytorin®, Simcor®) - St. John's wort (Hypericum perforatum) or a product that contains St. John's wort - triazolam (Halcion®).
    3. have had a severe skin rash after taking ritonavir (Norvir®).

    So...how long do you think it will be before enough people are sufficiently affected by ABBV's VIEKIRA PAK (or die from having used it) before the FDA puts a Black Box Warning on the treatment? (Frankly, I'm surprised it doesn't already carry one.)
    Dec 23, 2014. 11:27 AM | 2 Likes Like |Link to Comment
  • Acadia Remains On Track With Pimavanserin Program [View article]
    Don't get angry, PTSD Trader. It's pretty clear Realtor_k is caught in a terrible short position or is kicking himself for having sold too soon.

    Be well.

    Ted
    Sep 23, 2014. 08:20 AM | 1 Like Like |Link to Comment
  • Celgene: Do The Revlimid Polymorph And Use Patents Matter? [View article]
    Thanks for the reply.

    Ted
    May 8, 2014. 07:51 AM | Likes Like |Link to Comment
  • Celgene: Do The Revlimid Polymorph And Use Patents Matter? [View article]
    I just saw this on the CELG Investor Village board. Can you explain in layman's terms?

    Litigation alert


    Towards the end of today the following stipulation was filed. It eliminates any question that Natco's proposed generic would infringement certain, but not all, of the patents Celgene is asserting. I don't know which of the patents are involved here, meaning whether they are the ones with long out expiration dates, or the ones more close in. The stipulation leaves defendants free to challenge these patents as invalid or obvious. Remember that by its motion regarding the Canadian deposition Natco is offering to give up any "unenforceability" challenge to these patents. The reason for this stipulation is not given. One guess is that defendants don't have any viable way to argue for non-infringement and they are concerned about exposure for attorneys' fees, per that very recent Supreme Court decision. But that is just a guess. What's interesting is that they are making this concession even before the contested meanings for the Markman hearing are decided. It is possible that the terms up for the Markman don't operate in the claims of these patents, so the Markman arguments can't help the defendants with infringement exposure for these patents. Again a guess.




    STIPULATION AND [PROPOSED] ORDER REGARDING INFRINGEMENT


    Plaintiff Celgene Corporation (Celgene) and Defendants Natco Pharma Limited

    (Natco), Arrow International Limited, and Watson Laboratories, Inc. (collectively, the

    Defendants, which for purposes of this stipulation also includes Watson Pharmaceuticals, Inc.,

    Actavis Inc., Watson Pharma, Inc., and Anda, Inc.), by their undersigned counsel, hereby

    stipulate and agree that:

    WHEREAS Celgene represents that it owns United States Patent Nos. 6,045,501 (the

    ’501 patent), 6,315,720 (the ’720 patent), 6,561,976 (the ’976 patent), 6,561,977 (the

    ’977 patent), 6,755,784 (the ’784 patent), and 8,315,886 (the ’886 patent) (collectively,

    the Celgene Patents);

    WHEREAS Natco represents that it filed Abbreviated New Drug Application (ANDA)

    No. 201452 seeking approval to engage in the commercial manufacture, use, and/or sale of

    generic 5, 10, 15, and 25 mg lenalidomide capsules (Natco’s ANDA Products) before the

    expiration of the Celgene Patents;

    WHEREAS Defendants proposed to enter a stipulation regarding their infringement of

    the Celgene Patents;

    Case 2:10-cv-05197-SDW-MCA Document 304 Filed 05/07/14 Page 2 of 4 PageID: 9417




    NOW THEREFORE, the parties, their successors, and assigns hereby stipulate, and will

    not contest before this Court or any court on appeal, that:

    1. If approved by the FDA, the distribution of Natco’s ANDA Products in the United

    States would constitute infringement of each asserted claim of the Celgene

    Patents, specifically, claims 1 and 3-9 of the ’501 patent; claims 1-5, 7-8, 11-19,

    21, and 23-28 of the ’720 patent; claims 1, 3-6, 8, 10-13, and 15 of the ’976

    patent; claims 1-7, 9, 11-21, 23, and 25-30 of the ’977 patent; claims 1-7, 9, 11-

    21, 23, and 25-30 of the ’784 patent; and claims 1-7 of the ’886 patent

    (collectively, the Asserted Claims).

    2. Nothing herein shall be construed as precluding, restricting, or limiting discovery

    concerning the validity of the Asserted Claims, including, but not limited to,

    secondary considerations of nonobviousness.

    3. Nothing herein shall be construed as precluding, restricting, or limiting

    Defendants’ obligation to provide discovery concerning ANDA No. 201-452, and

    to comply with L. Pat. R. 3.6(j).
    May 7, 2014. 09:22 PM | Likes Like |Link to Comment
  • Addressing Revlimid Patents Questions From Celgene's Q1 2014 Call [View article]
    Thanks, Daniel. I appreciate the quick and insightful response.

    Ted
    Apr 28, 2014. 01:51 PM | Likes Like |Link to Comment
  • Addressing Revlimid Patents Questions From Celgene's Q1 2014 Call [View article]
    Thank you, Mr. Ravicher. This is one of the best overviews of the situation I have seen in the financial literature.

    If possible, would you address the matter of 'unclean hands' on the part of the generic company as well as their attempts to hide a critical witness (the ex-CELG employee who stole the drug from Celgene on their behalf) from Celgene's legal team?

    Ted
    Apr 28, 2014. 10:08 AM | 2 Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Don't mention it.

    Ted
    Mar 31, 2014. 02:55 PM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    I don't see any big mystery here. If you click on the link, you see the Confidential Treatment Order granting an extension of the previously granted confidential treatment of Exhibit 10.57 attached to the 10-K/A filed March 3, 2009. If you look at the Exhibit filed with that 10-K/A, you'll see that the confidential treatment relates to specific financial terms under the company's license of technology from the University of Michigan. This is very standard practice to prevent potential competitors and sublicensees from learning the specific deal terms, which could give them a competitive advantage. The request and grant of an extension simply suggests that the licensed technology is still of interest and that the company still believes (and the SEC agrees) that there is still value in protecting this information.

    Ted
    Mar 30, 2014. 09:30 PM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    We all get the picture, SS113. You don't like the company or the president. I don't think you could make it any, well, simpler.

    Thanks for your opinion(s).

    Ted
    Jan 27, 2014. 12:27 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    All of Vical's programs are based on the same core technology, which is their patented method of delivering genetic material (DNA or RNA) into living cells in the body. Once delivered, that genetic material is designed to cause production of the specific protein it encodes. Some applications use DNA (typically in closed loop form called plasmids) in a simple saline solution. Others use DNA plasmids in a lipid or polymer formulation. Some are injected into muscle. Some are injected into tumor lesions or other tissues. The delivery location, formulation and specific gene encoded within the plasmids determines which protein will be produced, in what quantity, for what duration, and in what location within the body. After that, the produced proteins will cause the specific biological or physiological effect for which they are selected. In the case of a vaccine, for example, the encoded protein would be one from the target pathogen. The desired physiological effect would be to develop an immune response against that protein to provide advance protection against the pathogen bearing that same protein.

    In the case of Allovectin, the selected protein(s) were designed to trigger an immune response against the cancer cells prevalent at the injection site. In the case of the AnGes angiogenesis treatment, the selected proteins were designed to induce production of new blood vessels at the injection site.

    So while the underlying gene delivery mechanism is the same, the encoded proteins really have unique mechanisms which differentiate the products.
    Jan 24, 2014. 03:59 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    No. And much to early to speculate.

    Ted
    Jan 18, 2014. 11:44 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Inept! They have no dedicated CFO, as I pointed out above. The original filings never should have been made in error.

    Ted
    Jan 17, 2014. 01:29 PM | Likes Like |Link to Comment
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