% | $
Quotes you view appear here for quick access.

Zalicus Inc. Message Board

  • pattonjim95 pattonjim95 Nov 15, 2013 9:03 PM Flag

    Somebody give me a heads up

    The SA article today reports that Exalgo 32 mg will be allowed to be released generically in the Spring. I never heard or read that before???? Is anybody up to speed on that or is it just another SA BS job??
    Jim Still calm

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • I read the same thing last week on SA. That is one of the main reasons I would be reluctant to trade ZLCS.

    • Actavis Reaches Settlement with Mallinckrodt Over Exalgo® 32 mg Dosage Strength

      PARSIPPANY, N.J, Feb. 14, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo® (Hydromorphone Hydrochloride Extended-Release) tablets.

      In January of 2012, Actavis and Mallinckrodt previously settled litigation involving the 8 mg, 12 mg and 16 mg dosage strengths of the product. Mallinckrodt filed its current lawsuit on October 25, 2012 in the U.S. District Court for the District of New Jersey following Actavis' filing of an Amendment to an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its product in the 32 mg dosage strength.

      Under terms of the settlement agreement, Mallinckrodt has granted Actavis a royalty-free license to U.S. patents relating to Exalgo to sell Actavis' 32 mg product starting on May 15, 2014. Other details of the settlement were not disclosed.

      Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of the 32 mg dosage strength of Exalgo® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

    • Guys:
      I went back and read everything I could find on this and I think your mistaken. Every reference I found including Zacks, Yahoo Finance and Reuters stated the exact same thing that I remembered 32mg Exalgo is NOT included in the settlement with Watson and ZLCS had the 32mg approved in 2012, The 2013 10-K says the same.That would start the protected periods clock running, my comment.
      Jim Still calm

    • Jim, I believe this is accurate. The lower doses are now generic and 32 mg will be generic in May. That means much lower royalty revenue so they'll miss analyst expectations again (not a good thing). There is really no positive news on the horizon, at least until 2nd quarter of next year. The cash burn, with high salaries and all, will eat away at the reserves forcing dilution and hence a price point lower than $1 which will force another RS. The company could try to transform itself into a tech company versus an R&D company. These are just a bunch of scientists trying to figure something out with a CFO acting like a Chief Commercial Officer (not!!!). It's sad as I was leveraged pretty good for about a year but bailed when I saw the writing on the wall. I wish it was different because I would've been joining the team here in the Caribbean for drinks and sunshine. Oh well.....maybe we can find the next best thing with another company.

    • Actually today, Nov. 15 is the day that it is available for generic. The company loses 50% of its royalties. Corrigan has never bothered to mention it. Just like nobody mentioned that severance for Renz and Cole increased from 12 months to 18 months. Why would they do something like that?

1.180.00(0.00%)Jul 15 4:00 PMEDT