Latuda will be generic in 2018 as planned

Discussion in 'Sunovion' started by Anonymous, Jan 15, 2015 at 11:51 AM.

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  1. Anonymous

    Anonymous Guest

    Sumitomo Dainippon Pharma Co. Ltd. (“Sumitomo Dainippon Pharma”) and its U.S. subsidiary Sunovion Pharmaceuticals Inc. (“Sunovion”) jointly filed patent infringement lawsuits on January 14 2015 in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Limited Emcure Pharmaceuticals USA Inc. and InvaGen Pharmaceuticals Inc. regarding their submissions of Abbreviated New Drug Applications (“ANDAs”) for generic copies of Latuda® (lurasidone HCl) tablets. The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 5532372 (“the ’372 Patent”).

    The ’372 Patent is exclusively licensed to Sunovion in the United States and Sunovion has been marketing lurasidone HCl tablets in the United States under the brand name LATUDA® since its launch in February 2011.

    Due to the commencement of these lawsuits the FDA approval of the ANDAs will be stayed at least until the earlier of April 28 2018 (plus an additional six months thereafter if Sunovion is awarded a pediatric exclusivity extension) or the date of a district court decision finding the ’372 Patent invalid unenforceable or not infringed. Should Sumitomo Dainippon Pharma and Sunovion successfully enforce the ’372 Patent ANDA approval should not occur at least until expiration of that patent on July 2 2018 (plus an additional six months thereafter if Sunovion is awarded a pediatric exclusivity extension).

    Sumitomo Dainippon Pharma and Sunovion believe that their patent position for LATUDA® is strong and they are prepared to vigorously protect their patent rights.

    About Sunovion Pharmaceuticals Inc. (Sunovion)

    Sunovion is a leading pharmaceutical company dedicated to discovering developing and commercializing therapeutic products that advance the science of medicine in the Psychiatry & Neurology and Respiratory disease areas. Sunovion’s drug development program together with its corporate development and licensing efforts has yielded a portfolio of pharmaceutical products including Aptiom® (eslicarbazepine acetate) Latuda® (lurasidone HCl) tablets Lunesta® (eszopiclone) tablets Xopenex HFA® (levalbuterol tartrate) inhalation aerosol Brovana® (arformoterol tartrate) inhalation solution Omnaris® (ciclesonide) nasal spray Zetonna® (ciclesonide) nasal aerosol and Alvesco®(ciclesonide) inhalation aerosol.

    Sunovion an indirect wholly-owned U.S. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. is headquartered in Marlborough Mass. More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.

    About Sumitomo Dainippon Pharma Co. Ltd.

    Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. Sumitomo Dainippon Pharma aims to produce innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co. Ltd. and Sumitomo Pharmaceuticals Co. Ltd. Today Sumitomo Dainippon Pharma has about 7000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com

    LATUDAis a registered trademark of Sumitomo Dainippon Pharma Co. Ltd. LUNESTA XOPENEX HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of Takeda GmbH used under license.

    APTIOM is under license from BIAL.

    Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co. Ltd.

    © 2015 Sunovion Pharmaceuticals Inc.

    For a copy of this release visit Sunovion’s web site at www.sunovion.com
    Business Wire
    http://www.businesswire.com/

    Last updated on: 14/01/2015

    More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=106547#.VLfvnSw0oow#ixzz3OuSdxff9
     

  2. Anonymous

    Anonymous Guest

    So when does the LOE strategy begin? Wasn't it 18 mos. Prior to Lunesta losing patent? Pediatric indication won't delay the LOE cuts. Thinking this ship will hit the iceberg come 2017 if not already.
     
  3. Anonymous

    Anonymous Guest

    that's assuming this place is still around by that time. Wouldn't be surprised if they sell off the rights of this drug to someone else after aripiprazole decimates this market
     
  4. Anonymous

    Anonymous Guest

    I am not worried because dasotraline will be approved by then. Aptiom can add trigeminal nerve pain and depression ( used in Europe ) indications and we can bring back Omnaris on a seasonal basis to generate revenue. Our future is bright indeed!
     
  5. Anonymous

    Anonymous Guest

    Right you are. Biggest mistake this company made was to let PS go. Under her leadership, Omnaris/Zetonna were guaranteed to break $500M at peak.
     
  6. Anonymous

    Anonymous Guest

    Nothing *new* here folks...

    The drug patent expiration has ALWAYS been listed as July 2, 2018 in the FDA Orangebook since the day Latuda was approved way back in October 2010, therefore this is OLD news, nothing new here except the names of the generic companies who filed the ANDA's.

    Latuda in Orangebook (FDA website):
    http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=200603&Product_No=001&table1=OB_Rx

    Latuda going generic was previously discussed over a year ago in Dec 2013 , post # 4:
    http://www.cafepharma.com/boards/showthread.php?t=547126


    ....Tick-tock, tick-tock

    ....Jan 2015, T minus 41 months and counting until generic Latuda

    ....Sales hit $1 Billion in 2017, then...

    ....Latuda dies a generic death halfway through 2018

    ....Rest in peace Latuda and Sunovion, good luck to all!
     
  7. Anonymous

    Anonymous Guest

    you're way too optimistic. Latuda is dead once generic Abilify hits the market
     
  8. Anonymous

    Anonymous Guest

    I don't necessarily agree with that. I wouldn't say dead. I would say that we have not baked into the plan the pressure that Abilify LOE will have on the Latuda trend line, though. Here's what I think will happen. As Abilify LOE adversely affects Latuda there will be more pressure put on the Latuda reps and DM's. Latuda territories where people quit will not be backfilled and there will be a very slow downsizing through attrition through 2016. Come 4Q of 2016 there will be a major downsizing on the latuda team and a year later it will be game over..

    Aptiom does not have such a rosy future. In June of this year, Aptiom sales force will be under severe scrutiny. We continue to have extremely flat NRx growth and I think we have been buying time by telling Japan that the monotherapy will be a game changer. All those I speak with in the field selling aptiom convey that they do not think that will be the case. I'm afraid there may be big slashing on the Aptiom side even before monotherapy may get approved. Sooner or later you have to just cut your losses and move on. Latuda can't continue to plug that cash bleeding gash forever.

    As for Brovana, I don't think anyone knows what the hell is going on with Brovana.
     
  9. Anonymous

    Anonymous Guest

    Look everyone, 2016-2018 is going to be a pivotal time for this company. Latuda and Aptiom will go generic, and a 6 months to a year before then the sales forces will be let go. That is assuming that past history of company behavior predicts future strategy. BBI 608 did not do so well in clinincal trials, and dasotraline is the old, failed SEP-289 molecule. Looking at the way the company has handled the arformoterol and ciclesonide franchises, does anyone have faith in SEP-101, which requires its own special nebulizer? And who will get those jobs, you, or someone from outside with respiratory experience? Again, past history may point out the answer to that question.

    The point that I am trying to make is this: Do you have the confidence in your management team to lead you through this critical time? It is only a year away. Will they be clever enough to find a decent product to in-license or co-market to keep the cash stream coming in? Do they inspire you to dig deep down inside yourselves to do what it takes to get the job done? Only you can answer those questions. If the answer is yes--then dig down deep and get going. If the answer is no, better look for greener pastures while you have this window of opportunity. I have decided. Have you?
     
  10. Anonymous

    Anonymous Guest

    Why do we even have a new product planning group? It's all a joke, we've hit the point of no return. DSP would have invested by now. Do they think we're fools?
     
  11. Anonymous

    Anonymous Guest

    CEO?
     
  12. Anonymous

    Anonymous Guest

    I have faith in my leadership team. Being part of the West and with a leader like CS and G-Man pulling the strings, there is nowhere to go but up. Je Suis G-man.

    PF Arizona rocks!
     
  13. Anonymous

    Anonymous Guest

    You dopey latuda reps don't get it, you'll have nothing to sell in 2 years and a few months.
     
  14. Anonymous

    Anonymous Guest

    You think it sucks to work here now? Just wait until March. The screws are beginning to tighten. I'm afraid the above post is dead on.
     
  15. Anonymous

    Anonymous Guest

    Brovana day is coming soon. Q1 will be the end. I know they brag that the Lincare contract continues to bring in extra revenue and raise the ASP but you can't continue to miss the goal quarter after quarter without heads rolling. We had a meeting last week with the brand team and they are worried.
     
  16. anonymous

    anonymous Guest

    please keep talking about the drug i need to function and be a sane person like its only value is the money it makes u fucking disgusting psychopaths. it's really endearing
     
  17. anonymous

    anonymous Guest

    Everything will be ok little snowflake! We have the G-man leading us and word is, Omnaris will be back in the reps hands very soon. Omari's! To the nose!!!!
     
  18. anonymous

    anonymous Guest

    Do not wolly rittle snohfrake, Ratuda good midcine, patent plotection good foh now. We fight to maintain excrusivity foh long time. You wait, you see.
     
  19. anonymous

    anonymous Guest

    10, 9, 8, 7, 6, 5, 4, 3, 2, 1..... LAYOFFS!! Big big big layoff. Heard ZS Associates helping HR start mapping the reduction at an off site venue. Could any of the home office people confirm? Will this happen before the end of the fiscal year? Please share. I have a family to provide for.
     
  20. anonymous

    anonymous Guest

    Still in the planning phase but I can confirm layoffs are coming. Announcements in 3rd quarter.

    Courtney