Archive | April, 2011

Pain Therapeutics (PTIE) positioned to cash in on the pain market?

20 Apr

About Pain Therapeutics, Inc.

  • Pain Therapeutics (PTIE) is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, a unique, abuse-resistant controlled-release oxycodone, the Company has three drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and PTI-721. Pain Therapeutics is also working on a new treatment for patients with hemophilia.

Product pipeline

  • The product we are focusing in on is REMOXY.  REMOXY is an exciting product, that is set to take on the $3B pain killer market for Oxycodone; so Blockbuster potential.  It is a reformulation, but is an abuse deterrent drug and its efficacy is good.  REMOXY comes in gel tab form that when crushed retains its form.  It also does not absorb in alcohol or water like the current drugs on the market do.  This allows for less abuse by addicts.
  • History of REMOXY
    • June 2008 filed NDA
    • Aug 2008 was given priority review
    • Nov 2008 panel was in favor
    • Dec 2008 FDA issued a CRL asking for no new trials, no change in formulation, but for stability data
    • Dec 2010 PTIE filed stability data
    • Jan 2011 received acceptance for NDA with PDUFA of6/23/11
  • Company will receive $15M upon approval from partner Pfizer (formerly King Pharmaceutical) and a 15% royalty on net sales for the first $1B of REMOXY plus 2 other abuse-resistant pain killers currently in clinical trials, and a 20% royalty on net sales > $1B.  PTIE gets a 10% royalty on international sales.

Financial information

From 10K filed2/3/11

  • At12/31/10had approx $ 91M in cash, and CFO expects less than $ 5M in cash expenditures in 2011 (does not include potential 15M milestone if REMOXY is approved)
  • Total assets $ 99M

From Yahoo! quote summary4/20/11

  • Market cap of $ 377M
  • Avg analyst target $12
  • P/E n/a
  • Shares o/s 43M, float 28.5M

 Stock data and trading plan

 

A great opportunity to buy on the dip here, PTIE is currently oversold and within the 50%-38% retracement zone so it is a screaming buy.  Bought more today and will add if it falls under $ 8.50 but I doubt it will.  I am very excited about playing this and think they will get an approval into this $ 3B market, it is a huge market, and they have a shot at being the first abuse deterrent Oxycodone drug on the market.  Run don’t walk to your broker – buy now and hold until it goes over $10.  Will post a comment if I am holding some through approval.

See my other reports under the Biotech Momentum tab and sign up at the bottom to subscribe for e-mail alerts:

https://pokerexpress.wordpress.com/category/biotech-momentum/

Disclosure:  currently long PTIE

Disclaimer: I have never ever been paid or compensated by anyone for any stock I trade or discuss. None of the information posted on this site is to be construed as financial or investment advice. This information is not to be construed as an offer to buy or sell any security mentioned on this blog. The creator of this blog is not a licensed broker or financial advisor of any kind. The information on this site is gathered from sources available to the public. As consideration in using this blog, all users agree, understand, and acknowledge the creator of the blog is not liable or responsible for the accuracy or use of the information provided on this site and agree to indemnify and hold the creator of this blog harmless from any liability resulting from the accuracy or inaccuracy of the information and from use of the information on this board. All of the information that I post on this blog is public information available to anyone! You are responsible for your own trades and not the creator of this blog.  Please be aware that investing in securities carries the risk of losing some or all of your money.

Is Transcept Pharmaceuticals (TSPT) new drug application a slam dunk for approval?

6 Apr

About Transcept Pharmaceuticals, Inc.

  • Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

 Product pipeline

  • Transcept has two products under development:
    • The main one is Intermezzo® (zolpidem tartrate sublingual tablet) for the treatment of insomnia which has a pdufa date of July 14, 2011

http://finance.yahoo.com/news/Transcept-Pharmaceuticals-prnews-422487675.html?x=0&.v=1

  • For info on Intermezzo, see the Companies website:

http://www.transcept.com/content/view/39/95/

  •   the other is TO-2061 for an adjunctive treatment of Obsessive Compulsive Disorder (OCD) which is is Phase II development

Financial Info

 From 10K for year ended 12/31/10; filing on

  • $ 67M cash & marketable securities
  • Total assets $ 74M
  • L-T debt $ 348k
  • Solid cash position, should not need to dilute further via shelf offerings

 From quote summary 4/6/11

  • Market cap $ 120M
  • Average analyst target $12
  • P/E n/a
  • Shares o/s 13.46M, float 5.68M

 Stock data and trading plan

 

Stock chart looks great, just bought today on the break in trend line and will add on a pullback or a break of $ 9.50.  Here’s the deal, although I am not as excited of the actual drug getting approved due to big time competition in this market, I also think its going to be a slam dunk approval for two reasons:

  1. As stated on the Company website, there was already at a CRL issued against Intermezzo in the past, so this is the second go around for the Company and getting this drug approved.
  2. More importantly, there has already been an approval for the same drug, for the same use, in a spray mist form this year.  See link for official launch:

http://finance.yahoo.com/news/Zolpimist-Oral-Spray-Launched-bw-760115425.html?x=0&.v=1

 Given the above, IMO Intermezzo should be approved and I will most likely hold the stock through approval unless the stock experiences strong momentum before the pdufa date.  My target price is $10-11 pre-pdufa and $12-14 post-pdufa if drug is approved.

 See my other reports under the Biotech Momentum tab and sign up at the bottom to subscribe for e-mail alerts:

https://pokerexpress.wordpress.com/category/biotech-momentum/

Disclosure:  currently long TSPT

Disclaimer: I have never ever been paid or compensated by anyone for any stock I trade or discuss. None of the information posted on this site is to be construed as financial or investment advice. This information is not to be construed as an offer to buy or sell any security mentioned on this board. The creator of this board is not a licensed broker or financial advisor of any kind. The information on this site is gathered from sources available to the public. As consideration in using this board, all users agree, understand, and acknowledge the creator of the board is not liable or responsible for the accuracy or use of the information provided on this site and agree to indemnify and hold the creator of this board harmless from any liability resulting from the accuracy or inaccuracy of the information and from use of the information on this board. All of the information that I post on this board is public information available to anyone! You are responsible for your own trades and not the creator of this board.  Please be aware that investing in securities carries the risk of losing some or all of your money.

Only 32 days until the Kentucky Derby!

5 Apr

Excitement is starting to brew in my head as I begin to see more hype surrounding the upcoming Kentucky Derby.  This weekend I will check out Uncle Mo in the Wood Memorial and also keep an eye on the Santa Anita Derby.  This will be the last chance to view most of the horses that will be in the Kentucky Derby.  I will not be placing bets this weekend, but previewing potential wagers for the Derby.

More to come as the Derby closes in.  In the meantime check out this cool NYRA calendar containing all of the big races:

http://www.nyra.com/Aqueduct/GeneralInformation/Calendar/NYRA_Calendar.pdf

NBA betting system

4 Apr

Hi all,

Sorry I haven’t posted any bets lately.  Most teams have now locked up a playoff spot so it is very difficult to place bets on them due to resting of players, etc.  So this is the end.  We hit exactly a 50% ratio of wins to losses 34-34.  Not good as the vig has eaten into our profits, making this NBA season a losing one.  I ill try again next year to see if we can do better.  Until then, see my stock picks and other posts and hopefully the NFL will have a full season so we can take advantage of the betting system on that!

50.0% W 34
  L 34
    68