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Research Background- I only invest in areas of interest that are familiar.
  • HALO Cata List December 2013- Checking It Twice Is Allowed 2 comments
    Dec 14, 2013 2:07 PM | about stocks: HALO

    Halozyme Cata List- Possible and Probable Catalysts- in Formation

    1. Partnered Meds

    A. Herceptin SC-

    1. Additional launches after UK, Germany, Portugal, Chile to be announced Q1 14 CC

    2. Q3 Rev/Royalties TBA Q1 14 CC

    3. Single Use Injection Device Reveal and Announcement of Use with other subcut products- Roche and other companies- Baxter,etc

    4. Further expansion of indications in Her2- Breast Cancer through research or Dr. Max Wicha- U of Michigan

    5. Further Restriction of use of Perjeta and Kadcyla by NICE due to cost

    B. HyQvia

    1. FDA Approval- June-July 2014

    2. European Launch Expansion past Germany and Netherlands and Q3 Revenue announcement Q1 14 CC

    3. Further Alzheimer's ApoE4 research demonstrating cognitive benefit of Gammagard (IV HyQ) in 40% of AD pts with gene

    4. Completion Baxter Gammagard/HyQ plant in Covington, Ga.- scheduled to be fully operational- 2018

    C. MabTheraSC

    1. CHMP positive review- Next possible date 12/20/13 after 5/13 positive PRAC review- "Approved without further plenary action"

    2. Further delay in GA-101 trials by RHHBY- 2 year estimated delay announced 12/12- planned filing 2017

    3. Positive result of New Study NCT01987505- Safety of switching from MabThera IV to sc in first line lymphoma Rx

    4. Pos Result NCT017224021- MabTheraSC for Large B Cell Lymphoma and NHL

    5. Pos Result NCT01808599- MabSC w Chlorambucil for Extranodal MALT lymphoma

    2. Proprietary Meds

    A. HTI-501

    1. 3 and 6 mo. Ph2 Data Report Q1 14 w photos

    2. Partnering Announcement- CEO noted Q3 CC that photos were currently in front of prospective partners- AGN vs PFE (PFE dropped alliance with AUXL on Dupuytren's Contracture as of 4/13- this is an indication of HTI-501, along with cellulite, frozen shoulder, Peyronie's Dis.

    3. Application of new Halozyme patent technology- Soluble Glycosaminoglycases- Patent no. 8580252- to develop topical or aerosol HTI-501 for cellulite

    B. PegpH20

    1. Continued Survival of 4 pts "on study" from high hyaluron cohort- As of 9/27/13 this group had a survival of 529 days- 2 gone 4 still alive as of Q4 13- so If all 4 live to 1/1/14, the survival value goes up to 600 days. The record for Pancreatic Stage 4b is 350 days with Folfirinox.

    2. Ph2 Study with Gem-Abraxane- Interim results ASCO June 2014

    3. Ph2 Study with mFolfirinox- Interim results ECC/ESMO Sept 2014- under CRADA- Cooperative Agreement w NCI-USGov gives Halozyme full patent rights to pegpH20-Folfirinox- once results emerge this CRADA will be seen as a coup

    4. Possible Strategic Alliance or Partnering with Celgene on the pegpH20-Abraxane-gem(generic) with Roche on pegpH20- Fol.

    5. Application of new patent 8580252 technology to develop oral administration of rhupH20 with activity noninferior to pegylated rhupH20 for use in high hyaluron (panc, bladder, ovarian, some breast) and in metastasis prevention.

    C. rhuInsulin- Analog, Ultrafast Insulin

    1. Results of Consistent I for Type 1 Diabetes on Insulin pump - Q1 14 topline results to be reported Q1 14

    2. Yale Artificial Pancreas Study using Halo Insulin- NCT01945099 interm results 6/13/14

    Page 2

    3. Humulog (NYSE:LLY) and Lantus (NYSE:SNY) coming off patent 2014-both are prospective partners for Halo rhuinsulin

    D. Hylenex

    1. Eye Surgical Anesthesia Market now dominated $20M mkt- over 50% Halozyme penetrance in 16 mos

    2. Psoriasis Indication- NCT01987609- 10/14 completion

    3. Postop Swelling Indication- Sustained release gel could partner with HTI-501 as additional dermatologic target

    onlinelibrary.wiley.com/doi/10.1111/ijd.12304/abstract

    3. Miscellaneous

    A. Insider Buying Buys - $25.2M Sales $756K- CEO bought 12/13

    B. Diagnostic Tool- Enzyme system for Detecting Hyaluron- a natural for acquisition by Roche Diagnostics- in a package with PegpH20-mFolfirinox patent rights- Q1 15 (est)

    C. Buyout Potential- 2014 Peg, Insuli, HTI results all can accelerate B/O mkt quickly if as positive as expected

    E. Cash Positivity- Q4 14 with increased Herceptin, HyQ , and MabThera Rev and deferred treatment of milestones

    Disclosure: I am long HALO.

    Stocks: HALO
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  • fezziwig2008
    , contributor
    Comments (153) | Send Message
     
    Author’s reply » F. PegpH20 given Breakthrough status- with accelerated review- by FDA
    G. Halt to Ph2 PegpH20 trial with compassionate treatment of control group by $halo
    18 Jan 2014, 05:13 PM Reply Like
  • fezziwig2008
    , contributor
    Comments (153) | Send Message
     
    Author’s reply » Hylenex Insulin has become the most pressing catalyst as of mid February 2014. Douglas B. Muchmore , M.D. Halozyme
    Vice President, Endocrinology Clinical Development presented excellent data on the subject at ATTD 14- held in Vienna on 2/7. Hylenex insulin resulted in a significant improvement in glycemic control- 30 mg/dl - and a reduction of the Tamborlane effect. This reduction lessens the variations seen as the infusion set ages, effectively extending the useful life of this costly equipment.
    Halozyme's CEO in her January update at JPM announced Halozyme was weeks away of meeting with the FDA on a new label for Hylenex. She has yet to publicize the presumably excellent topline data that has brought us to this point.
    15 Feb 2014, 09:52 AM Reply Like
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