Seeking Alpha

Andrew Nava's  Instablog

Andrew Nava
Send Message
Andrew Nava LLC is a healthcare focused consulting and investment firm. Prior to launching Andrew Nava LLC, I was a venture analyst, buy-side analyst, and most recently, the Director of Research at Actin Biomed, a New York-based healthcare investment firm where I was responsible for the medical,... More
My company:
Andrew Nava, LLC
  • BPAX Sample Note to Clients on June 17, 2010
    Below is an excerpt of the client note sent out last week (before today's announcements).  For client reasons, we've redacted some text with XXXX (not proportional to length of text).

    Overview

    Biosante Pharmaceuticals (BPAX) is reporting further safety data next week from its LibiGel Safety Trial.  XXXX is expecting the safety trial to continue with a low rate of adverse events (AEs).

    Safety Trial Background

    The LibiGel Phase III Cardiovascular (NYSE:CV) and Breast Cancer (NYSE:BC) Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that expects to enroll between 2,400 and 3,100 women treated with either LibiGel (300 mcg testosterone daily) or placebo for 12 months.  Primary endpoints (1EP) include 1. Combined rate of adjudicated, predefined CV events and 2. Rate of breast cancer events.  XXXXXXXX.

    CV events are defined as: CV death, nonfatal stroke, nonfatal myocardial infarction (NYSE:MI), hospitalized unstable angina, coronary revascularization, venous thrombo-embolic events.

    The rate of breast cancers in the study are similar to the rate of breast cancers observed in the placebo arm of the 50-60 year old women in the WHI estrogen only arm (0.26% vs 0.33%, respectively).

    Inclusion criteria in the safety study includes women age 50 or older, menopausal, positive diagnosis of HSDD and a presence of two or more of the following risk factors for cardiovascular disease (based on the RUTH Study, Barrett-Connor et al., 2006): age 60 to <70 years, age 70 or greater, diabetes mellitus, presently smoking, hypertension, dyslipidemia, ankle-brachial index <0.6, and a documented CV history.

    Timeline

    October 2009: The Independent Data Monitoring Committee (IDMC) reviews all "serious adverse events" and all "adverse cardiovascular and breast cancer events" in 1,055 women with 883 women-years of exposure. There were no deaths, one myocardial infarction and three breast cancers reported. The IDMC unanimously recommended continuing the study.

    February 2010: The IDMC again recommended continuing the study after reporting no deaths, seven adjudicated cardiovascular events and four breast cancers.

    June 2010: Next IDMC review of approximately 1,500 women enrolled to-date.

    Quick Facts - Clients Only

    For more on BPAX, Libigel, or competitors, please contact Andrew Nava for information on retail and institutional rates and services.

    Andrew Nava LLC provides institutional and retail healthcare investors with buy-side equity research tools that focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by consulting with KOL's, industry professionals, company management, and powered by our database of clinical trial data and upcoming company milestones.

    Disclosure: Long BPAX
    Tags: ANIP
    Jun 21 10:37 AM | Link | Comment!
  • Daily Updates at AndrewNava.com (Focus on ADLR, BPAX, CRIS)
    Below is today's morning note to clients detailing database updates and new milestones.  The updates are from AndrewNava.com, which currently tracks over 290 publicly-traded biotechnology and pharmaceutical companies, hundreds of clinical trials from more than 1,000 approved and development-stage drugs, devices and diagnostics, and over 700 company milestones across 17 different catalyst types...

    Dear Client,

    Here are the latest updates at AndrewNava.com...


    NEW MILESTONES

    ALKS: Vivitrol Psychopharmacologic Drugs AdComm September 16, 2010, PDUFA October 12, 2010 for opioid dependence.
    BPAX: Expected enrollment completion for Libigel safety trial 3Q10 with data 3Q11, est enrollment completion for both pivotal trials 4Q10 with data 3Q11; Expected Bio-T-Gel NDA filing YE2010 by Teva.
    CRIS: Still on track for several catalysts later this year and into 2011 (includes GDC-0449 ovarian cancer data expected 2H10 and advanced basal cell data expected 2011, as well CUDC-101 data in solid tumors expected at EORTC-NCI-AACR November 2010).

    DATABASE UPDATES

    IMMU, Clivatuzumab, TF2, Milatuzumab, Epratuzumab, NBIX/Elagolix, CRIS, GDC-0449, ONTY (Stimuvax, PX-866, PX-478), TTNP, TDLP, XOMA 052, CLSN, BTIM, MHAN, ADLS, Celution System, ADLR (ADL5859 and ADL5747), ONCY, RDEA594, ARDM

    Andrew Nava, LLC provides institutional and retail healthcare investors with buy-side equity research tools that focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by consulting with KOL's, industry professionals, company management, and powered by our database of clinical trial data and upcoming company milestones.


    Disclosure: No positions
    Jun 21 8:07 AM | Link | Comment!
  • What's Inside Our Daily Updates - Daily Biotech Milestones and Clinical Trial Data

    Our database of clinical trial results, stock catalysts, and product sales is updated on a daily basis.  If you're too busy to check what's new on our site we also offer daily updates on new milestones, updates to our database and stocks to watch for the day.

    Here's an example email sent to clients on May 4, 2010 (chosen at random):

    NEW MILESTONES

    ACUR: KG and ACUR said they would file an NDA for Acurox in early 2011 (Note: FDA Anesthetic and Life Support Drugs and Drug Safety AdComm voted 19-1 against approval)
    BPAX: Expect GVAX clinical hold to be lifted (to partial hold) soon w/ new prostate CA trial at Hopkins anticipated to begin in 4Q10.
    CORT: Pivotal Cushings data for Corlux on track for 4Q10.
    CRIS: CUDC-101 enrollment is now complete, final trial data is expected at EORTC-NCI-AACR November 2010 (company has seen responses in gastric CA after 4 cycles).
    STEM: HuCNS-SC data presented at AANS

    DATABASE UPDATES

    CLDA (Santen deal), OMER (OMS103HP data), ANX (financing), BSDM (financing), AUXL (Xiaflex, Testim sales), TRGT (expanded AZN deal), CORT (warrant exercise), POZN (Q1 Treximet sales), ISPH (all sales for Q1), VRX, RPTP (Cysteamine NASH data), PPHM

    STOCK WATCH

    ITMN: PDUFA today
    CRXX: Up pre-market
    KERX: Continues upward trend w/ heavy volume pre-market
    SLXP: Up pre-market
    VNDA: Up pre-market on higher than expected Fanapt revenue

    RESEARCH - Not disclosed, coming soon

    Andrew Nava, LLC provides institutional and retail healthcare investors with buy-side equity research tools which focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by consulting with KOL's, industry professionals, company management, and our database of clinical trial data and upcoming company milestones.

    As of June 2010, AndrewNava.com covers over 290 publicly-traded biotechnology and pharmaceutical companies, 100's of clinical trials from more than 1000 approved and development-stage drugs, devices and diagnostics, and over 800 company milestones across 17 different catalyst types.



    Disclosure: No positions
    Tags: ACUR, ANIP, CORT, CRIS, EPRS, ITMN, KERX, SLXP, VNDA
    Jun 16 7:18 PM | Link | Comment!
Full index of posts »
Latest Followers

Latest Comments


Posts by Themes
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.