Be sure to check out my latest reports about BPAX:
BPAX: Picking up the pieces (12/15/2011)
- Product for hypogonadism (aka male testosterone deficiency)- not licensed from AIS and no royalties owed to anyone on this pgm
- 2010 10K: 5m men in US (mostly over 40 years old) have low testosterone. Oral dosing is not possible-inactivation by liver. Injections require large needles- painful and not effecgive in maintaining blood levels throughout day. Patches can fall off and cause irritation. Two other gels are marketed and two more gels have been approved but not yet launched.
- Partnered w/ Teva (11/3/10 webcast stated $1.5m upfront, 5-10% royalties, no milestone for NDA submission, mid-single digit million $ milestone for FDA approval). Stopped development in 2005 but resumed June 2007.
- 4/13/2011: BPAX announces that Teva filed the NDA in January 2011 and it has been accepted by the FDA- PDUFA date is November 14, 2011 - click here for press release...timeline slipped from guidance for submission in 2010 as late as Sept 2010. 2/14/11 webcast had said hope to announce by end of 1q11 and 3/15/11 webcast "soon"
- 12/2010 Endo Pharma got Fortesta testosterone gel approved for men, metered dose pump (78% achieved normal test serum range at day 90; std dose 4 pumps= 40 mg, can titrate 10-70mg).
- Others competitors already on market (AndroGel from ABT, testin from Auxillum, Axiron). 3/15/2011 and 4/15/2011 webcasts: total market is >$1.2B. Typical cost in $11-12 per day (5/24/11 webcast)
- 4/15/11 and 5/9/11 webcasts: Androgel and Testin combine for $1.1b in 2010 US sales (5/24/11: Androgel makes up >$900m of this). Factoid: male testosterone market was just $25m in 1995 (5/9/11 webcast)
- Androgen and Testin have composition of matter patents covering their non-testosterone gel components..no one has active patent on testosterone itself (5/24/11 webcast)
- ABT has filed a patent infringement lawsuit against Teva regarding Bio-T-Gel. (5/9/11 webcast: Teva asserted non-infringement in NDA...so this confirms that the ABT lawsuit was regarding Bio-T-Gel rather than some other Teva generic testosterone product filed via ANDA pathway)
- 5/9/11 webcast question: how does Teva plan to position Bio-T-Gel upon approval? Answer: we dont know yet- Teva hasn't told us. Reiterated that BioTGel was filed as NDA not ANDA
- 1/2012: BPAX confirms that TEVA and ABT have settled the patent dispute. No details given, but a delay in launch if approved is strong possibility
- Low-dose estrogen transdermal gel (licensed from Antares-click here for the AIS page) FDA approved (5/24/11 webcast: one day before PDUFA date and by same FDA division as will handle Libigel NDA) and marketed product for the treatment of moderate-to-severe vasomotor symptoms (aka hot flashes) associated with menopause
- avoid skin irritation seen with patches and the effects of oral estrogen (not sure what these are specifically)
- $1.4B estrogen total market for indication (vast majority oral), elestrin has a 67% lower dose vs competing patch
- terminated Nycomed partnership and is now licensed to Azur (received $3.3m from Azur in 2009, relaunched 4/2009) and get 10-20% royalties and up to $144.5m sales milestones (~20% passed along to antares- only licensed for US?)-insignificant 1q09 (85k 2q09)
- 9/2011: Azur announces merger with Jazz Pharma. Merger presentation slides seemed to indicate ~$5m 2010 sales. Women's health sales force has 51 reps. Total women's health sales estimated at 10% of 2011 combined revenues, would correspond to $47.5m in first year of merged company. Slide shows Elestrin estimated to be ~20% of women's health sales in 2011.
- NDA filed for israel 6/09 by PharmaSwiss (company to be acquired by Valeant Pharma). 2010 10K: elestrin has been approved in Israel (I don't believe BPAX ever issued a PR confirming this)
- Estimated as $10-15m product 2010.
- 12/2009 sold royalty stream (but still eligible for milestones)- rec'd $1M at that date and $2.2M (12.5% to AIS) in next 75 days (1/12/10 had recd $2m-this represents 2-4 yrs of advance royalties!). Azur will still owe royalty share to AIS also.
- 2010 10k: as result of above transaction, will receive no more royalties and eliminated some milestones. But still eligible to receive up to $140m in sales-based milestones (certain predefined sales per calendar year thresholds)- consider this unlikely in the near term, if ever (5/24/11 webcast said not in next yr or two). 2010 Elestrin "market penetration was low"
- Formulation patent expires June 2022.
- 2009 10k: "In August 2001, we entered into a sublicense agreement with Solvay Pharmaceuticals, B.V. (which was purchased by Abbott Laboratories in February 2010) covering the U.S. and Canadian rights to the estrogen/progestogen combination therapy gel product licensed from Antares. Under the terms of the agreement, Solvay sublicenses our estrogen/progestogen combination therapy gel product for an initial payment of $2.5 million, future milestone payments (of which $950,000 has been received to date) and sales-based royalties. Solvay has been responsible for all costs of development to date. We believe that the product licensed to Solvay is not in active development by Solvay, and we do not expect its active development to occur at any time in the near future."
- Full-year 2011: Jazz/Azur sold a total of $35m women's health drugs, reflecting strong growth of Elestrin (but sales not broken out)
- "triple component" Pill-Plus adds androgen to birth control (for those w/ low sexual desire/activity), based on 3 issued US patents for estrogen/progestogen/androgen combo that expire in 2016
- 2010 10k: "Paradoxically, many women who use oral contraceptives have reduced sexual desire, arousabilty and activity due to the estrogen and progestogen in normal oral contraceptives."
- June 2010: Controlled p2 showed increased testosterone levels (82 pts, 5 month crossover periods comparing oral contraceptive to pill will androgen DHEA added, conducted in Netherlands)
- licensed from Wake Forest and Cedar Sinai- owe regulatory milestone payments, maintenance payments, and royalties
- Pill form partnered w/ Panterhei who pays for development and marketing. Undisclosed development and regulatory milestones, plus royalties and a percentage of any potential sublicense income. BPAX retains rights to transdermal delivery of triple contraceptives
- 6/2010: positive p2 data for sexual activity (82 pts, crossover 5 month periods adding androgen to pill).
- Additional phase 2/3 studies ongoing
- 2/2011 BIO CEO snapshot: listed as in phase 2, with future milestone being additional phase 2 studies
- 2/14/11, 3/15/11, 5/9/11 webcasts: additional efficacy data in 2011. 4/15/11 webcast reiterated and specified as oral, phase 2 data
- 2011: This is the only product BPAX is now pursuing that involves their phosphate nanoparticle technology (aka CaP)
- 2/2011: listed as being in phase 2 trials as a facial line filler (via BIO CEO snapshot)
- includes: Biovant vaccine adjuvant [US is only nation not to use adjuvant in h1n1 vaccine, uses 15 ug/dose instead of as low as 3.5 ug].
- Original patents licensed from Univ of California, last of these expire 2014. Have own additional patents expiring 2021 or later. Have discontinued maintaining these patents except for use in facial line filling
- Medical Aesthetics Technology Corporation (MATC) partnership for aesthetic medicine (got minor ownerhsip, eligible for future milestones and royalties): 2/2010: initiate p1 for "BioLook" as facial line filler "in next couple months. "-timeline slipping- there has been no mention of this asset since (once described as representing about 1% of the companies expenditures)
- 2010 10k: "Pre-clinical work to date by MATC indicates that our BioLook nanotechnology performs well as a facial line filler and may be at least as long lasting and safe as other injectable fillers. Preliminary results indicate long lasting effects with no adverse events. BioLook should be extremely user friendly with minimal risk of side effects and may improve both facial wrinkles and fulfill larger facial volume needs. Human clinical testing of BioLook for this use is being planned and is expected to be initiated by MATC in 2011. Although we believe our CaP technology has other potential commercial uses, we are not devoting any of our cash resources to pursuing any of these other potential uses."
- Based on above statement, alternative R&D described in 2009 10k into uses as vaccine adjuvant and oral/inhalation/intranasal drug delivery have been abandoned
- 2010 10k: "The 2A/furin technology is a novel expression system for producing high levels of multimeric proteins. The 2A/furin technology allows for continuous, equimolar expression of at least two proteins at high concentrations from a single expression vector making it particularly useful for recombinant antibody expression."
- 5 patent families including 4 issued patents and several pending, expiring 2023 to 2026
- 2010 10k: "In April 2010, we entered into an option agreement with an undisclosed pharmaceutical company to obtain a non-exclusive license for the use of our 2A/furin technology. The undisclosed company has chosen not to exercise this option. We are evaluating further development of our 2A/furin technology." [A press release was issued announcing the 6 month option...there had been no word since, and as expected, that meant that no deal came of this]
Oncolytic Virus Technology
- 11/2010: sold CEGE oncolytic virus assets to Cold Genesys for 19.9% equity stake and $95,000 upfront, possible future milestones and royalties
- 2010 10k: "uses replication-competent adenoviruses derived from Adenovirus type 5, a common “cold” virus that replicate in and selectively kill tumor cells."..."The oncolytic virus technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer."
- From CEGE merger, own a minority stake in privately-held gene therapy company
- 2010 10K this investment is carried at at value of $3.4m (slightly less than at 12/31/09 due to recent 3rd party investment in Ceregene)