Investment forecast for RB

[Anonymous]

Found this. May be interesting for those considering their future with RB.

Reckitt Benckiser
BDSI on Track to File ANDA for Suboxone-Like Film by Late 2012…
BDSI announced today it is on track to file an ANDA for a Suboxone-equivalent film product by late
2012/early 2013. We see the following sequence of threats to Reckitt Benckiser’s profitable Suboxone
business (c25% of total company EBIT): generic tablets by early 2012, the Titan implant by late 2012/early
2013, and the BDSI film by late 2013/early 2014. We maintain our sell stance on RB/ LN. In European
Food/HPC our top pick is Unilever (we recently downgraded L’Oreal to hold).
 In simple non-pharma terms, a Suboxone-like film could enter the market by late 2013 or early 2014, and
would face to patent issues according to BDSI. BioDelivery Sciences International (NASDAQ: BDSI) held a
conference call this morning to provide an update on the development of BNX (a Suboxone-like film blending
the two active ingredients, Buprenorphine and Naloxone), calling the product “the front running commercial
opportunity in the company’s pipeline”. BDSI has initiated a confirmatory pharmacokinetic study of a formulation
of Buprenorphine and Naloxone utilizing BDSI's “patented BioErodible MucoAdhesive (BEMA) drug delivery
technology”. According to management, BEMA Buprenorphine/Naloxone is being developed for the treatment
of opioid dependence and contains the same drug components as Suboxone but will utilize BDSI's proven
BEMA technology to efficiently and conveniently deliver buprenorphine. The current study, BNX-102, is
expected to be completed by this December and will be used to select the final doses of BEMA
Buprenorphine/Naloxone to be used in the “pivotal bioequivalence study compared to Suboxone”, which is
anticipated to start in January of 2012 and be completed by March (the pivotal bioequivalence study, or BNX-
103, is required for a New Drug Application, or NDA, and is targeted to begin in January 2012 with results
expected in March). BDSI management said that a positive outcome of BNX-103 will show that BEMA
Buprenorphine/Naloxone is bioequivalent to Suboxone, and at that point, an open-label safety study in opioid
dependent patients will be conducted; “how quickly full enrollment in this safety study is achieved, as well as
study results, will dictate the timing of an NDA submission, which is currently targeted for late 2012 or early
2013”. While the BDSI product is still at least two years away, it calls into question RBP’s assertion that its film
product is “patent-protected”.
 The Titan implant could be in the market by late 2012 or early 2013. Titan Pharmaceuticals has said it is on
track to file an ANDA for its Suboxone-type implant by early 2012 and is in negotiations to find a commercial
partner. Titan recently announced additional positive results from its Phase 3 tests for its Probuphine product
(implant to combat opioid dependency). According to the company, Probuphine is designed to deliver six
months of continuous round-the-clock, long-term therapeutic levels of the drug buprenorphine following a single
subcutaneous treatment. Management has said the product’s economics will be equivalent to Suboxone’s (i.e.
cost of implant and procedure vs. the monthly equivalent Suboxone treatment). The safety and effectiveness of
treatment with Probuphine has been demonstrated in several late-stage and Phase 3 studies conducted to date,
including a 163-patient placebo-controlled study which demonstrated clinically meaningful and statistically
significant treatment with Probuphine over a 24-week period and was published in the Journal of the American
Medical Association (JAMA) and a confirmatory study of 287 patients that showed statistically significant
efficacy versus placebo and non-inferiority with a currently marketed sublingual formulation of buprenorphine.
Probuphine was developed using ProNeura, Titan's continuous drug delivery system that consists of a small,
solid rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting product is a
solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and is

 

[Anonymous]

http://www.liberumcapital.com/pdf/aKXBFcIJ.pdf

 

[Anonymous]

so much for the early 2012 tablet generic!