Durante mucho tiempo no había principios uniformes para la Atribución de nombres a los antibióticos https://antibioticos-wiki.es . Más a menudo se les llama por el nombre genérico o especie del producto, con menos frecuencia-de acuerdo con la estructura química. Algunos antibióticos se nombran de acuerdo con el lugar donde se asignó el producto.
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January 17, 2013 Merus Labs International Inc. (MSL – TSX; MSLI - NASDAQ, $1.07) Rating: SPECULATIVE BUY Expands European Partnership Base for What Is Target Price: N/A Now Its Lead Product in Enablex/Emselex Changes Today?
Solidifies Growth Prospects for Urology Drug Enablex-Emselex with Promotion Agreements in Niche European Markets: Merus Labs
International Inc. (Merus) is firmly focused on driving sales growth for
Share data
what is now its leading pharma product in urinary incontinence drug
darifenacin (Novartis’ Enablex/Emselex) by consummating several co-
promotion agreements in Europe for the drug. New co-promotion
partners are with relatively small regionally-focussed firms, including
POA Pharma Scandanavia AB in Nordic nations (POA is a newly-
Company Description: Merus Labs is an emerging
founded specialty pharma firm headquartered in Goteborg, Sweden
specialty pharmaceutical firm, focused on com-
targeting multiple therapeutic areas, including urology), Proximum
mercializing mature pharma assets in niche medical
d.o.o. in Croatia (Zagreb-based pharma firm; lead product is hyaluronic
markets. Lead products include antibiotics Vancocin
and Factive, and urinary incontinence drug Enablex.
acid-based cosmetic brand Restylane) and SPCare Lda in Portugal. Each
of these niche European markets may seem minor compared to Merus’
overall Enablex-Emselex market opportunity, but they cumulatively
represent 20% of T12M sales of US$23 million. We recall that
Spain/Portugal was a market where Labopharm’s once-daily Tramadol
sales by partner Esteve SA were surprisingly strong and above sales
generated in larger markets like France, Germany and Japan. And with
Merus’ first quarter of Enablex-Emselex sales post-acquisition from
Novartis of only $3.9 million (well below T12M sales on a run-rate
basis), we believe Merus should at least explore the possibility that
Enablex-Emselex sales trajectory could be promotion-sensitive.
Enablex-Emselex Is a Relative Newcomer to the Crowded Urinary Incontinence Market, So Some Promotional Efforts Make Sense:
There are certainly signs beyond Merus’ Q4/F12 data that Enablex-
Emselex recent sales growth is modest. In the U.S., where NJ-based
specialty pharma firm Warner Chilcott owns distribution rights, Q3/F12
prescription volume declined 17% YoY even though sales held firm at
US$45 million on price increases (as reported for other peer drugs in
the quarter, like Allergan’s Sanctura XR) and reduced volume
discounts. Originally FDA-approved in Dec/04, Enablex competes with
at least five other anticholinergic drugs for treating overactive bladder,
and we assume some if not all of these agents are E.U.-approved as
well. Generic formulations for the major brands (but not yet for
Enablex) are already available. Peer anticholinergic agents include:
J&J’s extended-release oxybutynin form Ditropan XL (original drug
Ditropan approved in 1976 but XL approved in Dec/98, genericized by
Impax and Mylan in Nov/06, also available in topical forms Oxytrol
patch and Gelnique gel), Pfizer’s tolterodine form Detrol (Q3/12 global
sales of US$176 million down 17% YoY; approved in Mar/98,
genericized by Mylan in Nov/12 and by Apotex in Sept/12), Allergan’s
Douglas W. Loe, Ph.D. MBA Merus Labs International Inc.
trospium form Sanctura XR (approved in Aug/07, generic already approved by Watson in
Oct/12), Astellas’ solifenacin form Vesicare (F11 sales ¥97.2 billion; approved in Nov/04
with new adrenergic receptor agonist mirabegron/Myrbetriq was just FDA approved in
Jul/12, E.U.-approved in Jan/13 as Betmiga), and more recently, Pfizer’s fesoterodine form
Toviaz (Q3/12 global sales of US$52 million, up 6% YoY; approved in Oct/08). There is
limited data in the medical literature comparing these agents to each other instead of to
placebo, but where meta-analyses have been conducted on anticholinergic drugs as a
class, all candidates seem to have overlapping benefits and side effect profiles (all confer
dry mouth to some degree, for example). U.S. data from Consumer Reports shows
average monthly Rx cost is similar for branded agents in the U.S. market, though obviously
lower for generic forms of oxybutynin and tolterodine. Accordingly, with few
differentiation features among Enablex’s anticholinergic urinary incontinence peers, other
than perhaps oxybutynin’s longer clinical history, the market is one that should be
Summary: We maintain our SPECULATIVE BUY rating on Merus, with the firm’s existing
portfolio of C.difficile infection-targeted oral vancomycin brand Vancocin (acquired from
Iroko), lung infection fluoroquinolone Factive (acquired from Cornerstone), and more
recently Enablex-Emselex (acquired from Novartis as stated) performing well in recent
quarters despite pending risks. In Q4/F12, the first financial period incorporating Enablex-
Emselex sales, revenue/EBITDA/margin of $5.0 million/$3.7 million/73.8% was historically
strong for the firm, and full-year F2012 EBITDA margin of 58.4% was at the top end of
Merus’ specialty pharma peer group. Despite the now-substantial debt burden of
$54.1 mil ion that Merus’ incurred to fund Enablex-Emselex acquisition, debt/EBITDA run-
rate ratio of 3.7x is not outlandishly high for a rapidly-growing pharma firm in the early
days of its, well, rapid growth, and EBITDA/interest ratio of 2.6x was solidly above
threshold warning levels for us of 1.5x – 2.0x. We of course anticipate revenue erosion for
Vancocin in a Canadian market where generic oral vancomycin is now available from PPC
(offset by Q1/F13 seasonal strength), but generic pricing is set as high as 74% of branded
pricing in some provinces, which should partially mitigate pace of sales erosion. As well,
Enablex-Emselex European sales growth in promotion sensitive geographies could
mitigate Vancocin sales risk, possibly as early as F2013/14. There were no economic
details shared on the Enablex-Emselex co-promotion deals announced on Thursday, but as
would be conventional, new partners will likely receive a proportion of sales beyond
historic levels that each generates in partnered markets. Such an arrangement will
inevitably compress Merus’ EBITDA margin somewhat, but should still be accretive to
Douglas W. Loe, Ph.D. MBA 647.426.0472 DLoe@byroncapitalmarkets.com
Merus Labs International Inc. IMPORTANT DISCLOSURES
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Douglas W. Loe, Ph.D. MBA 647.426.0472 DLoe@byroncapitalmarkets.com
MINISTERIO DE RELACIONES EXTERIORES GUÍA DE ESTUDIO TEMAS NACIONALES Y DE POLÍTICA EXTERIOR TEMAS NACIONALES I. HISTORIA DE PANAMÁ A. PERÍODO COLONIAL 1. Colonización y evangelización de América 2. Papel del istmo como vía de tránsito B. PERÍODO DE UNIÓN A LA GRAN COLOMBIA 1. Congreso Anfictiónico de Panamá de 1826 2. Intentos separatistas de Panamá de
Enhanced Fuzzy Single Layer Perceptron Kwangbaek Kim1, Sungshin Kim2, Younghoon Joo3, and Am-Sok Oh4 1 Dept. of Computer Engineering, Silla University, Korea 2 School of Electrical and Computer Engineering, Pusan National University, Korea 3 School of Electronic and Information Engineering, Kunsan National University, Korea 4 Dept. of Multimedia Engineering, Tongmyong Univ. of Information