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`Melissa
`Leonhauser
`
`Melissa Leonhauser is
`Senior Manager,
`Marketing
`Communications, at
`IMS Health.
`Email Melissa
`Leonhauser
`
`Author Articles
`The Asthma Market:
`Unique Opportunities
`for Innovation
`
`Overactive Bladder
`Market: Managing the
`Future
`
`Market Watch:
`Managed-care
`Coverage Still at the
`Heart of
`Cardiovascular Market
`
`Overactive Bladder
`Market: Managing the
`Future
`
`Market Watch by Melissa Leonhauser on April 1st, 2012
`
`Because of memorable direct-to-consumer advertising campaigns, including the
`“Gotta Go” Detrol campaign that became part of American pop culture, many
`adults have some familiarity with overactive bladder (OAB) and its treatments.
`Brands that treat OAB face common issues, including patients’ reluctance to
`visit their physician, non-drug treatment options, generic competition, and
`inconsistent efficacy. But even with these challenges, some manufacturers,
`particularly Pfizer and Astellas, have chosen to extend their presence in the
`market.
`
`TREATMENTS
`
`Experts believe that OAB is under-diagnosed, although estimates of prevalence
`vary. Common belief is that patients with OAB, which is characterized by
`sudden, strong urges to urinate, may be embarrassed to see a physician about
`their condition or believe that its symptoms are a natural result of aging. When
`patients do visit their physicians, they’re able to discuss a number of treatment
`options. Prior to prescribing a drug, physicians may first recommend physical or
`behavioral therapy or lifestyle modifications.
`
`There are a number of OAB medications available, most of which are branded.
`Oxybutynin chloride and oxybutynin chloride ER, generic versions of Ditropan
`and Ditropan XL, are the only generics currently competing in the market.
`However, more generics soon will arrive, as Detrol is expected to lose patent
`protection later this year.
`
`In the 12 months ending January 2012, more than 17.8 million prescriptions
`were filled for drugs in the market, accounting for almost $2.1 billion in sales.
`Astellas’ VESIcare, which was promoted jointly with GlaxoSmithKline, led the
`market with 3.8 million prescriptions. Oxybutynin chloride and oxybutynin
`chloride ER followed closely with 3.7 million and 3.6 million prescriptions,
`respectively. Pfizer’s Detrol LA, which previously led the market, ranked fourth
`in total prescriptions with 3.3 million. Warner Chilcott’s Enablex and Pfizer’s
`Toviaz followed with 1.6 million and approximately 712,000 prescriptions,
`
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`Petitioner Alembic Pharmaceuticals Limited - Exhibit 1023 - Page 1
`
`

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`respectively.
`
`Market share for VESIcare and the two generics has been increasing and will
`continue to do so because they are the drugs most often prescribed to new-to-
`market patients and those switching treatments. This dynamic market segment,
`which represented 15% of prescriptions in January 2012, is a brand’s greatest
`growth opportunity (figure 1). Among new patient prescriptions, oxybutynin and
`VESIcare led with 27% and 24%, respectively.
`
`PFIZER’S SHIFT
`
`VESIcare, however, hasn’t always been the leading brand. As recently as April
`2011, Detrol LA led the market in total prescriptions (figure 2). Detrol LA has
`dominated the market for years, but the brand’s prescriptions began to decline
`in mid-2009 and continued to decrease thereafter. So what happened in 2009
`that changed Detrol LA’s trajectory? Pfizer launched Toviaz and shifted all
`promotion away from Detrol LA in favor of the new brand. Toviaz, which
`became available in March 2009, isn’t considered a true line extension but is
`structurally similar to Detrol and Detrol LA.
`
`Pfizer’s promotional shift from supporting Detrol LA to Toviaz wasn’t novel. In
`fact, many companies have done the same when launching a line extension. It
`wouldn’t even be worth highlighting had Toviaz grown rapidly and replaced
`much or all of Detrol LA’s original share of the market. But Toviaz’s monthly
`market share has not come close to mimicking Detrol LA’s success. In January
`2012, Toviaz accounted for only 4% of prescriptions in the market.
`
`Although Toviaz’s performance has been questionable, Pfizer hasn’t given up.
`At the end of 2011, Pfizer reported positive top-line results of a recent study
`for Toviaz and continues to promote the drug heavily. In the 12 months ending
`November 2011, over $252 million was spent promoting the brand, accounting
`for 38% of promotional spending in the market (figure 3).
`
`ASTELLAS’ FUTURE
`
`VESIcare is currently the leading OAB brand and isn’t expected to lose patent
`protection until 2018. VESIcare has been supported with significant promotion,
`accounting for 45% of promotional spending in the OAB market during the 12
`months ending November 2011. VESIcare has been promoted by a much larger
`field force than competitors, but that may change as GlaxoSmithKline is no
`longer marketing the brand.
`
`Moving forward, VESIcare might not be the only OAB product offered by
`Astellas. In August 2011, Astellas submitted a New Drug Application to the U.S.
`Food & Drug Administration for mirabegron. If approved, mirabegron will be a
`first in class treatment for OAB—one with a different mode of action than the
`currently available medications.
`
`With two drugs in the same market, Astellas will face a situation similar to what
`Pfizer encountered in 2009, although with some significant differences.
`VESIcare is the current leader among brands, but its dominance is not nearly
`as significant as Detrol LA’s was when Toviaz was introduced. In addition, as
`mirabegron will offer a different mode of action than VESIcare, it will not be
`viewed as a line extension.
`
`Knowing the risk of pulling back promotion, it will be interesting to see how
`
`Petitioner Alembic Pharmaceuticals Limited - Exhibit 1023 - Page 2
`
`

`
`Astellas chooses to handle marketing VESIcare if mirabegron is approved. It
`may choose, as Pfizer did, to pull back promotion for VESIcare completely so
`its field force can concentrate on a strong launch. Or, if it has the resources, it
`may choose to market both. If Astellas does market both, it’ll need to message
`each in a way that doesn’t negatively affect the other, by possibly positioning
`them for different patient segments.
`
`The OAB market’s future with the potential launch of mirabegron, introduction
`of generic Detrol, and Pfizer’s continued investment in Toviaz is sure to be one
`of much fluctuation.
`
`FIGURE 1:
`
`FIGURE 2:
`
`FIGURE 3:
`
`Petitioner Alembic Pharmaceuticals Limited - Exhibit 1023 - Page 3
`
`

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`Petitioner Alembic Pharmaceuticals Limited - Exhibit 1023 - Page 4