IMS Company Profiles - Report Buyer

IMS COM PANY PRO FILES TAKEDA
Takepron OD, has been de vel oped and was launched in the UK and in Ja pan and ap proved in the USA in
2002. TAP has launched a new ready-to-mix oral sus pen sion for mu la tion of Prevacid in the USA, in tended
for use by peo ple who have dif fi culty tak ing cap sules. TAP says this is the first drug in the PPI cat e gory to
be of fered in an oral sus pen sion form. It is avail able in 15mg and 30mg pack ets. In Jan u ary 2004, a
smaller cap sule for mu la tion was ap proved for use in Ja pan for Ogast, Agopton, Lansox (EU).
In 2003 the FDA ap proved a com bi na tion pack, Prevacid NapraPAC (lansoprazole de layed re lease cap -
sules/naproxen tab lets) for use by pa tients tak ing NSAIDs for treat ment of ar thri tis who are at risk for re -
cur rent gas tric ul cers. A tri ple ther apy pack for H. pylori erad i ca tion, con tain ing lansoprazole, amoxicillin
and clarithromycin, is mar keted as Prepac in the USA and Lansap in Japan.
In 2004, the US FDA ap proved Prevacid for the short-term treat ment of symp tom atic GERD and ero sive
esophagitis in chil dren aged 12 to 17 years, ex pand ing its ap proved use in chil dren aged one to 17 years.
Prevacid was the only PPI ap proved for use in chil dren as young as one year.
Also in 2004, TAP re ceived US FDA ap proval for an in tra ve nous for mu la tion, Prevacid IV, for pa tients
who are un able to take the oral for mu la tion. The prod uct is in di cated for short-term (up to seven days)
treat ment of ero sive esophagitis of any grade se ver ity, un til pa tients are able to take oral ther apy, when
they switch to the oral ver sion for up to six to eight weeks. The IV for mu la tion was ap proved in Ja pan in
Oc to ber 2006 and launched in December 2006.
Li cens ing: In May 2008, Abbott and Takeda con cluded their TAP joint ven ture and Takeda re tained the
rights to lansoprazole. TAP Pharmaceuticals, Takeda’s US jv with Abbott, mar keted lansoprazole in the
US, where it was launched in 1995 as Prevacid. Takeda Pharma mar kets it in Ger many, Aus tria and
Swit zer land. Abbott also has rights in Can ada and a num ber of Latin Amer i can coun tries (where
lansoprazole is sold as Ogastro). Roemmers (Ar gen tina) and Boehringer Ingelheim (Ger many) also
have rights in Latin Amer ica. Almirall Prodesfarma (Spain) is the li censee for Spain. Wyeth (USA) is the li -
censee for the UK, Den mark, Fin land, Swe den, Nor way, Aus tra lia and Pa ki stan, and uses trade names in -
clud ing Zoton and Lanzo. Aventis (France) has rights in France, the Neth er lands, Bel gium, Af rica and
the Mid dle East. Han Il (South Ko rea) the licensee for South Korea.
Pat ents: The main pat ent for lansoprazole ex pires in No vem ber 2009 and this is set to be the big gest ex -
pi ra tion of the year. Teva made at tempts to launch its ge neric lansoprazole in 2008 but court rul ings con -
cluded Takeda’s pat ents to be en force able and Teva now plans to launch in November 2009.
In June 2008, Barr Pharmaceuticals chal lenged the pat ents for Prevacid SoluTab af ter fil ing its ANDA to
the FDA in No vem ber 2007, which has been ac cepted for fil ing.
Lifecycle Man age ment: In 2009, Takeda re ported phase III tri als on go ing in Ja pan of lansoprazole for
risk re duc tion of NSAIS-as so ci ated gas tric ul cer and risk re duc tion of low dos age as pi rin-as so ci ated
gastric ulcer.
TAP an nounced a deal in Jan u ary 2006 grant ing Novartis the right to de velop an OTC ver sion of Prevacid
in the US, giv ing an op por tu nity to boost flag ging sales, hit by com pe ti tion from other ge neric PPIs, ahead
of its loom ing 2009 pat ent ex piry. Novartis will take full re spon si bil ity for the OTC-switch pro gram, in clud -
ing the de sign and con duct of clin i cal stud ies, reg u la tory sub mis sions to the FDA and man u fac tur ing, dis -
tri bu tion and launch ac tiv i ties. Fi nan cial ar range ments were un dis closed. In June 2003, the UK’s Na tional
Phar ma ceu ti cal As so ci a tion, which rep re sents com mu nity phar ma cists, said it was con cerned about an
ap pli ca tion to the UK au thor i ties to make the PPI antiulcerant, omeprazole, an OTC ther apy. The as so ci a -
tion said it pre ferred OTC lansoprazole in stead. Lansoprazole had been shown to be more ef fec tive when
used for episodic treatment and appeared to have a better safety profile.
TAP an nounced a li cens ing deal with Flamel Tech nol o gies’ (France) over the firm’s Micropump Tech nol -
ogy, a con trolled re lease plat form for po ten tial use in the de liv ery of lansoprazole, the ac tive in gre di ent in
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