Takeda submits NDA for Actos replacement as DPP-IV pipeline heats up

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Takeda Pharmaceutical has submitted a new DPP-IV diabetes drug candidate -- Alogliptin -- in hopes the drug will replace its major earner Actos which loses patent protection in 2011.

"We are hoping Alogliptin to boost our diabetes franchise, which is a very important field for us," said Takeda spokesman Toshiyuki Ikeuchi in a statement.

The approval process is expected to take about a year.

Nomura Securities senior analyst said he expects Alogliptin sales to reach ($2.8 billion) a year during the peak years, which is anticipated about  five years after launch. “I see the drug as very promising,” Ryoichi said.

Alogliptin, or SYR-322, is in a new class of oral agents for the treatment of type 2 diabetes, called DPP-4 inhibitor, regulating blood glucose levels, and the class also includes Merck & Co's Januvia and Novartis AG's Galvus.

“Safety evaluation is very strict for drugs in this category. There are some possibilities for the approval process would not go smoothly,” Nomura's Ryoichi said.

Studies have found evidence that certain diabetes drugs, including Takeda's Actos and Glaxo SmithKline's Avandia, raise the risk of heart failure.

Bear Stearns analyst John Boris wrote in a note to investors that there is a risk
of delays in the Alogliptin NDA.

“Although we have not seen Phase III data presented for Alogliptin, we found five phase III studies initiated in January 2006 out of nine phase III studies listed at ClinicalTrials.gov… these five studies do not exclude patients with renal impairment…there is a risk of Takeda not gathering enough exposures in all necessary ranges of renal insufficiency. FDA could also have a strict requirement
for a study targeting specifically the renally impaired population,” Boris wrote.

Meanwhile, the race to develop DPP-IV Inhibitors is heating up.

According to Boris, there are 16 other programs targeting DPP-IVs, indicating potentially strong competition in this class in the future.

For a closer look see chart below.

DPP-IV Inhibitors: Stage of Pipeline Development

Drug          Company Stage of Development

Galvus (Vildagliptin)

Novartis

Approvable in US with resubmission in 2009 or later; EU approved but not launched

Saxagliptin

Bristol-Myers Squibb/AstraZeneca

Phase III; mid-2008 filing expected

SYR-322 (Alogliptin)

SYR-322 (Alogliptin)

Phase III

GRC-8200

Merck KGaA/Glenmark

Phase II

PHX-1149

Phenomix

Phase II

PSN-9301

OSI Pharmaceuticals

Phase II (Assessing outlicensing or discontinuing the program)

PF-734200

Pfizer

Phase II

R-1579

Roche

Phase II

TA-6666

Tanabe

Phase II

BI 1356

Boehringer Ingelheim

Phase II

825964

GSK

Phase I

KRP-104

ActivX/Kyorin

Phase I

SSR-162369

Sanofi-Aventis

Phase I

TS-021

Taisho Pharmaceutical

Phase I

ALS 2-0426

Servier/Alantos

Phase I

LC15-0444

LG Life Sciences

Phase I

ABT-279

Abbott

Phase I

ARI2243

Arisaph Pharmaceuticals

Preclinical

S 40010

Unknown

Preclinical

-Courtesy Bear Stearns
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