The Japanese are taking a play from the US pharmaceutical industry’s rulebook and restructuring itself under the auspices of a fun catch phrase: “Transformation for a New Takeda.”

The punch line, however, isn’t too funny.

According to a two-year mid-range plan announced yesterday, Takeda will cut about 1,400 positions in the US to fend off loss of revenue due to looming generic competition. That number includes about 28 percent of the sales and marketing division and 20 percent of employees at the drug development center, according to Business Week.

Takeda’s billion-dollar blockbuster Actos is set to lose patent exclusivity in two years, and the company is still reeling from generic competition with its heartburn medication Prevacid.

Most of the job losses will be in the Chicago offices, particularly in the Deerfield and Lake Forrest offices and R&D center. According to the company, it plans to “shift to lean and flexible marketing organizational networks that can flexibly respond to changes in the business environment and product mix.”

“Takeda has experienced halted development in some pipelines and delays in obtaining drug approvals,” it stated in a release. “The company has therefore decided to respond flexibly to these changes in the business environment and ensure a sustained growth trajectory by developing and implementing a Mid-Range Plan starting in the fiscal 2010, one year ahead of schedule.”

Takeda is forecasting a net profit loss of 26 percent and a 4.5 percent drop in sales. The company is banking on a number of new products—primarily in metabolic/CV, oncology, and CNS. It currently has four new treatments filed, and another 10 in Phase II trials. The company expects to recover by 2016.

The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls. But with recent allegations of Avandia-research related misconduct from the Senate Finance Committee, and renewed unease about the drug’s safety profile, some researchers are wondering if the study places its subjects in harm’s way.

Glaxo has denied any suggestion of danger, and points to the study’s FDA-mandated structure and approval by ethics committees around the globe as proof of its safety and necessity. The company will have to wait until a July hearing to learn the fate of the trial—and possibly the drug itself, since further safety concerns in a study like this are inextricable from the drug’s safety profile, according to FDA’s principal deputy commissioner, Joshua Sharfstein.

But GSK can take some small comfort in the fact that it’s not alone: Pfizer received a warning letter just this week over one of its trials for antipsychotic Geodon (ziprasidone). The trial’s goal is to explore the drug’s use in bipolar children, but so far at least 13 of those subjects received enough medication to trigger an overdose, and the letter calls Pfizer out for failing to properly monitor the children. This comes after last year’s $2.3 billion settlement with the Department of Justice over illegal promotion of four drugs, including Geodon.

But shortly after the launch, the company began getting reports of dispensing errors. Some were due to prescription misreading, others to simple, honest mistakes. The two drugs causing all the confusion were AstraZeneca’s Casodex (bicalutamide) and Actavis’ Kadian (morphine sulfate extended-release), treatments for prostate cancer and chronic pain, respectively.

The number of incident reports was actually quite small: less than 20 out of over a million prescriptions. Still, Takeda decided not to take any chances and expedited reporting to the FDA. They released sales reps into the healthcare professional population to increase awareness of the name confusion, published announcements in journals—and saw a decrease in incidents.

Before the company could breathe a sigh of relief, though, the numbers started climbing again. That’s when Takeda’s conversation with the FDA took on a new urgency. “The FDA recognized the fact that lots of patients have come to rely on this medication,” said Robert Spanheimer, Takeda’s VP of medical and scientific affairs in North America. “Both parties knew how important it was to not have gaps in patient care.”

So Takeda swiftly came up with a list of possible names and sent them off to the FDA for review. After some back-and-forth, they agreed on Dexilant.

Name changes can be confusing for consumers as well as professionals, so as early as next week the company will send out an army of reps to educate pharmacists and pharmacy technicians about the switch—which is just the name, by the way. The formula and approved indications are the same, Spanheimer stressed.

What’s really interesting about this story isn’t the name switch; it’s the fact that the FDA and a pharma company worked together harmoniously—and quickly—to nip a potential fiasco in the bud. All those promises of a more efficient FDA seem to be the real deal….For now, at least.

And for the rest of us? Well, at least there’s the Healthcare Businesswoman’s Association (HBA) and its annual Leadership Conference. The event is being held next week in Chicago (and if it’s the hometown of the President, we expect it to be all the more exciting). With more than 600 attendees already registered, it will be the largest meeting of its kind. One-third of these women are vice presidents and above, so for the ladder climbers in the industry, this is the place to be.

Pharm Exec will be doing on-site blogging—so stay tuned for regular updates. In particular, we’re looking forward to the panel of “Hard Lessons, Sweet Successes,” moderated by Charlotte Sibley, HBA’s 2008 Woman of the Year. Charlotte shocked the luncheon crowd in May when she revealed her own story of the ups and downs of working in the pharmaceutical industry. (To read her story, click here) This time, she puts tough questions to an esteemed panel including Dierdre Connelly, President, Lilly USA; Len Kanavy, Vice President, Commercial Operations of Genentech; Renee Tannenbaum, Global Head, Commercial Operations, Novartis AG; Eisai’s President Lonnel Coats; and Ginger Graham, Two Trees Consulting, former CEO Amylin.