Otezla approved for the treatment of adult patients with active psoriatic arthritis
SUMMIT, N.J. — Celgene on Friday announced that the Food and Drug Administration has approved Otezla (apremilast), the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis. A chronic disorder, psoriatic arthritis is characterized by pain, stiffness, swelling and tenderness of the joints, inflammation of specific ligaments and tendons, and a decrease in physical functioning. Otezla is the only FDA-approved oral treatment for psoriatic arthritis.
Otezla is expected to be available in the United States in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies.
"Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis," stated Scott Smith, global head, Inflammation and Immunology, Celgene Corporation. "The FDA approval of Otezla is good news for patients and healthcare professionals who are looking for a different way to manage this disease."
"Otezla works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4," stated Philip Mease, director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. "The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care."
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints. At week 16, patients treated with Otezla achieved a reduction in tender and swollen joint counts compared with placebo. Otezla treatment resulted in improvement for each of the seven American College of Rheumatology components measured, compared with placebo, at week 16. Improvements were also seen in disease-related physical functioning.
Treatment with Otezla resulted in improvement in dactylitis (inflammation of fingers and toes) and enthesitis (inflammation at sites where tendons or ligaments insert into bone) in patients with these pre-existing symptoms. Enthesitis and dactylitis are specific disease manifestations related to psoriatic arthritis.
In Otezla clinical trials, the majority of the most common adverse reactions occurred within the first two weeks of treatment and tended to resolve over time with continued dosing. Adverse reactions reported in at least 2% of patients on Otezla 30 mg twice daily and at least 1% greater than that observed in patients on placebo for up to 16 weeks were diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis and upper abdominal pain. The proportion of patients who discontinued treatment due to any adverse reaction was 4.6% for patients taking Otezla 30 mg twice daily and 1.2% for patients taking placebo. The most common adverse reactions leading to discontinuation among patients treated up to 16 weeks with OTEZLA 30 mg twice daily were nausea (1.8%), diarrhea (1.8%) and headache (1.2%).
IMS Health to launch IPO
NEW YORK — IMS Health Holdings is expected to launch an initial public stock offering in two weeks, according to a report Sunday in the Wall Street Journal. The syndicated prescription data service could be valued as much as $7 billion, WSJ noted, citing people familiar with the matter, with a per-share price of as much as $21.
According to the report, private-equity firms are targeting around $1 billion raised from the sale, which would make IMS Health one of the larger IPOs in a year of large IPOs.
IMS plans to use most of the expected proceeds from the IPO to repay debt, WSJ reported.
Walmart bound to get bigger by going smaller
Good things happen in small boxes. That’s what Walmart is counting on with the introduction of its latest store concept — Walmart to Go. First the supercenter, then Neighborhood Market, then WalmartExpress and now Walmart To Go. The boxes just keep getting smaller. (Check out photos of the new format.)
But what if Walmart is on to something? What if tomorrow’s definition of convenience is ubiquity? Then it makes a lot of sense to start filling in the gaps between the supercenters with smaller formats.
“Customers’ needs and expectations are changing. They want to shop when they want and how they want, and we are transforming our business to meet their expectations,” said Bill Simon, Walmart U.S. president and CEO, in announcing the company’s capital commitment to the smaller format in February. “Customers appreciate the broad assortment of our supercenters for their stock-up trips as well as our small store formats for fill-in trips. By unlocking this growth opportunity and further combining our supercenters and small store formats with an unlimited selection available through ecommerce, we provide our customers with anytime, anywhere access to our brand.”
Tomorrow’s generation of consumers are going to be beyond tablet savvy. They’ll decide they want something, and with the swipe of a finger it’ll be theirs — bought and paid for — all they have to do is pick it up on the way home or have it delivered to their doorstep. Having those smaller footprints would serve both purposes — they could easily be positioned along commuter routes as well as within striking distance of neighboring communities; you know, if same-day delivery ever becomes commonplace.
That’s not to say that that’s Walmart’s thinking behind all of this. But what if?
Ubiquity may become the name of the new game. When asked what they would do if their favorite retailer shut down its local store, 53% of respondents to a recent PwC survey noted they would locate the next nearest physical store and 40% said they would increase ordering from that retailer’s website. Shoppers today assume retailers are everywhere and always connected like themselves, and retailers need to look at store portfolio management more strategically, noted PwC in its report on what lies beyond omnichannel retailing.
Walmart wouldn’t be alone in acting today on how shoppers might shop tomorrow. Take a look at what rival Target has done by taking product placement to a whole other level. They not only had an entire episode of TBS’ "Cougar Town" revolve around the Target shopping experience, but the 1.2 million people who watched that show live (according to Nielsen) had the opportunity to click and buy products placed on that episode through a simulcast on their tablets. If that’s not testing the waters on how tomorrow’s shoppers might shop, then what is?
Walmart also is not alone in testing ever-smaller formats. DSN reported in January that Target is looking to open a smaller store in the base of an apartment building currently under construction near the University of Minnesota campus that will serve as a test for the new format dubbed TargetExpress. And Giant Eagle earlier this year introduced its new Market District Express, which brought the best of Giant Eagle’s gourmet Market District food stores into the smaller footprint of its GetGo convenience stores.
Not to be overlooked is Fred’s Super Dollar’s development last year of a smaller pharmacy format. The 8,000-sq.-ft. locations are half the size of a typical Fred’s. The format was designed to fit into smaller markets — or markets with a lighter population density — where Walmart and other big-box retailers likely aren’t.
Well, that is, until now.