Watson confirms Velcade patent challenge
PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals’ Velcade.
Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
Millennium filed suit against Actavis on Dec. 21 in the U.S. District Court for the District of Delaware seeking to prevent Acatavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ended Oct. 31, 2012, Velcade had total U.S. sales of approximately $740 million, according to IMS Health.
Walgreens is paving the way toward a better pharmacy proposition
Walgreens executives last week were upbeat looking ahead to calendar 2013, identifying the company’s growing base of Well Experience format stores, the expanding role retail pharmacy plays in the delivery of health care and the promise to be realized through creating a global pharmacy operator as the three primary reasons lifting their spirits.
A new, fast-growing loyalty card program and closure to the company’s nine-month separation from Express Scripts’ pharmacy network are working wonders on improving the perception of Walgreens’ future potential. A fortified faith in Walgreens’ full potential never left the company’s executive suite, of course. It’s Wall Street analysts that still need a little convincing, and that may be coming along as well.
"If Walgreens can continue recovering customers (and/or adding to their customer base) they should be fine," noted Motley Fool analyst Joseph Harry in a recent blog on Walgreens. "The company does seem to be slowly gaining customers back, or adding new ones, and even though the number of prescriptions filled and profits have dropped [year-over-year], they are slowly improving from the previous quarters of this year."
Some analysts peg Walgreens’ Express Scripts patient recapture rate at 25% of what they lost, while others have that recapture rate closer to 40%. But there’s one fact you can bank on — as the clock starts ticking toward the greater implementation of Obamacare on Jan. 1, 2014, the less analysts will be thinking about which Express Scripts patients never came back into the fold and the more analysts will be talking about how Walgreens has continued to prepare for a steady influx of patients.
And not only the steady influx of patients who will be newly covered by insurance plans come January 2014, but also new patients who will be driven to the Walgreens solution by Walgreens’ employer-partners who are realizing healthcare cost savings when their employees shop the front-end fortified by OTC health guides and fresh-and-healthy food offerings. Or those employers will realize cost savings when their employees seek out a vaccination in a convenient setting or consult with a readily-accessible pharmacist positioned in front of the pharmacy. Or those employers will realize cost savings when their employees take advantage of Take Care Health Clinic services, whether they’re located at the employer’s headquarters or in a nearby Walgreens pharmacy.
And that doesn’t even begin to account for potential pharmacy patients attracted to Walgreens because of the Balance Rewards loyalty program that already boasts a whopping 45 million card-holders, or potential pharmacy patients who have been wowed by the prestige beauty offerings showcased across the company’s Well Experience footprint.
Then there are other growth drivers that have historically not been associated with a typical chain pharmacy operation. Take specialty for example. Walgreens already fields more than 700 HIV-specialized pharmacies and over 2,000 pharmacists with special HIV/AIDS-accredited educational training, as attested to by Walgreens’ senior manager for HIV/AIDS and hepatitis pharmacy services Glen Pietrandoni in a recent discussion with DSN.
So no matter what road a consumer takes in choosing a pharmacy — employer incentives, shopping experience or specialty need — Walgreens has been busy paving the way for those consumers to come to a Walgreens solution. Those are the reasons why Walgreens executives are upbeat about their immediate future. They’re also the reasons why Walgreens future earnings calls will have analysts concerned less about what’s happened in the recent past and more optimistic about what will happen in the not-too-distant future.
FDA approves NDA for Teva’s topotecan injection
SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.
The NDA provides for the use of topotecan hydrochloride injection in the 1 mg/mL strength in the treatment of chemotherapy-sensitive small cell lung cancer after failure of first-line chemotherapy and, in combination with cisplatin, for the treatment of stage IV-B, recurrent or persistent carcinoma of the cervix, cancer not amenable to curative treatment with surgery or radiation therapy.
As DSN reported in early December, the generic topotecan hydrochloride injection is also produced by Sagent Pharmaceuticals and is a version of GlaxoSmithKline’s Hycamtin.