PHARMACY

Mylan acquires rights to two Valeant drugs

BY Alaric DeArment

PITTSBURGH — Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.

Mylan announced that it had acquired the regulatory approval applications for generic clindamycin phosphate and benzoyl peroxide gel, a generic version of Valeant’s BenzaClin, and a license to manufacture and market fluorouracil cream in the 5% strength, a version of Valeant’s Efudex.

The first drug, which according to IMS Health had sales of about $205 million in 2011, is used to treat acne. The second drug, which had sales of $79 million, is used to treat basal cell carcinomas and actinic or solar keratoses, a skin condition that can be a precursor to skin cancer.


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Walgreens prepping cost-savings solution for total health care (not just scripts)

BY Michael Johnsen

WHAT IT MEANS AND WHY IT’S IMPORTANT — Walgreens is helping to redefine what it means to be a successful retail pharmacy operator. The proof is in this new direction that Walgreens is taking — approaching employers and payers with a comprehensive, cost-lowering strategy across that company’s entire health spend, not just their prescription spend. But the proof of the pudding is in the eating, and that’s why joining a veteran like Robyn Peters with Jeff Berkowitz, both of whom have operated extensively in the managed care space, will help Walgreens make what may be considered an unconventional pitch directly to employers and payers.

(THE NEWS: Walgreens setting stage for PBM selling season with 25-year vet at the helm. For the full story, click here.)

The other piece of news that will help bolster Walgreens’ cost-reduction pitch against the entire healthcare spend is its proposed acquisition of BioScrip’s community specialty pharmacies and centralized specialty and mail-service pharmacy businesses, which will help Walgreens reach an additional 500,000 patients with chronic and complex health conditions.

"As our healthcare strategy has been evolving … and the healthcare landscape has gotten more complex, we have been thinking long and hard about fully integrating our approach to the payer community, whether that be employers large and small, PBMs — large, medium and small — the health plans segment, the government segment, the health systems segment," Jeff Berkowitz, Walgreens SVP pharmaceutical development and market access, told Drug Store News. "What this integrated model allows us to do is go to the payer community and not just focus on the 10% or 8% that is the drug spend, but really partner with and focus with them on their entire medical spend and how to lower that," Berkowitz said. "That’s the real opportunity here."

But Walgreens does have a tough row to hoe with respect to not being in the Express Scripts pharmacy network. Walgreens’ January comparable-pharmacy sales were impacted by 10.6% because of the Express Scripts situation — that affirmed for at least one analyst that Walgreens will only retain 15% of the Express Scripts business by year end. And though Walgreens is working hard to retain much more than that — Walgreens noted that a hard marketing push against its Prescription Savings Card since January has netted a record 700,000 new signees — the pharmacy chain adjusted its annual prescriptions-filled projections for fiscal 2012 to be around the low end of its previously announced range of 97% to 99% of prescriptions filled versus fiscal 2011.

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New diabetes drug launches show primary care market still strong

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT — For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

(THE NEWS: FDA approves Bydureon. For the full story, click here.)

In the past week, the Food and Drug Administration has approved two new drugs for Type 2 diabetes: Bydureon (exenatide), made by Amylin Pharmaceuticals and Alkermes, and Jentadueto (linagliptin and metformin), made by Eli Lilly & Co. and Boehringer Ingelheim.

With most of the nearly 26 million Americans with diabetes having the Type 2 variety — a figure that’s expected to rise in the coming decades — and no cure in sight, the need for new and better therapies to manage the disease remains strong, and drug makers are responding in kind.

And they could stand to make a lot of money as well: According to some analysts, Bydureon could achieve annual sales of $1 billion, and some also expect it to displace Novo Nordisk’s Victoza (liraglutide). At the same time, healthcare market research firm Decision Resources expected Bydureon to gain a Type 2 diabetes market share of 2.6% by 2020.

But diabetes isn’t the only primary care-driven disease state seeing increased activity these days. According to the Pharmaceutical Research and Manufacturers of America, more than 50 drugs currently are under development for chronic obstructive pulmonary disease, which is estimated to affect more than 13 million adults in the United States, as well as potentially 12 million more who don’t know they have it.

The dominant trend over the past several years has been the patent cliff, with the assumption that primary care drugs would start to decline thanks to loss of patent protection and generic competition, with companies instead focusing on specialty drugs for conditions like cancer, multiple sclerosis and autoimmune disorders. That trend still is on, but it also appears that development of new drugs for conditions like diabetes and COPD will continue.

Whether they will achieve the kinds of mega-blockbuster sales of medicines like Pfizer’s cholesterol drug Lipitor (atorvastatin) — which achieved sales of more than $8 billion in 2011 and recently lost patent protection — remains to be seen, but the continued need for new drugs for old diseases remains strong.

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