NewsBytes — Chain Pharmacy, 11/5/12
FDA approves cardiovascular drug
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules. The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.
GPhA appoints CVS Caremark public policy director to head policy shop
WASHINGTON — An executive from CVS Caremark will guide policy for a generic drug industry trade association. The Generic Pharmaceutical Association said that it had appointed CVS Caremark senior director of public policy Christine Simmon to run its policy shop as SVP policy and strategic alliances, effective Oct. 24. Christine Simmon previously worked for the GPhA as VP policy, public affairs and development from 2002 to 2006.
“We are delighted to welcome Christine back to our professional team,” GPhA president and CEO Ralph Neas said. “Her vast experience working with legislators, regulatory agencies and industry leaders on key healthcare issues will serve our industry well. She will play a leading role in our mission to show that safe, effective and affordable generic medicines are a critical part of the solution to controlling costs and lowering the nation’s healthcare bill.”
Simmon also will help expand the GPhA’s partnerships with other industry, consumer and public policy organizations, the group said.
Ranbaxy launches authorized
generic for dry mouth
PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic drug for treating dry mouth associated with an autoimmune disorder, the company said.
The India-based generic drug maker announced the launch of cevimeline hydrochloride in the 30-mg strength under an agreement with parent company Daiichi Sankyo. The drug is used in patients with Sjogren’s syndrome, which affects the moisture- producing glands.
Daiichi Sankyo markets the drug under the name Evoxac. The drug had sales of $62.4 million during the 12-month period ended in June 2011, according to IMS Health.
An authorized generic is a branded drug marketed under its generic name at a lowered price. Apotex is marketing the generic version of the drug.
Mylan settles respiratory drug suit
PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said. The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.
Under the settlement, Mylan will be able to launch its product starting in April 2014. The company said it was likely the first company to file a regulatory approval application containing a Paragraph IV certification, a legal assertion that the patent covering the branded drug is invalid, unenforceable or not at risk of being infringed.
Orapred ODT had sales of $33.1 million during the 12-month period ended in June, according to IMS Health.
Watson-Actavis latest among generic M&As
In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis. Watson announced the $5.6 billion acquisition of Actavis in April, a deal that is expected to make Watson the third-largest generic drug maker in the world, after Teva Pharmaceutical Industries and Mylan. As a condition for the FTC’s approval, Watson and Actavis had to divest rights to nearly two dozen generic drugs and regulatory applications, selling most of them to Par Pharmaceutical and Sandoz.
While among the largest deals of its kind ever, the acquisition is just the latest in a plethora of mergers and acquisitions among generic drug companies. In May 2012, Sandoz, the generics arm of Swiss drug maker Novartis, announced that it would buy Melville, N.Y.-based Fougera for $1.5 billion, which would make it the world’s biggest manufacturer of generic dermatology drugs. Sandoz announced last month that the Food and Drug Administration had approved its generic version of Taro’s Topicort (desoximetasone) ointment, a treatment for symptoms of various skin diseases that was the first Fougera dermatology product approved since Sandoz’s acquisition of the company. In July 2012, Par Pharmaceutical — based in Woodcliff Lake, N.J., and the world’s fifth-largest generic drug maker — announced that private investment firm TPG would buy it for $1.9 billion.
In August, IMS Health VP industry relations Doug Long said at the National Association of Chain Drug Stores’ 2012 Pharmacy and Technology Conference in Denver that there would be a “big increase” in mergers and acquisitions among generic drug companies in the future.
The main reason, Long has said, is the gradual commoditization of primary care drugs due to the patent cliff. Such disease states as Alzheimer’s disease, psychotic and mood disorders, ulcers, cardiovascular disease and osteoporosis sit within what Long called the “cone of commoditization,” meaning that they are now or soon will be dominated by generics, making it less profitable for brand-name drug makers to develop new drugs for them. The dwindling number of new and easy-to-replicate primary care drugs with blockbuster sales — best exemplified by Pfizer’s cholesterol drug Lipitor (atorvastatin), which went generic one year ago this month and is now made in generic form by multiple companies — is causing branded companies to move into specialty drugs for such conditions as cancers and chronic viral infections, and will drive much of the M&A among generic companies, while many generic companies will move up the value chain as well into more complex modes of delivery patches and injectables.
Retailers’ new programs target nonadherence
Improving medication adherence in specialty pharmacy could be equivalent to introducing a new blockbuster drug. That’s how Diplomat Specialty Pharmacy president and CEO Phil Hagerman put it at Drug Store News’ Specialty Pharmacy Roundtable two years ago.
And he was only talking about specialty and the disease states it covers. The most commonly cited cost of poor medication adherence comes from a study published in the New England Journal of Medicine, which put it at about $290 billion; the latest drug trend report from pharmacy benefit manager Express Scripts has it pegged at more than $300 billion.
One of the ways retailers are improving medication adherence is medication therapy management. Last month, Rite Aid announced a collaboration with health insurer UnitedHealth Group as part of the Diabetes Control Program, itself a part of UnitedHealth’s Diabetes Prevention and Control Alliance. The collaborative program is now available to residents of Long Island in New York state who are enrolled in UnitedHealthcare’s employer-sponsored health plans. Diabetes patients enrolled in the program are able to connect with Rite Aid pharmacists at 27 stores who are trained in diabetes care and MTM, and offer consultations, education and support. The pharmacists also consult with enrolled patients to evaluate their success adhering to their drug therapies and review their test results for blood pressure, blood glucose and cholesterol.
Also last month, Walgreens announced WellTransitions, a program that creates a coordinated care model involving health systems, hospitals and the retail pharmacy chain to reduce re-admissions and costs, while improving outcomes and adherence. Under the program, Walgreens pharmacists work with hospital staff to oversee medication therapies and provide such services as medication review, whereby pharmacists review prescriptions upon admission to the hospital and after discharge, checking for potential interactions and simplifying regimens; bedside medication delivery, which includes medication education and instruction; medication counseling with patients and caregivers; follow-up calls to discuss patient progress and discuss regimens; and pharmacist support available 24 hours per day. WellTransitions is available at locations in Florida, Maryland and Indiana, and there are plans to roll it out throughout the United States.
CVS Caremark has some new plans for improving adherence as well. Currently, its Maintenance Choice program — which was launched in 2009 and offers patients the choice of picking up their drugs at the store or having them shipped to their homes at no increase in co-pay or payer pricing — covers 10.7 million lives under 880 plans. But during the company’s second-quarter earnings call in August 2012, president and CEO Larry Merlo discussed plans for Maintenance Choice 2.0, a version that will include less restrictive and voluntary plan design options. Maintenance Choice 2.0 is currently in pilot testing and is expected to become more widely available in January 2013.