PHARMACY

Q&A: Manning up

BY Michael Johnsen

Natural Products Solutions recently announced the launch of VirMax T Testosterone. As part of that launch, DSN caught up with NPS president and CEO Marty Gallant to discuss men’s health supplements. 


DSN: Men aren’t too proactive addressing their own health issues. How do you market to them?


Marty Gallant: Here’s the bottom line: A man will never admit he’s having problems. … Our market research has shown that when it comes to the retail-end, it’s the wife who usually does the purchasing.


DSN: Men are known to lose muscle mass after age 40; does testosterone help improve muscle function?


Gallant: That’s exactly what it is. If you can keep your testosterone levels high, then you’re not going to lose the muscle mass. 


DSN: John Sally, NBA-all star, serves as a spokesman for these products. How did that come about?


Gallant: I met John at a natural products show. … We spent about an hour talking, and he told me about how his father and his brother had prostate issues, and that he travels the country discussing prostate health for the Prostate Cancer Foundation.

To listen to the full audio Q&A, click here.

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NewsBytes — Chain Pharmacy, 11/5/12

BY DSN STAFF

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.


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Watson-Actavis latest among generic M&As

BY Alaric DeArment

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.

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