IMS Health exec to NACDS conference attendees: Expect opportunities, uncertainties for drug market
SAN DIEGO The U.S. drug market will present opportunities as well as uncertainties over the next decade, according to remarks made by IMS Health VP industry relations Doug Long at the National Association of Chain Drug Stores’ 2010 Pharmacy and Technology Conference held here on Monday.
A slideshow listed 20 drugs that will lose patent protection between 2010 and 2014, with a total market value of $107 billion, including Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin calcium) and Purdue Pharma’s painkiller Oxycontin (oxycodone hydrochloride).
“So you have this patent cliff, which means there are going to be plenty of generic opportunities between now and 2014,” Long said.
With eight of the drugs listed ranking on IMS’ list of the top 10 in terms of sales, the patent expiries will produce huge rewards for the first companies to market generic versions of these drugs, but after 2015, the number of top-selling drugs losing patent protection will drop. That, Long said, could affect not just generic drug companies, but also retailers and other businesses that benefit from generics.
Of course, use of generics has increased markedly, growing from 57.7% of total prescriptions dispensed to nearly 75% between 2005 and July 2010, even as their market share in terms of percentage of dollars fell from 85.4% to 80.7% during the same period. Sales for the top 10 generic drug companies have grown by 15.1% in the 12-month period ended in June, with Teva Pharmaceutical Industries and Mylan accounting for 34.4% of generic prescriptions, and Teva ranking as the eighth-largest drug maker overall in terms of sales.
Coinciding with the economic crisis, Long said, there was a growing trend of patients starting or continuing therapies with generic rather than branded drugs. Still, the market share of generic drugs, as measured by percentage of dollars, increased from 14.6% in 2005 to 19.3% as of July 2010, while market share as measured by prescriptions grew from 57.7% to 74.8%.
On the branded side, Long noted such trends affecting drug innovation as fewer products going to market, development skewed toward specialty drugs –– meaning those prescribed by specialist physicians –– and orphan drugs and away from primary care drugs, and greater control exerted by payers. Indeed, according to the Food and Drug Administration and IMS, the FDA has approved more specialty drugs than primary care drugs every year between 1998 and 2009, except in 2002.
Many top-selling branded drugs continue to have strong sales growth. Aside from Lipitor, which had sales decline by 4.3%, all of the drugs that IMS listed as the top 20 in terms of sales grew during the 12-month period ended in June, and sometimes quite strongly. AstraZeneca’s cholesterol-lowering drug Crestor (rosuvastatin calcium) had $3.5 billion in sales, growing 34.7%, while Otsuka American Pharmaceutical’s and Bristol-Myers Squibb’s antipsychotic and antidepressant Abilify (aripiprazole) had sales of $4.3 billion, growing 22.3%. Purdue’s Oxycontin had sales of $3.1 billion, growing by 18.6%.
MedImmune confirms second CRL from FDA for motavizumab
GAITHERSBURG, Md. AstraZeneca’s biologics unit has received a second complete response letter from the Food and Drug Administration regarding an investigational drug designed to treat respiratory syncytial virus disease.
In the second CRL, the FDA requested that MedImmune complete an additional clinical trial that supports a satisfactory risk/benefit profile to advance the registration of motavizumab, its investigational monoclonal antibody.
MedImmune filed the original biologics license application in January 2008 and received its first complete response letter in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory committee on June 2 of this year.
Somaxon, P&G to co-promote Silenor
SAN DIEGO A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia treatment.
Somaxon Pharmaceuticals and Procter & Gamble announced their co-promotion agreement for Silenor, in which Somaxon’s promotion of the drug will target physicans, while P&G will promote Silenor to targeted pharmacies.
Somaxon will record all sales of Silenor and will pay P&G a combination of fixed fees and a royalty based on U.S. net sales. Each party will be responsible for the costs of maintaining and operating its own sales force, and Somaxon is responsible for all other costs pertaining to the commercialization of Silenor.
The term of the agreement runs through Dec. 31, 2012, renewable thereafter, and Somaxon will pay P&G a reduced royalty based on U.S. net sales of Silenor for one year after the expiration of the agreement or its earlier termination under certain circumstances. Governance of the collaboration will occur through a joint commercialization committee.
“We are extremely excited to add Procter & Gamble’s highly regarded and tenured professional sales force to our commercialization effort for Silenor,” said Richard Pascoe, Somaxon’s president and CEO. “With the combined effort of both sales forces, we will target 35,000 of the highest prescribers of insomnia products, as well as 25,000 pharmacies, which we believe will allow us to be highly competitive in the insomnia market. In addition, we are excited about the potential to partner with Procter & Gamble for the OTC rights to Silenor as a future life cycle management opportunity.”