Drug Industry Daily - Oct. 8, 2010 Issue

Vol. 9 No. 196

IMS: Global Drug Sales Will Rise in 2011 Despite Patent Losses

Although patent expirations and limits on drug spending can hamper growth of drug sales in developed countries, global pharmaceutical sales are nonetheless expected to grow 5 to 7 percent in 2011, according to an annual forecast.

The global pharmaceutical market could reach $880 billion in 2011, up from $825 billion in 2010 (DID, Oct. 9, 2009), consulting firm IMS Health says. That expansion is driven in part by explosive growth in China, now the world’s third largest market for pharmaceutical sales. Drug sales in that emerging market are expected to grow 25 to 27 percent next year, to more than $50 billion.

Further bolstering worldwide growth are the 17 so-called “pharmerging” countries where sales are expected to rise 15 to 17 percent in 2011. Greater access to healthcare in those markets is driving demand for medicines, which could reach $170 billion to $180 billion next year.

However, the situation in the U.S., Canada and Europe is vastly different. Substantial generic price reductions in Spain and Canada, price pressures on brands in Germany, across-the-board price cuts for brands in Turkey and Greece, and the use of pre-authorization and cost-sharing provisions in the U.S. to cut healthcare costs has served to mitigate sales growth in those markets.

Generic competition will dampen sales for about $30 billion worth of drugs facing patent and exclusivity cliffs in the U.S. Those drugs include Pfizer’s cholesterol drug Lipitor (atorvastatin calcium), Sanofi-Aventis and Bristol-Myers Squibb’s blood thinner Plavix (clopidogrel bisulfate), Eli Lilly’s schizophrenia treatment Zyprexa (olanzapine) and Daiichi and Ortho-McNeil’s antibiotic Levaquin (levofloxacin). The last four drugs alone accounted for $17 billion in sales over the last 12 months.

However, 2011 promises a “new wave of innovation” as several specialty biopharmaceutical products, which target unmet medical need and have the possibility to significantly alter treatment paradigms, are expected to gain approval. They include five potential blockbuster treatments for stroke prevention, melanoma, multiple sclerosis, breast cancer and hepatitis C. Those drugs are expected to expand overall drug sales, redirecting spend away from lower-cost generics.

In addition, 2011 will be a critical year to see how healthcare reform impacts pharmaceutical sales, IMS Health says. — LaCrisha Butler


Affymax to Proceed with Hematide NDA Despite Arbitration Decision

An arbitration panel has ruled that Affymax and Johnson & Johnson (J&J) must share several patents related to erythropoietin-stimulating agents (ESAs), and given J&J full control over another, but Affymax says the decision will have no impact on its plans to file for approval of its anemia candidate Hematide.

The decision, which was announced by Affymax Wednesday, resolves a long-running dispute between the companies over ownership of the patents that were developed under an R&D agreement between the companies initiated in 2001.

Affymax filed suit against J&J in 2004, claiming that the company’s scientists had breached the R&D agreement by engaging in a course of conduct designed to obtain patents only for J&J and to deny Affymax patents on its scientists’ inventions, Affymax says in its most recent quarterly report.

J&J denied the claims, saying that it was Affymax employees who had filed patent applications in their own name claiming inventions of J&J employees, and that Affymax had removed the names of J&J employees from patent applications on which those employees had been identified as inventors.

While the arbitration panel determined that companies should be deemed co-owners of several of the patents at issue, it gave J&J full control of the ’078 patent.

That decision, however, will not change Affymax and its partner Takeda Pharmaceutical’s plan to submit an NDA for their anemia drug Hematide (peginesatide) in the first half of 2011, Affymax says (DID, Aug. 6).

The company “does not believe the claims in the ’078 patent are valid,” Affymax says. “Even in the event that claims of this patent were found to be valid, Affymax believes that they do not encompass Hematide.”

J&J could potentially still attempt to assert the ’078 patent as connected to the drug, but would be unable to do so until Hematide is approved by the FDA and on a path to commercialization, Sylvia Wheeler, a spokeswoman for Affymax, told DID.

If approved, Hematide would compete against other ESAs, including J&J’s Procrit (epoetin alfa), and Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).  — David Belian


Endo, Watson Reach Settlement in Opana ER Patent Case

Endo Pharmaceuticals has reached a settlement with Watson Laboratories in a patent-infringement case over the pain drug Opana ER.

The settlement, one of several reached by Endo recently, will give Watson a royalty-free license on patents covering Opana ER (oxymorphone HCl) and will allow the company to launch its generic version of the drug no later than Sept. 15, 2012, Watson said Thursday.

Endo had originally sued Watson in March after the generic-drug maker filed an ANDA to market a generic version of Opana ER 5-, 7.5-, 10-, 15-, 20-, 30- and 40-mg tablets. The companies did not disclose financial details of the settlement.

The deal will allow Watson to bring its generic version of Opana ER to market the same day as Sandoz and Barr Laboratories, who reached settlements with Endo earlier this year (DID, June 10).

Actavis, however, reached a deal with Endo last year that will allow it to bring its generic Opana ER to market more than a year earlier, in July 2011 (DID, Feb. 24, 2009).

For Endo, the deals will allow the company to stave off immediate generic competition to the drug that, when combined with Opana, the immediate-release version of the drug, had worldwide sales of about $180 million in 2009.

Meanwhile, the company is moving to strengthen its own generics business, agreeing last week to acquire Qualitest Pharmaceuticals, the sixth-biggest generic-drug maker in the U.S., for $1.2 billion (DID, Sept. 29). — David Belian


Roche Buys Out Hepatitis C Drug Danoprevir for $175 Million

Roche has purchased full development rights to hepatitis C drug danoprevir from development partner InterMune, allowing it to more easily develop combination therapies.

The $175 million price tag greatly exceeds what Baird analysts had expected for the drug, “as Roche clearly paid something for increased flexibility to pursue novel [specifically targeted antiviral therapy] combos,” Baird said Thursday.

Roche’s hepatitis C drugs also include Pegasys and RG7128, and the company plans to develop combinations of its own compounds with molecules from other companies, Roche said Thursday.

Danoprevir, a second-generation protease inhibitor, is in Phase II and has shown early efficacy as a monotherapy, in combination with RG7128 and when combined with Pegasys and Copegus (ribavirin). Roche and InterMune have co-developed the drug since 2006.

Pegasys is used in most hepatitis treatment development programs and is expected to become the backbone of future combination therapies, Roche said. RG7128, partnered with Pharmasset, is in Phase II and could be the first nucleoside polymerase inhibitor for treating hepatitis C.

InterMune is now left with just one late-stage candidate, the idiopathic pulmonary fibrosis treatment Esbriet (pirfenidone). The FDA, however, issued a complete response letter for the drug in May and requested the company conduct an additional trial (DID, May 13). — April Hollis


In Reversal, NICE Recommends Aricept, Three Other Drugs for Alzheimer’s

Reversing a controversial 2006 decision, the UK’s National Institute for Health and Clinical Excellence (NICE) Thursday recommended National Health Service funding of three acetylcholinesterase (AChE) inhibitors for the treatment of Alzheimer’s disease.

In a preliminary report, a NICE appraisal committee recommends Pfizer’s Aricept (donepezil), Shire’s Reminyl (galantamine) and Novartis’ Exelon (rivastigmine) for use in patients with severe Alzheimer’s disease and those with mild to moderate Alzheimer’s who show signs of cognitive, global, functional and behavioral benefits while undergoing treatment.

The committee also recommends Lundbeck’s Ebixa (memantine) as an option for people with moderate Alzheimer’s disease who are intolerant to or contraindicated for AChE inhibitors and for severe Alzheimer’s disease.

The recommendations update technology appraisal guidance 111, first published in 2004, and are based on new clinical data published since then. Among the new evidence are a systematic review of randomized clinical trials of Aricept since 2004 and a meta-analysis of six randomized controlled trials, including individual patient data for Ebixa.

Patients receiving any of the four drugs should be reassessed every six months, according to a consultation document released by the committee.

In terms of cost benefit, the committee found no significant difference between the three AChE inhibitors and concluded that the NHS should use the drug with the lowest purchase price.

All of the AChE inhibitors “dominated best supportive care,” the committee says. Reminyl had the lowest costs, but Aricept had the greatest gains in quality-adjusted life years (QALY), the panel says. Cost for the three drugs ranged from about $110,518 to about $110,486 and QALYs gained ranged from 1.613 to 1.619, it says.

Because of a roughly $50,973 per QALY base-case incremental cost-effectiveness ratio (ICER) for Ebixa, the committee says it is not cost-effective when compared to AChE inhibitors in moderate disease, even though it offers the best supportive care. However, the committee also notes that if the behavioral benefit of Ebixa is taken into account, the ICER would be less than about $42,076 per QALY for severe disease and is therefore a cost-effective use of NHS resources.

When evaluating the severity of Alzheimer’s disease, healthcare providers should consider any physical, sensory or learning disabilities or language difficulties a patient has and not rely solely on assessment scales and cognition scores, the committee says.

A second appraisal meeting is scheduled for Nov. 25. Comments on the consultation document are due Oct. 28.

The appraisal consultation document and evaluation report are available at www.nice.org.uk/guidance/index.jsp?action=folder&o=51044. — Meg Bryant



To clarify a story on patient-directed drug information that appeared in the Sept. 28 DID, Andrew Emmett, BIO’s managing director of science and regulatory affairs, said BIO would be willing to speak with Congress on additional congressional appropriations for the FDA.

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Reporters: David Belian, April Hollis, Virgil Dickson, LaCrisha Butler, Wilson Peden

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