With the acquisition of privately-held Oriel Therapeutics, Novartis' Sandoz unit gains a portfolio of generic drug candidates and related technologies for asthma and chronic obstructive pulmonary disease, a key therapeutic area for the generic drug maker.

The acquisition, announced April 19, builds on Sandoz's ongoing efforts to become a leader in the inhalable respiratory generic drug market, a business area with high growth potential given the blockbuster drugs expected to lose patent protection in the next few years. About $16 billion of the $32 billion branded global market for asthma and COPD medicines is expected to lose patent protection by 2016, Novartis said, citing data from IMS Health and Datamonitor.

Among the drugs that could lose patent protection in one or more countries during this time are GlaxoSmithKline's Advair (fluticasone/salmeterol), AstraZeneca's Symbicort (budesonide/formoterol), Merck's Singulair (montelukast) and Pfizer/Boehringer Ingelheim's Spiriva (tiotropium bromide), according to Novartis.

Inhalable respiratory drugs are a high-value marketing proposition for generic drug companies, since their complex delivery systems represent a barrier to market entry, thereby potentially limiting competition.

"This is a key area of focus that complements our global leadership position in biosimilars and complex injectables," Sandoz Division Head Jeff George said in a statement.

The strategy also complements the work Novartis is doing on the brand drug side in the respiratory category. The company has a long-acting beta 2 antagonist, indacaterol, in development for COPD. FDA issued a "complete response" letter for the drug last year, however, and the company plans to resubmit it in the second half of 2010. The drug was approved and launched in Europe, where it is marketed as Onbrez Breezhaler .

The acquisition of Oriel, based in Morrisville, N.C., will provide Sandoz with three development projects targeting leading medicines in the field, Sandoz said, though it declined to provide details on what those drug candidates are. Oriel also owns the novel drug delivery technology FreePath , which Sandoz said "has the potential to address some of the hurdles facing regulatory approval of generic inhaled medicines in the U.S."

It's not clear how the FreePath delivery technology might eliminate some of those issues, however. Inhaled drugs are one of several classes of drugs FDA has deemed as "complex" for which bioequivalence standards are lacking. In 2007, the agency issued a report calling for research on new methods to determine bioequivalence for complex drugs with the aim of encouraging the development of generic versions (Also see "FDA Proposes Bioequivalence Research On Inhalers, Other Complex Drugs" - Pink Sheet, 14 May, 2007.). The topic was later taken up by an advisory committee in 2008.

Sandoz has already invested a significant amount of money in the respiratory space. The company put $60 million towards the development of a new facility at its global respiratory center of excellence in Rudolstadt, Germany, which has full scale manufacturing capacity for both dry powder inhalers and metered-dose inhalers. Sandoz launched generic salbutamol in the EU last year, the first EU-wide approved generic inhalable product under new EU guidelines.

But in March, Sandoz returned U.S. rights to a combination asthma and COPD drug in development with the U.K. specialty pharma Vectura Group. The drug is being developed using Vectura's GyroHaler Dry Powder Inhaler devise. Sandoz is still developing the drug in Europe, however.

-Jessica Merrill (j.merrill@elsevier.com)

Novartis' Sandoz Unit Makes Respiratory Push With Acquisition Of Oriel

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