Biotechs acquiring rights to commercial drugs before gaining marketing approval of their own lead candidate is nothing new to the industry; an experienced sales force can be worth its weight in gold.

In 1994, Cephalon Inc. singed up to co-promote Bristol-Myers Squibb Co.'s Stadol NS (butorphanol tartrate) to establish a neurology sales force before approval of Provigil (modafinil). More recently Acorda Therapeutics Inc. acquired the U.S. rights to Zanaflex (tizanidine) from Elan Corp. plc ahead of its approval of Ampyra (dalfampridine), which Acorda had already licensed from Elan. (See BioWorld Today, Aug. 3, 1994, and July 30, 2004.)

Even big pharma has used the shortcut to commercial success. Novartis AG negotiated the rights to sell Extavia (interferon beta-1b), its brand of Bayer AG's Betaseron, establishing a multiple sclerosis sales force before gaining approval of Gilenya (fingolimod).

But two companies, XOMA Corp. and DARA BioSciences Inc., have jumped in a little earlier than historically seen. Both acquired rights to FDA-approved products last week despite the fact that their own programs are still far from launch – neither is in Phase III yet.

XOMA acquired the U.S. rights to hypertension treatment Aceon (perindopril erbumine) and fixed-dose combinations (FDC) of perindopril and other antihypertensives from French drugmaker Les Laboratoires Servier SA. (See BioWorld Today, Jan. 19, 2012.)

The biotech doesn't plan to establish a sales force for Aceon because the drug already faces generic competition. Sales through Servier's former licensee Abbott amounted to just $2.8 million last year.

Even without a sales force, XOMA's CEO John Varian thinks the deal is worthwhile. "We've put in place a skeleton" with the capabilities to manufacture, distribute, bill and collect, and perform pharmacovigilance on a drug, he told BioWorld Insight. "We have all those things in place in a completely low-risk way around a product that we have a very predictable revenue amount and cost structure such that we'll still have a margin."

XOMA's relationship with Servier that the two companies established to develop gevokizumab (formerly XOMA 052) was a driving force for XOMA's timing of establishing commercial operations. "We had this relationship with Servier that allowed us to get [a commercial product] this early in the process," Varian said. "We wouldn't have had an opportunity to do this deal if it wasn't someone we already had a relationship with." (See BioWorld Today, Jan. 5, 2011.)

Having a commercial operation could also help XOMA when it out-licenses the other drugs in its pipeline. "I have a very strong belief, as we all do here, that for us to benefit from our own discoveries ultimately we need to commercialize our own discoveries here in the U.S.," Varian said. "By having this commercial capability in place it makes it much more likely we can get that co-promotion option and utilize it in an effective way."

Varian sees acquiring commercial capabilities as a necessary step for biotechs. "You need to be able to control your own fate and being able to commercialize your drugs is important for companies."

DARA took a step toward controlling its destiny when it acquired Oncogenerix Inc. last week. The biotech gained exclusive U.S. rights to sell Soltamox (oral liquid tamoxifen citrate) for breast cancer. The newly acquired drug will provide revenue in 2012 and will "establish a platform whereby other cancer and cancer-support products may be accessed in the future through pending Oncogenerix licensing efforts, " David Drutz, DARA's President and CEO, said in the announcement of the deal.

Acquiring a sales force ahead of an expected approval doesn't always work out. Avanir Pharmaceuticals Inc. acquired rights to FazaClo (clozapine) in May 2006 through the purchase of Alamo Pharmaceuticals LLC, but sold rights to the drug a little over a year later to Azur Pharma after Avanir's Nuedexta (dextromethorphan HBr and quinidine sulfate) failed to gain FDA approval in a timely fashion. (See BioWorld Today, May 24, 2006 and July 5, 2007.)

Nuedexta was later approved and launched using a sales force that Avanir built, but sales have not lived up to initial analyst expectations. (See BioWorld Today, Nov. 2, 2010.)