What's Next(erone) for Baxter?

Pharma giant acquires Ligand partner Prism to bring Nexterone, an anti-arrhythmic agent, to market

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SAN DIEGO—Ligand Pharmaceuticals recently announced that its partner Prism Pharmaceuticals has inked an agreement to be acquired by pharma behemoth Baxter International. Prism Pharmaceuticals recently received U.S. Food and Drug Administration (FDA) approval for Nexterone, an anti-arrhythmic agent that Ligand (through its CyDex Pharmaceuticals subsidiary) originally developed with its patented Captisol formulation technology and licensed to Prism in 2006.

Baxter has been expanding and contracting as a company in the recent past, as it recently shed its multisource generic injectable business to Hikma and added capabilities in specific areas as evidenced by this purchase and that of all of the hemophilia-related assets of Archemix late last year.

"Baxter is very familiar with this product as the company was previously selected by Prism to be the contract manufacturer of Nexterone for the ready-to-use premixed IV bags and prefilled syringes," says Erin Gardiner, a Baxter spokesperson. "Nexterone leverages Baxter's unique non-PVC/non-DEHP GALAXY aseptic fill and finish technology."

Captisol is the trade name for Ligand's modified β-cyclodextrin platform formulation technology. Captisol has an excellent safety profile and superior drug carrier properties designed to improve the solubility, stability, bioavailability, safety and dosing of APIs.

Nexterone is a Captisol-enabled formulation of amiodarone, a commonly used anti-arrhythmic agent used for the treatment of ventricular tachyarrhythmia, or fast forms of irregular heartbeat. By formulating with Captisol, Nexterone allows for the elimination of formulation-limiting cosolvents like polysorbate 80 and benzyl alcohol found in current presentations of amiodarone. Cosolvent-free amiodarone can now be presented as Nexterone in the first and only ready-to-use premixed intravenous bag formulations as well as vials and a prefilled syringe.

"We're focusing on products that everyone uses that could benefit from Captisol delivery," says Robert McKay, senior director of business development for Ligand. "We can pump out a couple million dollars in drugs with very little development."

Ligand is eligible to receive milestones, royalties and Captisol material sales revenue from this partnership. Prism, which is based in King of Prussia, Pa., was founded in 2004 and received extensive start-up funding at that time. Its only product is Nexterone.

"Having the Baxter commercial infrastructure behind Nexterone adds significant value to this asset for Ligand shareholders, and we look forward to building a strong relationship with Baxter as we continue to supply Captisol for all Nexterone products," said John Higgins, president and CEO of Ligand, in a prepared statement.

"The acquisition of Prism Pharmaceuticals will add Nexterone to Baxter's complementary portfolio of critical, differentiated products and strong sales channel," says Gardiner. "In addition to prefilled syringes and vials, Prism recently received FDA approval for the first and only ready-to-use premixed IV bag formulation of this antiarrhythmic agent."

These ready-to-use formats require no admixing, eliminating potential medication errors associated with compounding. In addition, Nexterone can be stored at room temperature during its two-year shelf life and fits in automated dispensing cabinets and crash carts, putting the product in patient care areas ready for use during acute, time-sensitive and life-threatening situations.

"Prism's focus was on Nexterone, as the company didn't have other products under development," she adds.

Gardiner also says that Prism's 11 employees won't transfer to Baxter as part of the acquisition. Their only facility was leased office space used for manufacturing, she explains, since they had previously selected Baxter as their contract manufacturer.

"Every pharma company is trying to figure out how to best impact the bottom line," concludes McKay. "It might not be in the blockbuster drugs that can take years of expensive development. Our strategy is to make small products that can add up big on the bottom line."

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