Getting under our skin

Pfizer, Halozyme partner on subcutaneous biologics delivery in potential $500 million-plus deal

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SAN DIEGO—In pursuit of easing medicine administrationmethods for patients, Pfizer Inc. and Halozyme Therapeutics Inc. have announceda worldwide collaboration and license agreement to develop and commercializebiologics for subcutaneous delivery. The partnership brings togetherproprietary biologics from Pfizer's collections with Halozyme's Enhanzetechnology, a proprietary drug delivery platform based on Halozyme's patentedrecombinant human hyaluronidase enzyme, rHuPH20).
Per the terms of the agreement, Pfizer has been granted aworldwide license to develop and commercialize products that combine itsproprietary biologics, directed at up to six targets, with rHuPH20. The targetsmay be selected on an exclusive or non-exclusive basis. In return, Halozymewill receive an initial payment of $8 million, a sum that includes an upfrontfee for exclusive licenses to two specified therapeutic targets in primary careand specialty care indications, as well as the right for Pfizer to select up tofour additional targets upon the payment of additional fees. If certain development,regulatory and sales milestones are met, Halozyme stands to receive additionalpayments of up to $507 million, and is also eligible to receive royaltypayments on net sales of any licensed products.
"I am delighted about this opportunity, as it has thepotential to enhance Pfizer's ability to optimize treatments for patients,"Jose Carlos Gutierrez-Ramos, senior vice president of Pfizer BioTherapeuticsR&D, said in a statement.
Halozyme's Enhanze platform is based on rHuPH20. The enzymeremoves the limitations on the volume of biologics that can be administeredsubcutaneously by "temporarily [degrading] hyaluronan, a structural componentof the subcutaneous space that is just beneath the outside surface of the humanskin," the company notes on its website. This creates a window of opportunityfor the administration of larger injectable biologics such as monoclonalantibodies, allowing molecules as large as 200 nanometers to pass through thesubcutaneous space, the company claims.
"We look forward to working with Pfizer to apply Enhanze tothese exciting targets," Dr. Gregory Frost, president and CEO of Halozyme, saidin a press release. "Enhanze enables biologics to be delivered as a simplesubcutaneous injection."
Frost notes that following its acquisition of Wyeth, Pfizerhas emerged as a strong partner in biologics. The company, he says, is oneknown for its strength in oral medications and small molecules, but in recentyears, Pfizer's work with recombinant proteins has been growing as well.
"When you think of some of the first targets that we'recollaborating on, which are primary care and specialty markets, Pfizer hashistorically been a leader in these sorts of areas as well, from the commercialperspective. So the collection of those two really made for an excitingpartnership for us and a really good fit," says Frost. 
The Pfizer collaboration is one of several Halozyme hasestablished based on its Enhanze platform—with other partners like Roche,Baxter, ViroPharma and Intrexon—and Frost says he considers the approach a"win-win" for patients in seeking to simplify medicine administration. Greatmedicines and advancements have been made, he notes, and trying to turn thosemedicines into easy-to-use products for patients is very important, with theadded benefit of reducing healthcare costs.
"Biologics, things like monoclonal antibodies today, they'regreat medicines. We've made, as an industry, so much progress on them. But theyare not proteins that you can take as a simple pill. We would all agree that apill you take once per month would be nirvana—unfortunately, science is justnot there," says Frost. "Oral medications still have a very strong place in theindustry, but when you start developing things like monoclonal antibodies,there's been a tremendous shift away from the classic intravenous infusiontowards more simplified methods of administration. So self-administration forpatients is something which is a trend that the industry is very much goingtowards."

Pfizer licensesspinal muscular atrophy program from Repligen
WALTHAM, Mass.—Pfizer also recently entered into anexclusive worldwide licensing agreement with Repligen Corp. to advanceRepligen's program for the treatment of spinal muscular atrophy (SMA), anorphan neurodegenerative genetic disease that presents early in life.
The program includes RG3039, a small-molecule drug candidatein clinical development for SMA, as well as backup compounds and enablingtechnologies. Under the terms of the agreement, Repligen is entitled to receiveup to $70 million from Pfizer, starting with an upfront payment of $5 millionand total potential future milestone payments of up to $65 million, well asroyalties on any future sales of SMA compounds developed under the agreement.
Under the terms of the agreement, Repligen is responsiblefor completing the first two cohorts of an active Phase I trial evaluatingRG3039 in healthy volunteers, which it anticipates will occur during the firstquarter. Repligen will also provide certain technology transfer services toPfizer, which will then assume full responsibility for the SMA program movingforward, including the conduct of any registration trials necessary for productapproval. Repligen has previously received U.S. Orphan Drug and Fast Trackdesignations for RG3039 for the treatment of SMA, as well as Orphan MedicinalProduct designation in Europe.
"There is a critical need to expedite potential treatmentsolutions for rare diseases such as spinal muscular atrophy, where patientshave such limited options," said Jose Carlos Gutierrez-Ramos, senior vicepresident of Pfizer BioTherapeutics R&D, in a statement. "This partnershipwill combine our expert capabilities in advancing molecules for geneticdiseases with Repligen's leading SMA program."
The SMA program was originally in-licensed from Families ofSMA.

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