San Diego's Halozyme ($HALO) has granted Johnson & Johnson ($JNJ) rights to develop 5 candidates using its Enhanze tech for subcutaneous drug delivery--that which is just under the skin--instead of onerous intravenous administration. Halozyme got an initial payment of $15 million and has a chance to earn development, regulatory and sales-based milestone payments of up to an eye-popping $566 million, plus royalties, according to a December release announcing the deal.
The first J&J candidate is the multiple myeloma antibody daratumumab, being developed in partnership with Genmab. In March, Halozyme announced that it plans Phase I clinical trials of a subcutaneous formulation of the antibody. The candidate has advanced to late-stage trials as an intravenous drug.
The announcement occurred on the heels of promising data from the Phase II trial of the conventional formulation, which has raised hopes of a fast-track approval.
Halozyme's approved enzyme recombinant human hyaluronidase (rHuPH20) breaks down hyaluronan, a key component of the cellular structures just beneath the skin, enabling subcutaneous injection of biologics like monoclonal antibodies and other large therapeutic molecules, as well as small molecules and fluids, Halozyme says, adding that molecules as large as 200 nanometers can pass through the skin's subcutaneous space thanks to the Enhanze platform.
Advantages of subcutaneous as opposed to intravenous delivery include convenience, reduced cost and possible improvement in efficacy. And a novel formation can add years to a product's patent life, Halozyme points out.
Other Big Pharma companies have entered into partnerships with Halozyme as well. Roche ($RHHBY) received permission to use Enhanze on 8 candidates in 2006, with three already in clinical trials. A subcutaneous version of Genentech's breast cancer fighting Herceptin is in Phase III trials, as is a modified formulation of MabThera for the treatment of common forms of non-Hodgkin lymphoma. Both are already approved as intravenous drugs, and the subcutaneous formulation of MabThera was just approved in Europe.
Halozyme's partnership with Pfizer ($PFE) is worth up to $507 million in milestones, plus royalties. The deal struck in 2012 called for Pfizer to license Enhanze in two targets in the primary care and specialty care arenas.
The drug delivery specialist also helped Baxter ($BAX) get FDA approval for its subcutaneous treatment for adult patients with primary immunodeficiency, Hyqvia.
-- Varun Saxena (email | Twitter)
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