Horizon Pharma said today it will acquire rights to interferon gamma-1b outside of North America and Japan from Boehringer Ingelheim for €25 million ($28 million).
The deal gives Horizon Pharma global rights to interferon gamma-1b, as the company already owns the rights to the orphan drug, which it markets in the U.S., Canada, and Japan under the trade name Actimmune®.
Actimmune is indicated for reducing the frequency and severity of serious infections associated with chronic granulomatous disease and delaying time to disease progression in patients with severe, malignant osteopetrosis.
Last year. Horizon Pharma generated $107.4 million in net sales from Actimmune. The company added Actimmune to its orphan drug portfolio after it acquired Vidara Therapeutics for about $660 million, in a deal completed in September 2014.
Until now, Boehringer Ingelheim has commercialized interferon gamma-1b under the trade names Imukin®, Imukine®, Immukin® and Immukine® in about 30 countries, primarily in Europe and the Middle East.
“Obtaining worldwide rights for interferon gamma-1b solidifies our continued investment in the medicine, and pending the outcome of clinical studies investigating it in Friedreich's ataxia and advanced solid tumors, such as kidney and bladder cancer, strengthens our ability to expand its potential global use,” Timothy P. Walbert, Horizon Pharma’s chairman, president and CEO, said in a statement.
On May 5, Horizon Pharma said it completed target enrollment of 90 patients in the Phase III STEADFAST trial. The randomized, double-blind, placebo-controlled study aims to evaluate Actimmune in patients with Friedreich's ataxia.
Top-line results from the trial are expected by year’s end, Horizon Pharma said.
Under a separate agreement with an undisclosed third party, Horizon Pharma has licensed U.S., European, and Canadian intellectual property rights for interferon gamma-1b for Friedreich's ataxia—an indication for which the treatment is not approved.
In its deal with Boehringer Ingelheim, Horizon Pharma has agreed to pay €5 million ($5.6 million) upon signing, and €20 million ($22.4 million) upon closing of the deal.
The companies expect to close their transaction by the end of this year, subject to satisfaction of closing conditions.
Horizon Pharma added that it will immediately begin investing in related manufacturing, supply chain, regulatory, and commercial activities for interferon gamma-1b.
As a result, Horizon Pharma said, it anticipates a reduction to full-year 2016 adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) of approximately $10 million versus prior guidance. On February 29, the company issued guidance to investors forecasting EBIDTA of $505 million to $520 million, as well as net sales of $1.025 billion to $1.050 billion.
