(Bloomberg) -- The chief executive officer of Camurus AB says he expects to grab a tenth of the market for treating victims of the U.S. opioid epidemic and to reach $1.4 billion in sales with partner Braeburn Pharmaceuticals.
Camurus’s CAM2038 is an injectable solution that slowly releases buprenorphine -- the most common drug used to treat opioid addiction -- into the body, eliminating the need for daily dosages as well as the risk of the substance making its way onto the black market.
After gaining approval in the European Union last month, Camurus CEO Fredrik Tiberg expects the U.S. Food and Drug Administration to follow shortly. The FDA has scheduled a decision for Dec. 26.
“I am positive and optimistic,” Tiberg said in a phone interview. “We have just received approvals in the EU and Australia, and the prospects for U.S. approval should be even better.”
The company is currently preparing to launch the drug in the first European markets as early as January, and expects “substantial” sales of the treatment during 2019, though it will take three to six months to ramp up.
In the long term, a U.S. market share of 10 percent of the number of patients treated, or about $1.4 billion in annual sales, is a realistic goal, Tiberg said. With those sales prospects, Camurus should be able to generate positive results by 2020, which will enable it to finance the development of its other medicines.
Camurus has a distribution agreement with Braeburn for the U.S. market, and can expect a $35 million milestone payment if the FDA approves CAM2038. Braeburn will also give the company a “mid-teen” percent of product sales in royalties.
The U.S. market for treatment of opioid addiction is currently dominated by Indivior PLC’s Suboxone, a film placed under the tongue once a day. The advantage of treatments such as CAM2038 is that the patient gets continuous treatment without running the risk of missing doses and without having to visit clinics between injections.
“That gives the patient more freedom and enables him or her to lead a normal life instead of focusing on medication,” Tiberg said. “The combined consequences are huge.”
Opioid addiction has surged in the U.S. since the 1990s, when prescription drugs such as OxyContin and Vicodin became a common remedy for a number of conditions. Last year, more than 47,600 Americans died from overdosing on opioids. About 2.5 million people have been diagnosed with opioid dependence in the U.S., and almost one million are receiving treatment.
While most treatments today are taken in daily doses, the use of long-acting injections are expected to increase in coming years. Compared with a similar treatment marketed by Indivior, Tiberg said that CAM2038, which will be sold as Buvidal in Europe, has advantages in flexibility. Injection volumes are lower, it can be taken weekly as well as monthly and can be administered in different parts of the body.
--With assistance from Niklas Magnusson.
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