AB Science SA (AB) failed to win backing from a European Union advisory panel for masitinib to treat intestinal tract cancers, a setback in its plan to expand use of a medicine currently applied only on dogs. The shares plunged.
Masitinib was rejected by the European Medicines Agency’s Committee for Medicinal Products for Human Use to treat gastrointestinal stromal tumors that are resistant to first-line treatments, the Paris-based company said in a statement late yesterday. AB Science said it will appeal the decision. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation.
“AB Science will continue to work with the CHMP to respond to the pending concerns to reach positive consensus and obtain conditional approval” of the medicine, the French company said. The appeal should lead the CHMP to deliver a second opinion in 2014, it added.
AB Science shares lost as much as 31 percent today, the steepest intraday decline since the company’s initial public offering in April 2010. The stock was trading at 16.31 euros, down 14 percent, as of 1:10 p.m. in Paris.
Masitinib targets mast cells, which help govern immunity, and kinases, a type of enzyme that plays a role in the growth of cancerous cells. The company, led by Chief Executive Officer Alain Moussy, has said the medicine shows promise in other types of cancer as well as asthma and multiple sclerosis.
Gastrointestinal stromal tumors, also known as GIST, are cancers of the digestive system that affect 15 new patients per one million each year, according to AB Science. The company has also filed for EU approval of masitinib as a treatment for pancreatic cancer.
AB Science, which was founded in 2001, sold shares to the public in an initial public offering in 2010. As of yesterday’s close, the stock had climbed 50 percent since the IPO.
Masitinib is also being tested in rheumatoid arthritis, multiple sclerosis and asthma.
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