ThromboGenics NV and its partner, the Alcon unit of Novartis AG, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Jetrea (ocriplasmin) as a treatment for vitreous macular traction, paving the way for a European launch in the second quarter.

That move would trigger a €90 million (US$120 million) milestone payment to Leuven, Belgium-based ThromboGenics and provide it with even greater financial muscle as it starts to consider new deal possibilities that would broaden its footprint in ophthalmology. The company had €168.6 million cash on its balance sheet on Sept. 30.

Jetrea's progress has prompted market speculation that Basel, Switzerland-based Novartis might make a move for ThromboGenics. There is no such offer on the table, Patrik De Haes, CEO of ThromboGenics, told BioWorld Today, and the company's agreement prevents Novartis from making a hostile bid for the company.

The positive opinion covers the use of Jetrea for treatment of patients with vitreous macular traction (the condition is called vitreous macular adhesion in the U.S.), including those with a macular hole up to 400 microns in diameter. Macular hole was not explicitly included in the FDA label, following the drug's U.S. approval last year. (See BioWorld Today, Oct. 19, 2012.)

"The only difference is in Europe, a rep can talk about macular holes," De Haes said. Friday's news provided a neat bookend to the week, as ThromboGenics launched Jetrea in the U.S. last Monday. The first patients were treated at the Wills Eye Institute in Philadelphia, which previously participated in Jetrea's pivotal trial program.

Jetrea, a truncated form of the serine protease plasmin, breaks down the residual fibrous connections that form when the vitreous gel contracts. If untreated, the adhesions can cause visual distortion and retinal damage.

In the U.S., the drug, which is administered as a single intravitreal injection, is priced at $3,950 per vial. ThromboGenics commissioned market research, which suggested that a price as high as $6,000 could have been acceptable, but it made a "judgment call" on the basis of its discussions with the physician community. "We listened to the market," De Haes said. "There are numerous examples of companies that basically followed their data and did not fare very well."

ThromboGenics has assembled a U.S. commercialization arm numbering around 50 personnel, including 30 sales reps and 15 reimbursement executives. Their immediate target audience is the 2,000 retinal specialists in the U.S. Although awareness of the drug is already high, the company wants to ensure that they are fully appraised of the drug's potential. "We know the sweet spot of this drug," De Haes said.

"The more traction on the retina, the better the response," he noted.

Does promoting one product represent enough work for an organization of this scale? "In the short term there is more than enough work available," De Haes said. Getting specialists acquainted with the product over the next three years is crucial. "If they haven't touched the product in the first three years, they may never touch it," he said.

In the medium term, the company is interested in doing deals that would broaden its pipeline. "What is most interesting to us is a co-development deal," De Haes said. Alternatively, it might in-license an interesting asset. Its least favorite option is to acquire a company in order to gain access to an attractive asset. "We want to keep it simple," he said.

ThromboGenics' focus will remain on ophthalmology and, within that field, on back-of-the-eye diseases. Part of it – notably wet age-related macular degeneration (AMD) – is already quite a crowded market. De Haes sees more potential in dry AMD, for which no therapies or surgical interventions exist. "We're talking about the holy grail of course," he said. It is also complicated, however. "It's a preventative situation."

Diabetic retinal diseases are also of interest, including diabetic retinopathy. Jetrea has already completed a Phase IIa trial in that indication, but future plans for the product will depend on discussions with Alcon.

Shares in ThromboGenics (BRUSSELS:THR) closed Friday at €43.84, down 3.3 percent on the previous days close, as some investors decided to bank some profits. Should Novartis decide to table a bid, the market values the company at almost $1.6 billion at present. A buyer would, presumably, have to pay a little more.