Steady Thrombogenics must now deliver on Jetrea’s commercial promise

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ThromboGenics’ path towards US approval of Jetrea has seemed steady and reliable, providing the unsurprising newsflow that keeps investors happy, as reflected by a doubling of its share price since reporting positive pivotal trial data. The big test now comes: can it deliver in the marketplace?

Given that this will become ThromboGenics’ first marketed product, early sales numbers will be closely watched to determine how well the Belgian group has planned its commercial rollout. With surgery the alternative treatment, pricing will no doubt be an important determinant to Jetrea’s launch trajectory, as will success in achieving coverage and reimbursement from payers.

Broad label

The FDA gave on-time approval to Jetrea, known generically as ocriplasmin, for the condition vitreomacular adhesion (VMA). With normal ageing, the gel-like vitreous of the eye liquefies and separates from the retina. If the separation is incomplete, it can cause pulling, or traction, on the retina that distorts vision and causes damage, including macular puckers and holes.

Surgical removal of the vitreous has been the usual practice. Jetrea is an intravitreal injection that dissolves proteins that cause the traction and allow for normal separation.

In a pooled analysis of two pivotal trials it resolved 26.4% of VMA cases within 28 days, significantly more than the 10.2% seen in patients injected with a placebo. In addition, the trials also showed that significantly more patients injected with Jetrea saw resolution of macular holes.

The approved indication for Jetrea specifies only VMA without mention of macular holes. However, analysts from Nomura Code stated that the product would probably be used to treat the perforations based on the strong clinical trial data. A decision in Europe, where Novartis holds rights, will come in the first half of 2013; ThromboGenics will be eligible for a €90m ($118m) milestone on approval.

The Belgian company's shares were up 5% to €38.71 in mid-afternoon trading.

Commercial plans under way

Chief executive Patrik De Haes told analysts today that the company was bringing on board a US sales and marketing force of 70 people, including 30 sales representatives and 15 reimbursement specialists, a process that is being managed by Quintiles. Assisting reimbursement will be important during 2013 as an early-year launch will mean that the drug will go about a year without a J code for billing purposes, requiring physicians to use a miscellaneous code that will undergo greater review from payers.

The price will be an important factor in persuading retinal specialists to consider Jetrea, given that the alternative is surgery. Mr De Haes would not commit to a specific number other than to say that this would be above $3,000 in the US and €2,000 in Europe, a number supported by studies conducted by Novartis and a price that probably will be well below the cost of any surgery.

However, an important consideration for physicians will be the success rate. Nearly three quarters of patients did not see resolution of VMA in clinical trials – although these had somewhat short-term follow-up of 28 days – and thus many of those will proceed onward to surgery regardless of pharmaceutical treatment. Clinical experience will thus have an impact on ophthalmology specialists’ view and will no doubt affect the launch trajectory.

That may help explain some rather differing views of Jetrea’s potential, with Jefferies forecasting peak sales of $875m and Nomura Code $250m. In a note this morning, analysts from Nomura Code said the company’s market capitalisation of €1.33bn was not supported by the peak sales forecast; the bank has a “sell” rating on the stock and a price target of €26. Jefferies has a target of $40 and forecasts worldwide revenue at €293m ($383.2m) in 2016.

As with many first products launched by biotechs, the launch trajectory will be closely watched and could cause wild swings in the share price. Mr De Haes told analysts that initial sales numbers would probably not be announced until it reports financial results for the first six months of 2013 next August; investors will be holding their breaths until then.

To contact the writer of this story email Jonathan Gardner in London at jonathang@epvantage.com

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