Interview – Medicines Company looks away from the hospital bed

The Medicines Company has built its business on agents used on hospitalised patients suffering from acute infections or cardiovascular episodes. But its recent splash with the high-cholesterol agent ALN-PCSsc revealed an interest in projects aimed at keeping patients out of the hospital too.

Such a change in focus also might suggest a change in corporate strategy, but chief executive Clive Meanwell sees ALN-PCSsc as a product that can be sold by a hospital-based sales force. “The crossroads of all this is the hospital,” Mr Meanwell tells EP Vantage. “If you are unlucky enough to have an event without being detected in primary prevention, the first time you’re going to know it is on the way to the hospital in an ambulance.”

Replacing Angiomax

The Medicines Company in-licensed ALN-PCS as an intravenous agent from Alnylam Pharmaceuticals in 2013, at a time when the New Jersey-based group was contemplating a huge hit on its profit margins beginning this year with Angiomax’s patent expiry – Hospira, set to become part of Pfizer by year end, launched the first generic in July (Medicines Company braces for 2015 with Alnylam PCSK9 deal, February 4, 2013).

The company’s response has been to throw itself into R&D – $628m in the past five years. This effort has generated wins with approval of the skin-infection treatment Orbactiv in 2014, and the blood-thinner Kengreal and fentanyl patch Ionsys in 2015; phase III readout of its urinary tract infection drug carbavance is due in 2016.

None of these has the sellside speaking of blockbuster potential as it does with ALN-PCSsc – quite bullish talk given that the partners reported only phase I data for the subcutaneous formulation at the European Society of Cardiology meeting in London last week. The Medicines Company is now assuming responsibility for the clinical programme with the initiation of the Orion phase II trial by the end of this year, followed by pivotal studies beginning in 2017.

As a product, ALN-PCSsc represents a different clinical proposition versus small-molecule agents Kengreal or Angiomax before it. For one, it is an RNA interference project, seeking to inhibit synthesis of PCSK9, a protein that binds to receptors of low-density lipoprotein (LDL), or “bad cholesterol", reducing metabolism of LDL and increasing its plasma concentrations.

This pathway is being addressed by Sanofi and Regeneron Pharmaceuticals' Praluent and Amgen’s Repatha, the recently launched antibodies that bind to PCSK9. ALN-PCSsc works upstream from those agents.

Obviously, the competition will be Repatha and Praluent, and the group has already declared that the phase III will include a comparator arm against one of these drugs. Where the Medicines Company intends to differentiate is on dosing – based on duration seen in phase I, the group talks hopefully of twice-yearly injections, where Praluent is taken once every two weeks and  Repatha every two weeks or monthly (ESC – PSCK9 space may need to make room for RNAi, August 31, 2015).

In addition, Mr Meanwell also hints at some level of price competition when he noted that the production costs of the RNAi are less than that of an antibody.

Dosing advantage?

But on dosing Mr Meanwell could be on to something. Certainly, Eylea contributed to Lucentis’s loss of market share in wet age-related macular oedema by reducing the number of jabs patients have to endure, and he makes the case that this offers an opportunity to help patients manage their cardiovascular disease by having them attend appointments to receive their injections.

“You change adherence. That’s a notoriously difficult problem for people who are asymptomatic,” he says. “If you can carry people through their adherence journey you’re going to save more lives and reduce more heart attacks, and that’s measurable.”

But does it necessitate expanding the company’s playing field beyond the walls of a hospital? On this point Mr Meanwell is fairly clear.

“Amgen have got 800 reps in the US. It’s not what people think. People tend to think it’s 3,000-5,000 salespeople,” he says. “In the US, it is not out of the question that we can sell ourselves. Ex-US, you would probably partner.”

To get ALN-PCSsc over the clinical finishing line, however, Mr Meanwell is less certain how the company will finance the trials, and that will depend on what the likely patient totals are – and he hinted at a potential financing round if they turn out to be big.

“Can we afford to develop a drug like this as a small company? If it’s 5,000 patients then yes, because it’s $200m. If it’s 100,000 patients then somebody needs to lean in and help us,” he says.

“With a market this size, is the financial community going to be interested in financing this with us? Probably. I wouldn’t be too shy about asking financial institutions to come be part of the innovation cycle and invest.”

To contact the writer of this story email Jonathan Gardner in London at jonathang@epvantage.com or follow @ByJonGardner on Twitter

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