Angiomax Patent Decision, Seven Possible Approvals Mean Catalytic Year For The Medicines Co.

While readying an appeal to a patent ruling benefiting Hospira’s efforts to introduce an Angiomax generic, the hospital-care specialist has several drugs nearing regulatory decisions in the U.S. and Europe.

The near-term future for The Medicines Co. will fall on two primary factors – outcome of a patent dispute regarding top-seller Angiomax and seven pending drug approvals in the U.S. and Europe.

TMC already has won a dispute with Mylan NV over the validity of patents protecting Angiomax (bivalirudin), an anticoagulant that brought in $635.7 million in worldwide sales last year, up 4.5% from 2013, including $599.5 million in the U.S., up $49.3 million year-over-year.

But while two patents for the direct thrombin inhibitor challenged by Hospira Inc. have been upheld, the court also ruled that Hospira was not infringing TMC’s patents (Also see "Angiomax Generic From Hospira Might Launch At-Risk Launch In 2015" - Pink Sheet, 1 Apr, 2014.). An appeal will be heard in March, with a decision expected one to six months after oral arguments are heard, President and Chief Financial Officer Glenn Sblendorio said during the firm’s Feb. 18 earnings call.

At stake is whether competitors could introduce generic versions of bivalirudin in the U.S. by the middle of this year.

Because of the uncertainty around earnings for Angiomax, which contributed more than 80% of TMC’s product revenues in 2014, the company did not provide financial guidance for the coming year. Sblendorio said the scenarios resulting from positive or negative outcomes of the Hospira ruling appeal could vary too greatly for guidance to offer much value at present.

“If we are fortunate and are able to keep Angiomax beyond June of 2015, obviously that is very positive for the company. It shows a whole different revenue growth profile. And, in fact, things that we would do around cost, we would not do, whether that's reduction of headcounts or slowing programs down,” the exec said.

“In the situation where it was a negative decision, that would trigger, obviously, other decisions around cost structures and possibly people and the deployment of people around different programs,” he continued. “So, we thought, rather than put out a complex matrix of different scenarios, the best thing would be to wait … and provide that clarity and guidance once we had a decision.”

Commercial, Pipeline Aspirations

Beyond Angiomax, TMC hopes to spur growth by building the market for Cleviprex (clevidipine), an injectable anti-hypertensive intended for when oral blood pressure medications are not advisable, and by obtaining U.S. and EU approvals of cangrelor, Raplixa (dry powder topical formulation of fibrinogen and thrombin) and Ionsys (fentanyl iontophoretic transdermal system), all currently under review at both FDA and the European Medicines Agency. TMC also could obtain U.S. approval this year of a reformulation of the gram-positive antibiotic Minocin (minocycline), which could enable smaller volumes of infusion, Chairman and CEO Clive Meanwell told the earnings call.

Cleviprex, Minocin and three other products brought in a combined $24.3 million in 2014, so TMC has much riding on those pending approvals and launches, as well as increasing sales of Cleviprex. Meanwell said that despite the uncertainty around Angiomax, the company is not stinting on supporting those R&D and commercial efforts.

“We are not slowing down our R&D expenditures. We’re not necessarily saying what they are right now, because without the rest of the guidance, it doesn’t make much sense,” he explained. “But we are certainly pedal to the metal on all these programs because they’re extremely important value drivers for us.”

“I also don’t think we're skimping … when it comes to marketing and selling efforts around our launch products,” Meanwell added. “We’re very focused on driving growth there. So even in this first half of the year, we will not be shy to invest in these products.”

The year got off to a hopeful start when cangrelor (to be branded Kengraxal in Europe), Raplixa and the gram-positive antibiotic Orbactiv (oritavancin) all received positive recommendations for approval from the EU’s Committee for Medicinal Products for Human Use (CHMP) in January (Also see "European Obesity Market To Liven Up After CHMP Backs Saxenda" - Pink Sheet, 23 Jan, 2015.). Orbactiv was approved by FDA Aug. 6 to treat patients with acute bacterial skin and skin structure infections and launched in the U.S. during the fourth quarter (Also see "The Medicines Co. Joins Crowded Antibiotic Field With Q4 Orbactiv Launch" - Pink Sheet, 7 Aug, 2014.).

Raplixa, a surgical sealant product, was recommended by CHMP for approval as a supportive treatment in adults for whom standard surgical procedures are not sufficient to improve homeostasis.

Meanwell said TMC anticipates ratification of those three CHMP recommendations this year and that TMC envisions launching the products in Europe with a commercial partner. In a Feb. 18 note rating TMC shares “outperform,” Leerink Partners analyst Joseph Schwartz noted that TMC managed to maintain ex-U.S. sales for Angiomax in 2014 despite cutting back on its European infrastructure.

“Upside to our ex-U.S. sales estimates could come from [TMC] securing a partnership, which now seems more likely to us as the company could bundle multiple products in a deal,” he wrote.

Another AC Expected For Cangrelor

U.S. approval prospects for cangrelor, a quickly reversible small-molecule antiplatelet agent for use in cardiac stent procedures, are uncertain after FDA issued a “complete response” letter last May (Also see "FDA’s Cangrelor “Complete Response” Leaves Room For Approval Without New Trial" - Pink Sheet, 1 May, 2014.). Meanwell asserted that the CHMP positive opinion augurs a better result the second time around; TMC re-filed the NDA in late 2014 and second advisory committee review is expected in the second quarter.

Meanwell also reported that TMC is making progress on its commercial efforts for Cleviprex, Orbactiv and Minocin. For the latter two products, he noted that company’s “customer-facing resources” are working with 1,451 hospitals, including 1,008 that it regards as leading infectious disease centers domestically. TMC had engaged 827 of those hospitals as of a Nov. 5 investor day, a figure that has now reached 1,126, the CEO added.

For Cleviprex, TMC is seeing sales growth despite a minimal commercial effort so far, up 44% in 2014, Meanwell said. “We’re ramping up our field-based resources on Cleviprex as we speak, and we anticipate continued, perhaps accelerated, growth,” he said.

A change in acute stroke treatment protocols may benefit the drug, he added.

“There’s been a major change in the approach to, and outlook for, acute stroke treatment of late. And we, together with early-adopting experts and hospitals, believe that Cleviprex can play an important role in neuro-intervention procedures, as clinicians aim to operate in a strict bandwidth of blood pressure during the management of stroke. For these, and other neuro-intervention procedures, precise blood-pressure control, without overshoot to hypotension, is believed by these experts to be one of the keys to success.”