Filings In The Second Half Could Be Transformative For The Medicines Co.

The Medicines Co.’s transition away from near-total reliance on Angiomax seems ever closer to reality, given its full pipeline and intensive business development activities. The new products stretch beyond the hospital catheterization lab, as the company builds franchises in hospital anti-infectives, pain management, and hemostatis.

The Medicines Company is in the midst of a transition in 2013 and 2014. With five new drugs either under regulatory review or close to filing in the U.S. and European Union, as well a pending decision on whether to exercise an option to buy biotech ProFibrix BV, the company’s near-total reliance on hospital anti-coagulant Angiomax (bivalirudan) is coming to an end.

The company continues to concentrate on one of the toughest, albeit fastest evolving, healthcare markets-- acute and intensive care conditions treated in hospitals--even as it expands its scope within that remit. The extent of the company’s activities came into focus during its half-year earnings call on July 24, when CEO Clive Meanwell pointed out, “Our portfolio includes more compounds with successful Phase III clinical data readouts than any hospital biopharmaceutical company in the world.”

If all goes well over the next year or two, The Medicines Co. expects to introduce five new drugs. It’s planning worldwide launches of cangrelor, a rapid-acting intravenous antiplatelet; oritavancin, an anti-infective; and Ionsys, a patient-controlled analgesia system. In Europe and Asia, it also plans to market Cleviprex (clevidipine), a calcium channel blocker, and Recothrom (topical recombinant thrombin).

The company also will decide whether to acquire ProFibrix in the next few weeks, pending results of a recently completed Phase III study for Fibrocaps (fibrinogen/ thrombin), a topical fibrin sealant to stop bleeding during or after surgery (Also see "TMC Likes Its Options: Hospital Marketer Gains Rights To ProFibrix" - Pink Sheet, 4 Jun, 2013.). Fibrocaps would complement Recothrom, which is for milder surgical bleeding. “If we go forward, and we’re optimistic that we will, then that adds another successful post-Phase III asset to our portfolio,” Meanwell said, pointing out that Fibrocaps contributes to the hemostasis franchise that the company recently started building with the addition of Recothrom and Cleviprex. Meanwell would not say what factors will determine whether it acquires ProFibrix [See Deal].

Following release of positive results from a second Phase III trial, the company also is preparing for global regulatory submissions for oritavancin, an antibiotic for resistant Gram-positive skin infections (Also see "The Medicines Co. Prepares To Move Into New Commercial Territory" - Pink Sheet, 3 Jul, 2013.). Global peak sales for the drug could reach at least $400 million, said President and CFO Glenn Sblendorio. The company expects to file an NDA in the U.S. in the fourth quarter of 2013 and an MAA in the EU in the first half of 2014. While the initial indication is for acute bacterial skin infections, it is looking at the antibiotic’s use in other Gram-postive infections, including prosthetic joint infections, bacteremia, anthrax, and, potentially, Clostridium difficile.

On July 1, the company announced FDA acceptance of its filing for cangrelor, its rapid-acting intravenous antiplatelet drug for patients undergoing percutaneous coronary intervention and for bridging from oral anti-platelets to surgery. It also expects to file an MAA for this drug in the EU in late 2013, putting it on track with the timelines it announced earlier this year (Also see "The Medicines Co.’s Cangrelor’s Full CHAMPION PHOENIX Results Bode Well For Filing" - Pink Sheet, 19 Mar, 2013.). Cangrelor could become a $450 million product, globally at peak, Sblendorio told analysts.

The Medicines Co. is likely to submit Ionsys, the pain medication system it obtained when it bought Incline Therapeutics Inc. in late 2012, for U.S. regulatory filing in the first quarter of 2014, and in EU in the second quarter of that year. The system was approved in both the U.S. and EU and sold in 12 European territories, but was recalled in 2008. Regulatory authorities are seeking more data around comparability, reliability, and stability of the two-part system. Executives didn’t provide details, except to say they are “making progress.”

The Medicines Co. executives briefly discussed the company’s early-to-mid-stage pipeline, noting its global alliance with Alnylam Pharmaceuticals Inc. for development and commercialization of Alnylam’s RNAi treatment for hypercholesterolemia is proceeding according to plan [See Deal]. The Medicines Co. will provide more details at its analyst meeting in New York on Oct. 10.

Moving Away From Dependence On Angiomax

Facing a problem common to the industry—heavy dependence on one drug, which faces near-to-mid-term patent expiration, The Medicines Co. has spent the past year engaged in intensive business development. This has broadened its reach beyond Angiomax’ core market, the hospital catheterization lab. In addition to the hemostasis franchise, which was jumpstarted by a 2012 deal with Bristol-Myers Squibb to sell Recothrom, the company is also branching out into hospital anti-infectives and pain relievers (Also see "Everyone Wins In Deal Between BMS And The Medicines Co." - Pink Sheet, 12 Dec, 2012.). The Recothrom deal is for two years, and includes the transfer of 85 BMS employees to The Medicines Co. It also gives The Medicines Co. an option to buy the drug outright.

Angiomax’s U.S. sales grew 14% to $269.3 million in the first half of 2013 year on year, reflecting an even divide between increases in both price and utilization; its international sales grew 10% to $24.8 million. “In the U.S., as long as the product has exclusivity, it’s going to grow, not only because of high-risk coronary patients, but also the work we’re doing in peripherals,” said Meanwell. Angiomax faces generic competition in the U.S. beginning in 2019 at the latest, based on a settlement agreement with generics maker APP Pharmaceuticals Inc., a subsidiary of Fresenius Kabi AG[See Deal]. Even in Europe, where the key patents protecting the drug expire in August 2015, “there’s plenty of business left on the table,” he said.

About 60% of all percutaneous coronary interventions in the U.S. are now performed with Angiomax, including more than 46% of all high-risk U.S. heart attack patients undergoing primary PCI—a doubling of market share in that segment in the last four years, said Sblendorio. Near-term new hospital solutions will start driving revenue growth in 2014, led by oritavancin.

Recothrom sales were $26.5 million in the same period. Total half-year sales for The Medicines Co. were $328.6 million, up 25% from the same period in 2012. Guidance for the full year is unchanged since the beginning of the year, constituting a sales increase of 20% to 22% compared to 2012, Sblendorio said.