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Merck's pharma unit faces tougher 2017 as fertility boost recedes

Looks to new products to drive growth as fertility drug rivals return to market
Merck KGaA

A run of buoyant growth for Merck KGaA's fertility portfolio - driven by the withdrawal from the market of competitor products - is less likely to continue through 2017, according to the company.

Throughout 2016 Merck's Gonal-f fertility drug has benefited from reduced competition from Ferring's Bravelle range, which was pulled from the US market last year because of quality issues. In the third quarter Gonal-f grew 10% to €182m, a lower rate than in the prior two quarters.

Merck's chief financial officer Marcus Kuhnert said "at least one" withdrawn product has now been returned to the market and the company "does not expect … this accelerated growth momentum in 2017".

That's important because Gonal-f has buoyed Merck's healthcare unit in the face of declining sales for its two biggest products - injectable multiple sclerosis therapy Rebif (interferon beta-1a) and colorectal cancer therapy Erbitux (cetuximab) - which fell 5.5% to €436m and 1.9% to €219m, respectively.

Sales of another key product, the diabetes drug Glucophage (metformin) are also in decline, falling 13.5% to €89m in the third quarter, and Merck is now looking to its pipeline to deliver new products that will push growth.

Top of that list is oral MS therapy cladribine, which was submitted for approval in the EU in June, and according to Kuhnert is proceeding through regulatory review as expected. The company said recently it expects to see €2bn in revenue from new launches between 2017 and 2022, with a new product or indication launch every year.

A large chunk of that increase is expected to come from Pfizer-partnered PD-L1 inhibitor avelumab, which is in phase III trials for several types of cancer, as Merck's only other late-stage candidate is a biosimilar version of AbbVie's TNF inhibitor Humira (adalimumab). Last year, Merck abandoned plans to seek approval of evofosfamide in advanced soft tissue sarcoma and pancreatic cancer after phase III study failures.

Meanwhile, Merck suffered a setback in its mid-stage pipeline recently after its systemic lupus erythematosus (SLE) candidate atacicept failed to meet its objectives in a clinical trial, although it did show efficacy in a subgroup of patients with high disease activity.

"We are currently in consultations with the regulatory authorities and the scientific advisors to decide upon concrete next steps" for that programme, said Kuhnert.

Overall, Merck reported 19% group sales growth to €3.7bn - driven largely by its acquisition of chemicals business Sigma-Aldrich - and the company has raised its earnings forecasts for the year.

Article by
Phil Taylor

16th November 2016

From: Sales



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