Sycrest News and Research

RSS

Merck reports $342 million net income for 2010 third quarter

Merck & Co., Inc. today announced financial results for the third quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.85, which excludes purchase accounting adjustments, restructuring costs, merger-related expenses and a $950 million legal reserve.

29 Oct 2010

Lundbeck, Merck announce commercialization agreement for SYCREST sublingual tablets

H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST in the European Union (EU), where it is already approved, at the beginning of 2011.

12 Oct 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

Merck reports strong bottom-line performance in second quarter

Merck & Co., Inc. today announced financial results for the second quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the second quarter of $0.86, which excludes purchase accounting adjustments, merger-related expenses, restructuring costs and the gain on AstraZeneca's asset option exercise. Second-quarter GAAP EPS was $0.24.

2 Aug 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Emerging oral atypical antipsychotics to compete in increasingly crowded schizophrenia drug market

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the world's major pharmaceutical markets, emerging oral atypical antipsychotics will compete against each other and against established drugs for the same niche patient population in the treatment of schizophrenia.

24 Feb 2010

Final results of SAPHRIS clinical study released

Schering-Plough Corporation today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study.

14 Sep 2009

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

2 Jun 2009