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As of 8:04 PM 04/17/14 All times are local (Market data is delayed by at least 15 minutes).

merck & co. inc. (MRK) Key Developments

Merck & Co. Announces Food and Drug Administration Approves its New Tablet for Grass Allergies, Grastek, for Patients Five to 65 Years Old

Merck & Co. announced the Food and Drug Administration has approved its new tablet for grass allergies, Grastek, for patients five to 65 years old. Meant as an alternative to weekly allergy shots, the tablet dissolves under the tongue. Taken daily for a few years, it gradually reduces sensitivity to common grasses, instead of temporarily relieving symptoms including sneezing, runny nose, and itchy, watery eyes. The drug can cause severe allergic reactions and shouldn't be used by patients with severe asthma.

ALK Announces Food and Drug Administration Approval for Merck's Grass Sublingual Allergy Immunotherapy Tablet GRASTEK (GRAZAX)

ALK announced that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for Merck's grass sublingual allergy immunotherapy (SLIT) tablet GRASTEK(r). GRASTEK(r) is the US trade name of the grass SLIT-tablet which is licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX(r). GRASTEK(r) is an allergen extract. In the USA, GRASTEK(r) is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK(r) is approved for use in persons 5 through 65 years of age. GRASTEK(r) is not indicated for the immediate relief of allergic symptoms. ALK's partnership with Merck covers the development, registration and commercialization of a portfolio of sublingual allergy immunotherapy tablets in North America. GRASTEK(r) is the first of these products to be approved by the FDA and, following today's approval, Merck is expected to move ahead with its launch plans. The FDA is currently also reviewing Merck's BLA for a SLIT-tablet against ragweed allergy (RAGWITEK(tm)). Following a positive recommendation from the FDA's Advisory Committee in January, a decision by the FDA is expected in second quarter of 2014. The US approval of GRASTEK(r) entitles ALK to a milestone payment from Merck. Consequently, ALK is updating its financial outlook for 2014. The milestone payment will be booked as revenue from SLIT-tablets in North America and ALK now expects operating profit (EBITDA) to be DKK 375-400 million (previously 300-400) before special items, income from product supply, and potential sales royalties in North America. The higher end of this range assumes one additional product development milestone payment from Merck.

Julphar Signs Five-Year Deal with Merck

Julphar announced that it has signed a five-year licensing deal with global healthcare provider MSD (Merck in the U.S and Canada). Under the agreement, Julphar will have exclusive rights to produce, market, distribute and sell certain MSD medicines in UAE, Kuwait, Bahrain, Oman, Qatar and Iraq. Julphar will manufacture some MSD products for the first time in UAE, including therapies for diabetes, asthma, allergy, pain and inflammation. Both companies will seek the relevant authorities' prior approvals on registration and production of the products locally.

Merck Announces Results from Studies Evaluating Investigational Hepatitis C Treatments

Merck announced additional data from the ongoing C-WORTHy study, a multi-arm Phase 2 clinical trial evaluating the efficacy and safety of a once-daily, all-oral regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor, among patients with chronic HCV Genotype 1 infection (GT1). In an interim analysis of treatment-naïve, non-cirrhotic patients administered a 12-week regimen of MK-5172/MK-8742, with and without ribavirin (RBV), a sustained viral response (SVR) was observed in 98% (42/43) of patients administered MK-5172/MK-8742 alone and 94% (75/80) in those administered MK-5172/MK-8742 plus RBV. These data were presented, along with data on an 8-week regimen, at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress 2014, in London, UK. The interim results presented were from treatment-naïve, non-cirrhotic patients who received one of 3 regimens: A) MK-5172/MK-8742 + RBV for 8 weeks (N=30), B) MK-5172/MK-8742 + RBV for 12 weeks (N=85), and C) MK-5172/MK-8742 (without RBV) for 12 weeks (N=44). Among the five patients who relapsed in the eight-week regimen arm of PN035B, two patients had very low MK-5172 and MK-8742 levels during the course of therapy. The relationship between this finding and the relapse is being investigated. The most common adverse events recorded in the RBV and RBV-free treatment groups, respectively, were fatigue (32%, 23%), headache (20%, 33%), nausea (21%, 16%), diarrhea (13%, 9%) and insomnia (13%, 7%). There were no early discontinuations due to drug-related adverse events and no clinically significant abnormalities detected in routine laboratory analysis of hematologic markers. Additionally, new data from PN038, a Phase 2 dose-ranging clinical trial evaluating MK-5172 once-daily with peginterferon alfa-2b and ribavirin (PR, weekly), were presented, evaluating SVR24 in treatment-naïve, non-cirrhotic patients with GT1 infection. PN038 is a Phase 2 clinical trial investigating the efficacy and safety of MK-5172 doses (25 mg, 50 mg, and 100 mg) once-daily with PR over a 12-week treatment cycle in GT1 treatment-naïve, non-cirrhotic patients (n=87). The analysis presented was ITT, in which all patients who did not achieve SVR (including those who dropped out for non-virologic reasons), were recorded as failures.

Merck & Co Signs UAE Partnership Agreement with Julphar

Merck & Co has signed a licensing agreement with United Arab Emirates-headquartered Julphar. The agreement gives Julphar exclusive manufacturing, distribution, and marketing rights to a number of Merck & Co's medicines in Bahrain, Iraq, Kuwait, Oman, Qatar, and the UAE. The exact products to be included in the agreement have not been announced, but both companies hint that they may cover various therapeutic areas including allergy, asthma, diabetes, and pain and inflammation.

 

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