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News Breaks
April 7, 2014
08:09 EDTALNY, MRKAlnylam's McSwiggen patent upheld in European opposition proceedings
Alnylam (ALNY) announced that the European Patent Office has upheld the McSwiggen EP 1423406 patent in oral opposition proceedings in Munich, Germany. The McSwiggen patent estate describes chemical modifications of RNAi therapeutics that the company believes are critical for achieving “drug-like” properties in siRNA, the molecules that mediate RNAi. The patent is owned by Alnylam, and was recently obtained through the company’s acquisition of Sirna Therapeutics from Merck (MRK). The McSwiggen patent family comprises a core component of Alnylam’s overall intellectual property estate for the advancement of RNAi therapeutics as a new class of medicines.
News For ALNY;MRK From The Last 14 Days
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October 1, 2014
11:34 EDTMRKMerck completes sale of Consumer Care business to Bayer $14.2B
Merck (MRK) said it has completed the previously announced sale of the Merck Consumer Care business to Bayer (BAYRY). Bayer will acquire Merck’s existing over-the-counter business, including the global trademark and prescription rights for CLARITINTM and AFRINTM, for $14.2B or approximately $9B in after-tax proceeds, less customary closing adjustments as well as certain contingent amounts held back that will be payable upon the manufacturing site transfer in Canada and regulatory approvals in Mexico and Korea. In conjunction with this transaction, Merck has also entered into the previously announced worldwide collaboration between the companies to develop and commercialize soluble guanylate cyclase modulators. This collaboration includes Bayer’s ADEMPASTM. The collaboration also includes opt-in rights for other early-stage sGC compounds in development by both companies. Merck will be making an upfront payment of $1B in connection with the sGC collaboration.
08:06 EDTALNYAlnylam initiates EXPLORE trial
Alnylam Pharmaceuticals and collaborators from the American Porphyria Consortium and The European Porphyria Network have initiated the EXPLORE trial, a prospective observational study of patients with hepatic porphyrias, including Acute Intermittent Porphyria, Variegate Porphyria, and Hereditary Coproporphyria, suffering from recurrent attacks. With this study, Alnylam and clinical investigators aim to learn more about the clinical course, management, and disease burden of patients with hepatic porphyrias that suffer from recurrent attacks. Alnylam is currently advancing ALN-AS1, a subcutaneously administered investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of hepatic porphyrias, and expects to file an IND or IND equivalent in late 2014 or early 2015. EXPLORE is a prospective, multi-center observational study designed to enroll up to 100 patients with hepatic porphyrias and a history of recurrent attacks. The study’s primary objective is to characterize the natural history, clinical management, and disease burden of patients with hepatic porphyrias. The study’s secondary objectives are to further characterize a number of disease features of hepatic porphyrias, including: (i) signs and symptoms of porphyria during acute attacks; (ii) levels of plasma and urinary aminolevulinic acid and porphobilinogen, the toxic intermediates of the heme biosynthesis pathway that cause the symptoms and disease pathology of the acute hepatic porphyrias; (iii) expression levels of aminolevulinic acid synthase-1 during acute attacks; and (iv) medical and family history of hepatic porphyria patients. Data obtained from EXPLORE are expected to further the understanding of hepatic porphyrias and to assist the design of clinical trials with ALN-AS1.
07:28 EDTALNYLeerink to hold a roundtable
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September 30, 2014
16:39 EDTMRKCMS discloses drug makers' payments to doctors, WSJ says
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08:16 EDTMRKTetraphase price target raised to $32 from $20 at JMP Securities
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September 29, 2014
07:26 EDTMRKInforma Business Information to hold a conference
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05:44 EDTMRKMerck announces early data from investigational use of KEYTRUDA
Merck announced the first presentation of data on the investigational use of KEYTRUDA, the company’s anti-PD-1 therapy, in PD-L1 positive, advanced urothelial cancer. The early findings presented showed a confirmed overall response rate of 24% with KEYTRUDA as monotherapy, as measured by RECIST v1.1, central review including a complete response rate of 10%. At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64% of patients screened had tumors that were determined to be positive for PD-L1 expression.
September 28, 2014
12:53 EDTMRKMerck announces first presentation of data on investigational use of KEYTRUDA
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September 26, 2014
08:31 EDTMRKLigand, Merck receive approval for NOXAFIL
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07:32 EDTALNYBioCentury to hold a conference
21st Annual NewsMakers in the Biotech Industry Conference to be held in New York on September 26.
September 24, 2014
08:08 EDTALNYAlnylam initiates DISCOVERY trial
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September 23, 2014
07:33 EDTMRKOphthotech names Michael Atieh as EVP, Chief Financial and Business Officer
Ophthotech Corporation (OPHT) announced that Michael G. Atieh has been named EVP, Chief Financial and Business Officer and Treasurer effective September 30. Atieh replaces Bruce A. Peacock, Chief Financial and Business Officer and Treasurer, who has notified the company of his intention to retire effective September 30. Atieh spent the majority of his career in the pharmaceutical industry with Merck and Co (MRK), where he held various senior level positions over a 20 year period including Senior Vice President-Merck Medco Managed Care, Vice President-U.S. Human Health, Vice President-Public Affairs, Vice President-Government Relations, and Treasurer.
September 22, 2014
06:51 EDTMRKMerck to host conference call
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September 18, 2014
08:48 EDTMRKNeogen's dairy genomic program to be marketed by Merck
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07:49 EDTALNYAlnylam resumed with an Outperform at Leerink
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September 17, 2014
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

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