Key Developments: Merck & Co Inc (MRK)

MRK on New York Consolidated

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24 Oct 2014
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Latest Key Developments (Source: Significant Developments)

US FDA accepts for review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine
Monday, 20 Oct 2014 08:00am EDT 

Merck & Co Inc and Sanofi Pasteur:Says the Biologics License Application (BLA) filed for the companies` investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA).Says data from a Phase III study for the investigational pediatric hexavalent vaccine were recently presented at IDWeek in Philadelphia.Says this phase III study, a randomized, open-label, active-comparator controlled clinical trial with more than 1,400 infants at multiple centers across the United States, evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines.Says the partnership between Merck and Sanofi Pasteur draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines.Sanofi Pasteur, is the vaccines division of Sanofi.  Full Article

Merck & Co. Inc prices 2.5 billion euros debt offering
Monday, 6 Oct 2014 12:28pm EDT 

Merck & Co. Inc:Priced 2.5 billion euros public offering of three series of Euro-denominated senior unsecured notes.Notes include: 1.0 billion euros of 1.125 pct notes due Oct. 2021.1.0 billion euros of 1.875 pct notes due Oct. 2026.500 million euros of 2.500% notes due Oct. 2034.Intends to use all or substantial portion of net proceeds from offering of New Notes to purchase notes and debentures that are validly tendered in connection with tender offers launched by company for certain outstanding notes and debentures.If there are net proceeds remaining after tender offers, company intends to redeem in whole or in part, 4 pct Notes due 2015 and 6 pct Senior Notes due 2017.Any remaining net proceeds will be used for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.If net proceeds of offering for New Notes are insufficient to pay for all of notes and debentures acquired by company in the tender offers, company will fund any additional amounts from cash on hand, commercial paper borrowings or other amounts available to company.Offering is expected to close on Oct. 15.BNP Paribas, Deutsche Bank AG, London Branch and J.P. Morgan Securities plc are acting as active joint book-running managers for offering.Merrill Lynch International and The Royal Bank of Scotland plc are acting as passive joint book-running managers for offering.  Full Article

Merck announces proposed public debt offering
Monday, 6 Oct 2014 03:34am EDT 

Merck & Co. Inc:Announces the commencement of a public offering of three series of Euro denominated senior unsecured notes due 2021, 2026 and 2034.Intends to use all or a substantial portion of the net proceeds from the offering of the New Notes to purchase notes and debentures that are validly tendered in connection with tender offers launched by the company.Says if there are net proceeds remaining after the tender offers, the company intends to redeem in whole or in part, its 4.00 pct Notes due 2015 and 6.00 pct Senior Notes due 2017.Says any remaining net proceeds will be used for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.Says if the net proceeds of the offering for the new notes are insufficient to pay for all of the notes acquired by the company in the tender offers, the company will fund any additional amounts from cash on hand, commercial paper borrowings or other amounts available to the company.Says BNP Paribas, Deutsche Bank AG, London Branch and J.P. Morgan Securities plc are acting as the active joint book-running managers for the offering.Says Merrill Lynch International and The Royal Bank of Scotland plc are acting as the passive joint book-running managers for the offering.  Full Article

SANTEN PHARMACEUTICAL CO LTD completes to acquire ophthalmology assets from Merck & Co., Inc. (second time)
Thursday, 2 Oct 2014 03:00am EDT 

SANTEN PHARMACEUTICAL CO LTD:Completed to acquire ophthalmology assets from Merck & Co., Inc. (second time) with amount of 5.3 billion yen on Oct. 1.Plan disclosed on May 13 and the acquisition of first time was on July 2.  Full Article

Merck & Co Inc completes sale of consumer care business to Bayer AG for $14.2 bln
Wednesday, 1 Oct 2014 11:30am EDT 

Merck & Co Inc:Completes previously announced sale of the Merck Consumer Care (MCC) business to Bayer AG.Effective Oct. 01, Bayer will acquire Merck's existing over-the-counter business, including the global trademark and prescription rights for CLARITIN and AFRIN, for $14.2 bln or about $9 bln.  Full Article

Merck & Co Inc announces first presentation of data on investigational use of keytruda (pembrolizumab) in patients with advanced gastric cancer
Sunday, 28 Sep 2014 03:15am EDT 

Merck & Co Inc:Announced first presentation of data on investigational use of KEYTRUDA (pembrolizumab) - the company's anti-PD-1 therapy - in PD-L1 positive, advanced gastric cancer.Early findings presented showed an overall response rate (confirmed and unconfirmed) of 31 pct. with KEYTRUDA as monotherapy, as measured by investigator assessed, RECIST v1.1 (n= 12/39: 95 pct. CI, 17-47).Similar overall response rates were observed in Asian patients (population with high incidence of gastric cancer) and non-Asian patients.At time of analysis, response durations ranged from 8+ to 20+ weeks with 11 of 12 responders continuing on therapy.  Full Article

Merck & Co Inc to acquire Sigma-Aldrich to enhance position in attractive life science industry
Monday, 22 Sep 2014 06:28am EDT 

Merck & Co Inc and Sigma-Aldrich:Enters into definitive agreement under which Merck will acquire Sigma-Aldrich for $17.0 billion.Merck will acquire all of outstanding shares of Sigma-Aldrich for $140 per share in cash.Says agreed price represents a 37 pct premium to latest closing price of $102.37 on Sept. 19 and 36 pct premium to one-month average closing price.Closing is expected in mid-year 2015.Guggenheim Securities and J.P. Morgan are acting as financial advisers to Merck.Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal adviser to Merck.Morgan Stanley & Co. LLC is acting as financial adviser to Sigma-Aldrich and Sidley Austin LLP is acting as legal adviser.  Full Article

Sun Pharmaceutical Industries Ltd and Merck & Co. Inc. enter into licensing agreement for Tildrakizumab
Wednesday, 17 Sep 2014 08:30am EDT 

Sun Pharmaceutical Industries Ltd and Merck & Co. Inc:Says through their respective subsidiaries, announced an exclusive worldwide licensing agreement for Merck's investigational therapeutic antibody candidate, tildrakizumab.Under terms, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of US$80 mln.Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma.Transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.  Full Article

Merck & Co Inc receives accelerated approval of Keytruda (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Thursday, 4 Sep 2014 03:15pm EDT 

Merck & Co Inc:Announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA(pembrolizumab) at a dose of 2 mg/kg every three weeks.For the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.This indication is approved under accelerated approval based on tumor response rate and durability of response.An improvement in survival or disease-related symptoms has not yet been established.Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA's Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need.  Full Article

FDA approves Merck & Co Inc's BELSOMRA (suvorexant) for the treatment of insomnia
Wednesday, 13 Aug 2014 04:49pm EDT 

Merck & Co Inc:Announced that the U.S. Food and Drug Administration (FDA) has approved BELSOMRA (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep.BELSOMRA (pronounced bell-SOM-rah) is a selective antagonist for orexin receptors.Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake.FDA has recommended BELSOMRA be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled product.  Full Article

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Ex-Bank of New York Mellon employee pleads guilty to insider trading

NEW YORK - A former Bank of New York Mellon Corp employee on Friday pleaded guilty to insider trading based on tips from a former Merck & Co Inc employee about potential pharmaceutical mergers.

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