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TMCNet:  Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS® (raltegravir) 600 mg in the European Union

[May 19, 2017]

Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS® (raltegravir) 600 mg in the European Union

Merck�(NYSE:MRK), known as MSD outside�the United States�and�Canada, today announced that the�Committee for Medicinal Products for Human Use�(CHMP) of the�European Medicines Agency�(EMA (News - Alert)) has adopted a positive opinion recommending approval of ISENTRESS® (raltegravir) 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. In adults and pediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-na�ve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.

The once daily formulation of ISENTRESS is currently under review in the United States by the Food and Drug Administration.

"The CHMP's positive opinion recommending the approval of ISENTRESS 600 mg film-coated tablets is an important step toward a new option for people living with HIV who are looking for once-daily dosing, as part of an HIV treatment regimen, with proven efficacy and safety," said Dr. Eliav Barr, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories.

The CHMP positive opinion was based on findings from the ONCEMRK trial, an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial designed to evaluate the efficacy and safety of ISENTRESS 1200 mg, given as two 600 mg oral tablets once daily, compared to ISENTRESS 400 mg twice daily, each in combination with emtricitabine + tenofovir disoproxil fumarate in previously untreated HIV-1 infected adults. Once-daily ISENTRESS 600 mg (1200 mg total), when used as part of an HIV-1 treatment regimen, demonstrated comparable efficacy and safety to ISENTRESS 400 mg twice a day after 48-weeks of treatment across a variety of patient populations.

About ISENTRESS (raltegravir)

ISENTRESS is Merck's integrase inhibitor for the treatment of HIV-1 infection in adult and pediatric patients aged four weeks and older and weighing at least 3 kg as part of combination HIV therapy. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.

ISENTRESS is approved as part of combination therapy in 112 countries for treatment of HIV-1 infection in adults. ISENTRESS chewable tablets, in combination therapy, for use in children and adolescents with HIV-1 aged two years and older has also been approved for use in 69 countries, and ISENTRESS granules for oral suspension for infants at least four weeks of age is approved for use in 33 countries.

Selected Important Safety Information for ISENTRESS® (raltegravir)

Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

ISENTRESS chewable tablets contain phenylalanine, a component of aspartame, which may be harmful to patients with phenylketonuria.

Co-administration of ISENTRESS with drugs that are strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may result in reduced plasma concentrations of raltegravir. Co-administration of ISENTRESS with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir.

Co-administration of ISENTRESS and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions must be considered prior to and during therapy. Co-administration or staggered administration of aluminum and/or magnesium hydroxide-containing antacids and ISENTRESS is not recommended.

Rifampin, a strong inducer of UGT1A1, reduces plasma concentrations of ISENTRESS. Therefore, the dose of ISENTRESS for adults should be increased to 800 mg twice daily during co-administration with rifampin There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age.

The most commonly reported (=2 percent) drug-related clinical adverse reactions of moderate to severe intensity in treatment-na�ve adult patients receiving ISENTRESS compared with efavirenz were insomnia (4 percent vs. 4 percent), headache (4 percent vs. 5 percent), nausea (3 percent vs. 4 percent), fatigue (2 percent vs. 3 percent), and dizziness (2 percent vs. 6 percent) respectively. Intensities were defined as follows: Moderate (discomfort enough to cause interference with usual activity); or Severe (incapacitating with inability to work or do usual activity).

In treatment-experienced pediatric patients 4 weeks through 18 years of age receiving ISENTRESS, the frequency, type and severity of drug-related adverse reactions were comparable to those observed in adults.

Grade 2-4 creatine kinase laboratory abnormalities were observed in subjects treated with ISENTRESS. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase.

Rash occurred more commonly in treatment-experienced subjects receiving regimens containing ISENTRESS + darunavir/ritonavir compared to subjects receiving ISENTRESS without darunavir/ritonavir or darunavir/ritonavir without ISENTRESS. However, rash that was considered drug related occurred at similar rates for all 3 groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.

ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. In addition, there have been no pharmacokinetic studies conducted in pregnant patients.

To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

About Merck

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit�www.merck.com and�connect with us on�Twitter,�Facebook,�Instagram, YouTube and�LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2016 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC (News - Alert)) available at the SEC's Internet site (www.sec.gov).

Please see Prescribing Information for ISENTRESS (raltegravir) at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf, Patient Information for ISENTRESS at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ppi.pdf and Instructions for Use of ISENTRESS (raltegravir) for Oral Suspension at http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_ifu.pdf


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