Merck Acquires IOmet Pharma

Merck announced that it has acquired IOmet, a privately-held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. Under terms of the agreement, Merck, through a subsidiary, will acquire IOmet, including its comprehensive pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. Based on the transaction, IOmet will become a wholly owned subsidiary of Merck. 

IDO1 and TDO, the rate-limiting enzymes in the pathway that metabolizes the essential amino acid tryptophan, have emerged as key targets for the pharmaceutical industry in the cancer immunotherapy field. Overexpression of these enzymes has been detected in a variety of cancers – including glioma, melanoma, lung, ovarian, and colorectal cancers – and is associated with poor prognosis and survival. IDO1 and TDO overexpression leads to tryptophan depletion and high tumor levels of the breakdown product, kynurenine. This elevated kynurenine/tryptophan (K/T) ratio suppresses the body’s immune response to cancer, thus facilitating tumor progression and metastasis. Extensive preclinical evidence, and emerging clinical data, suggests that inhibition of IDO1 and/or TDO may synergize with, and help overcome resistance to, existing clinical cancer therapies, in particular other immunotherapy-based treatments. 

FDA Approves Expanded Indication of KEYTRUDA in Melanoma

Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA^® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for KEYTRUDA, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of KEYTRUDA is 2 mg/kg every three weeks

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

For details enter clinical trial of KEYTRUDA  visit here

FDA Approves Expanded Age Indication for GARDASIL 9 in Males

Merck announced that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) includes the greatest number of HPV types in any available HPV vaccine. GARDASIL 9 adds protection against five additional HPV types -- 31, 33, 45, 52 and 58 -- in addition to the four original HPV types covered by GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Seven HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90-95 percent of HPV-related anal cancers, approximately 90 percent of cervical cancers, and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2 and CIN 3) worldwide. These seven HPV types also cause 90 percent of HPV-related vulvar cancers and 85 percent of HPV-related vaginal cancers. HPV types 6 and 11 cause approximately 90 percent of genital warts cases in males and females.

Merck Decides Not to Pursue Evofosfamide

Merck  announced that it is not planning to file for approval of evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma. The decision was made in light of the results from two Phase III studies of evofosfamide in combination with chemotherapy in these two types of cancer, as reported by Threshold Pharmaceuticals Inc. today. Merck will now be redeploying its resources into high-profile future products, such as avelumab* and all other priority programs in oncology, immuno-oncology and immunology.

Merck’s pharmaceutical pipeline is focusing on oncology, immuno-oncology and immunology. In immuno-oncology, Merck, together with Pfizer, is researching avelumab, an investigational anti-PD-L1 antibody, in more than 15 tumor types.

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Merck Statement Regarding CUBICIN Patent Litigation

Merck issued the following statement regarding the decision of the U.S. Court of Appeals for the Federal Circuit. The decision validated the patent for CUBICIN^® (daptomycin for injection) that expires on June 15, 2016, but invalidated four patents with expiration dates in 2019 and 2020.The company is reviewing the decision and is considering its next steps, which may include seeking further review at the Federal Circuit or Supreme Court. 

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. 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 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission

Merck Animal Health to Acquire Harrisvaccines

Merck Animal Health and Harrisvaccines, Inc., announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals.

Harrisvaccines offers innovative technology and an important portfolio of vaccines, with a focus on production animals, an increasingly important segment as consumer demand for protein continues to grow worldwide. The company has a unique RNA Particle technology which represents a breakthrough in vaccine development.  It also has a highly versatile production platform able to target a wide range of viruses and bacteria. Pathogens are collected from a farm and specific genes are sequenced and inserted into RNA particles, making safe, potent vaccines able to provide herd-specific protection.

Glucophage® XR Can be Used for Type 2 Diabetes Patients

Merck, a leading science and technology company, announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage® XR (extended release metformin) for the treatment of patients with type 2 diabetes. The label change removes moderate renal impairment stage 3a and stable chronic heart failure from the list of the contraindications of Glucophage® XR. Earlier in the year, the French regulatory authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), had already approved an update of the labeling for Glucophage® IR (immediate release metformin) removing the same contraindications. The label changes apply to all countries in the European Union. Glucophage® IR is approved by a Mutual Recognition Procedure, where France acted as the Reference Member State. In the case of Glucophage® XR the label changes were approved via a Worksharing Procedure in the European countries involved, where the UK was acting as the Reference Member State.

The decisions are based on analyses of Merck’s extensive efficacy and safety data collected over many years as well as new clinical studies available for Glucophage®, which was first registered in 1959.

Until now Glucophage® IR and Glucophage® XR were contraindicated when glomerular filtration rate (GFR) was below 60ml/min. However, extensive post-marketing and clinical study evidence presented to the regulatory authorities supported that use of Glucophage® XR and Glucophage® IR has an acceptable safety profile in type 2 diabetic patients with moderate renal impairment stage 3a (when GFR is between 45ml/min and 59ml/min) at a reduced dose (max. 1000 mg/day), with no higher risk of adverse events.

A number of studies have demonstrated that the use of Glucophage® in the treatment of type 2 diabetes patients with stable chronic congestive heart failure has an acceptable safety profile. Until now metformin was contraindicated in heart failure in general due to the potential risk of lactic acidosis, a risk factor in acute worsening heart failure.

In 2013, 382 million people were suffering from diabetes globally, and by 2035 this figure is predicted to rise to 592 million.
 

Merck Receives Breakthrough Therapy Designation from USFDA

Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA^® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy Designation granted for KEYTRUDA. 

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. KEYTRUDA was previously granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC). 

The Breakthrough Therapy Designation in advanced colorectal cancer is based on data from a Phase 2 study evaluating the activity of KEYTRUDA in cancers with microsatellite instability, a well-established feature seen in cells with certain types of DNA repair defects. Findings from the study, led by researchers from Johns Hopkins Kimmel Cancer Center, were presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting and were published simultaneously in the New England Journal of Medicine.

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. 

New Findings Show Anti-Tumor Activity of KEYTRUDA

Merck announced the first-time presentation of findings investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy in patients with advanced unresectable nasopharyngeal carcinoma (NPC) – a type of head and neck cancer – whose tumors express PD-L1 (≥1% of cells in tumor nests or PD-L1+ bands in stroma). Data were from a Phase 1b study (KEYNOTE-028) and showed an overall response rate (ORR) (confirmed and unconfirmed) of 22.2 percent (95% CI, 8.6-42.3) in evaluable patients (n=27) who were treated with KEYTRUDA. 

Merck has initiated a comprehensive clinical development program evaluating KEYTRUDA in head and neck cancer across multiple lines of therapy as monotherapy and in combination with chemotherapy as well as other agents. In KEYNOTE-028, KEYTRUDA is being evaluated in patients with advanced unresectable NPC that is not responding to current therapy or for which current therapy is not appropriate. This is the second study to show early activity of KEYTRUDA in patients with head and neck cancer and the first study of an anti-PD-1 therapy to demonstrate clinical activity in patients with recurrent or metastatic NPC.

PD-L1, also called programmed death-ligand 1, is a protein expressed on many types of cells, including some cancer cells. Under normal conditions, the interaction of PD-L1 with another protein, called programmed death receptor-1 (PD-1), serves as an important immune system checkpoint, keeping the immune system in balance and preventing the body from attacking its own cells when inflammation or an infection is present. When cancerous tumors express PD-L1, however, they are able to escape detection and destruction by cytotoxic T-cells – a type of cancer-killing immune cell – allowing the tumor to survive and grow. Tumor PD-L1 expression has been observed at varying levels across many tumor types, including breast, lung, bladder cancer, and nasopharyngeal carcinoma. High levels of PD-L1 expression, called overexpression, are under investigation for potential use as a way to help identify patients with an enhanced likelihood to respond to certain immune-based treatment approaches.

FDA Approves Pediatric Indication for EMEND Capsules

Merck announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for EMEND^® (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, EMEND capsules are now approved for use in combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg (approximately 66 pounds) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use. 

 

With this approval, EMEND is the first and only NK1 receptor antagonist to be approved for the prevention of acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV) in patients 12 to 17 years of age and patients less than 12 years who weigh at least 30 kg receiving HEC or MEC. The approval was supported by data from a pivotal Phase 3 study that showed adding EMEND to a standard regimen for prevention of CINV in HEC or MEC regimens resulted in a reduction of emetic events. 

EMEND is contraindicated in patients with any known sensitivity to any component of this drug. EMEND is also contraindicated for patients taking pimozide.