FBI Cleveland Division Press Release:

California Man Charged in Stock Manipulation Scheme

U.S. Attorney’s OfficeFebruary 24, 2015

Northern District of Ohio(216) 622-3600

A criminal information has been filed in federal court charging Stephen J. Wilshinsky, 59, of Woodland Hills, California, and former stock broker with the Compass Group of Oppenheimer Inc. and Marquis Financial Services of Indiana, Inc. with one count of conspiracy to commit securities fraud, securities laws violations, and wire fraud, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio, and Stephen D. Anthony, Special Agent in Charge of FBI’s Cleveland Office.

The information charges that on or about March 13, 2008, through in or around September 2012, Wilshinsky, together with at least three other co-conspirators, agreed to defraud investors and potential investors in public companies Kensington Leasing, Ltd. and Lenco Mobile, Inc.

They did this by issuing millions of shares to themselves at little or no cost and then artificially controlling the price and volume of traded shares by, among other means, paying undisclosed commissions to brokers and former brokers for directing client funds to make both authorized and unauthorized investments and fraudulently concealing the co-conspirators’ ownership interests in the manipulated public companies, according to the information.

The co-conspirators then profited by selling their shares of the companies’ stock at artificially inflated prices to Wilshinsky’s clients at Oppenheimer and Marquis. Little or no portion of the investments went to fund the operations of the companies. Rather, Wilshinsky and his co-conspirators used the investments to enrich themselves, according to the information.

Wilshinsky received approximately $1.2 million in undisclosed cash commission payments and approximately 500,000 shares of stock from one or more co-conspirators as part of the scheme, which Wilshinsky then sold or transferred. In total, Wilshinsky received more than $1.4 million in cash and stock for participating in the conspiracy, according to the information.

The information was filed by Assistant U.S. Attorneys Christos N. Georgalis and Adam Hollingsworth after an investigation by agents of the Federal Bureau of Investigation.

If convicted, the defendant’s sentence will be determined by the Court after a review of factors unique to the case, including the defendant’s prior criminal record, if any, Defendant’s role in the offense, and the characteristics of the violation. In all cases the sentence will not exceed the statutory maximum and in most cases it will be less than the maximum.

An information is only a charge and is not evidence of guilt. A defendant is entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.

This content has been reproduced from its original source.

FBI Cleveland Division Press Release:

Concord Man Sentenced to More Than Three Years in Prison for Defrauding Credit Union

U.S. Attorney’s OfficeFebruary 23, 2015

Northern District of Ohio(216) 622-3600

A Concord Township man was sentenced to more than three years in prison for defrauding Taupa Lithuanian Credit Union out of $2.3 million, law enforcement officials said.

John Struna, 52, was sentenced to 43 months in federal prison and ordered to pay more than $2.3 million in restitution. He pleaded guilty to seven counts—one count of conspiracy to commit bank fraud, one count of bank fraud, one count of making false statements and four counts of money laundering.

Struna has forfeited a restaurant he owned—the Sunny Street Café in Concord Township—a condominium in Florida and a 2014 Mazda because they were purchased with proceeds of the fraud, according to court documents.

The guilty plea was announced by Steven M. Dettelbach, United States Attorney for the Northern District of Ohio, Stephen D. Anthony, Special Agent in Charge of the Federal Bureau of Investigation’s Cleveland office, and Kathy Enstrom, Special Agent in Charge of the Internal Revenue Service—Criminal Investigations.

The National Credit Union Administration and the Ohio Department of Commerce took possession of Taupa last year and placed it into receivership due to its insolvency. Taupa, based in Cleveland, had about 1,150 members and assets of approximately $24 million, according to court records.

Credit union CEO Alex Spirikaitis, former teller Michael Ruksenas and Vytas Apanavicius have previously been found guilty for their roles in conspiracies related to defrauding the credit union.

Struna maintained both personal and corporate accounts at Taupa dating back to 1995. He began a conspiracy with Spirikaitis in 2002 and continued through 2013, during which time Spirikaitis caused Taupa to make approximately 46 fraudulent transfers into Struna’s accounts, according to court documents.

In 2011, Struna requested and received $112,105 from Spirikaitis for the purchase of a condominium located in Ft. Myers, Florida. At no time did Struna submit any credit applications or loan documents, according to court documents.

The fraudulent transfers totaled approximately $2.3 million. From 2002 through 2013, Struna repaid only approximately $15,000 of the $2.3 million Spirikaitis transferred into his accounts, according to court documents.

This case is being prosecuted by Assistant United States Attorney Robert J. Patton and Special Assistant United States Attorney Derek Kleinmann. The case was investigated by the Federal Bureau of Investigation and the Internal Revenue Service.

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FBI Chicago Division Press Release:

Psychologist and Psychotherapy Services Owner Sentenced to More Than Seven Years and Employee Sentenced to More Than Five Years in $1.5 Million Medicare Fraud

U.S. Attorney’s OfficeFebruary 23, 2015

Northern District of Illinois(312) 353-5300

Bryce Woods, 37, an employee of Take Action, Inc., and Inner Arts, Inc., which claimed to provide psychotherapy services to Medicare beneficiaries residing in skilled nursing homes in the Chicago area, was sentenced today by U.S. District Court Judge Virginia M. Kendall to 70 months in federal prison for submitting false claims totaling more than $1.5 million to Medicare for psychotherapy services. Codefendant Keenan R. Ferrell, 55, who was the owner and operator of Take Action, Inc., and Inner Arts, Inc., as well as a licensed psychologist in Illinois, was sentenced to 88 months in federal prison back in August 2014.

“This is an abuse of a program designed for people who need it,” remarked U.S. District Judge Kendall in imposing the sentence today. “This was an egregious fraud.” Judge Kendall also ordered both Woods and Ferrell to serve two-year terms of supervised release and to pay $1,525,496 in restitution.

Ferrell and Woods, both of Chicago, were each convicted of six counts of health care fraud at a jury trial in June 2013. The defendants were convicted of submitting false claims to Medicare for over five years. In each fraudulent claim, Ferrell and Woods represented that Ferrell had provided 45-50 minutes of one-on-one psychotherapy to patients living in skilled nursing homes, when in fact, the sessions were conducted by Woods, psychology graduate students recruited by Ferrell, or others with limited or no supervision.

Knowing that psychotherapy services were reimbursable by Medicare only when performed by an enrolled provider or when “incident to” the services of an enrolled provider, Ferrell and Woods arranged for Ferrell, who was an enrolled Medicare provider and licensed medical doctor, to authorize Inner Arts and Take Action to accept assignment of his claims to Medicare. Ferrell and Woods arranged with psychology graduate students and others to see patients at various skilled nursing facilities. Ferrell himself did not attend or otherwise participate in or supervise any therapy sessions conducted in the nursing homes. As a result, Ferrell was not physically present and immediately available when Take Action and Inner Arts therapists were in nursing homes to visit with patients. As part of the scheme, Ferrell and Woods billed Medicare for more patient visits than had actually been conducted. The defendants also billed Medicare for psychotherapy sessions that Ferrell purportedly provided to patients who in fact were deceased at the time of the purported sessions. In his sentencing arguemnt, Assistant U.S. Attorney Paul Tzur said, “Defendant Woods filed over 31,000 separate claims to Medicare, which was an out and out lie.”

The sentence was announced by Zachary T. Fardon, United States Attorney for the Northern District of Illinois; Robert J. Holley, Special Agent-in-Charge for the Chicago Office of the Federal Bureau of Investigation; and Lamont Pugh, Special Agent-in-Charge of the Health and Human Services, Office of Inspector General.

The government is represented by Assistant U.S. Attorney Paul Tzur. The case was investigated by the FBI and the Health and Human Services, Office of Inspector General.

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Rick Perry: 'Unemployment rate is a sham' - Feb. 27, 2015

Potential presidential candidate Rick Perry dismissed the significant jobs gains under President Obama, telling a conservative group on Friday: "The unemployment rate is a sham."



The nation's unemployment rate has fallen to 5.7% in January, from 10% in October 2009, 10 months after Obama took office.



Rick Perry: 'Unemployment rate is a sham' - Feb. 27, 2015

Advice from Warren Buffett that could make you rich - Feb. 28, 2015

The Berkshire Hathaway annual letter is out, and Warren Buffett again finds new ways to preach what he's been saying for 50 years.



Such consistency has paid off for Buffett: A jaw-dropping return of 1,826,163% over the past half century. That's an average annual gain of 21.6%, compared to 9.9% for the S&P 500.



Advice from Warren Buffett that could make you rich - Feb. 28, 2015

Kelly Osbourne quits E!'s 'Fashion Police' - Feb. 27, 2015

"Fashion Police" is losing one of its most popular co-hosts.



E! announced on Friday that Kelly Osbourne will be departing the network's style and red carpet show to "pursue other opportunities."



Kelly Osbourne quits E!'s 'Fashion Police' - Feb. 27, 2015

From Bristol-Myers Squibb:

U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

Opdivo has the potential to be the first Immuno-Oncology agent approved for the treatment of advanced squamous non-small cell lung cancer

Friday, February 27, 2015 1:34 pm EST

"With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.

In the U.S., lung cancer is one of the leading causes of cancer deaths. Non-small cell lung cancer, one of the most common types accounting for approximately 85 percent of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30 percent of all lung cancers.

“With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,” said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb. “As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.”

Today’s filing acceptance is based on submission of clinical data from CheckMate -063, a Phase II single arm, open-label study designed to assess advanced squamous NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy.

Immuno-Oncology at Bristol-Myers Squibb

Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.

To address this unmet medical need, Bristol-Myers Squibb is leading research in an innovative field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.

Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.

About Opdivo

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.

In the U.S., Opdivo is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

IMPORTANT SAFETY INFORMATION

Immune-Mediated Pneumonitis

• Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 574 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.9% (5/574) of patients receiving OPDIVO; no cases occurred in Trial 1. In Trial 1, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; one with Grade 3 and five with Grade 2. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2.

Immune-Mediated Colitis

• In Trial 1, diarrhea or colitis occurred in 21% (57/268) of patients receiving OPDIVO and 18% (18/102) of patients receiving chemotherapy. Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; five with Grade 3 and one with Grade 2. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO.

Immune-Mediated Hepatitis

• In Trial 1, there was an increased incidence of liver test abnormalities in the OPDIVO-treated group as compared to the chemotherapy-treated group, with increases in AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs 5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis occurred in 1.1% (3/268) of patients receiving OPDIVO; two with Grade 3 and one with Grade 2. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis.

Immune-Mediated Nephritis and Renal Dysfunction

• In Trial 1, there was an increased incidence of elevated creatinine in the OPDIVO-treated group as compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or 3 immune-mediated nephritis or renal dysfunction occurred in 0.7% (2/268) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.

Immune-Mediated Hypothyroidism and Hyperthyroidism

• In Trial 1, Grade 1 or 2 hypothyroidism occurred in 8% (21/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Grade 1 or 2 hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO and 1% (1/102) of patients receiving chemotherapy. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.

Other Immune-Mediated Adverse Reactions

• In Trial 1, the following clinically significant, immune-mediated adverse reactions occurred in less than 1% of OPDIVO-treated patients: pancreatitis, uveitis, demyelination, autoimmune neuropathy, adrenal insufficiency, and facial and abducens nerve paresis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillian-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy.

Embryofetal Toxicity

• Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO.

Lactation

• It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.

Serious Adverse Reactions

• Serious adverse reactions occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase.

Common Adverse Reactions

The most common adverse reaction (≥20%) reported with OPDIVO was rash (21%).

Please see US Full Prescribing Information for OPDIVO.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regiments – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval in the U.S. for the indication described in this release or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Obama administration proposes a ban on assault rifle bullet - Feb. 27, 2015

The author uses terminology a bit loosely. The AR-15 is not an assault rifle. Assault rifles are automatic. The AR-15 is semi-automatic. But the point of the article is worth noting.





A proposal to ban a bullet that can pierce armor has upset the gun industry and its supporters.



The bullet in question is the M855 "green tip," which is used in the popular AR-15 assault rifles.



Obama administration proposes a ban on assault rifle bullet - Feb. 27, 2015

What You Need To Know About the Two-Tier ERP Strategy

All ERP solutions are not created equal – or designed for every manufacturing, production or corporate enterprise.

The three tiers of Enterprise Resource Planning (ERP) are distinct: ERP Tier 1, ERP Tier 2, and ERP Tier 3 .

What You Need To Know About the Two-Tier ERP Strategy

Ruble collapse makes bribery more expensive for Russians - Feb. 27, 2015

It costs a lot more to bribe a Russian these days.



Soaring prices and the weak ruble are creating corruption inflation: the cost of an average bribe shot up 37% in 2014.



Ruble collapse makes bribery more expensive for Russians - Feb. 27, 2015

India looks for economic magic in new budget - Feb. 27, 2015

India is bracing for its economic Super Bowl.



The government of Prime Minister Narendra Modi is set to reveal its second budget, an event so highly anticipated that TV news channels have doubled their advertising rates around Saturday's presentation.



India looks for economic magic in new budget - Feb. 27, 2015

China under pressure as money floods out of the country - Feb. 27, 2015

Yuan it up or yuan it down?



For years, China has kept its currency from strengthening too much against the dollar. Now, it might need to arrest a slide in the value of the yuan to prevent strain in the country's financial system.



China under pressure as money floods out of the country - Feb. 27, 2015

Duke Energy mobilizes additional personnel to join power restoration effort in N.C. - Duke Energy

CHARLOTTE, N.C. -

  More than 1,000 additional personnel are responding to Duke Energy's hardest-hit areas today – restoring power to thousands in North Carolina affected by an overnight snowstorm.

A total of 3,500 personnel are working to restore power to 78,000 customers (as of 5:45 p.m. EST), down significantly from earlier today when outages peaked at 224,000. Durham and Wake counties were the hardest hit and have the greatest amount of damage.

Duke Energy mobilizes additional personnel to join power restoration effort in N.C. - Duke Energy

Cable news and social media go all in on #LlamaWatch - Feb. 26, 2015

Thursday afternoon, social media and cable news were captivated when two escaped llamas ran free through Sun City, Arizona.



CNN, Fox News and local affiliates all broke into coverage of the nearly hour long llama chase.



Cable news and social media go all in on #LlamaWatch - Feb. 26, 2015

KFC is testing edible chocolate coffee cups - Feb. 26, 2015

KFC is planning to brew up something quirky for its customers in the United Kingdom -- a 100% edible chocolate coffee cup.



The cups are part of a marketing gimmick to mark the launch of Seattle Best Coffee (a Starbucks (SBUX) brand) at KFC (YUM) restaurants in the U.K.



KFC is testing edible chocolate coffee cups - Feb. 26, 2015

From Merck:

Merck’s 9-Valent HPV Vaccine, GARDASIL®9, Recommended by CDC’s Advisory Committee on Immunization Practices for Females Aged 9-26 and Males Aged 9-21

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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to include GARDASIL^®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in the recommendations for use of HPV vaccines. GARDASIL 9 has been added to the routine recommendations for vaccination of 11- and 12- year-old females and males. The vaccination series can be started at age nine. Vaccination is also recommended for females aged 13 to 26 and for males aged 13 to 21 who have not been vaccinated previously or have not completed the 3-dose series. GARDASIL 9 is not approved by the U.S. Food and Drug Administration (FDA) for use in males 16 years of age and above.

GARDASIL 9 was approved by the FDA in December 2014 for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous 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 also approved for use in boys 9 to 15 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 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].

"The CDC has made increasing HPV vaccination rates a public health priority,” said Jacques Cholat, M.D., president, Merck Vaccines, “and today’s recommendation for GARDASIL 9 is an important milestone in the shared effort to help further reduce the burden of HPV-related cancers and diseases.”

The ACIP also recommends that if vaccination providers do not know or do not have available the HPV vaccine previously administered, or are in settings transitioning to GARDASIL 9, for protection against HPV 16 and 18 any HPV vaccine may be used to continue or complete the series for females; GARDASIL or GARDASIL 9 may be used to continue or complete the series for males. As stated in the Prescribing Information for GARDASIL 9, studies using a mixed regimen of HPV vaccines to assess interchangeability were not performed for GARDASIL 9.

Due to the condensed meeting, the ACIP noted that vaccination with GARDASIL 9 in prior HPV vaccine recipients will be considered as a future policy discussion and vote at the June 2015 meeting. Efficacy of GARDASIL 9 in preventing infection and disease related to HPV types 31, 33, 45, 52, and 58, in individuals previously vaccinated with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] has not been assessed.

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) added to CDC’s Vaccines for Children program

During today’s meeting, the ACIP also voted to include GARDASIL 9 in the CDC’s Vaccines for Children (VFC) program for both boys and girls.

Since 1994, the VFC program has provided vaccines to children through the age of 18 who are Medicaid-eligible, uninsured, underinsured¹, American Indian or Alaska Native. After the ACIP has made a recommendation for the use of a given vaccine, the Committee votes on whether the vaccine should be included in the VFC program. Eligible children may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine have been completed.

GARDASIL 9 is also available through Merck’s patient assistance program for vaccines. Through this program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. More information can be found at www.MerckHelps.com.

About the ACIP

The ACIP develops written recommendations for the routine administration of vaccines to children and adults, along with schedules regarding the appropriate dosage and dosing frequency, and contraindications applicable to the vaccines. The Committee, which consists of 15 experts in immunization and related fields, provides advice to assist the CDC and the nation in reducing the incidence of diseases that may be prevented with vaccines and to increase the safe usage of vaccines and related biological products. The ACIP recommendations do not result in requirements for vaccine administration by individual states or coverage by insurance companies. However, state health authorities and private insurers typically follow the Committee’s guidance.

Details of the ACIP recommendations for GARDASIL 9 will be available from the CDC. The recommendations are under review by the director of the CDC and the Department of Health and Human Services and will become official when published in the CDC's Morbidity and Mortality Weekly Report.

Important Information about GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

Select Safety Information for GARDASIL 9

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].

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

The most common (≥10%) local and systemic adverse reactions in females 16 through 26 years of age were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in boys 9 through 15 years of age were injection-site pain, swelling, and erythema.

Dosage and administration for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh at the following schedule: 0, 2 months, 6 months.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other protections for innovative products; the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) athttp://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf. The Patient Product Information for GARDASIL®9 is also available athttp://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.

¹ Underinsured children receive VFC vaccines at Federally Qualified Health Centers.

GARDASIL^®9 and GARDASIL^® are registered trademarks of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.