Alexion Russia and Alexion Turkey maintained false books and records of these improper payments, which Alexion’s internal accounting controls were not sufficient to detect or prevent. The investigations have focused on operations in various countries, including Brazil, Colombia, Japan, Russia and Turkey, and Alexion’s compliance with the FCPA and other applicable laws. The Probe. Further, an Alexion Turkey manager directed that the description of the consultant’s claimed expenses should be written in pencil so that they could change or conceal the expenses. Its Audit and Finance Committee stepped up to lead the investigation in conjunction with some outside advisers, and Alexion also held off on making its Q3 regulatory filing with the Securities … Alexion unveiled the proposed $25 million settlement in its recent quarterly securities filing. Today, it was announced that Alexion finalized its settlement with the U.S. Securities and Exchange Commission (SEC) to resolve the previously disclosed investigation related to the company’s compliance in certain countries with the Foreign Corrupt Practices Act (FCPA) and other applicable laws. Stay Informed. The consultant used a portion of these funds to provide government officials with cash, meals and gifts to secure favorable treatment for Soliris. For example, Alexion began paying Physician C and C’s organization after learning that Physician C was assigned responsibility for advising the Ministry of Health regarding Soliris. Notably, both subsidiaries failed to maintain certain documents underlying a substantial number of financial transactions. The DOJ, meanwhile, has closed its parallel case without enforcement action. Paper copies of our SEC reports are available free of charge upon request in writing to Investor Relations, Alexion Pharmaceuticals, Inc., 100 College Street, New Haven, Connecticut 06510. Physician B was responsible for developing and submitting a list of rare diseases to the Ministry of Health, and Physician C was responsible for advising the Ministry of Health on Alexion’s application to include Soliris on an approved list of drugs to treat certain diseases. For example, in 2013 and 2014, an Alexion Brazil manager caused a PAO to pay for the manager’s personal expenses for alcohol and personal travel, and to submit a fictitious invoice, which was reimbursed by Alexion Brazil. Alexion engaged in bribery in Turkey and Russia, and accounting violations in Brazil and Colombia. After entering the market in Turkey, Alexion learned that it had to pay bribes to government officials to increase patient approvals. Alexion is a global pharmaceutical company. According to the SEC… Alexion made honoraria and research payments to Physician A in significant part to influence the regional budget in favor of Soliris. In determining the penalties, the SEC considered Alexion’s cooperation, which included regular briefings to SEC staff regarding the facts developed in its internal investigation in multiple countries and the forensic accounting review that Alexion undertook as well as identifying and providing translations of key documents. Alexion still hasn’t wrapped up its internal investigation of a former employee’s sales fraud allegations. “Alexion’s internal accounting controls failed to detect and prevent payments to foreign government officials by its subsidiaries,” said Melissa Hodgman, an Associate Director in the SEC’s Division of Enforcement. “Companies in frequent contact with foreign officials need to ensure that their internal controls appropriately address such risks.”. Its first drug, Soliris was approved to treat two ultra-rare diseases, paroxysmal nocturnal hemoglobinuria (“PNH”), which causes red blood cells to split apart, and atypical hemolytic uremic syndrome (“aHUS”), which reduces red blood cell count and causes kidney dysfunction. Further, the order finds that Alexion’s subsidiaries in Brazil and Colombia failed to maintain accurate books and records, including by creating or directing third parties to create inaccurate financial records concerning payments to patient advocacy organizations. Alexion Pharmaceuticals said in a regulatory filing that it is nearing a $25 million settlement with the Securities and Exchange Commission concerning an investigation into the company’s compliance with the Foreign Corrupt Practices Act spanning various countries. Alexion nears $25M settlement with SEC in FCPA probe. Alexion Pharmaceuticals reached US$21 million settlement with SEC over fraud charges. Alexion Pharmaceuticals settles FCPA investigation. Alexion subsidiaries in those two countries paid officials to influence patient prescriptions and regulatory approvals of Soliris, a drug used to treat rare blood diseases, an SEC investigation found. The Probe. The Boston-based company settled the claims without admitting or denying the regulator’s findings. The HCPs were responsible for approving or denying patient prescriptions for Soliris and were key influencers on regulatory matters such as treatment guidelines and reimbursement. Continuous Monitoring and Continuous Auditing to Enhance Compliance. As previously disclosed, Alexion first received a subpoena in May 2015 concerning an investigation by the SEC’s Enforcement Division “requesting information related to our grant-making activities and compliance with the FCPA in various countries.” The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). Alexion earned a total of over $14 million in unjust profits. The SEC order doesn’t say how regulators came to be aware of the misconduct, such as whether the company disclosed its misdeeds voluntarily. Physician A was paid over $100,000 from 2012 to 2015. But in the meantime, its CEO and CFO are hitting the road. Tags: Alexion PharmaceuticalsAlexion SEC Settlementbooks and recordsFCPA Violations, Episode 185 – Anti-Boycott Compliance: Interview of Alex Cotoia from the Volkov Law Group, Webinar: Leverage Due Diligence to Improve Enterprise-Wide Risk Management. From 2011 to 2015, Alexion paid Physicians B and C for honoraria, research and education expenses, and in grants to the institution that employed Physician C.  Physicians B and C were geneticists and chief advisors to the Ministry of Health. Alexion Pharmaceuticals, Inc. - SEC Investigation Update. Alexion Pharmaceuticals Strikes Tentative $25 Million Bribery Settlement The biopharmaceutical company has reached a settlement in principle with the SEC, it said. A federal investigation that Alexion Pharmaceuticals settled for $21.5 million last week found the drugmaker paid bribes to Turkish and Russian government officials to gain favorable regulatory treatment for its blockbuster drug Soliris, according to details released by the SEC. To see what you're missing. The pharmaceutical company has agreed to resolve a foreign bribery investigation by the SEC for under $25 million. The order finds that, from 2010 to 2015, Alexion Turkey paid Turkish government officials to improperly influence them to approve patient prescriptions and provide other favorable regulatory treatment for Soliris. Alexion’s disclosure states: “In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries. Alexion Pharmaceuticals Thursday morning said it would pay $21.5 million to settle a federal probe into allegations that it violated anti-bribery laws. From 2011 to 2015, Alexion paid over $1 million to these HCPs, which included funds to ensure that the HCPs took positions favorable to Alexion in connection with regional budget allocations, to increase prescriptions and to favorably influence regulatory treatment of Soliris. To assist with the patient approval process, Alexion hired a consultant, primarily because of the consultant’s connections to top Turkey Ministry of Health officials. This article is premium content. Keep up to date with significant developments in the corporate investigations world. Soliris was awarded 52 percent of the regional healthcare budget in Physician A’s region in 2013. Alexion is a global pharmaceutical company. To continue reading, please Sign In or Join at the top of this page. Sign In or Become a Subscriber! Subscribe now. Become a Paid Subscriber! Global Investigations Review - Alexion settles with SEC … An internal document stated that Alexion hoped to “receive support to include [ultra-rare diseases treated by Alexion drugs] in all possible lists.”  After making the payments to Physician C and his organization, an Alexion employee stated that Physician C “cooperated” with Alexion Russia on the “programs within [Physician C’s] influence on regions in terms of standards and funding, through [Physician C’s] specialized committee.”. 2200 Pennsylvania Avenue, An SEC investigation determined that Vijay S. Rajan of Bolingbrook, Illinois learned about the impending transaction in April 2015, through his work as an information technology executive at Alexion. These payments were inaccurately reported as honoraria and grants. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21 million for foreign bribery and books and records violations. In 2014 and 2015, the same manager and an employee in Alexion Brazil submitted grant requests to Alexion’s global grant review committee that misstated how the requested funds would be allocated to the different activities covered in the grant request. The investigation started in 2015, according to the company’s earlier SEC filings. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21 million for foreign bribery and books and records violations. Alexion paid HCPs in Russia who were employed at government institutions for services, including research, consu;ting on specific topics and hosting educational events. The Continued Evolution of Best Practices for Compliance Programs! Fourth Floor East, According to the SEC’s order, two Alexion subsidiaries made payments to foreign government officials to secure favorable treatment for Alexion’s primary drug, Soliris. The SEC’s investigation was conducted by Christina McGill and Brittany Hamelers. Alexion paid both physicians in significant part to influence them in favor of Soliris. Alexion is cooperating with these investigations. Soliris is approved for use in more than 50 countries. Without admitting or denying the SEC’s findings, Alexion agreed to cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA and pay $14,210,194 in disgorgement, $3,766,337 in prejudgment interest, and a $3.5 million penalty. But from then forward, Alexion did cooperate with the investigation and boosted its compliance efforts substantially. Rajan violated his confidentiality obligations to Alexion by trading Synageva stock based on nonpublic information concerning the transaction, reaping over $10,000 in illicit profits. Alexion is best known for its development of Soliris, a drug used to treat the rare blood and kidney disorders. Alexion did not elaborate on the nature of the investigation. Washington D.C., July 2, 2020 —. Alexion increased the number of patient approvals, and gained access to confidential information and advance feedback on regulatory submissions. Without admitting or denying the SEC’s findings, Alexion agreed to cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA and pay $14,210,194 in disgorgement, $3,766,337 in prejudgment interest, and a $3.5 million penalty. Some examples of Alexion’s illegal payment schemes include: In 2011 and 2012, Alexion targeted Physician A because Physician A was the chair of the committee that prepared recommendation on allocation of rare disease funds in one region of Russia and because Physician A was assigned to propose medical standards to diagnose and treat PNH. Red Flags That May Indicate You Might be at Risk of Violating FCPA, Sidebars — Reflections on White Collar Law and Federal Crimes. The investigation started in 2015, according to the company’s earlier SEC filings. To see what you're missing. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21 million for foreign bribery and books and records violations. Washington D.C., July 2, 2020 — The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). Submitted by Probes Reporter on Thu, 2018-06-14 06:05. Preliminary discussions have begun with the SEC to resolve the investigation. On one occasion in 2014, in order to provide funds to a PAO, an Alexion Colombia senior manager directed a PAO to submit an invoice that falsely described that the funds would be used for “legal support” services. This inaccurate invoice allowed Alexion Colombia to approve the payment locally instead of obtaining approval for the payment through the global grant process, as required by Alexion’s policies. Alexion Pharmaceuticals Inc. - SEC Investigation Update Submitted by Probes Reporter on Tue, 2017-02-14 06:07 Pharmaceutical company Alexion is in “preliminary discussions” with the SEC to resolve a foreign bribery investigation. Without admitting or denying the SEC’s findings, Alexion agreed to pay a $3.5 million penalty, plus $14.2 million in disgorgement and about $3.8 million in prejudgment interest. Boston-based Alexion Pharmaceuticals has resolved alleged violations of the Foreign Corrupt Practices Act after a five-year investigation. Alexion is a global pharmaceutical company. Legal news service Law360 reported the complaints stem from Alexion operations in Japan, Brazil, Turkey and Russia. Independent Investment Research Focused on Public Company Interactions with the SEC. In Turkey and Russia, Alexion paid government officials and doctors at state-connected hospitals to promote use of its blood-disease drug, Soliris. Alexion’s violations revolved around its primary drug, Soliris. Notwithstanding the pandemic and remote working arrangements, the In fact, for most of the time, the consultant provided little to no explanation for many expenses, including vague descriptions such as ”other expense.”  In some cases, the consultant listed the first name of the government official on specific expense reports or notes attached thereto. Further, Alexion Brazil and Alexion Colombia failed to maintain adequate books and records of certain of its financial transactions involving payments to third parties. In its May 2020 annual report filed with the United States Securities and Exchange Commission (SEC), Alexion Pharmaceuticals, Inc., said it reached an agreement in principle with the SEC to resolve the Foreign Corrupt Practices Act (FCPA) investigation against it.. Today, it was announced that Alexion finalized its settlement with the U.S. Securities and Exchange Commission (SEC) to resolve the previously disclosed investigation related to the company’s compliance in certain countries with the Foreign Corrupt Practices Act (FCPA) and other applicable laws. 5 Flickr 6LinkedIn 7 Pinterest 8 Email Updates. ... is the hub for global coverage of corporate investigations and their aftermath. Soliris sold through a national patient system and was reimbursed through regional healthcare spending. Alexion entered the Russia market in 2012. Alexion disguised some of the payments to the consultant by asking a third-party vendor to pay the consultant and provide false invoices for reimbursement to Alexion. 2020-05-07T14:19:00Z. These HCPs provided expert opinions to government decision-makers concerning the allocation of regional healthcare budgets and regulatory treatment of Soliris. Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions. From 2013 to 2015, Alexion Brazil and Alexion Colombia directed third parties to create inaccurate financial records concerning payments to third parties, including patient advocacy organizations (“PAOs”). By 2015 regulators were onto Alexion’s schemes. The order similarly finds that from 2011 to 2015, Alexion Russia made improper payments to Russian government health care officials to favorably influence the regulatory treatment of and the budget allocated to Soliris as well as to increase the number of approved Soliris prescriptions. The consultant provided insufficient documentation of expenses or services provided in return for the payments. By 2015 regulators were onto Alexion’s schemes. In addition to the consultant payments, Alexion managers paid over $100,000 to healthcare professionals (“HCPs”) serving on Ministry of Health commissions. The investigation was supervised by Timothy England and Melissa Hodgman. In its May 2020 annual report filed with the United States Securities and Exchange Commission (SEC), Alexion Pharmaceuticals, Inc., said it reached an agreement in principle with the SEC to resolve the Foreign Corrupt Practices Act (FCPA) investigation against it.. The SEC’s investigation was conducted by Christina McGill and Brittany Hamelers. At the same time, Pharma opened a court case against Alexion Pharma Belgium. N.W. A federal investigation that Alexion Pharmaceuticals settled for $21.5 million last week found the drugmaker paid bribes to Turkish and Russian government officials to gain favorable regulatory treatment for its blockbuster drug Soliris, according to details released by the SEC. The information found on our website is not part of this or any other report we file with, or furnish to, the SEC. On July 2, 2020, Alexion Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay $21.5 million to the US Securities and Exchange Commission to resolve charges that it had violated the books and records and internal controls provisions of the US Foreign Corrupt Practices Act. Note: The content provided by Michael Volkov on the Corruption, Crime & Compliance blog is not intended to be legal advice and viewing the materials does not create an attorney-client relationship. The gag order was revoked by the end of September 2013, but the case was still pending in March 2015. Physician A provided Alexion with a copy of draft diagnostic standards and solicited Alexion’s comments on the standards. Pharmaceutical company Alexion is in “preliminary discussions” with the SEC to resolve a foreign bribery investigation. 1 Twitter 2 Facebook 3RSS 4YouTube Free email alerts anytime we publish. STAY CONNECTED From 2010 to 2015, Alexion’s subsidiary in Turkey paid foreign officials for favorable regulatory treatment and to approve prescriptions for patients. These payments were recorded inaccurately in Alexion’s books and records as honoraria, education expenses, business meeting expenses, and scientific research. Some of the HCPs served at regional and federal position in the Russian healthcare system. The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the … Connecticut-based Alexion received a subpoena from the SEC in May. The SEC order doesn’t say how regulators came to be aware of the misconduct, such as whether the company disclosed its misdeeds voluntarily. It says the company’s co-operation included providing regular briefings on the facts developed in the internal investigation and forensic accounting review Alexion undertook, and identifying and providing translations of key documents. The company said the DOJ in October asked for the voluntary production of documents related to the investigation. In determining the penalties, the SEC considered Alexion’s cooperation, which included regular briefings to SEC staff regarding the facts developed in its internal investigation in multiple countries and the forensic accounting review that Alexion undertook as well as … Without admitting or denying the SEC’s findings, Alexion agreed to cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA and pay $14,210,194 in disgorgement, $3,766,337 in prejudgment interest, and a $3.5 million penalty. For example, from 2012 to 2014, Alexion paid over $15,000 to an HCP who was decision maker for reimbursement criteria for aHUS and for patient prescriptions for Soliris. Alexion Pharmaceuticals Inc. is an American pharmaceutical company best ... on June 12, Alexion received a court gag order against Pharma, preventing it from communicating its investigation. Terms of the agreement took into account remedial acts undertaken by Alexion and its co-operation with SEC officials, according to the order. During the time period of 2010 to 2015, Alexion paid the consultant over $1.3 million, consisting of consulting fees and purported expense reimbursements. But from then forward, Alexion did cooperate with the investigation and boosted its compliance efforts substantially. Additionally, Alexion was cited because some of its employees in Brazil destroyed documents after an internal investigation was initiated. In May this year, Alexion said it received a declination from the DOJ for the FCPA investigation. Alexion representatives said in a Friday statement to the News that they are fully cooperating with SEC’s and DOJ’s orders. Yesterday, the SEC announced that Alexion Pharmaceuticals (a company that has been under scrutiny since mid-2015) agreed to approximately $21.5 million to resolve an enforcement action based on the actions of foreign subsidiaries involving the company’s primary drug Soliris. From 2011 to 2015, Alexion’s subsidiary in Russia made payments to foreign officials to influence the allocation of regional healthcare budgets for Soliris, to increase the number of Soliris prescriptions and favorably influence treatment of Soliris. Washington, D.C. 20037, Alexion FCPA Violations: Lessons Learned (Part II of II), Webinar: Catching Up with DOJ Compliance Program Guidance, Dancing Around the Edges: A Journey in the FCPA Guidance, The FCPA Guidance and Voluntary Disclosures, A Call to Arms: Conduct a Risk Assessment, Board and Fraud – a Jonathan T. Marks Blog, Compliance Workshop! Washington DC (STL.News) The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA).
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