LONDON, Feb. 12, 2020 /PRNewswire/ - ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA" or "the Company") (TSX: ADVZ), a global pharmaceutical company focused on serving the needs of patients and healthcare providers around the world with enhanced access to high quality, niche-established medicines, today commented on the issuance by the UK Competition and Markets Authority ("CMA") of a Supplemental Statement of Objections ("SSO") in relation to the supply of hydrocortisone tablets in the UK.
In the SSO, the CMA has consolidated three investigations variously involving Accord UK (formerly Actavis UK and Auden McKenzie), Waymade and AMCo (the former name of a division of ADVANZ PHARMA).
A SSO is a provisional statement by the CMA that it considers that a competition infringement may have occurred. It is not a decision or a finding.
The Company commented: "We are committed to ensuring continued access to high-quality, off-patent medicines for patients in the UK and provide many medicines which offer significant savings to the NHS. We take competition law very seriously and do not believe that competition law has been infringed."
The CMA's decision today to consolidate three different investigations, that are both separate and factually distinct, is unprecedented.
Further, with respect to the investigation into ADVANZ PHARMA's subsidiary division, formerly known as AMCo, the CMA's provisional finding in the SSO appears to be substantially the same as the provisional finding that the CMA made in a Statement of Objections ("SO") almost three years ago, in March 2017.
In May 2017, the Company made written submissions that the CMA had misunderstood the facts of the case and that no infringement had occurred. An oral hearing took place in July 2017 before the CMA's Case Decision Group who decided not to progress that case to an infringement finding.
The Company continued: "Nothing has changed from our perspective. Despite the almost three years that have elapsed, we will continue to cooperate fully with the CMA. We will review its provisional position and will respond in detail to explain again that we consider that the CMA is wrong in its assessment."
The CMA commented: "No conclusion should be drawn at this stage that there has been an infringement of competition law. The parties have the opportunity to make written and oral representations in response to the SSO. The CMA will carefully consider such representations, and the evidence as a whole, before any final decision is taken as to whether competition law has in fact been infringed."
The SSO issued today includes matters that pre-date ADVANZ PHARMA's ownership of the International segment, formerly known as AMCo. ADVANZ PHARMA acquired the International segment as a result of its transaction to purchase Amdipharm Mercury Limited from Cinven Partners LLP ("Cinven") and certain other sellers, which closed on October 21, 2015.
The SSO is also addressed to Cinven as the ultimate parent company of AMCo from January 1, 2013 until October 20, 2015.
About ADVANZ PHARMA
ADVANZ PHARMA operates an international specialty pharmaceutical business with a diversified portfolio of more than 200 patented and off-patent products, and sales in more than 90 countries, and going forward, is focused on becoming the leading platform for niche-established medicines, with advanced commercial capabilities throughout Western Europe.
ADVANZ PHARMA's registered office is in Jersey, Channel Islands. The Company operates globally through its subsidiaries in Sydney, Australia; London, England; Mumbai, India; Dublin, Ireland; St. Helier, Jersey; and in Helsingborg, Sweden.
Notice Regarding Forward-looking Statements and Information:
This news release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding ADVANZ PHARMA and its business, which may include statements regarding competition law compliance and the Company's review of and response to the CMA assessment and the timing thereof . Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of ADVANZ PHARMA's management, and are based on assumptions and subject to risks and uncertainties. Although ADVANZ PHARMA's management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting ADVANZ PHARMA, including risks associated with ADVANZ PHARMA's securities, increased indebtedness and leverage, ADVANZ PHARMA's growth, risks associated with the use of ADVANZ PHARMA's products, the inability to generate cash flows, revenues and/or stable margins, the inability to repay debt and/or satisfy future obligations, risks associated with a delay in releasing ADVANZ PHARMA's financial statements (which could result in a default under ADVANZ PHARMA's debt agreements and a violation of applicable laws), ADVANZ PHARMA's outstanding debt, risks associated with the geographic markets in which ADVANZ PHARMA operates and/or distributes its products, the pharmaceutical industry and the regulation thereof, regulatory investigations and proceedings, the failure to comply with applicable laws, risks associated with distribution agreements, economic factors, market conditions, risks associated with growth and competition, the failure to obtain regulatory approvals, the equity and debt markets generally, general economic and stock market conditions, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), political risks (including changes to political conditions), risks associated with the United Kingdom's exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross-border tariff and cost structures and the loss of access to the European Union global trade markets), risks related to patent infringement actions, the loss of intellectual property rights, risks and uncertainties detailed from time to time in ADVANZ PHARMA's filings with the Canadian Securities Administrators, and many other factors beyond the control of ADVANZ PHARMA. Although ADVANZ PHARMA has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and ADVANZ PHARMA undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events, or otherwise.
Advertisement
In the SSO, the CMA has consolidated three investigations variously involving Accord UK (formerly Actavis UK and Auden McKenzie), Waymade and AMCo (the former name of a division of ADVANZ PHARMA).
Advertisement
A SSO is a provisional statement by the CMA that it considers that a competition infringement may have occurred. It is not a decision or a finding.
The Company commented: "We are committed to ensuring continued access to high-quality, off-patent medicines for patients in the UK and provide many medicines which offer significant savings to the NHS. We take competition law very seriously and do not believe that competition law has been infringed."
The CMA's decision today to consolidate three different investigations, that are both separate and factually distinct, is unprecedented.
Further, with respect to the investigation into ADVANZ PHARMA's subsidiary division, formerly known as AMCo, the CMA's provisional finding in the SSO appears to be substantially the same as the provisional finding that the CMA made in a Statement of Objections ("SO") almost three years ago, in March 2017.
In May 2017, the Company made written submissions that the CMA had misunderstood the facts of the case and that no infringement had occurred. An oral hearing took place in July 2017 before the CMA's Case Decision Group who decided not to progress that case to an infringement finding.
The Company continued: "Nothing has changed from our perspective. Despite the almost three years that have elapsed, we will continue to cooperate fully with the CMA. We will review its provisional position and will respond in detail to explain again that we consider that the CMA is wrong in its assessment."
The CMA commented: "No conclusion should be drawn at this stage that there has been an infringement of competition law. The parties have the opportunity to make written and oral representations in response to the SSO. The CMA will carefully consider such representations, and the evidence as a whole, before any final decision is taken as to whether competition law has in fact been infringed."
The SSO issued today includes matters that pre-date ADVANZ PHARMA's ownership of the International segment, formerly known as AMCo. ADVANZ PHARMA acquired the International segment as a result of its transaction to purchase Amdipharm Mercury Limited from Cinven Partners LLP ("Cinven") and certain other sellers, which closed on October 21, 2015.
The SSO is also addressed to Cinven as the ultimate parent company of AMCo from January 1, 2013 until October 20, 2015.
About ADVANZ PHARMA
ADVANZ PHARMA operates an international specialty pharmaceutical business with a diversified portfolio of more than 200 patented and off-patent products, and sales in more than 90 countries, and going forward, is focused on becoming the leading platform for niche-established medicines, with advanced commercial capabilities throughout Western Europe.
ADVANZ PHARMA's registered office is in Jersey, Channel Islands. The Company operates globally through its subsidiaries in Sydney, Australia; London, England; Mumbai, India; Dublin, Ireland; St. Helier, Jersey; and in Helsingborg, Sweden.
Notice Regarding Forward-looking Statements and Information:
This news release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding ADVANZ PHARMA and its business, which may include statements regarding competition law compliance and the Company's review of and response to the CMA assessment and the timing thereof . Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of ADVANZ PHARMA's management, and are based on assumptions and subject to risks and uncertainties. Although ADVANZ PHARMA's management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting ADVANZ PHARMA, including risks associated with ADVANZ PHARMA's securities, increased indebtedness and leverage, ADVANZ PHARMA's growth, risks associated with the use of ADVANZ PHARMA's products, the inability to generate cash flows, revenues and/or stable margins, the inability to repay debt and/or satisfy future obligations, risks associated with a delay in releasing ADVANZ PHARMA's financial statements (which could result in a default under ADVANZ PHARMA's debt agreements and a violation of applicable laws), ADVANZ PHARMA's outstanding debt, risks associated with the geographic markets in which ADVANZ PHARMA operates and/or distributes its products, the pharmaceutical industry and the regulation thereof, regulatory investigations and proceedings, the failure to comply with applicable laws, risks associated with distribution agreements, economic factors, market conditions, risks associated with growth and competition, the failure to obtain regulatory approvals, the equity and debt markets generally, general economic and stock market conditions, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), political risks (including changes to political conditions), risks associated with the United Kingdom's exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross-border tariff and cost structures and the loss of access to the European Union global trade markets), risks related to patent infringement actions, the loss of intellectual property rights, risks and uncertainties detailed from time to time in ADVANZ PHARMA's filings with the Canadian Securities Administrators, and many other factors beyond the control of ADVANZ PHARMA. Although ADVANZ PHARMA has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and ADVANZ PHARMA undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events, or otherwise.
View original content:http://www.prnewswire.com/news-releases/advanz-pharma-corp-limited-comments-on-cma-supplemental-statement-of-objections-related-to-hydrocortisone-tablets-301003644.html
SOURCE ADVANZ PHARMA Corp.
