Mylan Laboratories Ltd.

5th September 2023: ViiV Healthcare welcomes the news that both Aurobindo Pharma Limited and Mylan Laboratories Limited (a subsidiary of Viatris) have received tentative approval under the US FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine, for the treatment of HIV-1 infection in paediatric patients aged at least 3 months and weighing at least 6 kg to <25 kg. This milestone is the result of public-private partnerships between Clinton Health Access Initiative (CHAI), Unitaid, ViiV Healthcare and each of the two generic manufacturers, both of whom hold paediatric dolutegravir voluntary licences either through the Medicines Patent Pool Foundation (MPP) or directly with ViiV. Over the last 3 years, Aurobindo and Mylan have both been provided with technical expertise by ViiV and regulatory support from CHAI (funded by Unitaid) to accelerate the development and registration of generic dispersible formulations of the fixed dose combination of abacavir, dolutegravir and lamivudine – the first dispersible single-tablet regimen containing dolutegravir – to enable broad and affordable supply for children living with HIV in resource-limited settings as quickly as possible. An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste, presenting a real challenge to many caregivers’ ability to administer life-saving medicine. The availability of age-appropriate treatment is critical in ensuring the 1.5 million children and infants living with HIV1 can access optimal HIV care, and today’s news marks an important step forward in closing the gap between treatment options available for adults and children living with HIV in low- and middle-income countries. The views expressed in this news update are entirely those of ViiV Healthcare and do not necessarily represent those of CHAI, its donors, Aurobindo Pharma Limited, Mylan Laboratories Limited or any other party. ViiV Press Releases & Company Statements For our corporate press office, email: Rachel Jaikaran OR call +44 7823 523 755 For US-specific media enquiries,email: Audrey Abernathy OR call +1 919 605 4521 Reference: Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the GSK Reporting Tool link https://gsk.public.reportum.com/. By reporting side effects, you can help provide more information on the safety of this medicine. If you are from outside the UK, you can report adverse events to GSK/ ViiV by selecting your region and market, here. Connect with us ViiV Healthcare 79 New Oxford Street London United Kingdom WC1A 1DG Tel: +44 20 8047 5000 Contact us Terms of use Cookie policy Privacy notice Modern Slavery Statement Sitemap All our locations Our Clinical Trial Register GSK.com Carbon Reduction Plan Corporate ethics and compliance Social Media at ViiV Healthcare

May 28, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor The complicated attempted buy up of Pittsburgh, Penn.-based Mylan Pharmaceuticals, Inc. by Israeli company Teva Pharmaceutical Industries Ltd. took another acrimonious turn this week, after Teva bought 1.35 percent of Mylan NV ’s stock in an effort to force the company to accept its already rejected $43 billion bid. “Acquiring shares of Mylan underscores our commitment to consummating a transaction as soon as possible,” Teva said in a statement Wednesday. Mylan did not issue a statement on the move. Teva ’s efforts so far have officially been rejected by Mylan , with the company’s increasingly testy statements about the proposed merger becoming a very public testimonial to just how acrimonious the process is becoming. Mylan is one of the largest generics and specialty pharmaceutical companies in the world, with about 1,400 different products it markets. Teva also focuses on generics, as well as specialty drugs and active pharmaceutical ingredients. It has a portfolio of more than 1,000 molecules, employs more than 45,000 people worldwide and sells in 60 countries. Any eventual merger could mean more than $27 billion in revenue from the combined companies, although Mylan ’s public rebuke of its suite April 17, in which it raised concerns about antitrust issues, continues to worry analysts. After months of rumors about the deal, Teva finally made its bid official last month in an $82 a share in cash and stock deal that would be the biggest takeover attempt so far this year. That bid is 23 percent above Mylan ’s closing price April 16. But that price was far too low for Mylan , an ironic twist considering its bid for smaller company Perrigo Company was last week rejected by Perrigo for also being an undervaluation. “After thorough consideration, Mylan ‘s Board unanimously determined that Teva ‘s proposal grossly undervalues Mylan , and would require Mylan ‘s shareholders to accept what we believe are low-quality Teva shares in exchange for their high-quality Mylan shares in a transaction that lacks industrial logic and carries significant global antitrust risk,” said Mylan in a statement Monday. “In addition, we also believe that the proposal does not address the serious challenges of integrating two fundamentally different and conflicting cultures under a Teva Board and leadership team with a poor record of delivering sustainable shareholder value. We believe that these challenges would make it very difficult to generate value from this combination for Mylan shareholders.” A week after that bid, in a letter to Teva ’s management from Robert J. Coury , Mylan ’s executive chairman, made public by Mylan , it was clear the company is becoming increasingly irritated by what it sees as an attempt to railroad it into accepting the proposal. “Dear Erez,” wrote Coury. “First, let me say what a pleasure it was to meet you for the first time in New York last Friday. As we discussed, I was very disappointed by your decision to make your interest in Mylan public without first taking the time to speak to me or meet in person.” “As those who know me will attest, I always am willing to discuss opportunities to create value for Mylan ‘s shareholders and other stakeholders, and although it was after-the-fact, I was happy to grant you the opportunity to meet with me in person to hear your rationale outlined in your letter dated April 21, 2015. During our meeting, we touched on Teva ‘s many struggles throughout the last several years, including the approval of the first generic version of your flagship product Copaxone (despite Teva ‘s claims that an AB-rated generic would never be approved); the persistent turnover and turmoil amongst the Teva leadership and Board and the resulting strategic confusion; Teva ‘s consistent underperformance in comparison to the market and our industry; and your increasing need to find new sources of future growth. As I am sure you are aware, Mylan ‘s historical compound annual growth rates (CAGR) in terms of revenues and adjusted EBITDA from 2011-2014 are more than double Teva ‘s. He continued: “Erez, you told me in our meeting that Teva is different now and the challenges and cultural issues you have faced previously were now in the past. You assured me that Teva ‘s new Board and management team had brought a new approach to the way it does business. Yet, this change was not evident in the way you approached your interest in Mylan . Through your leadership, you had the opportunity to set the right tone, and show the world that there is a new Teva . Instead, you chose to approach Mylan in a way that demonstrates that the old Teva is very much still alive, which only continues to beg questions about Teva ‘s credibility.“ Teva did not have a responding statement Monday. Teva lost patent protection for multiple sclerosis drug Copaxone, for which Mylan makes a generic, last July after a U.S. Federal Appeals Court found the patent protecting the drug would expire in May 2014, not September 2015. “The attraction for Teva is that this deal would immediately allow them to grow and reduce their exposure to the impending drop in Copaxone sales,” said Sam Fazeli , an analyst at Bloomberg Intelligence in London, told Bloomberg . “We still would have to consider the ramifications of antitrust regulation.” The speculation surrounding which big deal Pfizer Inc. is likely to do in this white hot market reached another level Friday, after Mylan Executive Chairman Robert Coury said he view Pittsburgh, Penn.-based Mylan Inc. as a good fit for Pfizer if his company is successful in buying smaller generic drugmaker Perrigo . Pfizer has been besieged by rumors over the last two weeks that it will make a big M&A move soon, with analysts pushing it to consider buying struggling GlaxoSmithKline , which would double its portfolio and make it an instant pharma powerhouse. But now, new contenders are throwing their hats in the ring: Coury suggested in a recent meeting with shareholders that a Mylan-Perrigo combination sweet deal for Pfizer Inc. , particularly because Pfizer could move its address abroad, reaping lucrative tax benefits. There’s been over $92.5 billion of U.S. healthcare merger activity already in 2015, as healthcare and biotech have boomed over the last 13 months. Executives at all these companies have scrambled to keep up with the 73 percent more M&A activity this year, which has already seen more than 245 deals. Pfizer hasn’t been sitting entirely on the sidelines. It bought generic injectables firm Hospira in February for $16.8 billion and has said it is actively in the market for other smart deals. Indeed, Pfizer has done more deals than any other large pharmaceutical company. That aggressive pursuit DNA led Pfizer to take an unsuccessful run at acquiring British drugmaker AstraZeneca PLC for $119 billion—but that bid, too, fell apart, leaving Pfizer with a stack of cash and frustrated aspirations. Pfizer Chief Executive Officer Ian Read has said in the past that he is dedicated to building out the company’s businesses via “bolt-on” acquisitions or even wholesale takeovers. “Certainly I feel a sense of urgency on utilizing our balance sheet and our capital to do deals that are incremental, add incremental value and certainly add revenue growth in the innovative space,” said Read on a conference call with analysts in October. “We are aggressively looking at all alternatives.” The idea that Pfizer may buy something major soon came as no surprise to analysts. “We believe that other significant acquisitions are possible, though more likely to be aimed at [ Pfizer ’s innovative-pharma side of the company],” Jeffrey Holford , a biotech analyst for Jefferies Group , wrote in a report Thursday. Holder, however, believes Pfizer is better suited to yet another company, Shire , both for its Irish tax address and its complementary portfolio. As for Coury, he has plenty on his plate right now without courting a Pfizer bid. The complicated three-way takeover waltz being conducted between Mylan , Israeli company Teva Pharmaceutical Industries Ltd. (TEVA) and Perrigo Company (PRGO) took another weird turn two weeks ago, after Mylan said that while it still views Teva ’s unsolicited $40.1 billion bid as too low, it might want to acquire Teva itself eventually. Earlier this month Mylan made an unsolicited $28.9 billion bid for Perrigo , a move which Wall Street has taken as a catalyst for Teva to pounce before Mylan becomes a larger, and much more expensive, target. But Perrigo Company rejected that offer almost immediately, saying it “substantially undervalues” Perrigo and “its future growth prospects and “is not in the best interests of Perrigo ’s shareholders.” Now, however, the landscape is changing. Coury made it clear at the same meeting that if Mylan is able to cement its deal with Perrigo , it might go shopping again—and this time to buy Teva , not be bought. “We were just saying in a hypothetical situation, if it ever were to happen after all these other things, the only way it could happen is with us,” Mylan Chief Executive Officer Heather Bresch said at the time. The Perrigo deal would have been just the latest shopping trip for Mylan , which has been attempting to build out its brand via bolt-on acquisitions, including women’s health specialists Famy Care and a massive $5.3 billion tax inversion acquisition of Abbott Laboratories . On Feb. 2 Mylan acquired several women’s health care business units from Mumbai, India-based Famy Care Limited . The deal was handled through Mylan Laboratories Limited , Mylan ’s Indian subsidiary. Mylan does have a host of attractive assets that have been tempting to larger drugmaker, including recent clues from the U.S. Food and Drug Administration (FDA) that Mylan ’s generic ANDA, which is a stand-in for Natco’s multiple sclerosis drug Copaxone. Umer Raffat , a biotech analyst at ISI Evercore , said Monday that Mylan is poised to receive approval for that drug, which would quickly be rushed to market. “My base case continues to be that Mylan will get its Copaxone approved,” said Raffat, “and it intends to commercialize it at the time of market formation.” Will PfizerKline Become the Next Pharma Player? The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.” Gregg Gilbert , a biotech analyst at Deutsche Bank , wrote in a note to investors “Introducing PfizerKline ” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer ’s earnings per share by 10 percent to 16 percent beginning in 2016. “We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.” We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-pfizerkline-become-next-pharma-player", placeholder: "pd_1432740672" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

May 11, 2015 By Riley McDermid , BioSpace.com Breaking News Sr. Editor The complicated three-way takeover waltz being conducted between Pittsburgh, Penn.-based Mylan Inc. , Israeli company Teva Pharmaceutical Industries Ltd. and Perrigo Company took another weird turn Monday, after Mylan said that while it still views Teva ’s unsolicited $40.1 billion bid as too low, it might want to acquire Teva itself eventually. Earlier this month Mylan made an unsolicited $28.9 billion bid for Perrigo , a move which Wall Street has taken as a catalyst for Teva to pounce before Mylan becomes a larger, and much more expensive, target. But Perrigo Company rejected that offer almost immediately, saying it “substantially undervalues” Perrigo and “its future growth prospects and “is not in the best interests of Perrigo ’s shareholders.” Now, however, the landscape is changing An executive with Mylan told Reuters that recent comments from Robert J. Coury , Mylan ’s executive chairman, make it clear that if Mylan is able to cement its deal with Perrigo , it might go shopping again—and this time to buy Teva , not be bought. “We were just saying in a hypothetical situation, if it ever were to happen after all these other things, the only way it could happen is with us,” Mylan Chief Executive Officer Heather Bresch told the news service, saying Mylan is still wary of antitrust issues. A Teva spokesperson declined to comment. Meanwhile, other companies that have felt the ripple effects of these ongoing machinations have seen some unexpected windfalls: Abbott Laboratories , who is now the largest stakeholder in the company after selling its generic drugs unit to Mylan last February, said recently it will use that money to do some of its own M&A. Abbott sold its generic drugs unit in exchange for around 110 million shares of Mylan —which means it’s been reaping the gains of a major boost to its coffers. Abbott ’s equity position in Mylan increased “well north of $7 billion,” according to Abbott ’s Chief Executive Miles White said on an earnings callthat the company’s equity position in Mylan has ballooned from $5 billion at the time of the sale to “Well north of $7 billion” now. “I am watching the great theater out there that is surrounding Mylan ,” White told investors yesterday during a conference call. “I’m happy that we’ve been patient. It is clearly accruing value to us.” As for new M&A, White said on the same call that whatever deals Abbott does do, they will be significant, saying, “I wouldn’t want you to think you’re only going to see ‘little’ out of me.” After months of rumors about the deal, Teva finally made its first bid official last month in an $82 a share in cash and stock deal that would be the biggest takeover attempt so far this year. That bid is 23 percent above Mylan ’s closing price April 16. Any eventual merger could mean more than $27 billion in revenue from the combined companies, although Mylan ’s public rebuke of its suite April 17, in which it raised concerns about antitrust issues, continues to worry analysts. Teva lost patent protection for multiple sclerosis drug Copaxone, for which Mylan makes a generic, last July after a U.S. Federal Appeals Court found the patent protecting the drug would expire in May 2014, not September 2015. “The attraction for Teva is that this deal would immediately allow them to grow and reduce their exposure to the impending drop in Copaxone sales,” said Sam Fazeli , an analyst at Bloomberg Intelligence in London, told Bloomberg Tuesday. “We still would have to consider the ramifications of antitrust regulation.” Meanwhile, Perrigo Company remains steadfast in its rejection of a Mylan marriage, saying only it believes the company is worth more. “ Perrigo has a long history of driving above market shareholder value through consistent growth with a focus on profitability and operational excellence, which is reflected in our organic net sales CAGR goal of 5-10 percent for the next three years,” said Joseph C. Papa , chairman, president and chief executive, in a statement. But Coury has continued to press the issue, saying a merger would be a perfect fit. “We have studied the potential combination of Mylan and Teva for some time and we believe it is clear that such a combination is without sound industrial logic or cultural fit,” Coury said. The deal would have been just the latest shopping trip for Mylan , which has been attempting to build out its brand via bolt-on acquisitions, including women’s health specialists Famy Care and a massive $5.3 billion tax inversion acquisition of Abbott Laboratories . On Feb. 2 Mylan acquired several women’s health care business units from Mumbai, India-based Famy Care Limited . The deal was handled through Mylan Laboratories Limited , Mylan ’s Indian subsidiary. Mylan does have a host of attractive assets that have been tempting to larger drugmaker, including recent clues from the U.S. Food and Drug Administration (FDA) that Mylan ’s generic ANDA, which is a stand-in for Natco ’s multiple sclerosis drug Copaxone. Umer Raffat , a biotech analyst at ISI Evercore , said Monday that Mylan is poised to receive approval for that drug, which would quickly be rushed to market. “My base case continues to be that Mylan will get its Copaxone approved,” said Raffat, “and it intends to commercialize it at the time of market formation.” Mylan is one of the largest generics and specialty pharmaceutical companies in the world, with about 1,400 different products it markets. Teva also focuses on generics, as well as specialty drugs and active pharmaceutical ingredients. It has a portfolio of more than 1,000 molecules, employs more than 45,000 people worldwide and sells in 60 countries. Analysts have continued to dismiss the possible marriage, saying rumors the two might be merging aren’t credible and would do very little to solve Teva ’s current growth problems even if the companies did blend, said Wells Fargo analyst Michael Faerm . Calling it strategically unlikely, Faerm said continued buzz about a possible deal between the Israeli drugmaker and Mylan was overblown. Faerm said acquiring a generic drugs company is probably not a top priority for Teva , while Mylan has not indicated it would even be a willing seller, even if it currently in the process of designing a generic for Copaxone. Teva reported earlier this year that each month of delay in generic competition for Copaxone adds about $78 million to the company’s net revenue and $0.08 to its share price. David Maris , analyst with BMO , said in a note in March that most of the rumors so far about the deal have been baseless and are likely from sources “just putting out fluff.” Maris’s skepticism is related to Mylan recently acquiring some of Abbott Laboratories ’ sagging European generics as part of a tax inversion deal, pointing out that if Teva bought Mylan , the Israeli company would have two choices: Mylan to Israel, which has major tax disadvantages, or compete an inversion and change its domicile to the Netherlands, which would violate Teva ’s bylaws. Maris also believes the acquisition wouldn’t be very good strategically. “ Mylan bought the Abbott products to focus in on Europe—particularly France—and that’s not an area Teva is interested in,” he wrote. In addition, Maris thinks that Teva ’s debt capacity is too small to pull off a Mylan deal. Mylan has a $22 billion-plus market cap, and with a premium and the company’s debt, the deal would be at about $30 billion. “They’re not going to go to junk status,” Maris said in a note, “just to finance this deal.”