No. 3967 August 9, 2019 a very attractive acquisition attempt by rival Teva Pharmaceutical Industries Ltd. for $40bn in 2015. GROWTH THROUGH M&A Mylan acquired Merck KGaA’s generic drug business for $6.7bn in 2007, a pivotal deal that also gave the company the even- tual blockbuster EpiPen (epinephrine). A series of acquisitions from 2014 to 2017 built out the company as Mylan sought to diversify outside of the challenging US generics market, both geographically and through the portfolio mix. The company acquired the non-US es- tablished products business of Abbott Laboratories Inc. in 2014 for $5.3bn, a deal orchestrated in part to move the company outside the US to take advantage of ex-US corporate tax incentives. Through that deal, Mylan redomiciled from Pennsylva- The End Is Nigh For Mylan, But How nia to the Netherlands. Mylan acquired the Indian women’s Different Will The New Company Be? health company Famy Care Ltd. for $750m in 2015, the topicals/injectables firm Re- JESSICA MERRILL [email protected] naissance Pharma Inc. for $950m and the Swedish generic drug company Meda ylan NV has a long history in the business in mid-2020, as the companies AB for $9.9bn in 2016. (Also see “Mylan generic pharmaceutical mar- announced on 29 July. Between generic Turns To Meda In Sweden For Open Door Mket, maintaining its indepen- drug price fixing charges filed against Into Consumer Market” - Pink Sheet, 15 dence while plenty of other mid-sized Mylan by the Department of Justice, on- Feb, 2016.) That year, it also partnered specialty generic peers were absorbed going manufacturing setbacks at its plant with Momenta to develop six biosimilars, into larger corporations. Now the Mylan in Morgantown, West Virginia, exposure strengthening its position in complex bio- story draws to an end with the compa- to opioid litigation and the gloomy cloud logics gained through an earlier partner- ny’s planned merger with Pfizer Inc.’s off cast over the Mylan name by its handling ship with Biocon Ltd.. patent Upjohn business and the creation of EpiPen pricing, there are plenty of rea- By 2016, Mylan generated $11.08bn of a new company. sons why fresh branding may be better in sales, but that growth stalled. In 2018, Mylan’s evolution into one of the top received by investors. Mylan generated $11.43bn. generic drug companies in the world has Mylan was founded in White Sulphur been a roller coaster of highs and lows. Springs, West Virginia in 1961 and went EPIPEN PRICING: A CLOUD For investors, the farewell is touched with public in 1973. Over the last decade, THAT CAST A LONG SHADOW some relief. Mylan grew into a top generic drug The years-long price hikes on the life-sav- It’s no big surprise that a new corpo- manufacturer and top 25 pharmaceu- ing allergy rescue medicine EpiPen were rate name will be unveiled after Mylan is tical player through M&A, even as it one problem, erupting into public out- merged with Pfizer’s off-patent Upjohn fended off what now looks to have been CONTINUED ON PAGE 4 FOR THE LATEST BUSINESS INSIGHT ON THE BIOPHARMA INDUSTRY VISIT: SCRIP.PHARMAINTELLIGENCE.INFORMA.COM Big Pharma’s Q2 Takeda-Shire Merger Bayer’s AI Move Strong growth for some, not all Upbeat on integration and outlook Collaborates with Sensyne Health (p13) (p10-12) (p8-9) IN THIS ISSUE from the editor [email protected] Following on from last week’s news of Pfizer merging its ing sales of the PD-1 inhibitor Keytruda helped lift established products arm Upjohn with Mylan, we bring Merck & Co out of the drug pricing drag on sales. But you further analysis of the businesses behind the head- when it comes to M&A of the significant scale we have lines. For a review of Mylan and its challenges over recent seen with Pfizer/Mylan, Takeda/Shire, Bristol-Myers years, as well as consideration of what is to come, see cov- Squibb/Celgene and AbbVie/Allergan, big pharma ex- er story; turn to p5-6 for thoughts on the future of Up- ecs generally held back from declaring a desire to do john’s recently opened global headquarters in Shanghai. a mega-merger, emphasizing rather their interest in Mylan’s domicile is set to move from the Netherlands to “bolt-ons”. As for Takeda, it says it is progressing well Delaware, US, but Scrip’s China reporter Brian Yang asks with integrating Shire and reported a strong start to if broader geographical shifts are in store. its fiscal year (p8 & p9). Most big pharma companies have now reported At the other end of the biopharma spectrum, Mandy their results for the second quarter. The latest US drug Jackson dives into venture capital financing, with an in- pricing proposals are piling pressure onto firms al- terview with Vida Ventures, which has drawn much of ready challenged by price squeezes outside the world’s its senior talent from Kite Pharma and has just raised biggest pharma market (see p10-12 and p17). Soar- more biotech investment cash (p14-16). 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ISSN 0143 7690. 2 | Scrip | August 9, 2019 © Informa UK Ltd 2019 Shanghai Worries Pipeline Update Italfarmaco Holds Option 20 5 7 20 exclusive online content inside: COVER / The End Is Nigh For Mylan, But How Different Will The Honjo, Ono Remain At Loggerheads New Company Be? As Opdivo Dispute Simmers 3 Honjo, Ono Remain At Loggerheads As Opdivo IAN HAYDOCK [email protected] Dispute Simmers 5 Love From Shanghai: Upjohn Started Here But Will It Stay Post-Mylan? 6 Want To Fly In China‘s New Normal? Learn From Merck 7 Italfarmaco Options Inhaled Teicoplanin For MRSA Lung Infections 8 Takeda Keen To Show Shire Integration On Track 9 Takeda Raises Guidance On Divestments, Improved Velcade Outlook 10 Q2 Review: Big Pharmas Weigh In On M&A, Pricing Reform 12 Biocon Expects US Success For Biosimilar Trastuzumab Despite Amgen Launch The Japanese academic discoverer of the PD-1 protein and 13 Bayer CV Pact Gives AI-Focused Sensyne Health Its First Big the company that co-developed a blockbuster drug based Deal Since 2018 IPO on his work continue to be embroiled in a spat over patent royalties, with the protracted dispute seemingly coming to 14 Ready To Make Bigger Biotech Investments, a head. Vida Raises $600m For Second Fund Tasuku Honjo, a distinguished professor at Kyoto Uni- 17 Roche’s Pipeline Prospects Promise Steady Sailing versity in Japan and Nobel Prize winner, is now said to be To More Growth considering legal action against Ono Pharmaceutical Co. Ltd. should no other settlement be reached in the next 18 Almirall’s Dermatology Pitch Takes Shape few weeks. For its part, the company says it is continuing discus- 20 UCB Spotlights Bimekizumab And Other Later-Stage sions in good faith in the meantime for a possible out-of- R&D Projects court settlement, while also considering its responsibility 21 J&J Drops Alligator’s MAb ADC-1013 After Reviewing to shareholders. Combination Data Honjo, now 77, discovered the T-cell surface protein PD-1 in 1992 and subsequently conducted years of re- 22 Pipeline Watch search to elucidate its function and potential as an effec- 23 Indivior Submits Products For Approval Outside US tive oncology target. For this work, he shared the 2018 Nobel Prize in Physi- 23 Appointments ology or Medicine with James Allison, the inventor of the CTLA-4 checkpoint inhibitor ipilimumab (Bristol-Myers Squibb Co.’s Yervoy). Published online 30 July 2019 @PharmaScrip /scripintelligence To read the rest of this story go to: https://bit.ly/2YLVYSg /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com August 9, 2019 | Scrip | 3 HEADLINE NEWS CONTINUED FROM PAGE 1 of the new company and Malik will serve Mylan CEO rage and resulting in a Congressional in- Heather as president. Bresch is leaving, along with quiry in 2016. The company had raised the Bresch CFO Ken Parkes. The board of directors will price from $100 to more than $600 since have eight members designated by Mylan acquiring the medicine, resulting in an un- and three members designated by Pfizer, tenable situation for patients, who were leaving some industry observers to ques- shouldering steep out-of-pocket costs. tion how significant a change the new The big pricing blunder stoked public leadership structure will be. ire over the high cost of drugs, contribut- While investors approved of Mylan’s ing to broader scrutiny on the whole in- efforts to redomicile in 2015, to appreci- dustry and backlash for Mylan specifically, ate the tax benefits, analysts say it also from the public, pharmaceutical peers, sheltered management.