日本の医薬品業界のこれから

塩野義薬、業界の流れに逆行でも5年で売上高倍増へ－手代木CEO• 高価格帯の治療薬から距離を置き、低分子医薬品の開発にコミット• 塩野義にとっては「提携が道」と、CEOがインタビューで明言

【記者：Natasha Khan】

（ブルームバーグ）：製薬各社は複雑ながん治療薬や100万ドル（約1億900万円）もするような遺伝子治療など、利益率の高い分野の医薬品開発を急いできた。だが、塩野義製薬はこの業界の傾向にあえて逆らうことを決め、その戦略で向こう5年間に売上高の倍増を目指している。同社はブロックバスターとなったコレステロール降下薬「クレストール」の創製で知られる。

塩野義薬の手代木功最高経営責任者（CEO）はインタビューで、世界的な製薬会社の多くが注目しなくなってきている抗生物質のような、それほど複雑でない「低分子」医薬品の開発に引き続きコミットしていくと述べた。

同CEOによると、最高価格帯の新薬に注力しないと決定してから同社には多くの否定的なコメントが寄せられた。しかし戦略が奏功するにつれ、そうした声もやんだという。同社の株価は過去2年で3倍に値上がりしている。

手代木CEOはインタビューで、「私は当時、社内外から大変批判された。このような製品は安い上に古いと指摘され、常軌を逸しているとも言われた」と振り返った。

塩野義薬の2016年3月期の売上高見通しは3015億円。同社の中期経営計画では21年3月期に5000億円に拡大の見込みだが、手代木CEOによれば、社内的には同じ期間で6000億円にするのが目標。

同CEOの下、塩野義薬は国際展開する大手製薬会社と組んだ製品も含めて市場への投入を続けた。さらなる成長に向け、一段の提携に関心があると、手代木CEOは話した。アストラゼネカやグラクソ・スミスクラインといった既に提携しているパートナーを含め、将来の事業チャンスを迅速につかめるよう大手と連絡を取り合っているという。「提携が当社の進む道だ」と同CEOは明言した。

同社は出資先の英ヴィーブヘルスケアから入るHIV感染症治療薬のロイヤルティー収入のほか、他の承認薬や開発中の医薬品も売り上げをけん引すると期待している。

今年3月時点で塩野義薬の新薬パイプラインの約68％は、開発提携したものも含め自社発だった。手代木CEOによると、向こう数年はこの比率を50％以上に維持する方針という。

原題：Crestor Developer Sees Sales Doubling With Lower-Priced Drugs（抜粋）

関連ティッカー：4507 JP (Shionogi & Co Ltd)AZN LN (AstraZeneca PLC)GSK LN (GlaxoSmithKline PLC)

Crestor Developer Sees Sales Doubling On Lower-Priced Drugs

Photographer: Kiyoshi Ota/Bloomberg Photographer: Kiyoshi Ota/Bloomberg

(Bloomberg) — Across the pharmaceutical industry, companies have rushed towards medicines with sky-high prices — making bets in lucrative areas like complex cancer treatments and even gene therapy that could come with a $1 million price tag.

Japan’s Shionogi & Co., best known for its early development of the blockbuster cholesterol medicine Crestor, says it’s making a conscious decision to buck the trend -- and aims to double its revenue in the next five years through that strategy.

Shionogi is staying committed to developing less complex or “small molecule” treatments like antibiotics that many other global drugmakers are paying less attention to, Chief Executive Officer Isao Teshirogi said in an interview. The decision to not focus on the highest priced category of emerging medicines has drawn plenty of negative comments, he says, adding that has abated as its strategy has paid off. Shionogi’s shares have tripled over the past two years.

“At the time I got a lot of criticism – from the outside and the inside,” said Teshirogi. “People were saying: these products are cheap and they’re old – they were asking if I was crazy.”

The company’s sales forecast for the year ending March 2016 is 301.5 billion yen ($2.8 billion). This is projected to increase to 500 billion yen ($4.6 billion) for the year ending March 2021, the company said in its mid-term plan. Its internal target for the same time-frame is higher at 600 billion yen, according to Teshirogi.

Under Teshirogi’s leadership, Shionogi continued to bring products to market, including several that worked with big international partners. To drive growth, the company is interested in further tie-ups, he said. It’s constantly in touch with the biggest drugmakers -- including existing partners AstraZeneca Plc andGlaxoSmithKline Plc -- so it can quickly jump on future opportunities, he said. “Partnerships are the way to go for us.”

The company’s shares were up 1.06 percent at the close of Tokyo trading. The benchmark Topix index was down 0.73 percent.

Royalties

HIV medicine royalties from its stake in U.K.-based ViiV Healthcare, other drug approvals, sales for a flu drug it’s making with Roche Holding AG and antibiotic and opioid treatments under development will also help drive revenues, according to the company.

Teshirogi says that the company has chosen to tackle two ends of the patient market -- the young who are vulnerable to ‘sudden death’ from infectious diseases and the terminally ill whose last days can be made more tolerable through pain medicines. That philosophy has also kept it investing in antibiotics at a time when many companies have pulled back.

As of March this year, about 68 percent of Shionogi’s pipeline originated from its own labs, including collaboration products.

It does not intend to have that contribution drop below 50 in coming years, Teshirogi said. This is helped by working with Japanese start-ups at a very early stage to help groom talent and build on domestic scientific prowess, he added.

Shionogi holds 10 percent of ViiV Healthcare, from which it derives royalties and annual dividends. ViiV is a joint-venture that is majority-held by GlaxoSmithKline Plc and also counts Pfizer Inc. as a shareholder. AstraZeneca has global rights to sell Crestor. Shionogi developed Crestor until its mid-stage trials, or Phase 2a, after which it licensed the treatment out to AstraZeneca for further global development.

Royalties from HIV are projected to increase, Fumiyoshi Sakai, an analyst at Credit Suisse wrote in a February note. The company’s strategy of focusing on small molecules has worked so far, with success on drugs such as Crestor and HIV treatment Tivicay, he said.

Root Problems

Japanese pharma companies are facing increasing pricing pressures at home. An aging population and a massive government debt burden have Prime Minister Shinzo Abe’s government insisting on price reductions for branded drugs and pushing for a speedier transition to generics.

Drug prices will be the defining “root” issue for the industry for some time to come, Teshirogi said, especially with the number of drugs costing hundreds of thousands of dollars.

“We’ve factored in the potential cuts, but it needs a serious discussion -- who is taking the risk, who is making the developments and what is the process we are offering to each patient in each country?” said Teshirogi, who took over as CEO in 2008, after spending a few years as head of R&D.

The decision to stay away from higher priced drugs was shaped by his time as head of the Japan Pharmaceutical Manufacturers Association from May 2011 to May 2014. He also remembers conversations during those years with his elderly father –- age 88 at the time –- over the amounts to spend on treatments. “It gave me an opportunity to think,” he said.“How long can the world afford such high prices?”

Related ticker:4507 JP (Shionogi & Co Ltd)

• Shionogi made decision to stay away from expensive category• CEO says in interview that “partnerships are the way to go’’

By Natasha Khan

FOCUS ON PHARMA 02 // 03

新製品に賭け日本で大勝－小野薬、新種のがん治療薬で世界をリード

【記者：Natasha Khan】

（ブルームバーグ）：10年前、小野薬品工業の担当者らは開発中の新製品を試験してくれる医師を求めて病院巡りを続けていた。ヒトの免疫システムを、がんと闘わせるための新しい治療薬だったが、耳を貸す医師はいなかった。

免疫療法は流行の一つにすぎないと言われた。批判者の一人は同治療法について、がん患者にキノコを食べさせるのと変わらないとの意見まで出した。効果があったら頭を丸刈りにすると言う人もいた。

相良暁社長は、米ブリストル・マイヤーズ・スクイブと共に開発したがん免疫治療薬「オプジーボ」が2014年７月に日本で承認された時、大勢の人から謝罪を受けたと話す。

「抗ＰＤ―１抗体」と呼ばれる新種のがん治療薬として世界で初めて承認されたものだった。

オプジーボは、がん細胞自体を直接攻撃するのではなく体ががんと闘うのを助ける免疫腫瘍学という分野の治療薬の一つだ。科学誌サイエンスが13年にがんの免疫療法を

「今年のブレークスルー」と呼び、世界の大手製薬会社が一斉に参入している。

2月半ばに小野薬の目標株価を2万5000円に引き上げたクレディ・スイスのヘルスケア業界アナリスト、酒井文義氏は同社が世紀の宝を発見したと評価している。3月3日の終値は2万2605円と過去最高値を更新。過去1年で70％余り上昇した。

オプジーボは売り上げ低迷と特許切れ、後発薬との競争激化に苦しんでいた小野薬に息を吹き返させた。アナリストらは同社の年間売上高が２倍余りに拡大し、18年3月期には30億ドル前後に達するとみている。

平均的な米国のがん患者の場合で、オプジーボの治療は年間15万ドル（約1700万円、月1万2500ドル）程度の費用がかかる。ブルームバーグ・インテリジェンスによれば、アナリストのコンセンサス予想はオプジーボの世界売上高が20年までに年95億ドルに達する可能性を示唆している。他のがん種で承認獲得急ぐ

オプジーボが14年7月に悪性黒色腫（メラノーマ）の治療向けに承認されて以来、がん免疫治療薬の市場では競争が激しさを増しており、小野薬の現在の課題はリードを維持する新たな方法を見つけることだ。同社は血液がんなど他の20種余りのがん種に対するオプジーボの効果を調べる臨床試験の完了を急いでいる。

相良社長は大阪でのインタビューで、17年3月期の優先課題は胃がんや食道がん、頭頸部（とうけいぶ）がんの治療向けに国内で承認を得ることだと説明。オーファンドラッグ

（希少疾病薬）の指定を受けることで1年以内に承認を得られると考えていると語った。また、オプジーボと別の薬による併用療法についても国内での承認獲得を目指す。

相良社長によると、同社は国内でのオプジーボの販売促進のため営業スタッフを6倍の180人に増やした。今年はさらなる提携に向けて進展があるかもしれないと語ったが、詳細は明らかにしなかった。

原題：Drugmaker Wins Big in Japan As Its Gamble Leads To $150,000 Drug（抜粋）

関連ティッカー：4528 JP (Ono Pharmaceutical Co Ltd)BMY US (Bristol-Myers Squibb Co)—取材協力：黄恂恂. 

Drugmaker Wins Big in Japan As Its Gamble Leads To $150,000 Drug

(Bloomberg) — Ten years ago, representatives from Japan’s Ono Pharmaceutical Co. went from hospital to hospital, attempting to convince doctors to test a new product under development: drugs that helped the body’s immune system fight cancer. Nobody would listen.

Immuno-therapy was another fad, they were told. The treatment probably offered no bigger benefit than eating mushrooms to fight cancer, one critic opined. Another said he’d shave his head if it worked.

Ono’s Chief Executive Officer  Gyo Sagara  says he received plenty of apologies when Opdivo, the drug the Japanese company  worked  on with  Bristol-Myers Squibb Co., got the green light from regulators. The drug’s approval in Japan 20 months ago was the first worldwide in a new class of cancer treatments called PD-1 inhibitors.

It is among a string of therapies coming to market in the immuno-oncology category – medicines that help the body combat cancer rather than directly attacking the cancer cells themselves. The influential Science journal  calledcancer immunotherapy the “breakthrough of the year” in 2013, and the biggest global pharmaceutical companies are rushing into the field.

“They found the treasure of the century,” said Fumiyoshi Sakai, a health-care analyst with Credit Suisse, who boosted his target price for the stock to 25,000 yen in mid February. Ono’s shares closed at an all-time high of 22,605 yen on Thursday after climbing more than 70 percent over the past year.

The drug is pumping fresh life into Ono, which for years has battled slumping sales, patent expirations and rising competition from cheaper generics. Analysts now forecast that the Japanese company -- among the biggest makers of specialty pharmaceuticals in Asia with a market cap of about $23 billion -- will more than double annual revenue to about $3 billion by fiscal year end March 2018.

For the average U.S. patient, Opdivo costs about $12,500 a month, or $150,000 for a year of therapy. Bloomberg Intelligence says that consensus analystestimates suggest that by 2020, Bristol-Myers and Ono’s Opdivo could have global sales of $9.5 billion and Merck & Co.’s Keytruda $5.1 billion.

New Drugs

For Ono’s CEO Sagara, the challenge is to now find new ways to keep his company ahead in this lucrative market. Competition has become fierce since Opdivo’s approval first for melanoma, a type of skin cancer, and later for lung cancer. Opdivo was approved  in Japan in July 2014. By September, Merck’s Keytruda  had received  the green light from regulators in the U.S., beatingOpdivo’s U.S. approval by a few months.

To head off its rivals, Ono is racing to complete clinical studies to see how effective the drug might be in more than 20 other types of cancer, including blood cancer. The priority for the next fiscal year, which ends March 2017, is to get approval for gastric cancer, esophageal cancer and head and neck cancer in Japan, Sagara said in an Osaka interview.

He believes the company would be able to get those within a year, especially because they’re potentially ‘orphan’ drugs, which get quicker approval because they treat rare diseases. Ono will also try and get combination therapies approved in Japan -- possibly along the lines of a combo created by partner Bristol-Myers that joins Opdivo with another treatment. Bristol-Myers said in October its combination of two key cancer drugs would carry a list price of $256,000 a year on average.

Ono has hired six times as many sales representatives to promote Opdivo in Japan,  Sagara said, bringing the sales staff to 180. There also may be some developments on further partnerships, Sagara said, declining to provide details.

Lucky Gamble

Ono is an anomaly among Japanese pharmaceutical companies, most of which have struggled to find brand new medicines. Sagara credits his company’s success with Opdivo to a gamble it took more than a decade ago in working with some university researchers on a little known course of treatment.

For ten years, immunology professor Tasuku Honjo and his team at Kyoto University had studied the PD-1 protein that has the ability to weaken the functioning of attack cells within the immune system. PD-1 inhibitor drugs prevent that from happening, essentially triggering the immune system to act against the cancer. Honjo’s mentor had helped Ono bring some products to market and he himself had some collaborations there, and so he approached them.

Although it didn’t fund early research, Ono helped the scientist apply for a patent and the company and researcher were listed as co-inventors. Over the course of a year, Ono approached a long list of potential partners to see if they could co-sponsor a trial. But this was 2002, and no one bit. That changed when the company agreed to work with Medarex -- an American company founded by Dartmouth professors. A multi-year co-development partnership was struck in 2005, one that continued and expanded after Bristol-Myers bought Medarex in 2009.

Roller Coaster

Opdivo marked the first time in 12 years that the company was able to get a novel drug approved, and “everyone here is invigorated,” Sagara said. “Surprise. Surprise. We firmly believed we could make it, but then it was proven.’’Ono now derives a portion of its revenue from an agreement

By Natasha Khan

Photographer: Antoine Antoniol/Bloomberg

FOCUS ON PHARMA 04 // 05

Photographer: Mike Mergen/Bloomberg News

Ono now derives a portion of its revenue from an agreement with Bristol-Myers Squibb, which has rights to develop and commercialize the drug in North America and most other parts of the world.

The Japanese company gets 4 percent of any Opdivo sales in the U.S. and 15 percent of sales outside of North America, excluding Japan, Korea and Taiwan, where Ono has rights to sell the drug. 

Honjo, who still works with Ono on various projects, said he’s now negotiating with Ono to sort out the terms of a royalty agreement. Ono declined to comment on any talks.

Ono and Bristol-Myers also have legal issues to work around. In a Sept. 25  complaint filed in a U.S. district court against Ono, Bristol-Myers and Honjo, the Boston-based Dana-Farber Cancer Institute asserted that two U.S. researchers should be added as co-inventors on some patents related to PD-1 treatments. Dana-Farber said it had no further comment. Ono and Honjo referred questions to Bristol-Myers, which said it had no further comment on the complaint at this time.

The Japanese and U.S. partners, in turn, also have pending suits against Merck in the U.S. and other parts of the world alleging that Merck’s PD-1 product Keytruda had infringed their patents and claiming compensation for that. Merck said via e-mail it is confident that it will be able to market Keytruda in any country in which it is approved and that it won’t be prevented from doing so by the Ono or BMS patents or any pending patent.

Sagara faces other pressures at home. Japan has a national health-care system and investors worry that the government, which sets drug prices, will continue to push them lower. In Japan, Opdivo costs about 1.15 million yen ($10,200) a month for melanoma, and 2.6 million yen a month for a type of lung cancer. Japanese patients get a large portion reimbursed through the government system, and a patient with an average income might only end up paying about 100,000 yen a month for the lung cancer treatment.

The drug’s price could come down as sales volumes rise more than expected in the health system.

All that makes continued innovation even more important for Ono. “We need to collaborate with globally top-class academia because what we can do in the lab is limited,” Sagara said. The company has a team to explore new projects with ten people based in Osaka, four in the U.K. and five in the U.S.

“Challenger spirit. Never give up,” Sagara said, using a Japanese term that signifies perseverance and determination.

Related tickers:4528 JP (Ono Pharmaceutical Co Ltd)AZN LN (AstraZeneca PLC)BMY US (Bristol-Myers Squibb Co)MRK US (Merck & Co Inc)PFE US (Pfizer Inc)ROG VX (Roche Holding AG)--With assistance from Grace Huang. 

Photographer: Kiyoshi Ota/Bloomberg

そーせいG：新薬開発で近い将来さらなる提携模索－田村社長

【記者：Natasha Khan】

（ブルームバーグ）： バイオ医薬品会社のそーせいグループは今年、新薬の開発に加え、主力の肺疾患治療薬以外に事業を多角化するため、さらなるパートナーシップを結ぶ可能性がある。田村眞一社長が明らかにした。米ファイザーの日本法人が昨年11月、そーせいの第三者割当増資に応じ、株式約3％を取得している。

田村社長は都内でのインタビューで、同社のパイプラインには開発が進んだ段階に達しているものがあると説明。これらについては、いずれパートナーを得られると考えており、それが2016年の最初の大きなニュースとなり得ると語った。

そーせいは、がんや慢性閉塞性肺疾患（COPD）などの治療薬開発で、既に英アストラゼネカやスイスのノバルティスなどとパートナーシップやライセンス契約を結んでいる。昨年2月には、英国の同業ヘプタレス・セラピュティクスを買収した。この買収で新たな新薬候補を手に入れ、これらの一部が大手製薬会社の関心を引きつけている。

田村社長によると、ヘプタレスの製品は全て開発の初期段階にあり、商品化は少なくとも５年先だという。その間は、中期的に新薬候補のパートナーシップや技術提携から収入を得ることを計画していると述べた。

ジェネンテック出身の田村氏は1990年にそーせいを創業。当時、日本ではバイオテクノロジーの新興企業はまだ珍しかった。業界での長年の勤務や多くの拠点で仕事した経験を踏まえ、ベンチャーキャピタルファンドや業界関係者から投資機会について定期的に連絡を受けているという。同社のビジネス開発チームは常に積極的に行動していると説明。ヘプタレス買収など、大きな変化をもたらす取引は自ら指揮していると語った。

原題：Japan’s Sosei Says May Soon See More Partners To Develop Drugs（抜粋）

関連ティッカー：4565 JP (Sosei Group Corp)PFE US (Pfizer Inc)

Japan’s Sosei Says May See More Partners To Develop Drugs

(Bloomberg) — Japan’s Sosei Group Corp., which has seen its stock triple over the past year on tie-ups with international companies, could enter into more partnerships in 2016 to develop new medicines and diversify beyond its main lung disease treatment.

There are drugs in the company’s  pipeline  that are more advanced and “these I believe will be partnered sooner or later,’’  Chief Executive Officer  Shinichi Tamura  said in an interview in Tokyo. “So that could be the first big news in 2016.”

Sosei shares climbed 7.1 percent to 12,340 yen in Tokyo today, while the broad Topix index fell 1.1 percent.

The Tokyo-based drugmaker already has partnerships and licensing agreements with companies including AstraZeneca Plc and Novartis AG to develop treatments for conditions from cancer to chronic obstructive pulmonary disease. Sosei acquired a U.K. biotechnology company, Heptares Therapeutics Ltd., last February for as much as $400 million to help diversify revenue.

The Heptares acquisition brought additional drug candidates to Sosei, some of which have attracted the attention of large pharmaceutical companies.  Heptares has an experimental drug for Alzheimer’s disease in early-stage clinical testing, as well as other compounds for psychosis, migraines, diabetes and attention-deficit hyperactivity disorder. It uses a drug design technology -- called StaR -- to target GPCR proteins, which are the site of action of about 40 percent of drugs on the market today.

Commercialization for the Heptares drugs — all in early stages -- is at least five years away, Tamura said. In the meantime, Sosei plans to derive revenue from pipeline partnerships and technology deals in the mid-term, he said.

Pfizer Inc. said in November it would purchase $33 million of newly issued Sosei shares, representing about 3 percent of the enlarged Sosei share capital. Pfizer at the time said it would also enter  into a drug-discovery collaboration with Heptares to develop new medicines aimed at a handful of biological targets that may play a role in multiple diseases. In November, Heptaresentered into a pact with Israel’s Teva Pharmaceutical Industries Ltd. over a migraine treatment. The partnerships have helped Sosei’s shares triple over the past year.

Formerly an employee of Genentech, Tamura left and founded Sosei in 1990, at a time when biotech start-ups were not common in Japan. He says that through years of being in the industry and being based in multiple places, he is regularly alerted of investment opportunities from venture capital funds or others in the industry. The company’s business development team is “always actively doing something,” Tamura said, though he’s led transformative deals such as the Heptares transaction himself.

Related tickers:4565 JP (Sosei Group Corp)NOVN VX (Novartis AG)PFE US (Pfizer Inc)TEVA IT (Teva Pharmaceutical Industries Ltd)

By Natasha Khan

Photographer: Paul O’Driscoll/Bloomberg News Photographer: Paul O’Driscoll/Bloomberg News

FOCUS ON PHARMA 08 // 09

新生・武田、外に目を向け世界のリーダーに－初の外国人トップの抱負

【記者：Natasha Khan】

（ブルームバーグ）：昨年夏のある夕べ、米ボストンのバイオテクノロジー関連の重要人物が一堂に会した。サクソホンの演奏が流れるこのイベントのホストは武田薬品工業のクリストフ・ウェバー最高経営責任者（CEO）と研究開発責任者のアンディ・プランプ氏だ。

ボストンは世界のバイオテクノロジー研究の中心地。武田はここで足場を固め、大学や研究病院、有望な新興企業との関係を深めたいと考えている。

同社初の外国人CEOに昨年就任したフランス人のウェバー氏が新薬候補を拡充し、縮小する日本市場に代わる海外市場として米国や新興国の開拓に取り組む上で、ボストンは重要だ。米国人のプランプ氏とともに、年間売り上げ10億ドル

（約1180億円）超の大型新薬に育ちそうな実験薬の権利を手に入れるため買収や提携を模索していく方針だ。

マサチューセッツ工科大学（MIT）に隣接するボストンの同社研究開発（R&D）施設では約1000人の科学者らが、がんや消化器疾患の治療に役立つ新化合物の研究に励んでいる。この2つは武田が新たに選んだ重要分野だ。施設周辺の地下鉄網の列車内には最近、武田の広告が掲示されるようになった。

「10年前は日本国内で大手であるだけで世界を主導する大企業になれた。日本市場がそれほど大きかったからだが、今はそうはいかない」と、東京本社でインタビューに応じたウェバーCEOは話した。同CEOは武田を腫瘍と消化器疾患の治療で世界のリーダーにする抱負を語った。開発して世界各地で販売できるような新薬の権利を手に入れることを目指す考えも示した。

外に目を向ける必要性

235年の歴史を持つ武田は何十年もの間、日本の製薬業界を引っ張ってきた。同社の「アクトス」はかつて世界で最も売れた糖尿病治療薬だった。しかし最近は主力製品の特許切れや新薬開発の低迷、日本政府による後発医薬品普及を後押しする取り組みなどの逆風に見舞われ2014年3月期の利益は15年ぶりの低水準に落ち込んだ。

過去2年に6つの新製品を投入しこれらの利用を拡大させつつあるが、現時点で後期の開発段階にある重要な新薬は今年中に臨床試験の最終段階に入る見込みのデング熱ワクチンのみだ。

国内投資家の武田株に関するセンチメントは「かなり暗い」と言うクレディ・スイス証券の酒井文義アナリストは「プランプ

氏はこれから大仕事をしなければならない」と話す。「最終段階にある新薬は安くは手に入らない」し、新たな提携の成果が表れるまで５年以上かかる場合もあると同氏は指摘した。

ウェバー氏（49）は14年に最高執行責任者（COO）として武田に加わり15年4月にCEOに就任した。英製薬大手グラクソ・スミスクラインに20年在勤したベテランの同CEOは、ここ数カ月の間に海外の製薬会社から人材を起用し重要ポストに据えた。その1人が仏サノフィから武田入りし最高医学・科学責任者（CMSO）となったプランプ氏だ。

製薬業界では世界的に、自前の開発にこだわらない傾向が広がっている。ウェバーCEOも新薬を求めて外に目を向ける必要性を感じている。同CEOは「このごろは新しい分子の多くが大手製薬会社以外によって発見されている」と指摘。「従って、われわれも謙虚になり、社内での開発能力もあるが外部にも目を向ける必要があると認めなければならない」と語った。

昨年12月には、iPS細胞を初めて作製し12年のノーベル生理学・医学賞を受賞した山中伸弥教授との共同研究を開始した。同教授が所長を務める京都大学ｉＰＳ細胞研究所と締結した10年間の共同研究契約の下で、糖尿病やがんなどの分野の研究を進める。

最近数週間にはシカゴを拠点とするクール・ファーマシューティカルズ・デベロップメントとの契約など数件の提携を発表した。クール・ファーマは米ノースウェスタン大学ともに、小腸がグルテンに過敏に反応する自己免疫疾患であるセリアック病治療薬を開発している。プランプ氏は、今後6カ月にさらに、新薬開発に向けた多数の提携について発表すると述べている。

腫瘍と消化器疾患の分野での買収も

腫瘍と消化器疾患を武田の主要2分野と位置付けるウェバーCEOは、これらの分野での買収もあり得ると述べた。詳細には触れなかった。武田は過去2年に販売を開始した有力製品、潰瘍性大腸炎治療剤「エンティビオ」と多発性骨髄腫治療薬「ニンラロ」を軸に、この2つを重要分野に定めた。

プランプ氏は開発中の新薬の手持ちを急いで増やさなければならないという圧力は感じていないという。エンティビオなど最近投入した製品は長いライフサイクルを見込めるためだ。また、新薬獲得を他社買収のみに頼るのではなく、自社開発や初期段階での提携を通じて時間をかけて育てていきたいとの考えも示した。

「2世紀以上前からある会社で研究開発は100年やっているが、武田は新会社に生まれ変わったばかりだ。新たな視点と見通しを持つようになったのは恐らく5年ほど前で、これは製薬業界では赤ん坊のようなものだ」とプランプ氏は話した。

原題：As Fortunes Fade at Home, Japan Drug Titan Eyes Greener Shores（抜粋）

関連ティッカー：4502 JP (Takeda Pharmaceutical Co Ltd)

Shinya Yamanaka and Christophe WeberPhotographer: Yuriko Nakao/Bloomberg

FOCUS ON PHARMA 10 // 11

As Fortunes Fade at Home, Asian Drug Titan Eyes Greener Shores

(Bloomberg) — Japan’s Sosei Group Corp., which has seen its stock triple The balmy summer evening last year saw some of the most prolific biotech and scientific minds of Boston come together. There was theprovost of MIT, enjoying the saxophone music alongside a U.S. congressman and senior venture capitalists. Their hosts: the Frenchman and the American tasked with turning around the fortunes of Asia’s largest drugmaker, Takeda Pharmaceutical Co.

On the lawns of its Boston hub, the Japanese company was courting international partners as it builds a stronger foothold in the American city, an epicenter of innovation in the biotechnology world. It joins a race with other big pharma companies, who have built a presence there to tap universities, research hospitals and a robust start-up community.

Boston is key to the ambitions of Christophe Weber, the Frenchman who last year took over as Takeda’s first foreign chief executive officer. Weber is attempting to replenish the  235-year-oldcompany’s flagging pipeline of drugs and offset the shrinking Japanese market withgrowth in the U.S. and in emerging markets. Together with Andy Plump, the American he charged with managing research and development, he is hunting for acquisitions or partnerships to win control of new experimental medicines that can be turned into blockbusters — drugs with annual sales of more than $1 billion.

At the company’s Boston R&D facilities — adjacent to MIT and a short walk away from Harvard -- about 1,000 scientists are studying new compounds focused on conditions including cancer and gastrointestinal diseases, newly marked as a focus for the company. Trains on the area’s subway system were recently plastered with ads from the Japanese company.

“Ten years ago you could be a leading global company by just being big in Japan because the domestic market was so big, but today it’s impossible,” said Weber. In wide-ranging interviews at Takeda’s Tokyo headquarters, Weber laid out his ambitions to make the company a global leader in oncology and gastrointestinal treatments and gain control of new drugs the company can develop to sell worldwide.

Stock Price

Investors are displaying some skepticism. While Takeda’s shares have climbed about 8.5 percent over the past year, they have lagged the 18 percent gain in the Topix Pharmaceutical Index, a gauge of Japanese drug companies. Sentiment from domestic investors on the stock is still “quite gloomy,” said Fumiyoshi Sakai, an analyst at Credit Suisse.

For decades, the Japanese company was a pioneer in the pharma industry at home and even gained global attention for Actos, once the world’s best-selling diabetes drug. With about 1.78 trillion yen ($15 billion) in annual revenue, Takeda  ranks 18th among the 20 largest pharma companies worldwide. But in

recent years, it has faced an array of problems: patents for its biggest medicines expired, its 5,000 scientists produced few new drugs and Japan’s government pushed cheaper generic treatments to ease strained fiscal budgets. Earnings hit a 15-year low in the year ended March 2014. Global pharma rivals, meanwhile, have brokered multi-billion-dollar acquisitions and profited from the launch of new medicines.

Takeda has introduced six new products in the past two years and is expanding uses for those. Still,  the company has no significant late-stage experimental drugs in its pipeline besides a dengue vaccine that is expected to this year reach the final rounds of human trials. “Andy Plump has a huge job ahead,” said Sakai. “Clearly late-stage pipeline doesn’t come cheap.” Also, the company could face a wait of more than five years before it sees results on newer partnerships, he said.Weber, 49 years old, joined Takeda in 2014 as chief operating officer before ascending to the top role in April last year. A 20-year veteran of GlaxoSmithKline Plc, where he had been head of the vaccines business, he was recruited by predecessor Yasuchika Hasegawa, who was himself the company’s first CEO from outside the founding family.

In recent months, Weber has filled key executive positions with external hires from international pharmaceutical competitors. To revive research and development, he hired Plump from French drugmaker Sanofi to be Takeda’s chief medical and scientific officer. To mentor local talent, Weber’s also begun hosting leadership programs including a ‘President’s Forum.’ He also holds regular conference calls with the top 300 managers so they can have direct access to the CEO, not common in Japan.

International executives are rare in Japan and have had a mixed record. Howard Stringer, the former Sony Corp. president, stepped down in 2012 after overseeing four straight annual losses. Nissan Motor Co.’s Carlos Ghosn has been credited with turning around the carmaker.

In November, Takeda announced a joint-venture for Japan with Israel-basedTeva Pharmaceutical Industries Ltd., the world’s biggest generic drug manufacturer, to pool local resources to boost sales of generics. And on Weber’s watch, Takeda ended several years of litigation by agreeing to pay more than $2 billion to settle thousands of lawsuits in the U.S. that claimed the drugmaker hid the cancer risks of the Actos diabetes medicine. (The companydenies the treatment poses any risk.)It also sold a respiratory business to British drugmaker AstraZeneca Plc for $575 million in December as it focuses on its core areas. The company “might have a few businesses still to dispose” as it continues to focus on core therapeutic areas, Weber told participants of the J.P. Morgan Healthcare Conference in San Francisco this week, without specifying which assets.

By Natasha Khan

Weber’s move to settle the Actos suits was welcomed by several analysts,  andAtsushi Seki, an analyst with Barclays, said Weber has done a good job stabilizing Takeda during the transition. Even so “a lot of work is required to gain confidence from both Japanese and international investors,” Seki said.Seeking Innovation

Analysts, on average, are forecasting that Takeda will have earnings of about 81 billion yen for the year ending March 2016. That’s less than a third of what profits had been in 2011.

Globally the tide sweeping the big pharma landscape is innovation outside its laboratories, and Weber acknowledges the need for the Japanese company to be looking outwards to come up with new treatments. “The majority of new molecules discovered today are not by big pharma,” said Weber. “So we need to be very humble in a way and say yes we will have internal capability, but we need to think external as well.”

In December, Takeda began a tie-up with Shinya Yamanaka, the Japanese researcher who won the 2012 Nobel Prize for his research on stem cells. Under the ten-year, $170 million pact, Takeda will partner with the scientist’s center to study ways to use cell technologies for conditions such as diabetes and cancer.

In recent weeks, the company has announced several partnerships including one with Chicago-based Cour Pharma, which along with Northwestern University has researched treatments for celiac disease, a condition in which the small intestine is over sensitive to gluten. Plump says there is more

to come and in the next six months a number of other tie-ups on new medicines will be announced.

Weber wants to steer the company to two main therapeutic areas: oncology and gastrointestinal diseases. Acquisitions are a possibility in those areas, he said, without providing details. Those focuses were built around two high potential drugs Takeda has launched in the past two years: Entyvio for ulcerative colitis and Ninlaro for treatment of multiple myeloma, a cancer of plasma cells. Takeda has said Entyvio will reach peak sales of $2 billion, without mentioning a specific date.

Plump says he doesn’t feel pressured to populate Takeda’s pipeline immediately because recently launched drugs like Entyvio will have a long life cycle and give the company “a runway of at least five years assuming nothing awful happens.” Plump also says the company doesn’t want to solely rely on outside acquisitions and prefers, instead, to focus on building its pipeline and early partnerships over time.

“Despite the fact that it’s existed for more than two centuries and has been doing R&D for 100 years, it’s a newborn company,” said Plump. “It was given a fresh perspective and a new outlook maybe five years ago, but it’s like a baby in the industry.”

Related ticker:4502 JP (Takeda Pharmaceutical Co Ltd)

Christophe WeberPhotographer: Yuriko Nakao/Bloomberg

FOCUS ON PHARMA 12 // 13

白衣に試験管のCEO、写真から幹細胞へ－富士フイルム古森氏の賭け

【記者：松田潔社、 Natasha Khan】

　　（ブルームバーグ）：実験用の白衣に試験管を手にした富士フイルムホールディングスの古森重隆最高経営責任者

（CEO）兼会長の写真が日経ビジネス誌の表紙を飾った。

　　古森氏は科学者ではない。しかし、このいでたちこそ写真用フィルムから新たな科学技術の市場に足を踏み出した富士フイルムを体現している。エボラ出血熱の治療薬、アンチ・エイジング化粧水、幹細胞と時代の最先端を目指す。

　　デジタルカメラ普及に伴い、2000年以降写真用フィルム需要は急減。業界は大打撃を受け、最大のライバルだった米イーストマン・コダックは12年に経営破綻した。かたや富士フイルムは今期（16年3月期） 純利益見通しが1200億円で、前期に続き最高益更新を見込む。市場予想は1257億円。昨年11月に中期経営計画で定めた17年3月期の目標、1200億円の前倒しでの達成も視野に入る。先月の四半期決算発表時には最大1000億円の自己株式取得も表明した。

　　古森氏はさらに攻勢に出る。中計では17年3月末までに最大5000億円を合併・買収（M&A）に投じるとした。中でもヘルスケアは成長ドライバーの一つ。前期の売上高3943億円から19年3月期には1兆円を目指すという。古森氏は、成長の大きな要素となるのは再生医療だと話す。人工的に培養した細胞を使用するなどして、傷ついた臓器を修復する新しい治療法だ。

　　「勝ったとはまだまだ言えない」と75歳の古森氏は話す。 「状況はものすごいスピードでどんどん変わっている。絶えずいろいろなことに対応してなければならない」。

再生医療

　　再生医療の研究は初期段階だが、日本の規制環境が 古森氏の構想を後押しする。安倍晋三政権は昨年、薬事法を改正。再生医療に使う細胞や組織の早期承認が可能となり、 再生医療関連製品などを迅速に市場に投入できるようにした。

　　富士フイルムは3月末、バイオベンチャー企業、米セルラー・ダイナミクス・インターナショナル（CDI）を約3億ドル（約370億円）で完全子会社化する計画を発表した。資料によると同社は、あらゆる細胞に成長する能力のある人工多能性幹細胞（iPS細胞）を大量に安定生産する技術に強みを持つという。

　　こうした技術と、富士フイルムや昨年連結子会社化したジャパン・ティッシュ・エンジニアリング（J・TEC）が持つ技術を利用し、臓器再生医療を開発するのが狙い。J・TECは人工の表皮や軟骨などをすでに商品化している。

ゲームチェンジャー

　　「こう考えてみてはどうだろう。われわれは細胞を管理することを専門に行う会社だと」。医療分野を担当し、化学者でもある戸田雄三取締役は英語でのインタビューで話す。フィルム事業で極めて小さな環境をフィールドにしていた感性は、生体のミクロン環境でも役に立つとし、「勝てる領域でのゲームチェンジャー」を探しているという。

　　古森氏の改革が始まったのはCEOに就任した03年。デジタル化の波がフィルム需要を急激に侵食していた。古森氏は自社が持つ写真用フィルムに使用する技術などの再評価を技術者や幹部にさせ、市場拡大が見込める分野での応用の可能性を探った。こうして化粧品や液晶画面に使われるフィルムなど、新たなコア事業に結び付いた。

　　買収も行った。08年に子会社化した富山化学工業は、開発したインフルエンザ治療薬が昨年、エボラ出血熱対策に投与された。現在の売上高構成比の半分弱を占めるオフィスプリンターやデジタル複合機などのドキュメントソリューション部門は安定した収益を生み出しており、古 森氏は新しいバイオテクノロジーや医薬品事業が将来の成長ドライバーになると考えている。

もう一段のM&A

　　株式市場はこれまでの構造改革に理解を示す。株価は過去1年で7割上昇。バリューサーチ投資顧問の松野実社長は「コアとなる事業を失いながらも、事業の多角化に取り組み収益を立て直したことは評価に値する」という。ただ「各領域で世界的なリーディングカンパニーになるためには、もう一段のM&Aや戦略提携が必要」と指摘した。

　　会社にとって未踏の領域に踏み出していくことはリスクに直面することでもある。新製品がうまくいかなかったり、利益をもたらすのに時間がかかりすぎる可能性はある。

　　三菱UFJモルガン・スタンレー証券の小宮知希アナリストは、医薬品事業は「うまくいく可能性が、事務機やカメラと違っ

て低い」とみる。「リスク・リターンを考えると、どういう風に成長するかまだはっきりとみえていない」と話す。

　　古森氏は、自身の役割を軍の司令官になぞらえる。それはリスクをとる前にあらかじめ計算し尽くすことであり、13年に出版した自著「魂の経営」では、第二次世界大戦中に戦局を予測しドイツへの降伏を回避したチャーチル英首相に言及する。古森氏はトップの覚悟を「われわれの将来を賭ける、その度胸があるかどうかだ。決断は誰にでもできるものではない」と話す。

技術の転用

　　新規事業の中には、研究チームが新しいアイデアを試したことがきっかけとなったものもあった。R&D統括本部、医薬品・ヘルスケア研究所の田代朋子氏は育児休暇が明け、05年に研究チームに復帰した。写真印刷用のインクジェット紙の色あせ防止を研究していた田代氏に与えられた課題は、この技術をスキンケア化粧品に転用し商品化する可能性を探ることだった。

　　田代氏はインタビューで「当初は途方に暮れたものの、 しばらくして手ごたえをつかんだ」と話す。フィルムも肌も共通してコラーゲンが重要な役割を担っていた。約2年で、田代氏のチームは機能性化粧品アスタリフトの開発に漕ぎつけた。写真の劣化を防ぐ抗酸化技術などが、 肌のコラーゲンを守る成分に応用できたという。スキンケア製品の売り上げは100億円を超え、田代氏も気に入っているというジェリー状美容液

「ジェリーアクアリスタ」は9月からリニューアル発売する。

チェキ

　　写真に関わる製品やサービスなどを扱うイメージングソリューション事業でも14年3月期に黒字化を達成。富士フイルムは増益幅は拡大すると予想している。インスタントカメラ「チェキ」は世界中いたるところでの結婚式で使われる。

　　「今、あなたたちが目にしている新商品は氷山の一角に過ぎない」 と戸田取締役は言う。「何十年にもわたるわれわれの研究開発で培った技術とノウハウは、ようやくそれぞれの可能性の芽が出たばかり。これからもっともっと期待できる」。

An employee holds a jar of Fujifilm Corp.’s Astalift brand Jelly Aquarysta anti-aging serum at the company’s showroom in Tokyo. Photographer: Kiyoshi Ota/Bloomberg

FOCUS ON PHARMA 14 // 15

Pivoting From Photos to Stem Cells, Fujifilm Finds a Second LifeBy Natasha Khan and Kiyotaka Matsuda

(Bloomberg) — During a recent magazine shoot in Japan, Fujifilm Holdings Corp.’s Chairman Shigetaka Komori posed in a white lab coat, wielding a test tube in his hand.

Komori is no scientist, but the image embodies the Japanese brand’s shift away from photo-film and to new science and technology markets: Ebola drugs, anti-aging lotions and stem cell research.

Over the last decade, Komori diversified into new businesses as demand for the company’s trademark green photo-film boxes plummeted and archrival Eastman Kodak Co. went bankrupt. Fujifilm this year reported record profit of 119 billion yen ($950 million) and analysts expect a jump of more than 5 percent by next spring. Last month it announced a 100 billion yen share buyback -- its largest ever.

Now, the 75-year-old executive is venturing further into uncharted territory, with plans to spend more than 400 billion yen on acquisitions by 2017, add new product lines and make a more aggressive push into health care. Among the new ideas he is testing: a filter for natural gas purification and stem cells capable of regenerating tissue in the human body.

“I wouldn’t say we’ve won yet,” said Komori, who is also chief executive officer. “It’s difficult for any company to declare that because everything is changing so fast. We’re going to keep going.”

Regenerative Medicine

In an interview on the 12th floor of Fujifilm’s Tokyo headquarters, Komori laid out his ambitions for the next stage of the company’s makeover, which includes plans to double health-care revenue to 1 trillion yen by 2018. A part of that mission, he says, will be driven by regenerative medicine, which uses cells and other methods to repair damaged body organs.

While the science is nascent, Japan’s regulatory climate has just turned more favorable. Prime Minister Shinzo Abe’s government recently eased approval rules, making Japan one of the world’s fastest places to get a regenerative medical product on the market.

In March, Fujifilm agreed to pay $307 million for U.S.-based Cellular Dynamics International Inc., a producer of iPS cells, types of stem cells capable of morphing into any body part. Another Fujifilm unit called Japan Tissue Engineering Co. already has regenerated cartilage and skin products on the market, used by burn victims and others. The hope is that these businesses could someday create cells to help damaged organs like the liver or pancreas grow again.

“Think about it like this: we’re a company that specializes in managing cells,” says Yuzo Toda, the chemist Komori has entrusted to lead the push into cosmetics and pharmaceuticals.

“We look for game changers, areas which Fuji can win at. Controlling microenvironments? We know that.”

Japanese Reinvention

Other Japanese tech companies are also trying to reinvent themselves. Walkman inventor Sony Corp. has morphed into a supplier of camera sensors for smartphone makers. Panasonic Corp. has branched off into supplying batteries to Tesla Motors Inc.

Komori’s efforts began a decade ago, when the ascent of digital cameras and smartphones began cannibalizing film sales. That led him to push the company’s engineers and executives to take a long, close look at the technology that helps perfect the dozens of layers and compounds in photographic film. Fujifilm went on to reapply that expertise to new businesses, including skin care and film that holds LCD screens together.

The company made deals, including the acquisition of drugmaker Toyama Chemical Co., maker of an antiviral drug that was used by some Ebola patients last year. Photocopier machines and printers became its largest source of revenue after the slump in film. While these are likely to remain the biggest businesses, Komori sees the newer biotechnology and pharmaceutical operations as future drivers of growth.

Investors have so far applauded the strategic shift, pushing the stock up about 70 percent over the past year. “I can praise their efforts for revenue diversification with businesses such as regenerative medicine, cosmetic items,” said Minoru Matsuno, president of Value Search Asset Management Co., a Tokyo-based investment advisory firm. “For another stage of growth, they need more aggressive acquisitions and strategic alliances.”

Lengthy Payout

With his investments in unproven new areas, Komori faces risks: the possibility of unsuccessful products and a long wait for any payout.

“The field of regenerative medicine is difficult, but it’s one to look forward to,” said Tetsuya Wadaki, an analyst with Nomura Securities.

A lifelong Fujifilm employee who took over as CEO in 2003, Komori has sometimes likened his role to that of a general going into battle. He talks about taking calculated risks, and in his memoir “Innovating Out of Crisis” mentions reading Winston Churchill’s World War II account several times. Yuuki, the Japanese word for courage, is framed on a conference room wall where he receives guests. He speaks regularly to employees -- in videos, newsletters and company addresses.

“It’s like in the military,” Komori said. “Leaders need to be briefing their men every day on what is going on and what needs to be done, and make sure everyone acts all the way down.”

Facelift

Part of the challenge is to create research teams willing to try new ideas. Scientist Tomoko Tashiro, who had been developing molecules for preserving photographs, came back from maternity leave in 2005 to find that she had been reassigned. She was asked to look into applying the same technology to skin. “It was bewildering at first,” Tashiro said. “But soon after I could see how much value we could add.”

Collagen is a shared ingredient in both photographic film and human skin. Within two years, Tashiro had helped develop a beauty line called Astalift out of molecules she had been studying to prevent photo printing paper from fading. Now sales from the skin-care brand are more than 10 billion yen, and an updated version of her favorite product -- a face serum called Jelly Aquarysta -- will be re-launched next month.

Across the world in Tilburg, the Netherlands, Akira Kase, who now heads Fujifilm’s biopharmaceutical initiatives, remembers many brainstorming sessions with Dutch colleagues. A decade later, one of their ideas, a filter for the natural gas purification process to reduce energy costs, will soon come on the market.

Even photo sales which bottomed out in 2011 are beginning to pick up again, driven by the growing popularity of Fujifilm’s instant cameras and printers, which have become ubiquitous at weddings the world over.

“What you’re seeing right now is just the tip of the iceberg,” said Toda, who was promoted to executive vice president in June. “We have decades of technology and know-how backing us, and now that we’ve opened up these possibilities: expect much more to come.”

Skincare products of Fujifilm Corp.’s Astalift brand sit on display while a showroom attendant arranges the products at the company’s showroom in Tokyo. Photographer: Kiyoshi Ota/Bloomberg

FOCUS ON PHARMA 16 // 17

（ブルームバーグ）：2015年11月、世界の大手製薬会社2社による日本での提携に関する発表に、日本の医薬品業界は目を見張った。

日本の製薬会社最大手、武田薬品工業は11月30日、特許期間が満了した医療用医薬品事業を分離し、ジェネリック医薬品販売で世界最大手のイスラエルのテバファーマスーティカルと合弁会社を設立、国内流通網を共有すると発表した。日本政府が国民健康保険制度のコスト引き下げを目指し、 低価格のジェネリック薬の利用を奨励する中で、優位に立つのが両社の狙いだ。

製薬業界にとって日本はかつて、世界で最ももうかる市場の一つだった。しかし、人口高齢化や巨額の政府債務を受けて、安倍晋三政権はブランド医薬品の値下げを訴え、ジェネリック薬へのシフトを急ぐよう導入促進策を進めている。

武田のジャパン ファーマ ビジネスユニット プレジデント、岩崎真人氏は都内でのインタビューで、「これほど急激な変化が起こり得るとは誰も想像していなかった」と指摘。さらに「市場の成長が続くと誰もが考えていたが、今の政府の圧力が焦点を変えつつある」と付け加えた。

政府はジェネリック薬の処方薬全体に占める割合を現在の約50％から80％程度に引き上げたい意向。これはブランド医薬品メーカーにとっては悪い知らせだが、一部の予測ではジェネリック薬業界は年10％の成長が見込まれており、見通しは明るい。

市場調査会社フロスト・アンド・サリバンのコンサルタント、サンジーブ・クマー氏は、日本で業界再編が加速すると予想。日本の中小企業が競争力向上を目指す一方、国際的な大手製薬会社はジェネリック薬でより良い足場を固めるため企業買収を進めると見る。「武田とテバの提携は意表を突くものだった。同様の提携を受け入れるムードを高める先駆者になる可能性がある。国内プレーヤーも含めてこれを無視できる企業はないと思う」と述べた。

クマー氏によると、コスト競争力があるとされてきたインドのジェネリック薬メーカー、サン・ファーマシューティカルズ・インダストリーズやドクター・レディース・ラボラトリーズ、ルピンなどが、足場固めのため日本の中堅企業の買収を目指す可能性がある。直近の決算発表資料によると、アストラゼネカや ロシュ、ノバルティスなど複数の国際的企業は総収入に占める日本市場の割合は6－9％。

原題：Japan Takes Aim at Ballooning Drug Prices as Costs Strain Budget（抜粋）

関連ティッカー：4502 JP (Takeda Pharmaceutical Co Ltd)NOVN VX (Novartis AG)PFE US (Pfizer Inc)ROG VX (Roche Holding AG)TEVA IT (Teva Pharmaceutical Industries Ltd)

日本のジェネリック薬業界、武田とテバの提携を機にM&A加速も

【記者：Natasha Khan】

(Bloomberg) — When two of the world’s biggest pharmaceutical companies announced  a tie-up in Japan, the country’s $78 billion drug industry took note.

In November, the country’s largest drugmaker,  Takeda Pharmaceutical Co., said it’d separate its off-patent products and share its extensive Japanese distribution network with Israel’s Teva Pharmaceutical Industries Ltd., the world’s largest seller of generic medicines. Their goal: to gain an edge as Japan’s government seeks to lower costs for its national health-care program by encouraging the use of generics, which are cheaper.

The government’s push is reshaping what was once one of the world’s most lucrative drug markets, where favorable policies have for years aided the sales of international pharmaceutical brands such as AstraZeneca Plc, Roche Holding Ag and Novartis AG. But an aging population and a massive government debt burden now has Prime Minister  Shinzo Abe’s government insisting on price cuts on branded drugs and pushing for a speedier transition to generics. The shift began about two years ago, and recently the government has been targeting price reductions with more frequency.

“Nobody imagined that this radical change could happen here,” said Masato Iwasaki, who heads up Takeda’s domestic business unit, in a Tokyo interview. “Everybody had believed the market would continue growing, but now government pressure is changing the focus.”

Huge Opportunity

The government has said that in the next few years it would like to see generics make up about 80 percent of prescriptions in Japan from about 50 percent now. That’s bad news for makers of branded pharmaceuticals, especially those that are off-patent. Meanwhile, the generics industry — forecast to grow at 10 percent annually by some estimates — is turning into a rare bright spot.

Sanjeev Kumar, a consultant at market research firm  Frost & Sullivan  predicts more consolidation in Japan as small and mid-size companies seek to become more competitive and big international firms make deals to get a better foothold in generics.

“The Takeda-Teva deal took people by surprise, and is one that could be a trendsetter in gaining more acceptability for similar deals,” Kumar said. “I don’t think any companies — including domestic players -- can ignore this in any way.”

For example, Indian generics companies like Sun Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd. and Lupin Ltd. – long known for being cost competitive – could seek to acquire mid-sized Japanese companies to gain a foothold, Kumar said. Several international companies, including AstraZeneca, Roche and Novartis derive between 6 to 9 percent of their total revenue from the Japanese market, according torecent earnings reports.Drug spending in Japan, where the population is declining, is likely to rise by 3 to 4 percent over the next five years – the lowest

increase of any developed market, according to a November report from the  IMS Institute of Healthcare Informatics. In addition, sales tax increases that are expected in the next few years could offset the expected expansion and result in a “zero growth scenario” in those years, it said.

Health Efficiency

Japan has long been ranked one of the most efficient health systems in the world when measuring life expectancy versus per capita cost of care. The government’s national program covers a large portion of health-care costs. Its pharmaceutical industry is huge. While China has ten times the population of Japan, in 2015 the size of the Japanese drug market was $78.3 billion compared with China’s $115.2 billion, according to IMS.

For years, price was not a big factor in the Japanese pharma market as the national health-care system absorbed costs, one reason why the penetration of generics was much lower than other economies. It was also skewed towards domestic players like Takeda. “The burden on the government will reduce drastically,” said Frost’s Kumar about the efforts to lower prices.

Almost all Japanese pharma companies need to take care in such an environment, as “almost all face these difficulties,” said Iwasaki. The 30-year-old Takeda veteran spearheaded the search for a generics partner after the government’s changes and helped the company settle on Teva as the “best partner.”Teva will hold 51 percent of the companies’ joint venture, while Takeda will hold the rest. Sales from the off-patent products to be transferred to the new company were about 125 billion yen ($1.1 billion) in the 2014 fiscal year -- or about 7 percent of Takeda’s global revenue. The products include its treatments for hypertension, peptic ulcers and diabetes, the company announced in December, adding that those sales have continued to decline due to the push for generics.

In interviews, Takeda executives said the venture into the generics market was restricted to Japan due to market conditions there. Globally, the focus will remain on innovative drugs.

Given Japan’s battles with costs and aging, the government’s attempts are a “welcome model,” said Mark Britnell, London-based chairman of KPMG’s global health practice, who’s written a book on health systems. “Any country which tries to thumb its nose at the development of generics is a country that is going to look very foolish in the future.”

Related tickers:4502 JP (Takeda Pharmaceutical Co Ltd)NOVN VX (Novartis AG)PFE US (Pfizer Inc)ROG VX (Roche Holding AG)TEVA IT (Teva Pharmaceutical Industries Ltd)

Japan Takes Aim at Ballooning Drug Prices as Costs Strain BudgetBy Natasha Khan

FOCUS ON PHARMA 18 // 19

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