2014/4/24 15:45


AsiaNet 56578

共同JBN 0455 (2014.4.24)


*新会社のYL Biologicsは日本向けバイオシミラーの臨床開発、商業化に集中する。

医薬品大手のルピン社(Lupin Limited)は24日、富山に本社を置く日本の医薬品会社、陽進堂(Yoshindo Inc.)との間で新会社のYL Biologics(YLB)を設立する戦略的合弁事業協定を結んだと発表した。YLBは両パートナーが共同経営し、規制当局への申請、日本でのマーケティング認可取得を含め、数種類のバイオシミラーの臨床開発実施に責任を持つ。

新会社のYLBはルピンからモノクローン抗体(mAbs)をライセンスによって製品導入し、また生物学的製剤の開発、商業化に対する明確な規制態勢がすでに実施されている日本市場向けに世界各地の企業と提携する。プネーに置かれているルピンのバイオテクノロジー研究グループが開発したルピンのエタネルセプト(Etanercept)バイオシミラーが臨床開発のためにYLBにライセンス提供される最初の製品となる。エタネルセプト(最初の商品名はEnbrel=登録商標)は関節リウマチ、乾癬、強直性脊椎炎などの自己免疫性疾患の治療用に世界的に承認されているバイオ医薬製品である。Enbrelは日本では武田薬品工業が販売しており、売上高は4億9600万米ドル(IMS MAT、2013年3月)である。

日本の生物学的製剤市場の規模は現在120億米ドル近くに達しており、年率で2-3%成長している。mAbsは日本の生物学的製剤売上高全体のうち35億米ドルを占めており、成長率は5%である(IMS Health)。



陽進堂の下村健三社長は合弁事業についてのコメントで「YL Biologics社は陽進堂の活動を日本のバイオシミラー市場に拡大、当社を戦略的に象徴するための足場となる。ルピンと強力な提携関係に入ることを大変喜んでおり、これによって日本市場向けの有意義なバイオシミラー製品パイプラインの共同開発が可能になる」と述べている。



▽ルピン社(Lupin Limited)について


ルピンは米国で第5位と、最も急成長しているトップ5のジェネリック医薬品会社であり(処方せんの市場シェアは5.3%。IMS Health)、インドでは売上高3位の医薬品会社である。また日本と南アフリカで最も急成長しているトップ10のジェネリック医薬品プレーヤーである(IMS)。



Shamsher Gorawara

Head - Corporate Communications

Ph: +91-22-66402531

Email: shamshergorawara@lupinworld.com

セーフハーバー・ステートメント(http://www.lupinworld.com/safe harbor)

ソース:Lupin Ltd

Lupin Inks Strategic Joint Venture Agreement with Yoshindo Inc.


MUMBAI and BALTIMORE, Apr 24, 2014 /PRN=KYODO JBN / --

    - New Entity YL Biologics to focus on clinical development and

commercialization of Biosimilars for Japan

     Pharma Major, Lupin Limited (Lupin) announced today that it has entered

into a strategic joint venture agreement with Toyama based Japanese

pharmaceuticals company, Yoshindo Inc. (Yoshindo) to create a new entity, YL

Biologics (YLB). YLB will be jointly managed by both partners and will be

responsible for conducting clinical development of certain Biosimilars

including regulatory filings and obtaining marketing authorizations in Japan.

    The new entity YLB will in-license Monoclonal Antibodies (mAbs) from Lupin

and also partner with other companies across the globe for the Japanese market

which already has a clear cut regulatory regime in place for the development

and commercialization of Biologicals. Lupin's Etanercept biosimilar, developed

by its Biotechnology Research Group in Pune will be the first product to be

licensed for clinical development to YLB. Etanercept (Originator Trade name:

Enbrel(R)) is a biopharmaceutical product approved globally for treating

autoimmune diseases such as Rheumatoid arthritis, Psoriasis and Ankylosing

spondylitis. Enbrel(R) is marketed in Japan by Takeda Pharmaceutical and had

sales of USD 496 million (IMS MAT March, 2013).

    The Japanese Biological market is currently valued at close to USD 12

billion and growing at 2-3% annually. mAbs make up USD 3.5 billion of the

overall Japanese biological sales and growing at 5 % (IMS Health).

    Lupin will be entitled to milestone based licensing income in addition to

commercial supplies of the drug substance. Both Lupin & Yoshindo will then

market the product under their own brand names by leveraging their respective

sales networks.

    Commenting on the Joint Venture Dr. Kamal K Sharma, Vice Chairman, Lupin

Limited said, "We are very excited about the joint venture with Yoshindo, a

partner who shares our commitment to bringing biosimilars to market in Japan.

YLB is a reflection of Lupin's long-term commitment to the Japanese market and

is an important first step forward to establishing Lupin's global Biosimilar


    Commenting on the JV, Mr. Kenzo Shimomura, President, Yoshindo Inc. said,

"YL Biologics Ltd. is our bridgehead to expand Yoshindo's activities to the

Biosimilar market in Japan and highlight on the strategic representation of

company. We are very pleased to enter into a strong partnership with Lupin

which will make it possible to jointly develop a meaningful biosimilar product

pipeline for the Japanese market".

    About Yoshindo Inc.

    Yoshindo was established in Toyama, a city renowned for its long history of

trade in medicine. The company is supplying a large and diverse range of

pharmaceutical products such as generic formulations, APIs, infusion and

dialysis under R&D, manufacturing and marketing system. Yoshindo is now

focusing on biopharmaceutical products and developing it in cooperation with

university and striving hard to contribute actively and greatly to society

well-being and the health of individuals.

    About Lupin Limited

    Lupin is an innovation led transnational pharmaceutical company producing

and developing a wide range of branded and generic formulations and APIs

globally. The Company is a significant player in the Cardiovascular,

Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and

holds global leadership positions in the Anti-TB and Cephalosporin segment.

    Lupin is the 5th largest and fastest growing top 5 generics player in the

US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian

pharmaceutical company by revenues. The Company is also the fastest growing top

10 generic pharmaceutical players in Japan and South Africa (IMS).

    For the financial year ended March 2013, Lupin's Consolidated turnover and

Profit after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142

million (USD 242 million) respectively. Please visit http://www.lupinworld.com

for more information.


    For more information, please contact -

    Shamsher Gorawara

    Head - Corporate Communications

    Ph: +91-22-66402531

    Email: shamshergorawara@lupinworld.com or

    Safe Harbor Statement [http://www.lupinworld.com/safe harbor ]

    SOURCE: Lupin Ltd