エーザイとのライセンス契約を発表

ボストン・ストラテジクス: エーザイとのライセンス契約を発表

ボストン–(BUSINESS WIRE)– (ビジネスワイヤ) — 米国マサチューセッツ州ボストンに本社をおく臨床ステージの総合医薬品研究開発会社 Boston Strategics Corporation(BSC)は、日本のグローバル製薬会社であるエーザイ株式会社(エーザイ)と同社の抗がん剤 E6201 について独占的導入開発契約を締結したと発表しました。
E6201 は FLT3/MEK の二重キナーゼ阻害剤で、Phase 1 臨床試験を終了、抗腫瘍効果の兆候と良好な安全性プロファイルが確認されました。 テキサス州立大学 MD アンダーソンがんセンターで実施された最新の前臨床試験結果に支持された強力な科学的根拠に基づいて 、BSC はアンメットニーズの高い(新たな治療法が求められる)FLT3 変異型急性骨髄性白血病(AML)患者を対象に年内にも米国で臨床有効性実証(PoC)試験を開始します。
エーザイとの契約において、BSC は E6201 をすべてのがん適応症でワールドワイドに開発・販売する権利を取得しました。このコラボレーションは、BSC が“True” Open Innovation™プラットフォ ームを適用して患者さんのヘルスケアを著しく改善する可能性をもった有望な薬剤を開発するための最初の試みで、グローバル医薬品開発に対する新たな包括的アプローチを創造するための BSC のビジョン達成に向けた第一歩となるものです。
「今回の導入契約は、BSC にとって非常に重要なマイルストーンであり、成功確率(PoS)を増し、主要な戦略的パートナーとリスクを共有することで医薬品開発プログラムを推進するという我々のコンセプトを確証するものです」と語るのは、BSC の北山英太社長。「エーザイは、このようなアプローチの真価を認め、この新たなプラットフォームを足場とする E6201 のがん領域での開発を BSCに委ねました。BSC は、業界標準を凌駕するスピード、品質、投資形態により、我々のイノベ―テ ィブなアプローチが画期的な治療法の創出につながることを実証するために最善を尽くします。そして、その結果として、増大を続ける医薬品イノベーションと開発にかかるコストに歯止めをかけたいと考えています。」

テキサス州立大学 MD アンダーソンがんセンター(MDACC):
MDACC は、世界最大級のがんセンターで、2012 年には約 11.5 万人のがん患者に治療を提供し、そのうち約 8500 人が臨床試験に参加しました。2013 年7月、BSC は同センターと戦略的アライアンス契約を締結し、強力な臨床開発能力を確立しました。

連絡先:
Strategia Therapeutics, Inc. ストラテジア製薬
+1-781-761-0123 (オフィス)
Contact@StrategiaTx.com (E メール)
http://www.StrategiaTx.com (ホームページ)

富士フィルムとパートナーシップ提携

米ボストンストラテジクス社 富士フィルムとのパートナシップを発表

BOSTON–(BUSINESS WIRE)–Boston Strategics Corporation, an integrated research and development biotechnology company, Boston, MA, today announced a new drug development partnership with FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), Boston, MA, a global pharmaceutical development center of FUJIFILM Corporation, Tokyo, Japan. This strategic collaboration is the first of its kind between a Japanese pharmaceutical company and a pharmaceutical research and development provider, creating a novel and comprehensive approach to global pharmaceutical development.

Under this agreement, Boston Strategics will be the primary provider for FPHU global drug development services and resources for FPHU Oncology programs. This agreement will build onBoston Strategics strengths covering the spectrum from preclinical and early clinical development through Phase I and II human Proof-of-Concept (POC). Utilizing Boston Strategics’ internal oncology development expertise and ability to identify and collaborate with the best resources around the world, FPHU will expand its global reach in oncology drug development.

Boston Strategics will optimize and execute the global strategy of FPHU Oncology drug development programs. In this capacity, Boston Strategics will leverage its “True Open Innovation™” network to deliver superior outcomes, using highly efficient execution strategies and proven partners, such as the University of Texas MD Anderson Cancer Center, Houston TX (MD Anderson).

“True Open Innovation™ overcomes any limitations by reducing the need for large infrastructure, and draws on critical drug development expertise based on the unique needs of a particular program,” says Keizo Koya, Ph.D., CEO of Boston Strategics. “Our strong business relationships with our global resource networks are poised to assist pharmaceutical/biotech companies with strategy and launch of quality global drug development programs, and rapidly execute them to the next decision step/value inflection point. We are deeply committed to giving a new pharmaceutical R&D platform for FPHU, which look for an innovative and efficient way of globally developing their unique oncology pipelines. Entering into a special alliance of Boston Strategics this year with MD Anderson, a world leader in cancer treatment and oncology research, Boston Strategics will use this opportunity to provide global clinical development supports for FPHU.”

The ultimate goal of this unique partnership is to develop FUJIFILM’s oncology drug candidates globally using innovative approaches coupled with industry benchmark-beating timelines, quality, and financial investment.

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)

特別インタビュー 米Boston Strategics社の古屋CEO、北山社長に聞く

日経バイオテック 米Boston Strategics社の古屋CEO、北山社長に聞く、「創業から1年半で数十のプロジェクト契約を獲得できた」

“Boston Strategics has completed dozens of contracts after launching a company one and half years ago”

by Osami Kono

日本語記事へのリンク

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Keizo Koya, CEO (left), Nana Izumi, Office Manager (center), and Eita Kitayama, President (right)

Boston Strategics Corporation (US) was founded by Dr. Keizo Koya (CEO) and Mr. Eita Kitayama (President) in April 2012. Dr. Koya has led various pharmaceutical R&D organizations in multiple global companies, such as Fuji film and Synta Pharmaceuticals in US. Mr. Kitayama worked at Nippon Shinyaku (Japan), Covance (US), and Synta Pharmaceuticals (US). The primary service of Boston Strategics is to provide pharmaceutical R&D support for pharmaceutical companies developing therapeutics.

Boston Strategics has created a highly efficient pharmaceutical R&D platform by using “True” Open Innovation™. They had an exhibition booth at the Japan Cancer Association (JCA) annual meeting in Yokohama (October 3-5, 2013). I had an opportunity to meet with both of them to ask about the current status of Boston Strategics.

[Question] “What companies does Boston Strategics have as clients? What kinds of collaborations do you have?”

[Answer] “We have made contracts primarily with Japanese pharmaceutical companies so far. There are various types of contracts according to types of projects. Preferably clients ask Boston Strategics to create a strategic development plan and operate the plan to develop their drug candidates with keeping their own intellectual property (IP) and supporting all costs of R&D. It is much less efficient and costly if Japanese companies, which are not so familiar to global pharmaceutical development and have less experience working with CROs, try to manage the development by themselves. Their involvement sometimes causes more problems, unfortunately.” “In-licensing is another way to work with Boston Strategics. If clients do not want to invest further,Boston Strategics can license-in their drug candidates and develop them through raising additional fund. It is possible and might be better to establish companies focusing on developing these compounds separately from Boston Strategics when we have many in-license projects. According to the stipulations outlined in the contracts, we provide a wide variety of services. Some include preclinical development and Phase 1 or Phase 2 clinical trials; some take care of only strategic planning of drug development. We have made dozens of contracts and several candidates are in clinical development already.”

[Question] “Boston Strategics established a special alliance with MD Anderson Cancer Center (MDACC), University of Texas in July. MDACC is one of the greatest facilities in US for anti-cancer drug R&D. What does mean this alliance to Boston Strategics?”

[Answer] “It is not easy for Japanese pharmaceutical companies to have positive collaborations with MDACC unless they have considerably attractive drug candidates. Since Boston Strategics has established a special relationship with MDACC, we can motivate them to create very positive collaborative projects relatively easily. Oncologists at MDACC are very experienced and motivated to help their patients. They do not like to be told to just follow clinical protocols blindly provided by pharmaceutical companies with ‘deep pockets’, or asked too much  by staff at pharmaceutical companies who do not have enough expertise to develop oncology drugs. Rather, they truly want to have a collaborative and scientific partnership with appropriate partners who can communicate with them properly to provide the best translational and clinical research for their patients. They want to continuously improve clinical development plans by providing new proposals created based on new data, and become frustrated if the partner cannot, or does not communicate with them positively. Not many Japanese pharmaceutical companies have the right expertise to be their best partners. However, Boston Strategics can work with them, especially because several senior managers ofBoston Strategics used to work at MDACC and established positive relationship with them. One well-respected oncologist (MD) who has been working with them for many years will be joiningBoston Strategics soon. Scientists and oncologists at MDACC know various experimental and novel anti-cancer drug candidates very well. Many oncologists in Japan say that they know them as well. However most of them know these candidates mostly only by reading scientific papers. In contrast, oncologists at MDACC have worked with these drug candidates themselves. They are experienced with specific side effects of novel candidates in humans, for example. This type of difference in between Japanese oncologists and oncologists at MDACC is not insignificant. Rather, it is an important difference. We look forward to more positive collaborations with other Japanese companies and M.D. Anderson, and to the opportunity to assist them in adding significant value to their oncology drug candidate pipeline.”

[Original article in Japanese; translated by Strategia]

注目の企業:米ボストンストラテジクス社

注目の企業:米ボストンストラテジクス社 日系製薬会社のグローバル化を支援

日本語原本の記事をお求めの方は、こちらをクリックしてご連絡下さい。

pic-news-post-company-to-watch

Boston Strategics produces drug research and development process comprehensively for new drug candidates. Boston Strategics, a US company, was founded in April, 2012, by Keizo Koya, CEO, and Eita Kitayama, President, who both have a significant work experiences in Japanese and US pharmaceutical and chemical companies. Entering into an alliance last month with University of Texas’s MD Anderson Cancer Center (MDACC), a world leader in cancer treatment and oncology research, Boston Strategics will use this opportunity to provide global drug R&D support for Japanese companies.

Pharmaceutical companies have been evolving their drug R&D capability by adopting Open Innovation utilizing external alliances to fill their technology gaps. Boston Strategics employs a revolutionary business concept called “True” Open Innovation. “It is a potential risk to have a large internal organization to move products forward rapidly and successfully,” says President Kitayama.

Boston Strategics focuses on devising a development strategy with high probability of success by eliminating internal leniency or traditional practices.  Boston Strategics collaborates well with investigators or institutes like MD Anderson, a leader in translational medicine (bedside to bench) , in conjunction with selected Contract Research Organizations (CRO) or Contract Manufacture Organizations (CMO), to meet the particular strategic need of the client and put it into practice.

The developmental lead comes from Boston Strategics, with an external R&D team of contractors and other external experts, working on behalf of the sponsor company. It is global expertise and experiences of Boston Strategics’ employees that makes such a business concept possible. Boston Strategics has seven employees, but only elite players with drug R&D experiences in large pharma and biotech, and strong connections with academic, regulatory, pharmaceutical entities, and CRO and CMO partners.

Boston Strategics focuses on the oncology area because the development scale is relatively small in comparison to other therapy areas, and with its focused, expert developers, “We can develop products for clients at 10-20% reduced cost,” says President Kitayama. “We also can provide new drug development with a minimal research and development (R&D)  investment by optimizing R&D tax credit or grants in the US or Canada.”

In the Japanese market, Boston Strategics is focusing on companies with no development function in the US, including mid-size pharmaceutical companies or chemical companies with pharmaceutical divisions.  Boston Strategics already has three clients including pharmaceutical or chemical companies and multiple programs going into clinical phase in the US next year. Alliance with MD Anderson and clinical studies led by the world class oncologists enables Boston Strategics to provide broader strategies. “We would like to conduct business development capitalizing on our strength that we can develop products more rapidly with less investment,” says President Kitayama.

Boston Strategics also looks for opportunities to in-license compounds for development that were deprioritized due to changes in economic climate or investment/development strategy. Large pharmaceutical companies have many such compounds and Boston Strategics plans to develop such compounds by applying its innovative development strategy.

<Company Profile>
Foundation: April 7th, 2012, with $20,000 in capital.
Location: Boston, Massachusetts, USA.
Employee: 7
Business Lineup: Provide a platform for drug R&D utilizing strategic outsourcing
[Original article in Japanese; translated by Strategia]

 

MD アンダーソン癌センターとの制癌剤開発のための戦略的提携を発表

ボストン・ストラテジックス社、MD アンダーソン癌センターとの制癌剤開発のための戦略的提携を発表

Boston Strategics社 (BS) はテキサス大学 MD アンダーソン癌センター(MDACC)との戦略的提携を発表した。BSが構築した “真の”オープン·イノベーションネットワークによるトランスレーショナルリサーチや制癌剤臨床開発の専門知識とMDACCのリソースを統合することにより制癌剤開発を促進する。

BS は、MDACC との協働による効率的実行戦略により成果を出すため、”真の”オープン·イノベーシ ョンネットワークを活用し、製薬企業やバイオテック(顧客)のグローバル医薬品開発を最適化し、実施する。臨床開発を最適化するために、臨床開発癌専門医のインプットを効果的に活用する臨床開発のアプローチは、真の協働トランスレーショナル臨床開発プログラムを創ることになる。

また、パーソナル癌治療のための新しい研究所やそこでのトランスレーショナルリサーチとプレシジョン薬(分子標的と精密診断に基づき厳密に定義された特定の患者セグメントに対して高い効果を示す治療薬)でのMDACCのリーダーシップは、適切な患者たちへの癌治療を可能にする。

この提携契約は、BSの志す、癌治療や癌患者のマネジメントを改善しようとする専門家や機関とのグローバルネットワークを構築するためのものである。

「癌治療医薬品開発の専門知識を持つ MD アンダーソン癌センターと、Boston Strategics の”真の” オープンイノベーションネットワークとの強みを組み合わせることで、我々はグローバルな癌治療臨床開発のための新しく、効率的で合理的なモデルを作る」と BS社長、北山英太氏は言う。「これは、臨床薬剤開発のますます困難になる環境の中で製薬およびバイオテクノロジーの顧客の競争力を向上させながら、ハイクオリティーの科学を効率的かつハイスピードで臨床成功に変換することのできる革新的でユニークなコラボレーションである。」このパートナーシップの究極の目標は、BS のあらゆる地域のパートナーに、今までの製薬業界にないタイムラインと投資によって迅速で効率的な医薬品開発する道を示し、世界中の癌患者のための新たなる治療への道を提供することである。

「MD アンダーソンは、長期のコミットメントを確立しようとするパートナーたちとの連携を望んでいる」と、MD アンダーソンの戦略的産業ベンチャーVP の Ferran Prat 氏は語った。 「我々は、産学連携により、効率性を向上させより迅速な開発を達成するための解決策を考産み出せると信じている。このパートナーシップにより、我々は、これらの目標に到達するために協力し一緒に働いていくことができる。」

Boston Strategics について
Boston Strategicsは、ディスカバリーからトランスレーショナルリサーチ、そして臨床 POC(Proof-of-concept)までのグローバル創薬プログラムを最適化し実行することができる総合的バイオリサーチと医薬品開発会社であり、すでにいくつかの主要日本製薬パートナーとの提携を確立している。

MD アンダーソンについて
MD アンダーソンが毎年約 100,000 人の癌患者を治療している。2012 年には、ほぼ 8,500 人の癌患者が、新規制癌剤の臨床試験に参加しており、これは米国最大規模のものである。

連絡先:
Strategia Therapeutics, Inc. ストラテジア製薬
+1-781-761-0123 (オフィス)
Contact@StrategiaTx.com (Eメール)
http://www.StrategiaTx.com (ホームページ)