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CDP signs deal with Centella Therapeutics, Inc. to launch development of radiotherapy-enhancing drug

On May 25, 2011 Cancer Research UK and Cancer Research Technology – the charity’s development and commercialisation arm – reported partnership with Centella Therapeutics, Inc. of Palo Alto, California, to develop, manufacture and trial a promising new drug, CEN-209 in cancer patients with solid tumours (Press release, Cancer Research Technology, MAY 25, 2011, View Source [SID1234523323]).

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CEN-209*, discovered at the Auckland Cancer Society Research Centre and exclusively licensed to Centella from UniServices Ltd of New Zealand, is designed to provide benefit when used together with radiotherapy and chemotherapy to treat solid tumours. CEN-209 is the seventh drug candidate to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.

CEN-209 has the potential to destroy the areas of tumours which are low in oxygen – or hypoxic. Tumour cells become hypoxic because the blood vessels supplying them with nutrients and oxygen are often weak, twisted and ineffective due to the rapid growth of the tumour.

Cancer cells that are hypoxic are more resistant to chemotherapy and radiotherapy and often survive such treatment. By destroying the hypoxic part of tumours with CEN-209 in parallel to chemotherapy and radiotherapy, it is hoped that this combination treatment will be more effective.

CDP is a joint initiative between Cancer Research UK’s Drug Development Office and Cancer Research Technology, to develop promising anti-cancer agents from companies that are not able to take them through early phase clinical trials themselves. The CDP scheme allows companies to retain the background rights to their programmes while enabling Cancer Research UK to take on early development work to assess if there is a potential benefit to cancer patients. Two drugs from the CDP initiative are already in early phase trials.

CEN-209 is currently in pre-clinical development. Under the terms of the partnership, Cancer Research UK’s Drug Development Office will complete pre-clinical development of the drug and take it through the first Phase I clinical trial, which will be conducted through the charity’s Experimental Cancer Medicine Centres.

After the Phase I trial Centella will have the exclusive option to buy back the clinical trial data and conduct further clinical studies towards approval of CEN-209. If Centella does not exercise its option, the rights to the programme will be transferred to Cancer Research Technology to secure an alternative partner with the goal of making it possible for the drug to reach cancer patients.

Dr Thorsten Melcher, president of Centella, said: "We are very pleased to work in this public-private partnership with the experts from Cancer Research UK to advance CEN-209.

"The drug development experience of Cancer Research UK is very well respected and critical to evaluate the potential of CEN-209 for attacking hypoxic tumours for which few effective treatments are available today.

"Centella is particularly excited to launch this important project that may make radiotherapy even more effective, and to do it in the year that the United Kingdom has dedicated to raising awareness for radiotherapy."

2011 was launched as the year of radiotherapy to help raise awareness of the treatment and highlight the progress made over the last century**.

Dr Ian Walker, senior licensing manager at Cancer Research UK’s Drug Development Office, said: "Through this exciting partnership, we are taking a completely new drug which could treat a range of cancer types into clinical trials –bringing new hope for thousands of future cancer patients.

"We hope that the drug will enhance the effectiveness of radiotherapy, which is an incredibly important way to treat cancer as more than 40 per cent of cancer patients in the UK have radiotherapy as part of their treatment. We hope that finding new ways to increase its effectiveness through new drugs – such as CEN-209 – will help improve survival from a range of cancers."

Dr Nigel Blackburn, director of drug development at Cancer Research UK’s Drug Development Office, said: "The further development of this drug may not have been possible without the CDP initiative – which shows how we work with industry to develop new treatments – and we hope to continue to develop partnerships with the ultimate aim to license new treatments."

(Press release, Varian Medical Systems, MAY 24, 2011, View Source [SID:1234506218])

Takeda to Acquire Nycomed

On May 19, 2011 Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) and Nycomed A/S ("Nycomed") jointly reported that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for 9.6 billion Euro on a cash-free, debt-free basis (Press release, Takeda, MAY 19, 2011, View Source [SID:1234513468]). The boards of directors of each company unanimously approved the transaction which is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda, subject to antitrust clearance. The purchase would exclude Nycomed’s U.S. dermatology business.

The sellers are comprised of a consortium of private equity funds led by Nordic Capital Funds V and VI ("Nordic Capital"), including DLJ Merchant Banking Partners (a Credit Suisse affiliate), Coller International Partners IV and V, and Avista Capital Partners.

This transformational transaction is a strategic fit with Takeda’s sustainable growth strategy as it was outlined in its 2011–2013 Mid-Range Plan. Takeda has its strong presence in the Japanese and U.S. markets, while Nycomed has a significant business infrastructure in Europe and high-growth emerging markets that will enhance Takeda’s regulatory development expertise and commercialization capability. The acquisition includes the roflumilast franchise (Daxas; trade name in Europe), a first-in-class treatment for chronic obstructive pulmonary disease (COPD), which is expected to be a major source of revenue growth for Takeda. In addition, the acquisition will bring Takeda an immediate and stable increase in cash flow with Nycomed’s more than 2.8 billion Euro in annual revenue, excluding the U.S. Dermatology business.

"Takeda is committed to transforming our organization through the acquisition of Nycomed. Nycomed enables Takeda to maximize the value of our portfolio and gives us an immediate strong presence in the high-growth emerging markets while doubling Takeda’s European sales," said Yasuchika Hasegawa, President & CEO of Takeda. "Nycomed’s strength in a geographically wide range of markets and its diverse talent base will be a strong driver to helping us realize our important mission of striving toward better health for patients worldwide through leading innovation in medicine."

Nycomed, headquartered in Zurich, Switzerland, is a privately-owned pharmaceutical company with strong presence in Europe and emerging markets. Nycomed’s diversified product portfolio includes both established prescription pharmaceutical products as a primary revenue driver, and over the counter (OTC) products. It has a strong European commercial network and is aggressively growing in emerging markets which account for more than 50 percent of global pharmaceutical growth. Its key success factors include the utilization of its broad product range and the application of commercialization and development strategies that fit with the market environment and medical needs in each individual country and region.

"The combination of Takeda’s successful track record of innovation with Nycomed’s efficient commercialization and manufacturing infrastructure will create a global player with a phenomenal ability to bring medicines to patients and healthcare providers around the world," said Håkan Björklund, Chief Executive Officer of Nycomed.

Through the addition of Nycomed’s remarkable entrepreneurial corporate culture to Takeda’s corporate culture, nurtured for more than two centuries, Takeda is aiming to become a truly global pharmaceutical company with a diversified talent base capable of conducting global business effectively.

Since being acquired by Nordic Capital along with co-investors in 2005, Nycomed has followed an aggressive growth strategy that has propelled the company to an international player with a broad and strong market presence.

"The investment in Nycomed has outperformed even the highest expectations. We are proud to have contributed to Nycomed’s development into a world-class pharmaceutical company with a strong market position and product pipeline. I feel confident that Takeda will be able to further build upon Nycomed’s potential and create an even stronger company with a global market presence," said Kristoffer Melinder, Managing Partner of NC Advisory AB, advisor to the Nordic Capital funds.

1. Expected benefits

• Strong fit with Takeda’s sustainable growth strategy
– Strengthens pan-European platform
– Leverages Nycomed’s emerging markets strength to drive growth
– Allows Takeda to maximize the value of its portfolio supported by enhanced development expertise and commercialization capability in Europe and emerging markets
– Provides a significant growth driver with roflumilast (Daxas tradename in Europe)
• Immediate financial contribution(*)
– More than 30% increase of annual revenue
– More than 40% increase of operating income (excluding special factors derived from business acquisition)
– More than 30% increase of EPS (excluding special factors derived from business acquisition)
(*) Comparison with the original outlook of fiscal 2013 in 2011-2013 Mid-Range Plan, announced on May 11, 2011

• Complementary cultures and diverse talent pool

2. Acquisition summary

(1) Acquiring company: Takeda Pharmaceutical Company Limited
(2) Shareholders of Nycomed include Nordic Capital Funds V and VI, DLJ Merchant Banking Partners (a Credit Suisse affiliate), Coller International Partners IV and V, and Avista Capital Partners, Nycomed’s management and employees team
(3) Number of outstanding shares: 13,778,110 shares (as of December 31, 2010)
(4) Payment: Cash (Takeda will finance part of the transaction through a loan for about 600 to 700 billion yen)
(5) Acquisition amount: 9.6 billion Euro inclusive of the Nycomed’s net debt
(Fairness opinions from both Deutsche Securities Inc. and Nomura Securities Co., Ltd. have been obtained.)
(6) Planned date of completion: End of September 2011
Note: Shares of Nycomed US Inc., which focuses on specialty pharmaceuticals in dermatology, are excluded from the share purchase agreement.

3. About Nycomed

(1) Corporate name: Nycomed A/S
(2) Headquarters: Zurich, Switzerland
(3) Representative: Håkan Björklund (CEO)
(4) Established: 2005 (Operation started in 1874)
(5) Capital stock: 98,836 Euro
(6) Shares: non-listed ordinary shares
(7) Fiscal year: End of December
(8) No. of employees: approximately 12,500 (including Nycomed US)
(9) Relationship with Takeda: no matters to report regarding capital, personal and transactional relationship with Takeda
(10) Financial performance of the Nycomed Group for the recent two years
including Nycomed U.S. (unit: million Euro)

Fiscal year 2010 Fiscal year 2009
Net turnover 3,170.6 3,228.0
Gross profit Margin 2,181.7 2,332.7
Operating profit -44.2 288.0
Net profit -229.1 232.7
EBITDA after adjustment(*) 850.5 1,074.6
Total assets 7,477 7,886
Net assets 1,491 1,539
(*) After adjustment of the difference such as those derived from evaluation of
inventories in accordance with "Accounting Standard for Business Combinations"
EBITDA: earnings before interest, taxes, depreciation, and amortization

Takeda will announce the financial impact which this transaction will have on its consolidated financial statements of its fiscal year 2011 together with the revised financial outlook of the year.

Lentigen Corporation and the University of Pennsylvania Enter Intellectual Property License Agreement for Lentiviral Vector Technology

On May 19, 2011 Lentigen Corporation reported an exclusive, worldwide licensing agreement with the University of Pennsylvania relating to lentiviral vector technology (Press release Lentigen, MAY 19, 2011, View Source [SID:1234501067]).
The intellectual property, which was developed at Penn’s School of Medicine, has been granted to Lentigen to develop and commercialize products for both research reagents for laboratory research purposes and potentially, therapeutic purposes. No financial terms of the agreement were disclosed.

Dr. Boro Dropulic, Founder and CEO of Lentigen, commented, "Lentigen’s license agreement with the University of Pennsylvania is part of our goal to continue licensing lentiviral technology from both academic research institutions and the private sector, which we will then work to commercialize."

About Lentiviral Vectors
Lentiviral vectors (LV) are vehicles that can deliver genes or RNAi into cells with up to 100% efficiency and stability. By comparison, other viral vector systems such as non-viral, adenoviral and adeno-associated viral vectors have not been shown to achieve both high and stable gene delivery in dividing cells.
Gene delivery is accomplished by the binding and fusing of the LV pseudotyped envelope protein to the target cell membrane. The LV RNA containing the gene or gene silencing sequence is then incorporated into the cell via reverse transcription creating a DNA complex. This complex enters the nucleus incorporating into the chromosomal DNA creating a stable molecule. The gene sequence is integrated in the chromosome and is copied along with the DNA during ongoing cell division.

(Press release, PlasmaTech Biopharmaceuticals, MAY 10, 2011, View Source [SID:1234506207])