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Apexigen and Shanghai Duyiwei Biotechnology Co. Ltd Sign a License and Collaboration Agreement to Develop and Commercialize APX004

On March 6, 2012 Apexigen and Gansu Duyiwei Biological Pharmaceutical reported that they entered into a collaboration to grant an exclusive license to GDBP to develop and commercialize APX004 in China (Press release, Apogenix, MAR 6, 2012, View Source [SID:1234500908]). APX004 is a humanized monoclonal antibody directed against VEGFR2 for the treatment of certain cancers and angiogenic diseases. Under this agreement, GDBP will have an exclusive license and sole responsibility to research, develop and commercialize APX004 in China. Apexigen retains all rights to APX004 outside of China and will collaborate with GDBP to advance the development program. Under the terms of the agreement, Apexigen will receive an upfront payment, milestone payments on the successful achievement of regulatory milestones, and a royalty. Financial terms were not disclosed.

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"The pharmaceutical market in China today is very dynamic. We are pleased to be partnering with Gansu Duyiwei for the development and commercialization of APX004 in this vibrant market. We’re looking forward to a productive partnership," said Dr. Xiaodong Yang, Apexigen’s President and CEO.

"During the last century, people often said that the century to come will be the biological science century. The report of a survey from an American marketing research institute, Alt Assets, shows that the prospects for the global biotechnology industry are very promising. The sales revenue for products of the bio-economy, that is, products based on biological science and biotechnology, will exceed 15 trillion US Dollars in 30 years and the bio-economy will outrun the information economy and become the most powerful economic force in the world. The cooperation between Duyiwei and Apexigen will become a developmental milestone for Duyiwei. Based on its efforts, flexible mode of R&D and the continually increased investment on R&D, Duyiwei has the confidence and determination to constantly launch a series of original products in the near future to bring hope to the diseased and improve their quality of living," said Dr. Zhiping Duan, CEO of Gansu Duyiwei.

(Press release, Inovio, MAR 5, 2012, View Source;Neck-and-Other-HPV-Related-Cancers-Induces-Robust-T-Cell-Immune-Response-in-Mice/default.aspx [SID:1234504166])

CRT unveils ‘screen test’ for potential drugs to treat oestrogen positive breast cancer

On March 5, 2012 Cancer Research UK and its commercial arm, Cancer Research Technology reported that they have developed a unique test to discover molecules that could lead to potential new treatments for oestrogen receptor (ER)-positive* breast cancer (Press release, Cancer Research Technology, MAR 5, 2012, View Source [SID1234523274]).

The team at Cancer Research UK’s Cambridge Research Institute has unveiled a cell-based test that allows scientists to screen a library of 150,000 small drug-like molecules and identify those that switch off a cell signalling system called the FOXA1 pathway.

The team has previously shown that blocking the main protein in the pathway, FOXA1, blocks growth of ER-positive breast cancer cells, even in the presence of oestrogen receptors, which usually fuel the disease.

Current standard hormone treatments** block the oestrogen receptor or the production of oestrogen. But sometimes patients stop responding to these drugs.

Resistant ER-positive breast tumours often rely on cell signals triggered by the oestrogen receptor to continue to fuel the disease.

The discovery of molecules that block the FOXA1 pathway***, which prevents the oestrogen receptor driving the cancer, might provide new approaches to treat patients who are resistant to current approaches.

Dr Jason Carroll, group leader at Cancer Research UK’s Cambridge Research Institute, said: "There’s an urgent need to find new ways to treat breast cancer that is no longer responding to standard treatments, which work by targeting the effect of oestrogen in cancer cells.

"Our team has pinpointed the FOXA1 pathway, which we can target with new treatments to help combat this problem.

"We’ve designed a tailored test that identifies the molecules which switch off the pathway – and which we hope could one day be developed into a new class of drugs."

The team also discovered that blocking FOXA1 could prevent growth of molecular apocrine breast cancer cells. Women with this form of breast cancer have limited options for treatment and poor survival.

Dr Keith Blundy, CEO of Cancer Research Technology, said: "We’re proud that the work of Cancer Research UK has already helped to transform breast cancer treatment, leading to significant improvements in survival.

"The FOXA1 pathway is an exciting new area of research and we hope that our cell-based screen will allow us to identify potential new targets for drug development this year.

"We’d be keen to collaborate with industry to screen their library, alongside ongoing research input from our team, to form an effective partnership with exciting opportunities."

(Press release, ImmunoCellular Therapeutics, FEB 29, 2012, View Source [SID:1234506424])

Dainippon Sumitomo Pharma Co., Ltd. to Acquire Boston Biomedical Inc. (US Biotechnology Company)

On February 29, 2012 Dainippon Sumitomo Pharma reported the company has reached an agreement with Boston Biomedical Inc . (BBI) on the acquisition of BBI by DSP on this date (Press release, Sumitomo Dainippon Pharma, FEB 29, 2012, View Source [SID1234504359]).

According to the terms of the agreement, DSP will make an upfront payment of US$200 million to the shareholders of BBI and BBI on closing of the acquisition of its shares, and thereafter it will make development milestone payments up to US$540 million related to the compounds (BBI608 and BBI503) currently being developed by BBI. Furthermore, after the launch, DSP will also make milestone payments up to US$1,890 million, based on the achievement of various net sales targets with the last milestone being paid upon net sales of greater than US$4 billion in any fiscal year. DSP currently aims to commercialize BBI608 and BBI503 in 2015 or later.

1. Purpose of the Acquisition of BBI
BBI is a biotechnology company focusing on the oncology area and possesses two highly promising products in their pipeline called BBI608 and BBI503, which are small molecular oral drugs created by BBI with the aim to cause an antitumor effect in cancer stem cells. Anticancer drugs targeting cancer stem cells are attracting worldwide attention currently as a potent cancer therapy because they are considered to be effective against refractory, recurrent and metastatic cases, which are the main challenges in current cancer treatment. Due to the complexity of identifying a target molecule specific to cancer stem cells, so far, there have been no successful cases of such anticancer drugs. However, BBI608 and BBI503 are likely to become the first anticancer drugs in the world targeting cancer stem cells. BBI608 is currently in the preparatory stage for Phase III clinical trial for colorectal cancer in North America and in Phase Ib and II clinical trials for various solid tumors. BBI503 is in Phase I clinical trial for patients with various advanced solid tumors in North America.

DSP already signed an exclusive Product Option License agreement with BBI in March, 2011 on the rights of development and commercialization of BBI608 in Japan for all indications of cancer. After execution of the option agreement with BBI, DSP recognized BBI’s innovative development pipeline and its excellent ability of drug discovery/development, which led to DSP’s decision to acquire BBI.

In its second Mid-term Business Plan, DSP is determined to expand the pipeline for continuous new drug creation, aiming at providing innovative and first-in-class drugs for specialty areas, such as cancer and immune-related diseases, which DSP has chosen as one of its challenge therapeutic areas. In the oncology area, there are tremendous unmet medical needs and DSP considers it an extremely important mission as a R&D-oriented pharmaceutical company to work on drugs for cancer. On the other hand, within the market of cancer drugs, there are fast-growing sub-markets of novel drugs such as antibody drugs, molecular-targeted drugs, nucleic acid drugs, etc. DSP considers these to provide significant business opportunities in the future with the advancement of science.

Masayo Tada, Representative Director, President and CEO of DSP stated: "Acquisition of BBI is not only an acquisition of an innovative pipeline in the oncology area, it also represents obtaining an excellent drug discovery/development platform with the capabilities of BBI, enabling us to continuously create candidate compounds likely to advance into later development stages. Subsequently we intend to establish our R&D base in the US to expand our presence in cancer treatment globally. We are aiming to make the oncology area one of our future focus therapeutic areas next to the CNS area."

2. Outline of the acquisition
After the acquisition, BBI will become a 100% owned subsidiary of DSP and continue its operation in the Boston area, Massachusetts. BBI possesses the exclusive rights of BBI608 and BBI503 in Japan and North America.
The boards of directors of DSP and BBI have each approved this acquisition. However, meeting the terms and conditions based on the US Antitrust Law and the completion of statutory procedures is required to complete the acquisition. After completion of these procedures, the acquisition is deemed to be closed in April, 2012. In this transaction, Citigroup Global Markets Japan Inc. served as DSP’s financial advisor.

3. Outline of BBI
(1) Company Name: Boston Biomedical Inc.
(2) Headquarters: Norwood, Massachusetts, U.S.A.
(3) Name and Position of the Representative: Chiang J. Li, Chairman, CEO and CMO
(4) Established in November, 2006
(5) Capital: US$5.8million
(6) Private, unlisted company
(7) Major shareholder: 1Globe Health LLC (Founder: Dr. Chiang Li) owns the majority stake of BBI. There are 6 shareholders in total.
(8) Employees：30
(9) Relationship with DSP: As announced in April 7, 2011, DSP already signed an exclusive Product Option License agreement with BBI in March, 2011, on the rights of development and commercialization of BBI608 in Japan for all indications of cancer. Apart from the above, there is no significant relationship with BBI in terms of capital, human resources and business. Also, there is no significant relationship between the related parties and affiliated companies of DSP and their counterparts of BBI in terms of capital, human resources and business.
(10)Financial Information: Total Assets of US$15 million and Net Assets of US$7 million (Based on unaudited financial statements as of 08/31/2011). BBI currently recognizes no product sales, as it does not have launched products at the moment.
(11)Business description: BBI is a biotechnology company focusing on R&D in the cancer stem cell area. BBI is developing BBI608 and BBI503, which have potential to become the first anticancer drugs in the world targeting cancer stem cells.
4. Effects of acquisition on DSP’s earnings
Because the acquisition is deemed to be closed in April, 2012, there will be no effect on DSP’s consolidated financial forecast for the fiscal year ending March 31, 2012. DSP assumes there will be no material impact on its financial performance for the foreseeable future in and after the fiscal year ending March 31, 2013. However if this changes DSP will disclose any relevant information immediately.