Pullan Consulting

Biotech Business Development Consulting

www.pullanconsulting.com and www.lindapullan.com

email:  lpullan@msn.com  805-558-0361

Issue #41, November 2009

Pullan's Pieces

Commentary on Science & Business of Drug Development

Many proteins bind to DNA in addition to their known roles

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Johns Hopkins researchers looked at the ability of proteins to bind DNA and found 367 proteins previously not known to regulate gene expression (published in October 30^th issue of cell).  These were proteins (including the MAP kinase 1, also known as ERK2) known to do other cellular jobs, such as cell signaling.  No one thought of ERK2 as a DNA binding protein but mutating the DNA binding site showed that ERK2 normally suppresses a group of genes.  This extra role may be a feature of many more proteins, as the researchers looked at only a subset of proteins for the DNA binding.  The multiple roles of proteins may be a partial answer to why humans do not have proportionately more identified transcription factors to control genes than do simple yeast.  (www.eurekaalert.org/pub.releases/2009-10/jbmi-md102809.php )

China:  new support for innovation

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            China has about 20% of the world’s population, but its pharmaceutical market was estimated at only $20B in sales in 2008.  However, IMS predicts that by 2013, China will be the third largest pharmaceutical market worldwide in value terms; up from ninth in 2003. And by 2050, China is expected to be the largest pharmaceutical market.  http://www.bing.com/search?q=size%20of%20pharmaceutical%20market%20in%20China&form=MSNTBG

An indication of increasing innovation comes from the surging number of patent filings.  In 2007, China became the third largest patent-filing country in the world, behind only the United States and Japan in terms of number of annual patent filings. http://www.fiercebiotech.com/special-reports/chinas-rise-poses-challenges-opportunities-biopharma-industry#ixzz0WJqCVBO1

The Chinese government is committed to investing in health care.  A Chinese economic development group has started 20 VC funds to work with 7 provincial governments.   The total invested is to be $1.32 billion, with about 20% coming from the government of China and the regional governments, and the rest from private investors.  It is to be invested in electronics and information, energy and environment, and biological and pharmaceutical sectors.  http://www.reuters.com/article/rbssTechMediaTelecomNews/idUSPEK8730920091030

There is also a new Chinese stock market ChiNext, much like the US Nasdaq, intended to help raise funds for small and medium  tech companies,  The 28 listed companies soared on the opening and the trading was stopped several times in fear of speculation http://www.speroforum.com/a/21776/China---Take-off-in-Shenzhen-for-Chinese-Nasdaq-Dual-stock-prices . 

China:  Recent Product deals

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Recent product deals with Chinese companies and universities appear to be mostly early and relatively small financially.  

·         Simcere in-licensed a phase 1 cancer small molecule drug candidate from OSI. 

·         GlaxoSmithKline plc and Jiangsu Walvax Biotech Company have entered into a cooperation agreement to form a long-term joint venture to develop and manufacture pediatric vaccines for use in China.

·         QRxPharma Limited announced a strategic alliance with Liaoning Nuokang Medicines Co. Ltd., based in Shenyang, China, to develop and commercialize QRxPharma's haemostasis product candidates: Textilinin, an antifibrinolytic agent, and HaempatchTM, a potent pro-coagulant for the Chinese market.

·         Cleveland BioLabs, Inc. is getting an upfront of $1.65 million and a 10% royalty from  Zhejiang Hisun Pharmaceutical Co., Ltd., a China-based manufacturer of pharmaceuticals, for exclusive rights to develop and commercialize in China  a preclinical stimulator of hematopoietic stem cell proliferation. 

·         Pfizer, Inc. has announced a joint initiative with the Shanghai Institutes for Biological Sciences, a China-based division of Chinese Academy Of Sciences, to support fundamental research in China.  Pfizer China will provide $0.5 million each year over three years to fund health-related fundamental research projects and its application to drug discovery and development programs in China. 

·         SciClone Pharmaceuticals, Inc., has obtained commercialization rights for China and Vietnam for APR's Ondansetron RapidFilm(TM) for nausea and vomiting.  APR would receive an upfront payment of $1 million and milestone payments.

·         HUYA Bioscience International, LLC has entered into a co-development agreement with rights of first review and negotiation relating to certain novel therapeutic compounds owned or controlled by Shenyang Pharmaceutical University. 

China’s clinical development pipeline

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PharmaProjects lists 18 drug candidates from phase 1 to preregistration as originating from Chinese companies.  (For comparison, there are 1839 drugs in Phase 1 to preregistration from the US, 70 from Italy, and 10 from Taiwan).  Only a few of these are partnered or in clinical development outside the US. 

·         3SBio has a high dosage form of erythropoietin for chemotherapy-induced anemia, and a 2nd generation IL-2 for cancer, both awaiting Chinese approval. 

·         Botanic Century has a plant derived compound from traditional Chinese medicine in Phase 2 for post-operative ileus and is partnered with Phynova of the UK.  

·         China Medical Systems has a tripeptide awaiting approval in China and another tripeptide in Phase 1, both for cancer. 

·         Chipscreen Biosciences has an HDAC inhibitor that completed a Phase 1 trial in cancer (partnered with HUYA Bioscience of San Diego), and a PPARgamma inhibitor in Phase 2 for diabetes.

·         Chongqing Jiachen is developing a therapeutic synthesized peptide HBV vaccine in Phase 2 for chronic HBV. 

·         Sinobiomed has a recombinant snake venom derived batroxobin protein in Phase 2 to prevent surgical bleeding, a recombinant protein malaria vaccine in Phase 2 with support from the Gates Foundation, and a recombinant human stem cell factor for blood cell recovery after chemotherapy or radiation in Phase 1. 

·         Sinovac Biotech has an H1N1 swine flu vaccine approved in China and in Mexico and partnered with Boryung for South Korea. 

·         Uni-Bio Science Group has a recombinant formulation of the GLP-1 exendin-4 in Phase 2 in diabetes, an IL-11 for chemotherapy-induced thrombocytopenia in Phase 3, and a PTH for osteoporosis in Phase 3. 

·         Zensun has a recombinant human ErbB3 receptor fragment in Phase 1 as a therapeutic vaccine for breast cancer, and a peptide fragment of neuregulin-1 (β2a isoform in Phase 2 in Australia for treatment of heart failure. 

·         Zhejiang Beta Pharma has a nitrogen oxide derivative of aspirin in a Phase 2/3 trial in non-small cell lung cancer. 

BioEurope panel presentation and coverage by EBD Group

My next partnering forum: Biotech Showcase at the time of JP Morgan

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JP Morgan’s annual healthcare investment gathering in San Francisco in January has been used by many of us for “sidebar” partnering meetings with all the pharma execs who attend and have rooms set up at nearby hotels for partnering meetings.  Now, the EBD Group and Demy-Colton have created an adjacent partnering forum, Biotech Showcase.  On January 12-13^th, Biotech Showcase, will provide private and public presenting life science companies an opportunity to present to an audience of investors and biopharmaceutical business development executives during the course of the largest annual healthcare investor conference.  There is also the ability to set up the “speed dating” partnering meetings.  Last year, the first year, it was well attended by big pharma business development and by small private companies not featured at JP Morgan.  This year, it is open to public companies too.  http://www.ebdgroup.com/bts/

Pullan Consulting- all aspects of partnering

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From presentations to making contacts to strategy to negotiations, Pullan Consulting can help you with corporate partnering.  If you might be interested, let’s chat by phone or email. 

Pullan Consulting

Linda M. Pullan, Ph.D.

Biotech Business Development

www.pullanconsulting.com and www.lindapullan.com

e-mail: lpullan@msn.com

805-558-0361

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