关于药物产品技术的研究分析

Table of Contents 目录

 

 

 

         Radiation and surgery are two traditional forms of treatment for prostate cancer . If the disease spreads, hormone (androgen)

suppression therapy is often used to slow the cancer’s progression, but this form of treatment can eventually become ineffective.
We are aware of several competitors who are developing alternative treatments for castrate-resistant prostate cancer, some of which are directed against PSMA, including Zytiga ® (abiraterone acetate), Medivation, Inc.’s MDV3100, and Algeta ASA’s Alpharadin ® (radium-223 chloride).

 

        Recent evidence suggests that activation of complementary oncogenic pathways can confer resistance to PI3K inhibition , requiring

co-administration of agents targeting these “resistance” pathways. We are aware of several competitors who are developing small molecule PI3K inhibitors that co-target additional oncogenic pathways.

 

          A significant amount of research in the biopharmaceutical field is carried out at academic and government institutions . An element

of our research and development strategy has been to in-license technology and product candidates from academic and government institutions.http://www.ukthesis.org/dissertation_sample/在生物制药领域是学术和政府机构的一个重要的研究。我们的研究和发展的战略已经从学术和政府机构在许可技术和产品中选择出了新的代言人。

These institutions are sensitive to the commercial value of their findings and pursue patent protection and negotiate licensing arrangements tocollect royalties for use of technology they develop. They may also market competitive commercial products on their own or in collaborationwith competitors and compete with us in recruiting highly qualified scientific personnel, which may result in increased costs or decreasedavailability of technology or product candidates from these institutions to other industry participants.

 

         Competition with respect to our technologies and products is based on, among other things, product efficacy, safety, reliability,

method of administration我们的技术和产品与其他的东西相比，在竞争的基础上，产品的有效性，安全性，可靠性更好，以及一些管理方法更加有保证。
, availability, price and clinical benefit relative to cost; timing and scope of regulatory approval; sales, marketing andmanufacturing capabilities; collaborator capabilities; insurance and other reimbursement coverage; and patent protection. Competitive positionin our industry also depends on a participant’s ability to attract and retain qualified personnel, obtain patent protection or otherwise developproprietary products or processes, and secure sufficient capital resources for the typically substantial period between technological conception and commercial sales.#p#分页标题#e#

 

Product Liability产品责任

 

          The testing, manufacturing and marketing of our product candidates and products involves an inherent risk of product liability

attributable to unwanted and potentially serious health effects. 我们的产品候选人和产品测试的目的，在制造和销售中涉及的固有风险产品责任能够避免产生不必要的和潜在的严重的健康影响。To the extent we elect to test, manufacture or market product candidates andproducts independently, we bear the risk of product liability directly. We maintain product liability insurance coverage in the amount of $10.0

million per occurrence, subject to a deductible and a $10.0 million aggregate limitation. Where local statutory requirements exceed the limits ofour existing insurance or local policies of insurance are required, we maintain additional clinical trial liability insurance to meet these requirements. This insurance is subject to deductibles and coverage limitations. The availability of and cost of maintaining insurance may change over time.

 

Human Resources人类资源

 

         At December 31, 2011, we had 105 full-time employees, 21 of whom hold Ph.D. degrees, three of whom hold M.D. degrees and two

of whom hold both Ph.D. and M.D. degrees. At that date, 78 employees were engaged in research and development, medical, regulatory affairs and manufacturing related activities and 27 were engaged in finance, legal, administration and business development. We consider our relations with our employees to be good. None of our employees is covered by a collective bargaining agreement.

 

Item 1A. Risk Factors 风险因素

 

Overview; Significance of our RELISTOR collaborations and our focus on oncology.我们的的RELISTOR合作主要是专注于肿瘤的研究

 

          Our business and operations entail a variety of serious risks and uncertainties. Our business is inherently risky. We are subject to the risks of failure inherent in the development of product candidates based on new technologies. We, or our RELISTOR collaborators, must complete successfully clinical trials and obtain regulatory approvals for potential commercial products. Once approved, commercial products sales are subject to general and industry-specific local and international economic pressures such as those experienced worldwide over the last five years. Our product candidates other than RELISTOR are in pre-clinical or early clinical development. As an oncology-focused research and development strategy, these risks continue to be significant, and may increase to the extent the oncology space becomes more competitive or less favored in the commercial marketplace. We now rely on Salix to complete development and obtain regulatory approvals for additional formulations of and indications for RELISTOR, and in the Japanese market, we rely on Ono to conduct successful clinical trials and obtain regulatory approvals. The research and development programs on which we are now focusing involve novel approaches to human therapeutics.#p#分页标题#e#

  There is little precedent for the successful commercialization of products based on our technologies, and there are a number of technological challenges that we must overcome to complete most of our development efforts. We may not be able successfully to develop further any of our products.在成功的商业化产品的基础上这里是没有先例的，我们的技术，有许多技术挑战，我们必须克服的完成大部分的开发工作。我们可能无法成功地进一步发展我们的任何产品。