普生 唾液蛋白(PAC-113 from Pacgen)開發HIV感染白色念珠菌市場 (Phase III)

普生獲蛋白藥物全球獨家開發使用權 今富族網記者朱善恆／報導 2014-02-05 普生（4117）甫於農曆年前與加拿大公司Pacgen Life Science Corp. 簽定P113蛋白藥物開發和使用的全球獨家授權合約，按照合約，普生須支付權利金，有權取得P113蛋白藥臨床二期治療口腔潰爛全部資料，繼續完成產品開發工作，及全球使用之獨家授權。公司表示，此項蛋白藥物合約的簽訂，是普生公司跨入生物製藥業的首項方案。公司將針對P113產品開發與業務擴展，規劃穩定的財務結構，提供長遠發展的經營環境。 普生成立於1984年，專精臨床診斷試劑製造、行銷、服務，目前股本3.42億元，2011年合併營收1.71億元，稅前盈餘750萬元，EPS（每股盈餘）0.30元；2012年合併營收1.77億元，稅前盈餘1,487萬元，EPS 0.59元；2013年合併營收1.94億元，稅前盈餘1,046萬元，EPS 0.31元。

PAC-113, an anti-fungal for the treatment of oral Candidiasis infections, completed a Phase IIb clinical program in mid 2008. Opportunistic growth of Candida occurs in people with defective immune systems, or as a result of salivary dysfunction, and can be life-threatening if not treated. Candida albicans is the most common fungal pathogen among immune-compromised, hospitalized patients, accounting for roughly 50-60% of all bloodstream fungal isolates. Localized Candida infections, if untreated, can spread from the primary site of infection through the blood stream to cause a disseminated infection. Disseminated fungal infections are associated with a high mortality rate.

Target Patient Population

Asthma: Prolonged use of oral steroids causes a localized immunosuppression in the mouth, throat, and upper airways that leads to a high frequency of Candidiasis in asthma patients. Approximately half of the 15,000,000 asthmatics in the United States use inhaled steroids to manage their disease.

Cancer: Candidiasis occurs with high frequency in cancer patients due to either disease-related, or treatment-related immunosuppression. Both radiation and chemotherapy lead to a suppression of the immune system. The American Cancer Society statistics estimate 1.4 million new cases of cancer in 2005.

Diabetes: The Centers for Disease Control and Prevention report that there are about 21 million diabetics in the United States. Diabetics are predisposed to oral Candidiasis due in part to poor glycemic control providing a ready food source for candida and in part to a reduction in immune function.

HIV/AIDS: The frequency of oral candidiasis in AIDS patients varies with the disease state and is reflective of the underlying level of immune function. The frequency of OPC in HIV-infected individuals with good immune function is in the range of 7% to 48%, but rises to more than 90% in those with advanced disease. Furthermore, HIV patients frequently have a relapse of oral Candidiasis within 2 weeks to 3 months following completion of antifungal treatment. An estimated 1.1 million people are living with HIV/AIDS in the United States alone. In Asia, Japan and Western Europe, there are an additional 8.5 million HIV/AIDS patients.

Xerostomia: Dry mouth is a common side effect on a number of medications. Drugs causing this condition include many commonly used drugs such as: antidepressants, anticholinergics, antihypertensives, antipsychotics, anti- Parkinson agents, antihistamines, diuretics and sedatives. These medications are broadly prescribed and exacerbate the development of Candidiasis.

Modes of action: PAC-113 is a 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in saliva. In vitro studies demonstrate that it has potent anti-fungal activity against the Candida albicans, including drug-resistant HIV patient isolates. PAC-113 is an amphipathic molecule that interacts with fungal cell membranes, altering permeability which causes cytoplasmic leakage and cell death. PAC-113 also interacts with fungal mitochondria causing production of reactive oxygen species and fungal cell destruction. This activity is unique to histatin proteins. In addition, PAC-113 is active against growing cells, stationary phase cells and fungal biofilms. Rapid fungal lysis of fungal cells in a wide range of growth states may affect a more rapid and complete clinical cure.

普生取得加國蛋白藥物開發權利 2014/02/11 07:02:50 （中央社記者羅秀文台北2014年2月10日電）興櫃醫材廠商普生(4117)今天宣布，已與加拿大新藥開發公司Pacgen Life Science Corp.簽定P113蛋白藥物開發的全球獨家授權合約，跨入生物製藥領域。普生表示，P113蛋白藥物是抗黴菌感染及治療口腔潰爛的用藥，已經在美國完成第2期人體臨床試驗，將依合約取得P113臨床2期治療口腔潰爛的全數臨床資料，包括動物暨人類的安全性試驗數據，以及劑量、劑型的試驗數據。P113蛋白藥是美國波士頓大學牙醫學院Dr. Oppenheim實驗室所研發，對口腔、牙齒的抗菌有顯著效果。普生將依據授權合約，規劃第3期臨床試驗及多項相關產品開發工作。這也將是普生自臨床診斷試劑製造、行銷與服務領域，跨入生物製藥產業的第1項方案。Pacgen Life Science Corp.是位於加拿大卑詩省溫哥華的新藥開發公司，並在加拿大掛牌上櫃，主要從事開發傳染疾病和發炎疾病的治療法。普生在2010年投資Pacgen取得20%股權，主要是看好新藥產品的商品化價值。普生指出，根據這份全球獨家授權合約，普生除了取得P113蛋白藥物臨床2期治療口腔潰爛的全部臨床數據資料，未來普生將會根據所取得的臨床數據資料開發保健商品，預計多項商品今年內即可上市，貢獻普生營收。根據Pacgen公司預估，將來新藥開發完成後，單項藥品的銷售高峰將超過2.5億美元。