藥華藥首度參加美血液學會 加速新藥上市進度 鉅亨網 2015/08/27 19:11 興櫃新藥廠藥華醫藥(6446-TW)將首度獲邀參加血液疾病國際知名醫師會議「2015美國區血液增生疾病會議」，總經理黃正谷表示，在這場為期二天的會議上，將有自己的專屬攤位，可詳細向與會醫師介紹P1101在PV治療上的臨床結果和進展，提升醫師對此新藥的用藥意願，加速新藥上市進度。黃正谷進一步指出，國際大型藥廠最擅長且有效的行銷新藥手法就是於國際醫學會議擺攤或贊助相關疾病研討會，特別是能在會議中請來重要意見領袖的站台，直接提供他們更多相關的臨床研究或產品訊息，藉由與這些意見領袖的分享討論，有效提升新藥的曝光度及醫師的用藥意願。因此接下來的半年內，藥華藥將積極透過醫學會議或贊助主辦血液疾病論壇，為P110新藥上市後的行銷布局預先暖身。正谷表示，即將在美國登場的「2015美國區血液增生疾病會議」，便是由血液增生疾病權威醫生主持，每年參與出席的醫界精英多達數百人，擁有醫學與生物學雙博士學位，現任職於德州MD安德森癌症中心，長期專注於骨髓增殖性疾病領域之研究，且持續主導多項治療MPN新藥物的臨床試驗。黃正谷強調，P1101已完成三期臨床收案，目前正進行受試者療程階段及數據資料整理，由於BESREMi®的臨床設計為第一線用藥，副作用低、安全性高、耐受性也佳，根據AOP提供的資料顯示，以每2周注射一次，在給藥12周後，病人JAK2基因突變狀況即大幅減少，而若把治療滿一年的第二期臨床受試者，改為延長為每4周注射一次，其結果證實仍能維持療效，並達到整體副作用更為降低的目的。P1101將有機會成為全球治療PV疾病的第一個治癒型的新藥。
藥華PK美廠 搶申請藥證 2015-08-31 02:32:17 經濟日報 記者黃文奇／台北報導 分享藥華PK美國千億藥廠INCYTE，新藥拚明年首季上市申請。藥華醫藥總經理黃正谷表示，公司旗下抗真性紅血球增生症（PV）的新藥P1101為一線用藥，最快明年初即可向歐美藥品主管機關，包括歐洲EMA、美國FDA，遞件申請藥證。藥華進度最快的產品P1101，所聚焦的PV疾病在全球商機達百億美元，而法人指出，P1101為PV的第一線首選用藥，可望治療PV達75%病人，遠優於INCYTE已在美國上市的PV第二線新藥「Jakafi」，極具市場寡占性。藥華成立於2000年，由現任董座詹青柳、全球策略長林國鐘一手創立，聚焦罕見血液疾病、肝炎、腫瘤等門檻較高適應症的新藥研發。產品線分五大疾病領域，16種適應症，其中五項產品已進入臨床三期，並以P1101抗PV適應症進度最快。P1101為長效型新一代干擾素，沒有傳統干擾素的副作用，業界認為，這將能大幅提升病人與醫生的使用意願，為未來上市銷售加值，而藥華授權的歐洲夥伴AOP，目前已經在歐洲完成260人的臨床三期收案，數據最快年底即將公布。藥華於2009年將P1101歐洲等地區的商化權利授權給奧地利藥廠AOP，並以用於治療罕見血液增生疾病，授權區域包含歐洲、中東、前蘇聯獨立國， 而保留上述地區以外的製造、銷售權利；該產品目前都被美、歐認定為孤兒藥，因此未來上市後，將獨占七到十年的獨賣權與溢價（補助）空間。目前，藥華的主要對手INCYTE的PV二線用藥已經在美上市，該產品適應症以PV為主、骨髓纖維化為輔，今年首季銷售額度約2億美元（約新台幣64億元），法人預估，該產品今年有機會賣破6億美元，明年即向8億到10億美元邁進，登上重磅級大藥的行列。據悉，INCYTE的Jakafi今年初准用於PV適應症，該公司股價立即從1月初的80美元，一直攀升到6月間的120美元。雖然因全球股災而上攻力道趨緩，但仍維持在110到120美元區間，市值超過200億美元（超過新台幣6,000億元）。
閱讀祕書／真性紅血球增生症（PV） 真性紅血球增生症（PV）是一種罕見血液疾病，美國約有20萬個病人，歐洲則超過17萬人，目前平均一個療程達7.5萬美元，以20萬人的美國潛在市場估算，遠逾百億美元。PV的致病的原因為骨髓造血細胞長期不正常地製造過多的紅血球細胞，造成血液過於黏稠，常伴隨白血球與血小板數量也增加。血液循環上的問題包括血栓，也可能會轉變成骨髓纖維化或血癌，常見的症狀包含頭痛眩暈、眼結膜充血、視力障礙、血壓增高、皮膚泛紅，嚴重可能導致不正常的血小板功能、脾腫大、全身動靜脈栓塞、骨髓纖維化、和轉化成急性骨髓性白血病等併發症狀。（黃文奇）
Incyte Reports 2015 Second-Quarter Financial Results and Updates Shareholders on Key Clinical Programs. $142 million of 2015 second-quarter net product revenues from Jakafi® (ruxolitinib), representing 69 percent growth over the same period last year. 2015 guidance for Jakafi net product revenues increased to range of $560 million to $575 million, driven by strong underlying demand. Positive results from two pivotal trials of baricitinib in rheumatoid arthritis presented at EULAR. Multiple abstracts presented at ASCO and EHA, demonstrating continued progress across broad clinical portfolio
August 04, 2015 07:00 AM Eastern Daylight Time WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today reported 2015 second-quarter financial results, including revenue from Jakafi."The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera" The Company highlighted the continued momentum in the commercialization of Jakafi in the U.S., as well as progress being made across its clinical portfolio, including the results of two pivotal trials of baricitinib that were presented with Eli Lilly and Company ("Lilly") at the 2015 European League Against Rheumatism (EULAR) meeting in June. In addition, positive proof-of-concept results from the novel:novel combination of Incyte's PI3Kδ inhibitor INCB40093 and JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at both the 2015 American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings in the second quarter of 2015."The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera," stated Hervé Hoppenot, Incyte's President and Chief Executive Officer. "Recent data presented from our product candidates, and the progress we are making in recruiting multiple clinical trials, further illustrate the strength and diversity of our development portfolio." Jakafi is approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
2015 Second-Quarter Financial Results
Revenues For the quarter ended June 30, 2015, net product revenues of Jakafi were $142 million as compared to $84 million for the same period in 2014, representing 69 percent growth. For the six months ended June 30, 2015, net product revenues of Jakafi were $258 million as compared to $154 million for the same period in 2014, representing 68 percent growth. For the quarter and six months ended June 30, 2015, product royalties from sales of Jakavi® (ruxolitinib) outside of the United States received from Novartis, the Company's collaborator, were $17 million and $33 million, respectively, as compared to $12 million and $22 million, respectively, for the same periods in 2014. For the quarter ended June 30, 2015, contract revenues were $3 million as compared to $3 million for the same period in 2014. For the six months ended June 30, 2015, contract revenues were $31 million as compared to $13 million for the same period in 2014. The $18 million increase in contract revenues for the six months ended June 30, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the quarter ended June 30, 2015, total revenues were $163 million as compared to $100 million for the same period in 2014. For the six months ended June 30, 2015, total revenues were $322 million as compared to $189 million for the same period in 2014.
Ruxolitinib (INC424, INCB18424, trade names Jakafi and Jakavi, by Incyte Pharmaceuticals and Novartis) is a drug for the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative disorder that affects the bone marrow. It is also being investigated for the treatment of other types of cancer (such as lymphomas and pancreatic cancer), for polycythemia vera, for plaque psoriasis, and for alopecia areata. Ruxolitinib is a Janus kinase inhibitor with selectivity for subtypes JAK1 and JAK2 of this enzyme. Ruxolitinib inhibits dysregulated JAK signaling associated with myelofibrosis. JAK1 and JAK2 recruit signal transducers and activators of transcription (STATs) to cytokine receptors leading to modulation of gene expression. The phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor-I (COMFORT-I) and COMFORT-II trials showed significant benefits by reducing spleen size and relieving debilitating symptoms. In November 2011, ruxolitinib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis based on results of the COMFORT-I and COMFORT-II Trials.
Side effects Immunologic side effects have included herpes zoster (shingles; 1.9%) and case reports of opportunistic infections. Metabolic side effects have included weight gain (7.1%). Laboratory abnormalities have included alanine transaminase (ALT) abnormalities (25.2%), aspartate transaminase (AST) abnormalities (17.4%), and elevated cholesterol levels (16.8%). Other common adverse events are anemia (low red blood cell count) and thrombocytopenia (low blood platelet count). Grade 3 to 4 anemia occurs in up to 45% of patients and grade 3 to 4 thrombocytopenia occurs in 10% to 15% of cases, and requires medical intervention to return to near-baseline levels.
Novartis' Jakavi gets yes in Europe MARCH 17, 2015 10 PHARMATIMES REPORTER Novartis' Jakavi gets yes in Europe Novartis has been given the green light in Europe for Jakavi to treat a rare blood cancer. Specifically the drug, a JAK 1 and 2 tyrosine kinase inhibitor, has been approved by the European Commission for the treatment of adults with polycythemia vera who are resistant to or intolerant of hydroxyurea. PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack. It roughly affects one to three people per 100,000 globally. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease."The European Commission's approval of Jakavi is encouraging news for patients," said Dr Claire Harrison, study investigator and consultant hematologist, Guy's and St. Thomas' NHS Foundation Trust, London. "Jakavi will fill an unmet need as the first treatment shown to significantly improve hematocrit, as well as symptom control and reduce spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea." The approval of Jakavi (ruxolitinib) is based on data from the pivotal Phase III RESPONSE clinical trial demonstrating that a significantly greater proportion of patients achieved the composite primary endpoint of hematocrit control without use of phlebotomy and spleen size reduction, key measures of disease control, when treated with Jakavi compared to best available therapy. In the study, a 50% or more improvement in PV-related symptoms was seen in 49% of Jakavi-treated patients compared to 5% of patients treated with best available therapy."The approval of Jakavi in polycythemia vera underscores what's possible in today's era of precision oncology research," said Bruno Strigini, president, Novartis Oncology. "Jakavi specifically targets the JAK-STAT pathway, which regulates blood cell production and is known to play a key role in the underlying mechanism of this disease, bringing patients and physicians a new way to treat polycythemia vera."
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