攻 COPD !!益得生SYN007(Tiotropium) 505(b)(2)

益得生15日登興櫃；MDI利基產品全球搶市 MoneyDJ新聞 2014-07-14 18:04:28 記者 蕭燕翔 報導 擁有全球少數、亞洲唯一HFA MDI氫氟烷定量噴霧吸入劑研發技術平台的益得生技（6461），將於15日登錄興櫃，該公司主要專注於氣喘與慢性肺阻塞疾病的新劑型改良，現已有產品陸續上市，明年起還將有全球熱銷的複方學名藥接續上市，2016年起將進入收成的黃金五年。益得生創立前身為母公司健喬於2007年成立研發中心，2010年該公司正式自母公司獨立，目前資本額5.5億元，健喬持股比例約五成。該公司技術平台是獨特的MDI吸入劑技術平台，是全球「唯七」、亞洲「唯一」擁有該技術平台的廠商，並以治療氣喘及慢性肺阻塞為主要目標。該公司已獲得經濟部審定為生技新藥公司，也取得國內Duasma及Synvent等藥品許可證，產品已於2013年後陸續在台上市。益得生現有利用MDI技術開發的產品Pipeline，至少已有6個產品，除兩個取得國內藥品許可證的單方藥品，已分別送件中港澳與中國藥證申請外，其餘還有兩項複方產品，分別為Synflutide(F+S)與Budesonide(B+F)，前者原廠為Advair，全球年銷售額約90億美元，美國市場則有50億美元；現已正進行BE試驗，預計明年下半年在台上市，並爭取走綠色通道於二、三年後取得中國藥證，且為進軍國際市場，將已授權、合資或代工策略合作方式，與國際先進廠商合作，目標2019-2020年爭取成為全美首個學名藥。另個複方學名藥B+F，原廠為Symbicort，全球市場規模約30億美元，美國市場年銷額約15億美元，益得生計畫循新劑型(505 (b)(2))模式，進入美國市場。而該公司所研發新複方新藥Synbitide，現已處臨床二期，2015年底可望進多國多中心的臨床三期試驗；新劑型的藥物Syn007，預計全球市場約50億美元，美國市場約29億美元，也預計走505(b)(2)管道赴美國查登。因應未來訂單需求，益得生也計畫年底啟動新廠興建，完成後單條產線年產能可望朝3千萬支邁進。

Synflutide  Synflutide HFA MDI is a combinational product with inhaled corticosteroid fluticasone and long acting beta-2 agonist salmeterol (ICS+LABA). An on-going pivotal bioequivalence PK study is conducted and also preparing for international submission. Synflutide HFA MDI have a similar formulation to the originator (Advair). The indications are asthma and chronic pulmonary obstructive disease (COPD), with a market size of over US$8 billion. The product is expected to be the first generic after the originator patent expired.

SYN007  SYN007 contains long acting anti-muscarinic agent Tiotropium as active ingredient. The indication is chronic pulmonary obstructive disease (COPD). It is considered as a new dosage form for replacing the dry powder inhaler (DPI) product SPIRIVA, which is expected to relieve cardiovascular side effects through the adjustment of the particle size of the drug. It would be submitted under US. FD&C Act 505(b)(2).

The capsules cannot be taken orally - they will not be effective as respiratory medication if absorbed through the gastrointestinal tract and may have side effects if absorbed via this route.

Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler) [01-14-2010]  This is a Follow-Up to previous Early Communications issued in 2008 by the U.S. Food and Drug Administration (FDA) describing a potential increase in the risk of stroke, heart attack, or death from a cardiovascular cause related to the use of tiotropium, which is marketed as Spiriva HandiHaler. FDA has now completed its review and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events. FDA is advising healthcare professionals to continue to prescribe Spiriva HandiHaler as recommended in the drug label. Spiriva HandiHaler is a long-acting respiratory medication used for the treatment of chronic obstructive pulmonary disease (COPD). Consumers currently using Spiriva HandiHaler should talk to their healthcare professional if they have any questions or concerns about the use of this medication. The March 2008 Early Communication described data submitted by the manufacturer of Spiriva HandiHaler that suggested there may be a small excess risk of stroke in patients using tiotropium (the active ingredient in Spiriva HandiHaler) compared to placebo (2 cases of stroke per 1000 treated patients). The Updated Early Communication from October 2008 reported two additional publications that suggested an increased risk of death, heart attack or stroke in patients using tiotropium or drugs that work similarly to tiotropium.1,2 Since these initial communications, FDA has completed its analysis of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial. UPLIFT was a large, 4-year clinical trial that compared Spiriva HandiHaler to placebo in 5,992 patients with COPD. In the UPLIFT trial, there was no significant increase in the risk of stroke [0.95 (95% CI 0.70, 1.29)], heart attack [0.73 (95% CI 0.53, 1.00)], or cardiovascular death [0.73 (95% CI 0.56, 0.96)] between Spiriva HandiHaler and placebo. In November 2009, the FDA Pulmonary - Allergy Drugs Advisory Committee also reviewed data from the UPLIFT trial and voted that the UPLIFT findings adequately resolve the potential safety concerns for stroke, heart attack and cardiovascular death.

References:

1. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease. JAMA 2008; 300 (12): 1439-1450.

2. Lee TA, Pickard S, Au DH et al. Risk of Death Associated with Medications for Recently Diagnosed Chronic Obstructive Pulmonary Disease. Annals of Internal Medicine 2008; 149: 380-390.