NDA in review
CTA application filed
The Medicines Co.
NDA in preparation
CTA application planning
Neucardin™ is a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF). It is a genetically engineered recombinant peptide fragment of neuregulin-1 that has been clinically shown to directly improve cardiac function, reverse ventricular remodeling and increase the survival of heart failure patients.
Cardiovascular therapeutics are a large and fast-growing market in China. CHF has a large underlying patient base in China of approximately five million urban patients. It is expected that the prevalence of CHF in China will increase to over seven million urban patients over the next ten years, primarily due to the growing aging population in China and urbanization.
Heart failure, or CHF, develops as a result of the slow deterioration of cardiac muscle where the heart undergoes an irreversible process of maladaptive remodeling. In an attempt to compensate for impaired cardiac function, diseased hearts “remodel,” a process that can change the heart’s shape and thickness, thereby resulting in severe cardiac dysfunction. Drugs currently treating CHF tend to be mature products that can relieve symptoms, but none can actually reverse the maladaptive remodeling. One of the potential advantages of Neucardin is that it will not directly compete with existing therapies, given its unique mechanism of action, but rather it can be included as part of the comprehensive treatment of CHF involving multiple drugs.
Neucardin has strong patent protection on a worldwide basis, with 12 issued patents and more than 30 applications pending. A 1,600-patient Phase 3 trial is currently underway in China.
“It is one of the closest [new] products we have to the market and it is a big one, in the U.S. they [The Medicines Co.] sold more than $500 million in 2013 for that product. We feel that it also will be very attractive in China.”
-Dr. Blobel on ANGIOMAX, BioWorld Asia, December 24, 2014
ANGIOMAX® and CLEVIPREX®
ANGIOMAX® and CLEVIPREX® are partnered with The Medicines Company, in a strategic collaboration granting SciClone a license and the exclusive rights in China to promote both products.
ANGIOMAX® (bivalirudin) for Injection, is an anticoagulant indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. A Phase 3 registration trial was completed in China and is currently under review by the China Food and Drug Administration (CFDA) for marketing approval.
CLEVIPREX® (clevidipine) Injectable Emulsion is a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or desirable. The clinical trial application (CTA) for China was accepted, and a bridging trial is expected to start in 2016.
There are over 400,000 PCIs performed annually in China, and it is estimated that this number could potentially grow to exceed well over one million annual PCIs in the coming years, representing a significant market opportunity for ANGIOMAX. We believe that ANGIOMAX represents an attractive alternative to current treatment options in the large and growing PCI market, with the potential to achieve effectiveness, including reducing bleeding events, especially in high risk patients.
CLEVIPREX also represents a differentiated opportunity in the large and growing Chinese anti-hypertensive market, offering potential advantages when compared to conventional intravenous anti-hypertensives, due to its rapid onset, short half-life and arterial selectivity.
China’s rapid socio-economic development, lifestyle changes and aging population are driving the growing incidence rate and significant disease burden of cardiovascular disease in China. We believe ANGIOMAX and CLEVIPREX represent significant opportunities for SciClone, and have the potential to augment our cardiovascular franchise.
“VIBATIV is one of the few, if not the only, antibiotics proven to work against MRSA infection. Once vancomycin does not work anymore, and there are cases of resistance in China, then VIBATIV is the only drug that would be available.”
-Dr. Blobel on the value of VIBATIV in China, BioWorld Asia, June 3, 2015
VIBATIV® (telavancin), licensed from Theravance Biopharma, is a potent, once-daily, dual mechanism antibiotic with proven efficacy against difficult-to-treat infections including methicillin-resistant Staphylococcus aureus (MRSA). The drug represents a good fit for the China market as it targets a major public health concern, namely the high level of antibiotic resistance. Based on its many attractive product attributes, including its dual mechanism of action, bactericidal activity and well documented evidence of in vitro potency against a broad collection of difficult-to-treat and multi-drug resistant Gram-positive clinical pathogens, including MRSA, VIBATIV can become a valuable asset in the antibacterial armamentarium in China for multiple infection types.
We are planning to initially develop and commercialize VIBATIV in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), with the potential to expand to other indications such as complicated skin and skin structure infections (cSSSI) and bacteremia. Importantly, if VIBATIV is approved in China, we plan to leverage our deep knowledge of the infectious disease segment and ZADAXIN regulatory and commercial infrastructure to build the drug’s market success.
OTHER DEVELOPMENT PRODUCTS
Loramyc™, licensed from ONEXO (formerly BioAlliance) is a miconazole lauriad mucoadhesive tablet for oropharyngeal candidiasis.
SGX942, An innate defense regulator (IDR), a new class of short, synthetic peptides, with a novel mechanism of action in that it modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response; positive Phase 2 results in oral mucositis reported by Soligenix; SciClone has rights in Greater China.
ABTL0812, licensed from Ability Pharmaceuticals, is a first-in-class PI3K/Akt/mTOR signaling pathway inhibitor for solid tumors.
PT-112, licensed from Phosplatin Therapeutics, is a novel chemical entity, first-in-class development among platinum-containing compounds, for treatment of platinum-resistant advanced cancer.
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