Swiss drug maker Novartis AG greatly improved its presence in pain management on Monday by agreeing to purchase U.S.-Australian biotech firm Spinifex Pharmaceuticals This was according to separate statements made by the two companies on Monday. Spinifex representatives said Novartis was paying $200 million upfront. This will allow Spinifex shareholders to get further payments based on clinical development and regulatory milestones. This transaction is expected to close in the second half of this year, pending regulatory approval.
The acquisition will allow Novartis to use Spinifex’s experimental neuropathic pain drug EMA401, which showed positive mid-stage Phase II clinical trial results for post-herpetic neuralgia (PHN). This is a painful condition that develops after a patient had shingles. The results of the clinical trials for EMA401 were published in The Lancet medical journal last year and it mentioned that there were no central nervous system side effects or any serious adverse events after the drug was administered.
Chronic neuropathic pain, from nerve problems, is a relatively common condition. This affects up to 7-8 percent of the adult population. But even with the increased prevalence of this condition, current treatment options are limited and can be problematic.
EMA401 is an amazing pain medication that acts outside the blood-brain barrier and thus it can avoid common side effects such as dizziness or confusion which are very often experienced by patients taking painkillers affecting the central nervous system. Novartis plans to continue the development of EMA401. It also intends to start Phase IIb clinical trials in patients with PHN a condition called painful diabetic neuropathy which affects people with diabetes.
The acquisition highlights the Swiss group’s drive to expand its new medicines at a time of growing investor confidence across the drugs sector.
David Epstein, head of Novartis Pharmaceuticals mentioned in a statement, “Neuropathic pain is a chronic and debilitating condition with high unmet need. EMA401 could provide a novel, differentiated treatment approach.”
Established in 2005 and based in Stamford, Connecticut and Melbourne, Australia, Spinifex is backed by venture capital groups including Novo A/S, Canaan Partners, GBS Venture Partners, Brandon Capital Partners, Uniseed and the University of Queensland.
Novartis on the other hand is in a strong position when it comes to recent advances with new drugs, including the heart failure medicine LCZ696 and a psoriasis injection called Cosentyx.
About Novartis International AG
Novartis International AG is a Swiss multinational pharmaceutical company with headquarters located in Basel, Switzerland. Novartis ranks number one in drug sales (57.9 billion US$) among the world-wide industry in 2013. Novartis manufactures such drugs as clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan) and imatinib mesylate (Gleevec/Glivec). Additional agents include cyclosporin (Neoral/Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others.
In 1996, Ciba-Geigy merged with Sandoz, and the pharmaceutical and agrochemical divisions of both companies formed Novartis. Other Ciba-Geigy and Sandoz businesses were sold, or like Ciba Specialty Chemicals, spun off as independent companies. The Sandoz brand disappeared for 3 years, but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz. Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca, which also divested its agrochemical business. Novartis International AG stock market evolution: http://www.marketwatch.com/investing/stock/nvs
About David Epstein
David Epstein is the Division Head of Novartis Pharmaceuticals at Novartis AG since 2010. He holds a BS Degree in Pharmacy with high honors from Rutgers University College of Pharmacy in 1984 and an MBA in Finance and Marketing from the Columbia University Graduate School of Business in 1987.
About Spinifex Pharmaceuticals
Spinifex is a pioneer in the development of new treatments for chronic pain – a debilitating and often poorly treated condition that affects millions of patients all over the world. The demand for pain drugs continues to increase and this increases the growth of a market that is expected to be worth over US$35 billion by 2010. Spinifex’s lead programs are in neuropathic pain, due to nerve dysfunction. Spinifex is also targeting inflammatory pain such as that caused by osteoarthritis. A significant opportunity exists for new candidates that can deliver improved efficacy, side effect profiles, and time to onset and simplified dosing in chronic pain. EMA401, Spinifex’s lead clinical candidate, is being developed to address this unmet need and has successfully completed a Phase 2 clinical trial in post herpetic neuralgia (PHN), a neuropathic pain which follows herpes zoster (shingles) in some patients. In addition to PHN, EMA401 is being advanced as a potential treatment in other chronic pain indications and Spinifex has an active drug discovery program around its AT2 receptor antagonist technology.