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Novartis Agrees to Purchase Spinifex Pharmaceuticals for $200 Million Upfront

July 25, 2015 by Sabin Piso

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.

novartis 2

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

spinfex

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.

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Filed Under: Noutati Sabin Piso Tagged With: acquisition, David Epstein, Novartis International AG, Spinifex Pharmaceuticals

Aduro Biotech Partners with Novartis for Global Research and Development of Cancer Immunotherapy

April 1, 2015 by Sabin Piso

Aduro Biotech, Inc. has announced today the creation of a collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products. These cancer therapy products are derived from Aduro’s cyclic dinucleotide (CDN) approach to target the STING (Stimulator of Interferon Genes) receptor. According to Aduro research, when these receptors are activated this will initiate broad innate and adaptive tumor-specific immune responses.

Aduro Biotech

Stephen T. Isaacs, chairman, president and chief executive officer of Aduro was interviewed regarding the collaboration and he said “We are extremely pleased to enter into this relationship with Novartis as their strong commitment and spirit of collaboration was evident early in our conversations.” He added “We believe they are an ideal partner not only because of their stature as a premier healthcare company with a major focus in oncology, but also because they demonstrated a keen understanding and appreciation for our novel CDN approach, have synergistic innovation and scientific strengths and of course offer tremendous clinical and commercial expertise which we expect will broaden and accelerate the potential to bring products developed from this novel technology to patients in need.”

The agreement mentions that Novartis will make an upfront payment of $200 million to Aduro and, if all development milestones are complete, Aduro will receive up to an additional aggregate amount of $500 million. Novartis has also made an initial 2.7 percent equity investment in Aduro for $25 million and this includes a commitment for another $25 million investment at a future date.

The collaboration also mentions that Aduro will lead commercialization activities and will promote sales in the United States for any products developed and commercialized as a result of the collaboration. Novartis will lead commercialization activities in all other regions. The companies will share in profits, if any, in the United States, Japan and major European countries. Finally, Novartis will pay Aduro a mid-teens royalty for sales of products from the rest of the world.

Novartis’ Mark C. Fishman, M.D., president of the Novartis Institutes for BioMedical Research, commented, “We are delighted to collaborate with Aduro. We believe this target is among the most exciting in oncology today, the drug candidate to be of the highest quality, and the talent of our new colleagues from Aduro to be fantastic. We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents.”

The agreement covers the joint research, development and commercialization of CDN-based therapies in the field of oncology. Aduro shall maintain rights to its CDN technology in all other therapeutic areas, including infectious disease and autoimmunity.

About Aduro Biotech, Inc.

Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company focused on the development of technology platforms to stimulate an immune response against cancer. Aduro’s lead platform is based on proprietary strains of live-attenuated, double-deleted (LADD) Listeria monocytogenes that induce a potent innate immune response and have been engineered to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. Aduro has received Breakthrough Therapy designation from the FDA for its lead LADD regimen, CRS-207 in combination with GVAX Pancreas in pancreatic cancer.

About Stephen T. Isaacs

Stephen T. Isaacs is Chairman, President and CEO of Aduro BioTech. Before joining Aduro, Mr. Isaacs was founder (1991), President and CEO of Cerus Corporation, a biomedical products company commercializing the Intercept Blood Systems. Mr. Isaacs has published over 20 peer-reviewed scientific articles and is an inventor on over 40 issued patents. He holds a BA degree in Biochemistry from UC Berkeley, and had graduate training in organic chemistry in the PhD program in the Department of Chemistry at Berkeley.

About Novartis International AG

Novartis

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number one in sales 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). Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Novartis International AG stock market evolution: http://www.marketwatch.com/investing/stock/nvs

About Mark C. Fishman

Mark Fishman is a noted researcher and clinician in cardiology and the current President of the Novartis Institutes for BioMedical Research (NIBR),[1] the main research arm of Novartis Pharmaceuticals with over 6,700 employees and a 2012 budget of more than $9B.[2]Fishman was appointed President of the newly founded Novartis Institutes for BioMedical Research in 2002 to implement a new strategy in Novartis’ global drug discovery effort.

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Filed Under: Noutati Sabin Piso Tagged With: Aduro, collaboration, Mark C. Fishman, Novartis International AG, partnership, Stephen T. Isaacs