Novartis AG Beefs Up Pain Pipeline With $200 Million+ Spinifex Buy

Novartis Beefs Up Pain Pipeline With $200 Million+ Spinifex Buy
June 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff

STAMFORD, Conn. – Swiss-based Novartis AG will acquire Spinifex Pharmaceuticals, a maker of drugs for neuropathic pain, for an upfront payment of $200 million, the company announced this morning.

With the acquisition, Novartis will see to add Spinifex’ lead candidate EMA401, a angiotensin II type 2 (AT2) receptor antagonist. The drug is being developed as a potential first-in-class oral treatment for chronic pain, particularly neuropathic pain, without central nervous system (CNS) side effects, Spinifex said this morning after announcing the deal.

Novartis said there are about 7 to 8 percent of adults dealing with neuropathic, which is defined as pain “caused by a lesion or disease of the somatosensory nervous system.” The causes can include pain associated with diabetes, cancer or its treatment with therapeutic agents including chemotherapy, some viruses and nerve trauma. Current treatments for neuropathic pain do not relieve pain in all individuals or are not well tolerated, so drugs targeting a new treatment modality are needed urgently, Spinifex said.

David Epstein, head of Novartis Pharmaceuticals, said EMA401 could “provide a novel, differentiated treatment approach to provide relief for patients and healthcare providers worldwide.”

Novartis expects the Spinifex drug to reach a large audience. The company said neuropathic pain is a chronic condition with high unmet medical need, with approximately 40 percent of patients not responding to current first line treatments. Additionally, 25 percent of patients do not respond to second-line treatments, Novartis said. In announcing the acquisition, Novartis said including an AT2R antagonist in its pipeline is an important piece of the puzzle in treating pain.

“Leveraging peripheral targets, such as an AT2R antagonist, is an emerging and promising approach to neuropathic pain treatment because peripheral targets act outside the blood-brain barrier and therefore are expected to be devoid of common side effects in the central nervous system, such as dizziness or confusion,” the company said.

According to terms of the deal, Spinifex will receive the upfront payment as well as undisclosed clinical development and regulatory milestone payments. Spinifex shareholders are eligible to receive payments contingent on future clinical development and regulatory milestones. The deal is expected to close in the second half of 2015, per regulatory approval.

Following the acquisition, Novartis will continue to develop EMA401, and launch Phase IIb trials, following successful Phase II trials conducted by Spinifex. Novartis intends to pursue a broad peripheral neuropathic pain label for EMA401.

The Spinifex deal comes on the heels of Novartis backing out of a deal to acquire Israeli drugmaker Gamida Cell a year after the plan was initially floated. As part of the termination agreement, Novartis will pay $142 million to Elbit Medical, Gamida’s largest shareholder. This was the second time Novartis got cold feet in acquiring Gamida Cell. In May 2014, Novartis decided to back out of a $600 million plan to acquire Gamida. Gamida Cell Ltd., located in Jerusalem, makes stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine.

Novartis has had its share of up and down news over the past few months. The company has been working with a number of startups in hopes of forging new paths in therapies. In May Novartis partnered with the Bay Area’s Rani Therapeutics on a method to deliver large molecule drugs, which are typically administered as an injectable, in a “robot pill” form through the use of smart technology. Additionally, Novartis and Indiana-based Eli Lilly were part of a group that backed startup Aeglea BioTherapeutics in $44 million in Series B. Financing. The $44 million investment will be used to support the continued development of Aeglea’s pipeline of engineered human enzymes that target diseases at the extremes of abnormal metabolism.

But, the company has also seen its recent share of controversy. In February Japan’s health ministry ordered the Japanese unit of Novartis AG to halt sales and manufacturing of prescription drugs for 15 days for failing to report the side effects of some medications. In December The Japan Times reported Novartis failed to report a total of 3,264 cases of patient health problems possibly caused by adverse effects of 26 types of drugs sold by the company. The company conducted an internal probe of its practices after issues arose over data collected in trials its blood pressure drug Diovan and two leukemia drugs.

Also in March two former employees filed a $110 million gender discrimination suit against Alcon Laboratories, Inc. , a division of Novartis AG, alleging the company fosters a “boys club” attitude that is hostile to women.


As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be?
Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.

Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).

So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?

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