Biotech Values

[DewDiligence]

Portola, NVS Ink Antiplatelet Collaboration

Chances are high these guys get munched for a lot of money.

This deal for the company’s reversible antiplatelet agent may be even better than a munch insofar as Portola can separately monetize its FXa programs. $75M up-front plus $500M in potential milestones; the only drawback from Portola’s standpoint is that they pay half the cost of the phase-2 trial in progress in PCI (#msg-34267471).

http://www.novartis.com/newsroom/media-releases/en/2009/1289667.shtml

›Novartis Gains Worldwide Rights to Elinogrel, A Phase II Anti-Clotting
Compound With Potential to Reduce Risk of Heart Attack and Stroke

February 12, 2009 06:00 Central European Time

* Exclusive rights licensed from Portola Pharmaceuticals Inc. for elinogrel (PRT060128), further strengthening Novartis cardiovascular portfolio

* Elinogrel offers oral and intravenous formulations, has shown a fast onset of action and could offer physicians a rapid way to reverse its anti-clotting action if needed

* Novartis has responsibility for Phase III trials, manufacturing and commercialization, while collaborating with Portola on ongoing Phase II trials

* Novartis to make USD 75 million upfront payment, Portola eligible for milestones and royalties on future sales

Basel, February 12, 2009 - Novartis has gained the exclusive worldwide rights to elinogrel, a promising anti-clotting agent in Phase II clinical trials that has shown potential to offer clinical improvements over current anti-clotting medications in helping patients avoid heart attacks and strokes.

As part of the agreement with the US biotechnology company Portola Pharmaceuticals, Inc., Novartis will have responsibility for the Phase III development, manufacturing and commercialization of elinogrel.

Elinogrel belongs to a class of cardiovascular medicines that seek to prevent blood platelets circulating in the arterial system from sticking together and forming potentially dangerous clots. These clots can limit or stop the flow of blood to the heart or brain, leading to heart attacks or strokes.

"More than 13 million people die every year from complications related to blood clots, which underscores the ongoing and significant unmet need," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Elinogrel is a novel compound with attributes that have the potential to offer clinical benefits over currently approved antiplatelet therapies. Elinogrel will further diversify our cardiovascular pipeline and we hope it will prove to be a strong addition to our portfolio."

Elinogrel is being developed as oral and intravenous formulations. It has an instant onset of action that could quickly provide protection from clotting. Elinogrel's effect is also reversible, which may offer physicians a way to rapidly reverse its anti-clotting actions when necessary. Data from Portola's Phase I and Phase IIa trials showed elinogrel was well tolerated and had predictable, dose-dependent platelet inhibition.

INNOVATE-PCI, an 800-patient Phase IIb clinical trial, was initiated in December 2008 involving the intravenous and oral forms of elinogrel to explore the compound's clinical efficacy, biological activity, tolerability and safety. This trial includes a broad group of patients undergoing non-urgent surgery to repair a damaged blood vessel or to unblock a coronary artery (percutaneous coronary intervention). The trial involves a head-to-head assessment of elinogrel's intravenous and oral formulations against clopidogrel (Plavix®), considered the leading antiplatelet agent.

Clinical trials are planned for elinogrel in patients with acute coronary syndromes and more broadly in patients with a prior heart attack or stroke, and those with peripheral vascular disease.

Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes - both major public health issues. The portfolio includes the world's most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, a single pill combining two leading high blood pressure medicines, and a novel DPP-4 inhibitor. Novartis is dedicated to helping physicians and patients through effective medicines, programs and an ongoing commitment to research.

Terms of the agreement

Novartis will make an upfront payment of USD 75 million to Portola for the exclusive worldwide rights to elinogrel. Novartis will share with Portola the costs of the ongoing Phase II trial, but will have responsibility for Phase III clinical development, manufacturing and commercialization. Portola will also be eligible for additional payments based on achieving defined development and commercialization milestones and is also eligible to receive royalties on future sales. In addition, Portola has an option to co-promote elinogrel in the US limited to hospitals and specialty markets and an option to co-fund Phase III clinical trials and other development activities in return for additional royalties. This transaction is subject to customary regulatory approvals.‹