Novartis/Portola drug thinner heads into phase III trials

Portola Pharmaceuticals has announced positive results from the Phase 2 INNOVATE-PCI study of its blood thinner drug, elinogrel. Elinogrel is being developed in collaboration with Novartis, which acquired the worldwide development and commercialization rights to the drug in February 2009 in a deal worth up to $575 million. Novartis shared costs of the Phase II trial but will fully fund all Phase III trials. Novartis will start a Phase III trial of the drug early next year.

KYTHERA Biopharmaceuticals partners with Intendis

KYTHERA Biopharmaceuticals and Intendis, Bayer HealthCare’s dermatology business, have announced that they have entered into a licensing agreement granting Intendis rights to KYTHERA’s lead product candidate, ATX-101, outside of the US and Canada. ATX-101 is currently in clinical development for the reduction of localized fat under the chin.

Under the terms of the agreement, KYTHERA will receive an upfront payment of $43 million and may be eligible to receive up to $330 million for certain development, manufacturing and commercialization milestones. KYTHERA will also receive tiered double digit royalties based on net sales in Intendis’ territories. The agreement encompasses all potential indications with KYTHERA to retain development and commercialization rights to ATX-101 in the US and Canada. Intendis will be collaborating with KYTHERA to execute the currently planned ex-US Phase 3 clinical trials that are expected to start in Europe in late 2010.

Shionogi Pharma terminates licence agreement with LifeCycle Pharma

LifeCycle Pharma has announced that Shionogi Pharma has terminated the licence agreement between the company for the sale of LCP’s cholesterol-lowering drug Fenoglide in the US. LifeCycle Pharma signed an agreement in 2007 for the sale of Fenoglide with Sciele Pharma. Sciele Pharma was acquired by Shionogi in 2009. In 2008, the investments company Cowen Healthcare Royalty Partners acquired the drug’s North American royalty rights from LifeCycle Pharma. LifeCycle Pharma said it will assist Cowen Royalty in resumption of manufacturing and commercialisation of the product.

Meda buys Alaven Pharmaceutica

Meda AB has agreed to buy Alaven Pharmaceutical for $350 million. The acquisition, will strengthen Medas marketing capabilities in the USA and to expand its US portfolio in gastroenterology and women’s health. Alaven has annual sales of $800m and 180 employees.

Genzyme rejects Sanofi-Aventis’ $18.5 billion offer

Genzyme has rejected Sanofi-Aventis’ $18.5 billion buyout offer because it undervalues the company. Sanofi-Aventis had offered $69 per share for Genzyme, which has been struggling in the aftermath of manufacturing problems for key drugs. Genzyme shares traded above the offering price after it was announced.

Nestle and Novartis complete Alcon sale

Nestle has announced that it has completed the sale of its remaining shares in Alcon to Novartis for $28.3 billion. Those shares represent around 52% of Alcon’s share capital. Nestle and Novartis originally agreed the deal in April 2008. With the completion of the deal, Novartis said it’s now Alcon’s majority shareholder and controls around 77% of Alcon’s outstanding shares.

NsGene A/S signs new pain treatment deal with Biogen Idec

NsGene A/S has announced that Biogen Idec has signed a new and expanded agreement, giving Biogen exclusive global rights to commercialise Neublastin, a therapeutic protein for neuropathic pain, in all indications and all formulations. The new agreement replaces a license and collaboration agreement signed in 2000, under which Neublastin has been successfully brought into Phase I clinical development. NsGene will continue to receive development milestone payments in accordance with the 2000 agreement and with the expanded agreement gets a further upfront payment of $6 million, and an annual maintenance fee of $1.5 million, until acceptance of the first regulatory filing for a Neublastin product. The maintenance fee will be paid in those years in which NsGene does not receive a development milestone. In addition, NsGene will receive increased royalties on future sales of Neublastin products.

Cypress acquires rights to autism therapy

Cypress Bioscience has announced that it has acquired patent rights and technology related to an intranasal formulation of carbetocin, a potential treatment for the core symptoms of autism. The therapy was developed by Marina Biotech. Under the terms of the agreement, Cypress will make an upfront payment to Marina Biotech of $750,000. Subject to certain late-stage clinical and regulatory milestones Cypress may make up to $27 million in additional payments to Marina Biotech. Cypress will also fund all continuing development activities and pay single-digit royalties to Marina Biotech based on commercial sales, if any.

TiGenix spins out drug discovery activities into new company

TiGenix has announced that it has entered into an agreement with its academic partners, the Catholic University Leuven and Ghent University, Therosteon and a consortium of investors for the creation of a new small molecule drug development company, Arcarios, that will focus on the discovery and development of innovative, disease modifying drugs that target bone and joint diseases. TiGenix has an equity stake in the new company and retains the rights to drug candidates developed by Arcarios for local treatment of arthritic diseases.

Johnson/Addex candidate completes Phase I trials

Addex Pharmaceuticals has announced that the Phase I studies required to commence Phase II testing of ADX71149 have been satisfactorily completed. Subject to regulatory authorizations, Phase IIa studies in schizophrenia and anxiety, are scheduled to start enrolling patients in the first quarter of 2011. The Phase I program was conducted by Johnson & Johnson. In 2005, Addex Pharmaceuticals announced it had entered an exclusive worldwide research collaboration and license agreement withOrtho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson, to discover, develop and commercialize novel allosteric compounds for the treatment of anxiety, depression, schizophrenia and Alzheimer’s disease. The initial drug discovery research was conducted both at Addex and at Johnson & Johnson. Under the terms of the agreement, OMJPI paid Addex a €3 million upfront fee and research funding for 2 years. Addex is also eligible for up to a total of €112 million subject to successful completion of development and regulatory milestones. In addition, Addex is eligible for low double-digit royalties on sales of ADX71149, subject to regulatory approval and successful commercial launch.