Cristiana Bernini

The final agreement for the acquisition of clevidipine injectable emulsion, cangrelor and argatroban for injection has been signed between The Medicines Company and Chiesi Farmaceutici. The total value of the deal is $792 million. The three cardiovascular products are intended for use in the hospital setting and are approved for sale in the U.S. The transaction is expected to close in the third quarter of 2016 and, according to Chiesi, it is aimed to expand the product portfolioof the Italian multinational in the US to become a recognized leader in the hospital and adjacent specialties.

Menarini has signed the acquisition of the Lodichem’s pharmaceutical active ingredients manufacturing facility from Euticals. An investment of 10 million euro is planned for the development and re-launch of the facility, that will complement the Menarini plants of Pisa and Lomagna. Lodichem will produce high-quality active ingredients for strategic products. The project involves the construction of a new building for offices and quality-control laboratories, as well the refurbishing of numerous systems. The acquisition comes two months after the creation of VaxYnethic, a joint venture in the field of biopharmaceutical production signed between Menarini and BiosYnth.

Sanofi Pasteur and MSD announced the closure of their joint vaccines operations in Europe. The companies plan to integrate their respective European vaccine businesses into their operations in order to independently manage their product portfolios and pursue their own distinct growth strategies in Europe. The equally-shared joint-venture was created in 1994 to develop and commercialize vaccines originating from both companies’ pipelines The project should be completed by the end of 2016, subject to local labour laws and regulations and regulatory approvals.

A strategic agreement for the commercialisation of Newron’s lead compound safinamide for the treatment of Parkinson’s disease in the U.S. has been signed among Zambon and US-based WorldMeds.

The Italian company holds the global marketing rights for safinamide with the exception of Japan/Asia and has recently begun the commercialization of the product in the EU and Switzerland. The New Drug Application (NDA) for safinamide has been accepted for review by the U.S. Food and Drug Administration (FDA).

Novartis Pharmaceuticals and Novartis Oncology, forming together the Innovative Medicines Division, are the two newly created business units of Swiss giant Novartis. The leader of each business will join the Executive Committee of Novartis (ECN) starting from July 1, 2016. Paul Hudson will be appointed CEO, Novartis Pharmaceuticals and Bruno Strigini will become CEO, Novartis Oncology. Both will report directly to Joseph Jimenez, CEO of Novartis. The new structure reflects the integration of the oncology assets acquired from GSK.

The production company Neostell SAS will be jointly created by Neovacs (70%) and Stellar Biotechnologies (30%) and it will be based in the Paris area.

The joint-venture agreement will combine the skills of the two companies in order to manufacture and sell all types of conjugated vaccines to third party customers worldwide, as well as produce all of Neovacs’ Kinoids, including IFNα-Kinoid. Investments for the new production unit will start after the results of the Phase 2b study of IFNα-Kinoid in lupus conducted by Neovacs.

A. Menarini Asia-Pacific has signed a licensing agreement with Mitsubishi Tanabe Pharma to commercialize and promote avanafil in China, Hong Kong, Macao, Taiwan, Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam. Menarini Group has already been licensed to market the product in over 40 European countries, plus Australia and New Zealand.
Avanafil is a phosphodiesterase – 5 inhibitor (PDE5-i) approved In Europe and in the United States for the treatment of erectile dysfunction.

Janssen Biotech and Tesaro entered a worldwide collaboration and exclusive license agreement for the investigational compound niraparib in prostate cancer. The product is an orally administered poly polymerase (PARP) inhibitor, currently in late-stage development for patients with metastatic breast cancer and ovarian cancer. Janssen will have global rights and be responsible for all development and commercialization activities, except in Japan. Tesaro will maintain global development, manufacturing and commercial rights for all other indications. Separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation – JJDC, will also make an equity investment in Tesaro.

Gilead Sciences and Nimbus Therapeutics signed a definitive agreement for the acquisition of Nimbus Apollo and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, an ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases.