Acquisitions /mergers/joint-ventures

Teva acquires Allergan for $40.5 billion and forget everything you have been reading over the last months about the Teva-Mylan deal. Now the Israeli-based company has announced its intention to acquire Allergan’s generic business through a deal structured around $33.75 billion in cash and shares valued at $6.75 billion giving Allergan a 10% stake in Teva. Mylan congratulated Teva on the deal and reiterated its commitment to acquire Perrigo.

…..And in the meantime Allergan acquires Naurex (Evanston, IL, USA) for $650 million which gives it access to two experimental NMDA modulators, raspastinel (GLYX-13) and NRX-1074 for the treatment of depression. Under the terms of the deal, Allergan will pay $460 million upon the closing of the acquisition and $100 million by January next year as well as potential success and sales milestone payments.

Merck acquires Israel-based biotech cCAM for $605 million and extends its immuno-oncology portfolio. The deal is structured around a $95 million upfront to acquire all outstanding cCAM stocks and up to $510 million in milestone payments.

TiGenix (Belgium) acquires Coretherapix (Spain) and boosts its cardiology pipeline with the access to AlloCSC-01 an allogeneic cardiac stem cell product for the treatment of chronic ventricular tachycardia. Under the terms of the deal Tigenix will pay an upfront of €1.2 million in cash and €5.5 million in new Tigenix shares as well as another €15 million in Tigenix shares upon successful clinical milestones and up to $245 million in sales milestones.

Business

Sanofi Genzyme strengthens its endocrinology portfolio in acquiring Caprelsa (vandetanib) from AstraZeneca for the treatment of symptomatic or progressive medullary thyroid carcinoma, a rare disease. Under the terms of the agreement, Sanofi Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million and further development and sales milestones payments of up to $135 million.

….And Sanofi extends its collaboration with Regeneron and enters the immunotherapy field. The initial term of the partnership is five years. Companies agree to jointly advance PD-1 and other new immuno-oncology antibodies. Sanofi commits to an initial investment of up to $2.17 billion in the exclusive collaboration, including $640 million in upfront payments to Regeneron and a potential sales milestone of $375 million.

Laboratoires Guerbet (France) acquires Mallinckrodt’s contrast product business for $270 million and increases its international market share, particularly in the US.

Novartis spins out three of its mid-to late-stage biological products to UK-based Mereo Biopharma, namely: BPS-804 for the treatment of brittle bone syndrome, BCT-197 for acute exacerbations in chronic obstructive pulmonary disease (COPD) and BGS-649 to normalize testosterone levels in men with hypogonadotrophic hypogonadism. Under the terms of the deal Novartis will receive milestones and royalties on commercial sales.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves Sanofi and Regeneron’s Praluent (alirocumab), the first PCSK9 inhibitor available in the United States, a treatment of high LDL cholesterol in adults, to be injected once-every-two-weeks. The U.S. Wholesale Acquisition Cost (WAC) price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses. Express Scripts takes a dim view on the proposed price which is several orders of magnitude above the costs of statins which average $2-3 per day.

US FDA approves ReShape Integrated dual balloon system, a minimally invasive option for obese patients. The device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach "or by other mechanisms that are not yet fully understood," according to the FDA.

ReShape Integrated Dual Balloon System–Courtesy of ReShape Medical

Drugs at clinical stage

US FDA has awarded breakthrough therapy status to Progenics Pharmaceuticals' Azedra, a treatment for patients with pheochromocytoma and paraganglioma, both rare neuroendocrine tumors.

Miscellaneous

A two-step regimen of an experimental MERS vaccine showed promising results in animal studies.

Merck's Ebola vaccine, in development alongside NewLink Genetics, protected 100% of patients from contracting the virus in interim results from an ongoing phase 3 study conducted in Guinea.

Romanian authorities are investigating 11 pharma companies under suspicion of bribing physician to prescribe cancer drugs. In a statement, the Romanian National Anti-corruption Directorate (DNA) said: "The file is related to suspicions of corruption offences regarding the manner in which a series of medicines were prescribed and purchased by certain health institutions and medical doctors in Romania.”

Bioevents

• Pharmaceutical Congress Asia 2025 on August 3-6 in Singapore
• 3^rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
• BioPharm America 2015 on September 15-17 in Boston (USA)
• Innovation Days on October 5-6 in Paris (France)
• BIO Japan on October 13-16 in Yokohama (Japan)
• BIO Latin America on October 14-16 in Rio de Janeiro (Brazil).
• 15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
• BIO Europe 2015 on November 2-4 in Munich (Germany)
• Biofit 2015 on December 1-2 in Strasbourg (France)

Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com

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