Acquisitions /mergers/joint-ventures

March 16, 2015

Counterbids for Salix: Valeant comes out as the winner

In your previous newsweek we had indicated that “the bid for Salix could end up in a tough bidding war”. This already seems to be over with the new offer from Valeant. Endo’s last week proposal offered $175 per share, a bid composed of cash and Endo’s stock, meaning the deal’s value would fluctuate with Endo’s stock value. Valeant’s new offer removes that risk with a bid of $173 per share in cash. "This revised offer provides Salix shareholders with all cash at a significant premium and the certainty to close by April 1," Valeant’s CEO Michael Pearson said in a statement.

Business

March 12, 2015

WuXi plans to build a cell therapy manufacturing facility in Philadelphia

WuXi Pharma Tech (WuXi, China) announced that it will build a 145,000 square-foot facility in Philadelphia (PA, USA), opening in mid-2016, to manufacture viral cell therapy products such as chimeric antigen T (CAR-T) cell therapies.

March 15, 2015

Pharmacyclic’s Imbruvica with new positive clinical outcomes

Johnson & Johnson, a partner of Pharmacyclics, announced that it has stopped a study of Imbruvica after the drug met its primary endpoint in patients with relapsed forms of CLL. These results confirm that the drug has a significant market growth potential and may explain the high value Abbvie has recently proposed for the acquisition of Pharmacyclics.

March 17, 2015

Cellectis opens its IPO on NASDAQ

Cellectis (Paris, France) has started its IPO on New York City Nasdaq with a 3.5 million American Depositary Shares (ADSs) representing 3.5 million ordinary shares at $36.83 per ADS. The company already trades on the Alternext market on Euronext in Paris. Cellectis gene-editing technology allows it to create allogeneic Chimeric Antigen T (CAR-T) cells that harness the immune system to target and kill cancer cells. The uniqueness of this technology is its capability to create these engineered cells from healthy donors instead from patients. Pfizer had already recognized this value by striking a deal with Cellectis in June 2014 which was linked to a 10% stake in the French company.

Qiagen Marseille becomes HalioDx

Three years after Ipsogen became Qiagen Marseille, the French start-up based in Marseille (France) becomes independent again under the name of HalioDx. The company will focus its activity on immune-oncology diagnostic kits.

Novo Nordisk will be focusing on diabetes

In a recent interview, Novo Nordisk deputy CEO Kaare Schultz said the focus of the Danish company on diabetes was likely to account for 80-90 percent of sales in 10 years, up from 79 percent now. "This is the key focus for the company and we see strength in staying focused," he said in a recent interview in London.

March 18, 2015

Canon makes its first Biomedical deal

Just a few weeks after Nikon moved into the Biomedical field, Canon announces its first med tech deal in investing in Canadian Spartan Bioscience (Ottawa, Ontario) to develop rapid DNA testing. In addition to the strategic investment, Canon BioMedical and Spartan Bioscience plan to explore areas to work together on the development of future diagnostic products.

March 19, 2015

AstraZeneca selects Daiichi to promote Movantik in the US

AstraZeneca has selected Daiichi Sankyo (Tokyo, Japan) to help promote its non-constipation drug Movantik (naloxegol) in the US, as the firm prepares for its launch. Movantik, a first in class peripherally-selective opioid antagonist, licensed from Nekar, which will be launched in April, was approved by US FDA last September for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Under the agreement Daiichi will pay AstraZeneca $200 million up-front as well as sales-related payments of up to $625 million for joint commercialization rights.

March 20, 2015

Sanofi announces a strategic discovery deal with Evotec

Sanofi and Evotec AG (Hamburg, Germany) enter into a five-year drug discovery collaboration focusing on a newly developed small molecule discovery platform. Under the agreement both companies will combine their chemical libraries of 1.7 million compounds and propose them to Evotec’s partners, and Evotec will integrate about 200 former employees from the Sanofi discovery site in Toulouse (France) as of April 1. Under the terms of the contract Sanofi will pay Evotec a €40 million upfront cash payment as part of a €250 million over the next five years. Elias Zerhouni, President Global R&D for Sanofi, said it will “create a field of opportunities for our employees, while contributing to the vitality of the local ecosystem”.

March 19, 2015

Lilly and Hanmi sign a $690 million deal to develop a new drug for autoimmune diseases

Hanmi Pharmaceuticals (Seoul, South Korea) and Eli Lilly enter in an agreement to develop HM1224, an oral Bruton’s tyrosine kinase inhibitor, for the treatment of autoimmune diseases. The deal is structured around an upfront payment of $50 million and up to $640 million in regulatory and sales milestones and double-digit royalty payments. The drug is expected to enter Phase II shortly, and will be tested in rheumatoid arthritis, lupus, lupus nephritis, Sjögren's syndrome, and other related autoimmune conditions. Approval of drugs, vaccines, diagnostics and devices.

March 17, 2015

European Commission approves Novartis’s Jakavi

The EU Commission approves Novartis’s Jakavi (ruxolitinib) for the treatment of patients with polycythemia vera (PV), a rare blood bone marrow cancer associated with the overproduction of blood cells. Jakavi is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. It was previously approved for the treatment of myelofibrosis, another disorder of the bone marrow. Novartis licensed ruxolitinib from Incyte for development and commercialization outside of the US. Incyte retains commercialization rights in the U.S

US FDA finally approves Boston Scientific stroke-fighting Watchman device

The Watchman device–Courtesy of Boston Scientific

After several setbacks and FDA rejections in 2010 and 2014, Boston Scientific gets FDA approval for its stroke-fighting Watchman device. The device was approved for patients to seek a non-pharmacologic alternative to oral anticoagulation. The Watchman device is already approved in Europe and 75 countries around the world. Boston Scientific says 10,000 patients have received the device so far.

Drugs at clinical stage

March 18, 2015

US FDA grants Cell Medica drug CMD-003 orphan status

Immunotherapy firm Cell Medica (London, UK) has been granted orphan drug status by the FDA for CMD-003 for Epstein-Barr Virus positive non-Hodgkin lymphomas. CMD-003 is produced from patient immune cells taken from a blood sample for activation and expansion through a proprietary procedure developed for commercial-scale use. March 19, 2015 AstraZeneca combination lung disease drug, PT003 successful in late phase clinical trials Two Phase 3 clinical trials evaluations of PT003 (a fixed-dose combination of glycopyronium a muscarinic antagonist and formoterol, a beta-2 agonist) in patients with chronic obstructive pulmonary disease (COPD) achieved their primary endpoints versus placebo. The product was assessed in 3,700 patients in 275 study sites. The combination product was delivered in pressurized dose inhaler using the porous particle-co-suspension technology developed by Pearl Therapeutics.

Technology

Newest drug-eluting stents as effective as bypass surgery in coronary artery disease

According to a new study published in the New England Journal of Medicine, the latest generation of drug-coated stents is as effective as bypass in treating coronary artery disease (CAD).The study involving 18,000 patients looked at outcomes for more than 9,000 patients who received the Abbott everolimus-coated stent versus sample of 9,000 patients who had coronary bypass surgery. The study found that the stent group was not less likely to die after the procedures in a mean follow-up time of 2.9 years.

Ebola

March 16, 2015

Emergent Bio makes first clinical batches of Ebola vaccine

Emergent Biosolutions (Gaithersburg, Md, USA) announced that under multiple agreements with the University of Oxford, GlaxoSmithKline, and the NIH's National Institute of Allergy and Infectious Diseases (NIAID), it had manufactured an Ebola vaccine candidate, called a modified vaccinia Ankara Ebola Zaire, or MVA EBOZ. It will be tested with Glaxo's candidate in a Phase I trial at the University of Oxford (UK).

Miscellaneous

A Worldwide Pharma market of more than $1,000 billion in 2014

An IMS Health report indicates that the 2014 world pharma market had exceeded the $1,000 billion mark in 2014 and forecasts a growth of 4-7% up to 2018 with

… major Asia pharma expected to soar in 2015

Other reports indicate that Japan, China and India pharma markets are poised to grow at double digit rates. Japan and India are expected to grow at respectively 8% and 11% whereas China is expected to grow at 12% in 2015. China may well contribute 50% of the growth of the world market.

… as well as the one in the US

A GlobalData report shows that the US pharmaceutical industry will be worth $548 billion by 2020, compared with $395 billion in 2014. The underlying factors of this fast growth are higher health care spending, increasing rates of chronic diseases and easily accessible reimbursement for drug costs.

Bioevents

• Bio Asia International Conference on March 24-25 in Tokyo (Japan)
• China Bio Partnering Forum on April 22-23 in Shanghai (China)
• BIO International Convention on June 15-18 in Philadelphia (USA)
• Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)

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

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