Biopharmaceutical News Week 11

We wish to congratulate the EBD Group as well as Sanofi, the main sponsor, with the support of the BioCluster Medicen Paris Region, for a very well organized BIO-Europe Spring 2015 conference and for bringing the biopharmaceutical innovation community to Paris for the first time.

Acquisitions /mergers/joint-ventures

March 6, 2015

Targacept and Catalyst Biosciences announce their merger

Targacept (Winston-Salem, NC, USA) and Catalyst Biosciences (South San Francisco, CA, USA) entered into an agreement to merge their companies into a New Co named Catalyst Biosciences. The focus of the company will be on engineered human proteases to develop new biopharmaceutical treatments in major human diseases. In the proposed transaction, current Catalyst shareholders will own 65% of the combined companies. Sun and Ranbaxy are finalizing their merger Almost a year after the announcement of their merger, the High Court of India allows the marriage of Sun Pharmaceuticals and Ranbaxy Laboratories to create India’s largest pharmaceutical industry.

March 9, 2015

Concordia Healthcare acquires Covis for $1.2B

Covis Pharmaceuticals and Covis Injectables two subsidiaries of Covis Pharma Holdings (Zug, Switzerland) will be bought by Concordia Healthcare (Toronto, Canada) in a 1.2 billion deal.

March 11, 2015

Endo raises bid for Salix to $11B

In our newsweek9 we had indicated that “some analysts believed that $158- per share- does not represent the full value of Salix and are considering that Valeant’s rivals could offer up to $170 a share.” A new bid at $175 per share has now been proposed by Endo International (Dublin, Ireland), a premium of 11% over Valeant’s offer and may open the door for a tough bidding war.

March 12, 2015

Ember and Mariel announces their merger

Ember Therapeutics (Boston, MA, USA) and Mariel Therapeutics (New York, NY, USA) entered into an agreement to merge both companies into a New Co named Ember Therapeutics. The new company will be active in the diabetic related diseases as well in osteoarthritis and kidney fibrosis.


March 8, 2015

Merck announces the layoff of 120 employees at Cubist A few weeks after the $9.5 billion acquisition of Cubist Pharmaceuticals, Merck is said to be planning a job cut involving 120 employees at Cubist drug discovery site in Lexington (MA, USA).

March 9, 2015

MI-mAb, a new consortium the development of immunotherapy monoclonal antibodies

Sanofi and Innate Pharma sign up as founders of MI-mAb, a new consortium based in Marseille aimed at accelerating the development of immunotherapy monoclonal antibodies in France.

Siemens officially announces the spinoff of its healthcare business

According to a Reuters report Siemens will officially spin off its healthcare business unit of about 11,000 people into a separate company as of May 1, but probably not through an IPO. Revenues at Siemens Healthcare were up 6% to almost €2.9 billion in Q1 of 2015, but profit declined 13% to €413 million and profit margins declined from 17.6% to 14.5%.

March 10, 2015

Merck Serono and Illumina partner in cancer diagnostic deal

Illumina (San Diego, CA, USA) and Merck Serono (Darmstadt, Germany), have partnered to develop a universal, next-generation sequencing (NGS) oncology diagnostic. The financial details of the deal remain undisclosed. "Our collaboration with Illumina around next-generation sequencing will enable us to perform genome studies at a pace unheard of a few years ago, and could lead to the development of several diagnostics," Susan Herbert, Head of Global Business Development at Merck Serono, said in a statement.

Takeda transfers its HPV vaccine candidate to Japanese research institute

Takeda Pharmaceuticals (Tokyo, Japan) said it has brought development of its human papillomavirus vaccine candidate through the preclinical stage and now has transferred the license to the Chemo-Sero-Therapeutic Research Institute, known as Kaketsuken (Okubo, Japan), to develop it to market. Takeda considers that its product may not be competitive enough with already available vaccines for HPV. On the other hand the Japanese drug maker wants to stay active in the dengue field where there are no approved vaccines yet. Sanofi is currently leading the race and expects to launch its vaccine later this year.

OSE Pharma launches its IPO on Euronext

OSE Pharma (Paris, France), a biotech specializing in immuno-oncology, has started its IPO on Euronext Paris and expects to raise a minimum of €15.9 million. “With these funds we will launch the phase III pivotal study of Tedopi in non small cell lung cancers” said Dominique Costantini the founder of the company. Tedopi is a combination of epitopes which are chemically optimized and combined to amplify patient immune response.

Approval of drugs, vaccines, diagnostics and devices

March 6, 2015

US FDA Approves Zarxio, US first biosimilar

The FDA approved Novartis' Zarxio as a biosimilar of Amgen's blood-cell stimulator Neupogen. It is the first drug approved by the agency as a biosimilar. But the drugs are not considered interchangeable, meaning pharmacists cannot automatically substitute Zarxio for Neupogen although the drugs have similar labels.

US FDA Approves Astella antifungal drug

The FDA has approved Astellas Pharma (Tokyo, Japan) Cresemba (isavuconazonium sulfate), for the treatment of two rare fungal infections: invasive aspergillosis and invasive mucormycosis, diseases that mainly affect blood cancer patients. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. This approval triggers a CHF30 million milestone payment to development partner Basilea Pharma (Basle, Switzerland).

March 11, 2015

Pembrolizumab becomes UK’s first drug in early access scheme

Merck’s PD-1 inhibitor pembrolizumab, an immunotherapy treatment for advanced melanoma, is the first medicine to be approved through the UK’s Early Access to Medicine Scheme (EAMS). The EAMS enables patients with life-threatening and seriously debilitating conditions to receive innovative and promising new drugs as soon as the Medicines and Healthcare products Regulatory Agency (MHRA) has signaled that the benefits outweigh the risks, through a two-stage evaluation process. In stage one, if the MHRA considers a product to be a possible candidate for EAMS, it will issue a Promising Innovative Medicines (PIM) designation, based on early clinical data. In stage two, the Agency will issue an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value.


March 12, 2015

Ebola outbreak in Africa of 2014 may severely increase deadly measles epidemic

Researchers report that the African countries most affected by the 2014 Ebola outbreak could now be highly susceptible to measles epidemics due to severe disruptions in routine health care such as vaccinations.


March 7, 2015

Robert Langer, New scientific advisor at Nanobiotix

Nanobiotix (Paris, France) recruits Robert Langer (professor at the Massachusetts Institute of Technology, Cambridge, USA) as a scientific advisor.

March 9, 2015

Apple announces open-source data collection platform for mobile medical applications

Tim Cook, CEO of Apple, announced, in San Francisco, the launch of its open-source platform for creating mobile medical apps. The new framework, named ResearchKit, will simplify and enable clinical trials by allowing participants to sign off forms over their iPhones. ResearchKit will be made available to developers in April. The new kit will be more focused on helping medical researchers use and collect data. Five ResearchKit apps are already available :

• The Asthma Help app, which helps patients avoid areas with poor air quality.

• The mPower app, which measures dexterity, balance, memory and gait in Parkinson's patients.

• The GlucoSuccess app, which helps diabetic patients figure out how diet, exercise and medications relate to their blood glucose levels.

• The Share the Journey app, which lets breast cancer patients share information about energy levels, cognitive abilities and mood following chemotherapy.

• The MyHeart Counts app, which uses surveys and tasks to help researchers gather data from participants that will shed light on the risk factors of cardiovascular disease. March 11, 2015

GSK locates its Asian Headquarters in Singapore

GlaxoSmithKline is strengthening its presence in Singapore by establishing a new 15,000-square-metre global headquarters for Asia. The company has signed an agreement with Boustead Development Partnership to develop and lease a new building located in the Rochester Park area, near a biotech cluster called Biopolis, with construction expected to complete by the end of next year.

Is China considering making major changes in regulating the pharma industry?

In a long article titled “Healthcare for-profit non-profiting act”, in the China Daily of March 11, Zhiwu Zack Fang, a member of the Chinese State Council’s Healthcare Reform Expert Advisory Committee said “Enforcement of execution is urgent for the pharmaceutical sector in China, to protect quality and to encourage innovation. It is currently the only sector in the Chinese healthcare industry that is mainly privatized and commercialized. But unfortunately, it is also a showcase for legislation whose execution has failed.

The massive uncertainty and fast-changing regulations have badly hurt the structure of the industry. Very few pharmaceutical companies are willing to invest in quality and innovation, simply because of the uncertain margins and returns. Not surprisingly then, the pharmaceutical industry is mission limited. Luckily, there are techniques that can be used to improve the healthcare industry. The legislation covering multiple healthcare sectors can be well organized by tracing "four flows", namely the flows of people, goods, data, and money. Compared to the traditional way of reforming separate sectors, legislation covering reforms based on these four flows will cover the core processes. At the end, the process of service provision is what matters and this links the mission with margins in different healthcare industry sectors.

Author : Jean-Claude MULLER, Special Advisor, Innovation & International Relationship (I&IR)


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