Rare Disease Day is held the last day of February each year

and is the occasion to raise awareness for rare diseases.

Acquisitions /mergers/joint-ventures

February 22, 2015

Valeant proposes $14.5 billion to acquire Salix

Valeant Pharmaceuticals (Raleigh, NC, USA) agreed to pay $14.5 billion to purchase Salix Pharmaceuticals (Laval, Quebec, Canada).The deal, which gives Valeant access a strong portfolio of gastrointestinal disease drugs, is expected to be completed Q2 2015. "Combining Salix's leading market position in gastroenterology with Valeant's scale and resources will create a stronger and more diverse business committed to providing better health solutions to health care providers and their patients," Salix Chairman Thomas D'Alonzo said. Nevertheless some analysts believe 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.

February 23, 2015

BMS acquires cancer specialist Flexus for $1.25 billion

Bristol-Myers Squibb will spend up to $1.25 billion to acquire private Flexus Biosciences (San Carlos, CA, USA) and its oncology portfolio. The deal is structured around an $800 million upfront and as much as $450 million in milestones. The acquired asset consists of molecules that inhibit enzymes known as IDO and TDO, a class of products that disrupts processes that interfere with T cell function. A newly formed entity established by the current shareholders of Flexus will retain all of the non-IDO/TDO assets.

Sosei acquires Heptares in a $400 million deal

Sosei Corporation (Tokyo, Japan) acquires Heptares Therapeutics (Welwyn Garden, UK) for $400 million in a deal structured with a $180 million upfront and up to $220 million in milestones fees and revenue sharing.

February 24, 2015

Shire buys Meritage Pharma for an upfront fee of $70m

Meritage Pharma (San Diego, CA, USA) will be acquired by Shire for an upfront fee of $70 million and the promise of additional development and regulatory milestones. The acquisition gives Shire access to Oral Budesonide Suspension (OBS) to treat patients with eosinophilic esophagitis, a rare chronic inflammatory gastrointestinal disease.

Ipsen signs option to acquire UK Canbex Therapeutics

Ipsen (Boulogne-Billancourt, France) has signed an option of €6 million to acquire Canbex (London, UK), a spin-off of University College of London, to access VSNR16, a novel anti-spastic treatment. Canbex’s shareholders will receive up to an additional €90 million milestones and royalties on sales of VSNR16.

February 26, 2015

Cyberonics and Sorin to merge, creating a global medical technology company

Sorin (Milan, Italy), a leader in the treatment of cardiovascular diseases, and Cyberonics (Houston, TX, USA) with core expertise in neuromodulation, announced their merger to create a global leader in medical technologies with a combined equity value that values the NewCo at $3 billion. Andre-Michel Ballester of Sorin, will become CEO of NewCo and Dan Moore of Cyberonics, non-executive Chairman. The new company will be domiciled in the U.K. and apply for a dual-listing on the Nasdaq and the London Stock Exchange.

February 27, 2015

Nikon to buy Optos for $400M and become a med tech company

Nikon (Tokyo, Japan) will acquire the Optos Group (Dunfermline, Scotland, UK) for $400 million as part of its long-term plan to expand into the medical sector. Last June, the Japanese company unveiled a plan to leverage its optical technologies to expand into the medical industry. The Optos acquisition will serve to expand into internal diagnostics, ophthalmology treatment and regenerative medicine such as retina regeneration. Optimistic Optos shareholders are still looking for a white knight competitor to enter the deal and drive the current offer price of 340 pence to a higher figure.

Business

February 20, 2015

Takeda signs an R&D agreement with London Queen Mary University

Takeda Pharmaceutical and Queen Mary University of London enter into a collaboration in the research and development of new drugs for gastrointestinal disorders related to bowel’s sensory and motility dysfunctions.

February 23, 2015

Merck and NGM announce broad collaboration to develop new biologics

Merck & Co. and NGM Biopharmaceuticals (South San Francisco, CA, USA) agreed to collaborate in the discovery, development and marketing of novel biologic drugs. Under the agreement, NGM will receive an initial payment of $94 million, and Merck will buy a 15% equity stake for $106 million and fund NGM's projects for up to $250 million. NGM will be responsible for research and development of preclinical compounds, while Merck will have the option to license NGM's subsequent programs.

February 25, 2015

AstraZeneca signs an R&D agreement with UK

Orca AstraZeneca has signed an R&D agreement with Orca Pharmaceuticals (Abingdon, UK) to develop drugs against a range of auto-immune diseases. The agreement is focused on inhibitors of retinoic acid-related orphan receptor gamma (RORγt), an orphan receptor that plays a critical role in the control of genes responsible for the differentiation and activation of Th17 and lymphoid cells. The deal gives AstraZeneca rights to acquire compounds from the collaboration and pay Orca as much as $122.5 million.

Roche and German BioMed X collaborate to develop nanomaterial based biosensors

Roche and BioMed X, a life science incubator located in Heidelberg (Germany), announced that they entered into a collaboration agreement to create a diagnostics research group focused on biosensors and nanomaterials such as graphene.

February 27, 2015

Japan suspends Novartis with 15-day ban over inadequate side effect reports

As already suspected and mentioned in Biopharmaceutical News week6, the Japanese Ministry of Health, Labour and Welfare has issued a 15-day (March 5th – 19th) business suspension order to Novartis’s pharmaceutical operations for breaching adverse reporting rules of 3,264 cases of side effects pertaining to 26 drugs within the time frame specified by law. This is the first time the ministry has issued a suspension for failure to report side effects.

Approval of drugs, vaccines, diagnostics and devices 

February 20, 2015

The EU Commission grants Chiesi approval for its eye stem cell therapy

Chiesi (Parma, Italy) gets conditional marketing authorization from the European Commission for Holoclar for the treatment of a rare eye disease: moderate to severe limbal stem cell deficiency caused by chemical or physical burns. Chiesi says it is the first advanced therapy medical product (ATMP) containing stem cells approved in Europe for an eye disease. The product resembles a contact lens and is made from an epithelium graft from the patient's undamaged cornea.

US FDA grants Bioness for its chronic pain peripheral nerve implant

Bioness (Valencia, CA, USA), has gained clearance from the FDA for its StimRouter, a minimally invasive implantable neuromodulation medical device to treat chronic pain of peripheral nerve origin. StimRouter is the only implant cleared by FDA specifically for peripheral nerve stimulation. It consists of an implanted lead, external pulse transmitter (EPT), a conductive electrode and a hand-held wireless control unit. Transdermal electrical signals are transmitted from the EPT through the electrode and down the lead to the origin of the patient's pain.

February 23, 2015

US FDA approves Farydak for multiple myeloma

The US FDA has approved Novartis’ Farydak (panobinostat), the first histone deacetylase (HDAC) inhibitor to be authorized for the treatment of patients with multiple myeloma. HDAC inhibitors stop the proliferation of tumour cells by inducing cell apoptosis. Farydak was approved for use in patients who had at least two previous standard treatments including bortezomib (Velcade), a proteasome inhibitor, and dexamethasone, a corticosteroid.

February 26, 2015

US FDA clears Sanofi long acting insulin

The US FDA approves Sanofi's Toujeo (insulin glargine, 300 U/ml), a once-daily long-acting basal insulin, to improve glycemic control in adults with type 1 and type 2 diabetes. Tujeo should progressively replace Lantus which faces competition from biosimilars to be launched soon by Eli Lilly and Boehringer Ingelheim. The company expects the new product to be available in the U.S. at the beginning of Q2 2015. Payers may nevertheless be reluctant to paying more for a product which barely differentiate itself from its parent Lantus (with worldwide sales above $7 billion in 2014)

EU Commission approves Newron’s new Parkinson's drug

The European Commission approves Xadago (safinamide) from Newron Pharmaceuticals (Bresso, Italy), as on oral, once a day adjunctive therapy for any stage of Parkinson's disease (PD). Safinamide has a unique novel dual mechanism of action based on the enhancement of the dopaminergic function (through inhibition of MAO-B and of dopamine uptake) and inhibition of the excessive release of glutamate. Safinamide is partnered with Meiji Pharma, in Japan and Asian territories and with Zambon (Italy) in all other markets.

Drugs at clinical stage

February 23, 2015

US FDA grants breakthrough status to Celldex brain cancer immunotherapy

Celldex Therapeutics (Hampton, NJ, USA) experimental drug Rintega, or rindopepimut, obtained FDA breakthrough-therapy status for use in patients with EGFRvIII-positive glioblastoma (GBM). EGFRvIII is expressed in tumours in about 30% of patients with GBM.

February 25, 2015

US FDA accepts Teva's NDA for abuse-deterrent opioid

The US FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require around the clock and long-term opioid treatment. The product is formulated with a proprietary abuse-deterrent technology.

Technology and Health IT

February 22, 2015

US FTC fines melanoma diagnostic applications makers

The US Federal Trade Commission (FTC) has reached a settlement with two companies, and is pursuing charges against two others, in relation to applications that claim to detect melanoma. The FTC states the marketers involved acted deceptively in claiming the applications can detect melanoma symptoms based on photographs a consumer uploads to the application. "Truth in advertising laws apply in the mobile marketplace," said Jessica Rich, director of the FTC's Bureau of Consumer Protection. "App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps." This new action comes just weeks after the FTC settled with a computer software maker regarding deceptive claims tied to a game's ability to help boost children's mental acumen.

Apple drops health functions from its Apple Watch

The Wall Street Journal reports that the Apple Watch, expected to be launched on March 9, will come without its anticipated health features. Apple had been testing sensors that track stress by measuring the conductivity of skin and electrocardiogram features, but found the technology was not reliable enough, according to the article. The Cupertino based company decided to go with a more generic pulse-monitoring feature.

Device to detect cervical cancer being developed in Israel

Biôp Medical (Netanya, Israel) is developing the Biôp diagnostic medical device to detect cervical cancer in epithelial tissues. "The Biôp device is perfect for any setting, especially for doctors and nurses in rural areas who don't have the fancy equipment usually needed to test for cervical cancer," said CEO Ilan Landesman. "It's a big-data solution that can replace traditional methods of examining for cervical cancer".

Ebola

February 20, 2015

WHO approves Ebola test from Corgenix

The World Health Organization (WHO) approved the ReEBOV Antigen Rapid Test for Ebola, developed by Corgenix Medical (Broomfield, CO, USA). The test, which requires only a drop of blood on a paper strip, is capable of producing results within 15 minutes, compared with the standard 12 to 24 hours. According to the WHO, the test can identify approximately 92% of patients infected with Ebola and 85% of those without infection.

February 27, 2015

WHO delays Ebola mass vaccination until August

According the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), to commence the widespread introduction of an Ebola vaccine will not happen until at least August. Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health. More than 23,500 cases of Ebola have been reported in the western African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.

Events

• Bio-Europe Spring 2015 on March 9-11 in Paris
• Biomarkers Summit 2015 on March 18-20 in San Diego, CA
• Bio Asia International Conference on March 24-25 in Tokyo

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

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