Biopharmaceutical News Week 24

Acquisitions /mergers/joint-ventures

Actelion rebuffs Shire’s offer

Shire’s offer to acquire Actelion (Basel-Allschwil, Switzerland) values the Swiss company at $18.9 billion or about 160 Swiss franc a share. “Actelion board’s alleged unwillingness to open the books at 160 francs may suggest their expectations are far higher,” according to UBS AG Guillaume van Renterghem. “We believe Shire would be unlikely to come back with a higher offer. Over the last 10 years we are not aware of a situation where Shire would go hostile.

…. and so does Receptos to AstraZeneca’ bid

Receptos (San Diego, CA, US) rejected a $200 per-share-takeover bid from AstraZeneca and expects an offer of $350 per share since Gilead Sciences and Teva are claimed to be looking at this same target. Receptos' main asset is oxanimod (RPC1063), a sphingosine 1-phosphate 1 receptor (S1P1R) modulator in phase III testing for multiple sclerosis and phase II for Crohn's disease.

Cardinal Health acquires Harvard Drug for $1.12 billion

Cardinal Health (Dublin, OH, USA) plans to acquire The Harvard Drug Group (Livonia, Michigan, USA) for $1.12 billion in cash. The Harvard Drug Group is one of the largest US suppliers of prescription and over-the-counter medications and related products.

Teva keeps moving to acquire Mylan

Teva announced that they have taken a further step in reaching 3% of Mylan’s share making it the company eight’s largest investor. Under The Netherlands’ corporate law, that threshold gives Teva the power to submit agenda items at the next shareholder’s meeting.

Targovax and Oncos Therapeutics merger to form a Nordic immune-oncology company

Targovax (Oslo, Norway) and Oncos Therapeutics (Helsinki, Finland) have announced to an all-share merger plan to create a Nordic oncology company with a cancer vaccine portfolio. HealthcareCap, a Stockholm based venture capital company will become the largest shareholder.

Business

Vertex and Parion collaborate on cystic fibrosis treatments in a deal worth 1.17 billion

Vertex Pharmaceuticals (Boston, MA, USA) and Parion Sciences (Durham, NC, USA) agreed to form a partnership to develop new drugs and combination of drugs to treat cystic fibrosis and other lung diseases. The investigational drugs are epithelial sodium channel inhibitors (ENaC) and include P-1037 and P-1055. Both companies believe that the defective cystic fibrosis transmembrane conductance regulatory (CFTR) protein that causes cystic fibrosis increases the function of ENaC which contributes to the dehydration of the cell surface of lungs in people with the disease. Under the agreement Parion and Vertex will launch a Phase IIa study that adds P-1037 to treatment with the lumacaftor and ivacaftor for people with cystic fibrosis who have two copies of the F508del mutation in order to assess the value of the different combinations. Vertex will gain global development and marketing rights to the inhibitors, while Parion will receive an $80 million upfront payment and almost $1.1 billion in potential milestone fees plus low double digit to mid-teens sales royalties.

Several IPO’s : Abivax , China 3SBio , Pieris

Abivax launches its Initial Public Offering

Abivax (Paris, France), a biotechnology company focused on the discovery and development of anti-viral compounds and human vaccines, launches its Initial Public Offering (IPO) on the Paris NYSE Euronext stock exchange. The company expects to raise between €44.6 and €57.7 million in order to accelerate the development of its two lead products ABX203 (chronic hepatitis) and ABX 464 (HIV/AIDS).

China 3SBio raised $710.7 million in Hong Kong IPO

Two years after delisting from the NASDAQ, Chinese 3SBio has reached the high end expectations for its IPO on the Hong Kong stock exchange in raising $710.7 million. In its filing 3SBio said it has eight potential candidates in nephrology and six in oncology, including three monoclonal antibody therapies, as well as autoimmune disease targets, among the twenty potential products listed.

Pieris files for a $35 million IPO on NASDAQ

Pieris Pharmaceuticals (Freising-Weihenstephan, Germany), a company developing drugs for functional iron deficiency in anemic patients filed with SEC to raise up to $35 million in its US initial public offering. Pieris already trades on the US OTCQB with a market cap of $90 million.

Seattle Genetics and Unum collaborate on cancer immunotherapies in $645 million deal

Seattle Genetics (Bothell, WA, USA) and Unum Therapeutics (Cambridge, MA, USA) will team up to develop new antibody-coupled –T-cell receptor (ACTR) therapies for cancer. Under the terms of the agreement, Unum will receive a $25 million upfront payment and up to $615 million in potential milestone fees, plus royalties on sales outside the U.S. The firms will equally share the profits for developed products in the U.S.

Celgene and Lycera enter an exclusive cancer immunotherapy strategic collaboration agreement worth $105 million

Celgene (Summit, NJ, USA) agreed to license Lycera’s (Ann Abor, MI, USA) RORgamma agonist portfolio for the development of novel immunotherapies. Under the terms of the agreement Lycera will receive an upfront payment of $82.5 million plus potential short-term payments of $22.5 million, while Celgene will get an option to license Lycera's ROR gamma agonist compounds and an option to purchase Lycera. The firms also agreed to collaborate on the development of Lycera's lead program LYC-30937 as a treatment for inflammatory bowel disease.

Novartis reveals its strategy in immunotherapies

In 2014 Novartis acquired CoStim Pharmaceuticals giving it access to a PD-1 checkpoint inhibitor and in March of 2015 it signed a collaboration deal with Aduro to get access to a novel immunotherapy approach called STING. Novartis will present more details about its cancer immunotherapy strategy at a June 17-18 investor event in Boston.

Panasonic Healthcare acquires Bayer diabetes care division for €1.02 billion

After several months of speculation and a recent move by Chinese Sinocare, Bayer has agreed to sell its diabetes care division to Panasonic Healthcare for €1.02 billion, a business that had previously been valued at as much as $2.5 billion. Under the deal Panasonic Healthcare, which is controlled by U.S. private equity firm KKR, will buy blood glucose monitoring meters, strips and devices that are sold under the Contour, Breeze 2, Elite and Microlet brands.

Johnson & Johnson starts a collaboration with Washington University to prevent type 1 diabetes

Janssen Pharmaceuticals, a Johnson & Johnson division, announced a research partnership with Washington University Professor Dr. Emil Unanue to study how the immune system is involved in the initiation and the progression of type 1 diabetes.

Alibaba founder invests $142 million in Chinese medical imaging device company

Jack Ma, founder of Alibaba Group is investing $142million in China Resources Wandong Medical equipment, a Beijing based manufacture of medical imaging devices. As part of the deal, Wandong Medical will team with Alibaba's healthcare units Alijk and Yidegu to provide Internet-based medical imaging services as well as analyses of a patient's MRI and CT scans.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves Medtronic for MiniMed Connect

Medtronic (Dublin, Ireland) has received approval form US FDA for its MiniMed Connect which provides personal diabetes data. The company has designed MiniMed to provide a mobile connection to critical information for managing diabetes, allowing people with the illness to monitor their insulin pump and continuous glucose monitor (CGM) data on a smartphone.

…. and Roche’s test to diagnose herpes

A few days after the approval of its rapid test for Clostridium difficile on the cobas 4800, Roche received clearance US FDA 510 (k) clearance for the cobas HSV 1 and 2 test to differentiate between the two causes of genital herpes infection. The company launched the HSV test in Europe in 2014.

Roche obtains CE mark for Ariosa

Roch’es Ariosa Diagnostics has received CE mark approval for its Forte software which will support the company’s Harmony prenatal test.

Drugs at clinical stage

US FDA Endocrinologic and Metabolic Drugs Advisory Committtee has voted in favour of:

Sanofi and Regeneron’s Praluent (alirocumab), a PCSK9 inhibitor, for the treatment of high risk familial hypercholesterolaemia ……. and of Amgen’s Repatha (evolocumab) for its own PCSK9 inhibitor. Both companies are in a race to be the first to reach the US market with this new class of drugs.

US FDA Pulmonary-Allergy Drugs Advisory Committee unanimously supports the approval of GlaxoSmithKline mepolizumab for the treatment of adult patients with eosinophilic asthma but not for adolescents.

US FDA grants:

Breakthrough status to Roche’s Actemra/RoActerema, a humanized anti-interleukin 6 receptor antagonist monoclonal antibody, for the treatment of systemic sclerosis, a rare degenerative connective tissue disease caused by the overproduction of collagen.
Orphan drug status to :

– Apitope’s (Diepenbeek, Belgium) ATX-F8-117 to treat haemophilia A patients. Haemophilia A is a rare chronic bleeding disorder, which leads to inadequate clotting.

– Agio Pharmaceuticals’ (Cambridge, MA, USA) AG-120, a mutated metabolic enzyme isocitrate dehydrogenase 1 inhibitor for the treatment of acute myeloid leukemia treatment

– Arrowhead Research’s (Pasadena, CA, USA) ARC-AAT, an RNAi based therapeutic drug for the treatment of liver disease related to alpha-1 antitrypsin deficiency (AATD). AATD is a rare genetic disease that severely damages the liver and lungs of affected children and adults.

Lilly’s Trulicity superior to Lantus

Data presented at the American Diabetes Association Scientific Session in Boston by Eli Lilly, showed that Trucility (dulaflutide) provide superior hemoglobin Ac1 reduction compared to Sanofi’s Lantus (insulin glargine). Patients receiving Trucility also lost weight while those receiving Lantus gained weight.

Novartis’ Arzerra extends progression-free survival in blood cancer

A phase 3 study shows that Novartis’ Arzerra (Ofatumumab), a human monoclonal antibody that binds CD20, in combination with fludarabine and cyclophosphamide, improved median progression-free survival (PFS) by 54% versus the treatment with fludarabine and cyclophosphamide alone, in patients with relapsed chronic lymphocytic leukemia (CLL) Novartis’ Cosentryx effective in difficult to treat psoriasis

Novartis showed that Cosentyx (secukinumab), a human interleukin-17A antagonist, was effective in treating patients with plaque psoriasis of the palms, soles and nails, traditionally difficult to treat. Cosentryx was approved earlier this year in Europe and in the US.

Alnylam’s ALN –CC5 shows positive results in paroxysmal nocturnal hemoglobinuria

Alnylam’s (Cambridge, MA, USA) ALN-CC5 is a first in class C5 synthesis inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a chronic debilitating disorder characterized by the breakdown of red blood cells by the complement system with releases of hemoglobin in the urine.

Human papillomavirus (HPV) Vaccine

Recent clinical trials provide evidence that one dose of human papillomavirus (HPV) vaccine can prevent the large majority of cervical cancer as well as the current two and three-dose schedule.

Technology

OncoSec develops ImmunoPulse an immune-oncology delivery platform

OncoSec Medical (San Diego, CA, USA), a cancer immunotherapy company has raised $13.6 million to develop its ImmunoPulse platform. The platform is designed to improve the delivery and uptake of DNA-based therapeutics directly into tumors. The DNA is genetically engineered to code for immune-stimulatory proteins and is directly delivered into a tumor by a needle, which pulses electronically to increase the cell membranes' permeability and allow the DNA to enter the cells. The DNA is then free to create the protein within the cells to express antitumor effects.

Progress towards a Type 1 diabetes vaccine using nanotherapy

Spanish researchers (University of Barcelona) have designed nanoparticles that can stop the destruction of the beta cells and avoid diabetes development when injected in the body. This technique could become a candidate for a human vaccine.

Medical Devices and Diagnosis News

New blood test that reveals viral history

Researchers have develop VirScan, a blood test that can detect every virus a person has ever been exposed. The test identifies all of the antibodies present in an individual’s blood and matches them to the 206 know species of viruses.

Miscellaneous

South Kora’s MERS outbreak becoming very sensitive

Asian authorities are very sensitive about the spread of Middle East Respiratory Syndrome (MERS) and fear a situation similar to the Severe Acute Respiratory Syndrome (SARS) in 2003. MERS is a viral respiratory illness that was first reported in Saudi Arabia in 2012. Humans infected develop severe acute respiratory illness, fever, cough and shortness of breath and many of them have died. The risks of the disease spreading are high because of the vast packed daily commutes on public transports in Asian large cities. 14 deaths have already been reported in South Korea.

NICE does not recommend Celgene’s Otezla for psoriasis

The UK National Institute for the Health Care and Excellence (NICE) turns down Celgene’s Otezla (apremilast) for the treatment of patients with moderate and severe psoriasis on ground that its costs failed to fall within the range considered to be a cost-effective use.

Bio and Business Events

BIO International Convention on June 15-18 in Philadelphia (USA)
Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
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)
15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)

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

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