Ashley Roberts

	AstraZeneca announced on Feb. 5, 2015 that it had entered into a definitive agreement with Actavis to acquire the rights to Actavis’ branded respiratory business in the US and Canada for an initial consideration of $600 million upon acquisition completion and low single-digit royalties above a certain revenue threshold. The acquisition will increase AstraZeneca’s respiratory drug pipeline, which includes Symbicort (budesonide/formoterol fumarate dihydrate) and Pulmicort (budesonide), and accounted for over $4 billion of revenue for the company in 2014, with its entire respiratory portfolio pulling in over $5 billion by the end of year, according to a company 

	Under the terms of the agreement, AstraZeneca will acquire the developmental and commercial rights in the US and Canada to Tudorza Pressair (aclidinium bromide inhalation powder), which is a twice-a-day, long-acting muscarinic antagonist (LAMA) for chronic pulmonary disease (COPD), and Daliresp (roflumikast), the only once-daily oral PDE4 inhibitor for COPD. AstraZeneca will also acquire the developmental rights in the US and Canada for LAS40464, a combination fixed-dose of aclidinium with formoterol long-acting beta agonist (LABA) in a dry powder inhaler (approved in the EU under the name 

, respiratory, inflammation, and autoimmune diseases is one of the main areas of focus for the company. In October 2014, AstraZeneca announced that it acquired Almirall’s respiratory franchise for up to $1.22 billion to build its respiratory pipeline, marking the Actavis acquisition as an investment of more than $1.8 into respiratory assets for the company in the past six months. In June 2013, AstraZeneca 

 Pearl Therapeutics along with its lead product PT003, a combination (LAMA/LABA) meant for the treatment of severe COPD.

	“Our agreement with Actavis builds on our acquisition of Almirall’s respiratory portfolio and brings long-term value to one of our key growth platforms. With the addition of Tudorza and Daliresp, we will benefit from an immediate boost to revenue in our biggest market, further strengthening our growing respiratory franchise. This combined portfolio helps us to offer an even broader range of innovative treatments and formulations to physicians and pulmonary specialists for patients suffering with COPD,” said Paul Hudson, president of AstraZeneca US and executive vice-president, North America, AstraZeneca, in a press release.

 that they would be entering the LAMA space with a Theravance Biophama partnership to develop and commercialize a novel investigational treatment for COPD.

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AstraZeneca announced that it would strengthen its respiratory pipeline with the acquisition of Actavis’ branded respiratory business in the US and Canada.

AstraZeneca Reaches an Agreement to Acquire Actavis’ Respiratory Portfolio

	Sanofi announced on Feb. 3, 2015 that it launched FDA-approved Afrezza (insulin human) Inhalation Powder, which is now available for prescription in US retail pharmacies for the treatment of type 1 and type 2 diabetes. Afrezza is a rapidly absorbed, short-acting dry formulation of human insulin delivered from a small and portable inhaler to control blood sugar in diabetes patients. Administered at the beginning of a meal, Afrezza can help control high blood sugar, but should not be used in patients with chronic lung disease such as COPD or asthma.

	Mannkind Corporation developed Afrezza and can expect an upfront payment of $150 million, with potential milestone payments up to $775 million, with 35% of future profits. The inhalable version will be available for $7.54 per daily dose for 12 units, which is $4.40 (per dose or per unit?) more expensive than Sanofi’s injectable equivalent, Apidra (insulin glulisine [rDNA origin] injection), according to 

. The company’s press release lists one of the “limitations of use” as the need to continue long-acting insulin in combination with Afrezza for patients with type 1 diabetes, meaning the inhalable product cannot replace other forms of insulin for some patients.

	Sanofi’s diabetes division is responsible for $7 billion in sales annually. In 2014, Sanofi noticed a drop in sales for its diabetes treatment Lantus, contributing to CEO Chris Viehbacher’s termination, according to 

reports that the Lantus insulin patent is due to expire this year, meaning Sanofi expects little to no sales growth through 2018. Introducing the first FDA-approved inhalable insulin may up the game for Sanofi, securing its hold on the diabetes market. However, 

 continues by mentioning that industry analysts expect sales of only approximately $182 million per year by 2019 given previous inhalable insulin commercialization attempts by Pfizer that were unsuccessful.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

First Inhalable Insulin Comes to the US

	In the fight against antibiotic-resistant bacteria, NovoBiotic, Northeastern University, and the University of Bonn have partnered to discover a new 

 that blocks a microbes’ ability to build cell walls, thus killing it and inhibiting the bacteria from becoming resistant. According to NovoBiotic, the antibiotic, teixobactin, is highly potent against Gram-positive microbes, including 

 (MRSA) and vancomycin-resistant enterococci (VRE). Teixobactin works by binding to the undecaprenyl-PP-sugar region of bacterial cell wall components lipid II (peptidoglycan precursor) and lipid III (teichoic acid precursor), preventing cell wall formation.

	The antibiotic was identified using new methods to grow uncultured organisms by cultivation 

or by using specific growth factors. In 2012, Eric J. Stewart wrote in the 

that because most bacterial strains are unable to grow in laboratory environments, the antibiotic discovery pipeline had collapsed; the last antibiotic class that was successful was developed in 1987. Since then, derivatives and variations have been brought to market, causing a “discovery void.” Stewart further explains that bacteria have not been successfully grown in labs because of the inability of scientists to replicate a microbe’s natural environment.

 the group of scientists working on the antibiotic were able to combat the problem of growing microbes by developing a device called iChip to culture bacteria in its natural habitat. The device condenses the bacteria between two permeable sheets and is then put in the ground to allow the microbes to grow into colonies. After two weeks, the colonies had multiplied enough to allow the scientists to begin experiments. Pathogens were layered on the iChip while the scientists watched for the bugs that killed the pathogens above them, indicating that they produced natural antibiotics. The group studied 10,000 soil bacteria in which they found 25 new compounds, one of which was teixobactin.

 reported that MIT had successfully discovered two new classes of antibiotics to fight drug-resistant bacteria following a executive order signed by President Barak Obama that established a task force to fight the ongoing problem of antibiotic resistance. 

 further reported that the World Health Organization recently warned that the world was entering a “post-antibiotic era,” and the UK’s chief medical officer, Sally Davies, put antibiotic resistance on the government’s national risk register saying that more people will die from routine operations in the next 20 years if new antibiotics are not discovered.

NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.

New Antibiotic Puts up a Fight Against Superbugs

 that it had received clearance from the US Federal Trade Commission to acquire Covidien. The agreement includes a commitment to divest certain assets related to Covidien’s drug-coated balloon catheter product. Earlier in the month, Spectranetics 

 that it had reached an agreement to acquire Covidien’s drug-coated angioplasty balloon platform, Stellarex, for $30 million.

	Two days following US approval of Medtronic’s acquisition of Covidien, the European Commission has conditionally cleared the transaction. The approval is conditional on Medtronic’s commitment to divest Covidien’s drug-coated balloon business.

	The acquisition will bring together two companies that have been developing drug-coated balloons for the treatment of peripheral artery disease. Medtronic’s product, 

, has been tested in 29 clinical trials covering 4500 patients and 100 sites with the program testing 

 lesions, in-stent restenosis, BTK lesions, and combination therapies of debulking plus DEB. The acquisition will allow Medtronic to benefit from Covidien’s resources, while eliminating the competition.

	“There are few competitors currently active in this market and they exert limited competitive pressure on the market leader, Medtronic. It is likely that Covidien would have constrained Medtronic in the near future, in view of the promising first clinical trials' results of Stellarex, its drug coated balloon in development. The acquisition, as initially notified, would therefore have eliminated a credible competitor and would likely have reduced innovation in this area,” the European Commission stated in a 

, Medtronic has agreed to pay $43 billion for the acquisition of Covidien. Pending regulatory clearances, the transaction is expected to close in early 2015.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

Medtronic Gains US and EU Conditional Approval for $43 Billion Acquisition of Covidien

Thermo Fisher Scientific announced on Nov. 24, 2014 that it would collaborate with Samsung Electronics to jointly design, develop, and market new point-of-care (POC) solutions. The collaboration will focus on the detection of sepsis, drugs of abuse and therapeutic drug monitoring, detection of cardiac problems, and women’s health conditions. 

The press release states that the National Institutes of Health writes in its 

 that, “Empowering clinicians to make decisions at the ‘point-of-care’ has the potential to significantly impact health care delivery and to address the challenges of health disparities.”

In 2005, Thermo Scientific sold its POC business to Inverness Medical Innovations for $52.5 million, citing that the business did not fit with Thermo’s strategy. “Although the Point of Care and Rapid Diagnostics business has performed well, we do not believe it to be a strategic fit with Thermo's long term strategy for growth," said Marijn Dekkers, former president and CEO of Thermo Electron commented in a 

 from the 2005 sale. Now, Thermo will join with Samsung to expand the offering of POC platforms to meet the growing industry demand. A 

 from 2009 states that an increase in chronic diseases and an aging population requires an increase in healthcare options that are efficient and accessible.

Thermo Fisher Scientific announced a collaboration with Samsung to design, develop, and market new solutions for point-of-care.

Thermo Collaborates with Samsung to Develop Point-of-Care Diagnostic Solutions

	FUJIFILM Corp. will enter the vaccine CMO market with the acquisition of Kalon Biotherapeutics, a biologics development and manufacturing service provider out of Texas. FUJIFILM subsidiary, FUJIFILM Diosynth Biotechnologies (FDBU), will acquire 49% of the total membership interests in Kalon and will be entitled to appoint a majority of Kalon’s board members. Based on milestone achievements, FDBU may acquire 100% interest share.

	The acquisition will strengthen FUJIFILM’s stance in the pharmaceutical industry. This announcement comes shortly after the announcement that FUJIFILM would start producing 

FUJIFILM announced an agreement to acquire Kalon Biotherapeutics, a biopharmaceutical contract manufacturing organization specializing in vaccine manufacturing.