Iroko Pharma receives US patent for Zorvolex

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has received patent from the United States Patent and Trademark Office (USPTO) for the composition of matter covering Zorvolex (diclofenac) capsules 18 mg or 35 mg to treat mild to moderate acute pain and osteoarthritis pain.

The patent will be listed in the US Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book. Zorvolex which is approved by the US Food and Drug Administration (FDA) is available at pharmacies across the United States.

“We are excited to receive yet another patent on our flagship product, Zorvolex, which is another testament to our ongoing, successful collaboration with iCeutica,” said Osagie Imasogie, executive chairman of the Board and chief executive officer of Iroko Pharmaceuticals.

The term of the issued patent expires no earlier than 2030. In addition, Zorvolex has three years of regulatory exclusivity from date of product approval through FDA’s regulatory pathway. Iroko and iCeutica continue to prosecute additional patent applications for these and other products in the Iroko portfolio.

GE South Asia & Wipro appoint Milan Rao as president & CEO of healthcare business

GE South Asia and Wipro have appointed Milan Rao to lead GE’s healthcare business as president and CEO, GE Healthcare South Asia and managing director, Wipro GE Healthcare.

Effective May 1, 2015, he replaces Terri Bresenham, who has been leading GE Healthcare’s South Asia business since September 2011. Milan will report to Azim Premji, chairman, Wipro Ltd and Banmali Agrawala, president and CEO, GE South Asia.

Rao will build on Wipro GE’s expansion plans and continue to strengthen the company’s ‘In India, for India’ proposition of innovating disruptive technology and business solutions to enhance access to high quality, affordable healthcare solutions.

Terri, a 25-year veteran at GE, will move to a global role. In the last three years, she has led GE Healthcare to launch winning initiatives like skill building programmes, industry partnerships and breakthrough products such as discovery IQ and revolution ACTs.

“Rao  will take GE’s mission of a Healthier India forward through development of disruptive technologies and business models in India, for India, said Banmali Agrawala, president and CEO, GE South Asia.

“Wipro and GE have enjoyed a strong and enduring partnership lasting over 25 years that has made an indelible mark on India’s healthcare industry. I am confident Rao will further strengthen this relationship and give an added impetus to our mission to build a healthier India,” said Azim Premji, chairman, Wipro Ltd and non-executive chairman, Wipro Enterprises Ltd.

Mylan rejects drug company Teva's $40.1 billion buyout offer

NEW YORK: Mylan N.V. rejected Teva Pharmaceuticals' $40.1 billion buyout offer, saying the cash-and-stock proposal undervalues the company. 

Mylan said that it won't think about starting talks unless Teva offers more than $100 per share, far above its current offer of $82 per share. After the rejection Teva said it is committed to completing the deal and that a sale to Teva is Mylan's best option. 

The rejection comes as both Mylan and Teva look to further consolidate an increasingly competitive generic drug industry. Teva, the world's largest generic drug company, wants to strengthen its position by buying Mylan. Mylan is trying to buy Perrigo Co. of Ireland for about $30 billion in cash and stock, combining its own generic drug business with Perrigo's position in over-the-counter medications and other nonprescription products. Perrigo has rejected Mylan's offer, but the Dutch company says it stands by the bid.

Practo acquires FitHo Wellness

Practo, the doctor search engine, has acquired FitHo Wellness, which is a leading digital fitness solution that has over two million consumers globally.

The acquisition will help Practo rapidly expand its offerings and move into the preventive healthcare space. It will also bring the company to become the single health app for consumers need.

The founders of FitHo, Dhruv and Prachi Gupta will join Practo, with Dhruv taking on the role of product head for preventive and Prachi taking on the role of GM - operations, new segments.

Further, the company also acquires the proprietary algorithm and recommendation engine which automatically suggests custom diets and exercise regimes to users based on their lifestyle, fitness requirements and food preferences.

FitHo’s current offering will phase out over the next 6 months and Practo will launch a completely new preventive product that will leverage some of the technology from FitHo Wellness.

Awareness on vector-borne diseases necessity

World Malaria Day is celebrating on April 25, an effort towards spreading awareness about malaria and its prevention, Dr Rajkumar Chaudhary, Secretary, Association of Hospitals, says, “A continuing theme from last year is Invest in the Future, defeat malaria a part of the WHO initiative, holds the limelight for this year’s World Malaria day. The aim is to completely irradiate the ailment even if the number of cases is reducing year by year, a lack of awareness and preventive measures is still a major cause for concern. Improved awareness initiative programmes, will help to control this fatal disease. The nature of the disease is as such that is difficult to detect, and is not picked up in the first two blood samples. Due to this, there are several cases of patients landing in hospitals with lung, heart, liver problems.

Mumbai is a hotspot of vector-borne diseases owing to its unique environment and demographics. Mumbai is densely packed slums and these areas are always disproportionally impacted. Although the infection rates are high, many people cannot afford anti-malarial drugs, repellent or use mosquito nets. A major chunk of these individuals live below the poverty line and are unable to procure sufficient amenities to protect themselves and their families against Malaria”

The symptoms start around 7-10 days after being bitten by a carrier mosquito. The patient feels fatigued, has bouts of fever every few hours, shivers even when the outside temperature is normal, and suffers from headache, diarrhea, nausea, and vomiting. If immune system is weak, the symptoms may get triggered sooner than usual.

AstraZeneca collaborates with Celgene to develop PD-L1 inhibitor

AstraZeneca and its global biologics research and development arm, MedImmune, announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. Within the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and existing cancer medicines. Over time, the collaboration could expand to include other assets.

MEDI4736 was accelerated into phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

Merck's anti-PD-1 therapy,

Merck, a global healthcare leader, known as MSD outside the United States and Canada, announced results from the randomized, pivotal phase 3 study, Keynote-006, in the treatment of unresectable advanced melanoma. In the study, Keytruda (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).

On March 24, 2015, Merck announced that Keynote-00 would be stopped early based on these data (link). The results were presented at the American Association for Cancer Research (AACR) annual meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published in the New England Journal of Medicine.

“Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, Keytruda was statistically superior to ipilimumab for progression-free survival and overall survival, and also demonstrated a lower frequency of severe adverse events,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris and lead author of the New England Journal of Medicine publication.

In mid-2015, Merck plans to submit a supplemental Biologics License Application (sBLA) for Keytruda based on Keynote-006 for the first-line treatment of advanced melanoma. Merck recently submitted data from Keynote-002 in ipilimumab-refractory advanced melanoma as part of a supplemental application.

Keytruda was the first anti-PD-1 therapy approved in the United States and is currently indicated in the United States for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.