Pharmaceutical Newsletter - December 01 to 05, 2014

CCI has suggested Sun Pharma and Ranbaxy to make changes in proposed $4 billion merger deal, according to reports. Report said that this includes possible divestment of some brands.

Dec 05, 2014 11:12 IST India Infoline News Service

Top News
 
Europe bars imports from antibiotic injectables unit: Ranbaxy Laboratories
Ranbaxy Laboratories Ltd clarified, "The news item is misleading and we wish to clarify as follows in order to place it in the right perspective. The development pertains to only the Company's cephalosporin injectable unit at Dewas in Madhya Pradesh.
 
The European authorities along with those from Australia and Canada carried out an inspection in June 2014 of all the facilities in Dewas. Well before that time, the Company had decided, to stop producing cephalosporin injectables at Dewas. Since then, the agencies have approved all our facilities for manufacturing Dosage Forms and APIs (Active Pharmaceutical Ingredients) at Dewas including that for oral cephalosporins with the only exception of the cephalosporin injectable unit.
 
FIPB approves Sun Pharma's share issue to overseas Ranbaxy investors
Sun Pharmaceutical Industries Ltd has informed further to BSE that Foreign Investment Promotion Board (FIPB) has, as per the press release dated November 28, 14 released by FIPB unit of Ministry of Finance, Department of Economic Affairs, approved the proposal of the Company for issuing equity shares of the Company to the non-resident investors of Ranbaxy Laboratories Limited pursuant to the merger of Ranbaxy Laboratories Limited into Sun Pharmaceutical Industries Limited through the scheme of arrangement between Ranbaxy Laboratories Limited and Sun Pharmaceutical Industries Limited.
 
CCI suggests changes in Sun Pharma-Ranbaxy deal: Reports
CCI has suggested Sun Pharma and Ranbaxy to make changes in proposed $4 billion merger deal, according to reports. Report said that this includes possible divestment of some brands. The deal has been awaiting clearance from the competition watchdog. Sun Pharma-Ranbaxy transaction, had come under close scrutiny of CCI after it was found prima-facie that the "combination is likely to have an appreciable adverse effect on competition", says report. On April 6, Sun Pharma announced it would buy Ranbaxy in a $4-billion all-share deal.
 
Domestic News
 
Pfizer completes merger with Wyeth
Pfizer Limited announced the completion of the merger with Wyeth Limited. The company had received approvals from the Bombay High Court earlier and filed the order with the Registrar of Companies to conclude the merger process. The merger places Pfizer Limited among the top 10 pharmaceutical companies in India by market share.
 
Pfizer Inc.,USA, through its subsidiaries holds the majority stake in both companies and will continue to remain the majority shareholder with an approximate 63.9% holding in Pfizer Limited, post-merger. Pfizer Ltd now has a significantly stronger portfolio of offerings across a wider therapeutic universe. Importantly, the company now debuts its offering in Vaccines with India's largest vaccine brand and builds a robust presence in the areas of Women's Health with a portfolio that includes some of the best known brands in Oral Contraception and Folic Acid supplements.
 
Dishman Pharma may sell entire SEZ land
Dishman Pharmaceuticals and Chemicals Ltd clarified, "We would like to clarify that Dishman Pharmaceuticals and Chemicals Limited (DPCL) had acquired on a long term lease basis Land located at the Pharma and Finechem SEZ being developed by Dishman Infrastructure Limited (DIL), a company promoted by the promoters of DPCL.
 
However, owing to withdrawal of the benefits granted earlier to SEZ developers/units located therein by the Government, the said company DIL has suspended the work on the SEZ development since last around two years and is looking at various options including de-bonding the SEZ and selling off the entire SEZ land. If this happens, DPCL's lease will also be cancelled and DPCL will get back the money invested in the Land leased to it in the said SEZ.
 
Suven Life Sciences Limited Raises Rs. 200 Cr through a QIP
Suven Life Sciences Limited has concluded its Rs 200 Cr fund raising exercise through the Qualified Institutions Placement (QIP) process. Anand Rathi Advisors Limited acted as the Sole Global Co-ordinator and Book Running Lead Manager for this QIP.
 
The transaction saw participation by some highly reputed investors in India. The Company accordingly will issue 1,04,53,690 equity shares of face value of INR 1/- per equity share at a price of Rs. 191.32 including a premium of INR 190.32 per share. Post issue the promoters holding will be in excess of 59% as against 64.76% on September 30, 2014. The response to this QIP issue is a testimony to Suven's growth oriented financial performance and confidence of the investors in Suven's unique business model in CRAMS and NCE development.
 
Ranbaxy Laboratories launches India's first biosimilar of Infliximab drug, Infimab
Ranbaxy Laboratories announced the launch of Infimab (BOW015), the first Remicade(R) (Infliximab) biosimilar  in India.  The product was launched at the Indian Rheumatology Association Conference (IRACON) in Chandigarh, in the presence of over a thousand rheumatologists and doctors from around the country.
 
InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. InfimabTM marks Ranbaxy's entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.
 
Praj HiPurity Systems introduces BioWiz Smart Bioreactor for the biopharma industry
PrajHiPurity Systems (formerly Neela Systems), Praj Group Company,  introduced 'BioWiz' Smart Bioreactor, which will help the biopharma industrymeet requirements of various bio processes in laboratory, pilot and commercial units. BioWiz Bioreactor benchmarks international standards and delivers superior operational features and advantages required in today's global pharmaceutical industry. The 'Smart' aspect of this Bioreactor lies in the various innovative and smart features.
 
Mr.Gajanan Nabar CEO & MD of Praj Industries and Mihir Mehta, BU Head of PHS said, "A well-engineered process solution plays a  significant role in defining efficient functioning of the  production facility. High Purity industries like pharmaceuticals, biotechnology, healthcare & cosmetics are characterized by stringent demands on sterile and hygienic design and engineering. Manufacturing systems are required to meet high quality standards and guidelines set by international authorities like ISPE or ASME BPE. It is in this context that the BioWiz Smart Bioreactor has a major impact on productivity, quality and profitability of any manufacturing plant".
 
Piramal Swasthya partners with NACO
On the occasion of World AIDS Day, Piramal Swasthya part of Piramal Foundation has partnered with PSI on behalf of the National AIDS Control Organisation (NACO) to launch India's first national AIDS helpline - 1097. More than 80 percent of women and approximately 70 percent of men in India do not have comprehensive knowledge about HIV/AIDS. This is the first time where a national toll free number has been launched to provide information and tele-communication requirements of the population at higher risk to HIV infection. The goals of the fourth phase of the National HIV/AIDS Control Programme (NACP IV) are aligned with the government's 12th Five-Year-Plan.
 
First green operating theatre accreditation for hospitals launched in India
Abbott India joins hands with Bureau VERITAS Certifications (India) Pvt. Ltd. to provide a first of its kind accreditation for using green and safe practices in operation theatres. The Green OT certification project is a first in the world certification and also the first 'Make in India' certification protocol developed by Bureau VERITAS in conjunction with Abbott India and multi hospital stakeholders like clinicians, bio-medical, hospital QA, Green House Gas surveyors, administrators etc.
 
Surgical care is an integral part of health care throughout the world, with an estimated 234 million operations performed annually1. Every year, many millions of people undergo surgical treatment, and surgical interventions account for an estimated 13% of the world's total disability-adjusted life years (DALYs)2. While surgical procedures are intended to save lives, unsafe surgical care can cause substantial harm.
 
Sun Pharma clarifies on CCI approval
Sun Pharmaceutical Industries Ltd has clarified that in the matter of the Scheme of Arrangement between Ranbaxy Laboratories Limited and Sun Pharmaceutical Industries Ltd (the Transaction) that we have neither received any final order from Competition Commission of India (CCI) on the Transaction, nor has there been any rejection of the Transaction by CCI.
 
SPARC receives Complete Response Letter from USFDA for Latanoprost NDA
Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops.
 
While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. SPARC believes that this additional information request from the FDA can be addressed on priority.
 
MediGain will use US$38mn in growth capital to expand five-fold
MediGain Health Private Ltd has announced that it plans to expand its Indian operations five-fold with the recently-acquired $38 million in growth capital from Prudential Capital Group (Prudential). Deloitte Corporate Finance LLC (DCF) acted as a financial advisor to MediGain and helped facilitate the transaction.
 
"The $38 million in growth capital obtained by MediGain will have a very positive effect on our operations in Chennai, India," said Dinesh Butani, Chairman of MediGain, LLC. "Our presence in India will enhance from the current level of 300 employees to more than 1500 employees to support new business growth."
 
Two cardiac surgeries performed live within 45 minutes at Max Super Speciality Hospital
A traditional pacemaker enables a human being with a lifespan of 15 years (battery life). It keeps the heart beat ON and allows the cardiac patient to resumes a normal life. However, the picture painted isn't as rosy as it seems. In reality, a traditional pacemaker includes a high risk of heart failure and has resulted in fatality in 10-15% of cases worldwide. A new technique to introduce a safer and more reliable technology to address this issue has been performed "live" and within a short span of 45 minutes each at Max Super Speciality Hospital, Saket  by Dr. Vanita Arora, Associate Director & Head, Cardiac Electrophysiology lab & Arrhythmia Services  and her team on not one but two patients.
 
70 year old female was leading a peaceful life with her family at Delhi when suddenly, 6-8 months back, she fainted unexpectedly. With time her fainting spells began increasing in number and she eventually fractured her hip bone one day. Ignorant about the cause of fainting causing continuous concussions, the relatives decided to address her fracture first and consulted an orthopaedic surgeon.
 
Vyome BioSciences ropes in Dr Ranjan Pai in its Board of Directors
Vyome Biosciences, an innovation-driven dermatology company focused on hard to treat and refractory dermatology indications, today announced that MD and CEO of Manipal Education & Medical Group, Dr Ranjan Pai, has joined its Board of Directors. Dr Pai's venture firm Aarin Capital is an investor in Vyome. Dr Richard Buchta, formerly Head of GlaxoSmithKline's dermatology unit Stiefel Laboratories in Australia, has joined Vyome as Senior Vice-President of R&D.
 
Dr Pai is recognized as one of India's top corporate leaders. As Vyome scales operations and prepares to enter the commercialization phase, his addition adds tremendous strategic experience to the Board. The globalization and expansion of the Manipal Education and Medical Group through his strategic vision is an experience that will serve Vyome in good stead as the Company looks abroad for development and licensing opportunities, said N.Venkat, Co-founder & CEO.
 
International News
 
Global health problems span a wide spectrum: IMF
The December issue of the IMF's Finance and Development magazine looks at the serious health issues the world faces today, including infectious diseases such as Ebola fever and no communicable diseases such as cancer and mental health disorders.
 But any look at global health must include more than diseases.
 
The latest issue of F&D magazine examines a panoply of global health concerns--among them the growing importance of regional and local governments in health care delivery, the need for more efficient delivery of health services and for better functioning health systems, and the increasing number of organizations involved in the provision or health services--an area once almost solely the province of the World Health Organization (WHO).

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