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Pharmaceuticals Newsletter - August 06 to August 10, 2012

India Infoline News Service/ 17:19 , Aug 10, 2012

Strides Arcolab reportedly signed a deal with Gilead Sciences Inc to sell low-cost generic versions of latter's HIV medicine 'emtricitabine' in developing countries.

style="color: #3b339d">Top Stories 

Wockhardt set to exit CDR process

After three years of first choosing the option, Pharma company Wockhardt is ready to exit the process of Corporate Debt Restructuring, reports said.

Wockhardt’s debt last year was Rs. 34bn and Rs. 13bn was under CDR, reports said citing Wockhardt Chairman Habil Khorakiwala.

In March 2009 when Wockhardt approached the CDR cell through ICICI Bank, it was burdened with debts of over Rs. 38bn.

In October that year, Wockhardt defaulted on repaying its $110-mn Foreign Currency Convertible Bonds (FCCB), further worsening the issue.

Late last month, Wockhardt sealed the Rs. 16bn deal to sell its nutrition business to Danone.
 
The proceeds from the sale would go towards repaying the debt. Wockhardt had exited non-core businesses to restore its financial health.

As part of the CDR, all loans have been restructured, reports said citing Khorakiwala. The company would make a payment and settle with banks that do not want to continue with the CDR process, he added.

He went on to say that ready to pay the remaining Rs.2bn to FCCB holders.

Infocus News

When heart fails? What is the treatment?

A well known adhesive brand claims, “it could mend everything but broken hearts".  Well, mending broken hearts of lovers is still not possible medically. But there have been a lot of advancements treating heart disease and failure. Lot of people go into a panic mode, when they learn that they have unrhythmic heart beat, blockage in the heart or suffered a mild attack. What is needed is correct advice at the right time says Dr. Alla Gopala Krishna Gokhale, a Cardiothoracic Surgeon who is a noted name among the medical fraternity in general and cardiothoracic surgeons in India in particular.

Dr. Gokhale who has had the distinction of performing India’s first heart-kidney combined transplant and Andhra Pradesh’s first heart transplant, besides more than 6000 open heart surgeries — adult as well as pediatric and did a good number of minimally invasive cardiac surgeries including Bypass surgeries, Valve replacements, Mediastinoscopy and Endoscopic vein harvesting, etc. has seen hundreds of cases pertaining to heart disease and failure during his career spanning over 25years.

Sharing his knowledge and experience, Dr. Gokhale says that the two most common heart problems are angina (severe pain in the chest and left arm caused by heart disease) and heart failure. Heart failure doesn't mean that the heart has stopped working, it refers to conditions affecting the functioning of the heart. The inability of the heart to supply sufficient blood flow to meet the body's needs. Some of the symptoms experienced in such situations are shortness of breath and fatigue, sometimes even without any exertion. Legs and feet swelling is also seen. The term "heart failure" is often incorrectly used to describeother cardiac-related illnesses, such as heart attack or cardiac arrest (myocardial infarction),  which can cause heart failure but are not equivalent to heart failure.

Heart Failure is a major and growing health problem in India. The number of people with heart failure is increasing steadily. After age 65, 10 of every 1,000 people have heart failure. Many factors can lead to heart failure. Hypertension (high blood pressure) is a major contributor to numerous heart problems and conditions including heart failure: the lifetime risk of heart failure doubles in people whose blood pressure is greater than160 mmHg systolic /90 mmHg diastolic versus those whose blood pressure is less than 140/90 mm Hg.

Many of the behaviors that can lead to heart disease and heart attacks — such as poor diet, lack of physical activity, and substance abuse — also can cause heart failure.

Heart failure itself is not a reversible disease, but there are many treatments that can reverse underlying causes and improve symptoms. Many of the drugs target changes in the body’s hormone status.  Some hormones are naturally released by the body in response to heart failure but they can paradoxically either directly or indirectly damage the heart itself.

But now there are better survival rates thanks to the availability of better treatment. There are several options to treat heart disease and heart failure. In some instances, medicines alone will suffice to treat the ailment. If the doctors feel it is vital, then several others procedures can be performed based on the need.  Some of these are unheard of before.  There are new devices like Left Ventricular Assist Device informed Dr. Gokhale. Left ventricular Assist Device is in existence for the past many years in the western world and is available in India for the past five months.  This device is the only emergency option for the bad heart.

This device was recently used to save the life of a patient for the first time in the state of Andhra Pradesh by Dr. Gokhale. These devices can be used on left side or right side or on both sides of the heart based on which side pumping chamber is failing. Basically they take blood coming into that weak chamber and pumps into the body directly thereby doing the work of the heart. This way it gives some rest to the heart allowing it to recover (Bridge to recover) or in case heart is not recovering, it will keep the patient alive till a donor heart is available for heart transplant(Bridge to transplant).
 
When the heart is badly damaged and unlikely to recover, heart transplantation is another option. In that situation, damaged heart is replaced by a normally working heart taken from the body of a brain dead person. A patient can live as long as 25 years provided some precautions are taken. Dr Gokhale did the first heart transplant in the state of Andhra Pradesh in 2004.
 
Because there isn’t really a cure for heart failure, your best course of action is to stay as healthy as possible for as long as possible by following the advice and treatment plan provided by your doctor. Start by sticking with your medication schedule. If you experience side effects, talk to your doctor quickly.  Don’t stop a medication until your doctor says advises.

Result

Sun Pharma Q1 net profit at Rs7.95bn

Ranbaxy Q2 loss at Rs5.86bn

Ranbaxy Laboratories Ltd has posted results for the first quarter ended 30th June, 2012.

The Group has posted a Net (Loss) after tax, minority interest and share in loss of associate of Rs. (5857.25) mn for the quarter ended June 30, 2012 as compared to Net Profit after tax, minority interest and share in loss of associate of Rs. 2432.35 mn for the quarter ended June 30, 2011.
Total Income has increased from Rs. 21303.14 mn for the quarter ended June 30, 2011 to Rs. 32982.16 mn for the quarter ended June 30, 2012.
Commenting on the business results for the quarter, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Sales and profitability grew in the Quarter with overall improvement across major regions, aided further by exclusivity sales in some of the key markets. We capitalized on our product focus approach with the successful monetization of the Atorvastatin and Atorvastatin + Amlodipine opportunities. The launch Synriam, the first new drug from India was one of the high points of the quarter. The strategy to build long term, differentiated value drivers was rewarded with two NDA approvals in the dermatological space in the USA.”

Key Highlights/Developments

Business

Sales and profitability improved over the corresponding period.

Sales grew in major markets including USA, India, East Europe & CIS, West Europe and Africa over Q2 2011, on constant forex rates.

USA sales were robust helped by strong base business and exclusivity sales.

Exclusivity of Atorvastatin and Atorvastatin+Amlodipine ended during the quarter.

Ranbaxy attained peak market share of over 50% on both products during the exclusivity period. The Company has maintained strong market share and leadership, even after the entry of multiple generic players post exclusivity.

India sales growth was 13% in INR terms. Sales grew faster than the segment growth in which the Company participates. Read more…

Wockhardt Q1 cons net profit at Rs3779.70 mn

Cadila Healthcare Q1 net profit up 15%

Apollo Hospitals Q1 net profit at Rs. 697.40 mn

Claris Lifesciences Q1 cons revenue at Rs1.95bn

Hilkal Q1 Net Profit down by 66% at Rs. 50mn


Domestic News

Strides Arcolab signs agreement with Gilead Sciences

Strides Arcolab reportedly signed a deal with Gilead Sciences Inc to sell low-cost generic versions of latter's HIV medicine 'emtricitabine' in developing countries.

According to reports, the Indian firm would also promote fixed-dose combinations of emtricitabine, co-formulated with other Gilead HIV medicines.

Strides Arcolab said it has "entered into an in-licensing agreement to collaborate with Gilead Sciences Inc to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries".

In the agreement, Gilead will provide technology transfer for the manufacture of emtricitabine, together with investment assistance for process improvements to reduce overall manufacturing costs, reports added.
Mylan launches Commercial Operations in India

Aurobindo Pharma gets nod for Montelukast Sodium Tablet

Fortis Hospitals appoints Vijayarathna Venkatraman as Zonal Director

Super Religare renames itself as SRL Diagnostics with new Logo

Yale developing iPad video game to prevent HIV infection among youth

Public servants vow to eliminate gender bias, violence vs women

Digital subtraction angiography one-stop-solution to treat cancer

Suven Life Sciences secures 4 Product Patents

Alembic signs product development, license pact with Accu-Break

Radius Hospitality bags award at 3rd CMO Asia 2012

Dr. Reddy launches Montelukast Sodium tablets

Prathamesh Date wins International Downs Syndrome Award

Easy 16x Speed-up of “DNADist” Software to help Roche

Aurobindo, Glenmark get FDA nod for asthma tablets

Glenmark Pharma gets ANDA nod for Montelukast Sodium Tablets

Piramal Imaging signs global agreement with IBA Molecular

Strides Arcolab receives US FDA approval for Oxaliplatin Injection

Sun monitor set to reach markets

Mickey Mehta transforms the contestants of Indian Idol

VLCC launches revolutionary Perfect 10 Face Lift


International News

Pfizer settles bribery charges with DOJ, SEC

Pfizer Inc. announced it has resolved U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) matters related to certain improper payments in the operations of two of its subsidiaries outside the United States, which Pfizer voluntarily reported to the U.S.
government beginning in 2004. To resolve those historical issues, a Pfizer indirect subsidiary (Pfizer H.C.P. Corporation) will enter into a deferred prosecution agreement with the DOJ, and pay a fine of US$15mn. Under the terms of a civil settlement with the SEC, Pfizer Inc. agreed to a disgorgement of profits of US$16mn and prejudgment interest of US$10.3mn. The DOJ declined to bring a criminal action against Pfizer Inc.

In a separate civil settlement also announced today with the SEC, Pfizer’s Wyeth subsidiary has agreed to a disgorgement of profits of US$17.2mn and prejudgment interest of US$1.66mn to resolve issues involving certain improper payments in the operations of four subsidiaries outside the United States. Pfizer conducted a risk-based Foreign Corrupt Practices Act (FCPA) due diligence review of Wyeth’s global operations after it acquired the company in late 2009 and, as it had with its own issues, promptly and voluntarily disclosed these issues to the U.S. government.

There is no allegation by either DOJ or SEC that anyone at Pfizer’s or Wyeth’s corporate headquarters knew of or approved the conduct at issue before Pfizer took appropriate action to investigate and report it. As soon as these local activities came to the attention of Pfizer’s corporate headquarters, they were voluntarily brought to the attention of the DOJ and SEC. Today’s settlements are focused solely on these local activities.

Both the DOJ and SEC praised Pfizer’s cooperation with the investigation and its enhanced compliance program. In the deferred prosecution agreement, the DOJ noted “the extraordinary cooperation of Pfizer H.C.P.’s parent company, Pfizer Inc.,” including “thorough and responsive reporting of potential violations,” as well as “early and extensive remedial efforts.” The SEC highlighted Pfizer’s creation of “innovative and proactive anti-corruption compliance reviews” and its commitment to “comprehensive anti-corruption training throughout the organization.”

Amgen halts pancreatic cancer study

Nova Nordisk raise guidance as results beat views

Pfizer, J&J halt development of Alzheimer's drug




 



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