Perfint Healthcare Secures USFDA Clearance for MAXIO

Perfint Healthcare Secures USFDA Clearance for MAXIO

Perfint Healthcare, a world leader in planning and targeting solutions for image guided interventional procedures in Oncology and Paincare, today announced that the company received the 510(K) clearance from the USFDA for commercial marketing of its MAXIO  in the United States.

Commenting on the FDA 510(K) clearance, Mr. Nandakumar S, Chief Executive Officer, Perfint Healthcare said, “This is a significant milestone in the history of the company. We would like to dedicate this important achievement to the millions fighting Cancer and Pain. Our products, MAXIO and ROBIO, were used to perform over 2000 patient procedures around the world in the last year. This has been possible due to our focus on patient centricity and clinical excellence.”

He added, “The support from the Department of Biotechnology Government of India was timely and helped us reduce cost of R&D. I would like to congratulate my team and thank our clinical advisors for their significant contribution in this milestone achievement.”

Mr. Guruswamy K, Director-Sales, Perfint Healthcare further added, “We have been working with some of the best physicians in the USA over the last several years during the development and validation phases of MAXIO. Studies have been performed at the National Institutes of Health, Bethesda and Memorial Sloan Kettering Cancer Center, New York City.  Obtaining the 510(K) clearance allows us to start commercial marketing of MAXIO in the USA. It also makes it easier to scale up in several other markets globally. We are hoping to achieve Rs 100 Crore in revenue this year.”

Commenting on this important achievement, Mr. Mohan Kumar, Director on board of Perfint and Partner, Norwest Venture Partners said “In 2012, about 2.5 Million patients were diagnosed with Liver and Lung Cancer.  That number is only growing. Many of them are also inoperable. MAXIO has been proven to be very useful in providing tumor ablation therapy for such patients. Perfint with its established user base in Europe and Asia, now with the USFDA clearance, is uniquely positioned in the minimally invasive cancer care space”. Perfint is an outstanding example of Bio-Medical engineering that combines Robotics, Imaging software and Medical sciences, They are a terrific team.”

Commenting on other recent achievements and plans Mr. Nandakumar S added “We were recently awarded 3 patents by the US Patent office for our technologies. We also obtained the China FDA clearance recently. We hope to ramp in the USA and China in the coming quarters. We are raising additional equity capital to fund our next product roadmap and growth in global markets. Some of that funds will also be used for international acquisitions.  We hope to achieve Rs 500 Cr in revenue in the next few years.”

Perfint’s flagship product, MAXIO is an image-guided, physician-controlled stereotactic CT accessory which helps physician see, plan, treat and verify during CT guided procedures like Tumor Ablation or Paincare. 

Perfint has successfully raised $32.7MM through 4 rounds of venture funding with prominent investors such as IDG Ventures, Accel India Ventures, and Norwest Venture Partners participating. The company has a strong presence in India, APAC, Middle East, Europe & Australia among others and now eying lucrative markets like China and USA to further expand its global presence.

 

GSK India to benefit from global business swap deal with Novartis

GSK India to benefit from global business swap deal with Novartis

GlaxoSmithKline's India operations will benefit from the global business swap deal agreed to by its British parent and Swiss giant Novartis last month, a top executive has told ET. Glaxo will get Novartis' vaccine portfolio, including anti-rabies products such as Rabipur, while transferring its smaller oncology business. The two companies agreed on this swap last month. GSK India's oncology sales were around Rs50-55 crore.

Hasit Joshipura, MD of GSK, said Novartis vaccine products will add muscle to Glaxo's efforts to strengthen its presence in the Rs1,600-crore vaccine market. India has one of the largest numbers of births per year in the world, Joshipura said. "Typically as education and income increase, the obviously one thing Indians will do is spend on their children.

It is probably the most exciting vaccine market in world." He estimated that Rabipur alone would be worth about Rs110 crore, according to IMS while the size of the oncology business is estimated at about Rs50 crore. Glaxo, one of the oldest foreign pharma companies, in the country has recently been hit by price cuts in many of its products. Slowing growth and delays in clinical trials have hampered investment and frustrated many multinational companies.

But GSK has gone ahead and announced a new plant in India for about Rs800 crore, its first investment outside the headquarters in the UK in 20 years. Joshipura says the site has not yet been finalised though the press statement issued by the company in November last year indicated that the lead site is Bangalore. Joshipura said Bangalore is not a done deal though it is the intent. He hinted that Gujarat may be a suitable candidate. "Location is not guaranteed yet. Bangalore is the intended location. Pharma plant needs talented labour, Gujarat has a lot of pharma companies manufacturing," he added.

The sale of the oncology business did stump some GSK analysts and industry experts as cancer drugs are perceived to be the future of drug market. Joshipura says it was driven by pragmatism. "Globally, we are the 14th-largest oncology company, so even with the entire visible pipeline that we have, we would have been 10th or something like that. So we have to play to our strengths."

GSK is now expanding is its vaccine and respiratory portfolio in India. The private vaccine business in India is estimated to be close to

Rs1,600 crore and is growing at around 11%. However, GSK is betting on rising birth rates and income level in the country to make its mark.

What is intriguing is the company's optimism towards the Indian market. As global pharma companies lash Indian markets for slow approvals, regulatory confusions and over all slowdown, GSK assures there is nothing to worry. "We have built a model which is appropriate to this market. We moved manufacturing many years ago to India, then we have pricing which is India-specific, we got lucky in the early period where we have products specific for India's disease profile," said Joshipura.

 

Copied generic drugs from India have big market in China

Copied generic drugs from India have big market in China

Lung cancer has become the leading source of deaths among all types of cancer in China. Every year, 200,000 new lung cancer patients are treated with targeted drugs which could cost upwards of 15,000 yuan a month. But an Indian generic copy of a popular cancer fighting drug is being secretly sold online in China for a fraction of the cost, posing great risks to public health.

Type in a search for India Iressa and you’ll find many links selling it. But what people are buying is a generic copy of the cancer fighting drug Iressa, which is produced and patented by a UK pharmaceutical company.

The drug is used to treat many forms of cancer, including one of China’s top killers, lung cancer. Despite the dangers of buying generic copies of drugs, the low price tag is pushing many despearate people to take the risks.

This woman is selling generic copies of drugs from India, illegally in Qingdao.

"This is the price for five packs," she said.

She shows a receipt saying she spent 13,500 rupees, or about 1,400 rmb for 5 packs of Indian Iressa. That’s about 2 percent of the official price of what the British made drug costs when sold in China.

But she sells each pack for 600 rmb. Other sellers online can even ask for as much as 1600 rmb, which many people are willing to spend.

The sale of the Indian version of Iressa is not allowed in China because the Chinese government hasn’t given it an import licence. The drug authority has also warned people to be alert to such drugs sold online, as their quality can be suspect. But for patients in China, the huge difference in price from the original patented version, is sufficient to go in for it.

Ms Jiang from the city of Huludao in Liaoning Province, was diagnosed with lung cancer last year. She had to spend 15 thousand yuan a month to get the official UK produced Iressa drug from the hospital.

"If I spend 100 thousand or 200 thousand, and I sell my apartment, her cancer can be controlled, it’s ok. But everything is unknown, the medicine is too expensive," said a family member of patient.

Desperate to get her the drugs, the family chose to buy the medication from India via friends. And they are not alone. A Chinese law enforcement officer says half of the illegal drug cases he has investigated involved Indian cancer drugs.

"From the cases we dealt with, these kind of drugs are expensive. Some cancer patients can not bear the economic burden. We even find some doctors show sympathy to patients and hint that they buy Indian drugs online," said Huang Yong, Shenzhen People's Procurator.

But doctors warn about the risks involved in taking generic copies of drugs.

"Its effect may not be certain. The production technology is surely not as good as the original one. So when using it, the purity may not be enough. And the drug itself has side effects. It’s also a problem to control the side effects," said Li Lin, deputy director of Medical Oncology, Xuanwu hospital.

Despite all the risks involved both legal and to one’s health, many people in China are still looking to buy copied generic Indian drugs because of their low price.