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Showing posts with label Ranbaxy. Show all posts
Showing posts with label Ranbaxy. Show all posts

Tuesday, May 29, 2012

Ranbaxy gets US FDA nod for acne treatment drug


New Delhi: Ranbaxy Laboratories Ltd on Monday got approval from the US Food and Drug Administration to launch Absorica in the US market.

Through a business agreement with the Canadian firm, Cipher Pharmaceuticals Inc, Ranbaxy Laboratories Inc (RLI), a wholly owned subsidiary of RLL is expected to launch Absorica in the US in fourth quarter.

As per the agreement, Ranbaxy will pay royalties on net sales to Cipher. Absorica, a novel, is patented brand formulation of the acne medication isotretinoin, developed by Cipher, for treatment of severe recalcitrant nodular acne.

“Absorica is a milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialised dermatology sales force,” Mr Venkat Krishnan, Senior Vice President and Regional Director, Americas, Ranbaxy said in a company statement.

Sunday, April 29, 2012

Ranbaxy launches anti-malaria drug


New Delhi: Ranbaxy Laboratories, India’s top drug maker by sales, today launched a drug to treat malaria. Claimed to be the first original drug developed by an Indian entity, Synriam, the branded anti-malarial combination, will offer a more effective and shorter drug regimen to patients. The drug has been approved for use on adults.

According to Ranbaxy, the product is undergoing final stages of clinical trials in Africa, a region that accounts for 90 per cent of malaria-related deaths globally. India, however, accounts for 75 per cent of the 2.5 million cases of malaria reported in the Southeast Asia. Synriam would cost Rs 130 for a complete course (one tablet each for three days), Arun Sawhney, chief executive officer and managing director of Ranbaxy, said.

The company did not disclose the market potential of the medicine, as malaria medicines, by and large, are supplied through government channels. Ranbaxy expects the product to be included in government supplies soon. “We do not expect revenues from Synriam to have a major impact on our balance sheet. It is our CSR (corporate social responsibility) drug, as our prices will be the lowest among similar drugs,” Sawhney said.

Of the 17 medicines approved by the World Health Organisation for treatment of malaria, more than half are supplied by Indian drug companies such as Cipla, Ipca Laboratories and Ajanta Pharma. Other players include multinationals such as Sanofi Aventis and Novartis. A WHO pre-qualification is essential for including a malaria drug under any global programme. Ranbaxy also needs this international approval, if it has to supply its medicine for the treatment of one of the most fatal forms of malaria, falciparum malaria infection.

Ranbaxy got involved with the research project initiated by Medicines for Malaria Venture (MMV), a Geneva-based not-for-profit foundation, when Swiss drug multinational Roche, the original industry partner, decided to hand over the potential drug candidate to it.

Four years later, MMV stopped funding the project and transferred the rights for development and marketing of the medicine to Ranbaxy after it reviewed the progress of clinical trials in November 2006. According to MMV’s annual report for 2006, the decision was taken after “the review of the preliminary data and other portfolio priorities”. Ranbaxy roped in the department of science and technology (DST) to part fund the project.

Sawhney said the development cost of the drug was $30 million (Rs 150 crore). Of this, Rs 5 crore came in as DST grant.

The Ranbaxy-DST agreement necessitates the company supplying the medicine for use by government channels at a much lower rate. While Sawhney said the company was yet to work out the pricing formula with DST, government sources said Ranbaxy had to supply the drug at a price 10 per cent more than the actual cost of production. If the drug is exported, DST would be entitled to three per cent of the net profit earned by Ranbaxy.

Sudershan Arora, president of R&D, Ranbaxy, said the company expected to complete the final clinical trials by the first quarter of 2013.

Wednesday, December 21, 2011

Novartis, GlaxoSmithKline, Pfizer & Ranbaxy focus on hinterland

Mumbai: Sample this: India's rural market accounts for half of two-wheeler sales, a third each of fast-moving consumer goods sales and telephone subscriptions and 60% of gold consumption. In contrast, the drug industry in spite of the importance of medicine still sees the rural market accounting for just 20% of its revenues.

Big drugmakers such as Novartis, GlaxoSmithKline, Pfizer, Ranbaxy and Aventis are keen to emulate the consumer industry's success in the hinterland, but are facing a raft of challenges. "While aspiration products like mobile phones, and direct-to-home televisions have gained a strong share of the rural consumer's wallet, health is still a low priority in villages," says a Novartis India spokesperson.

Doctors are spread across wider geographies and people don't always seek treatment. There is only one doctor for every 25,000 people in rural areas including practitioners of Indian systems of medicine such as Ayurveda, compared to one doctor for almost every 500 people in urban areas.

"It's a long haul," says GlaxoSmithKline Pharmaceuticals Managing Director Hasit Joshipura. "Unlike the FMCG industry, which saw growth being created by the increasing penetration of media and good monsoons, in pharmaceuticals it is healthcare infrastructure in addition to the ability to pay that matters," he says.

IMS Health estimates that per capita spending on medicines in rural areas averages $2, or just over Rs 100, per year compared to $36, or almost Rs 2,000, in urban India.

Pratin Vete of Aventis Pharma, a subsidiary of European drugmaker Sanofi, says the standard of doctors and medical staff is an issue. "As we go deeper, the doctor's qualification diminishes," says Vete, who is senior director for tier 2 and internal medicine at Aventis.

Big drugmakers also face intense competition from small, regional players, he says. "These are not virgin markets and there is no dearth of drug brands." Then there is lack of infrastructure and investment.

Simple things like a refrigerator to store vaccines, or a computer to maintain records in the pharmacy, and an X-ray machine can improve medical diagnosis and availability of drugs, says Novartis India Vice-Chairman and Managing Director Ranjit Shahani.

Another problem is field force attrition. "A sales rep may attend a training programme from one company and then end up joining another," says a drug industry executive. Many field representatives are hired on contractors' books to keep costs down, making retention tough.

A September report by Mumbaibased MAPE Securities pegs the share of revenues of large listed pharma companies from this market at 5-10% of sales. But rural markets are expected to grow 25-30% a year, or at double the speed of urban markets, till 2016.

"The rural piece is getting urbanised," says Sunil Madhok, senior director, business operations, at Pfizer.

"If you go there now, you can get the first-mover advantage with the doctor, the supply chain, and the community." Some companies are thinking out of the box.

Aventis has started Prayas, an initiative that gives doctors in small towns and villages the chance to attend training sessions by doctors from major cities on a variety of relevant health issues. Popular topics include treating snakebites and pesticide poisoning.

Novartis educates 6 million villagers a year on health under the banner of Arogya Parivar. A large proportion of these people now go to doctors for timely treatment, a company spokesperson says.

Borrowing a page from the FMCG book, Novartis has also launched smaller packs of medicine that cost less. In a pilot, it also facilitates small loans to individuals to stock up on drugs.

Most companies are not sure whether their rural marketing efforts are bearing fruit, says Anjan Sen, director at Deloitte's life sciences and healthcare practice. "Ultimately any model has to be commercially viable," he says. But results of such initiatives are slow to appear.

Aventis' Vete says that out of every 15 doctors touched by Prayas, six might prescribe its brands. And Novartis agrees that smaller packs meant that patients may not necessarily complete treatment. Industry executives say medicine retail is not just about capital but regulation as well-hawking prescription drugs requires a drug licence.

To win over the rural markets, companies need to offer hefty discounts to edge out local players who work on much lower margins, says MAPE's Adhia. They also need to rework their compensation to field staff by adding a larger component of performance-linked incentives to overall pay, he adds. Partnerships with other sectors such as FMCG and medical technology are on the anvil.

Sunday, December 4, 2011

Ranbaxy Laboratories falls on payment concerns to Teva Pharmaceuticals, delay in settlment with FDA

NEW DELHI/MUMBAI: A day after Ranbaxy Laboratories launched its low-cost version of the world's best selling drug Lipitor in the US, its share price fell 1.66% due to concerns about payment to Teva Pharmaceuticals and delay in settlement with US authorities.

A Teva spokesman on Friday clarified that his company was not supplying ingredients to Ranbaxy for making the Lipitor clone, resulting in some analysts criticising the Indian drug maker for its profit sharing agreement with the Israeli company.

"Teva is getting the money for the security they assured, but without any services,'' said Centrum Broking's Ranjit Kapadia. But a Citigroup report said 'the disquiet over profit sharing to Teva is overdone'. "We believe Ranbaxy's agreement with Teva was an insurance policy to safeguard against the uncertainty surrounding Ranbaxy's generic Lipitor ANDA approval," said the report.

A similar point was made by Kotak Securities who in a note on Thursday said Ranbaxy had allied with Teva as a backup in case it approvals were held back because of its manufacturing issued with the US Food and Drug Administration. Some analysts had reduced their estimates about how much Ranbaxy would make from the drug on assumptions that it may have to pay as much as $130 million to Teva.

" But the amount will be quite small compared to what is being speculated because Ranbaxy is not using Teva's services," an industry analyst said. Analysts are disappointed that a comrehensive settlement on all of Ranbaxy's outstanding issues with the drug regulator had not come through.

"We expected clarity on the settlement along with the generic Lipitor approval. That would have allowed Ranbaxy to resume selling drugs from its two Indian plants," said Kapadia In 2008, the FDA banned 30 drugs and halted approval of new ones from two Indian plants after it found the Daiichi Sankyo-owned firm guilty of violating US drug manufacturing rules.

This had threatened the company's ability to get regulatory approval for manufacturing atorvastatin (chemical name for Lipitor), as the ban included the plant where it had originally planned to manufacture the drug. The Gurgaon-based firm closed at. 436.75 on Friday at the BSE. Meanwhile, the aggressive marketing tactics of Lipitor's original drug maker Pfizer Inc have come under the scanner of some US senators.

Three senate members have sought details of the deal between Pfizer, Pharma Benefit Companies and Insurance Companies, who had asked pharmacies not to sell generic versions. "By working with manufacturers to push brand-name drugs, PBM may be abusing Medicare to boost their profits and denying generic alternatives to patients," said Max Baucus chairman Senate Finance Committee in a press statement.