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MUMBAI: CIPLA, one of the largest domestic pharma companies, has posted a net profit of Rs 95.9 crore for the second quarter ended September '04, up 38% over the year-ago period, while net sales rose 29% to Rs 581.4 crore.

Exports continued to be the key growth driver for Cipla, with this business now contributing to 40% of total sales against 38.7% last year.

Revenues from international trade were up 31.6% to Rs 241.7 crore.

The maximum growth in the exports was in the formulations segment, which saw an increase of over 76% to Rs 157.9 crore.

The active pharmaceutical ingredients (API) business, however, saw a dip in revenues.

Sales in this segment were at Rs 83.8 crore for the quarter, down 10.9%, due to a decrease in API exports to regulated markets, the company said.

The company's domestic business has grown 24.9% to Rs 363.3 crore. According to a Cipla release, the company has performed well in the anti-asthmatic, antibiotics, anti-AIDS, cardiovascular and anti-inflammatory segments in the domestic market.

Other operating income has jumped 72% to Rs 16.2 crore during the quarter, largely due to payments received for product development and technology know-how under various agreements with foreign partners.

Depreciation has increased by 42% to Rs 12.5 crore, due to additional capital expenditure for the company's Goa unit and other units.

For the half-year ended September 30, '04, net profit was up 28.1% to Rs 175.1 crore. Net sales for the period were at Rs 1,110.8 crore, registering a growth of 26.6%.

Cipla shares fell 0.98% to Rs 267.30 on the Bombay Stock Exchange on Tuesday.

The Mumbai-based pharma major Cipla has tied up with the US company Pentech Pharmaceuticals for a range of generic products for the American market, the company's top management said on the sidelines of Cipla's AGM held on Tuesday.

Pentech is involved in developing therapies for lifestyle and quality of life conditions. It has a pipeline of drugs for a number of conditions including sexual dysfunction and Parkinson's disease in its portfolio. To begin with, Cipla will provide finished dosage formulations for two products. The agreement will be reviewed later and could be expanded to include more products.

Cipla currently has 140 ongoing projects with five companies in the US. It has a strategic alliance with the US generics major Watson, which it had entered into in late '02 to develop and commercialise generic pharmaceutical products.

The agreement was expanded in May and November last year, bringing the total number of generic products under development as part of the alliance to over 30. The company also has an alliance with other US generics companies - Ivax, Eon and more recently Morton Grove - for a range of products.

The company's alliance partners have filed 31 ANDAs and they will file an additional 35 ANDAs in the next 12-15 months. About 10 ANDA approvals are expected within the next two years. ANDAs, or abbreviated new drug applications, are filed with the US Food & Drug Administration, as part of the regulatory process to get a generic product approved for sale in the US market.

Cipla has done well for itself on the export front and is expanding its international business. The company now has a presence in over 150 countries world-wide. Its exports contribute over 40% to the company's revenues and will soon be in excess of Rs 1,000 crore annually.

Cipla is among the leading Indian players that have filed drug master applications for the US market. The company has registered an over 20% growth in sales for the five months ended August. It is expecting 15-20% sales growth in the year ended March '05.

The first clinical trial of generic AIDS drugs in a simple 3-in-1 pill has found that they work as well as brand-name drugs, researchers are reporting today.

Because of patent problems, brand-name drugs for first-line treatment do not come in 3-in-1 pills, and medicines that are deeply discounted for poor countries by their makers usually still cost more than generics.

The issue is important because the United States has refused to let the $15 billion that President Bush has committed to fighting AIDS in the third world be used for generic drugs, arguing that there is not enough proof they are effective.

Normally, the makers of generics need only prove that their drugs are chemically identical to brand-name drugs. But because of the skepticism about generics, Doctors Without Borders, a charity that wants to use the drugs widely in Africa and Asia, and the University of Montpellier's Research Institute for Development in France, which does scientific research benefiting poor countries, did the study to confirm that the drugs worked in the field.

The research was overseen by the French National Agency for Research on AIDS, a leading European research institution, and was published in the July 3 issue of the medical journal The Lancet.

The trial followed 60 patients in two hospitals in Cameroon for 24 weeks who took Triomune, a combination of nevirapine, stavudine and lamivudine made by Cipla Ltd. of Mumbai, India. The drugs are also known as NVP, d4T and 3TC or under the brand names Viramune, Zerit and Epivir.

One Triomune pill is taken twice a day, which helps patients take all their medicine and makes it nearly impossible to sell or give away part of a handful of pills - a practice, common in poor countries, that can encourage the virus to mutate drug-resistant strains and kill patients.

Nearly all the patients in Cameroon were in advanced stages of AIDS. By the end of the trial, 80 percent had the amount of virus circulating in their blood driven to very low levels. Most had increases in CD-4 cells, the immune-system cells that the virus attacks.

Most importantly, said Dr. Michel Kazatchkine, director of France's AIDS research agency, the levels of the three drugs in the blood was the same as would be expected from three mainstream drug brands.

A spokesman for the Pharmaceutical Research and Manufacturers of America, the lobbying group for the brand-name drug industry, said it had no comment on the study.

Only one patient dropped out because of adverse drug reactions.

Dr. Richard G. A. Feachem, executive director of the Global Fund to Fight Aids, Tuberculosis and Malaria, called the study "extremely good news."

The fund buys generics approved by the World Health Organization, including Triomune, so "this gives strong scientific support for the procurement policies the Global Fund has been pursuing for 18 months," he said.

Dr. Kazatchkine said it would also reassure African countries that had been buying W.H.O.-approved generics because they were the cheapest.

The Bush administration, under the president's emergency plan for AIDS relief, will not yet buy generic AIDS drugs, a stance that has put it in opposition to the rest of the world.

But on May 16, the Bush administration announced that companies that make generic drugs could apply to have their drugs approved by the Food and Drug Administration and that the usual $500,000 application fee would be waived.

None have applied yet, but several are expected to soon, said Dr. Mark R. Dybul, the medical adviser to the office of Randall L. Tobias, the administration's global AIDS coordinator.

Several calls and messages to Ambassador Tobias's office asking for comment on the Lancet study were not returned.

Cipla was not involved in the Cameroon study, said Amar Lulla, the company's joint managing director, and he said he had not seen the Lancet article. But "it is not surprising," he said, after reading a copy. An unpublished study of 1,200 patients in India followed for two years "found that our drugs are clinically efficacious," he said.

Similar pills are made by Ranbaxy Laboratories Ltd., another Indian company. Companies in South Africa, Brazil and elsewhere are expected to follow suit. As of last month, Doctors Without Borders was treating 13,000 patients in poor countries with 3-in-1 pills made by Cipla or Ranbaxy.

"We're getting good results in weight gain, CD-4 rise and viral load," said Daniel Berman, co-director of the medical charity's campaign for access to inexpensive drugs.

The only brand-name antiretroviral in a 3-in-1 pill is GlaxoSmithKline's Trizivir, which the company concedes is not an ideal starting regimen because it consists of three drugs in the same class, instead of a mix of classes.

In the past, brand-name companies said they could not cooperate to combine their drugs into one pill out of fear of prosecution under antitrust laws. But when the Bush administration made its May 16 announcement, which also encouraged the development of 3-in-1 pills, five brand-name companies quickly said they would discuss collaborating.

This is regarding the report that WHO has withdrawn two products (namely Duovir and Lamivir) from the list of approved products. This was a consequence of a recent audit conducted at a contract research organization (CRO) in Mumbai where the bioequivalence of these two products were carried out in 2001.

The reason for withdrawal is due to inadequate compliance with GCP/GLP in terms of documentation/ record keeping at the CRO. This does not mean in any way that the products are not bioequivalent. In fact, recently a bioequivalence study has been successfully conducted in the United States on Cipla's Lamivudine.

There has never been any question with regard to the quality of the product or Cipla's manufacturing facilities. Both these aspects have been examined in detail by WHO and acknowledged as such.

In conclusion, Cipla stands by the quality of the products and is committed to repeat the bioequivalence studies within the shortest possible time and we hope to receive the results by 31 st July, 2004 . This has been informed to the WHO and others.

One of HelpAge India 's most consistent supporters over the years has been pharma giant CIPLA.

HelpAge's MMU programme requires immense financial support and free medication, which is the most vital aspect of the project.

CIPLA has been providing this munificent support for many years. In 2000-2001, they donated Rs. 38 lakh worth of medicines to support the then existing 20 MMUs, benefiting 4 lakh elderly persons.

In 2002-03, HelpAge received nearly Rs. 1 crore worth of medicines from CIPLA, which helped treat over 1 million older people. It was due to this philanthropic support that the number of beneficiaries increased by 40%.

THE INDIAN pharma industry now has a godly connection. Cipla has joined a global initiative taken up by the Vatican in collaboration with global generic pharmaceutical manufacturers and the International Federation of Catholic Pharmacies and Academics to float CUMVIVIUM, an NGO, to take up the distribution of essential drugs, particularly anti-AIDS drugs in the developing world. Other Indian companies like Aurobindo, Matrix and Hetero Drugs are evaluating the possibility joining in on the deal, pharma industry sources told ET.

Cipla has signed an agreement with CUMVIVIUM - which means 'to live together in friendship' in Latin - the others have yet to decide, the sources said.

"The move would enable the generic manufacturers to tap the world's largest network, coordianted by the Catholic Church, for distributing affordable medicines to developing nations. The, Catholic Church has a huge network of 128,000 active health institutions that strives for improving the lives of people around the world."

CUMVIVIUM had earlier warned the governments in Europe as it felt that the new regulations adopted by the European Parliament last December, for extending data protec­tion up to 11 years, will seriously hurt access to affordable medicines in those countries,

The NGO felt that this type of regulations creates monopolies even for drugs that are not protected by patents and will further restrict access to affordable lifesaving drugs. It is of the opinion that problems of R&D in Europe will not be solved by granting monopolies even to the profitable firms.

It may be recalled that in November last year, the former US President Bill Clinton had signed up an agreement with four Indian drug companies and a South African company to back the pro­duction of low-cost, lifesaving medicines for HIV and AIDS patients in Africa and the Caribbean.

Pharma major Cipla has entered into a research alliance with Bangalore-based biotech company Avestha Gengraine Technologies, to develop biopharmaceuticals and a new class of biotech products called targeted therapies.

The partnership will develop products for auto-immune disorders and will subsequently be broadened to include other areas such as cardio-vascular disease and cancer.

Avesthagen, under the terms of the agreement, will focus on research and product development, while Cipla will concentrate on marketing and distribution.

This is the first research tie-up between a pharma major and biotech company in India .

Avesthagen struck a deal last year for tuberculosis treatment with bioMerieux, a 1bn euro French diagnostic giant. The companies will jointly develop a diagnostic kit based on the Affymetrix gene chip technology.

Avesthagen Gengraine started commercial operations in '01 and has since floated two other companies — Avesthagen, based in San Diego , California and Avesthagen Quality Agricultural Services (AQUAS) at the ICRISAT campus in Hyderabad .

Avesthagen develops biotech drugs extracted from natural compounds to treat obesity and diabetes. The company is ready with seven lead compounds that have been scientifically validated and clinically tried out against diabetes. Products are likely to hit the market in late '05.

The Company has fixed May 19, 2004 as record date for sub-division in face value of equity shares from Rs.10 to Rs.2

The National Pharmaceutical Pricing Authority (NPPA) got a rap on its knuckles, with the Allahabad High Court ruling invalid a series of notifications issued by the pharma pricing body from '00 to '03 for calculation of retail prices of formulations.

The court also quashed the NPPA notice to Cipla for recovery of over Rs 200 crore in arrears for overcharging on some scheduled drugs which have been brought back under price control. However, the court said NPPA can fix the price of formulations afresh in accordance with a properly formulated law. The court order was in response to Cipla challenging the NPPA notice served to it through the Inspector of Drugs, Varanasi, regarding payment of the arrears.

The order will be a big relief to Cipla, as otherwise it would have to cough up Rs 100 crore (50% of the arrears) immediately. Significantly, the arrears calculated are only till June '00, which means that if the NPPA seeks to recover the amounts for the remaining period, Cipla might be required to pay several hundred crores.

The court quashed the NPPA notifications and its notice to Cipla on the ground that the pricing body followed wrong methodology for fixing price revisions. Observing that factors such as material cost, conversion cost, packaging material and packaging cost are to be considered while calculating retail prices for drugs, the court said various costs keep changing and there has to be a fresh discussion every year for fixing retail prices.

"The DPCO (drug price control order) 1995 contemplated an investigation and enquiry by the government every year considering all the relevant factors and then fixing the norms to' be used in all inputs," the court order said. Sources said NPPA is currently studying the court order and would soon decide on appealing against the order.

Cipla was among half-a-dozen companies, including Ranbaxy and US Vitamin, which were found to have overcharged on seven scheduled drugs brought back under price control. While Cipla was slapped with a total bill of about Rs 200 crore (price differences calculated till June '00), Ranbaxy got a bill of Rs 50 crore. The companies were required to pay up 50% of the amount now, as the case relating to bringing these drugs under" price control is still pending in Mumbai High Court.

The court convened meeting of Members of Cipla Limited will be held at Amar Gian Grover Auditorium (Lala Lajpat Rai Auditorium), Lala Lajpat Rai Marg, Near Worli, Haji Ali, Near Race Course, Mumbai – 400034 on Wednesday, 21 st April, 2004 at 3.00 p.m. to consider and approve the scheme of arrangement between Cipla Limited and six private limited companies. This would be followed by an Extra ordinary General Meeting of Members to be held at the same venue to inter-alia consider and approve sub-division in face value of Equity Shares from Rs.10/- to Rs.2/-

MUMBAI-BASED pharma major Cipla has struck a long-term agreement with Morton Grove Pharmaceuticals Inc (MGP) of Illinois, US, for product launch in the US market.

Cipla will develop, manufacture, package and supply a range of prescrip­tion pharmaceutical oral liquid and semi-solid products for MGP. Cipla will also provide technical support for formulation and analytical development activities under MGP's new product development programme.

Amar Lulla, joint managing director of Cipla, said the two companies will be working together on a range of 15 products initially. "However, the agreement is an open one and there is a scope to expand the number of products that we will be developing for MGP," he said.

The abbreviated new drug applications (AN­DAs) will be filed by MGP for all the products. All regulatory applications will also be owned by the American company.

"The agreement is for a range of oral drugs and semi-solid formulations. These drugs cover a number of therapeutic areas," said Mr Lulla. Cipla started work on select products in '03, and' MGP plans to file a number of regulatory applications in late '04. This is the first collaboration agreement that MGP has entered into. Cipla now has a total of six alliances for the US market.

Cipla has a strategic alliance with the US generics major Watson, which it had entered into in late '02 to develop and commercialise generic pharmaceutical products. The agreement was expanded in May and November last year, bringing the total number of generic products under development as part of the alliance to over 30. The company also has an alliance with another US generics major Ivax for a range of products. Cipla is among the leading Indian players that have filed drug mas­ter applications for the US market.

CIPLA has become the first company in the world to ben­efit from the is­suance of a com­pulsory licence (CL) under the paragraph 6 of the Doha declaration on TRIPS and public health.

The Malayasian government has authorised Malay firm Syarikat Megah Pharma & Vaccines to hold a compulsory licence to import four specified anti-retroviral (HIV/AIDS) formulations - con­taining a total of three active phar­ma ingredients (APIs) - from Cipla. Under the licence, Cipla is empowered to export and sell these medicines under fixed ceiling prices to the Malaysian govern­ment for exclusive supply to gov­ernment hospitals for two years.

Among the APIs, the patents of Didanosine is held by Bristol-My­ers Squibb, while GlaxoSmithKline owns the patent of Lamivudine and Zidovudine. According to the CL issued by the Malaysian government, compensations to the patent holders have to be paid within two months of the date of import. The rate of compensation would be determined later.

The Para 6 provision is meant to enable a generic drug manufacturer to manufacture and export a patented drug to a country with in­sufficient or no manufacturing ca­pacity in the pharmaceutical sector. The facility can be used subject to specified conditions and safeguards formulated under the August '03 Geneva drug deal. In fact, the deal was wrested by developing coun­tries, led by Brazil and India , after a fierce battle with the US and the EU. The US , helped by a last minute U-turn on the EU stance, could incorporate difficult procedures for making use of the provision.

The global generic drug industry is not fully convinced of the fairness of the Geneva deal and feels that the Doha provision was weakened by the deal. "The licence issued by Malaysia could provide an interest­ing test case to assess whether the Geneva decision is workable or needs modification." a domestic pharma industry official said. In fact, export of a drug under the CL requires the government of the ex­porting country (in this case India ) to issue a complementary licence to the exporting company.

Mumbai: Drugmaker Cipla is in parleys with US biotechnology firm, Biogenerics, for a marketing and manufacturing alliance. "We are keen to tie-up with firms that have good, efficient cell lines which are not patent infringing," said Mr Amar Lulla, joint managing director.

Cipla is concurrently talking to two other firms, one in Russia, where they hope to source biogeneric products and another European firm. Under the alliance with Biogenerics, Cipla will market certain biogeneric products in India and also make some niche biotechnology products at their plant here.

Cipla has invested about Rs 10 crore in its biotech ventures with smaller companies overseas. Many of the products that Cipla plans to market will go off-patent in the US in the next ten years. One such drug is darbopoietin, a modern blood booster. Other products include interferon, erythropoietin and hepatitis vaccines.

Cipla is the country's second-largest drug company by market share. Commenting on the US alliance, Mr Lulla added, "With Biogenerics, we are currently going over specific US regulations regarding bioequivalence studies. The US' stand with regard to biotechnology generics is not clear."

The company's foray into the biotechnology segment could well rest on genetic engineering and stem cell research. The firm is also open to enter this segment via joint ventures. Cipla has also finalised two more strategic alliances with US generic companies, pocketing a total of five alliances for the US market.

The company has lined up a slew of generics. Some 9O DMFs (drug master files) are to be filed in the near future. Cipla has already filed 11 abbreviated new drug applications in the US, market.

In its 2QFY04 results, the company reported a 23 percent growth in the topline, buoyed by a strong growth in the domestic as well as international markets. However, a sharp increase in material and staff cost put pressure on its operating margins, thus resulting in a six per cent drop in the bottomline.

For 1HFY04, Cipla reported an 18 per cent growth in net profit and a marginal two per cent growth in bottomline.