December 1997 issue of PHARMACEUTICAL INNOVATOR

The beleaguered Indian manufacturers of Penicillin-G (Pen-G) are heaving a sigh of relief as world prices of the drug has increased 12 per cent over the last six months. The industry was facing stiff competition from imports as the drug was cheaper abroad and was being dumped in India.

However, large capacities exist, with J K Pharma (1,250 mmu), Spic Pharma (1,250 mmu), Torrent Gujarat (1,500 mmu) being some of them. In India the main producers are selling at more than Rs 650 against Rs 450 in September '97. With the closure of five plants in China and shutdown of a few plants in Europe, prices of Pen-G has been on the rise bringing relief to manufacturers in India.

Pen-G prices had plunged after touching a peak in January at Rs 720 per BU, from which it slid down to Rs 425 per BY in August and now stands at Rs 650 per BU. Reportedly, prices ae expected to stabilise at around the Rs 700 per BU level.

Domestic consumption of Pen-G is put at 11,000 mmu, of which 4,500 mmu is sourced in the country, and 6,500 mmu is imported. However, India has capacity to produce 6,500 mmu, with much capacity being unutilised. Also many new capacities have been added by new entrants like: Spic, J K Pharma, Torrent, Hindustan Max GB and Alembic. Now producers hope to sell their piled up stocks in an upbeat market.

China May Lower Prices of Drugs

China, which controls prices of drugs through a system of government controls may clamp down on prices of drugs because of the high spending on prescription drugs in the overall healthcare spending ( 52 per cent) compared to that of other developing countries (15 per cent to 40 per cent). The limit on mark up on drugs hence on profits will be focused on drugs developed and discovered outside China, while produces developed inside China will be allowed a higher mark-up.

India's First Hepatitis-B Vaccine Launched

India's first genetically derived Hepatitis-B vaccine is being launched by Hyderabad-based Shantha Biotechnics. Being genetically engineered it is highly immunogenic and provides effective antibody levels for longer periods compared to plasma produced ones which may contain blood contaminants.

Cadila Pharmaceuticals to Launch Herbal Formulations

Cadila Pharmaceuticals is launching herbal formulations in the country in association with American herbal products company - MMS Nature's Way Products. Nine products were launched in Ahmedabad, ten more will follow. A spokesperson of the American company said that there was tremendous interest in herbal products throughout the world and that the market was growing at 30 per cent.

The formulations being introduced are: Femiforme (for menstrual problems), Rekallex (to increase memory power) and Resistol (to increase body's resistance to viral infections). After Cadila Group was split into Cadila Pharma and Cadila Healthcare, Cadila Pharma had concentrated on bulk drugs and allopathic formulations. From Ahmedabad, distribution will be extended to Gujarat, then to the rest of the country.

Hoechst and Roussel to Merge in India

Hoechst had merged Marion and Roussel to form Hoechst Marion Roussel world-wide. Now Hoechst Marion Roussel (India) (HMRI) is buying the 33 per cent held in Roussel India by Roussel UK to fully acquire the company.

So far the two companies have been working closely though separately. Post-merger the company will find a place among the top four in retail formulations sale. Currently HMRI has 2.5 per cent share and Roussel India has 1.2 per cent share in retail sales. The sales force has been cut down with voluntary retirements and organised into three separate units to market Hoechst, Marion and Roussel products.

Has Johnson & Johnson Acquired Coldarin?

According to unconfirmed reports in the press, Johnson & Johnson may have bought the Coldarin brand from Knoll (India). The price put by Knoll (India) was 3.5 times the sales of Coldarin (around Rs 6 crore per annum). Knoll (India) has been looking for a buyer for the products it got through the take-over of Boots (India), ie, Coladarin, Aciguard and Burnol.

Glaxo and Ranbaxy Reach Settlement

Reportedly, Glaxo has withdrawn its case and arrived at a settlement with Ranbaxy Laboratories over the marketing of the off patent drug Ranitidine in the US. Ranbaxy will start marketing from January 1998 or February 1998, through its joint-venture with US-based Schien Pharmaceuticals. Since going off patent, the price of a Ranitidine tablet in the US fell from $1.40 to 28 cents.

ICI and Zeneca in Talks for Joint-Venture

ICI had spun off its agrochemical and pharmaceutical business worldwide into a new company - Zeneca. But it had retained its pharmaceutical business in India. Now talks are on between ICI and Zeneca for a joint-venture for ICI's 75-crore pharmaceutical business. Reportedly, though its pharmaceutical business is a profitable one, it doesn't figure in ICI's list of priorities. its agrochemicals division also was spun off in a similar manner earlier.

Pfizer Chooses India for Clinical Trials

Pfizer is developing a significant facility in India for clinical trials of its latest research products. It has completed phase III trials for Azithromycin for a new indication in treatment of typhoid; Droloxiphene ( an oestroagonist-antagonist for treat of breast cancer and osteoporosis); trufloxacin, a new quinolone and Ziprasidone (for treatment of Schizophrenia). Trials for the malarial drug Azithromycin has not been cleared yet, data for which would soon be submitted. These tests are not essentially for local marketing but also for drug development around the world.

Glaxo's Sale of Zantac Plunge in the US

Reportedly, Glaxo's US sales of Zantac, its best-selling ulcer drug, fell by 55 per cent in the three months after it lost patent protection. The company is reported to have anticipated this fall and has kept investors posed about the decline in sales.

TCW-ICICI Acquires Stake in Ajanta Pharma

An offshore fund TCW-ICICI, advised by TDICI has bought a 11.3 per cent stake in Ajanta Pharma. The fund bought shares at Rs 68 per share and invested Rs 6.8 crore. This is the second time that TDICI has helped in buying stake in Ajanta, the earlier one being when it enabled UTI's Vecaus II fund to buy a 5.6 per cent share at Rs 60 a share.

Ajanta Pharma is active in the fields of anti-bacterial, anti-TB, cardiovascular, psychiatric and nutritional segments and is famous for its OTC products: Thirty Plus, Pinkoo Gripe Water, Trimol and Beauty Plus. Reportedly, the company will utilise the fund for its expansion project at Waluj into antibiotics. The company has set up 200 tpa capacity for amoxycillin, ampicillin an cloxacillin and 60 tpa for rifampicin and has joint venture in Turkmenistan, Mauritius, Uzbekistan and Tajikistan.

Generics Trends Will Catch-up With India

With a growing number of branded products losing patent protection throughout the world, India is also likely to follow the trend according to an expert. In certain countries authorities are persuading doctors to prescribe generics products due to the price constraint. The US generics market is very price competitive. In Europe, UK is the only unbranded market. Some generics are branded and sold, prices of which are higher. In the US, a pharmacist is allowed to substitute a generic product for a branded product when filling a prescription. Also research based companies are getting into generics because that would mean higher prices for branded products.

Rhone-Poulenc and Bayer are into generics in France. The expert also felt that mergers and acquisitions will go on till there are about ten major research-based groups. There will be a large number of small research companies affiliated to the larger companies and besides that there will be the generics manufacturers.

Glaxo Eyeing Aurobindo, Natco

Reportedly, Glaxo, which is keen to pick up stakes in Indian companies is eyeing the Rs 222-crore semi-synthetic penicillin producer Aurobindo Pharma as a likely prospect for its bulk drug requirements. Aurobindo has facilities at Hyderabad and Pondicherry and manufactures ampicillin, amoxycillin, cloxacillin and dicloxacillin. An year back the promoters of Aurobindo had bought the Videocon group's 11 per cent stake in the company at Rs 65 per share.

According to reports, Glaxo is also looking at an alliance with Natco Pharma which manufactures a range of products including: naproxen, fluoxetime, omeprazole, lansaprazole, diltiazem and sumatriptan. It also does contract manaufacturing for companies like: John Wyeth, SmithKline Beecham, Parke-Davis, German Remedies and Ranbaxy.