Global pharma seeks cancer drug patents

The objections by Indian pharma companies to Swiss drug maker Novartis seeking a product patent for its Glivec blood cancer medicine has not deterred other global drug firms from applying for patents in this drug category in India.

At least five multinational pharma companies - Astra Zeneca, Pfizer, GlaxoSmithkline, Bayer and Bristol Myers Squibb - are known to have filed patent applications with various patent offices in India for about six new generation cancer drugs.

These are in the same class as the chronic myeloid leukaemia (a form of blood cancer) drug Glivec by Novartis.

Novartis has also filed a patent application for Tasigna (nilotinib monohydrate), a follow up drug for patients who are resistant or tolerant to Glivec.

Pending list
Applications pending with patent offices are one for Sutent (sunitinab malate) by Pfizer for the treatment of advanced renal cell carcinoma or kidney cancer, three for Tykerb (Lapatinib Ditosylate), GSK’s breast cancer drug and its salts, another for Sprycel (dasatinib), a blood cancer drug by Bristol-Myer Squibb and Nexavar (sorafenib tosylate) from Bayer for the treatment of kidney cancer.

All are from the class of Tyrosene Kinase inhibitors, an important group of molecular target agents for the treatment of various cancers.

Indian generic companies, patient groups and healthcare non-governmental organisations (NGO) had also voiced their opposition to two more drugs in this class, that is Iressa (gefitinab) from Astra Zeneca and Tarceva (Erlotinib) from Roche, both used in the treatment of small cell lung cancer. They are opposed to the grant of patents for cancer drugs in the fear that this may allow global pharmas to sell these essential drugs at unaffordable prices and block the entry of cheaper copycat generics.

Some worries
“These drugs are yet to come under the radar of Indian generic companies and NGOs as they are new drugs that have been approved recently by the US Food and Drug Administration (FDA). I am not aware of any opposition against any of these applications so far,” said Varun Chonkar, a patent expert who has gathered information on these patents.

Pfizer’s Sutent, which got US approval last year, has a mail-box patent application pending with the Delhi patent office. A few weeks ago, the safety and efficacy of this drug was questioned in an article in the Lancet, a renowned medical journal.

Novartis filed a patent application for Tasigna with the Chennai patent office in 2004. The drug was approved by the US FDA in October last year.

Chonkar informed that the drug was 50 times potent than Glivec and a patent for this drug could compensate for the denial of patent protection for Glivec.

Novartis is also facing opposition over the alpha crystalline form of Glivec, though the company has not yet launched a drug of this version.

High cost
GSK’s oldest patent application, for Tykerb, is pending with the Kolkata patent office since 1997. Two more patent applications by the company for Lapatinib species and salt are also pending approval. Tykerb was approved in the US in March last year. This breast cancer drug is expected to earn the company $890 million (about Rs 3,500 crore) globally by 2010.

A one-month course of the medicine costs about $2,900 (more than Rs 1 lakh).

A patent application by Bayers is pending with the Mumbai Patent Office. Details on Bristol-Myers’ Sprycel were not immediately available.

3 pharma firms in US patent soup

US-based drug major Forest Laboratories has sued three Indian pharmaceutical companies - Orchid Chemicals and Pharmaceuticals, Lupin and Wockhardt - along with four other manufacturers for coming up with imitations of patented drugs in the US.

Forest, along with Germany’s Merz Pharma, has filed lawsuits in Delaware’s District Court against the companies for infringing its US patent number 5061703 on Namenda (memantine), a drug for the treatment of Alzheimer’s.

The suit is in response to the abbreviated new drug applications filed by these companies with the US Food and Drug Administration (FDA).

The suit is filed on the basis of ‘Paragraph IV certifications’ which gives the patent holder the right to protect itself against imitations, Forest said in a release issued today.

The suit will restrict the USFDA from approving the marketing applications for 30 months. Namenda was formulated by Merz Pharma and was licensed to Forest in 2001.

The drug is one of the major revenue earners for Forest with sales of $192.9 million in the third-quarter of 2007 alone.

Wockhardt: Right diagnosis

The launch of anti-allergic cetirizine tablets in the US will give it the early mover advantage

The stock price of Wockhardt rose by 4 per cent after the company announced the launch of anti-allergic cetirizine tablets in the US market. Cetirizine, the generic for Zyrtec brand owned by Pfizer, has annual sales of $1.4 billion.

Other companies will soon get US FDA approval to launch the drug, resulting in a crash in the prices, but Wockhardt will have an early mover advantage.

Unlike other drugs going off-patent, cetirizine has another advantage. It has moved from being a prescription product to an OTC one and this would translate into better growth and margins.

The company will distribute cetirizine, besides the 56 products in its US portfolio, through Morton Grove Pharma, a US-based generic company acquired by it in October 2007. Morton Grove, with sales of $52 million largely from dermatological products, is expected to boost Wockhardt’s US sales efforts.

Wockhardt has also entered into a strategic tie-up with Leiner Health Products for distributing cetirizine to private label OTC markets.

Whereas the company has been active in the US market in the last seven years, sales from this region account for only 8 per cent of total sales for the nine-month period ended September 2007.

Analysts say the company’s product development to filing process has been slow and it has products in some highly competitive segments.

Europe accounts for 59 per cent of the company’s sales as it offers better opportunities, higher margins and is a relatively easier market to breach.

The company reported a 69 per cent jump in sales to Rs 738 crore for the quarter ended September 2007, largely on the back of its acquisition of France-based Negma Labs.

While the operating margins were up 230 basis points to 24.5 on account of lower R&D expenses, they were flat for the nine months ended September. At the current price of Rs 434, the company trades at 12 times estimated 2008 (December year end) EPS of Rs 36 and is attractively priced.

Cipla maintains No.1 position in Indian mkt

Tops pharma rankings with 5.42% market share, a head of Ranbaxy and GSK.

Cipla Laboratories continues to be the largest pharmaceutical company in the domestic market.

Cipla has topped the ORG-IMS rankings for the month of November with a market share of 5.42 per cent and sales of Rs 146.32 crore, edging out Ranbaxy which stood at second position with 5.09 per cent market share and Rs 137.49 crore sales.

In October, Cipla topped with Rs 152.04 crore sales and a market share of 5.23 per cent, ahead of Ranbaxy, which garnered Rs 148.40 crore sales and 5.11 per cent market share, said sources.

Cipla overtook Ranbaxy and GlaxoSmithKline India (GSK) to become the largest pharmaceutical company in the domestic market for the first time in May 2007.

While GSK has maintained its number three position in November, Zydus Cadila (fourth), Alkem Laboratories (fifth) and Sun Pharma (sixth) have moved one rank up from October.

Nicholas Piramal, which faced raw material shortages for its largest selling codiene based formulations, like Phensydyl, in recent months, slipped three positions to number seven in November.

ORG-IMS, the largest market intelligence company in India focusing on the healthcare sector, tracks sales of Indian pharmas on a monthly basis, through over 3,000 stockists and 6,000 doctors.

“Indian companies are increasing their share in the domestic market mainly due to increased number of high value new introductions, though the number of new introductions have reduced recently,” Shailesh Gadre, managing director, ORG-IMS, said in an interview last week.

Ranbaxy’s growth has been largely driven by new introductions such as Volix, an anti-diabetes drug launched in January, Oframax-Forte and anti-asthmatic drug Synasma, which it in-licensed from Eurodrug Laboratories.

Ranbaxy’s antibiotic Mox (amoxyllin), which was not among the top ten brands a year ago, has grown to become the fourth largest brand in the domestic market with monthly sales at Rs 9.8 crore in November, sources said.

Cipla’s growth was powered by positive growth in their existing portfolio, especially its respiratory products.

However, GSK has lost market share mainly in its main portfolios such as anti- infectives, dermatologicals and pain management drugs which grew slower than the market for these products, ORG-IMS said.

ORG-IMS named Alkem Laboratories as the only company among the top ten for which both older products (10 per cent) and new introductions (12 per cent) have contributed significantly to value growth.

“Our growth in the domestic market is mainly due to the growth of our anti-infective Taxim and other brands such as Taximo, Clavem, A to Z and Gemcal,” explained Vinod Dua, head, domestic business of Alkem Laboratories.

Alkem’s Taxim is now the third largest brand in the domestic market with sales of Rs 10.3 crore, behind Pfizer’s cough syrup Corex (Rs 15.2 crore) and Novartis India’s pain killer Voveron (Rs 11.6 crore).