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The pharmaceutical company has failed to get the US FDA’s approval for launching the generic version of Flomax, thereby missing the opportunity to launch the drug in America with exclusive marketing rights
Pharmaceutical company Ranbaxy Laboratories Ltd, a unit of Japan's Daiichi Sankyo Co, on Wednesday said that it has failed to get the US health regulator's nod for launching a generic version of Flomax, a prostrate drug, thereby missing the opportunity to launch the drug in America with exclusive marketing rights, reports PTI.
Flomax is a patent medicine from Japanese drug maker Astella Pharma's portfolio and the drug is also known by its generic name—Tamsulosin hydrochloride.
"We regret that, despite our best efforts, we were not able to get an approval for the product (Flomax), and hence will not be in a position to launch the product," a Ranbaxy spokesperson said.
Earlier in 2007, Ranbaxy Laboratories had signed an agreement with Astellas and Boehringer Ingelheim for ending the patent litigation regarding Flomax drug in US courts.
Under the terms of the agreement, Ranbaxy was supposed to enter the US market on 2 March 2010, eight weeks prior to expiration of the paediatric exclusivity.
During the period of paediatric exclusivity, Ranbaxy would have been the only generic manufacturer to commercialise this product in the US market.
However, the Gurgaon-based company has failed to get the approval from the US Food and Drug Administration (FDA), which is mandatory before launching the drug in the American market. Thus, the company missed an opportunity to launch the drug in the US market with exclusivity.
The total annual sales of Flomax are estimated to be $1.20 billion in the US.
Ess Dee Aluminium’s proposed merger scheme is stacked heavily against India Foils’ minority shareholders and the recent spurt in trading volumes of India Foils is highly dubious
The minority shareholders of Kolkata-based aluminium foils maker India Foils have been given a raw deal under the proposed merger scheme with packaging solutions provider Ess Dee Aluminium Ltd. In what appears to be another case of absolute apathy and discrimination against minority shareholders, the management of Ess Dee Aluminium has put a ridiculously low valuation on India Foils that will leave these shareholders high and dry.
Apparently, Ess Dee Aluminium is pushing for a share-swap ratio of 1,285:1 that means shareholders of India Foils will have to surrender their 1285 shares to get a single share of Ess Dee. When the same is calculated with Ess Dee’s current share price of Rs400 per share, the value of each India Foils share comes out to be a paltry 31 paise only. That too when during the last eight months, India Foils’ shares have been trading between Rs12-Rs16 per share.
According to an extra-ordinary general meeting (EGM) notice sent to shareholders, Mumbai-based chartered accountant firm MP Chitale and Co did the valuation for the merger.
In November 2008, Ess Dee bought a majority stake in India Foils for Rs130 crore from Anil Agrawal led Vedanta group as part of the rehabilitation scheme approved by the Board for Industrial & Financial Reconstruction (BIFR). Now Ess Dee wants to merge India Foils with itself and has proposed the merger scheme with 1285:1 ratio. Since Ess Dee promoters already hold 89.4% stake in India Folis, they are ‘forcing’ the merger on other minority shareholders, said an investor.
According to Hirjee Nagarwalla, a shareholder, he had held shares of India Foils for a long period. “When Ess Dee took controlling stake in India Foils, no open offer was made to the public. Then in 2009, Ess Dee announced that it would merge India Foils with itself. About a month ago, shareholders were notified that the merger ratio has been fixed at 1285:1. In effect, the value of India Foils has been put at 31 paise, when its average traded price for last one year is Rs14. Minority shareholders like me would be left with nothing,” he said.
An email sent to Ess Dee Aluminium officials remained unanswered till the time of writing the story.
India Foils’ shares last traded on the Bombay Stock Exchange on 19 September 2008 at Rs12.95. Before its last trading, the 52-week average share price of India Foils was Rs10.31 per share at the lowest end and Rs30.05 at the highest end. The shares remained untraded till its relisting on 19 June 2009 and on that day it rose to a high of Rs23.95 and a low of Rs17.41. On Wednesday, India Foils closed at Rs7.50, down 3.97% on the Bombay Stock Exchange (BSE), while the benchmark Sensex closed 1.36% higher at 17,000 points.
The minority shareholders also brought to light the heavy trading being carried out in India Foils’ shares. In middle of January 2010, India Foils’ shares surged to Rs20 on heavy volumes. Soon after that, the share witnessed a freefall. The share volumes have seen a sudden spurt, compared to its average volumes over the last few months. This sudden rise and fall in the share price, supported by higher volumes, suggests foul play.
Indeed, if Ess Dee goes ahead and completes the merger with India Foils at the proposed valuation, it will put minority shareholders at a loss. If it decides not to carry out the merger or the swap ratio is altered, then the trading in India Foils’ shares should raise some eyebrows. People who have been buying at low prices will benefit. Either way, the on-goings in this case demand careful scrutiny by the regulator.
Prices in the retail market for hot rolled coil have already gone up by almost Rs2,000 per tonne and analysts believe a price hike from April is imminent on account of excise duty hike and jump in raw material contract prices
Following in the footsteps of other mills, state-owned steel major Steel Authority of India (SAIL) on Wednesday hiked steel prices by up to Rs600 a tonne, effective from 1st March, on account of increase in excise duty.
According to a PTI report, SAIL chairman SK Roongta told reporters on the sidelines of an All India Induction Furnace Association meet that there would be a price increase of about Rs500 to Rs600 a tonne due to the excise duty hike and it would be effective from 1st March.
Partially rolling back the fiscal stimulus in the Budget, the government raised excise duty by 2%-10% across the board. To spur economic activities, the government had earlier initiated massive spending programmes and slashed duties from December 2008 in three stages following the global financial crisis that began in September in the same year.
Indian mills have increased domestic commercial hot rolled coil prices for April production on rising international prices and higher costs of production. Prices have risen by at least Rs1,000-Rs1,500 (about $21-$31) per tonne ex-mill to Rs30,500-Rs32,000 per tonne. Prices for end users are also rising because of an increase in excise duty, which has risen to 10% from 8%. While mills have yet to officially increase the price of cold rolled steel, basic prices, exclusive of taxes, have already risen by Rs1,000-Rs1,500 per tonne to Rs36,000-Rs36,500 per tonne.
The price hike from April is imminent on account of excise duty hike and jump in raw material contract prices for major players across the globe. Both iron ore and coking coal contracts for 2010 are expected at 35%-45% higher levels than last year, and this could push up the cost of production by about $75 per tonne of steel.
"We believe that companies like Tata Steel and SAIL will be the major beneficiaries of the price jump on account of their backward integration. Global steel demand scenario is also improving with strong last quarter growth in US and Japan. Overall, we remain bullish on the steel sector as a whole and we could see further hike in the next quarter," said Kisan Ratilal Choksey Shares and Securities Pvt Ltd in a research note.
On the demand side, improvement is being seen in developed economies particularly in the flat segment on account of pick up in automobile sales. However, long product demand still remains subdued as no major revival is seen in construction activities which are the major consumer of longs.
Enam Securities Pvt Ltd said, "We believe higher raw material spot prices could lead to an annual rise in FY11 contract prices (negotiations going on), which will support steel prices. However, we believe credit tightening in China is likely to put a brake on the substantial price hike in raw materials as well as steel.”
Echoing the same view, steel secretary Atul Chaturvedi also said that steel prices were set to go up. "They (steel prices) will go up now. You have to decide between inflation and recession. Companies have to earn money and this can be done either if raw material prices go down or steel prices go up," Mr Chaturvedi said.
When asked if the price rise was alarming, he said, "If we see steel prices in the last 30 months, the current scenario is not alarming."
Last week, BHP Billiton in its coking coal contract negotiations with Japanese steel makers pushed the April-June 2010 contract price by almost 55% over last year to $200 per tonne. This was a major shift for BHP from the earlier annual contract system to a quarterly system. But Japanese steel makers rejected the offer.
Similarly, huge disparity between spot and long-term contract prices is prompting large iron ore miners to shift away from annual contracts to shorter duration contracts.
With the delay in contractual negotiations, steel prices are likely to remain at higher levels in the near term.