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Strategies & Market Trends : Speculating in Takeover Targets -- Ignore unavailable to you. Want to Upgrade?


To: richardred who wrote (632)1/28/2005 1:45:07 PM
From: richardred  Read Replies (1) | Respond to of 7243
 
One of the leaders in the US is MYL. I've follow it closely since Carl bought inn. I bought some today. Depressed since the merger with King seems to have fallen apart.
MR. Icahn would be a willing seller.



To: richardred who wrote (632)2/20/2005 2:10:23 PM
From: richardred  Read Replies (1) | Respond to of 7243
 
GPhA urges FDA to support generic drugs

7/02/2005 - The Generic Pharmaceutical Association (GPhA) has praised the Food and Drug Administration for validating the science of generic biopharmaceuticals and making significant progress in establishing requirements to approve these medicines.

Approval of generic biopharmaceuticals would yield tremendous cost savings for America’s healthcare system. There is currently an economic need for more affordable versions of biopharmaceuticals. Already, marketed biopharmaceutical products account for approximately $30 billion (€23 million) in US sales and 12 per cent of total pharmaceuticals. By 2010, sales are expected to exceed $60 billion.
The GPhA claimed that because of their exceedingly high costs, biopharmaceuticals would consume a greater percentage of healthcare expenditures in the future and substantially burden health care purchasers, including the federal government, employers and consumers.

According to GPha, the average cost to a major US employer for a one-day supply of biopharmaceutical drugs is $45, while traditional drugs cost an average of $1.66 per day. Generic medicines can cost up to 80 per cent less than their brand counterparts.

Affordable biopharmaceuticals, even if they represented only a modest savings of 10 per cent to 20 per cent would create billions of dollars in savings for consumers, the government and healthcare providers.

The GPhA can turn to the example of Zantac as evidence. Widely used as an ulcer treatment, in 1997, the patents for Zantac expired. Within weeks, generic competitors entered the market and gave consumers the choice between an $83 per prescription cost for the brand or approximately $12 for the generic. Within months, more than 80 per cent of prescriptions previously filled by the brand name drug were being filled with more affordable generic versions of the drug.

The term, generic biopharmaceuticals, is used to describe those drug treatments, which are generally large protein molecules derived from living cells. Examples include insulin, human growth hormone, antibiotics, and monoclonal antibodies.

During the FDA-Drug Information Association public forum held to examine the scientific issues behind generic biopharmaceuticals, scientists from the FDA and MIT acknowledged that the science exists to create and characterise generic biopharmaceuticals.

Branded drug marketers are understandably concerned about these latest developments. They argue that patent protection under its current form is necessary to fund research and development for new, innovative drugs. Without these efforts from the branded companies, generics companies wouldn’t have a steady stream of products to copy. It seems in the best interest of all parties to strike a balance.

Pharmaceutical companies have taken measures to ensure equilibrium is met. Rather than fight these proposals, the trend now amongst the industry is to incorporate the generic factor into their overall corporate strategy, embracing its eventuality rather than avoiding the issue completely.

Sanofi-Synthélabo Group Generics, a newly created entity of the sanofi-aventis Group, was set up to distribute patent-free prescription products in Europe. It operates to offer a wide range of compounds identical to those of the original products whilst observing intellectual property rights. Its aim is to contribute cost savings for the patient.

Karen Katen, president of Pfizer Global Pharmaceuticals commented in the company’s third-quarter 2004 performance report: "We manage our portfolio by protecting our assets."

"Losses of exclusivity, for example, are particularly significant now and will affect several of our key medicines in the coming years."

The report also said that after a compound loses marketing exclusivity, they would consider marketing a generic version in the US through Greenstone, its generics subsidiary acquired with Pharmacia.

While the United States is debating the manufacture of generic biopharmaceuticals, citizens of other nations are already enjoying access to more affordable generic biopharmaceutical products.

In October 2004, for example, Australia approved Sandoz human growth hormone drug Omnitrope, becoming one of the first countries to approve a biogeneric. News reports suggest the medicine could be approved by the European Union later this year.

The potential for savings is set to multiply over the next decade. Fifteen blockbuster drugs, with annual sales ranging from about $500 million to more than $6.6 billion each, are scheduled to lose patent or market exclusivity in 2004 and 2005.

An example is the prospect of generic versions of Pfizer’s Norvasc (amlodipine). They are waiting for the end of patent protection for the best selling antihypertensive before hitting the shelves. To counter the threat, Pfizer is combining Norvasc with Lipitor to make its amlodipine treatment superior to the numerous generics likely to hit the market extend its sales life.

According to Cutting Edge Informtion, generics now account for more than 50 per cent of all prescriptions filled in the US and sales are projected to reach $60 billion by 2007.

drugresearcher.com



To: richardred who wrote (632)2/21/2005 12:34:19 PM
From: richardred  Read Replies (1) | Respond to of 7243
 
A big move by Novartis in to the US for generic drugs. I suspect Merck AG will not standstill.

Novartis Buying Drug Makers Hexal, Eon
Monday February 21, 12:24 pm ET
By Alexander G. Higgins, Associated Press Writer
Novartis Is Buying Generic Drug Makers Hexal of Germany, Eon of U.S.

GENEVA (AP) -- Novartis AG announced a major push into the U.S. and German generic drug markets Monday by buying Eon Labs of the United States and Hexal AG of Germany for $8.3 billion (euro6.4 billion) in cash.


The Swiss pharmaceutical giant said integrating the two companies into its Sandoz division would create the world's largest generic drug company.

The move also positions Sandoz for growth in the United States when millions more people qualify for Medicare prescription drug benefits next January under a change approved by Congress at the end of 2003.

Novartis said it will buy all of Hexal and the two-thirds of Eon Labs that the German company owns for euro5.65 billion (about $7.3 billion). Novartis also expects to spend close to $1 billion (euro770 million) for the remaining Eon shares.

With the acquisitions, Sandoz would supplant Israel's Teva Pharmaceuticals Inc. as the largest company specializing in generic versions of drugs that have lost patent protection. Teva had sales of $4.8 billion (euro3.68 billion) last year. Including Eon and Hexal, Sandoz would have had 2004 sales of $5.1 billion (euro3.91 billion).

"The acquisitions of Hexal AG and Eon Labs will significantly strengthen our geographic presence and product portfolio, our development and registration capabilities, and increase our scale to rapidly bring a broad array of generic products to patients," said Daniel Vasella, Chairman and CEO of Novartis.

Basel-based Novartis said it expects annual cost savings of $200 million (euro153.39 million) within three years after the deals close, with half in the first 18 months. The company, one of the world's largest drugmakers, said there would be "necessary reductions in the work force" but offered no details and said it also expected the deal to create some jobs.

Analyst Michael King of Code Securities said it was difficult to predict how many jobs would be lost.

"They maintain that the overlap is minimal in terms of specialty," King said. "Possibly they might argue that they wouldn't need to get rid of too many people."

But he said the level of cost savings announced would suggest "you're going to expect some job losses."

Pharmaceutical companies have complained in recent years that revenues were evaporating in part because of competition from generic drugs, which are significantly cheaper than drugs under patent protection.

But King said Novartis does not have the hostile attitude some branded pharmaceutical companies feel toward generic companies.

"Novartis see it very differently in that they believe that generics is a necessary product of the branded industry," encouraging drug companies to pursue research and development, King said. "So it sees it as quite a healthy existence between the two, and it looks to benefit its customers."

Novartis has built its generics unit through other acquisitions, including the European generics business of BASF AG in 2000 and the Slovenian company Lek in 2002. Last August it completed the acquisition of Sabex Holdings Ltd., a Canadian generic drug maker.

"In all likelihood you can expect a digestion period and a focus on internal growth and not a flurry of acquisitions," Vasella said. "Having said that, if a jewel does come available one would remain open."

Bob Pooler, an analyst at Lombard Odier Darier Hentsch in Zurich, said that having a strong presence in the United States was an advantage because U.S. health maintenance organizations prefer to buy drugs from a single source.

Vasella said that offering both generic and branded medicines increases Novartis' bargaining power in negotiations with large customers such as governments or chain pharmacies.

By 2010, he said, Novartis aims to command about 10 percent of the global generic-drugs market, which it expects to grow by then to $100 billion (euro76.69 billion) from $58 billion (euro44.48 billion) in 2004.

Vasella said he expects "tremendous" growth in revenue from generic drugs in Asia, especially in Japan, the world's second-largest market for pharmaceutical products.

Novartis shares rose nearly 3 percent Monday, closing at 58.85 Swiss francs ($49.71; euro38.07) on the Zurich exchange.

The company will offer $31 (euro23.75) each for the remaining Eon Labs shares, which closed Friday at $27.92 (euro21.39) on the Nasdaq Stock Market.

Hexal, one of the largest generic pharmaceutical companies in Germany, had sales of $1.65 billion (euro1.27 billion) last year and employs about 7,000 people. Eon Labs reported 2004 sales of $431 million (euro330.55 million) and has about 500 employees.

Novartis reported a record 2004 net profit of $5.8 billion (euro4.25 billion), up from $5.02 billion in 2003. Sales rose 14 percent to $28.2 billion (euro20.67 billion). Novartis has about 78,500 employees in more than 140 countries.

The company expects the deals to close in the second half of this year, subject to regulatory approvals in several countries.
biz.yahoo.com



To: richardred who wrote (632)6/11/2005 8:49:39 PM
From: richardred  Read Replies (2) | Respond to of 7243
 
Pharma sector rides consolidation wave

As the impact of WTO regulations kick in, Indian pharma players are learning to collaborate and consolidate to grow

If the industry is to be believed, the Matrix-Strides merger is only the beginning of the shakeout that the pharma sector is set to witness over the next few years. Though this is the first big merger in the post-patent era, over the last one year, mid-cap pharma companies have been particularly aggressive in forging global alliances, buying brands and investing in international companies and joint ventures.

Sun Pharma’s acquisition of MJ Pharma, Ipca’s joint venture (JV) with a Chinese company for a malaria drug, Iceland based Actavis’ acquisition of CRO Lotus Labs, Jubilant Organosys’ 75 per cent equity buy out in a US generics company, Glenmark’s JV with Shasun, Glenmark’s merger of Tasc Pharma’s operations into its own - all point to one thing - consolidation. Not only that global companies are taking a relook at their India plans and evaluating scalable models.

For instance, Sandoz, now the world’s largest generic player, is planning a new multipurpose plant at its recently acquired site at Mahad in Maharashtra. And Teva, which had acquired JK Drugs & Pharmaceutical not long ago, is reportedly in talks with Aurobindo Pharma, Cipla and Dr Reddy’s, according to industry sources.

The pharma sector accounted for the highest foreign direct investment in the financial year 2004, amounting to Rs 1,571 crore. “M&A activity is likely to be high in the generics manufacturing & early drug development space. Domestic generics companies are selling off non-core businesses and have been on a fund raising spree to mobilise large amounts of investible cash for inorganic growth,” says Utkarsh Palnitkar, industry leader, healthscience practice, Ernst & Young India.

Agrees Sanjiv Kaul, partner at ChrysCapital and former vice-president at Ranbaxy, “A shakeout is inevitable in the sector. Alliances are likely to happen in primarily two areas - among Indian companies in the generics space and among MNCs and Indian companies in R&D (contract research).”

Therefore the main drivers behind the spate of alliances are: Supply chain integration Domestic companies are looking to consolidate their position across the value chain by coalescing their strengths with partners having complementary skillsets. This was precisely the logic behind the Matrix-Strides merger. While Matrix is strong in the API (active pharmaceutical ingredient) area, Strides has capabilities in the finished dosages and formulations space. This is also why Jubilant Organosys is acquiring a US generic company.

“Not only would we be able to integrate our operations forward, it is also a means of addressing growth markets abroad,” said Shyam S Bhartia, chairman and managing director.

Risk mitigation

One of the key drivers behind alliances is risk mitigation. Over the last couple of years, several global generics majors have been ramping up their India presence. Players like Ivax and Watson are forging partnerships with Indian manufacturers. Teva has integrated JK Pharma (now called Reagents & drugs Ltd) into its global supply chain.

“These players have quite literally brought the battle for the international generics pie to the doorstep of their Indian competitors. This could in turn be a strong trigger for domestic majors to consolidate and coalesce their strengths to meet this threat,” says Palnitkar.

Scale economies

The large number of alliances pharma companies have forged across the value chain could very well be a precursor to mergers. The merger of two entities has the potential to increase the competitive force of the combined entity exponentially as it is a coming together of a coalition of companies allowing the merged entity to tap into a vast network of partnerships.

A very clear example is that of Matrix and Strides - now the combined entity is worth Rs 1,000 crore and the 7th largest player in India. “The merged entity offers much more potential in terms of enhanced footprint and will find it easier too to attract investment,” says Sandeep Dhupia, Partner, Transactions Services at KPMG. Drug discovery costlier Drug discovery is becoming expensive and lengthier as administrative and regulatory costs are on the rise. Moreover, given India’s strengths in chemical synthesis and process engineering, Indian companies have cost advantages over other destinations like Hungary and Israel.

“Many MNC companies are scouting for Indian partners especially in the area of contract research. There is a growing trend of early stage discovery being outsourced to India,” says Dhupia. Even among Indian organisations, Ranbaxy has recently tied-up with the Department of Science & Technology and National Chemical Laboratories to source leads for new chemical entities. Generic market opportunity In the next two years, drugs worth $80 billion are going off-patent.

Though there is a huge opportunity in this space, often Indian companies lack marketing muscle to go it alone in the global markets, especially. Thus we find players like Lupin entering a pact with Cornerstone to market Suprax, Wockhardt entering into joint ventures in Mexico and South Africa; and Glenmark tying up with Shasun. “It is virtually impossible to do all things on your own. Then it becomes imperative to draw on someone else’s competence. In our case, we do not have a global reach.

Therefore, we have entered into a number of co-marketing pacts,” says Glen Saldanha, CMD of Glenmark Pharma. Investment & fund raising M&As are also looked at as a fund-raising activity for R&D and expansion, especially in the biotech area. “There has been discussions with many companies in this sunrise industry. We are open to M&As so long as our partner is open to our philosophy of developing low cost vaccines,” says Varaprasad Reddy, chairman of Shantha Biotechnics.
expresspharmapulse.com



To: richardred who wrote (632)7/25/2005 12:14:55 PM
From: richardred  Read Replies (1) | Respond to of 7243
 
I still think Merck KGaA will be high on the list of generic competitors that wants to keep up.

Q2/2005: Merck KGaA Profit After Tax, Before Exceptionals +27%

Darmstadt, Germany, July 21, 2005 – Merck Group sales rose by 8.6% to EUR 1,482 million in the second quarter, aided by good performances from the Ethicals, Generics and Liquid Crystals divisions. Excluding exceptional items, Merck’s profit after tax for the second quarter of 2005 increased 27% to EUR 123 million from EUR 96 million.

The operating result rose 15% to EUR 203 million. Return on sales (ROS: operating result/sales) increased to 13.7% from 12.9% while return on capital employed (ROCE) rose to 18.5% from 16.7%. Merck completed the sale of its Electronic Chemicals business to BASF AG of Ludwigshafen, Germany, on April 15. The sales price was EUR 270 million and Merck booked a gain of EUR 138.7 million.

Earnings before interest and tax (EBIT) decreased 34% to EUR 340 million from the year-ago figure of EUR 513 million, which included the one-time extraordinary gain of EUR 292.5 million on the divestment of VWR International. All profit figures for the second quarter of 2005 showed similar decreases in comparison to the year-ago quarter because of the gain from the disposal of VWR.

Profit before tax fell 35% to EUR 322 million from EUR 494 million the year before. Profit after tax decreased 31% to EUR 252 million from EUR 364 million. Merck’s underlying tax rate remained at a lower level, dropping to 33.4% in the second quarter of 2005 compared to 38.8% in the year-ago quarter.

Gains from the divestments of VWR International and the Biomet-Merck joint venture last year and the Electronic Chemicals business this year are having a positive effect. Merck’s financial result was reduced a further 4.3% in the second quarter to a very low EUR – 18 million.

The number of Merck employees worldwide decreased by 59 people, or 0.2%, to 28,606 (as of June 30).

Highlights

The impressive acceptance of Erbitux® by patients and doctors led to sales in the second quarter of EUR 52 million, a 22% increase compared to sales of EUR 42 million in the first quarter of 2005. Since its approval in the European Union just a year ago, Erbitux® has been approved in 39 countries in Merck’s marketing territory, with Hong Kong, South Korea, Colombia and Israel approving it during the second quarter of this year.

Sales by the Liquid Crystals division rose 9.9% to EUR 183 million in the second quarter compared to record sales of EUR 167 million in the year-ago quarter. Compared to the first quarter of 2005, sales were up 25%. R&D expenses, mainly for the new OLED business, jumped 77% to EUR 19 million. In addition, the start-up phase of the new production facilities in Darmstadt is taking longer than expected. As a result, the second-quarter operating result fell by 8.1% to EUR 78 million compared to the year-ago quarter. This was a 14% increase compared to the first quarter 2005 operating result of EUR 68 million.

Outlook

Merck expects Erbitux® sales to continue to grow as it gains approval in more countries. In addition, Merck plans to seek approval for Erbitux® for the treatment of head and neck cancer in the European Union yet this year, possibly as early as the third quarter.

The Liquid Crystals division’s operating result, as well as its ROS and ROCE, suffered in the second quarter from high R&D costs for the new OLED business and from longer than expected start-up costs for the new production facility in Darmstadt. Nevertheless, Merck remains confident in this dynamic business. It is especially encouraged by the prospects in the growing flat-screen television industry. Merck expects the Liquid Crystals sales growth rate to accelerate in the second half of this year.

The Generics division continued its very satisfactory development in the second quarter. In fact, the success of its bestseller in the United States, the DuoNeb® inhaler for treating chronic obstructive pulmonary disease (COPD), has prompted five generics companies to apply to the U.S. Food and Drug Administration (FDA) for approval to market their generic versions of this value-added product before its patent expires in June 2022. An approval from the FDA, if any, remains subject to the outcome of the patent litigation filed by Merck, and Merck is using all legal means to vigorously defend its patent. The five cases will be consolidated in a trial in Los Angeles Federal District Court in 2006.

As a result of its focus on innovative, high-margin products, Merck expects its business to continue developing positively this year and in years to come. In June, the company raised its mid-term financial targets. The ROS target increased to 20% from 15% and the ROCE target rose to 25% from 15%. Merck emphasizes that these are mid-term targets and not a guidance.

For this year, Merck continues to expect that sales for the Group – excluding VWR International and Electronic Chemicals – should have a growth rate in the single-digit range.

Notes to Editors:

Please download the full Q2 Report in English and German as well as the financial charts from the company website:
merck.de
merck.de

A Conference Call for media and analysts will take place at 3 p.m. CET today.
Access: +49 69 4035 9616, quote “Merck”. Replay: +49 69 9205 3444

Merck KGaA stock symbols
Reuters: MRCG, Bloomberg: MRK GY,
Frankfurt Stock Exchange: ISIN: DE 000 659 9905 - WKN: 659 990

Forward-looking statements:
merck.de