Pharmaceutical Companies Exaggerating FSD Problem

To increase the sale of new drugs, many drug-making Companies are intentionally overstating the problem of female sexual dysfunction (FSD).

Ray Moynihan, an academic, said pharmaceutical Companies are giving much hype to the fact that ‘hypoactive sexual desire disorder’ among female is increasing and is quite widespread.

Mr. Moynihan, who is a broadcaster and lecturer at Newcastle University in Australia, also said that Companies even provide funds for those surveys that are designed to show that a lot of women are suffering from this problem.

A course for the U. S. doctors that was funded by Pfizer claimed that around 63% women were suffering from sexual dysfunction problem. The course even suggested treatment options like taking testosterone and Viagra.

On the other hand, many studies later found that Viagra was not useful for such a purpose.

Mr. Moynihan said, “The drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacturer”.

Medical experts say that FSD is nothing but women’s discontent with their partners, which the pharmaceutical Companies are purely exaggerating.

Mr. Moynihan in his book ‘Sex, Lies and Pharmaceuticals’ describes the partnership of science and marketing of FSD as a ‘corporate sponsorship

Amway India’s Himachal Production Facility To Tripple Capacity By End Of 2009

India, Shimla: Beating the slowdown by recording a 27 percent growth in Jan-July period, Amway India, the country’s largest direct selling FMCG company has set out a target of Rs 2500 crore sales by 2012, more than double of what it recorded in 2008.

Speaking after inaugurating a larger office here, William S Pinckney, MD & CEO of Amway India said that the vendor plant at Baddi was working to capacity, to meet growing demands for our products an additional Rs 55 crore was being spend to add 4 new production lines at the plant which would boost the production three fold.

After the additional investment a total of Rs 105 would have been made at the Baddi plant operated by Sarvotham Care, where Amway contract manufactures about 85 % of its products sold in Indian markets.

“Our new office in Shimla is almost three-times the size of the earlier office – our growing business warrants a larger facility in Himachal Pradesh,” said Pinckney.

Amway has two offices in HP – the other being at Dharamshala – and home-delivers products to 45 towns in the state. There are 15,300 Amway distributors in the state doing business worth Rs 68 lakhs per month in ’09 (as compared to Rs 53 lakhs per month in ’08, and Rs 44 lakhs per month in 2007. Taxes paid by Amway to the state exchequer exceed Rs 2 crores over the past three years.

Pinckney that in 2008 the company had recorded sales of Rs 1128 crores and handed out Rs 338 crores as direct commissions to over 5 lakh Amway business owners across the country.

Last year the company had shown a growth of 40 percent and surpassed the Rs 1000 Cr sale mark for the first time, he said. Against a sale of Rs 616 crore in 2008, we have has sales of Rs 780 crore in the January-July period, this year.

Launch of a new e-commerce portal had increases sales from Rs 1 crore per month to Rs 12, said Pinckney.

Over 50% of Amway’s business comes from the sale of dietary supplements and the Vitamin & dietary supplement market is poised to grow by 33% in India by 2013.

Amway India is country’s leading direct selling FMCG Company which is a subsidiary of US $ 8.2 billion Amway Corporation, Ada, Michigan, and USA.

The company has invested more than Rs 151 crores in India and has 130 offices and 55 city warehouses across the country that covers over 4000 cities and towns through its distribution and home delivery network set up with the support of independent logistics partners.

Major Pharmaceuticals Discontinuing Their Natural Desiccated Thyroid Drugs

The pharmaceutical manufacturer Major has reportedly received notice from the FDA that their complete line of natural desiccated thyroid drugs can no longer be manufactured, and that the designation of DESI -- Drug Efficacy Study Implementation -- can no longer be used for these drugs.

According to a press release from Major, the FDA is requiring that all manufacturers that wish to continue manufacturing submit an NDA -- New Drug Application -- or Abbreviated New Drug Application (ANDA) for approval. As a result, Major is discontinuing production of their desiccated thyroid drugs, which were being produced in 1/2 grain, 1 grain, 2 grain and 3 grain sizes.

Note from Mary: At this point then, Biotech, Time Cap Labs, and Major are no longer manufacturing natural desiccated thyroid drugs. There is a nationwide shortage of Thyroid USP, the raw material for desiccated thyroid drugs, which is manufactured by American Laboratories. RLC Labs' Nature-Throid and Westhroid is in short supply or unavailable around the nation, and is on long-term back-order, and they state that the product should be back on the market in 90 days. Forest's Armour Thyroid is is in short supply or unavailable around the nation, and the company has provided no estimated date as to when product might be available again.

Pharmaceutical Markets in Latin America are Worth US$50 billion - and Growing Fast Says New Report

Report Buyer, the online destination for business intelligence for major industry sectors, has added a report analysing 8 major pharmaceutical markets including Argentina, Brazil, Chile, Colombia, Cuba, Mexico, Peru and Venezuela.

According to the report “The Outlook for Pharmaceuticals in Latin America to 2014” available at http://www.reportbuyer.com/go/ESP00344 the eight leading Latin American pharmaceutical markets are expected to grow by a CAGR of 9.9% between 2008 and 2013, outpacing the slowing North American markets. Each country report provides a comprehensive analysis of the pharmaceutical market, including five-year market forecasts.

The eight Latin American markets represent a market of 474 million people with a GDP of US$3.4 trillion in 2008. The region is better prepared to face global instability than in the past but economic growth is expected to slow down in 2009 and 2010, after a recent period of remarkable growth. Access to medicines in the public sector has increased, particularly among the least well-off population, with initiatives such as Remediar in Argentina, PAC Saúde in Brazil, Auge in Chile, Seguro Popular in Mexico and Barrio Adentro in Venezuela. Governments are using their bargaining power to negotiate - and centralise - drug purchases in an effort to contain costs. At a regional level, MERCOSUR members have decided to establish a drug price database to compare and monitor drug prices. Overall, public drug expenditure in the region will continue to rise, as there is a considerable level of unfulfilled demand.

According to the report private pharmacy sales are surging, as countries such as Brazil, Mexico and Venezuela have higher disposable incomes in a climate of macroeconomic stability. Innovative drug prices have risen, but governments have started to control them, either directly or indirectly. Contrary to what has happened in developed markets, generics consumption in Latin America is low, with the exception of Brazil. Local protectionism, very low prices and high production capabilities have helped the country to develop a sizeable bioequivalent generics market which has proved tough for foreign generics producers. In Mexico, Calderon’s government has started a renewal process for drug registrations, and it is expected that there will only be patented and bioequivalent generics by 2010.

The PhRMA Deal: The Plot Thickens?

"In terms of savings for you as a Medicare recipient," President Obama told a town hall attendee yesterday, "the biggest (change) is on prescription drugs, because the prescription drug companies have already said that they would be willing to put up $80 billion in rebates for prescription drugs as part of a health care reform package."

Then the president said, "Now, we may be able to get even more than that.”

That sentence -- seemingly an aside -- could be significant. Because it may indicate that President Obama does not consider himself bound by an agreement upon which the pharmaceutical industry thinks the White House has signed off.

As you may know, there have been some questions as to just what the White House agreed to in a deal Senate Democrats have cut with the pharmaceutical industry. (See our blog post from Saturday for a fuller background, with links.)

Ken Johnson, senior Vice President of the Pharmaceutical Research and Manufacturers of America, or PhRMA , tells ABC News of the president's comment that "clearly it creates a little teeth-gnashing" among PhRMA members, "but we're in this for the long hall and at end of the day remain convinced the Senate Finance Committee will produce a bipartisan bill that will serve as a blueprint for comprehensive health care reform."

In other words, PhRMA remains convinced that Sen. Max Baucus, D-Mont., chair of the Senate Finance Committee, will uphold the deal.

In June, Baucus announced that pharmaceutical companies had agreed to a deal as part of an overall health care reform package, where the companies will provide, as Baucus put it, "affordable prices on prescription drugs when Medicare benefits don't cover the cost of prescriptions," as well as kicking in some money for health care reform efforts.

Former House Energy and Commerce chairman Bill Tauzin, R-La., now the head of PhRMA, said his industry had committed a specific amount of money and part of the deal was Democrats would refrain from seeking more than $80 billion.

That would preclude, for instance, a campaign pledge by then-Sen. Obama to re-negotiate the cost of pharmaceuticals through the Medicare prescription drug benefit.

"$80 billion is the max, no more or less," Tauzin said to the New York Times. "Adding other stuff changes the deal.”

Says Johnson: "in the beginning of this process we made pretty clear the dangers of going above $80 billion; the impact it could have on research and development and the potential job losses in a very fragile economy.

Tauzin said that after the deal was reached with Baucus, he confirmed the terms of the deal with White House Chief if Staff Rahm Emanuel, deputy Chief of Staff Jim Messina, and health care reform czar Nancy-Ann DeParle.

“They blessed the deal,” Tauzin told the Times. "As far we are concerned, that is a done deal. It’s up to the White House and Senator Baucus to follow through.”

On Friday, White House press secretary Robert Gibbs seemed to confirm the deal, saying, "we feel like $80 billion is -- is an appropriate amount. And I think the -- I don't have the statistic in front of me, but I think the House bill has $85 billion in it, so I would argue that we're all in the same ball park."

Asked a reporter: "there is a deal that you won't squeeze any more?"

Said Gibbs: "Well, I hate to blow our cover here, but we announced it publicly."

"But there had been some reports saying you privately told Democratic senators that there is no such deal," Henry said.

"I don't know where that's coming from," Gibbs said. "I don't what that's being based on."

But then the White House seemed to back off the notion that it had agreed to an $80 billion limit.

"The White House, Senate Finance Committee and PhRMA agreed that PhRMA would contribute $80 billion to lower costs as part of the health insurance reform legislation that the President expects to sign this year," Linda Douglass, the communications director of the White House Office of Health Reform, told ABC News Saturday.

Asked if the deal precludes the government engaging in direct negotiations for the Medicare prescription drug benefit, Douglass said "that issue was not discussed" during the White House negotiations with PhRMA.

The president's comments yesterday would seem to indicate that he's not on board with any $80 billion limit.

Says Johnson: "People need to recognize that $80 billion is a huge investment by our companies, and will require them to make some very difficult choices. It's not loose change found in the sofa, it's real money that carries some consequences for our companies."

Teva Animal Health closes shop

Teva Animal Health has stopped manufacturing generics and its DVM Pharmaceuticals line of products following a crackdown by the U.S. Food and Drug Administration (FDA) on the company’s quality control practices.

“We have no additional information to provide at this time, but will keep our customers apprised of the situation as we have news to share,” says Denise Bradley, senior director of Teva’s North America Corporate Communications.

Members of the Veterinary Information Network (VIN) report that some Teva Animal Health products are on backorder. The company is commonly known for its medicated shampoos and skincare products, as well as supplements.

In an e-mail to the VIN News Service, Bradley adds the following prepared statement:

“Teva Animal Health regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements. These actions include conducting a complete analysis of each individual product; retraining all of our production employees, and revalidating our equipment, processes and methods.”

Teva’s efforts are in response to a lawsuit filed by FDA on July 31 in U.S. District Court, suing Teva Animal Health, as well as the regulatory agency’s move last Friday to shut down the company’s Missouri plant. An injunction prohibits the company from manufacturing and distributing adulterated veterinary drugs.

FDA alleges that three regulatory inspectors documented “numerous” Good Manufacturing Practice violations.

Other FDA complaints include a reported failure by the company to establish a quality control unit, provide adequate employee training, conduct adequate equipment maintenance and reject drug products that failed to meet quality specifications.

Teva Animal Health is an arm of Israeli-based Teva Pharmaceutical Industries Ltd. It was born in January 2006, when Teva Pharmaceuticals acquired IVAX Corp., its subsidiary, IVX Animal Health. IVX Animal Health is comprised of Phoenix Science Inc., the largest manufacturer of generic pharmaceuticals for the U.S. animal-health market, and DVM Pharmaceuticals, a specialty veterinary pharmaceutical company focusing on topical dermatologicals and nutraceuticals for pets, which had merged in 2005 under the IVX Animal Health name.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” says Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, in a news release. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

Earlier this month, Teva Pharmaceuticals voluntarily recalled two lots of the anesthetic propofol following a federal government investigation of recent cases of nonrespiratory febrile reactions among human patients undergoing endoscopy in the United States.

Teva’s Bradley insists that the incident is not connected to FDA’s actions against Teva Animal Health.

According to the lawsuit’s consent decree, future violations will cost the company $20,000 for each day that Teva fails to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.

Watson sees windfall as Toprol XL generic wins OK

Watson Pharmaceuticals Inc said on Monday U.S. regulators have approved its generic form of popular blood pressure drug Toprol XL, opening it to a lucrative market after shipments of two rival generics were suspended due to manufacturing problems.

London-based AstraZeneca Plc (AZN.L) reaps more than $700 million in annual U.S. revenue from Toprol XL and an authorized generic marketed by Par Pharmaceutical Companies Inc (PRX.N) that uses the same active ingredient.

Two other generics had been sold in the United States by Swiss drugmaker Novartis AG (NOVN.VX) and by KV Pharmaceutical Co (KVa.N) (KVb.N), but the companies suspended shipments of those copycats more than six months ago due to manufacturing issues cited by the U.S. Food and Drug Administration.

Novartis, which introduced its generic in 2007, stopped shipments in December 2008. KV Pharmaceutical suspended shipments of its four dosage forms in January.

"We get these opportunities every once in a while and this is one of those unique opportunities," said Watson spokeswoman Patty Eisenhaur, referring to the sudden recent disappearance from the U.S. market of the rival Novartis and KV Pharmaceutical generics.

Eisenhaur said her company's approved 25- and 50-mg dosage forms are the two most widely prescribed strengths of Toprol XL, and will be shipped immediately. She noted that Watson is hopeful of winning U.S. approval later this year for the 100-mg and 200-mg strengths.

"To become one of the full suppliers of a drug of this magnitude is a terrific opportunity," Eisenhaur said.

Watson last week predicted its generic would be approved in "the near term."

AstraZeneca raised its full-year profit forecast on July 30 after better-than-expected second-quarter results, helped by its lucky break of escaping generic competition earlier in the year on the Novartis and KV Pharmaceutical generics.

KV Pharmaceutical is unlikely to pose a threat anytime soon to Watson's newly approved product.

The cash-strapped company last week said it does not expect to re-initiate shipments of its medicines prior to the third quarter of fiscal 2010, at the earliest.

The suburban St. Louis drugmaker expressed doubts about its ability to continue as a going concern, given that it has refrained from manufacturing and shipping any of its medicines due to a consent decree it entered with the FDA.

The FDA in August 2008 cited Novartis for failing to properly validate the manufacturing process for making Toprol XL tablets at a plant in North Carolina.

Indoco Remedies net profit dips by 31%, net sales by 10%

Indoco Remedies hit by lower domestic sales during the quarter ended June 2009 and its net profit declined sharply by 31.4 per cent to Rs 16.88 crore from Rs 24.60 crore in the similar period of last year. Despite higher exports its net sales declined by 10.2 per cent to Rs 98.34 crore from Rs 109.49 crore. The fall in profit impacted earning per share, which nosedived to Rs 13.74 from Rs 20.02 in the last period.

The company's exports increased by 16.1 per cent, but its domestic formulation sales declined by 17.5 per cent. The sales declined due to it introduction certain credit control measures in the current and previous quarters. However, the de-growth in domestic sales was much lower as compared to earlier quarters. The products like Cyclopam, Tuspel Plus, MCBM-69, Clokit, Febrex Plus Drops, etc., achieved positive trend during the quarter under review.

Exports to regulated market registered a growth of 15 per cent to Rs 22.47 crore from Rs 19.54 crore. Its Baddi facility received UK MHRA approval. The AOK (Germany) tender dispatches are in full swing and its API plant at Patalganga received approval for supply of metformin API for the OAK tender. The exports to emerging markets increased by 24.09 per cent to Rs 4.48 crore from Rs 3.61 crore.

Ajinomoto to buy P&G’s Japanese osteoporosis drug

Procter & Gamble Co., has agreed to sell Ajinomoto Co. the rights to its Japanese osteoporosis drug for $210 million, days after reports emerged that the consumer products maker is in talks to sell off its pharmaceutical business.

The deal gives the Japanese company the rights to research, develop, manufacture and sell the drug, a licensed product exclusive to the Japanese market, Ajinomoto said in a statement. The drug is marketed under the brand name Actonel.

The deal follows reports that P&G is in discussions to sell its pharmaceuticals business to the investment firm Cerberus Capital Management and to Warner Chilcott Ltd., a maker of specialty drugs. The selling price was pegged at $3 billion. P&G’s total pharmaceutical business generates sales of an estimated $2.2 million.

The Business Courier reported in December that Cincinnati-based P&G was considering selling off some or all of its drug brands. The pharmaceutical business is headquartered in Mason, where it employs more than 500 of its 2,700 pharmaceuticals employees worldwide.

Cincinnati-based P&G (NYSE: PG) is the world’s largest consumer products maker. It will report its fiscal fourth quarter and annual earnings on Aug. 4.

Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma Corporation Amend Agreement to Develop and Commercialize Telaprevir in Asia

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Mitsubishi Tanabe Pharma Corporation today amended their agreement for the development and commercialization of telaprevir for the treatment of hepatitis C virus (HCV) infection in Japan and other countries in the Far East. Telaprevir is an HCV protease inhibitor currently in Phase 3 clinical trials in Japan, as well as in the United States and in Europe. Under the terms of the amended agreement, Vertex will receive $105 million following signing, and will be eligible to receive further milestones upon approval and commercialization in Japan.

The previous agreement signed in 2004 between Vertex and Mitsubishi Tanabe provided certain development and commercial rights to telaprevir as a potential monotherapy for the treatment of Hepatitis C. The amended agreement announced today provides a fully-paid license to commercialize telaprevir as part of a combination regimen with interferon and ribavirin to treat hepatitis C in Japan and the Far East. Vertex retains exclusive development and commercial rights to telaprevir in North America. Janssen Pharmaceutica, an affiliate of Johnson & Johnson, holds development and commercial rights to telaprevir in Europe, South America, Australia, and the Middle East.

"This amendment recognizes the value of telaprevir-based combination therapy as a potential major advance in the treatment of hepatitis C in Japan and Asian countries, aligning the telaprevir development program on a global basis,” said Kurt Graves, Vertex Executive Vice President, Chief Commercial Officer and Head of Corporate Development. "Moreover, following this amendment, the cash received strengthens our corporate financial position during an important period of investment and growth as we advance two Phase 3 programs in hepatitis C and cystic fibrosis.”

Terms of the Agreement

Under the amended development and commercialization agreement, Mitsubishi Tanabe will receive a license in its territory for telaprevir-based combination therapy with interferon and ribavirin, as well as rights to manufacture telaprevir for sale in its territory. Mitsubishi Tanabe will pay Vertex $105 million upon signing. In addition, the parties have reached other commercial agreements in the amendment, including potential bonus milestone payments in lieu of royalties, that if realized would range between $15 million and $65 million.

Medicis Pharmaceutical Corporation (NYSE:MRX) Is TodayaEUR(TM)s Top NYSE Stock To watch

Medicis Pharmaceutical Corporation (NYSE:MRX), yesterday, July 27, 2009, announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 65mg and 115mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The stock closed at $16.14 in the last trading session.

Veeco Instruments Inc. (NASDAQ:VECO) on July 27, 2009, posted a wider-than-expected quarterly loss as data storage order rates were lower compared with historical levels, but forecast strong 3Q2009 revenue. For 3Q2009, the company expects to post a loss of 2 cents a share to a profit of 5 cents a share, excluding items, on revenue of $80 million to $88 million. Analysts on average were expecting 3Q2009 loss of $0.11 a share, before items, on revenue of $72.7 million, according to Reuters Estimates. Veeco posted 2Q2009 loss attributable to the company of $14.7 million, or $0.47 a share, compared with a profit of $3.5 million, or $0.11 a share, the previous year. Excluding certain items, it posted a loss of $0.38 a share, trailing analysts' average estimate of a loss of $0.20 a share, according to Reuters Estimates. Revenue slumped 37% to $72.0 million, beating analysts' expectations of revenue of $64.1 million. Yesterday, the stock ended at $14.67.

BP plc (ADR) (NYSE:BP) on July 28, 2009, reported 2Q2009 profit attributable to BP shareholders of US$4.39 billion or 23.16 cents per share, compared to US$9.36 billion or 49.23 cents per share last year. Pre-tax profit was US$6.77 billion, lower than US$14.5 billion in the same quarter last year. Sales and other operating revenues declined to US$54.78 billion from US$108.75 billion in the same period in the previous year. On July 28, 2009, BP plc announced a dividend of $0.14 per ordinary share to be paid in September. Holders of ordinary shares will receive 8.503 pence per share and holders of American Depositary Receipts $0.84 per ADS. The dividend is payable on September 08, 2009, to shareholders on the register on August 14, 2009. Participants in the Dividend Reinvestment Plan (DRIP) or the DRIP facility in the US Direct Access Plan will receive the dividend in the form of shares, also on September 8, 2009. In the previous trading session, the stock closed at $51.34.

Liquid Tycoon alerts its members on stocks that could generate higher than average returns. These include stocks with huge volume, penny stocks that are moving to the upside quickly, penny stocks with buy signals and companies with news. Our alerts are well known for producing incredible results in a short amount of time and our members have made outstanding profits of over 100%.

FDA Heat Fails to Scorch Appeal of Indian Pharma

BANGALORE -- Some Indian pharmaceutical companies are facing increased regulatory scrutiny in developed markets and that's perking up the view on the sector.

Generic drug makers like Ranbaxy Laboratories Ltd., Sun Pharmaceutical Industries Ltd., and Lupin Ltd. are in trouble with authorities in the U.S. over issues such as the quality of test data and manufacturing practices at their plants in India and abroad.

These companies are now scrambling to improve standards. As a result, they will be in a better position to increase their business over the next five years when $100 billion worth of drugs will go off-patent, say analysts.

With manufacturing costs nearly 40% lower in India than in the West and the global drive to cut healthcare expenses, India's generic drugmakers are unlikely to lose, they say.

Although competition from other countries such as Israel and China is increasing, India has an advantage in that it has 107 plants approved by the Food and Drug Administration, the highest number outside the U.S., and thrice the number in China.

"These plants are cost competitive. I think that's a huge value proposition," said Hitesh Gajaria, executive director at KPMG, who is bullish on India's generic drug makers.

Stocks in the sector have recovered most of the losses incurred in the wake of the FDA moves. Shares of Lupin, which said May 13 that it had received a warning letter from the FDA for not giving a satisfactory response to some non-compliance issues, have risen 21% since. The benchmark Sensex has risen 28% in the same period.

Lupin, India's fifth-largest drug firm by revenue, sells both generic drugs as well as branded products in the U.S., a market that accounts for about 35% of its revenue.

Following the FDA move, Lupin appointed a consultant to advise it on the regulator's quality requirements. It is also upgrading equipment to improve quality control methods.

Shares of Sun Pharma, the fourth-largest Indian drug firm by revenue, tumbled 13% on June 26 after the FDA seized drugs made by its Caraco Pharmaceutical Laboratories unit in Michigan.

The company subsequently withdrew its revenue forecast for the current financial year. Nomura estimates the FDA action could potentially shave at least 10% of its full-year revenue.

Sun Pharma closed Monday down 0.10% at 1244.75 rupees, 5% below its June 25 closing price.

Mohit Mirchandani, vice president and head of equity investments at Taurus Asset Management, said his fund has not sold any of the pharmaceutical stocks in his portfolio as a result of the FDA moves.

The U.S. is the biggest market for India's generic drugs such as sumatriptan succinate, the generic version of the migraine drug Imitrex.

Companies such as Ranbaxy, which was acquired by Japan's Daiichi Sankyo Co. last year, and Dr. Reddy's Laboratories Ltd. now get almost half their revenue from developed markets like the U.S. and European Union.

Some firms have also started selling generic drugs into newer markets like China, Japan, Brazil and Mexico in a bid to spread their revenue sources, a positive step according to industry watchers.

In June, Dr. Reddy's, the second-largest Indian drug firm by revenue, and GlaxoSmithKline PLC signed a partnership to develop and sell selected generic products across emerging markets, excluding India.

Lupin forayed into Japan, the second largest pharmaceutical market in the world after the U.S., by acquiring a majority stake in Kyowa Pharmaceutical Industry Co. in 2007.

However, not everyone is convinced that Indian pharma stocks are without risk.

Prateek Agrawal, head of equity at Bharti AXA Investment Managers, said the current regulatory climate is a deterrent for investors because some companies may face a sales ban like Ranbaxy unless they handle the situation effectively.

In September, the FDA banned Ranbaxy from selling some of its drugs in the U.S. saying it violated manufacturing guidelines at two plants in India.

Ranbaxy, India's biggest drug maker by sales, Friday reported a profit for the April-June quarter after posting losses in the past three sequential quarters, hit by unfavorable currency bets, regulatory problems in the U.S., and weak demand in emerging markets.

The FDA is now reviewing Ranbaxy's corrective action plan for one of the plants which it submitted in May.

OSI to benefit from uses for cancer drug-Barron's

NEW YORK, - OSI Pharmaceuticals (OSIP.O) shares could benefit as the Melville, N.Y.-based company expands the uses of its lung-cancer drug, Barron's said.

OSI's sales of Tarceva, the second-largest oral anti-cancer drug, hit $1 billion last year.

OSI trades for about $32 a share, about 18 times next year's earnings, Barron's said, projecting it could rally to $45 a share in the coming year with the help of Tarceva.

Caraco Pharma Now Faces Class Action Lawsuits

The Detroit generic pharmaceutical maker Caraco Pharmaceutical Laboratories Ltd. (NYSE Amex: CPD) said Friday that two purported class action lawsuits had been filed against it in federal court in Detroit on July 17 and 23.

Caraco said neither the company or the executives had ot yet been served with either suit. But even without seeing them, Caraco said it believes the suits are "without merit" and that it intends to "vigorously contest the actions."

Caraco said the suits "purport to represent the class of persons who purchased or otherwise acquired the common stock of the Company generally between May 29, 2008 and June 25, 2009."

And the suits allege that Caraco and executives "violated federal securities laws, primarily related to public statements on FDA compliance."

A Los Angeles, Calif. law firm, Glancy Binkow & Goldberg LLP, also announced last week that it had filed one of the suits on behalf of those who bought Caraco pharmaceutical sbetween May 29, 2008 and June 25, 2009.

The firm said that suit "alleges that throughout the Class Period defendants knew or recklessly disregarded that their public statements concerning Caraco’s business, operations, and prospects were materially false and misleading."

Specifically, that means failure to disclose that it had failed to meet the United States Food and Drug Administration's current Good Manufacturing Practice (“cGMP”) requirements; that the company failed to take corrective measures in order to have its manufacturing facilities comply with the FDA’s cGMP requirements; that the company had failed to remedy repeat violations of FDA regulations previously observed and documented by the FDA; yhat the foregoing significantly jeopardized the Company’s ability to gain FDA approval of pending new drug applications; and as a result, that the company would have to recall certain products.

On June 25, the FDA announced that U.S. Marshals had seized drug products manufactured by Caraco from the company’s plants. According to the FDA, this action followed Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs. The FDA stated that through the seizure it sought to immediately stop the vompany from further distributing drugs until there is assurance that Caraco complies with good manufacturing requirements. On this news, shares of Caraco declined $1.79 per share, or approximately 43 percent, to close on June 25 at $2.39 per share, on unusually heavy volume.

Plaintiff seeks to recover damages on behalf of class members and is represented by Glancy Binkow & Goldberg LLP, a law firm with significant experience in prosecuting class actions, and substantial expertise in actions involving corporate fraud.

Teva, JNJ settle birth control pill patent lawsuit

NEW YORK -Teva Pharmaceutical Industries Ltd. said Friday it will be able to launch a generic version of a popular birth control pill under terms of a patent settlement with Johnson & Johnson.

The Israeli drugmaker said it will be able to relaunch its version of the drug Ortho-Tri-Cyclen Lo on Dec. 31, 2015. Teva started selling its pill, called Tri-Lo Sprintec, earlier this month after gaining marketing approval from the Food and Drug Administration. Johnson & Johnson then sued Teva for patent infringement, and Teva halted shipments.

Teva said it will make a royalty payment to Johnson & Johnson, and in return, it will get a release for the previous sales. It did not disclose the size of the payment.

Teva, the world's largest generic drugmaker by revenue, said it will be able to launch Tri-Lo Sprintec earlier than Dec. 31, 2015, under some circumstances. It said the settlement will not take effect until a court enters a judgment upholding Johnson & Johnson's patents, which are scheduled to expire in 2019.

Ortho-Tri-Cyclen is marketed by Johnson & Johnson's Ortho-McNeill-Janssen unit, and Teva said U.S. sales were $400 million in the 12 months ended March 31.

In afternoon trading, Teva shares were unchanged at $50.19. Earlier, they set an annual high of $50.68. Johnson & Johnson stock rose 61 cents to $60.83

China's pharmaceutical market primed to explode

NEW YORK - China's ambitious $124 billion effort to provide basic health coverage for the vast majority of its 1.3 billion citizens by 2011 is a brimming opportunity for large global drugmakers.

As growth in the U.S. and European markets remains sluggish, many giant pharmaceutical companies are expanding their sales forces, distribution channels and research operations in China to tap into the country's robust drug market -- expected to expand at about 22 percent annually over the next five years, said Mandy Chui, senior principal of IMS Health Inc.

Chui is the China expert at IMS Health, which provides market data on the pharmaceutical and healthcare industries.

"We see companies continuing to invest in China because the other markets are not growing," Chui said in an interview. "For companies, (China's growth) is certainly a good story to tell to the Street, right?"

With a huge and aging population, rapid urbanization and adoption of Western lifestyles that give rise to hypertension, obesity and other diseases, China is poised to become the world's third biggest pharmaceutical market by 2013, up from its current No. 5 spot, said Chui.

The $24.5 billion market is expected to swell to $68 billion to $78 billion by 2013, Chui said, leaving it behind only the United States and Japan.

"China is taking over from Germany and France," she said. "It's like a big wake-up call. If they (Big Pharma) are not in there at this point in time, all of them are not going to grow."

In the race to penetrate the China market, she said European drug makers such as Bayer AG, AstraZeneca PLC and Sanofi-Aventis SA have taken the lead.

U.S. drugmakers were once content to grow in their home market but are now eager to "play catch up," she said.

Pfizer Inc Chief Executive Officer Jeff Kindler said on Wednesday that China is an increasingly important priority for the world's biggest drugmaker, which aims to make vaccines a big part of its China effort.

"Not only is it necessary to be there, we are there," Kindler said in a separate interview.

Chui said drugs for diseases commonly seen in China, such as hepatitis B, will have blockbuster potential.

An estimated 30 million of China's people have chronic infections with hepatitis B -- a virus that can lead to cirrhosis of the liver and liver cancer.

Many large pharmaceutical companies have geared up their outreach efforts to increase treatment rate for the liver disease that kills more than 300,000 Chinese a year, Chui said.

Bristol-Myers Squibb Co's hepatitis B drug Baraclude -- a pill introduced in 2006 -- has the clear market lead in China over GlaxoSmithKline PLC's antivirals Heptodin and Hepsera, Bayer AG's Nexavar and several interferons, she said. While no companies have any products of blockbuster scope, which typically means annual revenues of $1 billion or more, in China, Chui said some could arrive within five to 10 years.

Despite the price gap between generics and branded drugs, branded drugs that have lost patent protection still are favored in China as they are often deemed to have better quality and enjoy brand loyalty among large city hospitals, Chui said.

However, drugmakers from the United States, Europe and Japan still have to face tough competition from local Chinese companies, which have stronger sales and distribution channels across China's diverse provinces, especially in remote rural areas.

Chinese companies are clamoring to enter the market once Baraclude loses its patent protection in 2011, Chui said.

More than 30 companies have submitted applications seeking approval of the generic version of the drug, she said.

A Bristol-Myers spokesman, Brian Henry, said: "We have patents in force and patents pending in China (for Baraclude). We do not comment about potential competitors."

Other top-selling drugs in China that are made by multinational companies include blood-clot preventer Plavix, ulcer drug Losec, oral diabetes treatment Glucobay, the Novolin brand of insulin and antibiotic Avelox.

Multinationals currently hold 30 percent of the market with local drug companies taking 70 percent.

"Five years from now, I don't see any substantial change (to that ratio)," Chui said. "The whole pie is growing bigger."

China's health reform effort also includes the construction of 2,000 new county hospitals and upgrades of 30,000 township medical centers.

Chui said expansion of medical infrastructure will benefit makers of medical devices, vaccines and companies that specialize in medical imaging, diagnostics and electronic medical records.

Unichem Lab net sales declines by 7% in Q1, dividend at 80% for FY'09

Unichem Laboratories, a Rs 650-crore pharma company from Mumbai, India has suffered a minor setback during the first quarter ended June 2009 and its net profit declined to Rs 32.39 crore from Rs 33.38 crore in the corresponding period of last year. Its net sales also declined by 7 per cent to Rs 167.61 crore from Rs 180.16 crore. The board of directors recommended equity dividend of 80 per cent for the year 2008-09.

Its domestic sales declined to Rs 139.03 crore during the quarter under review from Rs 144.68 crore and its exports moved down to Rs 30.30 crore from Rs 36.86 crore in the similar period of last year.

Addressing the 46th Annual General Meeting of the shareholders, Dr Prakash Mody, chairman and managing director, said, "The company is setting up a formulation plant at Sikkim and same will go stream in next year. It will basically cater to Eastern and North Eastern market."

At Baddi (Himachal Pradesh) formulation plant, the company completed the third large formulation plant for cephalosporin at an investment of Rs 42 crore and added one more plant for soft gelatine capsules at this site, he pointed out.

The company has filed 247 DMFs (Drug Master Files) in various countries so far. It has set up bioscience R&D pilot plant and new training centre, QA/QC lab and pharma technology development lab at its Goa facility. "All these additions will make our Goa facility a truly one of its kind and state-of-the-art comprehensive formulation and bio-science facility in the country," Mody added.

Epix Pharmaceuticals is latest biotech to fall

Epix Pharmaceuticals Inc. has became the second Massachusetts biotechnology company in the past week to fold, raising fresh concerns about the health of the sector.

The cash-starved Lexington company, which had been working on treatments for Alzheimer’s disease and other ailments, yesterday confirmed it was moving ahead with “an orderly liquidation’’ of its assets after failing to find an acquirer or obtain additional financing to stay afloat. The company’s shares were delisted by the Nasdaq stock exchange on May 14 when it was unable to pay fees required to meet listing obligations.

Last week, Cambridge biotech Biopure Corp. filed for Chapter 11 bankruptcy protection. Biopure, which was developing a human blood substitute, plans to sell most of its remaining assets to OPK Biotech LLC of Delaware.

With many investors souring on biotechnology, and the cost of capital rising for the industry’s expensive research and development, more companies are being forced to pull the plug before they can bring new drugs to market, industry watchers said yesterday.

“You’re seeing a squeeze across the board,’’ said Kevin J. Gorman, managing partner of Putnam Associates, a Burlington consulting firm specializing in life sciences. “There’s not a lot of financing for biotechnology companies right now unless they have a really good product that’s close to going to market.’’

The funding crunch is affecting public companies like Epix and venture-backed biotech start-ups requiring additional money for drug development and clinical trials, Gorman said. “Investors are dialing back their appetite for risk,’’ he said, noting that uncertainty over national healthcare reform and understaffing at the Food and Drug Administration are contributing to delays and rising costs. “Unfortunately, there may be more [shutdowns] before the end of the year,’’ he said.

Epix, which had been collaborating with pharmaceutical giant GlaxoSmithKline on an Alzheimer’s drug, had about 90 employees at the end of 2008, but has since cut its staff to conserve cash. In April, it said that it might be forced to file for bankruptcy protection if it couldn’t restructure its debt. It also hired investment bankers to seek a merger partner or some other strategic alternative, but those efforts proved unsuccessful.

In a statement yesterday, the company said it transferred its assets to a private fiduciary, certified public accountant Joseph F. Finn of Wellesley, in a so-called assignment transaction. The transaction, an alternative to court-supervised bankruptcy, is a common law contract intended for the benefit of creditors. It was completed Monday.

“It is with great disappointment that the company must proceed with this decision,’’ Epix chief executive Elkan Gamzu said in a statement. “Over the past several months, we had taken several actions in an effort to improve the financial health of Epix.’’

Finn, founding partner of the Finn, Warnke & Gayton accounting firm in Wellesley, said he planned to notify creditors that he had been designated to dispose of Epix’s assets. He said he hoped to auction off the company’s lab equipment and other physical assets by the end of the summer and sell its intellectual property, including patents and clinical studies, by mid-September. With those funds, Finn said, he hoped creditors could be partially repaid within six months.

At least three other biotech companies have liquidated their assets in similar private assignment agreements over the past two years, Finn said, including ActivBiotics Inc. of Lexington, Spherics Inc. of Mansfield, and Prospect Therapeutics Inc. of San Diego.

“There’s a lot of biotechs around, and some are running out of money,’’ he said. “You need deep pockets to fund therapeutic drugs. These companies don’t have sales and they’re expense generators.’’

P&G Drug Unit Closer to Sale, Could Fetch About $3 Billion

Procter & Gamble Co. is getting closer to a possible sale of its prescription-drug business, and several parties, including specialty drug maker Warner Chilcott Ltd., and private-equity firm Cerberus Capital Management LP, are engaged in later-stage discussions, according to people familiar with the matter.

The unit could fetch about $3 billion, these people say.

An acquisition of the P&G business would substantially boost the profile of Warner Chilcott, a New Jersey-based company that focuses on women's health care and dermatology products. Folding in the division would triple Warner's revenue and give it access to drugs that focus on a wide range of women's health concerns.

Warner Chilcott didn't return calls seeking comment.

Cerberus, which proposes acquiring the division and turning it into a stand-alone company, is more circumspect about the transaction, according to people familiar with the situation. But it has lined up preliminary financing from some Wall Street banks, a small sign that banks are getting comfortable financing acquisitions, albeit ones with low amounts of debt financing and very steady cash flows.

"Cerberus can't get it if the strategic buyers are serious. They will pay more than Cerberus for it," said one person familiar with the situation.

The unit -- which makes roughly $800 million in operating profit -- was put on the auction block late last year, in a sales process led by Goldman Sachs & Co. A deal could be wrapped up by the end of summer, according to people familiar with the discussions, though they warned final discussions could still falter.

A P&G spokesman said the company will look at all options to maximize shareholder value, including "continued operations of our strong and profitable business, as well as divestiture of some or all of our pharmaceutical assets."

The division produces osteoporosis drug Actonel, bladder-control drug Enablex, ulcerative colitis drug Asacol and female sexual-dysfunction drug Intrinsa, which hasn't gained approval in the U.S. but is available in some European countries.

P&G will likely focus on one bidder sometime next month, say people with knowledge of the process.

There is at least one other bidder and the situation remains fluid amid the current economic conditions, these people added.

The consumer-products giant, known for its Tide detergent, Pantene shampoo and other staples, declared its drug business a potential divestiture candidate in December and said it would further cut research and development in the division, preferring to invest instead in its over-the-counter health brands, which include Vicks, Metamucil, Crest and Oral-B.

Its best-known drug is Actonel, an osteoporosis treatment for women. The division has annual sales around $2 billion and is headquartered in Ohio.

For years P&G has struggled to gain a foothold in the pharmaceutical industry, having aborted a 2000 plan to swallow drug makers Warner-Lambert and American Home Products. The failed takeover eventually led to the ouster of P&G's chief executive at the time, Durk I. Jager.

By 2006 the company announced plans to end most of its in-house work on drug discovery, investing instead in forging pacts with small biotech companies and universities.

In April, P&G said there had been "significant interest" in the pharmaceutical unit from potential acquirers but that it was still weighing a variety of options for the operation.

Over the past several years P&G has worked to prune slow-growing businesses, including selling off Jif peanut butter, Crisco shortening and Folgers coffee. Meanwhile, P&G has acquired brands in the personal-care and beauty industries, including its $57 billion acquisition of Gillette Co. in 2005.

Drug industry, Pfizer lead in health lobbying

WASHINGTON — The drug industry's trade group and one of the nation's biggest pharmaceutical companies reported spending more money than other health care organizations on lobbying in the second quarter of this year.

With the fight over President Barack Obama's effort to revamp the nation's health care system escalating, the Pharmaceutical Research and Manufacturers of America said it spent $6.2 million lobbying in April, May and June, according to reports to Congress due Monday. Pfizer Inc., the New York-based producer of numerous drugs, ranked second in the health care sector at $5.6 million.

In reports filed by 11 p.m. Monday, 22 health-related associations and companies had reported spending at least $1 million each lobbying during the quarter.

The stakes are huge for the health industry. Congressional Democrats are pushing legislation that could cost roughly $1 trillion over the coming decade, paid for in part by cuts in federal health care programs such as Medicare. Lobbyists have been flooding Capitol Hill for months, and many interest groups have already invested millions of dollars in ad campaigns favoring or opposing various portions of the emerging bills.

According to the nonpartisan Center for Responsive Politics, the health sector reported spending $127 million in lobbying during the first three months of this year, more than any other area.

It can take many days for all the reports to be filed. In the second quarter of 2008, 28 health care concerns reported spending at least $1 million lobbying.

Of the thousands of reports filed by Monday evening covering lobbying on all subjects, only three organizations reported spending more during the second quarter than PhRMA, the drug industry trade group. The American Coalition for Clean Coal Electricity reported spending $11.3 million lobbying at a time when Congress is considering energy legislation. The U.S. Chamber of Commerce, the nation's largest business group, reported spending $7.4 million, and the General Electric Co. reported $7.2 million in lobbying expenditures.

Including its latest report, PhRMA has now spent $13.1 million lobbying so far this year. Pfizer has reported $11.7 million in lobbying expenses for 2009.

Other top lobbying spenders among health-related organizations for this year's second quarter included the American Medical Association, $4 million; Eli Lilly and Co., $3.6 million; the American Hospital Association, $3.5 million, and the Blue Cross and Blue Shield Association, $2.8 million.

Also, GlaxoSmithKline, $2.3 million; CVS Caremark Inc., $2 million; Bayer Corp. and America's Health Insurance Plans, representing the health insurance industry, $1.9 million each; Novartis and the Biotechnology Industry Organization, each $1.8 million, and Metlife Group Inc., $1.7 million.

Also, Sanofi-Aventis U.S. Inc. reported spending $1.6 million in the second quarter; Johnson & Johnson Services Inc. $1.6 million; Merck & Co. Inc. $1.5 million; F. Hoffman-La Roche Ltd. and its affiliates, $1.5 million; the American College of Radiology Association, Wellpoint Inc. and Astrazeneca Pharmaceuticals LP, each $1.2 million, and Siemens Corp. and UnitedHealth Group Inc., $1 million each.