Ranbaxy

Ranbaxy probe includes AIDS relief meds

Tracy Staton — Tue, 15 Jul 2008 10:47:41 -0400

Ranbaxy can't be happy. The Indian company's stock is way down for the second day in a row, on news that the U.S. investigation into its operations includes allegations that it made weak or adulterated HIV drugs given to thousands of AIDS patients in Africa. The Indian company has U.S. government contracts to supply low-cost antiretrovirals for AIDS relief, but Justice Department and FDA investigators allege that some of those drugs were poorly made, unstable, or too weak to be effective.

Meanwhile, the company acceded to the government's requests for documents, saying it would turn over the papers. The disputed documents are audit reports from Parexel, a consulting firm that examined Ranbaxy's plants. You'll recall that investigators claim at least some of these documents were fabricated to cover up the fact that Ranbaxy had made substandard products. The company had claimed that the audits were "privileged" and were thus confidential.

Ranbaxy also reiterated its conviction that its sale to Daiichi Sankyo remains on track and that its licensing deals--including a recent pact with Pfizer to produce an authorized generic version of Lipitor--aren't affected by the probe, either. And the company says it "knows of no evidence to support" the U.S. allegations, which it acknowledged as "serious."

- read the Wall Street Journal story
- see the WSJ Health Blog item

Feds say Ranbaxy faked data

Tracy Staton — Mon, 14 Jul 2008 10:31:31 -0400

Ranbaxy Laboratories found itself in hot water with the feds late last week, just days after announcing its merger deal with Japanese giant Daiichi Sankyo. U.S. investigators and the FDA apparently have been probing the Indian generics maker for months, investigating whether it fabricated data and made false claims to get drugs approved for U.S. sale. Now, Justice has filed a motion in Maryland federal court alleging that Ranbaxy forged some documents, and the government is demanding that the drugmaker turn over the documents for verification.

According to the Star-Ledger, the government alleges that Ranbaxy plant officials used raw ingredients from unapproved sources, fabricated in-house test data to meet FDA standards, and tried to hide those fabrications from FDA inspectors. This "pattern of systematic fraudulent conduct," the feds claimed in the Maryland motion, resulted in generic drugs that didn't contain the right amount of active ingredients. Ranbaxy's stock fell almost 11 percent on the news, to its lowest point in seven years.

Ranbaxy says it's working with the authorities. And according to a press statement issued yesterday, it "strongly denies the allegations" set forth in the Maryland motion. Moreover, the deal with Daiichi remains on track, the statement says. (A Daiichi exec told the Financial Times that it's "keeping close eyes" on the probe.) Ranbaxy is planning to file a response today in court.

- see Ranbaxy's statement
- read the Star-Ledger story
- check out the coverage in the FT
- find the article in India's Business Standard

M&A menu: India's top 10 drugmakers

Tracy Staton — Thu, 19 Jun 2008 10:20:49 -0400

SPOTLIGHT: India's top 10 drugmakers
As soon as Ranbaxy's founding Singh family agreed to sell out to Japan's Daiichi Sankyo, the Indian press started speculating about which pharma firm might be next on the buyout list. Well, we can't pretend any knowledge of upcoming M&As, but we can point you to a ranking of subcontinental drugmakers--by revenue--for your own speculative pleasure. Changes are the next target would be among this top 10. Report

Pfizer, Ranbaxy settle Lipitor patent dispute

Maureen Martino — Wed, 18 Jun 2008 10:08:52 -0400

Pfizer and Ranbaxy have come to an agreement that will end most of their five-year battle over the generic production of Lipitor, the world's best-selling drug. Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the U.S. effective November 30, 2011, and on varying dates in seven additional countries. Lipitor's patent expires in 2010, but two patents covering the production of the drug don't run out until 2016. Pfizer had argued in the past that Ranbaxy's plans to produce a generic version of the $10 billion-a-year drug violated those two patents. Under the agreement, Ranbaxy gets access to all the patents it need to product generic Lipitor. Ranbaxy will have exclusive rights to the generic drug for the first six months of its production.

"This agreement is a win-win-win because it is pro-patient, pro-competition and pro-intellectual property," said Ian Read, president of Worldwide Pharmaceutical Operations for Pfizer. "The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents."

Daiichi Sankyo, of course, just made a $4.6 billion bid for Ranbaxy. Just one day after that deal was announced, reports circulated that Pfizer would consider a counter-offer, based partially on the fact that Ranbaxy was planning to launch a generic version on Lipitor.

- see this release for more
- here's the Wall Street Journal article

Indians ask Ranbaxy CEO who's next

Tracy Staton — Mon, 16 Jun 2008 09:01:45 -0400

In the investment world, the proposed Daiichi Sankyo-Ranbaxy Laboratories merger is just another big deal. But in India, it's taken on symbolic significance. The family-controlled company surrendering to the market, the domestic success story and conferrer of bragging rights selling out to outsiders, the company poised to make its own global mark settling for a spot underneath a multinational umbrella--is it a harbinger of things to come? Will more Indian drugmakers soon fall to M&A fever? For Malvinder Singh, Ranbaxy CEO and grandson of its founder, the questions have been incredulous.

"Have you actually sold your shareholding?" his friends have been asking. Yes, Singh says. And why? Because he and his family concluded that the company could do more as part of a multinational than it could on its own. From Daiichi, Ranbaxy will get expertise at developing new drugs; from Ranbaxy, Daiichi will get generics and low-cost manufacturing and an emerging-market foothold. "I was convinced that the business model in the global pharmaceuticals industry was going to change and that there will be a coming together of 'big pharma' and generics," Singh explains.

Hence the frenzied speculation about which Indian drugmaker is next. If Big Pharma and generics will be joining forces, then India's generics makers are logical takeover targets. And why wouldn't other domestic drugmakers sell out, now that they've seen what Ranbaxy will bring? "A huge positive for Ranbaxy but a negative for Indian pharma," one analyst sniffed.

And speaking of speculation, Singh told the Financial Times that talk of Pfizer quashing the Daiichi deal with a hostile bid of its own is "very speculative." He's not been in talks with the U.S. drugmaker, he says.

- see the BusinessWeek article on copycat deals
- check out the Singh interview in the FT

Will Pfizer counterbid for Ranbaxy?

Tracy Staton — Fri, 13 Jun 2008 09:41:21 -0400

We could have a takeover battle on our hands, folks. Pfizer is reportedly mulling a hostile bid for Ranbaxy, which just inked a buyout deal with Japan's Daiichi Sankyo. Daiichi contracted to buy the Singh family's 35 percent stake in Ranbaxy, plus mount a tender offer for another 20 percent or more of the outstanding shares. It's a deal worth almost $5 billion.

But hold on. As the story goes, Pfizer would swoop in and offer to buy out Ranbaxy's institutional owners--about 41 percent of the company--and individuals, who account for about 21 percent of the outstanding stock. Presumably, Pfizer would up the ante over Daiichi's 737-rupee-per-share bid. Neither Pfizer nor Daiichi would comment; Ranbaxy said the Daiichi sale is a done deal. But the markets reacted to the rumors anyway. Both Ranbaxy and Pfizer's Indian unit saw their shares leap on the Indian markets, while Daiichi's stock dipped a bit in Tokyo.

Pfizer had been in buyout talks with Ranbaxy about a year ago, sources told India's Business Standard, but those proved fruitless. Why would it want to step in now that Ranbaxy is pledged to another? For the same reasons Daiichi wants it: A major foothold in India's hot emerging market, a strong generics portfolio, access to Ranbaxy's low-cost manufacturing and distribution network. And then there's the $10 billion drug Lipitor. Ranbaxy just got FDA approval--and 180-day exclusivity--to sell a copycat version beginning in March 2010. Why should Pfizer lose all that cholesterol-drug revenue when, with a buyout, it could recapture it?

- see the London Times story
- check out Forbes' rationale for a deal
- read the Wall Street Journal Health Blog post
- find the coverage at India's NDTV
- get the news from India's Economic Times

Daiichi buys $4.6B stake in Ranbaxy

Maureen Martino — Wed, 11 Jun 2008 10:06:46 -0400

These days, emerging markets and generic drugs are hot, and Japan's Daiichi Sankyo just landed a deal that capitalizes on both trends. The company is shelling out a hefty $4.6 billion for a majority stake in India generics giant Ranbaxy. The deal values Ranbaxy's shares at 737 rupees a piece, a 31 percent premium over yesterday's close. Ranbaxy will become a subsidiary of Daiichi but Malvinder Singh will remain its CEO. In a statement, the companies outlined several reasons for the merger. Daiichi said the move allows it to diversify into generics; it also gets its foot in the door with the fast-growing emerging markets that so many drug developers are targeting. In addition, Daiichi gains access to the affordable Indian R&D and manufacturing facilities Ranbaxy brings to the table.

"The combination of the two companies will give Ranbaxy access to Daiichi's expertise in research while the Jap anese company will benefit from low-cost production on the sub-continent, amid a deepening profits crisis in Japan's drugs industry," observes the Times Online. Last year Daiichi announced a surprising sales-growth target: a whopping 60 percent over the next three years, based on its hopes for Azor and two other meds coming up the pipeline.

"This complementary combination represents a perfect strategic fit and delivers a considerable opportunity for the future growth of the new Daiichi Sankyo Group," said Takashi Shoda, CEO of Daiichi Sankyo

- check out this release for more on the deal
- read this article for more

ALSO NOTED: Pfizer gets new cancer team to advance key drugs; Bayer clearing Trasylol off U.S. market;

Fri, 16 May 2008 06:59:50 -0400

> With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies. Report

> Bayer is pulling its remaining stocks of the anti-bleeding drug Trasylol, leaving the drug on the market only under an investigational program, the FDA announced. Release | Report

> Sanofi-Aventis has instituted a precautionary recall of 11 batches of the anti-clotting drug Lovenox after some were found contaminated with low levels of oversulfated chondroitin, the same chemical found in tainted heparin recalled by Baxter earlier this year. Report | Report

> FDA has blessed a new tablet coating ingredient, Kollicoat IR, from the German chemical company BASF. Report

> In more bad news/good news on generics, prices for the copycat meds dropped by 9.6 percent in 2007 as some of the most common drugs had price declines of up to 70 percent. Report

> Canadian regulators may pull the Plan B contraceptive--otherwise known as the "morning-after pill"--out from behind the pharmacy counter. Report

> India's Lupin saw its stock leap on an FDA approval for its version of the Wyeth heart-failure and blood-pressure med Altace, aka ramipril. Report

> Ranbaxy got the FDA nod for its muscle relaxant cyclobenzaprine, a generic form of the Ortho-McNeil drug Flexeril. Report

> Sepracor shares were off 2 percent on news that its CFO was leaving the company. Report

> An older statin, fluvastatin, showed action against the hepatitis C virus in a new study. Report

> Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Stem cell reoprt

> Forbes Medi-Tech says it will slash a third of its staff and shelve all in-house drug development work as it focuses its efforts on the nutraceutical business. Report

> Sweden's Biovitrum AB has restructured its R&D operations, winnowing out about 100 people either through layoffs or by reassigning them to other work. Report

> Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 new drug approvals through April, the fastest rate of acceptance since 1998 and 2000. Report

And Finally ... Also from the ASCO data dump: Vitamin D may help curb breast cancer. Report

ALSO NOTED: Forest takes charge on Azor split; GSK launches Tykerb-Herceptin trials;

Tue, 13 May 2008 06:59:50 -0400

> Forest Laboratories will take a $44.1 million charge on termination of its deal to co-promote the hypertension drug Azor with Daiichi Sankyo. Report

> GlaxoSmithKline launched its large-scale trials pitting Tykerb against Genentech's Herceptin in early-stage breast cancer. Tykerb report

> Worried that antipsychotics are prescribed when they're not needed, Washington State is working on a plan to ensure that the meds are used appropriately in children on Medicaid. Report

> Schering-Plough is getting the country's largest rooftop solar-energy system, according to PPL Renewable Energy, which is installing the panels at Schering's Summit, NJ, campus. Report

> Already a problem in Southeast Asia, counterfeit malaria drugs are flooding African areas already hard hit by the disease, according to a new study. Report

> Daiichi Sankyo posted a 24.3 percent increase in fiscal-year profits to $941.5 million, but revenues fell by 5.3 percent, and it expects smaller profits in the year to come. Report

> Solvay reported a slight rise in first-quarter rise sales and profits. Report

> Following Wal-Mart, Kroger expanded its popular $4 generic drug program. Report

> India's Ranbaxy has flexed its research muscles once again, this time signing a five-year pact with Merck to develop new anti-infectives. Ranbaxy report

> Faced with a patent fight that has frustrated efforts to find a buyer, Trimeris has begun to hand back out $80 million in cash as it winds down its operations. Trimeris report

> Elixir Pharmaceuticals has dropped its bid for an $86 million IPO, saying that market conditions aren't right. At the same time, Aldagen, a small biotech company with 18 employees, is making a bid to raise $80 million in an IPO. IPO report

> Roche has racked up more late-stage data backing Actemra as a new therapy for rheumatoid arthritis. Report

Emerging Drug Developer: Resolvyx Pharmaceuticals. Profile

And Finally... The Republic Party's new slogan sounds a little familiar to the folks marketing Effexor XR. Report

Office upholds Pfizer's Lipitor patent

Thu, 01 May 2008 06:59:54 -0400

Pfizer is breathing a big sigh of relief. The U.S. Patent & Trademark Office has said it will confirm the drugmaker's basic patent on the blockbuster Lipitor drug. The office had been re-examining the patent in response to a request by Indian generics maker Ranbaxy Laboratories.

It's been a long road for Pfizer, fighting Ranbaxy's patent challenges on Lipitor. The company has grappled with the generics maker in multiple U.S. court cases over Lipitor--and won. This patent confirmation finally appears to shut the book on Ranbaxy's challenges, in the U.S. at least. Until March 2010, when that patent actually will expire.

Ranbaxy has been more successful with its Lipitor challenges in other countries. It prevailed in Norway, and in Canada it and other generics makers defeated Pfizer at the lower court level (Pfizer appealed). But Pfizer's biggest Lipitor challenge actually isn't in any court--it's Zocor, the now-generic statin. Generic-switching has been eating into Lipitor's sales; they dropped by 13.6 percent year-over-year through April 18.

- see the brief in BusinessWeek
- check out Motley Fool's take
- read CNN Money's assessment of Lipitor sales

AstraZeneca, Ranbaxy settle Nexium fight

Tue, 15 Apr 2008 06:59:58 -0400

AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. The copycat company agreed to wait till 2014 to sell its version of the heartburn med Nexium, AstraZeneca's top selling drug with $5.22 billion in revenues.

That's a huge coup for AstraZeneca, which has been fighting off the generic challenge since 2005. But it's also a good deal for Ranbaxy: the Indian drugmaker gets U.S. distribution rights to two off-patent AstraZeneca meds, Prilosec and Plendil, and will start supplying the active ingredient in Nexium to AstraZeneca beginning in 2009.

AstraZeneca still faces patent challenges on Nexium from Teva Pharmaceutical Industries and India's Dr Reddy's, but analysts said that Ranbaxy's willingness to settle may signal the strength of AstraZeneca's case. Market watchers also upped AstraZeneca's target share price.

- check out the press release from AstraZeneca
- read the piece in the Financial Times
- see the Wall Street Journal story
- find out how the market reacted at CNN Money

Related Articles:
AstraZeneca rivals could launch any day. Nexium report
FDA to review Nexium, Prilosec. Nexium report
Canada questions safety of Nexium, Prilosec. Nexium report
Nexium formulation wins FDA approval. Nexium report

Pfizer sues for Lipitor protection till 2016

Wed, 26 Mar 2008 07:59:54 -0400

Pfizer is hitting back at would-be Lipitor copycat Ranbaxy. The drugs giant sued the generics maker for patent infringement over the blockbuster cholesterol med Lipitor and Caduet, a combo of Lipitor and blood-pressure med Norvasc. Already blocked from selling copycat versions of the drugs till 2010, Ranbaxy would be stymied till 2016 if Pfizer's legal maneuvering succeeds.

Lipitor, of course, is Pfizer's cash cow, with $12.7 billion in 2007 sales, more than a quarter of the company's revenues; Caduet brought in $568 million. The suits allege that generic Lipitor and Caduet would trample on two Lipitor process patents, which don't expire until 2016. Pfizer asked the court to ban Ranbaxy from making, selling, or importing generic Lipitor till then. A Canadian court recently ruled in Pfizer's favor, protecting Lipitor from Ranbaxy until 2010.

- read the article at MarketWatch
- see the story at India Infoline
- check out Pfizer's release on the Canadian ruling

ALSO: EMTs to Lipitor's rescue? A union representing emergency medical techs and paramedics recently mailed a letter to its doctors' network endorsing the cholesterol med. "When appropriate, we ask that you please consider an agent like Lipitor for our members with high cholesterol," an official of the International Association of EMTs and Paramedics wrote. "IAEP leadership stands behind Lipitor as the lipid-lowering agent of choice." Report

Related Articles:
Lipitor patent gets U.S. thumbs-down. Report
Lipitor is No. 1, but faces generic threat. Report
Generic battle looms for Lipitor. Report
Pfizer, Ranbaxy get mixed ruling in Lipitor patent fight. Report

ALSO NOTED: Dutch court ruling protects Pfizer's Lipitor; J&J loses bid to dismiss whistleblower suit;

Thu, 21 Feb 2008 06:59:50 -0500

> Pfizer announced that a Dutch court ruled to prevent generics maker Ranbaxy from launching a copycat form of the best-selling Lipitor. Report

> Pfizer has demonstrated once again just how interested it is in biotech with its $195 million deal to buy Encysive. Report

> A federal judge denied Johnson & Johnson's attempt to get a whistleblower suit dismissed; the suit involves charges that J&J's Ortho-McNeil unit offered kickbacks to hospitals that purchased more of its Levaquin antibiotic than a rival med. Report

> Danish drug maker Lifecycle Pharma has launched its cholesterol med Fenoglide in the U.S., marketing it through U.S. partner Sciele Pharma. Release

> India's Aurobindo Pharma is investing $14.7 million in a manufacturing plant in Malta, planning to use it to strengthen its presence in Europe. Report

> The FDA gave its blessing to a new liquid allergy medication, Xyzal, made by UCB and Sanofi-Aventis; the drug's tablet form was approved in May 2007. Report

> An FDA advisory panel agreed Wednesday that GlaxoSmithKline's Rotarix vaccine was safe and effective, recommending the anti-rotavirus shot for agency approval. If approved for sale, Rotarix will compete with Merck's RotaTeq, which has been on the market since 2006. Report

> A Nobel Prize-winning biologist says that researchers are no closer to developing a vaccine against HIV than they were 20 years ago, when the scientific quest began. Report

> Can a vaccine control high blood pressure? Report

> There's growing evidence around the U.S. that the flu jab offers only marginal protection against the seasonal ailment. Report

And Finally... Is this a pharma opportunity? New research in Nature shows new infectious diseases are emerging at a rapid pace. Report

Agencies take aim at patent settlements

Wed, 20 Feb 2008 06:59:57 -0500

Are quid pro quo deals between brand-name drug makers and generics firms in real danger? Euro watchdogs are scrutinizing them, the FTC is suing over them, and the U.S. Congress is considering an outright ban on them.

Perhaps that's because Big Pharma has been cutting deals with generics makers right and left. There's the big Cephalon arrangement that's attracted the FTC's ire: That company paid Teva, Barr, Ranbaxy, and Mylan a total of $200 million to say out of the Provigil market until 2012. The FTC counts 100 deals like this since 2004.

The FTC hasn't had much success in the courts so far, but it's hoping for a grand slam in the Cephalon case. The agency would like the issue to go to the Supreme Court so it can be resolved "once and for all." There's no guarantee, though, that the newly conservative court would rule against these deals. The government's best shot may be in Congress. A Senate committee last week approved a bipartisan bill that would prohibit these arrangements; similar legislation is pending in the House.

Meanwhile, the generics market isn't growing at quite the pace it once was. According to preliminary figures from IMS Health, sales increased by 3.8 percent last year--the same rate as the overall drug market. The market research firm was surprised by those results: "I checked this number and checked it twice," an IMS rep told In Vivo. "We have seen generics growing over the last couple of years somewhere between 10 percent and 20 percent. So to come in...at 3.8 percent is quite dramatic."

- read the Fortune article
- check out the market figures at In Vivo

Related Articles:
FTC sues Cephalon for blocking generics. Report
AstraZeneca, Par collaborate on authorized generic. Report
Wyeth makes its own Protonix copy. Report
Analysts get bullish on generics makers. Report

Bentley to spin off drug delivery unit

Tue, 23 Oct 2007 06:59:56 -0400

Anyone want to buy a generics business? New Hampshire-based Bentley Pharmaceuticals says it will spin off its drug delivery unit into a separate company and explore "strategic alternatives" for its generics unit.

The drug delivery business--which is working on an intranasal form of insulin--brought in $8.4 million last year. After the spinoff, it will be a public company called CPEX Pharmaceuticals. The generics unit, on the other hand, posted $101.1 million in sales last year. Bentley's board hired Deutsche Bank to help handle the spinoff and strategic review.

- check out this release from Bentley
- read the story from Forbes

Related Article:
Ranbaxy spins off R&D unit. Report

Indian drug makers to drop Bradley bids

Tue, 25 Sep 2007 06:59:54 -0400

Count Indian drug makers Ranbaxy and Dr. Reddy's out of the bidding for Bradley Pharmaceuticals. The two companies entered non-binding bids of around $250 million to $300 million--much lower than those submitted by U.S. firms.

Bradley began accepting bids last month, saying it would definitely pursue a buyout. The company's market cap is around $330 million.

- read the report from India's Business Standard

Related Articles:
Rumor Mill: Dr. Reddy bids for Bradley. Report
Bradley Pharmaceuticals gets bids. Report
Dr. Reddy's takes a gamble on biogenerics. Report
Ranbaxy blueprints new facilities. Report

Rumor Mill: Indian drug makers court Par

Tue, 18 Sep 2007 06:59:56 -0400

At least three Indian drug makers were spotted with chocolate and flowers at the headquarters of Par Pharmaceuticals, one of the top 10 generics companies in the U.S. Several Indian newspapers are reporting today that Ranbaxy Laboratories, Wockhardt, and Sun Pharma are all three courting the company. The three would-be suitors declined comment.

Curiously, Ranbaxy has already been in the gossip columns about a purported offer for Bradley Pharmaceuticals, which took non-binding bids several weeks ago. And Sun Pharma has agreed to pay $454 million for Taro Pharmaceutical, an Israeli-based generics maker. Is Par Pharma--with a market cap of $692 million--a back-up plan? Well, as they say, all's fair in love and business.

- read this report from India's Economic Times

Related Articles:
Par to restate earnings. Report
Rumor Mill: Dr. Reddy bids for Bradley. Report

Lipitor is No. 1, but faces generic threat

Thu, 13 Sep 2007 06:59:58 -0400

When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling.

If this sounds like Lipitor to you, you're right. Today, the Pfizer drug was declared number one in the U.S. market with $9 billion in 2004 sales (rival Zocor pulled a trailing second with $4.7 billion). Also today--as if to emphasize the possible loss of this multibillion-dollar revenue stream--a Canadian court denied Pfizer's request to stop Indian generics maker Ranbaxy Laboratories from making one form of the drug.

Ranbaxy, of course, is the company that successfully challenged the drug's U.S. patent last year. Pfizer subsequently applied for a reissued patent, which would protect its exclusive rights to Lipitor through 2011. The company was denied (but not conclusively; the patent office called it a "non-final" rejection). No doubt Pfizer will continue building up its Lipitor defenses--but the generics makers will continue to circle, too.

- see Pfizer's release
- and Rabaxy's release
- read more on drug-sales rankings

ALSO: At this week's Bear Stearns Healthcare Conference, Pfizer told analysts that its future rests with biologics. Article

Related Articles:
Investors cheer Lipitor patent decision. Report
Generic battle looms for Lipitor. Report
Pfizer, Ranbaxy get mixed ruling in Lipitor patent fight. Report
Pfizer halts Torcetrapib development. Report

ALSO NOTED: Bayer expands production; India may replace drug agency; Ranbaxy in Bradley hunt;

Fri, 07 Sep 2007 06:59:50 -0400

> Bayer plans to more than double its production of over-the-counter meds in Indonesia, to 2,000 tons annually from its current 700 tons. The company acquired its West Java plant from Roche and spent about $25 million to expand it. Report

> The Indian government may overhaul its regulatory oversight of drugs. Parliament is expected to debate a measure that would replace its current regulatory agency with a new, more centralized authority. Report

> India's Ranbaxy Laboratories is one of the companies that bid for Bradley Pharmaceuticals, the Economic Times reports. Top Indian pharma Dr. Reddy's already was rumored to have submitted one of the non-binding offers Bradley announced last week. Deutsche Bank is advising Bradley on the sale. Report

> Don't look for pharmaceutical couterfeiters only in developing countries--they're right here in the American backyard. A New Hampshire medicine company has pleaded guilty to selling a fake drug trafficked from India and now faces up to half a million dollars in fines. Report

And Finally... Are hyperactive kids simply hepped up on food coloring? A study commissioned by the British government, and published in this week's Lancet, found that food coloring may stimulate hyperactivity. Article

Generic Coregs are coming

Thu, 06 Sep 2007 06:59:54 -0400

The FDA gave its blessing to more than a dozen generic versions of GlaxoSmithKline's Coreg (aka carvedilol), used to treat a variety of cardiovascular problems including high blood pressure and heart failure. Now, Glaxo will have to share the $1.7 billion carvedilol market with the likes of Actavis, Apotex, Caraco, Dr. Reddy's, Ranbaxy, Sandoz, Teva, and Watson, among others. A total of 14 generics were approved.

Ironically, the generic labeling may differ from the brand-name version because, while the drug itself is no longer under patent, certain bits of the labeling are.

- see the FDA release

Related Articles:
Riled investors look for big changes at GSK. Report
Patent 'cliff' looms for Big Pharma. Report