Merck Kgaa

Erbitux growth boosts German Merck

Tracy Staton — Mon, 27 Oct 2008 11:17:06 -0400

If you want more confirmation that drugmakers can grow sales even in this market, look no further than Merck KGaA. The German company expects to grow revenues between 6 percent and 8 percent this year, within its earlier guidance of 5-9 percent. And it's still predicting margins of at least 23 percent on those sales.

For the quarter, Merck reported profits of €200.1 million, or $251.8 million, compared with €36.2 million a year ago (when the company booked a €183 million charge on its buyout of Serono). Revenues for the quarter grew 8.7 percent to €1.89 billion. And unlike U.S. companies, whose sales were often inflated by currency gains, Merck's numbers reflect a "considerable" negative impact from currency, cutting organic sales growth by 4.8 percent.

Digging deeper, Merck's fastest-growing drugs were Erbitux, the cancer treatment marketed in the U.S. by Bristol-Myers Squibb and ImClone Systems, which mushroomed by 13 percent to €134 million. Rebif, Merck's multiple sclerosis treatment, grew by 10 percent to €338 million.

- read the story in the Wall Street Journal

EU issues Erbitux, Cymbalta decisions

Calisha Myers — Fri, 24 Oct 2008 12:15:30 -0400

The EMEA's Committee for Medicinal Products for Human Use (CHMP) issued a number of recommendations this week. Many, such as Merck received good news, but Eli Lilly was not so lucky. Here's a brief roundup:

GlaxoSmithKline received a positive recommendation to add a stronger version to its line-up of the over-the-counter obesity med, Alli (orlistat).
The committee supported Roche's application to extend the indication of Pegasys in combination with ribavirin to the treatment of hepatitis C.
The panel backed wider approval of Sepracor's Lunivia for insomnia.
Celgene's Vidaza (azacitidine) received a position opinion for wider indication for the treatment of myelodysplastic syndromes and acute myeloid leukaemia in adults.
Merck KGaA received a positive recommendation for the indication of Erbitux for head and neck cancer.
Eli Lilly and Boehringer Ingelheim's Cymbalta was given a negative rating for the treatment of fibromyalgia.

- check out the CHMP release for a complete list

Daiichi takes 130 reps off Merck KgAA's hands

Tracy Staton — Thu, 17 Jul 2008 10:00:14 -0400

More evidence that pharma sales is fraught with change: Daiichi Sankyo's German unit has agreed to take over most of Merck KGaA's primary care sales operation, which amounts to about 130 workers. Report

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

Erbitux, KRAS gene star at ASCO

Tracy Staton — Mon, 02 Jun 2008 11:26:14 -0400

As expected, headlines have been spewing from the American Society of Clinical Oncology meeting like ash from a volcano. And as promised, we bring you a roundup of the latest and greatest on using existing drugs against cancer. Here goes:

A growing body of evidence suggests that patients with a non-mutant form of the KRAS gene respond better to EGFR inhibitors such as ImClone's Erbitux and Amgen's Vectibix; you can get a link to the 300-odd KRAS hits from an ASCO search at the WSJ Health Blog. (By the way, just yesterday, the E.U.'s drug regulators recommended approval for Erbitux as a first-line colon cancer treatment--but only for those with the non-mutated KRAS gene.)
The Novartis bone drug Zometa surprised folks by helping prevent a recurrence of breast cancer--and not just in cutting spread of the cancer to the bones. Among those who took the drug in addition to chemo, 6 percent died or had a recurrence within five years of treatment, compared with 9 percent who got chemo alone.
A high dose of Pfizer's painkiller Celebrex may help keep smokers from developing lung cancer; Celebrex blocks the COX-2 enzyme that causes inflammation, which besides causing arthritis pain, has also been linked with cancer. Researchers said the findings need to be confirmed with other studies.
Despite all the good news on Erbitux at the meeting, analysts said they don't think growth in that drug will necessarily take away from Genentech's Avastin, which is already entrenched as a first-line treatment. Among the patients most likely to jump at the prospect of Erbitux are lung cancer sufferers who can't take Avastin because of the risk of side effects.

Stay tuned: The meeting goes on through today, so we'll have more updates tomorrow.

- check out the Merck KGaA release
- see the Health Blog KRAS item
- find the WSJ post on Zometa
- read the Celebrex story in the Washington Post
- get the Avastin-Erbitux comparison in the New York Times

ASCO already churning out news

Tracy Staton — Fri, 30 May 2008 11:06:50 -0400

Today marks the start of the annual American Society of Clinical Oncology meeting, always a big news generator in the pharma biz. We'll let our sister pub FierceBiotech keep you up to date on the in-development drugs, while we look at studies of existing meds--and so far, we've picked up a few interesting tidbits:

Analysts are hyped about Celgene, whose Revlimid blood cancer drug performed well as a first-line treatment for multiple myeloma in combo with Millennium's Velcade. Data on Revlimid as a non-Hodgkin's lymphoma treatment looks promising, too, one Wall Street type says.
New data on Avastin, Genentech's multitalented cancer drug, is expected at the conference, including results from a late-stage trial in breast cancer, for which the drug was approved in February. (One closely watched stat is sure to be dosing levels; we'll be looking to see whether low doses work as well as higher ones, because if they do, that could pressure Avastin sales.) Data on the drug as an add-on in early colon cancer is also expected. A third Avastin study on the docket: a mid-stagter in glioblastoma multiforme, the type of advanced brain cancer recently identified in Sen. Edward Kennedy.
Roche is already touting data on Herceptin, saying that two new studies show women with breast cancer should start with the drug and stay with it -- provided they test positive for a protein known as HER-2
In the anxiously awaited category: Lung cancer survival improvement data on Erbitux, the ImClone/Merck KGaA/Bristol-Myers Squibb med that's said to have met the main goal of a big trial, though no specific data has yet been released.

There's sure to be more as the weekend progresses, so check in Monday for an update.

- see the Associated Press ASCO round-up
- find the advance info from CNN Money
- read the Herceptin story at MarketWatch

ALSO NOTED: Novartis cuts malaria drug price; India bars Cipla from exporting Tarceva copy;

Wed, 23 Apr 2008 06:59:50 -0400

> Novartis is slashing the public-sector price of its antimalarial med Coartem by 20 percent, to 80 cents from $1, to make the treatment more widely available. Report

> Delhi's High Court prohibited Cipla from exporting its generic version of the still-on-patent cancer treatment Tarceva, made by Roche. Report

> Pharmaceutical services firm AmerisourceBergen reported an 8 percent revenue hike to $17.85 billion and higher-than-expected earnings in its second quarter. Report

> Legal wrangling between the Centers for Medicare & Medicaid Services and pharmacy trade groups will delay a proposed federal rule lowering the reimbursement for dispensing generic drugs under Medicaid. Report

> Kyowa Pharmaceutical, the Japanese subsidiary of India's Lupin, won regulatory approval to sell 10 products in Japan, including risperidone (J&J's Risperdal) and amlodipine (Pfizer's Norvasc). Report

> After fears that UnitedHealth Group might take its pharmacy benefits management in-house, Medco managed to keep its contract with the insurance giant through 2012. Report

> Yesterday's FDA rejection of Genzyme's Myozyme underscores the challenges biosimilars face in the United States. Report

> In the first quarter of this year, venture capital investment dipped 5 percent to $7.1B, signaling that the current economic slump could have an impact on venture financing. However, there was still a dose of good news for biotech, raising $1.27 billion with 126 deals. Report

> Alpharma has withdrawn its NDA for Embeda, its extended-release painkiller. Report

> With about 40 drug development projects in the pipeline, Germany's Merck KGaA says it will spend about €1 billion ($1.58 billion) on drug research this year. Report

And Finally... The U.S. government is creating a $265 million research initiative that will develop new stem cell technology to re-grow the skin, limbs and muscles of soldiers injured in Iraq and Afghanistan. Report

Stanley: Erbitux outperformed Avastin

Mon, 21 Apr 2008 06:59:57 -0400

Morgan Stanley got a juicy scoop on the Avastin versus Erbitux boxing match: Genentech's Avastin faces news that as-yet-unpublished data shows Erbitux delivering an "unexpected survival benefit" against metastatic lung cancer. Perhaps not coincidentally, the news comes as Genentech announced that a new trial showed Avastin improving progression-free survival in non-small cell lung cancer but didn't prolong life.

According to CNBC, this scores the match at two Phase III survival benefits for Erbitux, compared with only one for Avastin. Erbitux, as you know, is sold in Europe by Merck KGaA and in the U.S. by Bristol-Myers Squibb; Avastin is marketed by Roche and Genentech.

Morgan Stanley says it won't change its official sales estimates for either drug until it sees this mystery data (which, incidentally, the companies declined to confirm). But the brokerage did make a breathless estimate of €400 million in additional revenue if the rumor proved true.

- see the CNBC story
- get more from Pharmalot

Related Articles:
Erbitux clears late-stage hurdle for lung cancer. Report
FDA approves Avastin for lung cancer. Report

ALSO NOTED: Merck KGaA has money for deals; Alcon gets FDA OK for hay fever spray;

Thu, 17 Apr 2008 06:59:50 -0400

> Merck KGaA is pursuing acquisitions and licensing deals to shore up growth and has the funding ready to finance any transactions, CEO Karl-Ludwig Kley said. Report

> Alcon's hay fever nasal spray Patanase won FDA approval, with analysts predicting sales growth to $760 million by 2010. Release

> Sales of the Trimeris HIV drug Fuzeon plummeted during the first quarter to $42.7 million from $64.3 million during the first quarter of 2007. Report

> A trial testing Genentech's Rituxan med for use in lupus is due within a few weeks; the med already is approved for treatment of rheumatoid arthritis and non-Hodgkins lymphoma, but just failed a trial in MS patients. Report

> Pozen shares leapt Wednesday on news of approval for its migraine drug Treximet after years of back-and-forth with the FDA. Report

> A GlaxoSmithKline-funded study showed that the breast cancer pill Tykerb can reduce disease-causing stem cells. Report

> Pfizer's Lipitor added to the dementia med Aricept showed no additional cognitive benefit for Alzheimer's patients, a new study showed. Report

> A two-year follow-up study of Sanofi-Aventis' Acomplia (aka Rimonabant) found that in the second year patients on average gained weight despite an ongoing 600-calorie deficit in their daily dietary regimens; still, the participants netted a "clinically relevant" weight loss at the end of the two-year study. Report

> San Diego-based Illumina is commercializing three new products aimed at a better understanding of the molecular mechanisms that give rise to cancer. Report

> The nexus between academic researchers and investors is a prime breeding ground for biotech start-ups. The Wall Street Journal profiles one prime example: MIT scientist Robert Langer and Polaris Venture Partners' Terry McGuire, who have teamed up on 13 new companies in 15 years. Report

> Score one win for Ontario province in the field of economic development. Sanofi Pasteur, the vaccine arm of Sanofi-Aventis, will build a C$100 million R&D facility in Toronto with the province chipping in C$13.9 million through its Biopharmaceutical Investment Program. Report

> Dendreon is making bullish noises about its development efforts. Report

> Just a week after gaining regulatory approval for Lexiscan, CV Therapeutics sold off a 50 percent interest in its North American royalties to TPG-Axon Capital for $175 million and a $10 million milestone payment. Report

And Finally... Scientists have created the first comprehensive libraries of monoclonal antibodies against avian influenza. Report

ALSO NOTED: U.S. R&D headcount tumbles in key categories; Paion to buy troubled CeNes;

Thu, 10 Apr 2008 06:59:50 -0400

> Pharmalot has been crunching the numbers for R&D jobs and concludes that the U.S. is seeing a considerable amount of shrinkage in the field. Report

> Germany's Paion has agreed to buy CeNes Pharmaceutical, a struggling pain products manufacturer, in a $20.6 million share swap. Report

> U.K. drugmakers are proposing new pricing plans--such as money-back offers and discounts--for the National Health Service to try in its new pricing scheme. Report

> The FDA has hired Frank Forti as its first chief scientist, whose first duty will be to help launch an FDA Fellowship program. Report

> Merck KGaA will hand over the reins of its chemical division to Bernd Reckmann, a current board member, as of July 1; Reckmann will take over from Walter Zywottek, who's retiring. Report

> Endo Pharma has approved a $750 million share repurchase program and a $345 million convertible notes offering. Report

> Salix Pharmaceuticals says rival Novel Laboratories is challenging the patent on its bowel-cleansing drug Moviprep. Report

> Ista Pharmaceuticals has been subpoenaed by the U.S. Attorney's office in Buffalo for documents relating to its promotion and marketing of its Xibrom eye drug. Release

> Health experts say that an outbreak of mumps two years ago among college students occurred even though most of them had received a recommended vaccine. Report

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> An outbreak of dengue fever in and around Rio de Janeiro has afflicted more than 75,000 people since the beginning of the year, with 12 people dying in just the past week. Report

> With its planned merger involving Raven Biotechnologies on the rocks, a struggling VaxGen is cutting down to a skeletal staff, laying off 70 percent of its remaining 22 employees. Report

> Canada's streamlined approval process raises protests. Report

And Finally... Heavy-duty housecleaning for at least 20 minutes a week could relieve your stress and anxiety by 20 percent. Scrub brush, anyone? Report

ALSO NOTED: German Merck wants to make pharma buys; Novartis breast-cancer med prevents recurrence;

Tue, 11 Mar 2008 07:59:50 -0400

> Merck KGaA is on the prowl for pharma acquisitions, CEO Ludwig Kley told a German newspaper. Report

> Novartis' breast cancer med Femara can help prevent recurrence of the disease if it's administered after a preventive regimen of Tamoxifen--even if they start the Femara years later. Report

> In the case of a curious food-and-drug recall, Gorton's said that the pills a Pennsylvania family found last month in its fish filets were over-the-counter herbal supplements; the company subsequently took 1,000 cases of those filets off the market. Report

> Scotland's National Health Service can now use Cubicin to treat severe infections caused by the MRSA superbug. Report

> India's Dabur Pharma got regulatory approval to sell its copycat version of Pfizer's chemo drug Camptosar in Italy and Denmark; the company recently launched the generic in the U.S. Report

> Keryx Biopharmaceuticals' stock price wiped out on the rocky shores of a failed late-stage trial of its lead drug, Sulonex, for diabetes. Report

> India's Dr. Reddy's Laboratories is teaming up with 7TM on a drug discovery deal for metabolic disorders. Report

> The Translational Accelerator has opened its doors to all biotech companies in Arizona--or any life sciences company thinking about moving there. Report

> Wyeth has dumped a once-promising Curis collaboration. Report

> Japanese researchers have developed a new approach to make flu vaccines that are able to combat multiple strains of influenza, including strains of the bird flu virus, according to Japan's National Institute of Infectious Diseases. Report

And Finally... Shades of Barry Bonds or just a grown-up version of caffeine-fueled test-cramming? Academic researchers and scientists admit taking Adderall or Provigil to help them wrap up papers and studies. Report

ALSO NOTED: Jarvik takes fourth in ad ranking;Glaxo slashes AIDS drug costs for poor;

Wed, 20 Feb 2008 06:59:50 -0500

> Which TV drug ads lodged most securely in consumers' brains? That ubiquitous Nasonex bee hit No. 1, with Rozerem's talking animal coming in second. The Vytorin ads--pulled in the wake of the controversial Enhance trial--took third place, while the also-controversial Lipitor campaign featuring Robert Jarvik came in fourth. Report | Ranking

> Some biotechs are eager for the FDA approval of biogeneric drugs. Report

> A Nevada judge knocked down a $134 million jury award to three women who blamed Wyeth's hormone therapies for their breast cancer; the new figure is about $58 million. The company still faces some 5,000 similar lawsuits across the country. Report

> GlaxoSmithKline cut the cost of its AIDS drugs for patients in the world's poorest countries; one drug often used in children was discounted 40 percent. Report

> Covering the cost of drugs for people who have heart attacks would lengthen lives and lower medical costs, new research shows. Report

> Thailand's plan to review its compulsory licensing of four cancer drugs hit a big obstacle when three government ministers found that it cannot be revoked. Report

> Watson Pharmaceutical posted fourth-quarter profits of $38.4 million, a big swing upward from last year's loss of $489 million on acquisition and R&D charges. Sales grew slightly to $627.3 million. Release | Report

> India's Sun Pharmaceutical increased its stake in Israel-based Taro Pharmaceutical industries to 34.4 percent. Report

> Moody's upped its rating on Merck KGaA to "positive" from "stable," citing the German company's rapid de-leveraging. Report

> IDM Pharma said it had met minimum bid price requirements to regain compliance with Nasdaq Stock Market rules. Report

> A new survey has concluded that specialists feel Medicare's new anemia drug payment limits are hurting cancer patients. Report

> Do the psychiatric symptoms seen in some Chantix patients say more about cigarettes than about the drug? Report

And Finally... Here's a new business model for biotechnology: Pet cloning. South Korea's RNL Bio says it has its first $50,000 order to clone a dog from the biologic material remaining from a California woman's pet bull terrier. Report

ALSO NOTED: Forest sues generics over Namenda; Omrix gets new indication for Evicel;

Fri, 11 Jan 2008 06:59:50 -0500

> Forest Labs and Merck KGaA are suing several generics makers--including Barr, Cobalt, Lupin, Orchid, Teva, and Wockhardt--for infringing patents on the Namenda treatment for Alzheimer's. Report

> Omrix Biopharmaceuticals got the FDA's blessing for a new use of its Evicel sealant product. Report

> FDA approvals may be down in the doldrums, but approvable letters flew out of the agency in 2007--at a rate 40 percent higher than in 2006. Report

> The FDA is postponing its review of an anti-constipation drug candidate developed by Progenics and Wyeth. Report

> UK investors are turning up their noses at biotech these days, but a few companies are poised for a comeback. Report

> Is Pfizer a good buy now that shares are going for just 10 times forecast earnings? Smart Money does the analysis. Report

> UK pharmacies are launching an online registration system to help curb online sales of fake and dangerous medicines. Report

> Noven Pharmaceuticals got an FDA warning of potential manufacturing deficiencies at its Miami plant; the problems related to Noven's Daytrana transdermal product. Report

And Finally... Next time you fight with your spouse over getting directions, you'll know to blame your brain. Report

Pharma goes mad for biotech deals

Fri, 21 Dec 2007 06:59:55 -0500

One word: Biotech. As if acting on some wise elder's tip-off, Pharma got its biotech groove on in 2007. The reasoning is clear. Biologic drugs are among the pharma industry's hottest performers. Pharma badly needs new blockbusters. So, hoping to pump up deflated pipelines, drug makers licensed in-development drugs or simply bought entire companies.

Some of the numbers are eye-popping. AstraZeneca shelled out $15.2 billion for MedImmune. Schering-Plough paid $14.4 billion for Organon BioSciences (FYI, that's a 37 percent premium). By comparison, the $2.65 billion Shire plunked down for New River Pharmaceuticals looks like pocket change. Then there's Merck's $1.1 billion buyout of Sirna Therapeutics; the additional $350 million for NovaCardia look like pocket change. Pfizer snapped up Coley Pharmaceutical Group for $164 million--plus it invested $50 million in biotech startups, and it launched a new bio-oriented research center in California.

Meanwhile, licensing deals are flying. Merck KGaA just made a $421 million deal with Idera for cancer therapies. AstraZeneca inked a $400 million deal with Silence Therapeutics, developer of siRNA technologies for use in respiratory diseases and cancer. GlaxoSmithKline paired up with OncoMed to the tune of $1.4 billion, hoping to turn one of its oncologic candidates into the next big thing. And many, many, many more. In fact, biotech is so big in the industry, the old chemical-based drugs are passé, to the point that career chemists are finding their places at the bench dwindling.

The big question is whether drug makers can cherry-pick enough biotech candidates to fill their new-product baskets. Is the old model of in-house R&D on its last legs? Is Big Pharma just too big to deliver real innovation? Stay tuned in 2008.

- see our report on the top five buyouts of the first half of 2007
- read about Big Pharma's love affair with biotech at CNN Money

Related Articles:
Burrill bullish on M&As. Report
Should Pharma take the M&A cure? Report
M&A activity heats up as biotech IPOs struggle. Report

ALSO NOTED: Canada's drug market slowing; GSK files for Promacta approval;

Thu, 20 Dec 2007 06:59:50 -0500

> The Canadian pharma market has slowed to a growth level of 6 percent to 6.5 percent, down from a five-year average of 8.4 percent. Report

> GlaxoSmithKline submitted an NDA for Promacta, a platelet growth factor designed to treat thrombocytopenic purpura. Report

> Valeant Pharmaceuticals says it will sell its hepatitis C drug Infergen to Three Rivers Pharmaceuticals doe about $91.3 million. Report

> Par Pharmaceutical says its year-end profits will be at least $1.45 per share; previously, the generics maker had said it expected earnings of $1.35 to $1.50. Report

> Idera is pocketing a $40 million up front fee from Merck KGaA and hopes to make an additional $381 million in milestones from licensing its technology for cancer therapies. Report

> In a deal that starts small but has a big upside, Santaris Pharma has forged a $700 million development pact with GlaxoSmithKline to develop new antiviral meds. Report

> Boston-based venture capitalist Roger Kitterman has been able to coax investors to back badly needed therapies with none of the big upside that most would demand. Report

> The Wall Street Journal health blog pokes fun at Bystolic, the newly-approved beta blocker from Forest Laboratories and Mylan, as the ultimate "me-too" drug. Report

And Finally… Harvard Business School researchers have identified four types of healthcare consumers, each of which responds to entirely different marketing approaches. Report

Mylan CEO intent on new global biz

Mon, 10 Dec 2007 06:59:55 -0500

The rise of generic drugs has been bad news for Big Pharma, but not so bad for copycat makers like Mylan, which gets the profile treatment today from its hometown newspaper, the Pittsburgh Tribune-Review. Since Labor Day five stock analysts have upgraded their ratings on the company, which bought Merck KGaA's worldwide generics unit in October for $7.4 billion. And that deal followed January's big investment in India's Matrix Pharmaceutical Laboratories. With those buys, Mylan became the world's third-largest generics maker. "I thought global from day one," CEO Robert J. Coury told the newspaper.

One interesting note: To embark on his growth plan, Coury had to squeeze out one of the company's big investors, none other than Carl Icahn. Might some Icahn-burdened biopharmas do the same?

- read more from Mylan's CEO in the Tribune-Review

Related Articles:
Pharma faces "tidal wave" of generics. Report
Patent 'cliff' looms for Big Pharma. Report
Glaxo to let Mylan make generic Paxil. Report

ALSO NOTED: Investors to pay $1.3 billion for Axcan; Smith & Nephew recalls knee implants;

Thu, 29 Nov 2007 06:59:50 -0500

> Canada's Axcan Pharma has agreed to a buyout by the private equity firm TPG Capital for $1.3 billion. Release

> Device maker Smith & Nephew is recalling some 600 knee implants that may contain too much iron; about 275 of the devices have already been implanted into patients. Report

> Germany's Merck KgaA won approval from the European Commission to sell a treatment kit for cyanide poisoning. Report

> Health Canada gave its blessing to Cangene's liquid formulation of a blood-disorder drug used in infants. Report

> The Chinese government announced that it intends to impose heavy punishments on makers of counterfeit drugs; in some cases, this may include the death penalty. Report

And Finally... A doctors' group wants to standardize and simplify prescription labels to make sure patients understand when and how to take their medicine. Report

Glenmark to spin off generics business

Wed, 07 Nov 2007 06:59:54 -0500

India's Glenmark Pharmaceuticals plans to untie the apron strings by spinning off its generics business. Glenmark Generics, a wholly-owned subsidiary, will handle all the company's copycat drugs and active ingredients from discovery to market, while the mother ship will focus in on branded products. The new company will mount an IPO, but Glenmark Pharma will retain at least a 70 percent interest.

Terance Coughlin, who's now president of the company's active ingredients and U.S. generics unit, will run the new company as CEO. Glenmark Generics will take over the company's four plants in India, as well as sales operations in the U.S., the UK, and Argentina.

- read the report from the Business Standard

Related Articles:
Glenmark clears hurdle for European product launch. Report
Merck KGaA licenses Glenmark diabetes drug. Report

Bayer cuts its losses on new Betaferon

Mon, 29 Oct 2007 07:59:57 -0400

You win some, you lose some. Bayer is abandoning plans to launch a bigger dose of its multiple sclerosis treatment Betaferon. An internal study found that the 500 mcg dose wasn't any more effective than the already-on-the-market 250 mcg dose, nor was it better than Copaxone, the MS drug made by Teva. Bayer won't ask regulators for approval to sell the new strength, and it's taking a $218.6 million charge against third-quarter earnings as a result.

The BEYOND study did have one bit of good news in it: Fewer patients taking the 250 mcg dose of Betaferon dropped out because of side effects. The drop-out rate for that drug was just 13 percent, compared with 17 percent for Copaxone.

- see Bayer's release on the study
- read the article from the International Herald Tribune

Related Articles:
Schering: MS drug reduces onset by 50%. Report
Bayer outbids Merck KGaA for Schering. Report
Bayer Schering outlines global R&D restructuring. Report
Bayer plans to beef up biotech pipeline. Report

ALSO NOTED: Strong euro hitting Merck KGaA's revenue; U.S. sales boost Lupin's Q3 profits;

Wed, 24 Oct 2007 06:59:50 -0400

> German pharma Merck KGaA says a strong euro will depress its year-end sales; it reported a 74.9 percent drop in third-quarter profits on a one-time charge from its acquisition of Serono. Report

> Strong U.S. sales boosted Indian drug maker Lupin in the third quarter, lifting profits by 46 percent to $19 million; sales grew by 35 percent. Report

> Dr. Reddy's Laboratories grew revenues by 20 percent this quarter, but profits fell slightly to $67 million. Release

> Indian pharma Wockhardt did end up acquiring U.S.-based Morton Grove Pharmaceuticals as expected--but at $38 million, the price was lower than rumored. Report

> India's Dabur Pharma inked a deal with Spain-based Combino Pharm to sell generic cancer drugs in that country. Report

> With Biogen Idec on the market, reporters are delving into the possibilities for the company and the potential fallout in the Boston biotech cluster that the company calls home. Report

And Finally... Apparently, the White House didn't like what its CDC chief was planning to tell Congress about global warming's effect on health. Report