Merck KgAA

Merck Serono, Theratechnologies ink $215M deal

Maureen Martino — Wed, 29 Oct 2008 10:00:32 -0400

Merck Serono has signed a deal to license the U.S. commercialization right to tesamorelin, a drug to treat excess abdominal fat in HIV patients with lipodystrophy. Theratechnologies retains rights to the drug outside the U.S. Under the terms of the agreement, the company will receive an upfront payment of $30 million and up to $215 million in additional payments for the drug. Theratechnologies will be responsible for conducting research and development for additional indications.

Back in January, Theratechnologies said it was conducting a strategic review of its options, including selling the company. The deal gives the company an influx of cash that will allow it to explore other indications for the drug. "These milestone and royalty payments provide Theratechnologies with a fully-financed business plan through the commercialization of tesamorelin for its first indication in the US. Theratechnologies will also have the financial flexibility to pursue the development of a second indication and build the long term value of the compound," noted Mr. Luc Tanguay, Senior Executive Vice President and CFO of Theratechnologies.

- see the release for more

ZymoGenetics shares plunge after risks halt trial

John Carroll — Tue, 28 Oct 2008 09:09:13 -0400

Shares of ZymoGenetics were battered yesterday after the company announced that Merck KGaA had discontinued a trial on a partnered therapeutic after researchers noted a high risk of infection for volunteers. Its stock plunged 29 percent on the news.

Atacicept had been the focus of a mid-stage study of systemic lupus erythematosus. The drug, developed by ZymoGenetics, began testing in December in combination with immune suppressing therapeutics. The therapy is a genetically engineered protein designed to shut down the proteins that create B cells, which in turn spawn antibodies that attack healthy tissue. And a spokesperson for ZymoGenetics told the Seattle Times that the developer believes it was the other drugs that triggered infection.

Atacicept trials for rheumatoid arthritis and multiple sclerosis are ongoing. But at least one analyst says that the trial trouble could delay any commercialization of the therapy until 2014. The analysts had already been concerned by the slow sales growth of ZymoGenetics' Recothrom, which is used to control surgical bleeding. Its stock closed at $3.53 yesterday, well off the 52-week high of $15.23.

- read the report from the Seattle Times
- read the story from Xconomy

Merck KGaA eyes ImClone, but isn't mystery bidder

Maureen Martino — Wed, 01 Oct 2008 10:06:35 -0400

Merck KGaA is entering the Bristol-Myers Squibb/ImClone buyout fray. While the German company said it isn't prepared to bid for the whole company, it would be interested in partnering with another drug company to outbid BMS's current $62-per-share offer.

Merck doesn't have the cash on hand buy ImClone. But speaking to the International Club of Frankfurt Business Journalists, CEO Karl Ludwig Kley, had this to say: "[I[f anyone contacts us to ask whether we want to participate, we will certainly listen carefully... Anyone who wants to take Erbitux further would be well advised to talk to us." Kley claimed that he doesn't know who the mystery bidder is.

Currently BMS owns 61 percent of the U.S. rights to Erbitux and Merck owns 90 percent of the ex-U.S. rights. "Bristol-Myers can't be happy about Merck's statement that it would in effect support a rival bid," Erik Gordon, a management professor at Stevens Institute of Technology, commented in Forbes.

In mid-September, Kley stated that Merck KGaA is planning a series of acquisitions over the next three years to grow its consumer health and life sciences businesses.

- here's the Forbes article
- read this PharmaTimes report

Merck KGaA - Biotech Market Share Report

Maureen Martino — Sun, 28 Sep 2008 21:06:43 -0400

Company: Merck KGaA
2007 Sales: $2.7 billion
Market share: 3.6%
CAGR: 17.9%

What they have: When Merck KGaA bought out Serono in 2006 it inherited Rebif, a top-selling multiple sclerosis drug. Merck is also one of three companies partnered on cancer drug Erbitux (along with ImClone and Bristo-Myers Squibb, which are not on this list). The drug is approved for head and neck and colorectal cancer.

What to look for: Merck KGaA has filed two additional indications for Erbitux and has a new formulation of Rebif in the works. The company is also cunducting late-stage testing for atacicept, an experimental rheumatoid arthritis treatment.

ALSO NOTED: New York pumps biotech complex; Investors focus on NZ biotech; Questions about anti-TNF safety;and much more...

Thu, 05 Jun 2008 06:59:50 -0400

> The New York Times examines New York State's $43 million effort to develop a biotech hub on Long Island. Most of that money has gone into the Broad Hollow Bioscience Park on the Farmingdale State College campus. Report

> ZymoGenetics has launched a Phase II/III study of Atacicept which it is developing with Merck KGaA as a new therapy for systemic lupus erythematosus. Release

> New Zealand Venture Investment Fund and Pacific Channel Limited are partnering up to make new investments in New Zealand biotech companies. Report

> American Oriental Bioengineering announced today that it has withdrawn its convertible preferred stock offering, citing market conditions. Release

> Intercytex has closed recruitment for the Phase III trial of ICX-PRO in venous leg ulcers. Report

> Anti-trust officials have given Intercell AG an early green light for its planned acquisition of Iomai. Report

> Novartis CEO Daniel Vasella has a knack for the quotable quote. Here's the latest: "Teva is better than we are, and that's hard to take." Report

> In a development sure to spawn headlines across the country, the FDA is looking into a possible link between autoimmune drugs such as Remicade and Humira--known as TNF blockers for their action against tumor necrosis factor--and childhood cancers. Report

> Are new warnings on their way for epilepsy meds? The FDA and drugmakers are hashing out the issue. Report

> The AIDS Vaccine Research Subcommittee of the NIH has OK'd a new AIDS vaccine trial, prompting some skeptics to caution against plunging back into trials so soon after a Merck program misfired. Report

> Switzerland's Mymetics says that its experimental malaria vaccine could be ready for marketing as early as 2014. Report

And Finally... Scientists have been studying the genetic reason why some members of four Turkish families can only walk on all fours. Release

ALSO NOTED: BioSeek to collaborate with Merck KGaA; BioAlliance acquires drug rights; and much more...

Tue, 20 May 2008 06:59:50 -0400

> BioSeek has forged a collaboration deal with Merck KGaA to evaluate the potential of small molecules and proteins. Release

> BioAlliance Pharma has acquired the European rights to ondansetron Oral Spray, which is being developed by NovaDel Pharma. NovaDel gets a $3 million licensing fee and up to $24 million in milestones. Release

> Dr. Dale Bredesen is leaving the Buck Institute for Age Research and launching Prevarex, which will help people understand more about medical research and advances in diagnostics. Report

> A U.S. court hearing over Seroquel's patents has been bumped forward to today from June 4, boosting speculation that the drugmaker might just come out on top in the high-stakes case. AstraZeneca report

> Rep. Bart Stupak might be a severe FDA critic, but he's also shaping up to be the agency's dearest friend. Chief of the House Energy and Commerce committee's oversight-and-investigations group, Stupak helped push FDA commissioner Andrew von Eschenbach to ask for millions more in FDA funding. FDA report

> The British press is abuzz today with the fact that outgoing GlaxoSmithKline CEO Jean-Pierre Garnier abruptly ended a BBC interview when it turned adversarial. Report

And Finally… The Massachusetts Biotechnology Council and the American Cancer Society are raising $1.4 million to fund three years of research by 10 Massachusetts cancer scientists. Story

ALSO NOTED: U.S. hatches $265M regenerative medicine initiative; Merck KGaA budgets €1B for R&D;and much more...

Tue, 22 Apr 2008 06:59:50 -0400

> 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. And those advances in turn will be made available to the people burned and maimed in everyday accidents. Report

> With about 40 drug development projects in the pipeline, Germany's Merck KGaA says it will spend about €1 billion on drug research this year. That R&D budget represents about 22 percent of sales and is a big increase on last year's budget of €890 million. Report

> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny after finding herself in Senator Charles Grassley's crosshairs. Report

> Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S. Report

> To listen to news reports about incoming Biovail CEO Bill Wells, you'd think he was one of the horsemen of the Apocalypse. A director for three years, Wells is set to take over the helm May 1, and analysts say they're expecting him to come in swinging his sword. Report

> A new guerilla marketing campaign for over-the-counter Zyrtec is gaining attention in the blogosphere. Report

> Eye on FDA blogger Mark Senak examines recent goings-on at the FDA will change the agency. Report

And Finally... Companies are using nanotechnology as they pursue genome sequencing for the rock-bottom price of $100. Report

Avastin, Erbitux battle for lung cancer market

Mon, 21 Apr 2008 06:59:54 -0400

Genentech's stock was down this morning on results from a Phase III study of Avastin for non-small cell lung cancer. While the drug did meet the primary endpoint--an improvement in progression-free survival--it missed the secondary endpoint of prolonging overall survival.

Meanwhile, ImClone and European partner Merck KGaA are getting ready to announce results from a trial of Erbitux that shows the drug succeeded where Avastin did not. Erbitux successfully prolonged survival in lung cancer patients, but the specifics are being kept under wraps until the annual ASCO meeting in June. TheStreet observes that while the Avastin results won't cause doctors to stop using the drug, they may back off on the higher doses, which could shrink Genentech's revenue.

- see this release on the trial
- read TheStreet report for more on Erbitux

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

ALSO NOTED: Ablynx pockets upfront fee; Plexxikon publishes cancer data; Solvay drug on fast track; and much more...

Tue, 19 Feb 2008 06:59:50 -0500

> Belgium's Ablynx says it has received an undisclosed milestone payment from Novartis for an exclusive license for a program involved in their alliance on therapeutic nanobodies. Release

> Plexxikon has published data demonstrating that its targeted cancer compound selectively destroys tumor cells which contain the B-RafV600E cancer-causing mutation, a defect present in most melanomas and thyroid tumors and a large number of colorectal and other cancers. Release

> Sanofi-Aventis and UCB have received FDA approval of an oral solution version of the allergy drug Xyzal. Release

> The FDA has accepted Cephalon's NDA for the chemo drug Treanda. Release

> Chelsea Therapeutics says it has reached an accord with the FDA regarding the design of a late-stage trial for Droxidopa, a therapy for neurogenic orthostatic hypotension. Release

> Marshall Edwards has received orphan drug status for NV-196, a treatment for Stage IIB through Stage IV malignant melanoma. Report

> The FDA has put Solvay's Duodopa, the intestinal gel being developed for patients with advanced Parkinson's disease, on its fast track. Report

> Biolex Therapeutics announced that it has entered into an agreement with Merck KGaA to evaluate antibody optimization and production in Biolex' proprietary LEX System. Release

> Behind the scenes at Enhance: Schering-Plough statisticians reviewed some data before the study was complete, according to New Jersey's Star-Ledger. Report

> It was a glitch. That's what the FDA said last week when confronted with the news that it hadn't inspected the Chinese plant that made the main ingredient for Baxter's recalled batches of heparin. Now we know just how big that glitch was: The FDA inspected and approved the wrong plant. Report

> The FDA has finally released proposed rules that would allow pharma to distribute journal articles that support off-label uses of their products--two months after an irate Congressman pulled the veil off the same proposal. Report

And Finally… The Bill & Melinda Gates Foundation has come under a rare attack for its contributions to research efforts targeted at malaria. Report

Idera shares surge on Merck KGaA pact

Wed, 19 Dec 2007 06:59:58 -0500

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. The German Merck gains exclusive rights to Idera's two most advanced Toll-like Receptor 9 (TLR9) agonists for cancer--IMO-2055 and IMO-2125--for all uses with the exception of cancer vaccines. These Toll-like receptors are sentinels for chemicals in pathogens for cancer, infectious diseases, respiratory and autoimmune disorders. IMO-2055 has been involved in Phase I studies for solid tumors that have been unresponsive to standard therapy. Shares of Idera surged on the news.

- see the release
- here's the AP's report on the deal

Related Articles:
Idera inks $455M pact for Merck vaccines. Report
Merck KGaA CEO eyes new acquisitions. Report
Mylan inks $6.6B deal for Merck's generic drug biz. Report
Merck KGaA buying control of Serono. Report

Merck KGaA starts Phase III Parkinson's trial

Wed, 28 Nov 2007 06:59:54 -0500

Merck KGaA has launched a late-stage study of safinamide for Parkinson's disease. The drug is designed to help improve motor function, but the study will also explore its affect on cognitive function and quality of life. Some 650 volunteers are being signed up to get two doses of the drug in combination with dopamine agonists in comparison to dopamine agonists alone. Merck gained a worldwide license to the therapy from Newron last year.

- see this release
- here's the AFX report on the trial

Related Articles:
More tests planned after Parkinson's drug fails trial. Report
New approaches pursued on Parkinson's. Report
Molecule could reverse Parkinson's. Report

Big Pharma takes an interest in cancer vaccines

Maureen Martino — Wed, 19 Sep 2007 10:49:50 -0400

For two decades, biotech companies have struggled to develop therapeutic cancer vaccines designed to treat the disease by stimulating the immune system to attack cancer cells without harming normal cells. This approach would be a major step forward for cancer treatment, as current therapies attack both diseased and healthy cells and can result in hair loss, vomiting and infection.

So far, the FDA has yet to approve a single therapeutic cancer vaccine. The issue is that the vaccines must do more than slow tumor growth – they must actually improve patient survival, which can take years to measure, requiring long Phase III trails. But a crop of late-stage cancer vaccines are showing a lot of promise and attracting the attention of large pharma and biotech companies. “There are possibilities here, and now the big companies are starting to be interested, but they haven't had the courage before because it has been too risky for them," noted Haakan Mellstedt, a professor in oncological biotherapy at Karolinska Institutet in Stockholm. Cancer treatment is a $50 billion annual market, and research firm Arrowhead Publishers says that if approved, cancer vaccines could grab $6 billion in annual sales by 2010. Analysts expect the cancer vaccine market will soar to $8 billion by 2012. Here’s a look at some of the late-stage drug candidates that could revolutionize the cancer treatment field:

Earlier this year, Sanovi-aventis bought the rights to TroVax from Oxford BioMedica for $720 million (in fact, it was one of the top 5 deals of the first half of 2007). TroVax is currently in Phase III for renal cancer, but the company is exploring its utility in a range of cancers including colorectal, lung, breast and prostate cancer.
Glaxo said it will be recruiting 2,000 patients for a Phase III trial of its lung-cancer vaccine MAGE-A3, making it the largest cancer vaccine study ever.
Also competing in the lung cancer market, Merck KGaA is recruiting patients for a Phase III study of Stimuvax, bought from Canada's Biomira in January. In the Phase II trial, patients taking Stimuvax lived an average of 30.6 months compared to an average of 13.3 months for patients receiving supportive care alone.
Genitope is developing MyVax for an incurable form of non-Hodgkin's lymphoma. The company plans to wrap up a trial of the vaccine by the end of this year. The developer hoped to end the trial sooner, but last month an independent board recommended that the clinical trial continue.
Antigenics has reported positive data for Oncophage, a brain cancer treatment. Previously, Antigenics took a beating when Oncophage failed late-stage trials for skin and kidney cancer.

For more:
- read the Wall Street Journal article

Related Article:
Vaccine "renaissance" attracts huge new venture investments. Report

ALSO NOTED: Gates gives $280M to fight TB; Merck drug proves positive in Phase II;Merck KGaA exec eyes acquisitions;much more..

Wed, 19 Sep 2007 06:59:50 -0400

> Merck says that its mid-stage trial for the osteoporosis drug Odanacatib (formerly MK-0822) significantly boosted bone mineral density after 12 months. The trial tested four doses of the drug, with the highest dose achieving the best overall results. Report

> ReachBio has opened for business in Seattle. The company will focus on providing specialized contract assay and contract research services utilizing in vitro and in vivo stem cell and progenitor cell assays. Release

> Provectus Pharmaceuticals has announced that a Phase I trial of Provecta demonstrated minimal side effects, significant efficacy and bystander effect on metastatic melanoma tumors in stage III patients. Release

> Johnson & Johnson's restructuring has come home to roost in Belgium. Drug maker Janssen-Cilag, a J&J subsidiary, will slice 521 full-time and 167 part-time workers from its payroll of 4,723 in-country. Report

> Merck KGaA's new chairman, Karl-Ludwig Kley (photo), says he's planning a series of acquisitions over the next three years to grow the company's consumer health and life sciences businesses. Report

> Report: Pharma lobbies big-time in '07. Report

And Finally... Forget the European regulators' fight with Microsoft, Gates still has plenty of money for new research work. The Bill & Melinda Gates Foundation announced today grants totaling $280 million to help fight tuberculosis. The 11 new grants will speed research and development on vaccines, diagnostic tests and treatments to help reduce the global TB burden. Report

Erbitux clears late-stage hurdle for lung cancer

Tue, 11 Sep 2007 06:59:57 -0400

ImClone once again is feeling the tonic effects of positive trial data. Its stock price took off this morning, rising 19 percent after its European partner, Merck KGaA, reported that Erbitux helped increase the survival rate of lung cancer patients. The data may help clear the way to a new approval with blockbuster potential. The trial volunteers were diagnosed with advanced non-small cell lung cancer and divided into two groups that received either a combination of Erbitux and chemotherapy or chemotherapy alone. Last July Erbitux failed a separate late-stage study as a treatment for lung cancer.

Good news for ImClone and its U.S. partner, Bristol-Myers, was bad news for Genentech, which saw its share price clip on the news of a potential competitor.

- see ImClone's release on the trial
- read the AP report

ALSO: Repligen says that ImClone has agreed to pay $65 million to settle patent infringement charges related to Erbitux. Release

Related Articles:
ImClone names new CEO. Report
ImClone shares dive after Erbitux fails a Phase III. Report
Erbitux data underscores leaked disappointment. Report
ImClone buoyed by new Erbitux data. Report
ImClone touts survival rate in Erbitux cancer trial. Report

Matuzumab in doubt after trial failure

Wed, 29 Aug 2007 06:59:56 -0400

There's trouble at Merck Serono's program for Matuzumab, which is in development for colorectal cancer. Merck KGaA says it is "reconsidering" further development of the therapy after the drug failed to hit its endpoint in a Phase II trial. Merck Serono and Takeda have a joint development pact for the drug, which failed to meet their expectations. More work, though, is being planned for other tumor types.

- check out the release

Related Articles:
Takeda expands R&D budget, may look for buyout. Report
Merck KGaA buying control of Serono. Report

Gene Logic looks for new potential in Solvay drugs

Mon, 27 Aug 2007 06:59:56 -0400

Gene Logic's makeover as a drug developer took another step forward today as it announced a deal to take a second look at drugs Solvay either discontinued or chose not to prioritize. The key qualifier: The compounds Gene Logic hopes to resuscitate weren't left to die because they proved unsafe during trials.

Originally a genetic data company, Gene Logic has more recently been striking deals to see if sidetracked experimental therapies have undisclosed potential in unexpected areas. In the deal announced this morning, Gene Logic has the potential to earn revenue from any new drug developed in the program and also has the option to license any therapy that Solvay opts to leave on the back burner. In those cases, Solvay would be positioned to earn milestones and royalties.

- see the release
- read the report from the Baltimore Sun

Related Articles:
Gene Logic takes fresh look at Merck KGaA drugs. Report
Gene Logic, Abbott strike development deal. Report
Gene Logic re-examines Organon candidates. Report
Gene Logic to give Lilly drugs fresh look. Report

Gene Logic takes fresh look at Merck KGaA drugs

Fri, 24 Aug 2007 06:59:56 -0400

Merck Serono has enlisted Gene Logic to help breathe new life into abandoned drug candidates. The companies will seek alternative development paths for several Merck Serono drug candidates which have been discontinued or de-prioritized in clinical trials for reasons other than safety. Financial details of the deal weren't disclosed, but Gene Logic will receive success-based milestones and royalties.

Gene Logic's Drug Repositioning Program is designed to find alternative development paths for failed or stalled drug candidates. The program offers pharmaceutical partners an opportunity to bolster their pipelines with drug candidates that originated from their own R&D efforts. Other biotech and pharmaceutical companies that are giving Gene Logic's program a try include Abbott, Organon and Eli Lilly.

- check out this release on the agreement

Related Articles:
Gene Logic, Abbott strike development deal. Report
Gene Logic re-examines Organon candidates. Report
Gene Logic to give Lilly drugs fresh look. Report
Gene Logic cuts jobs at struggling genomics division. Report

New tests planned after Parkinson's drug fails trial

Wed, 22 Aug 2007 06:59:58 -0400

Merck KGaA and its development partner, Newron, say that a late-stage study of their experimental therapy for Parkinson's failed to demonstrate any significant effect. But the two developers refuse to walk away from safinamide. Researchers are planning to mount new trials with lower doses to find the right formula.

"The primary endpoint, time to intervention, did not reach statistical significance when data from both safinamide dose groups were pooled," the companies said, after reviewing 18 months of combined data from patients taking the 50-100 mg and 120-200 mg doses. But researchers said that a lack of response among patients taking the highest dose could have skewed the data. Adding safinamide to dopamine agonist therapy at 50-100 mg daily could delay the time to therapeutic adjustment.

- see the release on the trial data
- read the AFX report

Related Articles:
Italy's Newron gains $99 million in IPO. Report
Newron launches a Phase III trial on eve of IPO. Report
Serono licenses Newron Parkinson's therapy. Report

Eli Lilly inks drug R&D deal with Chi-Med

Tue, 21 Aug 2007 06:59:57 -0400

Eli Lilly has struck a development deal with the research arm of Hutchison China-Meditech that is worth up to $29 million in milestones for each new drug candidate developed from its library of herbal remedies. The partnership marks another step forward for biotechnology R&D in China, as local companies strike up new deals with drug developers around the world. In addition to the milestones, Chi-Med is pocketing an undisclosed upfront fee along with payments to support the research, which will initially focus on oncology and inflammation. Some analysts say the deal should be a boon to China's drug development industry, which has been afflicted by a series of scandals.

- see this release
- read the article from The Telegraph

ALSO: What do you do with a booming antidepressant? Broaden its scope, of course. Eli Lilly has filed for FDA approval to sell Cymbalta as a fibromyalgia remedy. FiercePharma

Related Articles:
Merck KGaA inks deal with China's Chi-Med. Report
China pushes drug development as R&D soars. Report
China drug czar executed for corruption. Report
China to overhaul drug safety regulations. Report

ALSO NOTED: Advanced Life confirms data; Regulators probe Merck KGaA release; UCB to name new CFO; and much more...

Mon, 02 Jul 2007 00:01:30 -0400

> Advanced Life Sciences has confirmed positive supplementary data for cethromycin for pneumonia. Release

> German regulators are probing Merck KGaA's reported release of financial information to a select group of analysts ahead of the official release. Report

> Belgium's UCB says it will name a replacement for departing CFO Luc Missorten as soon as the last legal hurdles are cleared. Report

> Cytogen is raising $10.1 million through a private placement. Release

And Finally… The first baby to be created from an egg that had been matured in the laboratory, frozen, thawed and then fertilized, has been born in Canada. Report