News

Merck KGaA licenses Glenmark diabetes drug

Germany's Merck KGaA has agreed to pay €25 million up front and up to €190 million in total to license Glenmark's DPP-4 inhibitor, GRC 8200, which is in Phase II trials. Glenmark retains marketing rights to India while Merck KGaA gains North America, Europe and Japan.

- see the press release on the pact

ALSO: As expected, …

SPOTLIGHT: Portola gains $20M


Portola Pharmaceuticals of Palo Alto, CA has gained $20 million in new funds from Hercules Technology Growth Capital. "Portola has achieved many significant milestones in building a pipeline of antithrombotic drug candidates," said Kathy Conte, managing director of life sciences at Hercules. "Currently, the company has two drug candidates in clinical development--an oral Factor Xa inhibitor in a Phase II trial for the prevention of deep vein thrombosis in patients undergoing knee …

ALSO NOTED: Memory suspends trial; FDA rejects Cytomedix claim;and much more...

> Memory Pharmaceuticals has suspended a midstage trial of its Alzheimer's therapy as it addresses the FDA's request for more information on revisions to toxicology reports. Report

> The FDA has rejected Cytomedix's claim that its AutoloGel wound healing gel is equivalent to similar therapies on the market. Report

> Dr. Mauro …

Editor's Corner


Genentech deserves some support for its move last week to cap the annual price on Avastin at $55,000 as it won approval to use the drug to treat lung cancer. Few patients or …

FDA expected to approve Januvia soon

The Financial Times notes that Merck's Januvia could be approved by the FDA as early as today. Januvia is a new type of diabetes drug that regulates sugar and insulin production. Analysts expect Januvia to be a blockbuster, which would be a welcome relief to the embattled Merck. But Merck won't own the DPP-IV inhibitor market for long. Novartis' Galvus is expected to get an approval next month.

- here's the …

Wave of clinical studies complicates drug debate

The tidal wave of clinical trial data has made it virtually impossible for physicians to keep up with the latest developments in evidence-based medicine. Proponents say that the evidence-based movement is critical to eliminating the use of dangerous therapies. Critics counter with their argument that a strict adherence to the data undermines a doctor's role in choosing the best medicine for a patient along with the whole doctor-patient relationship. But with 25,000 medical journals around …

Bayer suspends employees over Trasylol study

After finding itself under a barrage of criticism for failing to reveal the safety issues raised in a new study of Trasylol, Bayer has suspended two "senior" employees in Germany who the company says failed to notify the FDA about the new data. The study demonstrated that Trasylol raises the risk of death, heart failure, stroke and kidney damage but was released only a week after an FDA committee met to consider the drug's …

FDA wants more data on new Aranesp doses

Shares of Amgen slipped slightly on Friday after the biotech giant announced that the FDA wants a new clinical trial of its monthly dose of the anemia drug Aranesp in patients with chronic kidney disease not on dialysis. The agency also asked for more data on a once-every-two-weeks dose of Aranesp. Amgen, though, countered that it would ask the FDA to consider additional data on the new doses that was not available when it …

Serono licenses Newron Parkinson's therapy

Switzerland's Serono has won the worldwide development rights to Newron Pharmaceuticals' safinamide Parkinson's therapy. Newron recently unveiled positive data from an early Phase III trial of safinamide. Serono is talking over the development costs on the drug, is paying an undisclosed up front fee and has committed to up to $200 million in milestones. "This partnership enables us to expand our neurology portfolio by …

SPOTLIGHT: Antisoma in licensing talks


The UK's Antisoma is sounding bullish about its licensing prospects for its flagship drug, AS1404, a potential blockbuster cancer therapy. Antisoma chief Glyn Edwards says that he's in talks with a number of big pharma companies, but couldn't say exactly when a deal might be completed. Antisoma also announced positive Phase II data for AS1404 today. Report

ALSO NOTED: Wall Street waits on new Pfizer CEO; HGS touts Phase II hep C trial; and much more...

> Wall Street is waiting to see how Jeff Kindler, the new CEO at Pfizer, will handle his role on Thursday as he announces the company's third quarter performance. Analysts want some idea of what new directions he has in mind for Pfizer. Report (WSJ sub. req.)

> Omrix Biopharmaceuticals says that its Phase III non-inferiority study of human thrombin …

Discovery Labs' shares surge on new BPD data

Shares of Discovery Laboratories surged on new data from a mid-stage trial of its Surfaxin lung therapy. Researchers announced that fewer prematurely born infants died from the lung disease Bronchopulmonary Dysplasia--or BPD--after being treated with Surfaxin. Researchers noted that 57.8 percent of infants taking Surfaxin died compared to 65.9 percent of infants given a placebo. Surfaxin is a synthetic version of a natural substance the liver needs to absorb oxygen. Researchers also noted …

MGI therapy "approvable," but FDA wants new trial

The FDA has issued an approvable letter for MGI Pharma's therapy for oral mucositis, but is requiring the drug developer to do a new Phase III trial before a full approval is made. The news of a new trial requirement sent its shares down as investors considered the likely impact on MGI. MGI CEO Lonnie Moulder said that the company will evaluate ways to "maximize the value of Saforis." He also noted that MGI hadn't been anticipating a significant financial contribution from the therapy next year.

- here's the AP report on MGI

Diabetes prevention spurs development programs

Researchers at a group of big drug companies, including GSK, Takeda and Novartis, have begun to study whether drugs currently prescribed to treat diabetes can be used to prevent the disease. The winners in this field can potentially open up a huge new market for drugs that already offer a good safety profile. Amylin and Eli Lilly are both active here as well. Some analysts peg the market for diabetes-prevention at $15 billion. Some 54 million Americans are considered …

AnorMED gives Genzyme bid thumb's up

The bidding war for Canada's AnorMED is far from over. The company 's board announced that Genzyme's sweetened offer of $13.50 a share--or $580 million--was superior to Millennium's bid. AnorMED gave Millennium three days to match or beat the Genzyme bid. If it does, AnorMED says they'll go with Millennium. If it doesn't, AnorMED will sign on to Genzyme's offer. Genzyme got the bidding war going with its unsolicited offer of $380 million.

- check out the AFX

Endo to buy RxKinetic for $20M up front

Endo Pharmaceuticals has agreed to buy Boulder, CO-based RxKinetic for $20 million up front and up to $95 million in milestones. RxKinetic is developing a therapy to treat oral mucositis-mouth sores-in cancer patients. The developer wrapped a Phase II trial of RK-0202 in March and announced positive data that would allow it to push into a late-stage trial. The company, which has 21 employees, will continue as a subsidiary of …

SPOTLIGHT: Parexel buys trial group

Parexel has agreed to buy California Clinical Trials Medical Group and Behavioral and Medical Research for $65 million. The operations offer specialty Phase I through IV clinical research services through four clinical sites in California. Report

ALSO NOTED: New timeline for gaboxadol; Boehringer to buy Zantac;and much more...

> Merck and Lundbeck have pulled the plug on their timeline for the closely-watched sleep therapy gaboxadol. Researchers from the two companies, which are collaborating on the drug's development, say that much slower than expected enrollment into a Phase III trial will make it impossible for them to file for FDA approval in the first quarter of next year. They have pushed back their timeline for an NDA to mid-2007, which would delay any potential approval until the end of 2008. …

2006 Mid-Atlantic Bio: The challenges of infectious disease

On the second day of the 2006 Mid-Atlantic Bio conference, Dr. Tony Fauci, director of the NIH’s National Institute of Allergy and Infectious Disease (NIAID), delivered a fascinating speech on emerging and re-emerging infectious diseases. He kicked off his talk with a quote from physician and anthropologist T. Aidan Cockburn. “We can look forward with confidence to a considerable degree of freedom from infectious diseases at a time not too far in the future. Indeed…it seems reasonable to anticipate that within some measurable time…all the major infections will have disappeared.”

Cockburn predicted the eventual eradication of infectious disease in 1963, just as Dr. Fauci was embarking on a career in the field. But fortunately for Fauci, Cockburn’s prediction couldn’t have been farther from the truth. What Cockburn didn’t take into account was that infectious disease never really abated in other countries and that disease would evolve in the U.S. In recent years we’ve seen the emergence and re-emergence of some of the most serious infectious diseases the world has ever know, including HIV/AIDS, bird flu, SARS, West Nile virus, malaria, and, most recently, extreme drug-resistant tuberculosis. These diseases have challenged scientists and health workers alike, but they’ve also opened up new opportunities for the healthcare industry to develop new methods of dealing with infectious disease.