Merck

Merck, Dynavax announce Heplisav results

Maureen Martino — Wed, 06 Aug 2008 11:06:49 -0400

Dynavax and Merck announced that their hepatitis B vaccine Heplisav achieved the primary endpoint in a Phase III study. In the study, 95.1 percent of subjects who received Heplisav developed protective antibodies to hepatitis B versus 81.1 percent of subjects who received Engerix-B, a marketed drug. Heplisav is being developed for patients with end-stage renal disease.

Back in April the FDA put a clinical hold on the drug's development because one subject was suspected to have Wegener's granulomatosis, an rare inflammation of blood vessels. The hold is still in effect, and the FDA has requested a review of clinical and preclinical safety data along with all available information about the Wegener's granulomatosis case.

- here's the release

Merck puts HIV development program on hold

John Carroll — Mon, 28 Jul 2008 11:30:24 -0400

Canada's Ambrilia Biopharma says that Merck has placed the development program for the HIV therapy--MK-8122--on hold as it focuses on basic science efforts to evaluate other PL-100 prodrugs and formulation options. Ambrilia says that Merck is also exploring possible back-up compounds.

"Ambrilia believes in the potential of PPL-100/MK-8122 and related compounds to offer advantages to HIV patients over the currently commercialized protease inhibitors," said Dr. Philippe Calais, the CEO of Ambrilia. "Our partnership with Merck continues and we look forward to further progress on potential back-up compounds." Dr. Calais continued, "Both companies remain focused on the partnership and determined to provide the best compounds available to help people with HIV/AIDS."

- check out the release

Pharma giants to collaborate on new discovery tech

John Carroll — Thu, 10 Jul 2008 11:27:36 -0400

Three of the biggest pharma companies on the planet are joining forces to back an unusual venture aimed at developing "breakthrough" discovery technology that can reduce the frequency of trial failures and save them huge amounts of money. Eli Lilly, Merck and Pfizer--which often compete on new therapies--are joining forces with PureTech Ventures to provide $39 million to finance the launch of Enlight Biosciences. Enlight in turn plans to spin off new companies if the technology looks promising enough. Some of the new technologies the collaboration will explore include finding ways to deliver drugs across the blood-brain barrier and new biomarkers.

"Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind," Enlight co-founder Raju Kucherlapati, a genetics professor at Harvard Medical School, told the Wall Street Journal.

"The biopharmaceutical industry has a great need for innovative enabling technologies that will catalyze fundamental transformation of the drug discovery and development process. A collaborative entrepreneurial initiative such as Enlight that is dedicated to such technological innovation in R&D meets that need in an ideal way. We are excited about our partnership with Enlight and its team of world-renowned scientists," said Dr. Steven Paul, the executive vice president, science and technology, at Eli Lilly.

- see this release
- read the article from the Wall Street Journal

Merck, Schering-Plough end respiratory collaboration

Maureen Martino — Fri, 27 Jun 2008 11:59:04 -0400

Merck and Schering-Plough have withdrawn their NDA for a pill combining Claritin and Singulair and are breaking up their respiratory collaboration, which has been in place since 2000. The goal of the joint venture was to develop and market a product made from the two blockbusters. Merck and Schering-Plough stressed, however, that this action has no impact on the their cholesterol collaboration, which has been put under stress due to the Vytorin brouhaha. As a result of the termination of the respiratory joint venture, Schering-Plough expects to receive payments totaling $105 million from Merck.

- check out the release

Study projects new wave of globalization in biopharma

John Carroll — Wed, 11 Jun 2008 11:13:18 -0400

Don't be misguided by dated reports discounting the impact Indian and Chinese scientists are having in drug development and other key technologies, says a new study from Duke and Harvard. Looking at recent data, research teams from those two countries have swiftly expanded their work in the field. A look at 2006 data shows a four-fold increase in the number of patents filed since 1995. And pharma giants like Merck, Lilly and J&J have been shifting research and manufacturing to India and China as they seek new ways to develop drugs on a lean budget, pushing a new wave of globalization.

"Driven by cost pressures and growth opportunities, they are partnering with firms there to do sophisticated drug research and clinical testing," writes Vivek Wadhwa in BusinessWeek. "Indian and Chinese companies are making strides in the segments of global value chains that are most lucrative. They are also now performing their own drug discovery with the hope of marketing new products through their multinational partners."

- read the article from BusinessWeek

Daiichi Sankyo acquires Ranbaxy in $4.6B deal

John Carroll — Wed, 11 Jun 2008 11:12:29 -0400

Ranbaxy's drive to become a research-based drug developer and major manufacturer has led it straight into the welcoming arms of Japan's Daiichi Sankyo, which announced it is buying a majority stake in the Indian pharma company. After Sankyo completes a buyout of the founding Singh family's stake in the company, Ranbaxy will become a subsidiary operation. The deal is valued at $4.6 billion and will create a combined company worth about $30 billion.

That move positions Daiichi Sankyo to become a major supplier of low-priced generics to Japan's aging population and accelerates a trend by Japanese pharma companies to enter emerging Asian markets, where they see much of their future growth. The acquisition stunned investors and analysts alike, who were caught off guard by a bold move from a conservative player in the industry.

- check out this release for more on the deal
- read the report from The Times

DPP-4 inhibitors get spotlight at ADA meeting

John Carroll — Mon, 09 Jun 2008 11:55:40 -0400

Researchers are unveiling positive data at the American Diabetes Association's meeting for new DPP-4 inhibitors for diabetes. Takeda is the latest, demonstrating that its alogliptin can control blood sugar alone or in combination with other therapies. AstraZeneca has already presented data on saxagliptin. Taken for 26 weeks, says Takeda, alogliptin can cut hemoglobin A1C by 0.6 percent at its strongest dose. DPP-4s have a mixed record. Merck has a therapy on the market--Januvia--while Novartis' Galvus has yet to be approved.

Merck, meanwhile, revealed new data backing Januvia, saying the drug targets key cells in attacking diabetes. And researchers said the DPP-4 inhibitor reduced the risk of hypoglycaemia, a potentially fatal side effect.

- read the AFX report
- read the story from Hemscott

Merck's osteoporosis drug performs in Phase II

Wed, 28 May 2008 06:59:56 -0400

Merck's experimental osteoporosis drug odanacatib turned in positive results in a Phase II trial. The drug reduced measures of bone turnover (breakdown and rebuilding of bone) in women with breast cancer that has spread to the bones. Odanacatib beat out Novartis's med Zometam in the trial.

Odanacatib inhibits cathepsin K enzyme, which plays a key role in breaking down the protein in bone. By inhibiting cathepsin K activity, odanacatib could offer a different approach for treating metastatic bone disease.

"Based on these findings, larger Phase III studies using the 5 mg daily dose of odanacatib are being planned for patients with breast and prostate cancer," said Antonio Lombardi, M.D., senior director, Merck Research Laboratories.

- check out Merck's release for more
- read the BusinessWeek article

Amgen's D-mab beats Fosamax in trial

Wed, 28 May 2008 06:59:55 -0400

In a head-to-head trial, Amgen's twice-yearly osteoporosis drug denosumab outperformed weekly oral doses of Merck's Fosamax. D-mab, as it's known, showed greater improvement in bone mineral density in the hip and spine compared to Fosamax. "The novel means by which denosumab inhibits osteoclast-mediated bone breakdown shows the promise of RANK Ligand inhibition," said Javier San Martin, Global Development Lead for the denosumab osteoporosis program.

- see Amgen's release
- read the report for more

Merck shelves study of cholesterol drug

Wed, 21 May 2008 06:59:57 -0400

Saying it had the wrong patient population, Merck has discontinued its ACHIEVE imaging study for its cholesterol drug MK-0524A. Its steering committee recommended a new imaging study that included a "more appropriate patient population." The ACHIEVE trial was intended to gauge the drug's impact on the thickness of artery walls.

Merck emphasized that the decision to discontinue the trial was not related to a recent Not Approvable letter from the FDA and that all other studies would proceed as planned. The FDA turned thumb's down on MK-0524A last April. The drug is a combination of the B vitamin niacin and the drug laropiprant.

- here's the release
- read the report from Hemscott