Merck signed a deal on Monday with Indian generics giant Ranbaxy to codevelop a new line of anti-infectives. As part of the agreement, Ranbaxy stands to receive more than $100 million for each drug that passes a certain milestone. That's on top of an undisclosed upfront payment.

The deal is set to help Merck bolster its pipeline in anti-infectives and anti-fungals and to help Ranbaxy bolster its reputation outside the generics-only category.

Although Ranbaxy could not be reached for comment on this story, a representative spoke to Pharm Exec a few months ago about its plans for growth. "[Ranbaxy] is evolving into an R&D company, but will also maintain generics. We are looking at both biotech and biogenerics, and have eight new molecules in the pipeline," said Charles Caprariello, vice president of corporate communications and government affairs. "[Recent] deals with GSK and Bayer will flush out further compounds. This issue of cooperating and competing is one that we will see more of—it is not going away."This is Merck's first alliance with Ranbaxy, but it isn't the drug giant's first foray into India. For those keeping score, the company secured similar discovery collaborations with Nicholas Piramal for cancer meds.

"Ranbaxy is looking to expand its drug-discovery capabilities, and Merck's had a longstanding strategy of leveraging the best science to complement its internal R&D," Ian McConnell, a spokesperson for Merck, told Pharm Exec on Monday. "This collaboration is a great opportunity to advance our pipeline by gaining access to tap into Ranbaxy's growing R&D expertise."

McConnell said that Merck already has some anti-infective drugs in the works but wouldn't elaborate on whether they would be shifted to Ranbaxy. Merck also owns Cancidas, an injectible antifungal used to treat aspergillus and candida.

"This is not an outsourcing deal," McConnell said. "What you do here is mitigate the risk [by partnering] and still ensure the prospect of getting the upside. Fundamentally, we go where the research is."

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In a win-win situation for both companies, Merck gets access to one of the hottest generics firms in the world while Ranbaxy gets a chance to hang with the big boys.

Merck Signs $100M Development Deal with Ranbaxy

In an effort to cut off counterfeiters at the knees, Genzyme announced on Monday that it is implementing an ePedigree system to keep tabs of its entire pipeline.

While many pharma companies have gone on record with their track-and-trace projects, Boston-based Genzyme is one of the first biotechs to tackle counterfeiting and diversion head-on, whether there is a 

January 2011 deadline for compulsory ePedigree in California

 was merely an accelerator to implement the technology. The company began evaluating its supply chain three years ago, evaluating each drug's  risk and quickly deciding to establish its security program.

"Genzyme did not purchase ePedigree specifically to comply with California—they purchased it because they have identified either counterfeiting or diversion issues that they are going to serialize their product to combat it," said Kim Loughead, director of healthcare solutions at Axway, the ePedigree software provider for Genzyme.

Traditionally, oncology and renal treatments—Genzyme's two top specialties—are not thought of as targets for counterfeiters, but the company said that the high cost of biologics is driving a black market for these types of drugs. Genzyme's Vice President of Security David Kent told 

 Genzyme does not have these problems, but is being proactive to keep its drugs out of the black market.

The company said that it has been involved in raids in third-world countries where  fake Genzyme packaging has turned up, but no product was evident.

 Peter Norton, serialization project manager at Genzyme, told 

 on Tuesday that its supply chain security is different from traditional pharma companies, particularly because of the limited number of drugs running through it. This allows the company to have added control for regulation of the product temperature.

The company installed an EPCIS-compliant database that creates a digital signature every time a product passes a particular point on the supply chain. The package can be tracked throughout the entire process.

As for serialization, Genzyme chose to go with the more affordable 2-D barcodes, but not because of price. While some pharma companies, such as Pfizer and Purdue, are using radio-frequency labels for increased security and easier scanablility, Genzyme noted that the technology still hasn't been proven when affixed to containers of liquid. Since many biologics are in liquid form and often shipped in vials and syringes, the radio frequencies might be negated by the moisture. There is also concern that the exposure to the radio signal could possibly modify the drug.

"By the time the drug gets to the end user, it could have had five to ten exposures—and who knows what the long-term effect will be on efficacy," Norton said.

Genzyme is currently building and testing the system and plans to go live well in advance of the Cali deadline. Says Axway's Loughead: "We work with organizations like Genzyme and AstraZeneca that see the value of serializing the product and have a specific problem that they are dealing with. The other group [of pharma companies] is dealing with complying with legislation and doing the lower-cost option. We believe that going forward, the market will continue to be fragmented."

This article was updated on May 14, 2008, to include additional comments and clarifications from Genzyme.

Rather than wait to see which ePedigree legislation becomes law, biotech firm Genzyme has taken the initiative and implemented an electronic track-and-trace program to clamp down on fake meds.

Genzyme Launches Digital Assault on Counterfeiters

The Hershey Center for Applied Research (HCAR) on Wednesday launched 

, an online meeting ground for the life sciences community, including scientists, researchers, venture capitalists, and educators.

Rather than a traditional brick-and-mortar approach, HCAR distinguishes itself from other brain pools by including a virtual research park that allows experts from around the world to share ideas. "The research park is the nexus for academia, industry, government, and support organizations," said Laura Butcher, executive director of HCAR. "I think we are in a special position to provide a platform where these groups can communicate easily and collaborate."

HCAR was looking for a way to hook up its resident researchers with outside partners. Using social-networking tools, the organization established KnowledgeMesh—a scientific mapping online community. Members will come from pharma and other industries, academia, advocacy groups, and technical trades.

When you enter the site, you access a dashboard that lists communities aligned with nearby Penn State research strings. As on LinkedIn and Facebook, each KnowledgeMesh user has their own profile. Community members can join blogs, forums and wikis.


Design firm IntelMarx built KnowledgeMesh, but the project was inspired by Pfizerpedia, a resource-sharing Web 2.0 site from a team of Web-savvy colleagues at Pfizer.

"The way we chose to facilitate this discussion was through a community blog, which I called 'Discussion Group about the World Wide Web,' or DIGWWW," said Simon Revell, manger of enterprise technology and development at Pfizer and the keynote speaker at Wednesday's KnowledgeMesh launch. "The blog was set up to enable anybody to post—we deliberately wanted to lower the barrier to participation. Both [Pfizerpedia and DIGWWW] were initiated at the grassroots level and spread virally. One soon heard about the other, and that resulting in some beneficial 'cross-selling.'"

Pfizerpedia is now an official part of the Pfizer IT landscape, and Revell hopes that HCAR will do the same for researchers on a larger playing field. The only hurdle might be Web 2.0 oversaturation.

"There have been so many instances where people have built great communities, but then without providing reasons to join, [the communities] fall flat on their face," Butcher said. "From the beginning, we have taken great strides to think about a plan to garner usership and provide value."

According to Revell, part of the trick is not to headline with 'Try this new web 2.0 social networking tool,' but instead to ground it in the realities of the average user. "There's huge potential to take the LinkedIn approach, and apply it in untapped niche areas such as this," Revell said.

The Hershey Center for Applied Research is bringing social networking to researchers and academics with a new platform that could become a Facebook for the life science community. Does the site, dubbed KnowledgeMesh, have what it takes cut through the Web 2.0 clutter? Pharm Exec takes a closer look.

Pharmaceutical Executive-05-14-2008

Merck Signs $100M Development Deal with Ranbaxy

Genzyme Launches Digital Assault on Counterfeiters

Researchers to Share Ideas in Virtual Research Park