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Gilead Signs Potential $146M Licensing and Development Deal with UNC Spinout Parion

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Parion Sciences, a 2001 University of North Carolina-Chapel Hill spinout, and Gilead Sciences last week announced an exclusive licensing and co-development agreement related to Parion’s P-680, an epithelial sodium channel inhibitor showing promise for the treatment of pulmonary diseases.
 
The deal, which may be worth as much as $146 million to Parion, may also be a boon for UNC-Chapel Hill, which holds an undisclosed equity stake in Parion. Furthermore, because of its unique expertise in the field and its relationship with Parion, the university would be a “logical choice” to participate in ongoing discovery efforts at Parion and Gilead, according to a Parion executive.
 
Parion, based in Durham, NC, uses its small-molecule chemistry platforms and epithelial cell biology expertise to discover and develop therapeutics for diseases resulting from the failure of the body’s mucosal defenses, including chronic obstructive pulmonary disorder, cystic fibrosis, bronchiectasis, Sjogren’s syndrome, and dry eye.
 
The company was founded on research conducted by Richard Boucher, a professor of medicine at UNC, and chief of pulmonary medicine and director of the UNC Cystic Fibrosis/Pulmonary Research and Treatment Center.
 
Boucher also retains a role with Parion as chairman of its board.
 
Boucher said he and Parion have been aware of Gilead for “a long time,” but that the company became an extremely attractive potential partner last year when it acquired Seattle-based drug developer Corus Pharma, which developed aerosolized antibiotics for CF.
 
“It’s something you always dream about,” said Boucher, who is also co-director of the UNC Gene Therapy Center. “Gilead is a very well-run, very scientifically sound company that’s moving into the pulmonary arena in force, and they acquired one of the best development groups in the world in our space when they acquired Corus.”
 
Terms of the Parion deal call for Gilead to provide an upfront payment of $5 million to license a portfolio of intellectual property from the company related to epithelial sodium channel (also called ENaC) inhibitors and Parion’s proprietary ENaC-based chemistry platform.
 
The agreement grants Gilead worldwide commercialization rights to P-680 for the treatment of pulmonary diseases, including cystic fibrosis, chronic obstructive pulmonary disease, and non-CF bronchiectasis. In addition, the companies said that they will collaborate on a research program to identify other promising ENaC blocker-based drug candidates using Parion’s discovery technology.
 
As part of the deal, Gilead will supply research funding and may make payments upon the achievement of certain undisclosed milestones, resulting in a potential deal value of approximately $146 million, the companies said.
 
Parion will also perform the investigational new drug-enabling studies for P-680, and will transition development responsibilities to Gilead for Phase I clinical trials. Parion will also be eligible to receive up to double-digit royalties based on potential future product sales, the companies said.
 
UNC-Chapel Hill stands to benefit financially from the deal, although the magnitude of this benefit is unclear. Mark Crowell, associate vice chancellor for economic development and technology transfer for the UNC system, wrote in an e-mail to BTW that UNC received an undisclosed percentage of initial equity in lieu of a license fee when it licensed IP related to Boucher’s work to Parion after it spun out of the university in 2001.
 
In addition, he said that the agreement also included royalties on net sales of licensed products as well as undisclosed payments upon reaching important clinical milestones, such as receipt of IND or NDA.
 
But it is unclear whether the IP licensed by Gilead from Parion is an extension of the IP originally licensed by Parion from UNC. Boucher has multiple US patents and patent applications on which he is the inventor and UNC is the assignee, and two patent applications in particular – Nos. 20020158255 and 20020165239 – are related to sodium channel blockers.
 
However, Parion has assigned to it nearly 40 patents and patent applications related to sodium channel blockers, none of which names Boucher as an inventor, so it has developed an extensive patent portfolio independent of Boucher’s lab and possibly unrelated to the original IP upon which Parion was founded.
 
“The bottom line is that [Parion CEO and president] Ross [Johnson] has created what he likes to call almost a ‘big company’ patent portfolio at Parion,” Boucher said. “Virtually all the compounds of interest are new chemical entities that have been patented at Parion, principally by Ross.” Johnson was unavailable for comment for this story.
 

“We are committed to technology transfer and to ensuring that our research discoveries reach the marketplace to benefit the public. This partnership certainly enhances the chances for successful development and market introduction for this potentially important CF treatment.”

Regardless of the magnitude of UNC’s financial return, Crowell sees Parion’s deal with Gilead as a tech-transfer success story.

”To say we are thrilled and excited is an understatement,” Crowell wrote in his e-mail. “First and foremost, we are committed to technology transfer and to ensuring that our research discoveries reach the marketplace to benefit the public. This partnership certainly enhances the chances for successful development and market introduction for this potentially important CF treatment.

”Second, for economic development reasons, we emphasize where appropriate the formation of start-up companies to undertake the initial parts of the commercialization process,” he added. “Increasingly, such start-up companies must look to form strategic partnerships with major bio/pharmaceutical companies as the preclinical and clinical development phases of development progress. As one of the world’s largest and most successful bio/pharmaceutical companies, [and] with a proven track record in the pulmonary area, Gilead clearly represents a ‘gold standard’ partnership opportunity for Parion.”

 
Crowell also wrote that the agreement was a “textbook example of ‘venture philanthropy’” because UNC and Parion in particular received crucial grant funding for the development of P-680 from Cystic Fibrosis Foundation Therapeutics, the drug-discovery arm of the Cystic Fibrosis Foundation.
 
UNC-Chapel Hill may also stand to benefit from the Parion-Gilead deal as part of future sponsored research agreements. Not only does Boucher, who is a full-time professor at UNC, retain close ties with Parion, but his son, Paul Boucher, is director of operations at Parion.
 
“The work that Gilead is doing with [Parion] is exclusively with us,” Paul Boucher told BTW. “There are periods where we do contracts and research collaborations with various universities, and the situation may arise that we decide to do some of these projects with the University of North Carolina. They’d be a logical choice, and they’ve done a great job so far.”

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