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Shire stakes a claim
May 2012
by Lori Lesko  |  Email the author


BOSTON— Working toward broadening its pipeline and acquiring future innovative therapies, global specialty biopharmaceutical Shire PLC recently made two significant investments in potentially innovative treatment protocols. In early March, the company agreed to buy privately held FerroKin BioScience for an upfront payment of $100 million, plus potential milestone payments of up to $225 million, in an effort to boost its hematology business. In addition, Shire also purchased the worldwide exclusive license for the development and commercialization of an adenosine A2A antagonist from United Kingdom-based Heptares to treat central nervous system (CNS) disorders.  
Shire was strongly attracted to Ferrokin's lead product, a potential treatment for iron overload that is being studied in Phase II clinical studies in patients who have received multiple blood transfusions.   In the agreement with Heptares, Shire has agreed to pay the company an upfront option grant, plus future development and commercial milestone payments that could total $190 million, as well as royalties on product sales. Further terms of the agreement were not disclosed.  
Jeff Jonas, senior vice president of research and development for Shire's Specialty Pharmaceuticals and Regenerative Medicine unit, says Shire is continuously searching for innovations that have the potential to help the company develop differentiated medicines.  
"This agreement with Heptares is a reflection of our growth strategy of investing and focusing on highly targeted drug discovery platforms," Jonas says. "We are impressed with the novelty and quality of the A2A antagonist leads generated by Heptares, resulting from what we believe to be the first time a structure-based drug discovery approach has been applied from the beginning to a GPCR drug target."  
Currently in preclinical development, adenosine A2A is a G-protein coupled receptor (GPCR) involved in the regulation of dopaminergic pathways in the brain. Inhibition of the A2A receptor is a validated mechanism in the treatment of CNS disorders, but Heptares has taken it one giant step farther by actually discovering and developing new medicines targeting GPCRs, which are linked to a wide range of human diseases.  
Adenosine A2A, in fact, could eventually prove to be a new treatment for a range of CNS disorders. While the specific CNS disease targets have not been disclosed, similar rival drugs are already in development to treat Parkinson's disease.  
Heptares already has development deals with Takeda, AstraZeneca, MedImmune and Novartis Option Fund, and has raised $40 million in venture financing from MVM Life Science Partners, Clarus Ventures, Novartis Venture Fund and Takeda Ventures.  
Malcolm Weir, CEO of Heptares, tells ddn, "From Heptares' perspective, Shire is one of the world's leading CNS specialty pharmaceutical companies—and the fit of product opportunity and company cultures was particularly good. Heptares aims to be the leading company that discovers and develops new medicines targeting GPCRs, and it believes its unique approach and capabilities will enable this through the development of a broad pipeline of drug candidates for serious CNS and metabolic disorders, internally balanced with strategic alliances with pharma partners. The upfront fees and potential profits will be used to execute the company's strategy and grow Heptares through its structure-based drug discovery capabilities and advancement of its internal pipeline."  
Heptares' discovery of entirely new types of chemical structures for inhibiting the A2A receptor and potentially possessing best-in-class drug-like characteristics represents "a radical advance after decades of largely unsuccessful medicinal chemistry," Weir adds.  
The major problems with CNS therapies are lack of efficacy and side effects that result from non-specific binding of sub-optimal small molecule drugs, he notes. Many CNS disorders can be traced back to GPCR activity. GPCRs are key in signal transduction pathways.
"Heptares has overcome this major obstacle," Weir said. "Its technology can stabilize GPCRs in pharmacologically relevant conformations and generate detailed structural information that can enable drugs to be designed atom-by-atom, thus offering high potency and specificity, fewer side effects and potential first-in-class or best-in-class drug opportunities."

Shire acquires Pervasis Therapeutics to bolster regenerative medicine business  
DUBLIN, Ireland—Shire PLC announced April 12 that it has signed an agreement to acquire substantially all the assets of Pervasis Therapeutics, for an undisclosed sum.  
Per the company's announcement, Shire will provide Pervasis with an upfront payment in addition to potential post-closing milestone payments that are dependent on Shire's achievement of certain clinical development, regulatory and sales targets.  
According to Shire, the acquisition complements its 2011 purchase of Advanced BioHealing and further demonstrates Shire's commitment to investing in and building out its portfolio of regenerative medicine therapies.  
Pervasis' clinical development assets bring to Shire a new cell-based technology platform—endothelial cell technology—with potential global opportunity. The company's lead program, Vascugel, addresses a significant unmet medical need for acute vascular repair technologies focused on improving hemodialysis access for patients with end-stage renal disease (ESRD). With diabetes being the global leading cause of ESRD, and accounting for approximately 40 percent of ESRD patients in the United States, Pervasis' Vascugel therapy complements ABH's Dermagraft, which is indicated for diabetic foot ulcers, a condition highly prevalent among diabetic dialysis patients.
Shire will initially focus on completing a Phase II program to address maturation and maintenance of arteriovenous (AV) access for hemodialysis patients, which will instruct a future development pathway.  
"There are currently no approved therapies that directly target the underlying physiological processes associated with the creation of AV access sites in hemodialysis patients, including inflammation, thrombosis, and restenosis," said Shire Regenerative Medicine President Kevin Rakin in a statement. "As a result, there remains a significant unmet need for technologies that improve hemodialysis access for patients with ESRD. We believe Vascugel has the potential to enhance the rate of blood vessel repair while also providing for increased maintenance of the access site for a prolonged period of time as compared to current treatments. This acquisition marks a very important step for Shire in building a Regenerative Medicine business focused on tissue repair and regeneration."
The closing of the acquisition is subject to ancillary conditions.
Code: E051223



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