Tour of Italy

VERONA, Italy—Fresh off its July announcement that itacquired operations at GlaxoSmithKline's (GSK) Medicines Research Centre (MRC)here, Aptuit Inc. has forged a strategic partnership giving a minority stake inthe Italian venture to Siena Biotech S.p.A., a clinical-stage drug discoverycompany focused on neurodegenerative diseases and oncology.

Under the agreement, Aptuit and Siena Biotech willcollaborate on the development of Siena Biotech's pipeline of compounds,focused in three key therapeutic areas: Alzheimer's disease, Huntington'sdisease and oncology. Financial terms of the deal were not disclosed.

The addition of the Verona operations extends Aptuit'sexisting capabilities across the drug development spectrum with expertise indrug discovery, lead optimization, API development and manufacturing andpreclinical and clinical drug development.

"We are delighted to strengthen our existing relationshipwith Siena Biotech, which will be a valuable partner as we expand our presence,particularly in the Italian marketplace," says Timothy C. Tyson, chairman andCEO of Aptuit. "Siena Biotech's commitment is an important validation of thecapabilities and expertise gained via our recent acquisition of the VeronaMedicines Research Centre from GlaxoSmithKline."

The MRC operation is also known for specific expertise indrug discovery and development in the neurosciences, which complements theneeds of Siena Biotech's development pipeline.

According to Giovanni Gaviraghi, CEO of Siena Biotech andformer R&D director at the Glaxo MRC, the effective integration ofdisciplines and technologies, from target discovery to clinicalproof-of-concept studies, is essential for the development of new medicines atSiena Biotech.

"Aptuit has technologies, processes and skills which arecomplementary to those of Siena Biotech, and therefore represents the ideal partnerfor us as we advance our drug candidates through development for a host ofdevastating neurodegenerative and oncologic diseases with important unmetmedical needs," he says. "Furthermore, we are delighted to contribute to boostAptuit's Verona operations, thus preserving and further increasing research anddevelopment activities, as well as jobs in the pharmaceutical and biotechnologysector, in Italy."

According to Gaviraghi, several factors motivated theformation of the partnership. He says Siena Biotech's business model "activelycapitalizes on partnering and forging R&D agreements in neurodegenerativeand proliferative disorders, with risk/reward sharing models such as thislatest partnership with Aptuit, and is demonstrative of a larger industry trendto streamline R&D and to bring much-needed medicines to patients moreefficiently through strategic collaborations."

"Siena Biotech's decision to make Aptuit a provider ofchoice is based on Aptuit's scientific expertise, capabilities—particularlythose gained through the recent acquisition of the Verona Medicines ResearchCentre—and reputation as a leading strategic outsourcing partner, as well asthe company's own history working with Aptuit," adds Gaviraghi.

As a provider of choice for Siena Biotech, Aptuit will playa key role in collaborating with the company on R&D efforts to advance itspromising pipeline candidates. The companies are actively engaged and areworking together to develop strategic plans and establish timelines around thework.

"Aptuit has served as a partner to Siena Biotech on severalprojects to date, including analytical support around a currently ongoing +100kg GMP campaign," says Gaviraghi. "Aptuit has also conducted clinical trial support work through itsclinical operations business for Siena Biotech."

Moreover, he points out that the partnership won't bestarting from scratch when it comes to developing novel drug candidates.

"Siena Biotech has a variety of promising drug candidatesfor orphan and neurological diseases that it is advancing," says Gaviraghi."Currently, SEN0014196, a SirT1 inhibitor, is in Phase I clinical trials forthe treatment of Huntington's Disease. SEN0014196 was granted orphan drugdesignations from both the FDA and EMEA."

Tyson notes the strategic relationship does not mark achange in the type of work or manner in which Aptuit engages with its clients,"as our integrated offering has always centered on adding value to clients'R&D programs through top quality, strategic service and projectmanagement."

"Rather, the nature of this collaboration marks a change inhow pharma and biotech companies are viewing outsourcing partners such asAptuit as key contributors to their R&D programs, and a shift in themindset around the way in which drug development is conducted to maximizeresources, capacity and expertise," he says. "The partnership is also centeredon collaboration across projects and on an ongoing or repeat basis, basedAptuit's exceptional capabilities, expertise and reputation both in theindustry and in working with Siena Biotech."

Tyson explains that strategic, collaborativepharma/outsourcing partner relationships are part of a larger trend in theindustry in the effort to move toward more productive, sustainable R&Doperations, and he says Aptuit is positioned to partner with pharma and biotechcompanies across all aspects of R&D from discovery and lead optimizationthrough to commercialization.

"As an integrated development organization, Aptuit has thescientific and drug development expertise, capabilities and technologies inplace across the drug development continuum and its 19 global locations toeffectively engage in strategic partnerships and risk-sharing relationshipswith pharma companies that will ultimately result in bringing much-neededmedicines from the bench to patients as efficiently as possible," he says.