Swiss companies aiming for peptide pinnacle

STANS, Switzerland—Research company mondoBIOTECH, whichreviews and develops already known peptides and other naturally occurringimmunomodulating substances with an eye toward out-licensing candidates,announced in late September a long-term deal with Bubendorf, Switzerland-basedBachem AG for cooperation on the development of peptides for the treatment ofrare and neglected diseases—which is the focus of mondoBIOTECH's work.

"The agreed cooperation is another step in our longstandingsuccessful collaboration with mondoBIOTECH and offers Bachem additional marketpotential," says Walter Isler, head of marketing and sales at Bachem, who citesa long-standing history of cooperation between the two companies in the fightagainst rare diseases. "On the basis of this agreement, Bachem gets access to amultitude of peptide projects and thereby also further broadens its competencyin the manufacturing of sterile finished products."

Bachem will provide what Isler calls "its comprehensiveknow-how on peptides and its longstanding experience in the manufacture ofpeptides and finished pharmaceutical products" and receive unlimited access tothe "comprehensive and further increasing number of development projects ofmondoBIOTECH for the treatment of rare diseases."

Under the terms of the deal, Bachem will be in charge ofproviding peptide-based active ingredients required by mondoBIOTECH, sterilefinished products to be used in clinical trials and appropriate regulatorydocuments. Bachem would also produce developmental orphan drugs formondoBIOTECH, once those drugs are approved.

Currently, some 7,000 rare diseases are known to exist,notes Fabio Cavalli, CEO and chief business architect of mondoBIOTECH, and theypose heavy burdens for patients and their families. Although these diseases arerare in terms of causing a specific clinical syndrome in fewer than one out ofevery 2,000 people, Cavalli points out that collectively, such diseases affectbetween 27 million and 36 million people in the European Union alone, and thatmakes their impact far from "rare."Cavalli sees the 300 current compounds athis company as having the potential to treat as many as 600 rare diseases.

As both Isler and Cavalli note, the companies have asignificant history together. Notably, they signed a deal in summer 2004 forproduction and supply of mondoBIOTECH's lead compound Aviptadil, which hadreceived orphan drug designation for the treatment of pulmonary arterialhypertension and chronic thromboembolic pulmonary hypertension by the EuropeanAgency for the Evaluation of Medicinal Products.

In spring 2005, the companies signed a collaborationagreement for the development and production of Thymopentin, which was thenentering Phase I clinical trials in the treatment of severe pulmonary diseases.

And in spring 2006, they entered into a far broaderagreement under which Bachem granted mondoBIOTECH exclusive general access toits peptide library for screening and selecting suitable compounds for thedevelopment of new medications. In return, Bachem gained the right to produceany peptides selected as potential drug candidates for development and, ifapproved as pharmaceuticals, to provide the active pharmaceutical ingredientsfor those drugs.

Based in particular on that 2006 deal, and this 2009 deal,Cavalli describes the relationship between the companies as "excellent" and"long-term oriented."

"As a global company located in Switzerland, we very muchlook forward to the opportunity of jointly manufacturing products 'made inSwitzerland' with Bachem, the world leader in peptides," Cavalli says.

The deal between mondoBIOTECH and Bachem dovetails off otherimportant deals recently for the two companies, with mondoBIOTECH havingpartnered with personal genetics company 23andMe in January to advance researchinto rare diseases, and Bachem in March securing a long-term supply deal to continueproviding triptorelin pamoate, the active ingredient for fellow Swiss companyDebiopharm's increasingly successful drug Decapeptyl, marketed worldwide fortreating advanced prostate cancer,

endometriosis, precocious puberty and uterine fibroids—as wellas for use in in vitro fertilizationprograms.

To date, mondoBIOTECH now has two compounds in Phase IIItrials, three in Phase II, 18 more in preclinical and nearly 300 productcandidates for undisclosed targets for which the company has secured patents.