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Swiss companies aiming for peptide pinnacle
STANS, SwitzerlandóResearch company mondoBIOTECH, which reviews and develops already known peptides and other naturally occurring immunomodulating substances with an eye toward out-licensing candidates, announced in late September a long-term deal with Bubendorf, Switzerland-based Bachem AG for cooperation on the development of peptides for the treatment of rare and neglected diseasesówhich is the focus of mondoBIOTECH's work.
"The agreed cooperation is another step in our longstanding successful collaboration with mondoBIOTECH and offers Bachem additional market potential," says Walter Isler, head of marketing and sales at Bachem, who cites a long-standing history of cooperation between the two companies in the fight against rare diseases. "On the basis of this agreement, Bachem gets access to a multitude of peptide projects and thereby also further broadens its competency in the manufacturing of sterile finished products."
Bachem will provide what Isler calls "its comprehensive know-how on peptides and its longstanding experience in the manufacture of peptides and finished pharmaceutical products" and receive unlimited access to the "comprehensive and further increasing number of development projects of mondoBIOTECH for the treatment of rare diseases."
Under the terms of the deal, Bachem will be in charge of providing peptide-based active ingredients required by mondoBIOTECH, sterile finished products to be used in clinical trials and appropriate regulatory documents. Bachem would also produce developmental orphan drugs for mondoBIOTECH, 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 they pose heavy burdens for patients and their families. Although these diseases are rare in terms of causing a specific clinical syndrome in fewer than one out of every 2,000 people, Cavalli points out that collectively, such diseases affect between 27 million and 36 million people in the European Union alone, and that makes their impact far from "rare."Cavalli sees the 300 current compounds at his company as having the potential to treat as many as 600 rare diseases.
As both Isler and Cavalli note, the companies have a significant history together. Notably, they signed a deal in summer 2004 for production and supply of mondoBIOTECH's lead compound Aviptadil, which had received orphan drug designation for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension by the European Agency for the Evaluation of Medicinal Products.
In spring 2005, the companies signed a collaboration agreement for the development and production of Thymopentin, which was then entering Phase I clinical trials in the treatment of severe pulmonary diseases.
And in spring 2006, they entered into a far broader agreement under which Bachem granted mondoBIOTECH exclusive general access to its peptide library for screening and selecting suitable compounds for the development of new medications. In return, Bachem gained the right to produce any peptides selected as potential drug candidates for development and, if approved as pharmaceuticals, to provide the active pharmaceutical ingredients for 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 much look forward to the opportunity of jointly manufacturing products 'made in Switzerland' with Bachem, the world leader in peptides," Cavalli says.
The deal between mondoBIOTECH and Bachem dovetails off other important deals recently for the two companies, with mondoBIOTECH having partnered with personal genetics company 23andMe in January to advance research into rare diseases, and Bachem in March securing a long-term supply deal to continue providing triptorelin pamoate, the active ingredient for fellow Swiss company Debiopharm's increasingly successful drug Decapeptyl, marketed worldwide for treating advanced prostate cancer,
endometriosis, precocious puberty and uterine fibroidsóas well as for use in in vitro fertilization programs.
To date, mondoBIOTECH now has two compounds in Phase III trials, three in Phase II, 18 more in preclinical and nearly 300 product candidates for undisclosed targets for which the company has secured patents.