Protein Production Services (PPS) is one of the 19 Israeli Life Science companies that won a place in the Israeli national pavilion at the BIO Convention, Chicago May 3-6, 2010.
PPS was selected to participate in the EU 7th Framework Program (FP7) for Research & Technological Development. The company is now part of a Stem Cell Consortium titled "Cardio Repair European Multidisciplinary Initiative", which has begun operation on March 1. The company will be in charge of development and production of two growth factors – IGF-1 and HGF – including GMP production for clinical trials.
Established in 2005, PPS is an Israeli CRO/CMO for process development, production and purification of recombinant proteins. This makes PPS a unique company in Israel.
Protein production Services (PPS) was founded in January 2005 by Mr. Meir Azulay (CEO), a former employee in a key position at InterPharm (Serono). "A strong expertise in the field of biological development and manufacturing was acquired by the employees of InterPharm, many of which were hired by PPS", Elisheva Yonish-Rouach, Ph.D., PPS Chief Operating Officer, tells ILSI. "Thus, PPS personnel have a combined experience of many years in recombinant protein process development and production, analytical testing development, commercial manufacturing and registration of products in FDA and EMEA".
PPS is a service provider (CRO/CMO) for protein production, and most of its projects involve biopharmaceutical drug candidates. The services include process development from cloning to production and purification of material for pre-clinical and clinical studies (Phase I/II), as well as analytical methods development to support product development and release.
Yonish-Rouach says the customers of PPS are start-ups and established biotech and biopharma companies, from Israel and abroad. "PPS is currently the only CRO/CMO in Israel that provides all the range from cloning to cGMP manufacturing for the biotech industry". PPS is also developing its own platform of products, which are mainly Biosimilars and 'Biosimilars Plus”. These products are in different development stages, and are developed in collaboration with other companies that provide complementary resources and/or proprietary technologies. The company's development is partially financed by grants from different sources- OCS, European and bi-national funds.
Q: PPS is active in the biological manufacturing market where Israeli presence is rare. How would you describe this market from a global point of view?
Yonish-Rouach : "The global situation for CRO/CMOs is complex. Until mid 2008, the market growth was 15% annually, as large investments were made in start-up biotech companies. Furthermore, many large companies outsourced significant part of their development in order to fill their pipeline rapidly.
“The economic crisis started to impact leading international companies in mid 2008. Many orders by start-up companies, mainly for pre-clinical and early clinical development, were put on hold or cancelled; some projects were abandoned because clients could not commit to payments. And large companies preferred to acquire CMOs and turn them to into R&D arms (Avecia acquired by Merck; Cobra by Recipharm).
"The only untouched segment was the commercial manufacturing, where contracts are of long-term nature and the demand for these products has not decrease (Lonza Bioscience).
"Companies had to re-organize and adjust costs (i.e reduce manpower and close lines), or even shut facilities (Charles River’s facility in Shrewsbury, Massachusetts). As a consequence and in response, companies reduced their prices significantly and were willing to negotiate every deal.
"At present, the feeling is that the market will return to rapid growth soon, and the companies that survive the crisis will benefit from larger demand and higher fees.
Q: What are PPS’ plans and intentions based on your analysis of the global market situation?
- Focus on the Israeli market, where the added value is maximal;
- Build a commercial manufacturing plant for PPS and client’ products; a multi-purpose facility designed to produce kilogram quantities of API or Final product for Phase III clinical trials and commercial sales.
- Strengthen the development of own portfolio products.
Q: What is the company's situation in terms of cash flow? Do you have any plans for fund raising in the near future?
"PPS is a private company, fully owned by its employees, and is currently not seeking investment. The company operates with cash-flow it generates from its services. However, different type of financing model will be required for the manufacturing plant, and investment, partnerships or IPO will be considered. In any case, the business concept of PPS is to maintain the manufacturing rights, and sub-license the distribution rights only. Using this approach, which is the unlike the 'exit orientation' should allow the company a sustainable income that may further increase as the market returns to growth".
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