ALEXANDRIA, VA -- (Marketwired) -- 06/24/14 -- Shifting and compacting markets, disappearing branded drug queues, and economic pressures mean generic companies must seek new avenues to augment slowing revenue streams. Some generic manufacturers are redefining strategies, expanding their mix of products to include other types of pharmaceuticals, such as specialty drugs, through acquisitions and partnerships. At the 7th Product & Pipeline Enhancement for Generics Conference, Richard will delve into the various qualities one should look for in a solid business partner. Richard gives pre-conference insights into his session and how to leverage partnerships to enhance portfolio offerings in a highly-competitive market:
How could cultivating quality business partnerships add value to an organization's portfolio and why do you think this is this relevant for companies right now?
Partnerships make every task easier. Each party has a list of tasks to execute, provided both parties are in agreement. The result is increased value to the generic portfolio, with a "go to" partner for future products. However, partnerships can be challenged by unexpected events, and this is why partnerships are relevant for generic companies right now. In October 2013, FDA's Office of Generic Drugs (OGD) changed its operational model as a result of GDUFA. There is no communication on a submitted ANDA until OGD issues a complete response letter, a tentative approval or a final approval. It is important to involve the partnership in creation of the ANDA's documentation, and avoid a "refuse to receive" letter upon submission, or a very difficult-to-correct Complete Response Letter.
What are the must-have qualities of a business partner?
Are there any best practices when drafting a contract between an organization and its business partner?
Licensees of generics prefer to pay milestones later rather than up front. We have found it mutually agreeable to pay an extra milestone on the back end by specifying the last milestone is due 90 days after launch.
How would you see this interest in developing partnerships impacting or shaping how generics companies might do business in the future?
Partnerships are absolutely necessary to cope with the new OGD, so it is here to stay.
About Richard DiCicco
Chairman, Harvest Moon Pharmaceuticals.
Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of products developed since 1984. Harvest Moon Pharma develops, manufactures, markets and exports worldwide, complex generic drug products and biosimilars. Small molecule generics include a complete line of transplant drug products; complex hospital injectables such as enoxaparin, glatiramer, octreotide LAR, risperidone depot, lanreotide depot, paliperidone palmitate depot; complex oral solids such as dronedarone and mesalamines; inhalation and nasal products; and, oral controlled release products such as methylphenidate and nifedipine XL.
Biosimilar products include adalimumab, rituximab and trastuzumab entering phase I clinical trials in Europe. These mAbs are manufactured in the USA and comply with the EMA mAb revised guidelines. There are 15 additional biosimilar mAbs and two fusion proteins which will be registered by 2017 in various countries.
Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines, a member of the Licensing Executives Society, speaks often and is widely published in generics and biosimilars.
About marcus evans
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